chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection red, warm to the touch, swollen, and itchy. Pt started on Medrol Dosepak
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site red, warm to touch, swollen, and itchy Medrol Dosepak given
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dehydration, Dyspnoea, Feeling of body temperature change
Clinical narrative: elevated heart rate, difficulty catching breath, violent shaking, stabbing pains in joints and organs, inability to sleep, dehydration, hot and cold chills, headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Insomnia, Tremor, Visceral pain
Clinical narrative: elevated heart rate, difficulty catching breath, violent shaking, stabbing pains in joints and organs, inability to sleep, dehydration, hot and cold chills, headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Patient experienced a warm red band form below the site of injection as well the normal side effects of fatigue, fever, swelling, pain and redness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient experienced a warm red band form below the site of injection as well the normal side effects of fatigue, fever, swelling, pain and redness
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Flushing, Loss of consciousness, Posture abnormal, Urinary incontinence
Clinical narrative: At 1641 Tdap, and polio, in that order, were administered to the LD.  Pt did not shows signs of distress nor did she make any complaints. This nurse moved to the rt side and administered the Menveo, Havrix and Gardasil 9.  Bandages were applied.  Pt then started to droop her head and nurse moved to protect her from falling.  She then lost consciousness for approx 5 seconds  when she regained consciousness.  Face was flushed and pt had been observed to have urinated. Nurse was joined by BSN.  Pt was moved to the bed at 1643 and bed head was at 45 degrees.  She was alert, given water, a sucker and a granola bar.  Her  vitals were taken at 1646 BP 111/79, P 88, and Temp 97 degrees F.  Pt does not complain of dizziness or light-headedness.  Color is returning to normal.  BP 112/76 and pulse 88 at 1650. HOB was increased to 90 degrees, no complaints or dizziness or light-headedness BP 104/70 and P 80.  1652 BP 106/70 P 94. 1655 Pt stood, no complaints BP 106/70 P 94 at 1655.  Instructions were given to seek medical advice from dr if questions or concerns arose after hours and to contact this office tomorrow for any further questions.  Mom stated understanding and felt comfortable taking her daughter home.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling
Clinical narrative: pt had red swollen arm and chills the next day. pt was to ice arm
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hiccups
Clinical narrative: Patient has had hiccups since receiving the vaccine (6 days). They have not responded to treatments given to him by him MD including multiple medications
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest X-ray, Computerised tomogram, Computerised tomogram head, Fall
Clinical narrative: Fatigue adn nausea, fever. throughout night.  By 6am on Tuesday morning, EXTREME nausea, sweating, weakness, collapsed onto kitchen tiled floor, hit head and hip on kitchen tile floor.  Called ER, ambulacnce to hospital. .  Needed ctscan of head and neck, receiving excess radiation which should not have been needed if I had been fully informed of severity of possible effects.  Needed expense of ambulance, ctscan of head, neck, xray of chest and hospital ER stay..
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head injury, Hyperhidrosis, Joint injury, Nausea
Clinical narrative: Fatigue adn nausea, fever. throughout night.  By 6am on Tuesday morning, EXTREME nausea, sweating, weakness, collapsed onto kitchen tiled floor, hit head and hip on kitchen tile floor.  Called ER, ambulacnce to hospital. .  Needed ctscan of head and neck, receiving excess radiation which should not have been needed if I had been fully informed of severity of possible effects.  Needed expense of ambulance, ctscan of head, neck, xray of chest and hospital ER stay..
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue adn nausea, fever. throughout night.  By 6am on Tuesday morning, EXTREME nausea, sweating, weakness, collapsed onto kitchen tiled floor, hit head and hip on kitchen tile floor.  Called ER, ambulacnce to hospital. .  Needed ctscan of head and neck, receiving excess radiation which should not have been needed if I had been fully informed of severity of possible effects.  Needed expense of ambulance, ctscan of head, neck, xray of chest and hospital ER stay..
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pruritus, Injection site scab, Injection site swelling
Clinical narrative: PATIENT CLAIMS TO HAVE BLED ON DAY 2 AT INJECTION SITE. HAD SEEN PRIMARY CARE BUT DID NOT CORRELATE THE REACTION TO THE VACCINATION. PRIMARY CARE HAD RECOMMENDED SHE CONSULT A DERMATOLOGIST. PATIENT CAME TO THE PHARMACY FOR THE FIRST TIME SINCE VACCINATION TO CONSULT ABOUT ADVERSE REACTION. CURRENT STATE OF INJECTION SITE IS SWOLLEN WITH A BUMP, BLED YESTERDAY, SCABBED. PATIENT STATES IT IS ITCHY, WITH NO PAIN.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cyst, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: Patient states that his entire life has been turned upside down. Unable to use arm or do anything with it. Now says a cyst in arm after MRI.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Computerised tomogram, Confusional state, Disorientation, Dizziness, Hemiparesis
Clinical narrative: Confusion, dizziness, right sided weakness, and disorientation.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Confusion, dizziness, right sided weakness, and disorientation.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling and pain at injection site over the past 2 days. pt did not treat symptoms until after the 2nd day. following the 2nd day, he treated with ice packs (15-20min on/off) and tylenol. He refused to seek medical attention.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Dysphagia, Loss of consciousness, Throat tightness
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Anger, Angina pectoris, Asthenia, Cardiac discomfort, Crying
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Discomfort, Dizziness, Drooling, Dyskinesia, Dysphagia
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dyspnoea, Emotional distress, Feeling abnormal, Feeling cold, Heart rate increased
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Hypokalaemia, Hypopnoea, Loss of consciousness
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Movement disorder, Peripheral coldness, Pharyngeal swelling, Rhinorrhoea, Speech disorder
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Swelling face, Tongue movement disturbance, Tremor
Clinical narrative: Patient was extremely nervous before I administered the vaccine. Patient stated that she started feeling dizzy after the administration and stated that she "blacked out for a second." Made patient sit down and had water readily available to her. Patient was still communicative when asked questions. Patient stated about 10 mins later that she is having a hard time swallowing and feels like her throat is closing up. Told patient about the option of EPIPEN. Patient stated that she does not feel like she felt when she had her reaction to chicken (chicken reaction was worse). EPIPEN was administered - 1 dose only. 911 called and picked her up to go to ER.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash morbilliform
Clinical narrative: Patient developed a rash over upper part of her body (arms/chest).  She described rash as a "measle like" rash.  Pharmacy team was made aware of reaction to initial vaccine when they reached out to patient about receiving her second dose in the series.  Patient still wanted to receive second dose.  Patient was instructed to take Claritin and Benadryl before and after receiving vaccine.  After speaking with patient today (5/8/19) she reported she developed same rash the day after the vaccine was administered but had seen improvement.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Vaccination site swelling
Clinical narrative: Came with swelling and redness to left upper arm on the vaccine site, stated started around 11 am on 5/8/19 , seen by Dr in the clinic and diagnosed as cellulitis. Prescribed keflex  liquid 200 mg, PO, Q6hr x 10 days , circled the area to monitor and advised to return if worsening or not improving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: woke up the following morning with "itchy bumps on her injection arm that spread over the following 5 days down the right side of her body then to the rest of her body".  Gone now.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Erythema, Injection site reaction, Urticaria
Clinical narrative: Generalized hives - red welts - legs, buttocks, thighs, shoulders.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills, headache, muscle aches, nausea, tired, sharp shooting abdominal pains. Due to taking Meloxicam, I can't take other NSAIDS. I took Vicodin for the headache and muscle aches. By 5/8/16 a.m. all symptoms gone except for lingering headache which was gone by noon.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: chills, headache, muscle aches, nausea, tired, sharp shooting abdominal pains. Due to taking Meloxicam, I can't take other NSAIDS. I took Vicodin for the headache and muscle aches. By 5/8/16 a.m. all symptoms gone except for lingering headache which was gone by noon.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Ageusia, Condition aggravated, Eyelid function disorder, Facial pain, Facial paralysis
Clinical narrative: On previous visits i was told that i needed to get this shot since i was pregnant and the whooping cough was deadly in infants, i declined several times. On this particular date i felt pressured because i was so close to my due date (Jan 29) and i gave in and got it. My arm was very sore for a couple of days, and on December 11th  i began to have no taste buds. The very next day my jaw started to hurt really bad like a toothache. Few days later the right side of my face was in pain and i couldn't hear very well either. Then the next morning my eye was very watery and i couldn't fully close my eyelid. So i finally went to the hospital December 19th , 2018 and was diagnosed with Bell's Palsy.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoacusis, Lacrimation increased, Limb discomfort, Pain in jaw
Clinical narrative: On previous visits i was told that i needed to get this shot since i was pregnant and the whooping cough was deadly in infants, i declined several times. On this particular date i felt pressured because i was so close to my due date (Jan 29) and i gave in and got it. My arm was very sore for a couple of days, and on December 11th  i began to have no taste buds. The very next day my jaw started to hurt really bad like a toothache. Few days later the right side of my face was in pain and i couldn't hear very well either. Then the next morning my eye was very watery and i couldn't fully close my eyelid. So i finally went to the hospital December 19th , 2018 and was diagnosed with Bell's Palsy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Redness, swelling, pain in Lt arm around injection site. Chills x 3 days following injection. Blistering in mouth, nose, & on lips. Pain in posterior neck with looking up-red patch present on skin, posterior neck.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lip blister, Neck pain, Oral mucosal blistering
Clinical narrative: Redness, swelling, pain in Lt arm around injection site. Chills x 3 days following injection. Blistering in mouth, nose, & on lips. Pain in posterior neck with looking up-red patch present on skin, posterior neck.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Nausea, Pulmonary pain
Clinical narrative: Headache, nausea, shortness of breath, lung pain then fell asleep. Continued to have a headache and nausea
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: swelling - pain in arm
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Bronchitis, Chest X-ray normal, Chest discomfort, Chills
Clinical narrative: 6-7 hours after vaccination, tightnes in upper chest and throat. Developed fever of 102 and chills. Strong muscle pain in both arm. Symptoms subsided over 2-3 days except chest tightness and generally not feeling well.  08/23/2018 Fever gone but short of breath, chest tightness when laying down, dry cough and feeling ill. 08/23/2018 Family doctor said to use ProAir and use Benadryl. 08/25/2018 Temp of 100.5, fatigued, coughing and tightness. 08/26/2018 Went to Urgent Care due to increasing cough, chest tightness. Treatment: Z-PAK, steroid injection, Albuterol nebulizer & antihistamine routinely.  08/30/2018 Bronchitis and fever. Symptoms tightness in chest occurred for 2 1/2 months after Shingrix
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Fatigue, Malaise, Myalgia
Clinical narrative: 6-7 hours after vaccination, tightnes in upper chest and throat. Developed fever of 102 and chills. Strong muscle pain in both arm. Symptoms subsided over 2-3 days except chest tightness and generally not feeling well.  08/23/2018 Fever gone but short of breath, chest tightness when laying down, dry cough and feeling ill. 08/23/2018 Family doctor said to use ProAir and use Benadryl. 08/25/2018 Temp of 100.5, fatigued, coughing and tightness. 08/26/2018 Went to Urgent Care due to increasing cough, chest tightness. Treatment: Z-PAK, steroid injection, Albuterol nebulizer & antihistamine routinely.  08/30/2018 Bronchitis and fever. Symptoms tightness in chest occurred for 2 1/2 months after Shingrix
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Streptococcus test negative, Throat tightness
Clinical narrative: 6-7 hours after vaccination, tightnes in upper chest and throat. Developed fever of 102 and chills. Strong muscle pain in both arm. Symptoms subsided over 2-3 days except chest tightness and generally not feeling well.  08/23/2018 Fever gone but short of breath, chest tightness when laying down, dry cough and feeling ill. 08/23/2018 Family doctor said to use ProAir and use Benadryl. 08/25/2018 Temp of 100.5, fatigued, coughing and tightness. 08/26/2018 Went to Urgent Care due to increasing cough, chest tightness. Treatment: Z-PAK, steroid injection, Albuterol nebulizer & antihistamine routinely.  08/30/2018 Bronchitis and fever. Symptoms tightness in chest occurred for 2 1/2 months after Shingrix
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Loss of consciousness, Syncope, Tremor
Clinical narrative: Two brief episodes of syncope, loss of consciousness and shaking of arms and legs. Each episode lasted less than 10 seconds. Afterwards she was awake, alert and oriented x3.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: she had a little redness and swelling to injection site
Age: 2.25
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Cellulitis, Hypersensitivity, Rash
Clinical narrative: Taken to Urgent care after 1 week of rash. Was Diagnosed with cellulitis and allergic reaction on 10/19/18.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 90x80 Induration, Redness and warm
Age: 85.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Death
Clinical narrative: None stated.
Age: 5.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; received second dose of PROQUAD that had expired; Information has been received from a nurse referring to a 5 years old patient with unknown gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 10-APR-2019, the patient inadvertently received the second dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot number: N028444; expiration date: 09-APR-2019; strength was not reported), subcutaneously for prophylaxis which had expired (Expired product administered). No adverse effects reported. The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: rash; redness at the injection site; itching at the injection site; swelling at the injection site; chills; aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HZ, expiry date 9th June 2021) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On 22nd April 2019, the patient experienced injection site erythema, injection site itching and injection site swelling. On 28th April 2019, the patient experienced injection site rash. The patient was treated with hydrocortisone. On 23rd April 2019, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site rash were recovering/resolving and the outcome of the chills and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site rash, chills and pain to be related to Shingrix.  Additional details were provided as follows: A day later the symptoms went away, except the itchiness at the injection site. On Sunday (28th April 2019), the patient woke up with a rash on her arm, where the patient received the injection. The rash was pretty much throughout the deltoid muscle. The patient had used compresses and hydrocortisone on the rash and it was a bit better but the patient still had the rash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: rash; redness at the injection site; itching at the injection site; swelling at the injection site; chills; aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HZ, expiry date 9th June 2021) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On 22nd April 2019, the patient experienced injection site erythema, injection site itching and injection site swelling. On 28th April 2019, the patient experienced injection site rash. The patient was treated with hydrocortisone. On 23rd April 2019, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site rash were recovering/resolving and the outcome of the chills and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site rash, chills and pain to be related to Shingrix.  Additional details were provided as follows: A day later the symptoms went away, except the itchiness at the injection site. On Sunday (28th April 2019), the patient woke up with a rash on her arm, where the patient received the injection. The rash was pretty much throughout the deltoid muscle. The patient had used compresses and hydrocortisone on the rash and it was a bit better but the patient still had the rash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: rash; redness at the injection site; itching at the injection site; swelling at the injection site; chills; aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HZ, expiry date 9th June 2021) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On 22nd April 2019, the patient experienced injection site erythema, injection site itching and injection site swelling. On 28th April 2019, the patient experienced injection site rash. The patient was treated with hydrocortisone. On 23rd April 2019, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site rash were recovering/resolving and the outcome of the chills and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site rash, chills and pain to be related to Shingrix.  Additional details were provided as follows: A day later the symptoms went away, except the itchiness at the injection site. On Sunday (28th April 2019), the patient woke up with a rash on her arm, where the patient received the injection. The rash was pretty much throughout the deltoid muscle. The patient had used compresses and hydrocortisone on the rash and it was a bit better but the patient still had the rash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: rash; redness at the injection site; itching at the injection site; swelling at the injection site; chills; aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HZ, expiry date 9th June 2021) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a week after receiving Shingrix, the patient experienced chills and pain. On 22nd April 2019, the patient experienced injection site erythema, injection site itching and injection site swelling. On 28th April 2019, the patient experienced injection site rash. The patient was treated with hydrocortisone. On 23rd April 2019, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching and injection site rash were recovering/resolving and the outcome of the chills and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, injection site rash, chills and pain to be related to Shingrix.  Additional details were provided as follows: A day later the symptoms went away, except the itchiness at the injection site. On Sunday (28th April 2019), the patient woke up with a rash on her arm, where the patient received the injection. The rash was pretty much throughout the deltoid muscle. The patient had used compresses and hydrocortisone on the rash and it was a bit better but the patient still had the rash.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: gave shot in upper back sitting face to face Has Been experiencing pain since 4/16/19 Has progressively gotten worse going down whole arm
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: 5-10 minutes after vaccination patient developed erythematous rash in patches mainly over mid to upper back and chest area some raised spots 1mm. No facial swelling,wheeze, cough or fever. Pt was kept in observation for >1hour where frequent 10-15 minute assessments were made. The rash increased in area but didn't appear in other areas.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: 5-10 minutes after vaccination patient developed erythematous rash in patches mainly over mid to upper back and chest area some raised spots 1mm. No facial swelling,wheeze, cough or fever. Pt was kept in observation for >1hour where frequent 10-15 minute assessments were made. The rash increased in area but didn't appear in other areas.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Dysphagia, Loss of consciousness, Throat tightness
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Anger, Angina pectoris, Asthenia, Cardiac discomfort, Crying
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Discomfort, Dizziness, Drooling, Dyskinesia, Dysphagia
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dyspnoea, Emotional distress, Feeling abnormal, Feeling cold, Heart rate increased
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Hypokalaemia, Hypopnoea, Loss of consciousness
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Movement disorder, Peripheral coldness, Pharyngeal swelling, Rhinorrhoea, Speech disorder
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 29.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Swelling face, Tongue movement disturbance, Tremor
Clinical narrative: Within 10 seconds of the injection, my vision went black. I was "blacking out" and couldn't gain control of my body or mouth. I was unable to speak, my body felt strange sensation, extreme dizziness, breathing heavily, heavy rapid heartbeat. This was all within 60 seconds. Shortly immediately I sweated profusely and was dripping wet. Within 5-10 minutes of the shot, I went from sweating so badly to extreme cold. My entire body was shaking uncontrollably. My hands were cold to the touch, completely white nails, fingers, hands and arms. I was fidgeting non-stop, moving and shaking my legs and arms all over the place. Unable to get comfortable. I was asked questions by workers but was unable to answer for at least 5 minutes. I was unable to swallow the water I had, I bend my head down to force myself to swallow- It has been 22 hours since that- my throat is still not 100% functioning. I still am struggling to swallow. My speech was short, rapid and difficult to understand. As I gasped every few breaths. 15 minutes into the shot, my heart started pressure, I felt the familiar feeling of a heart being squeezed when I was hospitalized for a food allergy 10 years prior. I recognized the heart pain. My lungs were fine, my breathing was OK- just shallow and quick short breathes with dizziness. At this time, I could NOT feel my arms, or face. I was drooling, my nose was dripping, my tongue felt weak. I couldn't feel my mouth as I spoke. I shook for 15 minutes straight non-stop. I was emotional, crying to being ok, to angry- my emotions were all over the place. No hives but had weakness, difficulty breathing, extremely high heartbeat, swelling of throat and face, dizziness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Limb discomfort, Pain
Clinical narrative: Sore arm, headache, shivering, body ache - 2 days
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed red, raised area at injection site on 5/7/2019 as observed by a friend.  By morning (upon waking), patient developed itching at the injection site.  Encouraged patient to take ibuprofen & diphenhydramine for comfort and observe symptoms.  If no improvement in 2-3 days, encouraged patient to RTC or call PCP.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Extreme arm pain and weakness
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Lymph node pain, Pyrexia
Clinical narrative: Fever, chills, headache, nodes in back of neck hurting, flu like symptoms
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test negative, Therapeutic product effect incomplete
Clinical narrative: the vaccine was about 80 per cent effective; I also know the vaccine is safe; in the review of the HPV studies, severe adverse; Information has received from a physician. The physician concerned unspecified number of female patients of unknown age (also reported as older) who was beyond the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination age and they missed the opportunity to get the vaccine as kids. The patients' concurrent conditions, medical history and concomitant medications were not reported.  By coming through the data from one of two big drug industry-funded studies to measure the effectiveness of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine in older women, the physician realized that the vaccine was about 80 percent effective at preventing infection with Human papillomavirus (HPV) 16 and 18 in women whose cervical swabs were negative for these strains, regardless of past exposure (therapeutic product effect incomplete). The physician reported that in the review of the HPV studies, severe adverse events were rare and were not significantly higher in vaccine recipients than in those who received a placebo injection (adverse even).   The outcome of therapeutic product effect incomplete and adverse event was unknown. Causality assessment was not provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient was inadvertently administered a dose of GARDASIL 9, that was improperly stored.; This spontaneous report has been received from a registered nurse regarding to a patient of unknown age and gender. The patient's concurrent condition, medical history, concomitant medication, drug allergies or reactions were not provided.   On 25-APR-2019, the patient was vaccinated with an improperly dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (dose and anatomical location of vaccine were not provided) that could be one of these products; lot # N022583 and expiration date 20-JUN-2020; Lot # R020200 and expiration date 05-MAY-2021 or lot # 1586752 and expiration date 16-FEB-2021 for prophylaxis. The doses of the vaccines experienced a temperature excursion at (29.9 ° F) for a time frame of 19 minutes. The highest temperature excursion was above 47.6 °F (9 Celsius degrees) for 1 hour. The lowest temperature excursion was below 34.5°F (2 Celsius degrees) for 35 minutes. This report was called because of a data logger. There was no adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: my left arm is THROBBING in pain! It's been awhile since I've gotten any kind of shot, so not having full mobility in my left arm is quite the shock.; MY ARM! Starting to wonder if this is normal post-vaccination soreness; This spontaneous report was received from a consumer referring on herself a female patient via company representative. As concurrent condition she had asthma and allergy issues. As concomitant therapies she used binto vitamins, allergy medications, and eucalyptus oil. There was no information about the patient's previous drug reactions or medical history.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her left arm (formulation, strength, dose, frequency, route of administration, indication, lot #, and expiration date were not reported).    On an unknown date, 1 day after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) her arm was throbbing in pain (pain in extremity) and without full mobility (injected limb mobility decreased). Also, 2 days after the administration she still with pain in her arm.   The outcome and the causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were unknown.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose of PROQUAD; Information has been received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent condition and concomitant medication were not reported.   On 26-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose unknown; lot # N029155 with expiration date 16-APR-2019 ) subcutaneously for prophylaxis.  No known adverse effects were reported.