chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Shingrix (batch number M77B4, expiry date August 2019) for prophylaxis. On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 8th August 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th August 2018, the patient experienced tingling and numbness. On 11th August 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, tingling and numbness to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right deltoid. Two days, after receiving Shingrix, the patient had developed numbness and tingling that was progressed from her midsection down to her toes. The patient had an appointment with her physician on Friday and all of her reflexes were fine. The patient called back and provided lot number and expiration date. The patient also called her previous physician and he told her that numbness and tingling were the top 5 side effects for Shingrix and that he was aware of 3 nurses that had the same side effect. This case was 1 of the cases, reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Nerve compression, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Shingrix (batch number M77B4, expiry date August 2019) for prophylaxis. On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 8th August 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th August 2018, the patient experienced tingling and numbness. On 11th August 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the tingling and numbness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, tingling and numbness to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right deltoid. Two days, after receiving Shingrix, the patient had developed numbness and tingling that was progressed from her midsection down to her toes. The patient had an appointment with her physician on Friday and all of her reflexes were fine. The patient called back and provided lot number and expiration date. The patient also called her previous physician and he told her that numbness and tingling were the top 5 side effects for Shingrix and that he was aware of 3 nurses that had the same side effect. This case was 1 of the cases, reported by same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: A day and a half after receiving the vaccine, my left flank became numb and tingling. From my belly button around to my back. A day later, the numbness and tingling traveled down my left thigh and my left shin. Two days later, it traveled to my left toes (only the big toe and the first toe). A day later it progressed to all of the toes on my left foot. It comes in waves with my left foot being totally numb, then just tingling, and then my arch becomes numb. The numbness has not left any affected area or become better. My lips are tingling today 8/29/2018, which seems to be a new symptom.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Nerve compression, Paraesthesia, Paraesthesia oral
Clinical narrative: A day and a half after receiving the vaccine, my left flank became numb and tingling. From my belly button around to my back. A day later, the numbness and tingling traveled down my left thigh and my left shin. Two days later, it traveled to my left toes (only the big toe and the first toe). A day later it progressed to all of the toes on my left foot. It comes in waves with my left foot being totally numb, then just tingling, and then my arch becomes numb. The numbness has not left any affected area or become better. My lips are tingling today 8/29/2018, which seems to be a new symptom.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Headache, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving Shingrix, the patient experienced fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain. On an unknown date, the outcome of the fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain were recovered/resolved. It was unknown if the reporter considered the fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported that, she experienced fever (the patient's body temperature was recorded as 101.4 degree F) and pulse went as high as 119 beats per minute. The patient planned to continue follow-up with her pharmacist on an unknown date.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving Shingrix, the patient experienced fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain. On an unknown date, the outcome of the fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain were recovered/resolved. It was unknown if the reporter considered the fever, pulse rapid, headache, dizziness, nausea, stomach pain and chest pain to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported that, she experienced fever (the patient's body temperature was recorded as 101.4 degree F) and pulse went as high as 119 beats per minute. The patient planned to continue follow-up with her pharmacist on an unknown date.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had to start a course of VALTREX 10 days after a dose of SHINGRIX because the patient developed shingles.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site erythema, Injection site hypoaesthesia, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 60-year-old female patient who received Shingrix (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd May 2018, less than a day after receiving Shingrix, the patient experienced pain, spaced out, erythropapular rash, rash hemorrhagic and insomnia. On 4th May 2018, the patient experienced injection site numbness and injected limb mobility decreased. In May 2018, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the pain, injection site erythema, spaced out, erythropapular rash, rash hemorrhagic, injection site numbness, injection site warmth, insomnia and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain, injection site erythema, spaced out, erythropapular rash, rash hemorrhagic, injection site numbness, injection site warmth, insomnia and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The medical assistant stated that the patient had a reaction to the shot of the Shingrix. The patient mentioned at bedtime she was in pain and could not sleep, she did not mention where the pain exactly was. The patient also noticed tiny red bumps on her left foot which was sore and occasionally bleeding. The patient felt spaced out throughout the day of vaccination. Next morning (on 4th May 2018), the patient felt numbness in her arm at the injection site, and she could not lift her arm. On third day, after vaccination the patient's injection site was red and hot to touch. The patient stated it lasted for a few days and she recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Purpura, Rash papular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 60-year-old female patient who received Shingrix (batch number 3S354, expiry date 4th July 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd May 2018, less than a day after receiving Shingrix, the patient experienced pain, spaced out, erythropapular rash, rash hemorrhagic and insomnia. On 4th May 2018, the patient experienced injection site numbness and injected limb mobility decreased. In May 2018, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the pain, injection site erythema, spaced out, erythropapular rash, rash hemorrhagic, injection site numbness, injection site warmth, insomnia and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain, injection site erythema, spaced out, erythropapular rash, rash hemorrhagic, injection site numbness, injection site warmth, insomnia and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The medical assistant stated that the patient had a reaction to the shot of the Shingrix. The patient mentioned at bedtime she was in pain and could not sleep, she did not mention where the pain exactly was. The patient also noticed tiny red bumps on her left foot which was sore and occasionally bleeding. The patient felt spaced out throughout the day of vaccination. Next morning (on 4th May 2018), the patient felt numbness in her arm at the injection site, and she could not lift her arm. On third day, after vaccination the patient's injection site was red and hot to touch. The patient stated it lasted for a few days and she recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Dizziness, Fatigue, Feeling cold, Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cognitive impairment in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting. On an unknown date, the outcome of the cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting were not recovered/not resolved. It was unknown if the reporter considered the cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient inquired how long did the side effects last with Shingrix. The patient was feeling hot, cold, nausea, headache, tired, lightheadedness and vomiting since past two days of getting the Shingrix vaccine. The patient was given medical disclaimer and was provided information from content in regards to how long the side effects lasted. The patient was angry and did not want to provide any information and disconnected the call before any questions from the template could be asked.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cognitive impairment in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting. On an unknown date, the outcome of the cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting were not recovered/not resolved. It was unknown if the reporter considered the cognitive impairment, feeling hot, nausea, headache, tiredness, light headedness, feeling cold and vomiting to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient inquired how long did the side effects last with Shingrix. The patient was feeling hot, cold, nausea, headache, tired, lightheadedness and vomiting since past two days of getting the Shingrix vaccine. The patient was given medical disclaimer and was provided information from content in regards to how long the side effects lasted. The patient was angry and did not want to provide any information and disconnected the call before any questions from the template could be asked.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear discomfort
Clinical narrative: My annual physical exam was on 5-7-18. Excellent and all blood work, etc. came back stable. Just as I was leaving the room, Dr. suggested I get this SHINGRIX shot. He is a firm believer in preventative procedure. I got the first shot on 6-8-18. I noticed my left ear felt plugged-thought it was earwax. It was a slow, gradual feeling much like swimmer's ear. After cleaning the ear for normal wax a hearing test determined the left ear had significant hearing loss.  would like to know if you have received other people notifying your office about this vaccination. I am scared to go bac for the second shot of this SHINGRIX 2 step process. This problem with my left ear is so much worse. Right now my right ear is far better than my left ear. I (since this happened to me) have heard of 2 other people who had Adverse affect - I only wish I would have hear about the problem before I got the SHINGRIX 1 shot. Was this vaccine fully tested on a large group of people before being put out to the public.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of increased blood pressure in a female patient who received Shingrix for prophylaxis. Co-suspect products included Aubagio for drug use for unknown indication. On an unknown date, the patient received Shingrix. In February 2018, the patient started Aubagio at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix, the patient experienced increased blood pressure. The action taken with Aubagio was unknown (Dechallenge was unknown). Rechallenge with Aubagio was unknown. On an unknown date, the outcome of the increased blood pressure was unknown. It was unknown if the reporter considered the increased blood pressure to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. On 8th June 2018, the patient began experiencing forgetting that she should not have live vaccinations while taking Aubagio, and took 1 injection of the shingles vaccine Shingrix. Since starting February 2018, the Aubagio in patient began experiening, her blood pressure being elevated.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy rash in a 75-year-old male patient who received Shingrix for prophylaxis. On 30th July 2018, the patient received the 1st dose of Shingrix. On 31st July 2018, 1 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with nystatin and Clobetaso). On an unknown date, the outcome of the itchy rash was not recovered/not resolved. The reporter considered the itchy rash to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix at a local pharmacy and on the next day the patient developed a rash around neck, forehead and both hands. As per reporter no other vaccine was administered on the same day. The reporter said the patient still has the rash and it has been three weeks since the vaccine was administered. The patient and reporter believed the adverse reaction was related to the vaccine. The patient visited his doctor's office and concerned about this reaction. On 16th August 2018, the nurse spoke to reporter and she provided some additional details regarding this adverse event report. The patient was seen in the physician's office on 13th August 2018 when he reported that 3 weeks earlier he received Shingrix at a local pharmacy. The day after receiving Shingrix, the patient experienced a rash that was itchy but with no drainage. The patient had been applying Nystatin cream to the rash, but this did not help. The doctor prescribed Clobetasol when he was seen on 13th August 2018. However, patient has not returned to the office for follow up. The reporter agreed again that she would be open to follow up from safety.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 67-year-old female patient who received Boostrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. On 15th June 2018, the patient received Boostrix. On 2nd August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Boostrix and less than a month after receiving Shingrix, the patient experienced shoulder pain, stiff neck, headache and pain in joint involving hand. The patient was treated with Aspirin and Aleve. On an unknown date, the outcome of the shoulder pain, stiff neck, headache and pain in joint involving hand were unknown. It was unknown if the reporter considered the shoulder pain, stiff neck, headache and pain in joint involving hand to be related to Boostrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 66 or 67 years. The patient 67 years old at the time of reporting. The patient was healthy who played doubles tennis 3 times per week. The patient never had tetanus or shingles. Sometime after 15th June 2018, the patient experienced pain in both shoulders, stiff neck, headache like feeling and joint pain especially in left hand (the patient was right handed). The patient received 2 Aspirin or 1 Aleve to keep the pain at bay, but she woke up every morning with a lot of pain in my shoulders among other quirky pains. The patient had to stop playing tennis. The patient wanted to find out whether the reaction was to 1 or both vaccines and the cure.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Petechiae
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Shingrix for prophylaxis. On 19th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 20th August 2018, the patient experienced petechial rash. On an unknown date, the outcome of the injection site swelling, injection site erythema and petechial rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and petechial rash to be related to Shingrix. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No effects, the patient experienced other than mild swelling and faint redness at injection site. The day of reporting, the patient developed a petechial rash on the injection arm, that began at the level of the injection site and on the day of reporting (throughout the day) had spread to patients forearm. There were no other side effects. The patient asked did this require treatment.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Burning sensation, Erythema, Paraesthesia, Urticaria
Clinical narrative: Reports burning and tingling to left upper extremity, neck and face. Visible raised red welts noted to left side of neck. Denies shortness of breath. Mother reports family history of anaphylactic shock. Mother returned with patient 15-20 minutes after injection reporting these symptoms.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction
Clinical narrative: Patient developed local red reaction on day of vaccination about the size of a half-dollar. The pharmacist recommended to pay close attention to local reaction and come back if it enlarges. Patient came back in today with redness on inner bicep area covering most of inner, upper arm. No troubled breathing but recommending she go to the doctor office to get it checked.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Hives from one shoulder to the other, down center of back, behind each ear, two on left side of face and several in scalp. 3" in diameter, raised, smooth, 1/4" red circumference. Itching. Dizziness. Continued until 25 mg BENADRYL taken at 17:05, second dose of 25 mg at 21:00. Next day, mild itching at just a few sites.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Facial pain, Facial paralysis, Interferon gamma release assay, Malaise
Clinical narrative: The patient had general malaise since receiving immunization on 8/14/18. On 8/26/18 developed right side facial pain. Over last 2 days developed facial droop of right lower face. Seen in clinic today an diagnosed with Bell's Palsy.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Patient jumped during injection and had an immediate local reaction of redness with an induration. Dr. notified immediately and patient was given Benadryl. About 10minutes prior to giving vaccine patient was given Mortin, due to her history of having frebrile seizures.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient reported a non-painful rash that lasted 4-5 weeks after the injection with a raised/slightly swollen area where the shot was given. Patient reported that the swollen area resembled a bug bite.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient is having some redness, hardness and mild pain at injection site.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Blood urine absent, Breech presentation, Chromaturia, Exposure during pregnancy
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal death, Foetal heart rate abnormal, Foetal hypokinesia, Glucose tolerance test normal, Glucose urine absent
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: HIV test negative, Haematocrit decreased, Haemoglobin normal, Mean cell volume normal, Nitrite urine absent
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet count normal, Protein urine absent, Protein urine present, Red blood cell count decreased, Specific gravity urine normal
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Treponema test negative, Ultrasound antenatal screen abnormal, Urine analysis, Urine bilirubin decreased, Urine ketone body absent
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Urobilinogen urine increased, Vomiting, White blood cell count increased, White blood cells urine negative, pH urine normal
Clinical narrative: Prenatal patient (G3P2) with EDD 11/3/18 given Tdap at 28 5/7 weeks gestation on 8/16/18. The patient returned to urgent care on 8/27/18, reporting not feeling fetal movement in over 48hrs. In urgent care, unable to find fetal heart tones with a doppler & no heartbeat seen on bedside ultrasound. Patient was transferred to the hospital (Medical Center) for probable fetal demise, confirmation and induction.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Fever (101.4), erythema, soreness.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt's mom states the day after receiving the shots (8/24/18) she noticed a little redness and slight warmth on his Left arm. The next day (8/25/18) the redness was increased a lot and the area was quite warm and swollen. The swelling extended to his wrist. She took him to the ER and he was prescribed Amoxicillin. She states today (8/29/18) she can barely see the redness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug eruption
Clinical narrative: Drug-type rash primarily on the torso with some extending to the upper arms, thighs and neck.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: PT HAD A INJECTION SITE REACTION TO PNEUMOVAX 23  WITH RED RASH, SWELLING AND FEVER OF 101.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Swelling
Clinical narrative: Big bump, itchy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: HIGH FEVER, UNCONTROLLED SHAKING, DIZZINESS, SHORTNESS OF BREATH WITHIN AN HOUR OF IMMUNIZATION. FATIGUE AND EXTREME WEAKNESS IN RIGHT ARM X 3 DAYS. RASH BILATERAL LOWER EXTREMITIES (2 DAYS LATER AND CONTINUED FOR APPROXIMATELY 3 DAYS.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Tremor
Clinical narrative: HIGH FEVER, UNCONTROLLED SHAKING, DIZZINESS, SHORTNESS OF BREATH WITHIN AN HOUR OF IMMUNIZATION. FATIGUE AND EXTREME WEAKNESS IN RIGHT ARM X 3 DAYS. RASH BILATERAL LOWER EXTREMITIES (2 DAYS LATER AND CONTINUED FOR APPROXIMATELY 3 DAYS.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Injected limb mobility decreased, Injection site bruising, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's right arm is swollen and warm to the touch. The injection site has a small bruise the size of a pea. Pt cannot raise or extend arm and is experiencing pain. Pt is applying cool compress and taking ibuprofen over the counter to help relieve the pain and inflammation/swelling.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: Patient's right arm is swollen and warm to the touch. The injection site has a small bruise the size of a pea. Pt cannot raise or extend arm and is experiencing pain. Pt is applying cool compress and taking ibuprofen over the counter to help relieve the pain and inflammation/swelling.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin tightness, Skin warm
Clinical narrative: Per client's mom, his entire arm was swollen, hot and red. The skin was tight, but no wounds. She took him to his PCP Dr on 8.22.18, were she prescribed antibiotics. Mom stated that the swelling continued for 2 more days and spread to chest and back of shoulder blade. Client had low grade temp of 99.2. Symptoms resolved by 8.24.18.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: Per client's mom, his entire arm was swollen, hot and red. The skin was tight, but no wounds. She took him to his PCP Dr on 8.22.18, were she prescribed antibiotics. Mom stated that the swelling continued for 2 more days and spread to chest and back of shoulder blade. Client had low grade temp of 99.2. Symptoms resolved by 8.24.18.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Nausea, Pallor, Presyncope
Clinical narrative: Near syncope episode (pale, diaphoretic, nauseous) 8 minutes after the injection.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site reaction, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Severe weakness in upper left arm. Cannot lift arm above head. Weak, limited use pain is also in armpit and pec. Completely NOT normal for me...I understand a swollen injection site but this is not the case.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 5 minutes after administration of vaccine, patient was found to have 1 solitary hive below site of MMR vaccine. Hive about 3x3cm with central area of 1x1cm. No other systemic symptoms.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Pt states area turned red right away, redness continue to get larger, now has hives on other side of arm as well as neck and face.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Approximately 2 hours after the dose the area became red and raised. By morning there were weeping blisters ranging from a few mm to 3/4 inch radius.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Approximately 2 hours after the dose the area became red and raised. By morning there were weeping blisters ranging from a few mm to 3/4 inch radius.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dysphonia, Fatigue
Clinical narrative: Pain at injection site. Headache (up to 101.8 by 08/25/2018 08:00A). Rash on chest under breasts and back (08/25/2018 through 08/27/2018). Uncontrollable shivering (08/24/2018 11:00P through 08/25/2018 05:00A). Muscle and joint aches (08/24/2018 08:00P through 08/27/2018). Nausea/upset stomach (08/24/2018 through 08/27/2018). Vomiting (08/25/2018 07:00A). General fatigue (08/24/2018 07:00P through 08/27/2018). Vocal hoarseness (08/24/2018 through 08/2/2018).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Rash
Clinical narrative: Pain at injection site. Headache (up to 101.8 by 08/25/2018 08:00A). Rash on chest under breasts and back (08/25/2018 through 08/27/2018). Uncontrollable shivering (08/24/2018 11:00P through 08/25/2018 05:00A). Muscle and joint aches (08/24/2018 08:00P through 08/27/2018). Nausea/upset stomach (08/24/2018 through 08/27/2018). Vomiting (08/25/2018 07:00A). General fatigue (08/24/2018 07:00P through 08/27/2018). Vocal hoarseness (08/24/2018 through 08/2/2018).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pain at injection site. Headache (up to 101.8 by 08/25/2018 08:00A). Rash on chest under breasts and back (08/25/2018 through 08/27/2018). Uncontrollable shivering (08/24/2018 11:00P through 08/25/2018 05:00A). Muscle and joint aches (08/24/2018 08:00P through 08/27/2018). Nausea/upset stomach (08/24/2018 through 08/27/2018). Vomiting (08/25/2018 07:00A). General fatigue (08/24/2018 07:00P through 08/27/2018). Vocal hoarseness (08/24/2018 through 08/2/2018).
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Rash erythematous
Clinical narrative: Pt stated she had red spots develop on Rt leg and below knee and on both feet. She states these look like blood spots which were large. No reaction at vaccine administration site. She did not seek medical care because she was between insurers. She had moved. Spots went away in 4-5 days. These areas were itchy per her report. No fever. No associated DIB or SOB. No oral or facial swelling reported by client. No HA or neck pain. Pt. states she has been feeling well. Expressed  to client the importance of seeking medical care with complications following a vaccine. Client verbalized understanding. Advised not to take Meningitis vaccine in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-APR-2012, the patient was inoculated at a medical center/hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or (as reported) 28-JUL-2016, the patient was treated by a physician/MD at a medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster dermatitis of the eyelid. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Severe herpes zoster dermatitis of the eyelid was determined to be a medically significant event. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: PAIN/SORENESS/REDNESS IN AREA WHERE THE PATIENT RECEIVED THE VACCINE, SO HE WENT TO SEE HIS DOCTOR AND WAS GIVEN ANTIBIOTIC. AS OF TODAY, PATIENT REPORTED THAT HIS ARM IS STILL IN PAIN/REDNESS, BUT IT'S GETTING BETTER.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Fine pink/erythematous popular rash on left arm and chest; itchy.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult Hep B dose.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: C-reactive protein, Decreased appetite, Erythema, Fatigue, Full blood count
Clinical narrative: Mom woke up him up for school at 6am and noted that his legs looked "red and patchy", she looked further and found rash on his arms and left side of his face. Left side of face was swollen.  Right knee and thigh notable swollen with "pitting edema". Mom has a picture on her phone. He feels like he slept well and wasn't itching. He denies that his throat felt swollen, fuzzy, or having trouble breathing. He does say that he felt itchy and tired. Mom gave BENADRYL at 7:30am. He doesn't feel tired. Feels itchy. Appetite decreasd. No headache.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Joint swelling, Metabolic function test, Oedema, Peripheral swelling, Pruritus
Clinical narrative: Mom woke up him up for school at 6am and noted that his legs looked "red and patchy", she looked further and found rash on his arms and left side of his face. Left side of face was swollen.  Right knee and thigh notable swollen with "pitting edema". Mom has a picture on her phone. He feels like he slept well and wasn't itching. He denies that his throat felt swollen, fuzzy, or having trouble breathing. He does say that he felt itchy and tired. Mom gave BENADRYL at 7:30am. He doesn't feel tired. Feels itchy. Appetite decreasd. No headache.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash, Swelling face, Urine analysis
Clinical narrative: Mom woke up him up for school at 6am and noted that his legs looked "red and patchy", she looked further and found rash on his arms and left side of his face. Left side of face was swollen.  Right knee and thigh notable swollen with "pitting edema". Mom has a picture on her phone. He feels like he slept well and wasn't itching. He denies that his throat felt swollen, fuzzy, or having trouble breathing. He does say that he felt itchy and tired. Mom gave BENADRYL at 7:30am. He doesn't feel tired. Feels itchy. Appetite decreasd. No headache.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Swelling
Clinical narrative: Swollen, throbbing, sore arm, and chills.
Age: 49.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient under 65 years of age was vacinnated with FLUAD. Pharmacist in haste and without proper knowledge, thought she was vaccinating patient against flu but did not realize she was using an age specific product.
Age: 49.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 years of age was vacinnated with FLUAD. Pharmacist in haste and without proper knowledge, thought she was vaccinating patient against flu but did not realize she was using an age specific product.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Paraesthesia, Rash, Tachycardia
Clinical narrative: Pt reports taking the first dose of VIVOTIF on 8/14/18 @ 1900, then began experiencing rash, tachycardia (HR 135), and tingling fingers on 08/16/18 at 1100. Denies taking any other new medication. He presented to local emergency room where he reports that Benedryl was administered. States that this relieved all symptoms.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient experienced redness, swelling and skin was hot to touch. Extended to elbow and under arm.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: I experienced severe pain and loss of mobility in the injected arm. That evening I had a temp of 99.6 and severe fatigue, the following day (Thur. 8/23/18) I continued to feel ill. Temp still elevated and severe fatigue. I went to bed early that night (6:30 PM) hoping to sleep the reaction away. At 12:30 AM I was awakened by a severe pain in my right hip. I was unable to stand or put any weight on the right leg. I spent Saturday with this severe pain and hobbled around the house using furniture as a crutch. On Sunday the pain relented slightly and I was able to limp around, but still experiencing severe pain in right hip. It has been that way till today, I called the Dr. and went in to see the PA. She sent me for x-ray and it showed no mechanical damage. I was prescribed meloxicam. I have not started this treatment yet. I can only guess, as well as the PA, that this is a severe reaction to this vaccine.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Malaise, Pain in extremity, Weight bearing difficulty, X-ray of pelvis and hip normal
Clinical narrative: I experienced severe pain and loss of mobility in the injected arm. That evening I had a temp of 99.6 and severe fatigue, the following day (Thur. 8/23/18) I continued to feel ill. Temp still elevated and severe fatigue. I went to bed early that night (6:30 PM) hoping to sleep the reaction away. At 12:30 AM I was awakened by a severe pain in my right hip. I was unable to stand or put any weight on the right leg. I spent Saturday with this severe pain and hobbled around the house using furniture as a crutch. On Sunday the pain relented slightly and I was able to limp around, but still experiencing severe pain in right hip. It has been that way till today, I called the Dr. and went in to see the PA. She sent me for x-ray and it showed no mechanical damage. I was prescribed meloxicam. I have not started this treatment yet. I can only guess, as well as the PA, that this is a severe reaction to this vaccine.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT ARRIEVED COMPLAINING OF ITCHING AND PAIN AT INJECTION SITE. THE AREA WAS HOT TO THE TOUCH; RED AND RAISED ABOUT 4" X 2" IN SIZE. THE PATIENT VISITED HER DOCTOR AND WAS PRESCRIBED MOMETASON 0.1%. WHICH CLEARED THE RASH IN 3 DAYS AFTER APPLICATION.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT ARRIEVED COMPLAINING OF ITCHING AND PAIN AT INJECTION SITE. THE AREA WAS HOT TO THE TOUCH; RED AND RAISED ABOUT 4" X 2" IN SIZE. THE PATIENT VISITED HER DOCTOR AND WAS PRESCRIBED MOMETASON 0.1%. WHICH CLEARED THE RASH IN 3 DAYS AFTER APPLICATION.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 50 yo female presents to clinic on August27, 2018 with concern for possible reaction to vaccines. Patient received MMR, varicella, hepatitis B and Td Vaccine on August 20, 2018. Patient reports some warmth and redness on left upper arm but right upper arm was normal. Denies of any fever, increase pain or swelling, weaknesses. Notes: local rxn, non-infected. Ice, NSAID as directed prn. RTC in few days if inc redness, pain o/o proportion. Afebrile, vss. immunizations education material provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: 100 degree fever, widespread severe aches, mild nausea, which resolved within 48 hours. Acetaminophen taken helped. This was  followed the next few days by very sore, swollen, red arm at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 100 degree fever, widespread severe aches, mild nausea, which resolved within 48 hours. Acetaminophen taken helped. This was  followed the next few days by very sore, swollen, red arm at injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient stated that she noticed in the morning of 8/28/18 that her arm was red and swollen. Redness extended length of her bicep. Her arm still looked red and swollen but she stated it was looking much better than the day before. She said it is warm to the touch.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: Patient called us a few days after the vaccine, he hadn't felt well for a few days afterward. He had stomach issues including diarrhea and his arm felt very sore. He couldn't work one day
Age: 58.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Discomfort, Injection site erythema, Nausea, Pyrexia
Clinical narrative: The patient reports the evening of vaccination she had redness around the injection site - the redness spread over the next couple days, and was uncomfortable, also reports fever and nausea. Today, 8/29, some redness remained and went to see her physician at 2:15pm. Patient came here to pharmacy at approximately 6pm this evening to report the incident.
Age: 58.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: The patient reports the evening of vaccination she had redness around the injection site - the redness spread over the next couple days, and was uncomfortable, also reports fever and nausea. Today, 8/29, some redness remained and went to see her physician at 2:15pm. Patient came here to pharmacy at approximately 6pm this evening to report the incident.
Age: 22.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dehydration, Dizziness, Pallor, Peripheral coldness
Clinical narrative: After giving her the vaccines (FLUARIX QUAD and GARDASIL 9), patient told me that she felt dizzy. I noticed that her face looked pale and I felt her hands and that they were cold. I asked the patient to lie down in the chair and elevated her legs. She mentioned that she recalled having "the same reaction" when she was a child but forgot to tell me about it (she checked the "NO" box for that question (#3) in the Informed Consent for Immunization when I reviewed the form with her). She also reported that she was dehydrated before coming to the pharmacy (she teaches volleyball), hence I gave her some food and water to hydrate herself while waiting in the pharmacy waiting room. (Her PCP recommended her to get her GARDASIL injection hence the visit at the pharmacy). I checked on her for 30 minutes until she asked me if she can leave because she felt okay. I took her blood pressure with the machine we have in the room and her BP was 138/66 with pulse rate 75 before leaving. I offered to call somebody for her but she refused. She felt okay and there were no other signs or symptoms noted or reported before leaving the pharmacy. I called the following day to check on her but it led me to a voicemail box so I left her a message to give me call if she has any questions or concerns.