chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: I have swallow of about 2" and red; I have swallow of about 2" and red; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and experienced swelling of about 2 inches and redness. The reporter wanted ton know should he/she be concerned.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: felt a little fevers; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th May 2020, the patient received Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix around 6 p.m and felt a little fever this afternoon (on the day of reporting) which was recorded as 99.9 degree F. The reporter wanted any suggestion.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Having tingling after shower; This case was reported by a other health professional via interactive digital media and described the occurrence of tingling 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, unknown after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown.   It was unknown if the reporter considered the tingling 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 it was selected as an adult as per the vaccine indication. The patient received Shingrix and had tingling after shower.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Myalgia
Clinical narrative: muscle aches; Chills; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, immediately after receiving Shingrix, the patient experienced muscle pain and chills. On an unknown date, the outcome of the muscle pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle aches & chills. The reporter asked could I take some acetaminophen to help with those reactions.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Social problem
Clinical narrative: think I have shingles; 'pharmacy' never had second one; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine over 6 months ago and never had second one. The reporter asked would missing second shot make getting shingles more likely. The patient did not want to go physician office due to Covid 19.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: I also have headache; I've been feeling dizzy; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had feeling dizzy and still went to work and had been here all day. The patient also had headache. The reporter just wanted to make sure that the he/she did not had to run the emergency room or something. The reporter wanted to make sure that what he/she feeling was basically normal.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site cyst, Injection site mass, Muscular weakness, Pain
Clinical narrative: cyst the size of a quarter at the injection site / th issue with the lump in my arm is unique; arm weakness; difficulty raising arm; injection site lump; This case was reported by a consumer via call center representative and described the occurrence of injection site cyst in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had a mild shingles outbreak 14 years and took Valtrex with 72 hours). Previously administered products included Zostavax (received several years ago) and valtrex. Concomitant products included Herpes zoster (Shingrix).   On 22nd May 2019, the patient received the 2nd dose of Shingrix. On 21st December 2019, 213 days after receiving Shingrix, the patient experienced injection site cyst, weakness of arms, injected limb mobility decreased and injection site lump. On an unknown date, the outcome of the injection site cyst, weakness of arms and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site cyst, weakness of arms, injected limb mobility decreased and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and developed a cyst the size of a quarter at the injection site on her left arm that has not gone away. Her physician was recommending that she has the cyst surgically removed. The reporter consented to follow up. The patient received 2nd dose on 22nd May 2019. The patient reported this event to her physician and to Pharmacy. Initially the patient had frustration in talking with staff about my situation. But the more we talked, the more the patient realized that the adverse complaint had not gone to GSK. It went to the FDA. And he did not any way of checking the adverse complaint. And issue with the lump in arm was unique. It was not really reported in the information that GSK gives out, when people get the Shingrix vaccine, like experienced. And the patient had the vaccine early in the marketing of this drug, since the drug started in November of 2018 and got shot in March of 2019. But nonetheless, the more we talked, the more the patient realized that there probably more data but everything was anonymous to protect your privacy. The patient was going back to my doctor next month, to try and see what we can do about the pain and the problem that persists because of shot number one from Shingrix in my left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: may have had shingles after her first dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had Shingles.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Hyperhidrosis
Clinical narrative: Sharp abdominal pain after eating; Sweats; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MY7JS, expiry date 30th April 2022) for prophylaxis.   On 7th May 2020, the patient received the 2nd dose of Shingrix. On 9th May 2020, 2 days after receiving Shingrix, the patient experienced abdominal pain and sweating. On an unknown date, the outcome of the abdominal pain and sweating were unknown.   It was unknown if the reporter considered the abdominal pain and sweating to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and two days later started to be experienced sharp abdominal pain and sweats after she eats. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number A55XP, expiry date unknown) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 10th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the rheumatoid arthritis aggravated was unknown.   It was unknown if the reporter considered the rheumatoid arthritis aggravated to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient who was currently taking steroid medication because of a medical condition, Rheumatoid arthritis, and wanted to receive the second dose of Shingrix.   The pharmacist did not know how was the medical condition before Shingrix The reporter did not consent to follow-up.  No patient initials, and no vaccine expiration date was provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Erythema, Herpes virus infection
Clinical narrative: History of Herpes and had a re-occurrence; Redness; Chills; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 26th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced erythema, chills and herpes virus infection. On an unknown date, the outcome of the erythema and chills were recovered/resolved and the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the erythema, chills and herpes virus infection to be related to Shingrix.  Additional details were provided as follows: The patient called with an inquiry but mentioned that that when she received dose of Shingrix, she had redness and chills within the first 24 hours of receiving it.  The patient also stated that she has a history of Herpes and had a re-occurrence within 24 hours as well, noting that she has not had an outbreak in years.  The redness and chills lasted about 24 hours. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles vaccine many years ago).   On 10th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 12th February 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient experienced pain at injection site after getting the dose of Shingrix vaccine. The pain started the next day after vaccination and it lasted for total of one day. She has had the original Shingles vaccine many years ago. The reporter did not consent to follow-up.  The case has been linked with the case US2020080767 reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles vaccine many years ago).   On 10th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 12th February 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that his wife experienced pain at injection site after getting the first dose of Shingrix vaccine. The pain started the next day after vaccination and it lasted for total of one day. She has had the original Shingles vaccine many years ago. The reporter did not consent to follow-up. The case has been linked with the case US2020080763 reported by same reporter.
Age: 24.0
Sex: U
Vaccine: MMR, MNQ, TYP, YF
Symptoms: Chest pain, Flushing, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Pain in chest sharp + burning. Knot in throat, flush in face  0855 - called to see pt for Cp after immunization, 0900 - 120/82 - 84 - 99% CP continued mid chest radiating up to throat, sharp, 0915 - 105/68 - 80 - 99% CP  continued, flushed, itching, hives, Rolaids x 2, 0920 - insurance called per clinic - called EMS, 0925 - 107/74 - 99% - 88 - 22, - clearing throat - hives to (B) UE's, throat, jaw line, 0930 - 112/74 - 98% - 83 -20, Tums x 3, 0937 EMS arrived
Age: 24.0
Sex: U
Vaccine: MMR, MNQ, TYP, YF
Symptoms: Sensation of foreign body, Throat irritation, Urticaria
Clinical narrative: Pain in chest sharp + burning. Knot in throat, flush in face  0855 - called to see pt for Cp after immunization, 0900 - 120/82 - 84 - 99% CP continued mid chest radiating up to throat, sharp, 0915 - 105/68 - 80 - 99% CP  continued, flushed, itching, hives, Rolaids x 2, 0920 - insurance called per clinic - called EMS, 0925 - 107/74 - 99% - 88 - 22, - clearing throat - hives to (B) UE's, throat, jaw line, 0930 - 112/74 - 98% - 83 -20, Tums x 3, 0937 EMS arrived
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: sore and warm arm at site of injection, fever to 100.1F, achy joints.  just lasted a few hours the day after the vaccine.  all resolved now.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Lethargy, Nausea, Pain, Palpitations
Clinical narrative: Fever 100 deg, headache, extreme body ache, extreme lethargy, nausea, racing heart from this second of 2 series of Shingles immunizations 4 months apart.  Advil every 4 hours helped fever that began 15 hours after shot, and ended 60 hours later.  Severe headache remaining after other symptoms ended.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 100 deg, headache, extreme body ache, extreme lethargy, nausea, racing heart from this second of 2 series of Shingles immunizations 4 months apart.  Advil every 4 hours helped fever that began 15 hours after shot, and ended 60 hours later.  Severe headache remaining after other symptoms ended.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: headache; muscle ache; mild intermittent cold; mild fever; Chills; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included infliximab (Remicade).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, myalgia, cold, fever and chills. On an unknown date, the outcome of the headache, myalgia, cold, fever and chills were unknown.   It was unknown if the reporter considered the headache, myalgia, cold, fever and chills to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient was on Remicade and wanted to know recommendation of acetaminophen or ibuprofen. The patent was a retired critical care hospital representative and realize legally can only advise accordingly. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Dyspnoea, Foreign travel
Clinical narrative: symptomatic for COVID-19; short of breath; This case was reported by a consumer via call center representative and described the occurrence of suspected covid-19 in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included endoscopy.   In August 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In February 2020, between 6 and 7 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced suspected covid-19 and shortness of breath. On an unknown date, the outcome of the suspected covid-19 and shortness of breath were unknown.   It was unknown if the reporter considered the suspected covid-19 and shortness of breath to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine not confirmed as Fluarix or Flulaval in August.  The patient was in another country in February and symptomatic for COVID-19.  The patient experienced short of breath. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal fusion surgery
Clinical narrative: Spinal fusion back surgery with cage insertion; This case was reported by a consumer via call center representative and described the occurrence of spinal fusion surgery in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st February 2020, 92 days after receiving Shingrix, the patient experienced spinal fusion surgery (serious criteria hospitalization). On an unknown date, the outcome of the spinal fusion surgery was unknown.   It was unknown if the reporter considered the spinal fusion surgery to be related to Shingrix.  Additional information was provided as follows: The patient went through a spinal fusion back surgery with cage insertion. The patient was hospitalized for total of one day, and discharged next day. The reporter consented to follow up. No other details were provided. This case had been linked with US2020079555, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Diarrhoea, Fatigue
Clinical narrative: ON 5/14/2020 STARTED FEELING TIRED, AND THEN HAD DIARRHEA, NAUSEA, KNEES ACHE,PAIN IN R UPPER ABDOMEN, WEAKNESS, TEMPERATURE WAS 98.4( USUAL TEMP IS 96.9 ). STOOL AND URINE ARE NORMAL COLORS. EXPOSURE TO HEP A WAS ON MAY 1, 2020. CLIENT SPOKE WITH PMD AND WILL HOLD VIDEO APPOINTMENT TOMORROW.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea
Clinical narrative: ON 5/14/2020 STARTED FEELING TIRED, AND THEN HAD DIARRHEA, NAUSEA, KNEES ACHE,PAIN IN R UPPER ABDOMEN, WEAKNESS, TEMPERATURE WAS 98.4( USUAL TEMP IS 96.9 ). STOOL AND URINE ARE NORMAL COLORS. EXPOSURE TO HEP A WAS ON MAY 1, 2020. CLIENT SPOKE WITH PMD AND WILL HOLD VIDEO APPOINTMENT TOMORROW.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: Flu-like symptoms.  Severe body aches, chills, exhaustion, coughing, tight chest, headache, nausea
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: Flu-like symptoms.  Severe body aches, chills, exhaustion, coughing, tight chest, headache, nausea
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Rash erythematous
Clinical narrative: She was ding well until 5/15/20 when mother noted a red firm lump on the left leg where the injection was given. The red lump is still present. She has red bumpy rash around it. She has no fever.  No joint swelling. She is eating fine. Patient was prescribed hydrocortisone ointment and Benadryl for reaction.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Child was inadvertently given ActHIB instead of the flu vaccine.  Therefore, child received Pentacel, ActHIB, PCV13, and Rotateq today. Still needs flu vaccine. Mom was notified and states will RTC for flu vaccine.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site oedema
Clinical narrative: On 5/14/20 evening (approx 34hrs post vaccination), noted increasing fatigue and arm soreness with local reaction to injection site (redness approx 4-5cm diameter, edema, pain with arm movement). Poor sleep overnight, no night sweats. Treatment included 500mg acetaminophen. On 5/15/20 morning (approx 44hrs post vaccination) noted significant myalgia, chills, headache, fever (101.3 - 102.6F max throughout the day), right arm with expanding local reaction, up to 5-6cm patch, significantly tender to touch.  Employee Health contacted as it was a work day, suggested a COVID test due to fever (no URI symptoms). Test was negative. Treatment of 1gm acetaminophen given q6-8hr with 220mg naproxen q8-12hr. Slept well overnight. On 5/16/20 morning, awoke with only mild headache, right arm soreness/redness improving, Temp max of 100.7F. Mild myalgia returned, in afternoon/evening. Treatment requiring 1gm acetaminophen and 220mg naproxen at bedtime. 5/17/20 Complete resolution of fever, myalgia, right arm only with mild soreness/tenderness to touch, slightly fading 5cm patch of swollen skin. Afebrile.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Myalgia, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: On 5/14/20 evening (approx 34hrs post vaccination), noted increasing fatigue and arm soreness with local reaction to injection site (redness approx 4-5cm diameter, edema, pain with arm movement). Poor sleep overnight, no night sweats. Treatment included 500mg acetaminophen. On 5/15/20 morning (approx 44hrs post vaccination) noted significant myalgia, chills, headache, fever (101.3 - 102.6F max throughout the day), right arm with expanding local reaction, up to 5-6cm patch, significantly tender to touch.  Employee Health contacted as it was a work day, suggested a COVID test due to fever (no URI symptoms). Test was negative. Treatment of 1gm acetaminophen given q6-8hr with 220mg naproxen q8-12hr. Slept well overnight. On 5/16/20 morning, awoke with only mild headache, right arm soreness/redness improving, Temp max of 100.7F. Mild myalgia returned, in afternoon/evening. Treatment requiring 1gm acetaminophen and 220mg naproxen at bedtime. 5/17/20 Complete resolution of fever, myalgia, right arm only with mild soreness/tenderness to touch, slightly fading 5cm patch of swollen skin. Afebrile.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, SARS-CoV-2 test negative, Skin swelling, Tenderness
Clinical narrative: On 5/14/20 evening (approx 34hrs post vaccination), noted increasing fatigue and arm soreness with local reaction to injection site (redness approx 4-5cm diameter, edema, pain with arm movement). Poor sleep overnight, no night sweats. Treatment included 500mg acetaminophen. On 5/15/20 morning (approx 44hrs post vaccination) noted significant myalgia, chills, headache, fever (101.3 - 102.6F max throughout the day), right arm with expanding local reaction, up to 5-6cm patch, significantly tender to touch.  Employee Health contacted as it was a work day, suggested a COVID test due to fever (no URI symptoms). Test was negative. Treatment of 1gm acetaminophen given q6-8hr with 220mg naproxen q8-12hr. Slept well overnight. On 5/16/20 morning, awoke with only mild headache, right arm soreness/redness improving, Temp max of 100.7F. Mild myalgia returned, in afternoon/evening. Treatment requiring 1gm acetaminophen and 220mg naproxen at bedtime. 5/17/20 Complete resolution of fever, myalgia, right arm only with mild soreness/tenderness to touch, slightly fading 5cm patch of swollen skin. Afebrile.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Limb mass, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Right Arm swelling, lump and severe pain.  Persisting 2 mos later.  Weakness.  Pain has now migrated up into neck and then moved to left arm and then feet.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Complex regional pain syndrome, Computerised tomogram, Dyspnoea, Ear pain, Epstein-Barr virus infection
Clinical narrative: -Complex Regional Pain Syndrome  (May 2017) -ER Visit for Gastrointestinal Pain (October 2017) -ER Visit for Dyspnea (Nov. 2017) -Hospitalized with Viral Labial Swelling (February 2018) -Diagnosed with Epstein Barr Virus  & Elevated Mycoplasma Pneumoniae (March 2018) -Hospitalized with Chronic Pain (August 2018) -Hospitalized for Pain Rehabilitation?Management Program(September 2018) -ER Visit for Ear Pain (January 2019) -ER Visit for Head Pain (Nov. 2019) -Hospitalization for Gastrointestinal Pain (February 2020) -
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Gastrointestinal pain, Headache, Laboratory test, Magnetic resonance imaging, Mycoplasma test positive
Clinical narrative: -Complex Regional Pain Syndrome  (May 2017) -ER Visit for Gastrointestinal Pain (October 2017) -ER Visit for Dyspnea (Nov. 2017) -Hospitalized with Viral Labial Swelling (February 2018) -Diagnosed with Epstein Barr Virus  & Elevated Mycoplasma Pneumoniae (March 2018) -Hospitalized with Chronic Pain (August 2018) -Hospitalized for Pain Rehabilitation?Management Program(September 2018) -ER Visit for Ear Pain (January 2019) -ER Visit for Head Pain (Nov. 2019) -Hospitalization for Gastrointestinal Pain (February 2020) -
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Oedema genital, Pain, Ultrasound scan, X-ray
Clinical narrative: -Complex Regional Pain Syndrome  (May 2017) -ER Visit for Gastrointestinal Pain (October 2017) -ER Visit for Dyspnea (Nov. 2017) -Hospitalized with Viral Labial Swelling (February 2018) -Diagnosed with Epstein Barr Virus  & Elevated Mycoplasma Pneumoniae (March 2018) -Hospitalized with Chronic Pain (August 2018) -Hospitalized for Pain Rehabilitation?Management Program(September 2018) -ER Visit for Ear Pain (January 2019) -ER Visit for Head Pain (Nov. 2019) -Hospitalization for Gastrointestinal Pain (February 2020) -
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Food allergy
Clinical narrative: After having vaccinated the minor, the mother reports that she believes that she is allergic to eggs, since her other son is allergic to eggs. She also says that she believes that the minor is allergic because he gave it to her to eat and it made her want to vomit. Based on what mom specified, the next day we called to verify that patient had not presented any significant event that requires our attention, such as skin rashes and respiratory distress, which patient did not present. This report is sent is for corresponding action.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Body chills; low grade fever (99.8-100.8); mild headache; malaise; approximately 3 inch circular, hard, red and warm to touch area at injection site.  Area painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: Body chills; low grade fever (99.8-100.8); mild headache; malaise; approximately 3 inch circular, hard, red and warm to touch area at injection site.  Area painful.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Patient received vaccines on Friday afternoon at 3:00 PM and the patient woke up the following morning (Saturday) with localized swelling, redness and pain to both injection sites on the upper deltoids. The following day (Sunday) had full body urticaria rash which subsided only with Benadryl and Allegra but still had localized swelling and redness to upper deltoids. Patient came into the clinic on Monday due to swelling and redness had not subsided on both injection sites.
Age: 34.0
Sex: F
Vaccine: JEV1
Symptoms: Biopsy skin, Discomfort, Rash
Clinical narrative: Patient received second dose of Japanese Encephalitis. Pt states less than a month later her face broke out in a severe rash attended to in the ER. The patient continue to experience a noticeable and uncomfortable rash all over her face for over a year.  Rash has not responded to treatments from 2 different Primary Care Provider and 2 dermatologists.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Diarrhoea, Dysarthria, Food allergy, Hypersensitivity
Clinical narrative: I ate eggs which I?ve always eaten with No issues- and it caused throat constriction, both of my arms to break out in massive hives (I have photos), slurred speech, heart palpitations, muscle weakness, and diarrhea . I now can?t have eggs and more nut proteins like almonds and hazelnuts are now sensitive, when I was eating almond butter by the jar in December. Nothing is changed but the fact I got the Flu vaccine required for me to volunteer in the hospital.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Palpitations, Throat tightness, Urticaria
Clinical narrative: I ate eggs which I?ve always eaten with No issues- and it caused throat constriction, both of my arms to break out in massive hives (I have photos), slurred speech, heart palpitations, muscle weakness, and diarrhea . I now can?t have eggs and more nut proteins like almonds and hazelnuts are now sensitive, when I was eating almond butter by the jar in December. Nothing is changed but the fact I got the Flu vaccine required for me to volunteer in the hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: About 12 hours after receiving the vaccine, I felt extreme fatigue and chills. I also had a headache and muscle pain. I went to bed and woke up an hour later and had a temperature of 101.7 degrees F. I had muscle pain in my thighs and stomach as well as nausea. I took tylenol and went back to sleep. The next morning, my temperature was still elevated, 99.9 degrees F, but I felt better. By noon, all the symptoms had subsided.  I've never had a reaction to an immunization before.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: About 12 hours after receiving the vaccine, I felt extreme fatigue and chills. I also had a headache and muscle pain. I went to bed and woke up an hour later and had a temperature of 101.7 degrees F. I had muscle pain in my thighs and stomach as well as nausea. I took tylenol and went back to sleep. The next morning, my temperature was still elevated, 99.9 degrees F, but I felt better. By noon, all the symptoms had subsided.  I've never had a reaction to an immunization before.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Injection site erythema, Injection site pain, Lip discolouration, Lip pain
Clinical narrative: Four days of extreme soreness and redness around injection site (both doses). Second dose had a fever of 99.6 (normally is 97.5). Not sure if this is related, but four days later I am experiencing pain in my lower lip. It is purple inside and has sores on it. I have never experienced this before.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Four days of extreme soreness and redness around injection site (both doses). Second dose had a fever of 99.6 (normally is 97.5). Not sure if this is related, but four days later I am experiencing pain in my lower lip. It is purple inside and has sores on it. I have never experienced this before.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Henoch-Schonlein purpura, Purpura, Vasculitis
Clinical narrative: Pt developed purpuric vasculitis approximately 10-12 days after receiving vaccine. It started on legs then spread to arms and hips. Spoke to Dr. on 5/18/20 and it turns out dx is Henoch-Schonlein Purpura
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash @ forehead to mid nose - inner aspect of left eye  Valtrex 1 gm TID Medrol dose pack > treatment
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Allergy to vaccine, Chills, Headache, Urticaria
Clinical narrative: 11:54 AM Mom called. Patient complaiNed of having chills & headache to back of head. No difficulty Breathing. Advised ibuprofen & rest per MD. 2:58 PM Follow up Phone call. Hives to face later. No rash elsewhere. No Breathing difficulty. Benadryl 25 g was given Spoke with MD Labeled Trumenba allergy in chart. Advised ClaritiN or Zyrtec 10 mg daily x 5 - 7 days. Spoke with Mom 5/18/20 AM - Pt symptoms resolved the evening of 5/15/20. Hives have Not returned.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: 5/16/2020 awake c/o body aches, chills + fever, temp @ 101.0 + headache. Took one Tylenol. 5/18/2020 Better today with slight (L) deltoid soreness.
Age: 0.33
Sex: U
Vaccine: PPV, PPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 months old patient was vaccinated with PNEUMOVAX23 in error instead of PREVNAR 13; This spontaneous report was received from a medical assistant regarding to 4 months old patient of unknown gender. The patient's concurrent conditions, history conditions, concomitant medications, drug reaction and drug allergies were not reported.  On 14-MAY-2020, the patient was vaccinated for prophylaxis with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (IM) (dosage regimen was not provided, lot number: S033516, expiration date: 29-JUN-2021). The reporter stated the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in error instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (wrong vaccine administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 0.33
Sex: U
Vaccine: PPV, PPV, UNK
Symptoms: Wrong product administered
Clinical narrative: 4 months old patient was vaccinated with PNEUMOVAX23 in error instead of PREVNAR 13; This spontaneous report was received from a medical assistant regarding to 4 months old patient of unknown gender. The patient's concurrent conditions, history conditions, concomitant medications, drug reaction and drug allergies were not reported.  On 14-MAY-2020, the patient was vaccinated for prophylaxis with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (IM) (dosage regimen was not provided, lot number: S033516, expiration date: 29-JUN-2021). The reporter stated the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in error instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (wrong vaccine administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Non-stop screaming, wailing, inability to console through the entire night (4-5 hours)
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported.; an expired dose of VARIVAX was administered on 5/5/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 05-MAY-2020, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N022983 with expiration date: 23-AUG-2019, strength, dose and route were unknown) for prophylaxis. Merck sterile diluent (lot # and expiration date were unknown) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; on 4/24/2020 a patient was administered a dose of improperly stored Varivax; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 24-APR-2020, the patient was administered a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# S028920, expiration date 16-SEP-2021, strength and dose were not provided) subcutaneously for prophylaxis. The Merck sterile diluent (lot # and expiration date were unknown) used for administration was properly stored.  The improperly stored of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -8.1 degree Celsius for 1 hour and 30 minutes. There was no previous temperature excursion reported. The digital data logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient received improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   07-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# S028926, expiration date 16-SEP-2021, for prophylaxis (strength, dose, route and frequency were not reported), reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# S002624 and expiration date reported as 05-NOV-2021).  The temperature excursion was of 15 Fahrenheit degrees (°F) to 46°F (9°C to 8°C) 21.5°F, during 25 minutes. However, a previous temperature excursion of 6°F to 14°F (-14°C to -10°C) 6.6°F for 5 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Laboratory test, Milk allergy, Respiratory syncytial virus infection
Clinical narrative: diarrhea, bloody stools; RSV (Respiratory syncytial virus); milk allergy; This spontaneous report was received from a physician referring to a 6-weeks-old patient whose gender was not specified. Information about the patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was not provided.  On an unspecified date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, as rotavirus prevention (dose, vaccination scheme frequency, lot number and expiration date were not reported).  On unspecified subsequent dates, the patient experienced diarrhea, bloody stools (haematochezia) and developed respiratory synctial virus (RSV). The patient sought for medical care and was hospitalized (inconsistent information, as it was also reported being unknown if the patient was already hospitalized and a prolonged hospitalization occurred after rotavirus vaccine, live, oral, pentavalent (ROTATEQ) use) and after unspecified tests were performed was diagnosed with a milk allergy. The patient received an unspecified treatment.  The event of haematochezia resolved on an unspecified time, by the time of reporting the physician stated that next dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had been given to the patient and the patient had not had any gastrointestinal symptoms. Besides, since the patient's diagnose had been made the outcome of respiratory syncytial virus infection and milk allergy were reported as resolving. The causal relationship between the administered vaccine and the occured events was not provided by the reporter.  Upon internal review, the event haematochezia was determined to be medically significant.
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses of GARDASIL 9 on 5/12/2020; patient received two doses of GARDASIL 9 on 5/12/2020; patient received two doses of GARDASIL 9 on 5/12/2020; This spontaneous report was received from a physician and refers to a 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 12-MAY-2020, the patient received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (the second dose with lot #1621934 verified to be a valid lot number for syringe and expiration date 29-JAN-2022) (lot # and expiration date for the first dose, strength, exact doses, site of administration were not provided) for prophylaxis (overdose and inappropriate schedule of product administration). No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient recived a dose of improperly stored PROQUAD; No additional adverse effect reported; This spontaneous case was received from an healthcare worker regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 27-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S009756 with expiration date on 27-SEP-2020) administered subcutaneously for prophylaxis (strength and dose were not reported). The vaccine was reconstituted with a properly stored sterile diluent. The vaccine was exposed to a temperature between 6 °F and 14 °F (with an average temperature of 11.3 °F) for 12 hours and 30 minutes. No previous temperature excursion was reported. No adverse effect was reported. The report was received due to a data logger.   Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S009756) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2005USA004443: