chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Eye swelling, Rash, Scratch
Clinical narrative: Parents stated that at around 6pm on 1/10/2019, they noticed child was crying and left eye was slightly swollen. Assessed by Dr., few scratches on the forehead, and few small rash was noticed on the upper back, not swollen. No nasal flaring or stridor. No respiratory distress. No wheezing. Patient was sent to ER for further observation. ER notes as follows: Physical Exam Constitutional: She appears well-developed and well-nourished. She is active. HENT: Head: Anterior fontanelle is flat. Right Ear: Tympanic membrane normal. Left Ear: Tympanic membrane normal. Nose: Nose normal. Mouth/Throat: Mucous membranes are moist. Oropharynx is clear. NO PERIORAL OR PERIORBITAL EDEMA. Eyes: Conjunctivae are normal. Red reflex is present bilaterally. Pupils are equal, round, and reactive to light. Neck: Normal range of motion. Neck supple. Pulmonary/Chest: Effort normal and breath sounds normal. No nasal flaring or stridor. No respiratory distress. She has no wheezes. She exhibits no retraction. Abdominal: Soft. Bowel sounds are normal. She exhibits no distension. There is no tenderness. There is no rebound and no guarding. Musculoskeletal: Normal range of motion. She exhibits no tenderness. Lymphadenopathy: No occipital adenopathy is present. She has no cervical adenopathy. Neurological: She is alert. She has normal strength and normal reflexes. Suck normal. Skin: Skin is warm and moist. Capillary refill takes less than 3 seconds. Turgor is normal. Rash noted. Erythematous rash almost resolved blotchy to upper back no rash to neck at present. Nursing note and vitals reviewed.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient reported dime-sized circle of warm redness on the left arm at site of injection and a quarter-sized warm redness one-quarter inch below injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Tic
Clinical narrative: Child developed Tic - a Blinking Tic. Tic was very frequent the day after the vaccines, then continued on and off the next several days, especially with fatigue. The Tic subsided about a week after the vaccines. The Tic has never been present before the vaccines.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Nasopharyngitis, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Feeling of warmth, nausea, low grade fever, cold like symptoms (runny nose, sneezing).
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Sneezing
Clinical narrative: Feeling of warmth, nausea, low grade fever, cold like symptoms (runny nose, sneezing).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information was provide regarding the patient's concomitant medications, pertinent medical history, drug reactions and allergies. On 04-JAN-2019, the patient was vaccinated with a dose of PROQUAD, therapy type: recombinant human albumin (rHA), lot # R013126 with the expiration date of 04-NOV-2019 (exact dose and dose number were not reported), via intramuscular route for prophylaxis. The vaccine was reconstituted with sterile diluent (lot# R001254, expiration date 20-SEP-2020). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On 10-JAN-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, route and site of administration were not reported) lot # M025186, expiry date 18-MAY-2018, for prophylaxis. The vaccine was reconstituted with sterile diluent, lot number M034781, expiry date 11-APR-2019. No adverse effects were reported.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX and PNEUMOVAX 23. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, chills, fatigue, general body pain and activities of daily living impaired. On an unknown date, the outcome of the fever, chills, fatigue and general body pain were recovered/resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the fever, chills, fatigue, general body pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient had fever, chills, fatigue and body aches that lasted 4 days and the patient was unable to function. The patient also received PNEUMOVAX-23 on the same day. The reporter provided the consent to follow up. It was unknown if the reporter considered the fever, chills, fatigue, general body pain and activities of daily living impaired to be related to PNEUMOVAX-23 as well.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Injection site swelling, Poor quality sleep
Clinical narrative: Mom came to office on 1-9-19 approx 10:20am without child to state that her daughter is having a reaction to Men B shot. She "can not function today and was awake all night". Offered office visit and declined. Went home to speak further to adult child. Called office back on 1-9-19 at 11:41am to state that child is very fatigued, pain at site. Not red but swollen. No fever. No SOB.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Being an RN, the injection hurt more than it should have. I was concerned it was too high. It did lessen in pain until during the night and I could not hardly move my arm, especially in a raising it straight out to my side. I went back to the pharmacy and showed them how limited my movement was. I read the side effects for both the 13 and 23. The 13 mentions limited arm movement. The 23 made NO mention. So for days I had very limited movement. There were certain movements you should be able to do with your shoulder and I could not without severe sharp pains. It began to get more motion but somethings still hurt. I am still a working RN full time and this is not helping me. Today 3 months later I am having issues with movement and pain.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Abnormal faeces, Diarrhoea
Clinical narrative: Diarrhea. Extremely rancid, thick, pulpy, brownish poop. Abnormal as baby is breastfed and usually has liquidy lighter-colored poop.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. developed shingles infection on forehead and (R) upper eyelid 2 days after SHINGRIX vaccine given.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from medical assistant and refers to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chromaturia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of electric shock sensation in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose of SHINGRIX in November 2018 refer case (US2019GSK001363)). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced electric shock sensation, fever, increased blood pressure, urine discoloration and nausea. On an unknown date, the outcome of the electric shock sensation, fever, increased blood pressure, urine discoloration and nausea were unknown. It was unknown if the reporter considered the electric shock sensation, fever, increased blood pressure, urine discoloration and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The second shot went like this when needle hit muscle felt like electrical jolt and all downhill after got home. Temperature was 100 degree C and blood pressure elevation to 150/90 mmHg and no rapid pulse but kidneys had very dark urine output for 2 days, now okay after 3rd day but still a little nauseous. The patient writing because 1st shot went so well and had no negative effects to prevent for 2nd return. The patient did not go to emergency room because of heartbeat stable but did call doctor, just for information exchange. This case linked with US2019GSK001363, reported by same reporter for the same patient. Lab Comments: Lab test performed on unknown date.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a sore arm that lasted for days.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 72-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash and itchy upper limbs. On an unknown date, the outcome of the rash and itchy upper limbs were recovered/resolved. It was unknown if the reporter considered the rash and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 71 or 72 years old. The patient developed rash on lower right abdomen and had severe itching on left arm and chest. The symptoms resolved by own. The patient did not receive the 2nd dose till the time of reporting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number 524S7, expiry date unknown) for prophylaxis. On 14th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fever of 103 degree F. The physician gave consent for follow up contact. Lab Comments: On an unknown date, the patient's body temperature was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling; Injection site redness; Injection site discomfort; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site discomfort were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in her sixties. The patient experienced 7 inches X 4 inch injection site reaction which was described as redness and swelling and this causes discomfort in the patient. All these events resolved within 4 to 5 days. Till the time of reporting, the patient had not received 2nd dose os SHINGRIX. The reporter did not respond to consent request.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in hand in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced numbness in hand. On 20th November 2018, the patient experienced pain in hand and injection site erythema. The patient was treated with PARACETAMOL (TYLENOL). SHINGRIX was discontinued. On an unknown date, the outcome of the pain in hand and injection site erythema were recovered/resolved and the outcome of the numbness in hand was not recovered/not resolved. It was unknown if the reporter considered the pain in hand, injection site erythema and numbness in hand to be related to SHINGRIX. Additional details were provided as follows: It was reported that within 24 hours after vaccination the patient experienced severe bilateral hand pain with redness to the injection site for 10 days that dulled with Tylenol. After 10 days the patient experienced numbness of the left thumb and index finger and to the third finger on the right hand and any pressure on these fingers was still painful. The patient asked if it was the normal vaccine reaction and asked whether she could receive the 2nd dose of SHINGRIX and the nurse advised her not to receive the 2nd dose of SHINGRIX and recommended to report this as a reaction and asked if there was any data on the reaction like this.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patients experienced fever, influenza-like symptoms, fever, influenza-like symptoms and condition aggravated. On an unknown date, the outcome of the fever, influenza-like symptoms, fever and condition aggravated were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the fever and influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the fever, influenza-like symptoms and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per product indication. The reporter and her husband were both on the phone. They mentioned that, they had several friends who got the SHINGRIX vaccine and that the side effects of fever and flu-like symptoms were worse after the second dose versus the first dose of SHINGRIX. This case was linked with case US2019001668, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Pain in extremity, Pruritus, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hives (developed due to wheat allergy in 2018). Concurrent medical conditions included allergy to grains (developed in 2018 (last year)). On 4th January 2019, the patient received the 1st dose of SHINGRIX. On 4th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and stomach pain. In January 2019, the patient experienced hives, pruritus and papular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, headache, stomach pain, pruritus and papular rash were unknown and the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, hives, pruritus and papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient has never had allergies before, but last year (in 2018), he developed a wheat allergy that results in hives similar to what he had recently. The patient received SHINGRIX in left deltoid and experienced arm soreness, headache and stomach pain that night. About 29 hours after the vaccination, he developed hives on he neck, head and back that appeared as itching, raised bumps. He took some Benadryl and the hives resolved in about an hour.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hives (developed due to wheat allergy in 2018). Concurrent medical conditions included allergy to grains (developed in 2018 (last year)). On 4th January 2019, the patient received the 1st dose of SHINGRIX. On 4th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and stomach pain. In January 2019, the patient experienced hives, pruritus and papular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, headache, stomach pain, pruritus and papular rash were unknown and the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, hives, pruritus and papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient has never had allergies before, but last year (in 2018), he developed a wheat allergy that results in hives similar to what he had recently. The patient received SHINGRIX in left deltoid and experienced arm soreness, headache and stomach pain that night. About 29 hours after the vaccination, he developed hives on he neck, head and back that appeared as itching, raised bumps. He took some Benadryl and the hives resolved in about an hour.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGIRX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGIRX (intramuscular). On an unknown date, less than a year after receiving SHINGIRX, the patient experienced pain in arm and feeling bad. The action taken with SHINGIRX was unknown. On an unknown date, the outcome of the pain in arm and feeling bad were recovered/resolved. It was unknown if the reporter considered the pain in arm and feeling bad to be related to SHINGIRX. Additional information was provided as follows: The age at vaccination was not reported. The patient received first dose of SHINGIRX in early October 2018 and experienced sore arm and felt bad for 4 to 5 days. The events were resolved. The patient did not ask for doctor information or permission to follow up.
Age: 66.0
Sex: F
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 66-year-old female patient who received SHINGRIX for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th January 2019, 60 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in the left deltoid. On 8th January 2018, the patient was diagnosed with shingles her local physician's assistant. The physician assiastant prescribed antivirals and antivirals creams this morning. The consent for follow up with the pharmacy was given to obtain additional details.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 71-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced weakness, fatigue and pain of skin. On an unknown date, the outcome of the weakness, fatigue and pain of skin were recovered/resolved. It was unknown if the reporter considered the weakness, fatigue and pain of skin to be related to SHINGRIX. Additional details were reported as follows: The patient's husband also received 1st a dose of SHINGRIX. After vaccination, the patient experienced fatigue, weakness and no energy. The patient also experienced that her skin hurt all over. The symptoms began around the same day as the injection and lasted for about 2 days. The reporter did not consent to follow up.
Age: 75.0
Sex: F
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 elderly female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 27th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year 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 were provided as follows: The age at vaccination was not reported however; it could be 75 or 76 years. The patient received SHINGRIX in left arm. The patient developed shingles following her 1st dose of SHINGRIX and her physician instructed her not to get her 2nd dose. The reporter was unsure of timing of shingles following SHINGRIX. The reporter consented to follow up. This case has been linked to case US2019003399, reported by same reporter.
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 male patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 16th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, 21 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 were provided as follows: The age at vaccination was not reported. On 15th June 2018, the patient received the 1st dose of SHINGRIX with batch number TP5E5 and expiry date 15th November 2020. The patient received 2nd dose of SHINGRIX in left arm. The patient developed shingles following his 2nd dose of SHINGRIX. The reporter believed that, the shingles occurred 3 to 4 weeks following the 2nd dose. The reporter did not want to provide additional details regarding patient at the time of reporting. The reported batch number for the 2nd dose of SHINGRIX C789P was corrected to C7B9P as per sales data review. The reporter consented to follow up. This case has been linked to the case US2019003395, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected as adult as per vaccine indication. The caller reported that her target pharmacist told her that they had had many patients experience hives after getting SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The patient experienced mild injection site pain after receiving SHINGRIX. The patient called for a different reason and mentioned in passing about his mild pain. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Culture, Incisional drainage, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient is a 57-year-old male who is seen in consultation for evaluation of right arm injection site reaction. Patient states he had the influenza vaccination injection on 10/3/18 in his proximal right upper extremity. Patient states he noticed a reaction in his right upper extremity site of injection in December 2018 which began as a "mosquito bump". Patient states since then the area has become increasingly erythematous. Denies drainage from the lesion. Does report that the area on the proximal right upper extremity is itchy and sore. States the pain is worse with palpation. Rates pain 2/10. Denies fever, sweats, chills, nausea, vomiting. I&D performed, cultures obtained, wet-to-dry dressing BID.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pruritus
Clinical narrative: Patient is a 57-year-old male who is seen in consultation for evaluation of right arm injection site reaction. Patient states he had the influenza vaccination injection on 10/3/18 in his proximal right upper extremity. Patient states he noticed a reaction in his right upper extremity site of injection in December 2018 which began as a "mosquito bump". Patient states since then the area has become increasingly erythematous. Denies drainage from the lesion. Does report that the area on the proximal right upper extremity is itchy and sore. States the pain is worse with palpation. Rates pain 2/10. Denies fever, sweats, chills, nausea, vomiting. I&D performed, cultures obtained, wet-to-dry dressing BID.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymph node pain, Pain, Pyrexia
Clinical narrative: Patient reports fever, aches, swelling at injection site, pain around lymph nodes on right armpit area, explained to patient these can be included side effects, especially upon 2nd dose in series, and to follow up if symptoms persist beyond 48 hours.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Patient is a 57-year-old female who is seen for evaluation of injection site reaction in left arm. Patient states she had hepatitis A vaccination injection on 10/8/18 in her proximal left upper extremity. Patient states that about 2-3 weeks ago her left deltoid became red and inflamed. Patient states that has since improved. Denies drainage, nausea, vomiting, fever, sweats, chills. Patient reports some mild erythema of the proximal left upper extremity. Patient states she also received influenza and pneumonia vaccination injections in her right upper extremity, but states she has not had issues with these. Patient denies having taken any antibiotics.
Age: 75.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Swelling face
Clinical narrative: Immunization was given on a Friday. The patient called on Monday morning to let me know that about an hour after receiving the vaccine she experienced facial swelling and a headache. She did not have any respiratory/breathing issues at that time. She did call the paramedics who checked her out. They told her that all of her vitals were WNL and they didn't think she needed any meds or need to go to the hospital for any further care. She said the effects lasted about 24 hours. She informed me that she felt better and was not experiencing any other issues.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Haemorrhage, Injection site reaction, Purulent discharge, Secretion discharge
Clinical narrative: Patient is a 62-year-old female who is seen in consultation for APRN, for evaluation of left arm injection site reaction. Patient states she had hepatitis A vaccination injection in her proximal left upper extremity on 10/8/18. Patient states that 3 weeks after she got the vaccination, she noticed her proximal left upper extremity near the injection site became red, warm, and it drained. Patient states the area improved following the drainage. Patient states that the area has since worsened and improved again since then. Patient states she has tried antibiotic ointment, peroxide, and clean bandages. Patient states that the drainage has been thick pus followed by black bloody drainage. Denies fever, sweats, chills. States she has not had any antibiotics. States she has not had the lesion lanced. Patient states the area has not drained in 2-3 weeks.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Skin lesion, Skin warm
Clinical narrative: Patient is a 62-year-old female who is seen in consultation for APRN, for evaluation of left arm injection site reaction. Patient states she had hepatitis A vaccination injection in her proximal left upper extremity on 10/8/18. Patient states that 3 weeks after she got the vaccination, she noticed her proximal left upper extremity near the injection site became red, warm, and it drained. Patient states the area improved following the drainage. Patient states that the area has since worsened and improved again since then. Patient states she has tried antibiotic ointment, peroxide, and clean bandages. Patient states that the drainage has been thick pus followed by black bloody drainage. Denies fever, sweats, chills. States she has not had any antibiotics. States she has not had the lesion lanced. Patient states the area has not drained in 2-3 weeks.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: Around 5:00 PM FRIDAY, 1/11/19 THE DAY OF THE INJECTION I STARTED GETTING SO COLD MY BODY WAS SHAKING. I FELT DRUGGED AND EXTREMELY WEAK. I SLEPT FOR APPROX. 2 HOUR, WOKE UP AND COULDN'T GET AWAKE ENOUGH TO TAKE OUT MY CONTACTS. I ACHED ALL OVER INCLUDING HEADACHE. SO TODAY (1/15/18) WHEN I WOKE UP I REALIZED THAT THE TERRIBLE NIGHT SWEATS AND HEAD SWEATS (HAIR SOAKED) - THAT I HAVE HAD THE PAST 4 NIGHTS, FRIDAY, SATURDAY, SUNDAY AND MONDAY MUST BE RELATED TO THE INJECTION. I AM HAVING DIAHREA TODAY AND UPSET STOMACH. I DIDN'T HAVE ANY OF THIS BEFORE THE INJECTION SO IT MUST BE RELATED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Night sweats, Pain, Tremor
Clinical narrative: Around 5:00 PM FRIDAY, 1/11/19 THE DAY OF THE INJECTION I STARTED GETTING SO COLD MY BODY WAS SHAKING. I FELT DRUGGED AND EXTREMELY WEAK. I SLEPT FOR APPROX. 2 HOUR, WOKE UP AND COULDN'T GET AWAKE ENOUGH TO TAKE OUT MY CONTACTS. I ACHED ALL OVER INCLUDING HEADACHE. SO TODAY (1/15/18) WHEN I WOKE UP I REALIZED THAT THE TERRIBLE NIGHT SWEATS AND HEAD SWEATS (HAIR SOAKED) - THAT I HAVE HAD THE PAST 4 NIGHTS, FRIDAY, SATURDAY, SUNDAY AND MONDAY MUST BE RELATED TO THE INJECTION. I AM HAVING DIAHREA TODAY AND UPSET STOMACH. I DIDN'T HAVE ANY OF THIS BEFORE THE INJECTION SO IT MUST BE RELATED.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Clumsiness, Dyspnoea, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: First I got really sluggish and clumsy, I kept bumping into things and forgetting what I was about to say. My legs felt really weak and I was kinda just going through motions without thinking about what I was doing. I started spacing out towards the end of the night, according to friends I got super quiet. I got home and fell asleep right away. I woke up twice that night, the first time I woke up and I was sweating, my head was pounding, my ears were ringing super loud and I could barely see. I couldn't move any of my muscles and I couldn't speak. Then the ringing stopped and everything became muffled, I couldn't breathe and my vision turned to black. I went from a state of extreme panic to just being numb in a way, I didn't feel like I was in my body anymore I felt separated. I can't put the feeling into words I've tried but I can't. In the moment I 'knew' i was dying, all these thoughts of people I love and things that I want to do came rushing through me and I got this soul-crushing feeling of disappointment that everything was over. I tried calling out because I didn't want to die by myself but I couldn't get any words to come out. Then something snapped and I told myself I wasn't going to let myself die and I focused all of my energy into breathing and staying awake. Then I felt like I was back in my body and I could move again, i kept my eyes open and just breathed for I don't know how long. Eventually I let myself fall asleep again. I woke up again three hours later drenched in sweat and shaking. I got up,  went downstairs and got water and cheese and focused on staying steady and breathing. The above is in my daughters words. She was feeling better the next morning (the 12th) but was very shaken up. She had difficulty falling asleep the next 2 nights because of fear. She is still shaken up from the incident.  No treatment other than time.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypoacusis, Hypoaesthesia, Insomnia, Muscle disorder, Muscular weakness
Clinical narrative: First I got really sluggish and clumsy, I kept bumping into things and forgetting what I was about to say. My legs felt really weak and I was kinda just going through motions without thinking about what I was doing. I started spacing out towards the end of the night, according to friends I got super quiet. I got home and fell asleep right away. I woke up twice that night, the first time I woke up and I was sweating, my head was pounding, my ears were ringing super loud and I could barely see. I couldn't move any of my muscles and I couldn't speak. Then the ringing stopped and everything became muffled, I couldn't breathe and my vision turned to black. I went from a state of extreme panic to just being numb in a way, I didn't feel like I was in my body anymore I felt separated. I can't put the feeling into words I've tried but I can't. In the moment I 'knew' i was dying, all these thoughts of people I love and things that I want to do came rushing through me and I got this soul-crushing feeling of disappointment that everything was over. I tried calling out because I didn't want to die by myself but I couldn't get any words to come out. Then something snapped and I told myself I wasn't going to let myself die and I focused all of my energy into breathing and staying awake. Then I felt like I was back in my body and I could move again, i kept my eyes open and just breathed for I don't know how long. Eventually I let myself fall asleep again. I woke up again three hours later drenched in sweat and shaking. I got up,  went downstairs and got water and cheese and focused on staying steady and breathing. The above is in my daughters words. She was feeling better the next morning (the 12th) but was very shaken up. She had difficulty falling asleep the next 2 nights because of fear. She is still shaken up from the incident.  No treatment other than time.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Sluggishness, Tinnitus, Tremor, Visual impairment
Clinical narrative: First I got really sluggish and clumsy, I kept bumping into things and forgetting what I was about to say. My legs felt really weak and I was kinda just going through motions without thinking about what I was doing. I started spacing out towards the end of the night, according to friends I got super quiet. I got home and fell asleep right away. I woke up twice that night, the first time I woke up and I was sweating, my head was pounding, my ears were ringing super loud and I could barely see. I couldn't move any of my muscles and I couldn't speak. Then the ringing stopped and everything became muffled, I couldn't breathe and my vision turned to black. I went from a state of extreme panic to just being numb in a way, I didn't feel like I was in my body anymore I felt separated. I can't put the feeling into words I've tried but I can't. In the moment I 'knew' i was dying, all these thoughts of people I love and things that I want to do came rushing through me and I got this soul-crushing feeling of disappointment that everything was over. I tried calling out because I didn't want to die by myself but I couldn't get any words to come out. Then something snapped and I told myself I wasn't going to let myself die and I focused all of my energy into breathing and staying awake. Then I felt like I was back in my body and I could move again, i kept my eyes open and just breathed for I don't know how long. Eventually I let myself fall asleep again. I woke up again three hours later drenched in sweat and shaking. I got up,  went downstairs and got water and cheese and focused on staying steady and breathing. The above is in my daughters words. She was feeling better the next morning (the 12th) but was very shaken up. She had difficulty falling asleep the next 2 nights because of fear. She is still shaken up from the incident.  No treatment other than time.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Patient had a red, swollen left foot which started around 8pm on the day he received vaccines. No fever or other joint swelling. Slightly more fussy. No vomiting. Had a loose stool the next morning.  No complications after two month vaccines. Feeding normally. Normal energy. Otherwise well appearing. The next morning the foot was basically back to normal, maybe still mild swelling but nothing mother would've noticed if she hadn't seen the changes last night. There is not overt erythema or swelling at the injection sites.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: Within 24 hours of receiving the flu shot - Frozen shoulder/limited mobility, extreme arm weakness, intense pain in the shoulder and deltoid muscle, aching and sometimes numbness. Issues with everyday activities and sleeping. I began physical therapy on 12/3/18, a little less than a month after the shot was administered. This was the recommendation from the Urgent Care that I visited 2.5 weeks after I got the shot. My shoulder/arm was not getting better, it was actually getting worse at this point. I have been to 12 physical therapy visits. I am still currently going. I was initially going twice a week and now am down to once a week because we are having issues getting the insurance to clear more visits. The physical therapy has worked very well to get most of my mobility back in my shoulder, but all the other symptoms listed are still an issue.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Myalgia, Periarthritis
Clinical narrative: Within 24 hours of receiving the flu shot - Frozen shoulder/limited mobility, extreme arm weakness, intense pain in the shoulder and deltoid muscle, aching and sometimes numbness. Issues with everyday activities and sleeping. I began physical therapy on 12/3/18, a little less than a month after the shot was administered. This was the recommendation from the Urgent Care that I visited 2.5 weeks after I got the shot. My shoulder/arm was not getting better, it was actually getting worse at this point. I have been to 12 physical therapy visits. I am still currently going. I was initially going twice a week and now am down to once a week because we are having issues getting the insurance to clear more visits. The physical therapy has worked very well to get most of my mobility back in my shoulder, but all the other symptoms listed are still an issue.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Shaking and chills.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Injection site paraesthesia, Swelling face, Throat tightness
Clinical narrative: Patient described tingling sensation to left upper arm (injection site) soon after receiving vaccine then reported mild facial swelling and throat constriction within 45 minutes of receiving vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Able to use ice and Tylenol.
Sex: F
Vaccine: HPV9
Symptoms: Angioedema
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in January 2019, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date of vaccination, the patient experienced an unspecified angioedema. The reporter also stated that, on the same date, the patient ate shrimp and she believed that the angioedema was related to the consumption of shrimp (food allergy). In addition, the patient was referred to an allergist, however, no treatment was given for the mentioned events and it was unknown if laboratory diagnostics or studies were performed. At the reporting time, the outcome of angioedema and food allergy was reported as recovered on an unknown date in January 2019. The reporter did not provide a causal relationship between the events and GARDASIL 9. Upon internal review, the event angioedema was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Quality of life decreased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-DEC-2018, the patient was vaccinated with an expired dose of ROTATEQ vial, lot # N013885, which had expired on 09-DEC-2018 (concentration and exact dose were not reported). No known adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a nurse and refers to a 29-year-old non-pregnant female patient. The patient's drug reactions included allergy to amoxicillin (hives). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in approximately 1990 (reported as at approximately one year of age) and on an unknown date in approximately 1993 (reported as at fours years of age), the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not provided) for routine immunization. On an unknown date in November 2018, the patient had ''negative titers'' for measles (less than 25.00 (units not provided)), rubella (less than 0.90 units not provided)) and mumps (10.50 (units not provided)). On 13-DEC-2018, the patient received one dose of M-M-R II to treat negative titers. The patient sought medical attention via seeing a physician. The outcome of the events and the causality assessment were not provided.