chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills and shivering that lasted about an hour and a half, piled blankets on and eventually warmed up again
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever (100.3), headache,backache,chills,shaking,nausea  approx. 5.5 hours after dose. morning after fever (99.0), no shaking, no chills, back still sore.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: fever (100.3), headache,backache,chills,shaking,nausea  approx. 5.5 hours after dose. morning after fever (99.0), no shaking, no chills, back still sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Evening of the vaccine I had achiness in both shoulders and neck, but then got chills in the night and body aches , fatigue with headache the next day.  Body aches, fatigue, headache and chills continues into Day 2 with Temp of 100.4 and then felt some swollen neck glands.  Day 3 with Temp 100.2, headache, body aches and fatigue are improving but neck/throat glands more swollen (no nasal congestion but feels like a sinus headache), Day 4- chills (did not check temp), body aches improved, headache continues with swollen sore throat. *I had traveled and flight was 2 days before receiving the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Neck pain, Oropharyngeal pain, Pain, Pharyngeal swelling
Clinical narrative: Evening of the vaccine I had achiness in both shoulders and neck, but then got chills in the night and body aches , fatigue with headache the next day.  Body aches, fatigue, headache and chills continues into Day 2 with Temp of 100.4 and then felt some swollen neck glands.  Day 3 with Temp 100.2, headache, body aches and fatigue are improving but neck/throat glands more swollen (no nasal congestion but feels like a sinus headache), Day 4- chills (did not check temp), body aches improved, headache continues with swollen sore throat. *I had traveled and flight was 2 days before receiving the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus headache
Clinical narrative: Evening of the vaccine I had achiness in both shoulders and neck, but then got chills in the night and body aches , fatigue with headache the next day.  Body aches, fatigue, headache and chills continues into Day 2 with Temp of 100.4 and then felt some swollen neck glands.  Day 3 with Temp 100.2, headache, body aches and fatigue are improving but neck/throat glands more swollen (no nasal congestion but feels like a sinus headache), Day 4- chills (did not check temp), body aches improved, headache continues with swollen sore throat. *I had traveled and flight was 2 days before receiving the vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: Patient developed a large 3-4 inch diameter redness around the injection site and complainted heavily that her arm was so sore and could hardly move it.  Adverse reaction stayed localized within 3-4 inches of the injection site.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site cellulitis
Clinical narrative: Patient developed redness in the evening after administration of Menactra in morning, then seen in clinic the following day (9/18/19) with concern for cellulitis vs allergic reaction at injection site, recommended follow-up in ED, seen at ED (9/18/19) and currently admitted for cellulitis.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardioversion
Clinical narrative: persistent atrial fibrillation over a period of about 2 weeks, eventually requiring cardioversion.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient stated her arm was sore and red
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Loss of consciousness
Clinical narrative: about thirty seconds after the vaccination her daughter started to "pass out"; had a headache later that night and went to bed early; This spontaneous report was received from a patient's mother via a company representative and refers to a 13-year-old female patient. The patient did not have any pertinent medical history, concomitant therapies, drug reactions or allergies. On an unknown date in April 2019 (reported as about five months ago), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) to prevent Human Papillomavirus (HPV). About thirty seconds after the vaccination, the patient started to pass out, she was caught by a nurse and, according to the reporter, she was "okay". On that same day (reporter as later that night), the patient experienced a headache and she went to bed early. On an unknown date in April 2019 (reported as the next day), the patient recovered from the event (reported as "she woke up and she was fine"). The patient did not sought medical attention and had no lab diagnostics or studies performed. She did not receive any treatment for the events.  The causality assessment was not provided.  Upon internal review, the event of "started to pass out" was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; patient received VARIVAX via intramuscular route; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 14-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly into left deltoid, lot# R010469, expiration date: 10-APR-2020 (exact dose and frequency were not reported), reconstituted with sterile diluent. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad for a day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for her sister in law. The age at vaccination was not reported. IT was reported that the patient received dose of Shin US2019163768 No further details were available. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; Pain at injection site.; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The emergency room physician called to report that the patient received Shingrix, and had pain and reddness, demarcated area approximately 7cm, on deltoid, for 5 days. The Shingrix was given at another location listed in adverse event.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Pain in extremity
Clinical narrative: Redness at the injection site had spread from the injection site down the arm to near the elbow; Arm soreness; pain at injection site; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and shivering. On 7th September 2019, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the injection site pain, erythema of extremities, shivering and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, erythema of extremities, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose one of Shingrix and experienced injection site pain.  The patient also reports shivering and arm soreness.   The patient reported that one day after, the redness at the injection site had spread from the injection site down the arm to near the elbow. The reporter had consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Dysstasia, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache; Nausea; Vomiting; Fatigue/ Tired; Difficulty standing; This case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 3rd September 2019, the patient received Bexsero. In September 2019, less than a day after receiving Bexsero, the patient experienced headache, nausea, vomiting, fatigue and difficulty in standing. On an unknown date, the outcome of the headache, nausea, vomiting, fatigue and difficulty in standing were recovering/resolving.   It was unknown if the reporter considered the headache, nausea, vomiting, fatigue and difficulty in standing to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that within 12 hours of receiving the Bexsero patient experienced headache, nausea, vomited once, felt fatigue and tired that she could not even stand up. The patients condition was slowly improving. No further details were provided.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Blepharospasm, Excessive eye blinking, Facial paralysis, Muscle twitching
Clinical narrative: Facial Drooping; Eye, facial and then shoulder twitching, his neck, nose and legs twitch as well.; facial and then shoulder twitching, his neck, nose and legs twitch as well; Eyes blink repeatedly; This case was reported by a consumer via call center representative and described the occurrence of facial droop in a 6-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number YZ7TR, expiry date 30th June 2019) for prophylaxis.   On 27th September 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular) .5 ml. On an unknown date, 5 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced facial droop (serious criteria GSK medically significant), blepharospasm, twitching and excessive eye blinking. On an unknown date, the outcome of the facial droop and blepharospasm were not recovered/not resolved and the outcome of the twitching and excessive eye blinking were unknown.   It was unknown if the reporter considered the facial droop, blepharospasm, twitching and excessive eye blinking to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by patient's father. The patient had eye, facial and then shoulder twitching.  The patient's eyes blink repeatedly and that his neck, nose and legs twitch as well. The patient also experienced facial drooping. The patient was referred to health care professional (HCP) and provided medical information (MI) phone number for HCP reference. The reporter inquired about post-marketing experience regarding how many patients reported nervous system disorders and how symptoms were managed. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Cough, Fatigue, Influenza, Nasal congestion
Clinical narrative: tired; mild flu; temp 100; nausea; sore throat; congestion and everything; cough; bronchitis; This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 62-year-old female patient who received Flu Seasonal QIV (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 6th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 6th September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis. On 7th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness, nausea, sore throat, nasal congestion, cough and bronchitis were not recovered/not resolved and the outcome of the influenza was unknown.   It was unknown if the reporter considered the tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The case was reported by patient herself who was a health care worker. The patient had received FluLaval Tetra 2019-2020 season on left deltoid. The patient felt tired, had mild flu, temp 100, nausea ,sore throat ,congestion and everything, cough, bronchitis. On the day of reporting, it was her first day she did not have fever. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: tired; mild flu; temp 100; nausea; sore throat; congestion and everything; cough; bronchitis; This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 62-year-old female patient who received Flu Seasonal QIV (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 6th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 6th September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis. On 7th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness, nausea, sore throat, nasal congestion, cough and bronchitis were not recovered/not resolved and the outcome of the influenza was unknown.   It was unknown if the reporter considered the tiredness, influenza, fever, nausea, sore throat, nasal congestion, cough and bronchitis to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The case was reported by patient herself who was a health care worker. The patient had received FluLaval Tetra 2019-2020 season on left deltoid. The patient felt tired, had mild flu, temp 100, nausea ,sore throat ,congestion and everything, cough, bronchitis. On the day of reporting, it was her first day she did not have fever. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: hearing loss; Drug dose administration interval too short; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received sometime in May).   In July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than 2 months after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and drug dose administration interval too short. On an unknown date, the outcome of the hearing loss and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The reporter had no information regarding lot numbers or expiration dates for the two doses of Shingrix. The patient experienced a sporadic loss of hearing, which she described as her hearing goes in and out. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The patient's doctor had an MRI done. The reporter consented to follow up. It was reported that the patient had not received Shingrix from her pharmacy.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: claims they had a Prevnar 13 reaction that was/at the placement/administration site; Symptoms included pain, swelling, etc. at the placement/administration site.; Symptoms included pain, swelling, etc. at the placement/administration site.; This is a Spontaneous report based on the information received from a contactable consumer by Pfizer.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot # X91013) via an unspecified route of administration at single dose on an unspecified date for immunisatio.   The patient medical history and concomitant medications were not reported.  The patient experienced PREVNAR 13 reaction and symptoms included as pain, swelling, etc. at the placement/administration site on 26Jun2019. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: Excessive redness, pain after 2 days of injection; Excessive redness, pain after 2 days of injection; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age (reported as 65, unit unknown) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W62465, expiry date not reported), via an unspecified route of administration on 15Apr2019 at a single dose for immunization. Medical history and concomitant medications were not reported. On 17Apr2019, the patient experienced excessive redness, pain after 2 days of injection. The patient had to come to office for acute visit on 19Apr2019. It was reported that the patient was prescribed with cefalexin (KEFLEX). No other vaccines were given on the day of shot. Clinical outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Redness , left deltoid; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age (reported as 71, unknown unit) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: W62465), via an unspecified route of administration on 26Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, left deltoid on an unspecified date. Nurse practitioner prescribed Keflex.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Axillary pain, Fatigue, Feeling abnormal
Clinical narrative: Patient called office next day states that she has been sweating every 30 minutes after receiving TDap and hurting under her armpit. Also states that the injection site was red, swollen, and warm to touch. Patient also states that she has taken Ibuprofen and Tylenol for pain. Patient was informed to go to the ER if any signs or symptoms of an allergic reaction occurs. Phone call to patient to inform her to go to her PCP or the ER.  9/5/19 Patient states that she was still not feeling well from receiving the injection. inquired if she went to urgent care, PCP or ER as instructed on 9.4.19, to be evaluated. Patient states that there was nothing wrong with the injection site but that her body is in pain and wants this reported to the FDA. Phone number was provided to the patient per her request. Also on 9/5/19 patient reports ti the ER and reports she had body aches, joint pain, and had red bumps to her forearms. States that she feels generally weak and fatigue, "not myself" and that she took 2 doses of 50mg of Benedryl and rash has resolved.  Per ER: "suspect immune reaction to recent immunization. no signs/symptoms of anaphylaxis. UA negative for infection as this was a concern because patient felt like it was her kidneys were hurting. Decadron give possibility of allergic rash itching."
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Immunisation reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called office next day states that she has been sweating every 30 minutes after receiving TDap and hurting under her armpit. Also states that the injection site was red, swollen, and warm to touch. Patient also states that she has taken Ibuprofen and Tylenol for pain. Patient was informed to go to the ER if any signs or symptoms of an allergic reaction occurs. Phone call to patient to inform her to go to her PCP or the ER.  9/5/19 Patient states that she was still not feeling well from receiving the injection. inquired if she went to urgent care, PCP or ER as instructed on 9.4.19, to be evaluated. Patient states that there was nothing wrong with the injection site but that her body is in pain and wants this reported to the FDA. Phone number was provided to the patient per her request. Also on 9/5/19 patient reports ti the ER and reports she had body aches, joint pain, and had red bumps to her forearms. States that she feels generally weak and fatigue, "not myself" and that she took 2 doses of 50mg of Benedryl and rash has resolved.  Per ER: "suspect immune reaction to recent immunization. no signs/symptoms of anaphylaxis. UA negative for infection as this was a concern because patient felt like it was her kidneys were hurting. Decadron give possibility of allergic rash itching."
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pain, Rash, Rash erythematous, Urine analysis normal
Clinical narrative: Patient called office next day states that she has been sweating every 30 minutes after receiving TDap and hurting under her armpit. Also states that the injection site was red, swollen, and warm to touch. Patient also states that she has taken Ibuprofen and Tylenol for pain. Patient was informed to go to the ER if any signs or symptoms of an allergic reaction occurs. Phone call to patient to inform her to go to her PCP or the ER.  9/5/19 Patient states that she was still not feeling well from receiving the injection. inquired if she went to urgent care, PCP or ER as instructed on 9.4.19, to be evaluated. Patient states that there was nothing wrong with the injection site but that her body is in pain and wants this reported to the FDA. Phone number was provided to the patient per her request. Also on 9/5/19 patient reports ti the ER and reports she had body aches, joint pain, and had red bumps to her forearms. States that she feels generally weak and fatigue, "not myself" and that she took 2 doses of 50mg of Benedryl and rash has resolved.  Per ER: "suspect immune reaction to recent immunization. no signs/symptoms of anaphylaxis. UA negative for infection as this was a concern because patient felt like it was her kidneys were hurting. Decadron give possibility of allergic rash itching."
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: Fever, headache, loss of appetite. 3 days for headache, 2 days for fever, 1 day for loss of appetite. Treated with 400 mg Ibuprofen. Resolved on its own.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Feeling of body temperature change, Heart rate increased
Clinical narrative: On 9/18, 5 hrs after injection: Dizziness (vertigo), rapid heart beat, nausea, hot/cold, a little difficulty breathing (chest tightening) On 9/19 most symptoms have subsided, just a little dizziness remains. No treatment
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vertigo
Clinical narrative: On 9/18, 5 hrs after injection: Dizziness (vertigo), rapid heart beat, nausea, hot/cold, a little difficulty breathing (chest tightening) On 9/19 most symptoms have subsided, just a little dizziness remains. No treatment
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: localized swelling, pain, itching, redness at injection site.  Painful facial lesions on same side that injection was give that developed redness and pus, later scabbing and scarring. Swelling on side of face where lesions were present, ear pain.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Pain, Pustule, Scab, Scar
Clinical narrative: localized swelling, pain, itching, redness at injection site.  Painful facial lesions on same side that injection was give that developed redness and pus, later scabbing and scarring. Swelling on side of face where lesions were present, ear pain.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Skin lesion, Swelling face
Clinical narrative: localized swelling, pain, itching, redness at injection site.  Painful facial lesions on same side that injection was give that developed redness and pus, later scabbing and scarring. Swelling on side of face where lesions were present, ear pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac arrest, Cardioversion, Immediate post-injection reaction, Laboratory test, Resuscitation
Clinical narrative: Patient arrives via EMS for post cardiac arrest CPR per EMS, patient was at work and received a flu shot from Pharmacist, Immediately after vaccine was administration patient collapsed and went unresponsive, EMS states initial rhythm on their arrival was VFIB, patient was shocked and rhythm was then Torsades, EMS states the patient was shocked 5 additional times, 2 grams magnesium IVPB given, 300mg amiodarone, and 2mg Narcan given by EMS prior to arrival at Hospital Emergency Room. Patient arrives with IO to right lower distal Tib Fib and nasal trumpet in place being bagged by EMS. Patient has a history of hypertension (taking hydralazine), EMS brought flu vaccine information that was being administered by the pharmacist at the patient's place of employment.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Torsade de pointes, Unresponsive to stimuli, Ventricular fibrillation
Clinical narrative: Patient arrives via EMS for post cardiac arrest CPR per EMS, patient was at work and received a flu shot from Pharmacist, Immediately after vaccine was administration patient collapsed and went unresponsive, EMS states initial rhythm on their arrival was VFIB, patient was shocked and rhythm was then Torsades, EMS states the patient was shocked 5 additional times, 2 grams magnesium IVPB given, 300mg amiodarone, and 2mg Narcan given by EMS prior to arrival at Hospital Emergency Room. Patient arrives with IO to right lower distal Tib Fib and nasal trumpet in place being bagged by EMS. Patient has a history of hypertension (taking hydralazine), EMS brought flu vaccine information that was being administered by the pharmacist at the patient's place of employment.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Photophobia, Pyrexia
Clinical narrative: Fever of over 103 degrees, shivering, joint paint, severe headache, sensitivity to light
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm red, firm, and swollen
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Malaise, Visual impairment
Clinical narrative: Mother called clinic approximately 15 min. after leaving clinic  (10:00 am) and reported child is not feeling well with symptoms including feeling clammy and vision is going black. Advised mother to seek medical treatment at nearest emergency room for child symptoms as we do not have a physician on staff.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Decreased appetite, Injection site pain, Pain, Pyrexia
Clinical narrative: Weakness, fever, vomit, no appetite, extreme pain in my entire body.  Soreness at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Weakness, fever, vomit, no appetite, extreme pain in my entire body.  Soreness at injection site.
Age: 1.33
Sex: F
Vaccine: DTAP, HEP, HIBV, VARCEL
Symptoms: Injection site mass
Clinical narrative: Mom reported small lump at injection site left leg 13 days after immunizations given. No redness or pain at site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Poor quality sleep
Clinical narrative: Bad headache at top of the skull; stiff neck; shivering  that kept me up several hours at night; fatigue the next day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: This was the 2nd vaccine of the 2 part series, the first being ~10/3/18.  I developed a mild case of shingles on the left side of my body primarily in the exact location that I had shingles the previous January 2018.  They resolved quickly.  The injection site erupted  2 times since the vaccination with a large sore that itched and scabbed like a shingles sore.  The 2nd time the injection site erupted in June I broke out with another case of shingles this time in 2 dermatomes on my face with a bit of random scattering on other places of my body (chest, back).  I have been on 3000 mg of Acyclovir for over 6 weeks now and am still having new blisters erupt 3 1/2 months after the breakout on 6/9/19.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab, Rash vesicular
Clinical narrative: This was the 2nd vaccine of the 2 part series, the first being ~10/3/18.  I developed a mild case of shingles on the left side of my body primarily in the exact location that I had shingles the previous January 2018.  They resolved quickly.  The injection site erupted  2 times since the vaccination with a large sore that itched and scabbed like a shingles sore.  The 2nd time the injection site erupted in June I broke out with another case of shingles this time in 2 dermatomes on my face with a bit of random scattering on other places of my body (chest, back).  I have been on 3000 mg of Acyclovir for over 6 weeks now and am still having new blisters erupt 3 1/2 months after the breakout on 6/9/19.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Fall, Loss of consciousness, Presyncope
Clinical narrative: At checkout patient had a vasovagal episode and passed out.  No trauma was noted.  She may have lost consciousness for a few seconds but awoke immediately upon falling on the ground.  She was placed in a exam room and was hemodynamically stable.  No trauma noted.  Most likely this was a vasovagal episode due to getting her flu and shingles vaccine.  She was observed for 10 minutes with normal hemodynamics and felt well.  Random blood sugar was 107.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on scalp.  Resulted in itchy scalp.  Treated with oral diphenhydramine and topical menthol shampoo.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Patient called stating that he thinks he may have had a reaction to the oral typhoid vaccine that he started taking yesterday.  He states that he took the first dose as instructed (on empty stomach, swallowed whole and with cool water) and approximately 45 minutes later, he experience dizziness, felt faint and he noted facial numbness.  He states that he laid down and his symptoms resolved within approximately 15 minutes but he is now wondering if he should continue the subsequent doses or if he should not take any more.  He denies that he had any fever, rash, facial swelling, fast heart beat, difficulty swallowing or difficulty breathing.   Patient did not get any other vaccines yesterday (9/18/19).  The most recent vaccination was administered on 9/5/19 (Td)
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature increased, Cough, Discomfort, Influenza, Nasal congestion
Clinical narrative: Symptoms of cold/flu within 24 hours of vaccination which included slight increase  in body temp, coughing, nasal congestion, restless sleep and sense of uneasiness.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Nasopharyngitis, Poor quality sleep, Restlessness
Clinical narrative: Symptoms of cold/flu within 24 hours of vaccination which included slight increase  in body temp, coughing, nasal congestion, restless sleep and sense of uneasiness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Pruritus
Clinical narrative: headache, flu like, red rash, hives, dizzy, very weak, itchy when the hives start to go away, NOT GOOD!!!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Urticaria
Clinical narrative: headache, flu like, red rash, hives, dizzy, very weak, itchy when the hives start to go away, NOT GOOD!!!
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Feeling very tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On the last Thursday, the patient received Shingrix. Till the time of reporting, the patient was feeling very tired and the patient asked was this normal.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 8-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2018-2019 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of FluLaval Quadrivalent 2018-2019 season (intramuscular) .5 ml. On an unknown date, less than 2 weeks after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced injection site erythema and injection site swelling. The patient was treated with amoxicillin trihydrate (Amoxicillin). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FluLaval Quadrivalent 2018-2019 season.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient received private dose of FluLaval. The patient experienced redness and swelling at injection site. No co-administration of other vaccines. The reporter stated that adverse event was a result of vaccine. The reporter denied permission to follow up. This case has been linked with case US2019AMR164466 reported by the same reporter.
Sex: U
Vaccine: RV1
Symptoms: Rotavirus test positive
Clinical narrative: Rotavirus detected after having received the first dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of rotavirus test positive in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced rotavirus test positive. On an unknown date, the outcome of the rotavirus test positive was unknown.   It was unknown if the reporter considered the rotavirus test positive to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as infant as per vaccine indication. The patient recently had rotavirus detected after vaccination with Rotarix. This case has been linked to US2019AMR164484, reported by the same reporter.      Lab Comments: On an unknown date, lab test was perfomed
Sex: U
Vaccine: RV1
Symptoms: Rotavirus test positive
Clinical narrative: Rotavirus detected after having received the first dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of rotavirus test positive in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced rotavirus test positive. On an unknown date, the outcome of the rotavirus test positive was unknown.   It was unknown if the reporter considered the rotavirus test positive to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as infant as per vaccine indication. The patient recently had rotavirus detected after vaccination with Rotarix. This case has been linked to US2019AMR164474, reported by the same reporter.      Lab Comments: On an unknown date, lab test was perfomed
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash, Rash pruritic
Clinical narrative: Rash on her entire body with mild itching; Rash seems to have spread into an entire mass of red; This case was reported by a pharmacist via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   The patient's past medical history included rash (experienced rash on an unknown date when she had a virus).   On 5th September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 6th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced itchy rash and generalized erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash and generalized erythema were recovering/resolving.   It was unknown if the reporter considered the itchy rash and generalized erythema to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose of Shingrix experienced rash on her entire body with mild itching. The patient on the same day received Flu vaccine and experienced injection site extremely red and rash. The patient took Benadryl and felt little better on the day of reporting. The patient did not experienced any trouble breathing. The reporter asked whether patient had a stronger reaction because she received the flu and shingles vaccines on the same day. The reporter asked whether patient should receive the 2nd dose if Shingrix in November or wait longer. The reporter thought that the patient might be little afraid to get the 2nd dose at all after the reactions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrophy, Back pain, Dysstasia, Gait inability, Herpes zoster
Clinical narrative: couldn't walk; leg has atrofied; shingles; back pain; leg pain; bump; prevented him from sleeping; unable to work; Couldn't stand; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 21 days after receiving Shingrix, the patient experienced unable to walk (serious criteria disability), atrophy (serious criteria disability), shingles, back pain, leg pain, swelling, sleep decreased, inability to work and difficulty in standing. The patient was treated with ibuprofen and gabapentin. On an unknown date, the outcome of the unable to walk, shingles, back pain and leg pain were recovered/resolved and the outcome of the atrophy, swelling, sleep decreased, inability to work and difficulty in standing were unknown.   It was unknown if the reporter considered the unable to walk, atrophy, shingles, back pain, leg pain, swelling, sleep decreased, inability to work and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: A little over 2 months before the time of reporting, the patient received a 2nd dose of Shingrix on an unknown arm. Less than three weeks after vaccination, the patient experienced back pain and shingales. Three weeks after vaccination, the patient experienced left leg hurt so bad that the patient could barely walk. The patient saw his physician and she saw the bump on his back that looked like a spider or insect bite. The patient did not develop a rash. The physician diagnosed it as shingles and prescribed him Gabapentin and Ibuprofen. The patient had pain in his left leg from his knee to his hip that was so bad and the patient could not stand or walk. The patient was unable to work because of the pain and it prevented him from sleeping. At the time of reporting, the patient was on his third month of having shingles and the pain was resolved, but his leg had atrophied so the patient had to build it back up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Insomnia, Pain in extremity, Swelling
Clinical narrative: couldn't walk; leg has atrofied; shingles; back pain; leg pain; bump; prevented him from sleeping; unable to work; Couldn't stand; This case was reported by a consumer via call center representative and described the occurrence of unable to walk in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 21 days after receiving Shingrix, the patient experienced unable to walk (serious criteria disability), atrophy (serious criteria disability), shingles, back pain, leg pain, swelling, sleep decreased, inability to work and difficulty in standing. The patient was treated with ibuprofen and gabapentin. On an unknown date, the outcome of the unable to walk, shingles, back pain and leg pain were recovered/resolved and the outcome of the atrophy, swelling, sleep decreased, inability to work and difficulty in standing were unknown.   It was unknown if the reporter considered the unable to walk, atrophy, shingles, back pain, leg pain, swelling, sleep decreased, inability to work and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: A little over 2 months before the time of reporting, the patient received a 2nd dose of Shingrix on an unknown arm. Less than three weeks after vaccination, the patient experienced back pain and shingales. Three weeks after vaccination, the patient experienced left leg hurt so bad that the patient could barely walk. The patient saw his physician and she saw the bump on his back that looked like a spider or insect bite. The patient did not develop a rash. The physician diagnosed it as shingles and prescribed him Gabapentin and Ibuprofen. The patient had pain in his left leg from his knee to his hip that was so bad and the patient could not stand or walk. The patient was unable to work because of the pain and it prevented him from sleeping. At the time of reporting, the patient was on his third month of having shingles and the pain was resolved, but his leg had atrophied so the patient had to build it back up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Flu-like symptoms; Low Grade Fever; Feeling of not wanting to do anything; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, fever and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. After receiving Shingrix, the patient experienced flu-like symptoms including a low grade fever. These symptoms resolved within 2 to 3 days. However he had the lingering feeling of not wanting to do anything for about one week. The patient also stated that, his physician told him that he had 10 patients with flu-like symptoms.  The patient would not provide any additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Immediate post-injection reaction
Clinical narrative: Experienced a reaction to Shingrix; This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The physician stated that, the patient's friend experienced a reaction to Shingrix and as a result got a lower dose, which led to underdose. No further details were provided, since it was reporter's patient's friend.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: redness at injection site; soreness at injection site; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema, injection site pain, muscle pain and tiredness. On an unknown date, the outcome of the injection site erythema, injection site pain, muscle pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for himself. The patient received Shingrix about 2 months before the reporting date. The patient experienced redness at injection site, soreness at injection site, muscle pain, tiredness. All of these events were resolved in about one week. The patient consented to follow up and provided his doctor's details.