chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Cough, Lip swelling, Peripheral swelling, Pharyngeal swelling, Throat tightness
Clinical narrative: At 8:30PM patient exhibited a cough and throat tightness. Symptoms continued through the night. Patient woke up with full body hives, lip swelling, swollen throat, and left arm swelling. Patient has had the flu shot vaccine in the past with no issues. The Shingrix is a new vaccine for this patient.
Age: 54.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: At 8:30PM patient exhibited a cough and throat tightness. Symptoms continued through the night. Patient woke up with full body hives, lip swelling, swollen throat, and left arm swelling. Patient has had the flu shot vaccine in the past with no issues. The Shingrix is a new vaccine for this patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Brachioradial pruritus, Injection site reaction, Paraesthesia, Rash, Rash pruritic
Clinical narrative: One week after patient received vaccine she developed an itchy, tingling rash down entire right arm.  Diagnosed with Brachioradial pruritis.  This rash continues to persist 7 weeks after onset.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in right hand
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: PATIENT REPORTS SHINGLES BREAKOUT ON RIGHT ARM 2 TO 3 DAYS FOLLOWING VACCINE.  THIS IS NOT THE ARM VACCINE WAS GIVEN IN.  PATIENT STATES HAVING RECEIVED ZOSTAVAX IN THE PAST AND ALSO HAVING 2 CASES OF ACTIVE SHINGLES.  THE CURRENT 'BUMPS' ARE BURNING AND STINGING.  PATIENT SAYS THE RASH IS TOLERABLE AND DOES NOT PLAN TO SEE HER PHYSICIAN.  SHE HAS APPLIED HYDROCORTISONE TO THE AREA WHICH HAS HELPED.  THIS RASH IS AT A DIFFERENT LOCATION THAN THE PREVIOUS 2 CASES OF SHINGLES.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Cardiac monitoring, Dizziness, Dyspnoea, Tremor
Clinical narrative: I waittl my bathroom on the 25th and I had a hard time breathing. I went out of the bathroom and I felt a little better. I went to work and at about 12:30 I began to feel dizzy and I thought I was going to faint. I went to sit down and I started shaking uncontrollably. The next about 5 minuted I could hardly breath. I had people trying to help me. My daughter took me to the ER. I could not walk, I was shaking so bad. When I was in the ER I could not breath again. I was terrified. They took tests lots of blood work and a heart monitor. I was in the hospital for 2 days.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Dizziness, Dyspnoea, Syncope, Tremor
Clinical narrative: I waittl my bathroom on the 25th and I had a hard time breathing. I went out of the bathroom and I felt a little better. I went to work and at about 12:30 I began to feel dizzy and I thought I was going to faint. I went to sit down and I started shaking uncontrollably. The next about 5 minuted I could hardly breath. I had people trying to help me. My daughter took me to the ER. I could not walk, I was shaking so bad. When I was in the ER I could not breath again. I was terrified. They took tests lots of blood work and a heart monitor. I was in the hospital for 2 days.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Nausea, Tachycardia, Vomiting
Clinical narrative: GI - nausea/vomiting, tachycardia, and injection site rash within 30 min of injection
Age: 88.0
Sex: M
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Blister, Blister rupture, Furuncle, Skin discolouration, Swelling
Clinical narrative: Patient's arm developed dark streaks, swelling, and a blister/boil that later opened. Seen by Dr 8/28/19, treatment and outcomes pending/unknown.
Age: 88.0
Sex: M
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Injection site erythema, Injection site rash, Vaccination complication, Vasculitis
Clinical narrative: Patient's arm developed dark streaks, swelling, and a blister/boil that later opened. Seen by Dr 8/28/19, treatment and outcomes pending/unknown.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Headache, Lethargy, Pyrexia
Clinical narrative: I was informed by the pharmacist that it was likely I would have extreme soreness at the site.  I was not informed that other common reactions were fever, chills, headache, vomiting.  I awoke with 102 fever, which persisted about 36 hours, a pounding headache, lethargy, chills.  I was home alone because I was not prepared for these symptoms.  I was lethargic, slipping in and out of sleep from about midnight Friday to around 5 pm Saturday.  During that time, I had nothing to eat or drink.  I was confused and not together enough to realize I needed someone with me.  With dehydration being a real concern for someone my age, this could have been a real risk.  In my opinion, people should be encouraged to have someone with them in the 24 hour period after taking the Shingrix vaccination.   I am a healthy, active person, and it would have been so simple for me to stay with friends, had I known about these likely reactions.  For me not to call for help tells me I was zoned out by the vaccine.  It is Wednesday and I am fine, if still a little lethargic.  I am reluctant to take the second vaccination in 2 to 6 months for fear this will happen again.  I had both my children with no pain medication, so I am not a crybaby.  In the summer of 2017, I drove alone to Lake and across to campground where I camped out a couple of weeks before driving to another city and then home.  I am not typically helpless. This episode really frightened me for my own safety.  I was told to have someone with me after I had cataract surgery, and this was exponentially much worse than that recovery.  These were listed as "common" reactions (fever, headache, chills) on the GlaxoSmithKline website but I was not informed.  I'm not reporting the vaccine as dangerous, but it should be accompanied with a more specific recommendation for precautionary action by recipients, especially elderly recipients.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: INJECTION SITE WAS REALLY RED FOR 1 DAY, ABOUT 4 - 5 INCH IN LENGTH
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Pyrexia
Clinical narrative: fever, upset stomach, loss of appetite
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Very sore arm at injection site within 2-3 hours. Developed fever of 99.6°F the morning after injection. Fever/malaise/body aches persisting 24 hours after injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Husband described flu-like symptoms (not mild) with a rash.  Stated they were going to reach out to the patient's doctor.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Angiogram cerebral normal, Aphasia, Arteriogram carotid normal, Borrelia test negative
Clinical narrative: Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative, Computerised tomogram head abnormal
Clinical narrative: Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cytology normal, Drug screen negative, Electroencephalogram abnormal, Generalised tonic-clonic seizure, Herpes simplex test positive
Clinical narrative: Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test normal, Lacunar infarction, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction
Clinical narrative: Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Scan with contrast abnormal, Treponema test negative
Clinical narrative: Awoke the morning after the Shingrix vaccine was administered and carried out his usual routine. He developed word-finding difficulty and left facial numbness. He had a witnessed tonic-clonic seizure in the Hospital ER.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Malaise, Tachycardia, White blood cell count increased
Clinical narrative: Pt states she started feeling sick 3 days after the 2nd dose of the shingrix vaccination and ended up in the ER with tachycardia, cough and increased WBC. Pt states ER doctors did not believe this was due to the shingrix vaccination, but pt does think it is due to the vaccination. Pt got fluids in ER and felt better. She did not have a reaction with the first dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore, red arm at site of injections
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient started to have arm pain the day after the shot.  Two days later she developed redness that started at the top of her arm and ran all the way down to her elbow. She is still in pain and has redness 4 days later
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Stevens-Johnson syndrome
Clinical narrative: STEVENS-JOHNSON SYNDROME; This case was retrieved from a VAERS download on date 28JUN2019.   A 49-year-old female who developed Stevens-Johnson Syndrome, following the administration of BioThrax (anthrax vaccine adsorbed).  On 12JAN2019, the patient received BioThrax  On 12JAN2019, she developed Stevens Johnson Syndrome. She was in hospital for less than 24 hours. Outcome was unknown.  The patient's medical history included high blood pressure,  There was no known drug allergy reported.  Current illness included occasional alcohol use.  Concomitant medications included Lisinopril and hydrochlorothiazide (HCTZ).  FOLLOW UP 19AUG2019: Results of an internal investigation completed 19AUG2019: Lot number is unknown, so no lot linkage can be performed.  The root cause of the adverse event cannot be determined as no medical records or medical assessment were provided in the VAERS report.  No corrective actions are required as no safety signals have been identified for Stevens-Johnson syndrome and it is already a listed event on the product insert.   Company Comments: The described event "Stevens Johnson Syndrome" is a known effect of BioThrax vaccine, and therefore considered to be causally related to the administration of BioThrax.; Sender's Comments: The described event "Stevens Johnson Syndrome" is a known effect of BioThrax vaccine, and therefore considered to be causally related to the administration of BioThrax.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Asthenia, Palpitations
Clinical narrative: Guillain-Barre syndrome. Patient went to the hospital and was diagnosed with syndrome after receiving vaccine.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome. Patient went to the hospital and was diagnosed with syndrome after receiving vaccine.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Decreased appetite, Influenza like illness, Malaise, Urethral stenosis
Clinical narrative: Flu-like symptoms, malaise, urethral stricture, no appetite, upset stomach
Age: 4.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: rednessat the injection site; swelling at the injection site; This spontaneous report was received from a safety clinical coordinator and a nurse referring to a 4 years old female patient. Her concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 14-AUG-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) ; 1 dose subcutaneously for prophylaxis.  (strength, anatomical location were not reported); Lot  number S006833  has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date as reported  02-SEP-2020 , and upon internal validation established as the same. Other suspect therapies included sterile diluent, with Lot number: N030845 and expiration date: 12-JUN-2020 lot number: N028091 and expiration date:10-MAR-2020; lot number: N028744 and expiration date: 11-MAR-2020; and lot number: N028746  and expiration date: 17-MAR-2020; which the lot check  for all numbers was requested by the reporter and upon internal review all number were verified.   On 14-AUG-2019,  the patient experienced "redness and swelling at the injection site".  The events were treated with Benadryl and ice; Laboratory diagnostic or studies were not reported. The outcome of injection site erythema and injection site swelling was reported as resolved on the same day.  The casualty assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), the sterile diluent and the occurred events was not reported. This is one of several same reporter cases.; Sender's Comments:  US-009507513-1908USA007079: US-009507513-1908USA007529:
Sex: F
Vaccine: HPV9, MENB
Symptoms: Seizure, Syncope
Clinical narrative: had a seizure in the office; the patient fainted; This spontaneous report has been received from  a physician via a company representative a 21-year-old female patient. Information about concomitant medication, medical history and drug reactions /allergies were unkown by the reporter.  On 05-AUG-2019, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), by intramuscular route indicated to prevent Human Papillovirus (HPV). (concentration, indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported). On the same day, she was vaccinated with meningococcal b rfhbp vaccine (e. coli) (TRUMENBA). (concentration, indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported).  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) and the reported events was not reported.  Upon internal review, Syncope and Seizure were determined to be medically significant events
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irrigation
Clinical narrative: Vaccine sprayed in Nurse's eye; Vaccine sprayed in Nurse's eye; Vaccine sprayed in Nurse's eye; This spontaneous report was received from a medical assistant regarding a female nurse of unknown age. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 23-AUG-2019, the nurse vaccinated a patient with varicella virus vaccine live (Oka/Merck) (VARIVAX), lot# R035223 with expiry date of 04-DEC-2020 for prophylaxis. During vaccination a minute amount of reconstituted vaccine sprayed in her eye (Accidental exposure to product, Occupational exposure to product and Exposure via eye contact). The nurse flushed her eye. The nurse sought medical attention by consulting a MD in office. Medical assistant reported that the patient had received full dose. No product quality complaint (PQC) was identified.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness; Pain; Swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. In July 2019, unknown after receiving Bexsero, the patient experienced erythema, pain and swelling. On an unknown date, the outcome of the erythema, pain and swelling were unknown.   It was unknown if the reporter considered the erythema, pain and swelling to be related to Bexsero.  Additional case details were reported as follows: The healthcare professional could not provide patient demographics, the number of patients, lot numbers, or expiration dates. The age at vaccination was not applicable for this report. The reporter reported several patients experienced a variety of events following Bexsero administration.  The patients experienced redness, pain, and swelling. The healthcare professional described pain as lasting for a couple of weeks in one patient.  The healthcare professional noted these events had been takes place over the last month, no specific time frame reported. No start or end date of any of the events provided. The reporter gave permission to follow up. This case had been linked to the case US2019151259, US2019151261 and US2019AMR157403 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: breakout; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a an unspecified number of adult patients 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 skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not provided, but selected as an adult as per vaccine indication. The reporter reported that, the nurse at his doctor's office told him that, she had seen cases of the patients breaking out after getting Shingrix vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness; Injection site swelling; felt like he had the flu; Wrong Route of Administration; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 17th August 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 18th August 2019, the patient experienced influenza like illness. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling, influenza like illness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and influenza like illness to be related to Shingrix.  Additional information received were as follows: The caller was physician and also the patient. The patient received Shingrix on left arm this past weekend of the reporting date at a local pharmacy. The patient stated that he was given the injection subcutaneously in her left arm just above the elbow toward the back of the arm, which led to inappropriate route of vaccine administration. The patient did not had the paperwork from the pharmacy. Less than a day after receiving Shingrix, the patient noted that he experienced slight swelling and redness at the injection site. The patient reported that the day after his injection, he felt like he had the flu. The patient called on the reporting date inquiring about the efficacy of the vaccine given subcutaneously. This was related to patient. The caller was warm thanked to MIS.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Influenza like illness, Swelling
Clinical narrative: Swelling; Redness; mild Flu-like Symptoms; Wrong route of administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 15th June 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling, erythema, influenza-like symptoms and intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling, erythema, influenza-like symptoms and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling, erythema and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was in their 60's. The pharmacist reported that another pharmacist gave the second dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient reported redness, swelling and mild flu-like symptoms after receiving the vaccine. The reporter consented to follow up.   The pharmacist did not have any further of the data for the report.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: muscle aches; chills; This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date unknown) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced muscle pain and chills. On an unknown date, the outcome of the muscle pain and chills were recovered/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 health care professional did not provide expiry date of Shingrix. After vaccination with dose of Shingrix, the patient experienced muscle aches and chills for 1 week. The patient refuses to receive 2nd dose of Shingrix.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Cerebrovascular accident, Gait inability, Head discomfort, Headache
Clinical narrative: felt like she was going to have a stroke; weakness; head throbbing; could not walk; head felt like it would explode; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix. On 4th April 2019, 1 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and weakness. On 5th April 2019, the patient experienced head throbbing, unable to walk and head pressure. On an unknown date, the outcome of the stroke, weakness, head throbbing, unable to walk and head pressure were recovered/resolved.   It was unknown if the reporter considered the stroke, weakness, head throbbing, unable to walk and head pressure to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Shingrix in the pharmacy. On the same night of the day of vaccination, the patient felt weak and the next day the weakness was worse that the patient could not walk without assistance. On 5th April 2019, the patient's head was throbbing and get worse and felt like was going to to have a stroke and her head felt like it would explode. The patient took 2 weeks, to feel better. The patient did not want to take 2nd dose, and get encouraged to discuss this with health care professional. The patient consented to follow up. The patient know the 2 other patients with adverse events after the Shingrix shot, she would give them the number to report their experiences. Hence 2 cases were created for same. This case was 1 of the 3 cases reported  by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: felt like she was going to have a stroke; weakness; head throbbing; could not walk; head felt like it would explode; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix. On 4th April 2019, 1 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and weakness. On 5th April 2019, the patient experienced head throbbing, unable to walk and head pressure. On an unknown date, the outcome of the stroke, weakness, head throbbing, unable to walk and head pressure were recovered/resolved.   It was unknown if the reporter considered the stroke, weakness, head throbbing, unable to walk and head pressure to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Shingrix in the pharmacy. On the same night of the day of vaccination, the patient felt weak and the next day the weakness was worse that the patient could not walk without assistance. On 5th April 2019, the patient's head was throbbing and get worse and felt like was going to to have a stroke and her head felt like it would explode. The patient took 2 weeks, to feel better. The patient did not want to take 2nd dose, and get encouraged to discuss this with health care professional. The patient consented to follow up. The patient know the 2 other patients with adverse events after the Shingrix shot, she would give them the number to report their experiences. Hence 2 cases were created for same. This case was 1 of the 3 cases reported  by same reporter.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles/ Shingles rash; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date 15th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On 23rd August 2019, 8 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that, the patient experienced shingles, defined as shingles rash, 1 week after the vaccination with dose of Shingrix. The health care professional stated that, rash was not worsened or improved since it developed, it was diagnosed as shingles by primary care physician on 23rd August 2019.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asthma, Cough, Hypersensitivity
Clinical narrative: Cough Asthma  Allergies
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea
Clinical narrative: PATIENT CALLED STORE AND COMPLAINED OF NAUSEA AND DIZZINESS. SHOT WAS GIVEN 8/27/19 2:15PM AND SHE EXPERIENCED SYMPTOMS 8/28/19 IN MORNING TIME. PATIENT ALSO SAID SHE EXERCISED RIGHT BEFORE IN BED THEN GOT DIZZY/NAUSEATED WHEN GETTING UP.  PATIENT DID NOT HAVE A BLOOD PRESSURE MACHINE OR GLUCOMETER TO CHECK LEVELS. PATIENT LOGGED A CALL TO MD AND WILL CALL HOSP IF SYMPTOMS WORSEN
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: The liquid component of one lot of Menveo was mixed with the powder component of another lot of Menveo. The two lots involved were lot AMVA087A and lot AMVA013A. Therefore, the complete vaccine was administered, just out of two different lots. The patient's parent was notified and mailed a letter explaining the event, and it was reported that the patient experienced no adverse effects from the Menveo vaccine. The patient's parent notified the patient's physician. The extra components out of each lot involved were wasted appropriately.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: After the last vaccine which was HPV, patient had syncopal episode and jerking movement for few seconds. ammonia given and patient's conscious returned. placed patient on recliner chair with Trendelenburg position. initial BP was 74/58, HR:101. patient and mother stated that she did not eat before vaccination. water and gonorla bar were provided. BP rechecked 108/76. HR:88. Patient stated that she felt much better. Denies pain or discomfort. Advised patient to rest yesterday. if any abnormal signs are found again, patient and parents were told to call the clinic or pmd or go to nearest ER. They verbalized understanding.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Client was administered adult hepatitis A vaccination instead of pediatric hepatitis A vaccination
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema
Clinical narrative: Injection was given in right gluteal muscle. Client presented 24 hours following injection (8/29/19) with a softball size area of localized redness around the injection site. Point of injection could be visualized within reddened area. Client did not report any itching at injection site. Client reported experiencing chills on 8/28/19 but did not take her temperature. It was recommended to client that she follow up with her doctor on 8/29/19.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Anaemia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient had severe pain and swelling at the injection site. It was red and hot to the touch. It later spread to the back of the arm and down the arm. I frequently run a low grade fever. I am now being treated for anemia. At its peak, all I wanted to do was sleep, took frequent naps during The day. As of today 8/28/19, I am beginning to feel better, pain in muscles is lessening. However, now my left leg is swollen from the knee to the foot - no injury involved. Had a DVT Ultrasound, no sign of blood clots. For multiple lab tests and results, contact office of DR.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Myalgia, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: The patient had severe pain and swelling at the injection site. It was red and hot to the touch. It later spread to the back of the arm and down the arm. I frequently run a low grade fever. I am now being treated for anemia. At its peak, all I wanted to do was sleep, took frequent naps during The day. As of today 8/28/19, I am beginning to feel better, pain in muscles is lessening. However, now my left leg is swollen from the knee to the foot - no injury involved. Had a DVT Ultrasound, no sign of blood clots. For multiple lab tests and results, contact office of DR.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: The patient had severe pain and swelling at the injection site. It was red and hot to the touch. It later spread to the back of the arm and down the arm. I frequently run a low grade fever. I am now being treated for anemia. At its peak, all I wanted to do was sleep, took frequent naps during The day. As of today 8/28/19, I am beginning to feel better, pain in muscles is lessening. However, now my left leg is swollen from the knee to the foot - no injury involved. Had a DVT Ultrasound, no sign of blood clots. For multiple lab tests and results, contact office of DR.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: A dose of YELLOW FEVER was mixed with the incorrect (sterile)diluent. Per DHA consultant, Dr.,  the member was contacted and advised to receive another dose on the same day with the correct diluent.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, TDAP
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The liquid component of one lot of Menveo was mixed with the powder component of another lot of Menveo. The two lots involved were lot AMVA087A and lot AMVA013A. Therefore, the complete vaccine was administered, just out of two different lots. The patient's parent was notified and mailed a letter explaining the event, and it was reported that the patient experienced no adverse effects from the Menveo vaccine. The patient's parent notified the patient's physician. The extra components out of each lot involved were wasted appropriately.
Age: 17.0
Sex: U
Vaccine: HPV9, MNQ
Symptoms: Erythema, Skin warm, Tension
Clinical narrative: Redness of the arm 8/22/2019-8/25/2019.  Client's mother reports that area felt warm. Tenseness 8/22/2019-Present.  Client's mother reports that client complains arm feels tense when she moves it.  Client still able to use arm effectively.  Describes more as being tense rather than painful.    Patient's mother called doctor and they suggested they call Health Department.  Mother may schedule a visit with patient's PCP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Decreased appetite, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Child's mother called 8/29/19 at 9:15 am to report child had experienced a reaction to one of the vaccines, she was looking to find out which vaccine was given in the left arm in the area below the shoulder and not at the back of the arm. *this was the DTaP*. Mother reports the day after the vaccines was given (Tuesday) she noted some redness at the injection site, he also had a mild fever that night 100.4 and did experience vomiting. She report Wednesday the redness had progressed to be from the shoulder to the elbow, and that the area of the injection looked bruised, and she now noted swelling from the shoulder to the elbow. Child reports pain in arm but also generalized pain, neck, back, legs, and stomach with associated vomiting and decreased appetite. Mom reports that she has not taken the child to see his provider yet. This nurse strongly encouraged she get the child in to see his provider as soon as possible, guided mom to be sure to report the severity of the symptoms to doctor when calling to schedule as he should be seen today. Read through the VIS with the mother, outlining the information in the "Risk of Vaccine Reaction" section which does indicate that this type of swelling can occur but it is more rare. Did discuss alternative rare reactions which could include abscess at the site of injection. Again, strongly encouraged she get the child in to be evaluated by his provider.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Child's mother called 8/29/19 at 9:15 am to report child had experienced a reaction to one of the vaccines, she was looking to find out which vaccine was given in the left arm in the area below the shoulder and not at the back of the arm. *this was the DTaP*. Mother reports the day after the vaccines was given (Tuesday) she noted some redness at the injection site, he also had a mild fever that night 100.4 and did experience vomiting. She report Wednesday the redness had progressed to be from the shoulder to the elbow, and that the area of the injection looked bruised, and she now noted swelling from the shoulder to the elbow. Child reports pain in arm but also generalized pain, neck, back, legs, and stomach with associated vomiting and decreased appetite. Mom reports that she has not taken the child to see his provider yet. This nurse strongly encouraged she get the child in to see his provider as soon as possible, guided mom to be sure to report the severity of the symptoms to doctor when calling to schedule as he should be seen today. Read through the VIS with the mother, outlining the information in the "Risk of Vaccine Reaction" section which does indicate that this type of swelling can occur but it is more rare. Did discuss alternative rare reactions which could include abscess at the site of injection. Again, strongly encouraged she get the child in to be evaluated by his provider.
Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Adverse reaction
Clinical narrative: not sure which shot caused reaction. pt was given FluAD (65 older).  has gotten HD in past.  unknown wheather reaction caused by shringrix or fluad
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Very sore and swollen at the injection site, very tired, headache and muscle aches (entire body), I want to go back home and get into bed.
Age: 88.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/redness tennis ball sized- increased heat to area. Sent to ER for evaluation 8/28/19.
Age: 88.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness tennis ball sized- increased heat to area. Sent to ER for evaluation 8/28/19.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Urticaria
Clinical narrative: fever; redness; welting; Aching; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, erythema of extremities, welts and pain. On an unknown date, the outcome of the fever, erythema of extremities, welts and pain were recovered/resolved.   The reporter considered the fever and pain to be related to Shingrix. It was unknown if the reporter considered the erythema of extremities and welts 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 adult as per the vaccine indication. The patient had welting and reaction to elbow. The patient also had hot redness and some welting The patient had aching and low fever expected. Went to pharmacy. Showed her reaction. They tried calling drug company and had not heard. The patient had not received 2nd dose of Shingrix till the time of reporting. The 2nd dose could be given anytime between 2 and 6 months after the 1st dose. The patient asked with the upper arm welting should he get 2nd dose of Shingrix. The events were recovered after one and a half week.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Hyperhidrosis, Pain
Clinical narrative: Pain as lasting for a couple of weeks; redness; swelling; This case was reported by a nurse via call center representative and described the occurrence of pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. In July 2019, unknown after receiving Bexsero, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Bexsero.  Additional case details were reported as follows: The healthcare professional could not provide patient demographics, lot numbers, or expiration dates. The age at vaccination was not reported. The reporter reported patient experienced a variety of events following Bexsero administration.  The patient experienced redness, pain, and swelling. The healthcare professional described pain as lasting for a couple of weeks in a patient.  The healthcare professional noted these events had been takes place over the last month, no specific time frame reported. No start or end date of any of the events provided. The reporter gave permission to follow up. This case had been linked to the case US2019151259, US2019151261 and US2019151262 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: flu-like symptoms; Product supply issue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and product supply issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional detials were provided as follows: The age at vaccination was not reported. Around April 2018, the patient received dose of Shingrix and experienced influenza-like symptoms. The patient reported that, she did not receive 2nd dose of Shingrix due to back order, which led to product supply issue. The patient did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: itching at site; redness at injection site; swelling at injection site; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zoster Vaccine (received in 2014).   On 19th August 2019 12:00, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever and chills. On 19th August 2019, the patient experienced injection site itching. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site itching, injection site erythema, injection site swelling and chills were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site swelling, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm at around 12 noon on Monday. The patient stated that on same day evening, she had itching at the site. Less than a day after vaccination, the patient experienced injection site erythema, injection site swelling, fever and chills. During the night, on 20th August 2019, she had chills and a fever of 100.4 degree F. The patient took Ibuprofen for the fever and noted it lasted for about 24 hours. On 20th August 2019, on the next morning, she awoke with redness and swelling at the injection site of about 2 inches in diameter. The reporter was consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date unknown) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line with a patient reported muscle aches since their first dose of Shingrix. The site of injection or follow-up not queried.
Sex: M
Vaccine: MENB, UNK
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A male patient of an unspecified age (reported as 18, unit unknown) received a single dose of meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine conjugate (MVC4) both on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The nurse gave to the patient the vaccines and on an unspecified date after vaccinations, patient had syncope. The outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, White blood cell count normal
Clinical narrative: Redness, heat and swelling at injection site that traveled down arm.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: Redness, heat and swelling at injection site that traveled down arm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient developed hives 20 minutes after receiving the injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Axillary pain, Fatigue, Pain in extremity, Rash
Clinical narrative: Saturday: very sore arm, extreme fatigue, large painful lump in my left armpit (assuming it was swollen lymph node). Went away by Sunday, but then today (Thursday, August 29) almost a week after the vaccination, I woke up with a large patchy rash on my upper left arm (near the injection site); I do not know if this is related to the shot or not. It does not hurt or itch, but I thought I should report it so if others experience this, they will know others have too.  I still plan to get my follow up shot on November 1 regardless, better than getting Shingles.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with redness, swelling, heat on distal side of upper left arm.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Patient presented to the ED on 7/15/19 with complaint of itchy rash. Patient received zoster vaccine and pneumococcal 23 vaccines on 7/10/2019 and stated he initially had hives after the vaccine administration. Physical exam on 7/15/19 revealed erythematous scattered rash without hives. Per ED discharge note, Patient has taken diphenhydramine which helped relieved symptoms. Patient was prescribed prednisone taper and camphor/menthol lotion outpatient. Patient was discharged from the ED on 7/15/19.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came in for the Back to School Vaccination Clinic. On File it showed she was due for Tdap, but in Records it showed she was current. I was given the vaccination form from the front office who checked the vaccines prior to giving then to the nurse for administration. Patient was given Tdap too early due to her age.