chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: There was a large red, swollen, hot patch and rash at the injection site that traveled way down the left arm to the left side of the waist.; rash; There was a large red on arm; hot patch; itchy on arm; severe headache; The arm is still untouchable due to the pain/muscle pain; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hemiplegic migraine.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, 5 hrs after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, rash over arms, redness, hot feeling in hand, itchy, headache and muscle pain to be related to Shingrix.  Additional information was received as follows: The patient started to experience the symptoms 5 hours after the vaccination. There was a large red, swollen, hot patch and rash at the injection site that traveled way down the left arm to the left side of the waist. The arm was still untouchable due to the pain. She had been icing the areas. The patient was treated with benadryl and ibuprofen. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Antibody test negative, Serology test, Therapy non-responder
Clinical narrative: recent blood work shows no immunity; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine and Hepatitis B vaccine. On an unknown date, 7 years after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. In 2013, the reporter received Hepatitis B and A series as separate shots.  She completed the series for both shots.Brand name of hepatitis A and B shots unknown.  The reporter reported recent blood work shows no immunity to Hepatitis A or B and her gastroenterologist recommends re vaccination with Twinrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: it itches too; swollen; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a day after receiving Shingrix, the patient experienced swelling. On 17th August 2020, the patient experienced pruritus. On an unknown date, the outcome of the swelling and pruritus were unknown.   It was unknown if the reporter considered the swelling and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and get swollen but on the day of reporting it itches too.  was that ok  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Feeling hot, Gastric disorder, Headache
Clinical narrative: area on her left arm that was the size of a quarter, red / area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard / the area grew larger and harder/ area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard and warm/ area became warmer.; bad headache/nagging headache; nausea; her stomach wasn't feeling well; and she just didn't feel right; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). In June 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix in June 2020. She had pain and soreness at the injection site which was her left arm. The next day she had an area on her left arm that was the size of a quarter, red and hard and warm that lasted for 3 days and then after the third day the area grew larger and harder and became warmer. She had a bad headache the day after the initial injection. The patient had a nagging headache for a week to a week and a half after that. The diameter of the area was 6 inches across and was a big, red hard area. After about 7 to 8 days, she contacted her physician and they put her on steroids. During that time, patient's stomach was not feeling well and she was not felt right with nausea.  Everything had resolved at time of reporting.  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site pain, Nausea
Clinical narrative: area on her left arm that was the size of a quarter, red / area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard / the area grew larger and harder/ area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard and warm/ area became warmer.; bad headache/nagging headache; nausea; her stomach wasn't feeling well; and she just didn't feel right; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). In June 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix in June 2020. She had pain and soreness at the injection site which was her left arm. The next day she had an area on her left arm that was the size of a quarter, red and hard and warm that lasted for 3 days and then after the third day the area grew larger and harder and became warmer. She had a bad headache the day after the initial injection. The patient had a nagging headache for a week to a week and a half after that. The diameter of the area was 6 inches across and was a big, red hard area. After about 7 to 8 days, she contacted her physician and they put her on steroids. During that time, patient's stomach was not feeling well and she was not felt right with nausea.  Everything had resolved at time of reporting.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Coronavirus test positive, SARS-CoV-2 test positive
Clinical narrative: family tested negative for COVID-19 but he was positive; This case was reported by a physician via call center representative and described the occurrence of coronavirus test positive in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included exposure to communicable disease (positive for Covid 19).   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced coronavirus test positive. On an unknown date, the outcome of the coronavirus test positive was unknown.   It was unknown if the reporter considered the coronavirus test positive to be related to Shingrix.  Additional information was provided as follows: The patient's complete family tested negative for COVID-19 but he was positive. The patient wanted to know if as he received Shingrix on 14th August 2020, that should be related to test positive to COVID 19 or to have a false positive. No further information were provided. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Feels the pharmacist injected the vaccine into his shoulder joint/ injected the Shingrix vaccine about 1/8 of an inch belowthe shoulder joint, at a 45 degree, needle angled downwards; Pain/Severe shoulder joint pain / Pain was localized to his right shoulder joint; Could not move his right arm/ needed assistance from his left hand to move the right arm.; This case was reported by a other health professional via call center representative and described the occurrence of pain in joint involving shoulder region in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season).   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccine administered at inappropriate site. In August 2020, the patient experienced pain in joint involving shoulder region and injected limb mobility decreased. On an unknown date, the outcome of the pain in joint involving shoulder region, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain in joint involving shoulder region and injected limb mobility decreased to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix vaccine in his right arm and received the flu vaccine (name unknown) in his left arm.  The patient stated that pharmacist injected the Shingrix vaccine about 1/8 of an inch below the shoulder joint, at a 45 degree, needle angled downwards. The patient felt that the pharmacist injected the vaccine into his shoulder joint (vaccine administered at inappropriate site) and stated that for three days, he could not move his right arm at all because of severe shoulder joint pain and needed assistance from his left hand to move the right arm. He did not have right arm pain and the pain was localized to his right shoulder joint. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Tenderness
Clinical narrative: she feels so tired; her left arm is tender; she has body aches; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. On 19th August 2020, 1 days after receiving Shingrix, the patient experienced tiredness, pain in arm and general body pain. On an unknown date, the outcome of the tiredness, pain in arm and general body pain were not recovered/not resolved.   The reporter considered the tiredness to be related to Shingrix. It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on her left arm and at the time of report, she felt so tired and her left arm was tender and that she had body aches.  The reporter wanted to know how long these reactions would last and if she would have the same reactions with her next dose of Shingrix. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Feeling hot, Headache, Pain in extremity
Clinical narrative: headache; feeling tired; feeling hot; sore arm; feeling hot and cold; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced headache, fatigue, feeling hot, pain in arm and feeling cold. On an unknown date, the outcome of the headache, fatigue, feeling hot, pain in arm and feeling cold were recovered/resolved.   It was unknown if the reporter considered the headache, fatigue, feeling hot, pain in arm and feeling cold to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix in the left arm.  Later on that same night of vaccionaton, the patient reported a sore arm, feeling hot and cold, feeling tired, and headache.  All of these symptoms lasted for one day and resolved. The reporter did not consent to follow-up.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: experienced a metallic taste; This case was reported by a pharmacist via call center representative and described the occurrence of taste metallic in a 32-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 2BB77, expiry date 30th June 2021) for prophylaxis.   On 19th August 2020, the patient received FluLaval Tetra 2019-2020 season. On 19th August 2020, 30 min after receiving FluLaval Tetra 2019-2020 season, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown.   It was unknown if the reporter considered the taste metallic to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient experienced a strong metallic taste approximately thirty minutes after receiving a dose of Flulaval.  The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Neck pain, Pyrexia
Clinical narrative: Fever; Neck pain; This is a spontaneous report from contactable other-HCP via Pfizer Sales Representative.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever and neck pain on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Urticaria
Clinical narrative: urticaria; body turns red; Initial information was received on 12-Aug-2020 regarding an unsolicited valid non-serious case from the physician.  This case involves a female patient of unknown age who experienced urticaria and her body turns red (erythema), while she received vaccine TETANUS TOXOID.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer for prophylactic vaccination (batch number and other dosing details were not reported).  On an unknown date, the patient developed non-serious urticaria (urticaria) and her body turns red (erythema), (unknown latency) following the administration of TETANUS TOXOID.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAP
Symptoms: High-pitched crying, Pyrexia, Seizure
Clinical narrative: she had a seizure; having a fever of 103 Fahrenheit; high pitched crying for hours; Initial information received on 13-Aug-2020 regarding an unsolicited valid serious case received from a physician (Pediatrician).  This case involves a 15-month-old female patient who experienced high pitched crying for hours (high-pitched crying), fever of 103 Fahrenheit (pyrexia) and had a seizure (seizure), while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.   On 10-Aug-2020, the patient received 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date 10-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On an unknown date, the patient developed non-serious high pitched crying for hours (high-pitched crying) and fever of 103 Fahrenheit (pyrexia) unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date, the patient had a seizure (seizure), unknown latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  No other laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the events was not reported (it was reported that the patient had seizure until fever went down).; Sender's Comments: This case involves 15 month old female who experienced high-pitched crying, pyrexia and seizure following the vaccination with DAPTACEL. The time to onset was compatible. Medical history, concurrent condition, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Concomitant vaccine is a confounding factor. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Mass, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch; Initial information was received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 35 year old male patient who had a swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch (feeling hot, swelling, tenderness and pain) while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 10-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA, expiry date: 12-Apr-2022) via unknown route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swollen bee sting that was the size of a quarter and it was a slightly raised lump that was tender, painful and warm to touch (feeling hot, swelling, tenderness and pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. He had no fever.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: MENVEO is supplied in 2 vials that must be combined prior to administration: reconstitute the MenA lyophilized conjugate vaccine component with the MenCYW-135 liquid conjugate vaccine component immediately before administration.   The administrator only gave the liquid vial.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SEVERE SWELLING THAT WENT DOWN TO HIS ELBOW AND HE DESCRIBED IT AS A BUBBLE IN HIS ELBOW. HE SAID HE HAS NEVER HAD THIS REACTION BEFORE WITH ANY VACCINATION THAT THE SWELLING GO DOWN TO HIS ELBOW AND HE COULDNT LIFT HIS ARM
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Nausea
Clinical narrative: Patient was asked prior to admin if he ever passes out with vaccines. Patient mother noted that he does get light headed around needles. Head of bed elevated so patient could lean about back in case of anything. Patient slightly anxious. Vaccines administered and advised patient to take a couple minutes prior to leaving. About 4 minutes later, mother updated us that patient was nauseated and felt like he was going to vomit. Patient given cold compress and water.  Patient symptoms relieved and patient left with mother.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Hives on R arm and swollen area and redness around injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: First sore arm and then fatigue, severe muscle aches, headaches, chills, and feverish flu-like symptoms began about 9 hours after vaccination and got severe about 12 to 14 hours after. They gradually improved over the next 24 hours. Please note that this vaccination was given to me at the same time as the 2020 influenza vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: First sore arm and then fatigue, severe muscle aches, headaches, chills, and feverish flu-like symptoms began about 9 hours after vaccination and got severe about 12 to 14 hours after. They gradually improved over the next 24 hours. Please note that this vaccination was given to me at the same time as the 2020 influenza vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 24 hours after vaccines. Tactile temp reported by parent.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PROQUAD expired and was administered; PROQUAD has had one temperature excursion in the past; This spontaneous report was received from a nurse and refers 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 17-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, recombinant human albumin (rHA), lot # S003866, expiration date was reported as 08-AUG-2020, and upon internal validation established as 08-AUG-2024 (route of administration was not reported) for prophylaxis.  The administered vaccine experienced one temperature excursion in the past on 10-AUG-2020: 74.8 degrees F for 15 hours. No additional Adverse Event reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate knot and pain at injection site, swollen and redness at injection site, warm to the touch, weakness/dizziness, headache.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immediate knot and pain at injection site, swollen and redness at injection site, warm to the touch, weakness/dizziness, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Malaise, Vomiting
Clinical narrative: complaining that does not feel well, symptoms vague except one episode of vomiting
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Flushing, Injection site urticaria
Clinical narrative: Child developed a hive near injection site of MCV4 and ears turned red and face flushed on 8/20/2020.  Mom reportedly gave child Benadryl as per recommendation of physician and placed an ice pack on the site and it resolved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Lymph node pain, Pain
Clinical narrative: aches all over, glands hurt, really tired, localized pain where shot was given.  Felt like really bad 24 hour virus.  I was in bed all day
Age: 59.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Chills, Injection site pain, Tremor
Clinical narrative: Client states about 14 hours after his vaccine he had violent chills and shaking that lasted for about 3 hours with severe pain at the injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The vaccine that was ordered was DTaP-IPV (Quadracel).  The vaccine that was given by mistake was DTaP-Hib-IPV (Pentacel). The patient recieved an exta dose of Hib, and no other symptoms/reactions have been reported by the patient's parents.
Age: 6.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Decreased appetite, Headache, Lethargy, Pruritus, Pyrexia
Clinical narrative: Severe headaches, fever, lethargy, blurry vision, loss of appetite, rash.   Visit to Urgent Care advised to monitor closely and cease medications and vaccinations, control fever etc.  Patient has ongoing headaches, itchiness, blurry vision which weren't present prior to vaccination.
Age: 6.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Rash, Vision blurred
Clinical narrative: Severe headaches, fever, lethargy, blurry vision, loss of appetite, rash.   Visit to Urgent Care advised to monitor closely and cease medications and vaccinations, control fever etc.  Patient has ongoing headaches, itchiness, blurry vision which weren't present prior to vaccination.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: Fever, chills, sweating, muscle aches, joint pain in hands/knees, pain at injection site, runny nose, sneezing (almost exactly the same Adverse Event as original shingles vaccine 6 months ago)
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Fever, chills, sweating, muscle aches, joint pain in hands/knees, pain at injection site, runny nose, sneezing (almost exactly the same Adverse Event as original shingles vaccine 6 months ago)
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhage, Loss of consciousness, Loss of personal independence in daily activities, Product administration error, Pyrexia
Clinical narrative: Went in so slow, no pulling back on plunger Fever, vomiting, passed out, called 911, was out of work for 1 week, bled excessively.  Spoke to doctor about it, give benadryl prior to immunization.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Went in so slow, no pulling back on plunger Fever, vomiting, passed out, called 911, was out of work for 1 week, bled excessively.  Spoke to doctor about it, give benadryl prior to immunization.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Fatigue, Feeling hot, Insomnia, Peripheral swelling
Clinical narrative: feeling whot & pinkeak ,tired ,threw up twice , restless could not sleep ,fever at night of 100 . Shot arm swollen and hot and pink . Was feeling better 2 days later . Never had a reaction from any shots i`ve had ever.And I always get my vacines on time.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Restlessness, Skin warm, Vomiting
Clinical narrative: feeling whot & pinkeak ,tired ,threw up twice , restless could not sleep ,fever at night of 100 . Shot arm swollen and hot and pink . Was feeling better 2 days later . Never had a reaction from any shots i`ve had ever.And I always get my vacines on time.
Age: 5.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Headache, Incontinence, Pain
Clinical narrative: Headache, body ache, incontinence.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Dizziness, Heart rate increased, Syncope
Clinical narrative: PATIENT RECEIVED TWO VACCINES, ONE IN EACH ARM. PATIENT REPORTED FEELING FINE AFTER VACCINE, BUT FELT DIZZY AND FAINTED MOMENTARILY UPON LEAVING IN FRONT OF THE ELEVATOR. DAD HELD DAUGHTER. PATIENT WAS MOVED TO ROOM AND LAID ON EXAMINE TABLE AND VITALS WERE TAKEN. PULSE WAS SLIGHTLY ELEVATED.PATIENT CLAMMY. PATIENT REPORTED FEELING DIZZY. PATIENT REPORTED SHE HADN'T EATEN MUCH. PATIENT WAS GIVEN WATER AND REMAINED LYING DOWN FOR 10 MIN.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Fall, Generalised tonic-clonic seizure, Loss of consciousness, Neurological examination
Clinical narrative: Was administered a DPT vaccination at Dr. office.  Within a couple of hours, I had a gran mal seizure.  Mother was RN and witnessed the seizure.  Fell to the floor and was unconscious for about 30 minutes. Mother notified Dr. and he recorded the event.  My son. also had life altering adverse reactions to DPT at 10 months.  He had 3 seizures within a few hours of the DPT vaccination.  He stopped breathing, eyes rolled back in his head, went limp and turned purple in my arms.  Paramedics worked on him for 40 minutes to revive him.  He had a complete neuro workup, EEG with Dr.  I have entered him in VAERS, also.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; dose of pediatric VAQTA (lot S009562 & expiration date 7/26/2020 was administered on 7/30/2020 to a pediatric patient; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 30-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) syringe, lot # S009562 was confirmed to be valid, expiration date reported as 26-JUL-2020, but upon internal validation, it was established as 05-MAY-2019 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effects were reported. There was no temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; she missed her scheduled dates for receiving her follow up shots for GARDASIL-9; This spontaneous report as received from a female patient of unknown age who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in June 2018, the patient was vaccinated with dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot # and expiration date were not reported) as a required shot.  On an unknown date in August 2018, the patient missed her scheduled dates for receiving her follow up shots for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). There was no adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of VAQTA; This spontaneous report was received from an office manager, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 12-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 ml (injection site, route of administration were not provided, lot # S009562 was confirmed to be valid, expiration date was reported as 26-JUL-2020, but upon internal validation, it was established as 05-MAY-2019) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S009562; expirationdate: 05-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Fatigue, Influenza like illness, Pain
Clinical narrative: Patient stated had pacemaker placed on February 21, 2020; flu-like symptoms; feeling achy; tiredness; This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included artificial cardiac pacemaker user.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), influenza-like symptoms, pain and tiredness. On an unknown date, the outcome of the arrhythmia was unknown and the outcome of the influenza-like symptoms, pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the arrhythmia, influenza-like symptoms, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix in late January or early February 2020 in left arm. The patient reported tiredness, feeling achy, and flu-like symptoms occurred the day after receiving the first dose of Shingrix and these resolved after one day.  The patient stated had pacemaker placed on 21st February 2020. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2020164413.; Sender's Comments:  US-GSKCCFUS-Case-00787580_AE-45991: US-GLAXOSMITHKLINE-US2020164413:same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Facial pain, Gingival blister, Gingival pain
Clinical narrative: had blisters in his throat; and on the left lower portion of his gums.; pain on his left face/minimal pain remaining on his face; gum; pain in ear; eye; throat; scalp; This case was reported by a other health professional via call center representative and described the occurrence of throat blister in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number GB429, expiry date 5th December 2021) for prophylaxis.   On 24th July 2020, the patient received Shingrix. On 12th August 2020, 19 days after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), gingival blister, facial pain, gum pain, ear pain, eye pain, throat pain and scalp pain. On an unknown date, the outcome of the throat blister, gingival blister and facial pain were recovering/resolving and the outcome of the gum pain, ear pain, eye pain, throat pain and scalp pain were not recovered/not resolved.   It was unknown if the reporter considered the throat blister, gingival blister, facial pain, gum pain, ear pain, eye pain, throat pain and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of shingrix and developed pain on his left face, gums, ears, eye, throat, scalp and ear. In addition to the left sided pain, he had blisters in his throat and on the left lower portion of his gums.  The blisters had resolved, all except 1, per the reporter. The patient reported minimal pain remained on his face.  The reporter did not diagnose the incident as shingles, nor prescribed any medication. The reported batch number was updated from  BG429 to GB429, as per sales data sheet. The follow up consent was granted
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal pain, Pain of skin
Clinical narrative: had blisters in his throat; and on the left lower portion of his gums.; pain on his left face/minimal pain remaining on his face; gum; pain in ear; eye; throat; scalp; This case was reported by a other health professional via call center representative and described the occurrence of throat blister in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number GB429, expiry date 5th December 2021) for prophylaxis.   On 24th July 2020, the patient received Shingrix. On 12th August 2020, 19 days after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), gingival blister, facial pain, gum pain, ear pain, eye pain, throat pain and scalp pain. On an unknown date, the outcome of the throat blister, gingival blister and facial pain were recovering/resolving and the outcome of the gum pain, ear pain, eye pain, throat pain and scalp pain were not recovered/not resolved.   It was unknown if the reporter considered the throat blister, gingival blister, facial pain, gum pain, ear pain, eye pain, throat pain and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of shingrix and developed pain on his left face, gums, ears, eye, throat, scalp and ear. In addition to the left sided pain, he had blisters in his throat and on the left lower portion of his gums.  The blisters had resolved, all except 1, per the reporter. The patient reported minimal pain remained on his face.  The reporter did not diagnose the incident as shingles, nor prescribed any medication. The reported batch number was updated from  BG429 to GB429, as per sales data sheet. The follow up consent was granted
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Itchy rash; arm swell; Diagnosed with cellulitis; Fever; Over all feeling bad; sore arm; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 5 hrs after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), fever, feeling bad and pain in arm. On an unknown date, the patient experienced itchy rash and extensive swelling of vaccinated limb. The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). On an unknown date, the outcome of the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb were recovered/resolved.   It was unknown if the reporter considered the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: It was reported that the symptoms of fever, sore arm and over all feeling bad presented 5 hours after the vaccination. The symptoms lasted 3 days. Four to five days later the arm swell and a itchy rash appeared. It was spread from the injection site all the way around the arm down to the elbow.  The patient was treated in the emergency room with Benadryl and Cephalexin. The patient was diagnosed with cellulitis.  The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; arm swell; Diagnosed with cellulitis; Fever; Over all feeling bad; sore arm; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 5 hrs after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), fever, feeling bad and pain in arm. On an unknown date, the patient experienced itchy rash and extensive swelling of vaccinated limb. The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). On an unknown date, the outcome of the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb were recovered/resolved.   It was unknown if the reporter considered the cellulitis, fever, feeling bad, pain in arm, itchy rash and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provided as follows: It was reported that the symptoms of fever, sore arm and over all feeling bad presented 5 hours after the vaccination. The symptoms lasted 3 days. Four to five days later the arm swell and a itchy rash appeared. It was spread from the injection site all the way around the arm down to the elbow.  The patient was treated in the emergency room with Benadryl and Cephalexin. The patient was diagnosed with cellulitis.  The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: Prostate-Specific Antigen (PSA), had increased; This case was reported by a consumer via call center representative and described the occurrence of psa increased in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, 3 days after receiving Shingrix, the patient experienced psa increased. On an unknown date, the outcome of the psa increased was not recovered/not resolved.   It was unknown if the reporter considered the psa increased to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received the first dose of shingrix and got his blood work drawn on 14th August 2020 and his Prostate-Specific Antigen (PSA), had increased.  The patient stated that his PSA levels was the same for the last five years, and they only increased after receiving the vaccine. The health care professional did not provide a diagnosis or change his plan of care, but he would be get his PSA checked again in 6 weeks.  The health care professional informed patient to call back with new results. The patient consented to follow up.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired pentacel vaccine was given to a patient during a visit, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case from other health professional in the United States.  This case involves a 14 months old male patient who was vaccinated with an expired dose  of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (first dose in series, lot number: UJ073AAA and expiration date: 13-Jun-2020), intramuscularly in the left thigh as prophylactic vaccination on 14-Aug-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination on the same visit that is on 14-Aug-2020.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Chest pain, Dizziness, Headache, Hypertension
Clinical narrative: Vaccine was administered into the left arm.  Patient was instructed to remain near pharmacy for 10 minutes after vaccination.  Around 5 minutes later, I was notified that patient felt she was having a reaction.  Patient stated pain started as back pain, then head pain and then it was chest pain.  I took patient's blood pressure and it was 169/85, which the patient stated was higher than hers normally ran.  She started to feel better, she stood up to move to the consultation room and experienced dizziness.  The injection site bled but there was no swelling/redness present.  I called the primary care physician and they advised her to go the ER since she has a previous history of heart attack.  She had a friend take her to the ER.  I spoke with her that afternoon and they were going to keep her overnight for observation.  She stated they had told her it was a reaction to the vaccine.  All tests they ran came back ok.  Spoke with patient the following day and she had been discharged and was feeling better.