chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Abscess, Abscess drainage, Culture, Erythema, Swelling
Clinical narrative: The patient received the Boostrix vaccine in his L arm on 9/11/19.  On 10/25 the patient came in and showed me his arm which had a quarter sized red, swollen mark on it.  He was asking when he received the vaccines here and I gave him the date and told him the Tdap was administered in his left arm.  I advised him to have his arm looked at by a physician.  He came back on 10/29 and advised he did have his arm looked at today and the abscess was drained and cultured.  The doctor gave him antibiotics for the abscess.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: after 5 days went urgert had serious pain in shoulder.  Then patient came today at 10/29/19 and indicated had terrible arthritic  pain from possible shot
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Cardiac function test normal, Chest X-ray, Chest pain
Clinical narrative: after 5 days went urgert had serious pain in shoulder.  Then patient came today at 10/29/19 and indicated had terrible arthritic  pain from possible shot
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site pain, Malaise, Pain, Paraesthesia
Clinical narrative: after 5 days went urgert had serious pain in shoulder.  Then patient came today at 10/29/19 and indicated had terrible arthritic  pain from possible shot
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Restlessness, White blood cell count increased, X-ray limb abnormal
Clinical narrative: after 5 days went urgert had serious pain in shoulder.  Then patient came today at 10/29/19 and indicated had terrible arthritic  pain from possible shot
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: SEVERE INJECTION SITE REACTION, BRUISING REPORTED THAT SPREAD TO THE LOWER ARM FROM THE SITE OF ADMINISTRATION. VERY RED, INFLAMED AND HOT TO TOUCH.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: SEVERE INJECTION SITE REACTION, BRUISING REPORTED THAT SPREAD TO THE LOWER ARM FROM THE SITE OF ADMINISTRATION. VERY RED, INFLAMED AND HOT TO TOUCH.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Dizziness, Eye pain, Nausea
Clinical narrative: Thursday morning: dizzy and weak. Late evening, 9 pm nausea and vomited. Friday: am nasea, dizzy. Saturday: weak, temperature 99.5, evening felt like had sniffles and eyes stinging. Sunday: light sniffles. 98.4 at noon.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Thursday morning: dizzy and weak. Late evening, 9 pm nausea and vomited. Friday: am nasea, dizzy. Saturday: weak, temperature 99.5, evening felt like had sniffles and eyes stinging. Sunday: light sniffles. 98.4 at noon.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Body temperature increased, Chest X-ray, Irritability, Pain, Rash
Clinical narrative: Rash associated with temp of 103, very fussy. Parents convinced patient was in pain. Taken to the emergency department. Normal follow-up.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Urine analysis
Clinical narrative: Rash associated with temp of 103, very fussy. Parents convinced patient was in pain. Taken to the emergency department. Normal follow-up.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: "swollen, red, and achy" -10/2/19 numbness and tingling in fingers - 10/2/19 sweaty, dizziness - 10/2/19
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Swelling
Clinical narrative: "swollen, red, and achy" -10/2/19 numbness and tingling in fingers - 10/2/19 sweaty, dizziness - 10/2/19
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Joint swelling
Clinical narrative: Pronounced swelling around the medial epicondyle of the (L) elbow following pneumovax inj. in (L) deltoid. Red + swollen. Pt reports today it is improving from yesterday. Swelling + redness have moved distally down arm to elbow. 10/25/19 Pt reports issue has cleared.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient at field trip next day became pale, had to sit down passed out for 15 seconds had had good breakfast. Was standing watching Blacksmith when got pale, syncope and passed out for 15 seconds.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest discomfort, Dizziness, Ocular hyperaemia, Syncope
Clinical narrative: Patient had very sharp pain in back,light headed like she was going to faint, eyes bloodshot,slight tightness in chest. Called 911 rescue squad came after they got her out of store EMT came back in and said she was doing a little better he said it appeared to be syncopy. The took her to ER as a precaution.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: RASH (per mom) Not examined No FuRTHER Complaints
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: While The Vaccine was being injected The material Seeped at the junction of the Needle and The Lauer Lock. The Lock Piece was Loose + rotated freely. This occurred twice on the Same Lot. Faulty Syringe
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: REDNESS DEVELOPED DAY AFTER VACCINE 2ND DAY: LARGE AREA BELOW INJECTION SITE ON ARM RED, HOT, PAINFUL. PATIENT USED COLD PACK TO HELP WITH PAIN 3RD DAY: 10/29/19 PATIENT CALLED DR. REDNESS SLIGHTLY BETTER
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Fall, Tension, Unresponsive to stimuli
Clinical narrative: Patient was being administered the Meningococcal B. vaccine when I saw patient leaning backwards slowly. I supported patients fall. I called provider to assist me with patient. Patient tensed / unresponsive for a good 20 seconds. -patient observed
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of upper extremities; Information has been received from Food and Drugs Administration (FDA) (HA # 802902 - 1) on 04-OCT-2019.  This spontaneous report was received from a registered nurse and refers to a non-pregnant female patient of unknown age who was taken at the time of vaccinatiom albuterol (VENTOLIN) inhaler (indication not reported), and had drug allergy to sulfamethoxazole (+) trimethoprim (SEPTRA).     On 20-FEB-2019 14:35, at the age of 11, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, in the right arm, for prophylaxis, (reported lot# R028155) (no expiration date was reported). At the same time, the patient was vaccinated with the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot# U6219AA), intramuscularly on her left arm; and the second dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot # U6202BA, intramuscularly in her right arm (indication and expiration date were not reported for both).      On 21-FEB-2019 08:00, the patient experienced numbness of upper extremities (hypoaesthesia). It was reported that the numbness in right arm, got slightly worse the first day and then had been getting better, however, the outcome was reported as unknown. It was reported that the patient did not have adverse events following any previous vaccine.   The causality assessment between events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Lot number R028155 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information has been received on 29-OCT-2019 from the reporting nurse. It was reported by the nurse that there was no record of this patient at her office.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: Intensely Nauseated; Could not stand up; Could not consume any food or water; Lost about 5 lbs; Wretching up; Unpleasant experience; Was unable to do anything / missed work; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostrix (had Zostrix with no adverse events) and unknown vaccines (had many other vaccinations with no adverse events).   On 1st August 2019, the patient received the 1st dose of Shingrix. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired. On an unknown date, the outcome of the nausea, difficulty in standing, oral intake reduced, weight loss, retching and feels awful were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd and 3rd August 2019, the patient was intensely nauseated so that, could not really stand up or consume any food or water. The patient lost 5 lbs, dyr wretching up what saliva had felt. The patient reported that it was unpleasant experience, missed work of course and was unable to do anything. The patient still supposed to get 2nd dose and asked if there any prescription or over the counter medicine could take to reduce the nausea. The patient stated that as per the popular media information several days of illness were better than a case of shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Feeling abnormal, Hypophagia, Loss of personal independence in daily activities, Nausea
Clinical narrative: Intensely Nauseated; Could not stand up; Could not consume any food or water; Lost about 5 lbs; Wretching up; Unpleasant experience; Was unable to do anything / missed work; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostrix (had Zostrix with no adverse events) and unknown vaccines (had many other vaccinations with no adverse events).   On 1st August 2019, the patient received the 1st dose of Shingrix. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired. On an unknown date, the outcome of the nausea, difficulty in standing, oral intake reduced, weight loss, retching and feels awful were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd and 3rd August 2019, the patient was intensely nauseated so that, could not really stand up or consume any food or water. The patient lost 5 lbs, dyr wretching up what saliva had felt. The patient reported that it was unpleasant experience, missed work of course and was unable to do anything. The patient still supposed to get 2nd dose and asked if there any prescription or over the counter medicine could take to reduce the nausea. The patient stated that as per the popular media information several days of illness were better than a case of shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Retching, Weight decreased
Clinical narrative: Intensely Nauseated; Could not stand up; Could not consume any food or water; Lost about 5 lbs; Wretching up; Unpleasant experience; Was unable to do anything / missed work; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostrix (had Zostrix with no adverse events) and unknown vaccines (had many other vaccinations with no adverse events).   On 1st August 2019, the patient received the 1st dose of Shingrix. On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired. On an unknown date, the outcome of the nausea, difficulty in standing, oral intake reduced, weight loss, retching and feels awful were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the nausea, difficulty in standing, oral intake reduced, weight loss, retching, feels awful and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd and 3rd August 2019, the patient was intensely nauseated so that, could not really stand up or consume any food or water. The patient lost 5 lbs, dyr wretching up what saliva had felt. The patient reported that it was unpleasant experience, missed work of course and was unable to do anything. The patient still supposed to get 2nd dose and asked if there any prescription or over the counter medicine could take to reduce the nausea. The patient stated that as per the popular media information several days of illness were better than a case of shingles.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Exploding head syndrome
Clinical narrative: Hearing a clicking noise at night; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number H547E, expiry date 22nd February 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th May 2019).   On 11th September 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient came into the pharmacy for a flu shot on 11th October 2019. At that time, she reported to the pharmacist that after receiving the Shingrix vaccine, she started hearing a clicking noise at night time that wakes her up. She did not hear it during the day. She hears it when at rest only.The exact date of onset was not known. The reporter thinks it might had started after the 2nd dose was administered. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Hearing a clicking noise at night; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number H547E, expiry date 22nd February 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th May 2019).   On 11th September 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient came into the pharmacy for a flu shot on 11th October 2019. At that time, she reported to the pharmacist that after receiving the Shingrix vaccine, she started hearing a clicking noise at night time that wakes her up. She did not hear it during the day. She hears it when at rest only.The exact date of onset was not known. The reporter thinks it might had started after the 2nd dose was administered. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: shingles; Four different spots around her waist; Itching; Horrible burn; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On 13th October 2019, 11 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shingles, rash, pruritus and burning sensation. On an unknown date, the outcome of the shingles, rash, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the shingles, rash, pruritus and burning sensation to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: This case was submitted but it did not write over. The patient received Shingrix and unknown manufacturer's flu shot on left arm at the same arm at the same time as Shingrix. The patient broke out with itching and a horrible burn there were four different spots around her waist. On 17th October 2019, the patient went to her heathcare professional and was told she had shingles. The lot number and expiration date were unknown. The patient gave permission to contact physician.
Age: 73.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Rash
Clinical narrative: shingles; Four different spots around her waist; Itching; Horrible burn; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On 13th October 2019, 11 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shingles, rash, pruritus and burning sensation. On an unknown date, the outcome of the shingles, rash, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the shingles, rash, pruritus and burning sensation to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: This case was submitted but it did not write over. The patient received Shingrix and unknown manufacturer's flu shot on left arm at the same arm at the same time as Shingrix. The patient broke out with itching and a horrible burn there were four different spots around her waist. On 17th October 2019, the patient went to her heathcare professional and was told she had shingles. The lot number and expiration date were unknown. The patient gave permission to contact physician.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Hypersensitivity, Oropharyngeal pain
Clinical narrative: Patient experienced symptoms of allergic rxn (swelling eyes, sore throat) 4 hours after receiving the flu shot. She went to the ER and was discharged with Benadryl.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: On same evening 10/26/19 after receiving vaccine patient developed itching and hive-like rash on her legs. Took Benadryl at home, which decreased itch enough for her to sleep. When rash and itching started spreading to rest of body came back to hospital on evening of 10/30/19. Given 50mg IV Benadryl which improved symptoms but not complete.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Injection site arm pain, redness, swelling pretty immediate; felt faint by 2pm; felt feverish with body aches by evening, getting worse after 6pm  with chills, bad headache & fever of 101. Fever around 100, headache & body aches continued until Monday 10/21/2019. Arm redness & swelling persisted for a week. Treated with Tylenol and Advil. Injection site is still sore to the touch today, but redness & swelling gone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Injection site arm pain, redness, swelling pretty immediate; felt faint by 2pm; felt feverish with body aches by evening, getting worse after 6pm  with chills, bad headache & fever of 101. Fever around 100, headache & body aches continued until Monday 10/21/2019. Arm redness & swelling persisted for a week. Treated with Tylenol and Advil. Injection site is still sore to the touch today, but redness & swelling gone.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Muscle aches, joint pain, fatigue the day after.  Redness, heat, pain about 1 inch below injection site.  Muscle pain has resolved, but the redness, heat and pain below the injection site persists.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Muscle aches, joint pain, fatigue the day after.  Redness, heat, pain about 1 inch below injection site.  Muscle pain has resolved, but the redness, heat and pain below the injection site persists.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Patient had a spell of dizziness the evening after receiving the vaccine, the day after she also had a spell of dizziness, and today 10/30/19 she is experiencing dizziness again along with increased heart rate.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Several hours following vaccinations, patient reported getting hives, rash all over her body, including face, and extreme itching. She used several over-the-counter anti-itch medications to alleviate her itching, including Benadryl products. A few days after the event the patient reported less itching and subsiding of rash, hives.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cryotherapy
Clinical narrative: patient had recently been diagnosed with CIN II; This spontaneous report was received from a nurse prescriber referring to a female patient of unknown age.  Information about medical history, concurrent conditions and concomitant therapies was unknown.      On unknown dates the patient was vaccinated with 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb, Vaccine (GARDASIL) (route of administration, strength, lot # and expiration date were not reported) for prophylaxis. The patient had received the full quadrivalent human papillomavirus (types 6,11,16,18) recomb, Vaccine (GARDASIL) series at an unspecified time. On an unknown date, papanicolaou (PAP) smear was performed. On an unknown date, the patient diagnosed with cervical intraepithelial neoplasia II (CIN II).  The patient had sought medical attention and treated with cryotherapy.  The outcome of the event was reported as recovered.  Causality assessment was not provided.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: high anxiety/very anxious; body felt hot; pain and redness in her arm/deltoid pain and redness at injection site; pain and redness in her arm/deltoid pain and redness at injection site; This spontaneous report was received from a 35 years old female nurse via a company representative referring herself. The patient's concurrent conditions included epidural abscess, pulmonary outflow tract obstruction(POTOS), abnormal pulmonary arterial pressure(PAP), attention deficit disorder, anxiety, depression, insomnia, migraine and drug allergy(cyclobenzaprine, penicillin, pregabalin(LYRICA)). Concomitant therapies included tizanidine hydrochloride, amphetamine aspartate(+)amphetamine sulfate(+)dextroamphetamine saccharate(+)dextroamphetamine sulfate(ADDERALL XR), escitalopram oxalate(LEXAPRO) and topiramate(TOPAMAX).   On 31-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, lot # and expiration date were not reported)Intramuscularly (IM) for prophylaxis.      On 01-AUG-2019, the patient experienced pain and redness in her arm,high anxiety(also reported as she developed deltoid pain and redness at injection site and started to get very anxiouse), and body felt hot. On the same day, the patient received dexamethasone (DECADRON) 10 mg intramuscularly and hydroxyzine one to three times daily (also reported as 25 mg as need (PRN)) for anxiety from her primary provider. The outcome of events was reported as recovered on 02-AUG-2019. The reporter considered tizanidine hydrochloride, amphetamine aspartate (+)amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL XR) and topiramate (TOPAMAX) to be related to the events. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse effects reported; The patient, who is pregnant, received a dose of Gardasil 9; This spontaneous prospective pregnancy report was received from a medical assistant via a company representative and refers to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-FEB-2019, the patient became pregnant.  On 14-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R011630, expiration date 12-DEC-2020 (dose, route and frequency were not reported) for prophylaxis (exposure during pregnancy).   It was stated that, at the time of vaccination, the patient was 33 weeks and 3 days of gestation. The patient's estimated delivery date (EDD) was reported as 01-DEC-2019. The pregnancy outcome was outcome pending. No adverse effects were reported.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Died unexpectedly in 2008, shortly after receiving the Gardasil human papillomavirus (HPV) vaccine; This spontaneous report was received from a lawyer via social media referring to a 21 years old female patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.  On an unknown date in 2008, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. The patient died unexpectedly shortly after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered death unexpectedly to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored VARIVAX administered to patient; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 16-OCT-2019, the patient received an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot number R018933 has been verified to be a valid lot number, expiration date reported as 02-JUL-2019, but upon internal validation established as 02-JUL-2020; strength, dose, route of administration and anatomical site were not provided). The vaccine was exposed to a temperature excursion of 15 Fahrenheit degrees to 46 Fahrenheit degrees (34.2 Fahrenheit degrees) during a time frame of 4 hours. It was stated that there was no previous temperature excursion and that the call was not because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 14-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose and frequency were not reported) (lot # S015460, expiry date: 20-MAY-2021) subcutaneously for prophylaxis. It could not be determined, if the sterile diluent(STERILE DILUENT) was properly stored. The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of -11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effect; Adult patient received pediaric dose of VAQTA; This spontaneous report as received from a nurse refers to an adult patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 18-OCT-2019, it was reported that, adult patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 vial (0.5 milliliter) (lot # S007265, expiry date: 07-JUL-2020) (frequency and route were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; was administered an improperly stored dose of VAQTA; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 21-OCT-2019, the patient was vaccinated with a dose of improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) Lot# S007770, expiration date on 24-JUL-2020 (strength, dose number, route and anatomical location were unknown) for prophylaxis.   The vaccine was stored in temperature below 36 Fahrenheit degrees (32.7 F) for 3 hours 20 minutes above 47 Fahrenheit degrees (52 F) for 39 minutes. There was a previous temperature excursion above 47 Fahrenheit degrees (50.2 F) for 31 minutes. Digital data logger was involved and no adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 24-OCT-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002738, expiration date 28-JAN-2021, dosage detail, strength and route were not provided) for prophylaxis. Administered doses of vaccine experienced temperature excursion of 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celsius to -10 degrees Celsius) for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse symptoms were reported.
Age: 39.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; an adult patient received improperly stored PROQUAD via the intramuscular route; an adult patient received improperly stored PROQUAD via the intramuscular route; an adult patient received improperly stored PROQUAD via the intramuscular route; This spontaneous report was received from a medical assistant referring to a 39 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On 16-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant human albumin (rHA); lot # S005879, expiration date 25-AUG-2020; dose unknown) via intramuscular route for prophylaxis and properly stored sterile diluent (STERILE DILUENT) (dose unknown; lot # S002625, expiration date 09-NOV-2021) via intramuscular route for prophylaxis. No adverse effects reported.    Time frame for temperature excursion of the vaccine was 30 minutes and temperature  was -7.6 Celsius degree. No previous temperature excursion. The call was because of a data logger.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015390:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported.; the patient was inadvertently administered a dose of VAQTA (Lot#R024007/Exp:10/12/2019), that was expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications was not provided.  It was reported that on 23-OCT-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated (VAQTA) 20/0.5 (units not provided) for prophylaxis (dose number, route of administration and anatomical location of vaccination were not provided; lot number R024007 has been verified to be valid; expiration date 12-OCT-2019), that was expired (expired product administered).  No adverse effect was reported.
Sex: F
Vaccine: TDAP, UNK
Symptoms: Labelled drug-drug interaction medication error, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Labelled drug-drug interaction; Itchy; Large swelling on my arm; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis  Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   In October 2019, the patient received Tdap Vaccine and Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a week after receiving Tdap Vaccine and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced swelling arm and pain in arm. On 20th October 2019, the patient experienced pruritus. On an unknown date, the patient experienced labelled drug-drug interaction medication error. On an unknown date, the outcome of the swelling arm, pain in arm and pruritus were not recovered/not resolved and the outcome of the labelled drug-drug interaction medication error was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and pruritus to be related to Tdap Vaccine and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were priovided as follows: The age at vaccination was not reported. The patient stated that, a week ago received Flu shot and Tdap shot in the same unknown arm. The patient did not know which vaccine had the patient sore and swollen because they gave in the same arm. On the day of reporting, the patient had itching.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Injection site erythema, Myalgia, Nasopharyngitis
Clinical narrative: Redness at the injection site; Extreme leg muscle pain; Dry cough; Full blown cold; This case was reported by a consumer and described the occurrence of injection site erythema in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, 1 day after receiving Bexsero, the patient experienced injection site erythema, myalgia, dry cough and cold. On an unknown date, the outcome of the injection site erythema, myalgia, dry cough and cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, myalgia, dry cough and cold to be related to Bexsero.  Additional details were provided as follows: The case was reported by the patient's parent. Few weeks ago from the date of reporting, the patient received dose of Bexsero. The patient stated that, 2days after vaccination the patient experienced extreme leg muscle pain and shortly after (day 3) developed a dry cough which has since turned into a full blown cold.  The patient asked if to continue for 2nd dose though had reaction with 1st dose. The patient's parent did not want to have 2nd dose for the patient untill the patient was recovered from the present cold which may or may not be not be related.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Severe redness down her arm; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had severe redness down her arm that lasted for a week. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (got on medication and it was cleared up within 2 weeks).   On 30th September 2019, the patient received the 1st dose of Shingrix. On 19th October 2019, 19 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. The patient got shingles after vaccination. The patient in terms of getting the second of the two Shingrix vaccinations was unsure how to proceed and whether it will do any good for that matter. The patient asked to advise how to proceed given that had gotten shingles after havine had the first vaccine.
Age: 53.0
Sex: M
Vaccine: FLUR3, VARZOS
Symptoms: Headache, Rash
Clinical narrative: Rash all over his body; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a male patient who received Herpes zoster (Shingrix) (batch number 4F7B4, expiry date 15th November 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUBLOK. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced headache. On 20th October 2019, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash and headache were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient received Flublock in the left arm approximately 1 inch away from Shingrix injection site.  On the same day after vaccination, the patient had headache and 5 days after vaccination had rash all over the body. The reporter stated that, the rash was not itchy or bothersome. It was unknown if the reporter considered the generalized rash and headache to be related to Flublok
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Genital rash, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Failure of the Shingrix vaccine with the patient/suspected vaccination failure; Experienced a rash on one testicle and buttocks and the PA was confident it was shingles; rash on one testicle; Rash related to the vaccine / rash on one testicle and buttocks; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In October 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, genital rash and rash. On an unknown date, the outcome of the vaccination failure, shingles, genital rash and rash were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The reporter considered the genital rash and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash related to the vaccine. It was reported that it was a failure of the Shingrix with the patient. The patient received both the doses of Shingrix and experienced a rash on one testicle and buttocks and the reporter was confident it was shingles. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown. This case is 1 of the 4 cases reported by the same reporter.
Sex: F
Vaccine: RAB
Symptoms: Facial paralysis
Clinical narrative: Bells palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a female patient who received Rabies NVS (RabAvert) (batch number ARBA241B, expiry date 31st July 2022) for prophylaxis.   On an unknown date, the patient received RabAvert (intramuscular) 1 ml. On an unknown date, unknown after receiving RabAvert, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not provided. It was unknown if the patient received RabAvert for pre or post exposure prophylaxis. The patient was given the Rabavert in her right deltoid, dose series unknown. The patient developed Bells Palsy.  Additional information was unspecified. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: Severe pain in all joints normally affected by her arthritis; This is a spontaneous report received from a non-contactable healthcare professional reporting for herself via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation.  Medical history included ongoing rheumatoid arthritis. Concomitant medications were not reported. The patient experienced severe pain in all joints normally affected by her arthritis for 30 hours afterward. The event recovered spontaneously. She had the same experience 8 weeks later after Pneumovax 23 vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Hot flush, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: I had the shot at 11:30 am, and by 5:00 pm I was having extreme chills and uncontrollable shaking.  My body ached and I had a headache.  My eyes turned very red.  I took 2 Aleve and went to bed.  Within a couple hours, the shaking had stopped but still had aching body and headache.  Next morning I had hot flashes and sweating.  I took my blood pressure and it was 101/61.  I normally have high blood pressure even taking my medications.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Tremor
Clinical narrative: I had the shot at 11:30 am, and by 5:00 pm I was having extreme chills and uncontrollable shaking.  My body ached and I had a headache.  My eyes turned very red.  I took 2 Aleve and went to bed.  Within a couple hours, the shaking had stopped but still had aching body and headache.  Next morning I had hot flashes and sweating.  I took my blood pressure and it was 101/61.  I normally have high blood pressure even taking my medications.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Fatigue, Somnolence, Wheezing
Clinical narrative: Experienced fatigue and drowsiness five minutes after the flu shot. Five hours later, took a brief nap and woke up wheezing and finding it very difficult to breathe. Wheezing faded after a few hours or so.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Injection site erythema, Injection site swelling, Lip swelling
Clinical narrative: patient developed right lower lip swelling, but resolved on its own,  2-3 hours later developed arthralgias in left arm. Used aleve. Had LUE swelling and redness same day, used Benadryl 50mg last night.  Progressive redness, swelling, feels like sunburn.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Patient developed a localized oval shaped 2in x 1in area in the left arm. This area was red, warm and increased in size 2 days after vaccines were given. Patient was prescribed Triamcinolone Acetonide 0.1%.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Lethargy, Malaise, Pain
Clinical narrative: Patient received the vaccination in the morning 10/17/19 and by the evening was feeling lethargic, achy, chills, feverish, general weakness and sick.  This continued for a few more days and symptoms peaked about 2 days after the vaccination patient reports.  She stated that she also got a whole body rash that seemed to "move around her body" during these few days after the vaccination was administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received the vaccination in the morning 10/17/19 and by the evening was feeling lethargic, achy, chills, feverish, general weakness and sick.  This continued for a few more days and symptoms peaked about 2 days after the vaccination patient reports.  She stated that she also got a whole body rash that seemed to "move around her body" during these few days after the vaccination was administered.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Extreme flu like symptoms after the flu shot. 99.8 fever and body aches and nausea