chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger; the arm was stiff and difficult to move; the arm was stiff and difficult to move; headache; experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10; body temperature rose from a baseline of 96. D degrees Fahrenheit to 99.1 degrees Fahrenheit; This is a spontaneous report from a contactable nurse received by Pfizer from Merck and Co., Inc. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiration date not reported), via an unspecified route of administration in the upper left arm on 25Nov2019 16:00 as single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that about 4 p.m. on 25Nov2019, and subsequently experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered. Nurse reported that the patient described the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger. Nurse reported that the pain began about 4 hours post vaccination. Nurse also reported that the patient's body temperature rose from a baseline of 96.5 degrees Fahrenheit to 99.1 degrees Fahrenheit, approximately 8 hours after receipt of the vaccine. Nurse reported that the following morning, the patient awoke with a severe headache, but that the arm pain, was reduced to a 6/10, but that the arm was stiff and difficult to move. Nurse reported that the patient is treating herself with 1000 mg of TYLENOL every 6 hours as well as 50 mg of BENADRYL every six hours. The outcome of the event experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10 was recovering; while the rest of the events are unknown.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Muscle aches and pain from head to hips. severe chills with shaking. vomited 3 times after taking tylenol or advil. severe abdominal pain after vomiting
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Muscle aches and pain from head to hips. severe chills with shaking. vomited 3 times after taking tylenol or advil. severe abdominal pain after vomiting
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Adrenal disorder, Arthralgia, Back pain, Chromaturia, Contusion
Clinical narrative: 65 yr old female presents with an adverse reaction to flu vaccine that she was mandated to have despite her PMH of adverse reaction to the flu vac            pt has vaccine on 11/22/19 then then next day started to have nausea as well as intense backpain then she had Brown urine - she did drink lots of water already but increased fluid intake and the next day urine was now yellow but still had nausea and then started to have more nausea and sinus discharge and cough with subsequent ribs out - 2 ribs out when saw chiropractor and said her immune system was very compromised from flu vaccine - pt also had severe headache now with nerve pain as well 4-5 days after the flu vaccination that then further progressed to joint pain that was extreme            she also went to see a medical doctor who said that her kidney and adrenals are/were greatly stressed from fighting the vaccination - the foreign material in her body            she also fell from nerve pain and muscle spasm and scraped her right shin and bruised it with gradually increase in redness and warm hot despite cleaning with soap water and otc anti-bacterial            she went back to her chiropractor on 12/9 and concern over leg wound and also immune system overload from flu vaccine
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Erythema, Fall, Headache, Immunodeficiency
Clinical narrative: 65 yr old female presents with an adverse reaction to flu vaccine that she was mandated to have despite her PMH of adverse reaction to the flu vac            pt has vaccine on 11/22/19 then then next day started to have nausea as well as intense backpain then she had Brown urine - she did drink lots of water already but increased fluid intake and the next day urine was now yellow but still had nausea and then started to have more nausea and sinus discharge and cough with subsequent ribs out - 2 ribs out when saw chiropractor and said her immune system was very compromised from flu vaccine - pt also had severe headache now with nerve pain as well 4-5 days after the flu vaccination that then further progressed to joint pain that was extreme            she also went to see a medical doctor who said that her kidney and adrenals are/were greatly stressed from fighting the vaccination - the foreign material in her body            she also fell from nerve pain and muscle spasm and scraped her right shin and bruised it with gradually increase in redness and warm hot despite cleaning with soap water and otc anti-bacterial            she went back to her chiropractor on 12/9 and concern over leg wound and also immune system overload from flu vaccine
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Nausea, Neuralgia, Paranasal sinus hypersecretion, Renal disorder
Clinical narrative: 65 yr old female presents with an adverse reaction to flu vaccine that she was mandated to have despite her PMH of adverse reaction to the flu vac            pt has vaccine on 11/22/19 then then next day started to have nausea as well as intense backpain then she had Brown urine - she did drink lots of water already but increased fluid intake and the next day urine was now yellow but still had nausea and then started to have more nausea and sinus discharge and cough with subsequent ribs out - 2 ribs out when saw chiropractor and said her immune system was very compromised from flu vaccine - pt also had severe headache now with nerve pain as well 4-5 days after the flu vaccination that then further progressed to joint pain that was extreme            she also went to see a medical doctor who said that her kidney and adrenals are/were greatly stressed from fighting the vaccination - the foreign material in her body            she also fell from nerve pain and muscle spasm and scraped her right shin and bruised it with gradually increase in redness and warm hot despite cleaning with soap water and otc anti-bacterial            she went back to her chiropractor on 12/9 and concern over leg wound and also immune system overload from flu vaccine
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Wound
Clinical narrative: 65 yr old female presents with an adverse reaction to flu vaccine that she was mandated to have despite her PMH of adverse reaction to the flu vac            pt has vaccine on 11/22/19 then then next day started to have nausea as well as intense backpain then she had Brown urine - she did drink lots of water already but increased fluid intake and the next day urine was now yellow but still had nausea and then started to have more nausea and sinus discharge and cough with subsequent ribs out - 2 ribs out when saw chiropractor and said her immune system was very compromised from flu vaccine - pt also had severe headache now with nerve pain as well 4-5 days after the flu vaccination that then further progressed to joint pain that was extreme            she also went to see a medical doctor who said that her kidney and adrenals are/were greatly stressed from fighting the vaccination - the foreign material in her body            she also fell from nerve pain and muscle spasm and scraped her right shin and bruised it with gradually increase in redness and warm hot despite cleaning with soap water and otc anti-bacterial            she went back to her chiropractor on 12/9 and concern over leg wound and also immune system overload from flu vaccine
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site infection
Clinical narrative: Patient experienced an infection at the site of injection which required medical attention.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient experienced a large red circle around the injection site starting 24-48 hours after the vaccination. Patient states area is warm to the touch and hurts a little. Advised patient to use OTC pain relievers and Neosporin on the site (after verifying no allergies to medication). Told her to alert her physician if condition worsens or becomes bothersome.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Pain, Papule, Rash
Clinical narrative: rash started 11/23 or 11/24. Not painful or itchy but has been experiencing pain in the right hip. Burning/aching pain. Today noticed the rash had spread to his right inner thigh as well. No fever or chills. No other complaints  .Skin: there is a vesicular erythematous rash with clusters of vesicles and papules covering right lower back buttock and lateral thigh. Several clusters on right medial thigh as well.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: rash started 11/23 or 11/24. Not painful or itchy but has been experiencing pain in the right hip. Burning/aching pain. Today noticed the rash had spread to his right inner thigh as well. No fever or chills. No other complaints  .Skin: there is a vesicular erythematous rash with clusters of vesicles and papules covering right lower back buttock and lateral thigh. Several clusters on right medial thigh as well.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client had been vaccinated 12/4/19 with MMR. Minimum interval between live vaccines not met.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Epistaxis, Influenza like illness
Clinical narrative: Per patient: approximately 1 hour after receiving the first shingrix vaccine, he states he got a nose bleed that lasted a couple hours before it stopped. He also said he got flu-like symptoms for a few days after as well. He said nothing out of the normal happened that day that should have caused it. No further incident after this.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Fever of 101 Hot, red lump on thigh 1? to the right of the injection site.  Injection site is also warm, red, and swollen  Gave dose of ibuprofen for fever and pain at 9 AM on 12/12/19
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Fever of 101 Hot, red lump on thigh 1? to the right of the injection site.  Injection site is also warm, red, and swollen  Gave dose of ibuprofen for fever and pain at 9 AM on 12/12/19
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/19. Minimal interval for live vaccines not met. Varicella vaccine to be repeated at appropriate interval.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Severe Headache, muscle pain (all over body), chills, shaking, fever, weakness
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe Headache, muscle pain (all over body), chills, shaking, fever, weakness
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR  12/04/2019. Minimum interval between live vaccines not met. Varicella to be repeated 1 month.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/19. Minimum intervals between live vaccines not met. Varicella to be repeated at appropriate interval.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/2019. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 14-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving defendants' zoster vaccine live (ZOSTAVAX) vaccine, on 18-OCT-2014, the patient was diagnosed with shingles after experiencing extreme pain, a rash and an outbreak of blisters on her back, spine, breast and ribcage resulting in medical treatment. This outbreak lasted for months and resulted in post-herpetic neuralgia. Zoster vaccine live (ZOSTAVAX) caused these injuries and the need for medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of shingles and post-herpetic neuralgia were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events of shingles and post-herpetic neuralgia to be disability.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood test, Dizziness, Injection site pain
Clinical narrative: Pain injection site; Dizziness; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain injection site with outcome of recovered on 09Dec2019 and dizziness on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test on 09Dec2019 but results were unknown.    The information on the lot number has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Area is the upper arm/shoulder left side. Loss of mobility, can't reach back (pain) and hard to sleep on the left side because of the soreness. It wasn't until last week I put two and two together and figured out that it happened right after the shot. Called the pharmacy they looked up to confirm the shot was give in the left upper arm. Asked them about side effects but they didn't think it was related?? Haven't had any issues before the shot with pain or being able to reach backwards.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/19. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/19. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Age: 0.58
Sex: M
Vaccine: MMR
Symptoms: Contusion, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Patient presenting with bruising, petechiae, thrombocytopenia about 3 weeks following MMR administration. ITP. Treated with IVIG infusion x1.
Age: 0.58
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenia
Clinical narrative: Patient presenting with bruising, petechiae, thrombocytopenia about 3 weeks following MMR administration. ITP. Treated with IVIG infusion x1.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/19. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Redness, wheal only at site at injection.  Itching at sire
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received MMR 12/4/2019. Minimum interval between live vaccines not met. Varicella to be repeated at appropriate interval.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: C/O soreness and swelling at immunization site. Afebrile.  Area is not warm to touch.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Breast tenderness, Nipple disorder, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: right breast very tender; nipple was red; Pain in arm; was running a fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2019AMR218952).   On 26th November 2019, the patient received the 2nd dose of Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced pain in arm and fever. On 30th November 2019, the patient experienced breast tenderness and nipple disorder. Rechallenge with Shingrix was positive. On 28th November 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, breast tenderness and nipple disorder were unknown.   It was unknown if the reporter considered the pain in arm, fever, breast tenderness and nipple disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and my arm was so sore and was running a fever. The fever went away but the arm was still very sore. The patient right breast very tender and the nipple was red. The reporter asked could all of this be from the medication in the shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness, swelling, warm treat with warm compresses
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse reaction. The child was observed in office for 15minutes without any problems which is standard procedure in our office.  Called the clinic and was asked to report it via this form.  Mom of the patient has been notified and the child is well.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac monitoring, Echocardiogram, Fatigue, Oropharyngeal pain, Swelling
Clinical narrative: Localized swelling, sore throat, fatigue, PVC's.  Was seen in ER on 10/30/2019 for frequent PVC's, Followed up with the Cardiologist , had a heart echo cardiogram and wearing a 30 day heart monitor.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Ventricular extrasystoles
Clinical narrative: Localized swelling, sore throat, fatigue, PVC's.  Was seen in ER on 10/30/2019 for frequent PVC's, Followed up with the Cardiologist , had a heart echo cardiogram and wearing a 30 day heart monitor.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pruritus, Rash
Clinical narrative: later in the day pt noted widespread pruritis then wednesday night she noted a rash at the trunk, arms, neck. the L upper deltoid, inferior to the injection site is erythematous, painful and itchy.
Age: 27.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given the wrong vaccine.  Patient was suppose to be given TDAP and was given Prevnar 13 instead.  Patient is 27 plus weeks pregnant.  Patient has not had any reaction to the shot at this point and is aware that the wrong immunization was given.  CDC was also notified and did not find any reason that there should be any reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: As I was pulling my left arm out of sleeve, told I didn't need to as she pulled blouse off my shoulder and gave shot.  Shot felt very painful and got rogressively sore that evening with trouble lifting  or moving my arm.  Realized bandaid was on shoulder where shot given. Returned to office next day as too painful to move are.  Given Rx for Flexeril, Ibuprofen, and then 4 days of Prednisone.  Had left shoulder x-ray done and started physical therapy around Nov.2 and am still going 3 times weekly.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Corneal abrasion, Eye irritation, Pruritus
Clinical narrative: Developed severe conjunctivitis and itching following administration of Shingrix. Due to vigorous rubbing of her eyes, developed corneal abrasion requiring ER visit and ophthalmologic consultation
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Lyme disease
Clinical narrative: I was told to reach out to you about the possibility that the HPV9 vaccine may have made my daughters Lyme disease active. She was diagnosed with Lyme disease after getting the vaccine.
Age: 1.75
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: "Giving patient influenza vaccine. During administration, needle penetrated thigh and when plunger was pushed, vaccine sprayed out sideways through unseen whole plastic hub. Sprayed on mother. Site bandaged per routine. No visible break or hole in syringe yet leak evident between hub and syringe where needle is screwed in. Only the second syringe administered in this box lot# UT6647JA Sanofi." This reporter followed up with the RN who wrote the above statement and she said that no other vaccines in that lot had issues.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Monoplegia
Clinical narrative: patient received pneumovax23 and reported complete arm paralysis 3 hours after the immunization
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: I have Rheumatoid Arthritis, and 3 days after my 2nd Shingrix shot I developed a major RA flare. The injection site became hard, red and swollen. It is now 19 days later and the injection site is still hard, red and sore, and the RA flare continues with the fingers of my opposite hand burning, stinging and remaining hot and sensitive.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Rheumatoid arthritis, Sensitive skin
Clinical narrative: I have Rheumatoid Arthritis, and 3 days after my 2nd Shingrix shot I developed a major RA flare. The injection site became hard, red and swollen. It is now 19 days later and the injection site is still hard, red and sore, and the RA flare continues with the fingers of my opposite hand burning, stinging and remaining hot and sensitive.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram thorax normal, Cough, Dyspnoea, Pulmonary fibrosis, Pulmonary function test normal
Clinical narrative: Onset pulmonary fibrosis with persistent cough since 2nd Shingrex See provider note from 12-4-19 Pt recieved Shingrex vaccine.  1. CREST syndrome, had been clinically stable 2. Recent shingles vaccination, 2nd dose, with significant reaction 3. Acute onset shortness of breath with apparently normal pulmonary function studies and normal chest CT scan 4. Cough. One of her major symptoms
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Feeling hot, Pain, Rash macular
Clinical narrative: Redness (splotchy red areas on left arm) some pain and feeling hot per patient. Recommended Benadryl 25 1-2 PO q 4-6 x 24hr. Benadryl 25 mg 1-2 PO q4-6h pm for 24 hours + follow-up w/pharmacy or doctor if not improving
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: Mom reports within 1 hr after receiving 1st flu vaccine- patient stopped breathing. Mom Did chest compressions x2. Took to Hospital and was completely normal.
Sex: F
Vaccine: FLUR4, MMR, UNK
Symptoms: Pain, Swelling
Clinical narrative: she had a bump on her shoulder and it was sore for a couple days; she had a bump on her shoulder and it was sore for a couple days; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who had a bump on her shoulder and it was sore for a couple days (Injection site mass) and she had a bump on her shoulder and it was sore for a couple days (Injection site pain), while she received vaccines MMR, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, the patient received a dose of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE not produced by Sanofi Pasteur (Dose and route were unknown) (Lot number and expiry date was unknown) used for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of Flublok QIV, MMR and Diphtheria, Tetanus and Acellular Pertussis vaccine, patient experienced bump on her shoulder and it was sore for a couple days (Injection site mass) and (Injection site pain).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome for event injection site mass was reported as recovered and event outcome was unknown for injection site pain.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HCP stated the Flublok was given to 3 kids who are under the age of 3; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is a linked case with 2019SA331939 (same reporter).  This case involves a 9 months old patient who experienced hcp stated the flublok was given to 3 kids who are under the age of 3 (product administered to patient of inappropriate age), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was a case of actual medication error due to product administered to patient of inappropriate age.   It was not reported whether the patient had any adverse effect.  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 and Module VI of the 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.  Information on the batch number of FLUBLOK QIV was requested.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission
Clinical narrative: patient received pre-exposure vaccine last Sunday, they ordered the product and it hasn't come yet, no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 21 years old female patient who missed her dose of RABIES (HDC) VACCINE [IMOVAX RABIES] since they ordered the product and it hasn't come yet (missed dose).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.  On 24-Nov-2019, the patient received a dose of 1 ml ofRABIES (HDC) VACCINE (lot number P1E522M, exp date: Oct 30, 2020, via intramuscular route in the left deltoid) as pre-exposure vaccine.  It was an actual medication error due to missed dose (product was ordered but did not come yet).  At the time of reporting, the patient had no adverse event.  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.
Age: 65.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a male received an expired Ipol without side effects; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a non healthcare professional.  This case involves a 65 years old male patient who was vaccinated with an expired 0.5 mL dose of vaccine IPV (VERO) [IPOL] (lot N1J45, expiry date: 05-Oct-2019) via intramuscular route in the left deltoid on 03-Dec-2019.  Medical history included stem cell transplant. Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA), HIB VACCINE CONJ (TET TOX) (ACT-HIB) ; HEPATITIS B VACCINE (HEPATITIS B VACCINE)  and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: DTaP-IPV component of Pentacel was given minus the ActHIB in error/no ae; Initial information received on 05-Dec-2019 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 8 months old female patient who was vaccinated with DTaP-IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without ACT-HIB in error (inappropriate reconstitution technique) (frequency once) lot number: U6396AA, expiry date: 14-Oct-2020 via intramuscular route in the upper right leg on 04-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  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 and Module VI of the 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.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Swelling, Ultrasound scan
Clinical narrative: Patient received Toradol and Flu vaccine in the left Deltoid, presented to the Clinic on 12/5/19 with redness, swelling and pain. Patient had full range of motion, afebrile.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash developed around the injection site: about 6 inches in diameter. No other complaints.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Urticaria, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: WARMTH, ERYTHEMA, INDURATION AT VACCINE SITE URTICARIA /  HIVES  GENERALIZED TO BODY INCLUDING FACE WITHOUT RESPIRATORY DISTRESS
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called to report ongoing arm pain, particularly with abduction. I advised her to follow up with MD. She saw Dr. and was given prednisone and meloxicam. Patient refused physical therapy but was given paperwork with exercises to do and asked to come back in 2 weeks. Patient states she will go back in 1 month and we have asked her to follow up with us after her appointment as well.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: Red raised macules around injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: During injection, felt burning sensation as vacine traveled through upper left arm. Few hours later, upper left arm very painful to touch & cannot be moved without intense pain. Next day, upper left arm not so sensitive to touch but not able to move or lift left arm without intense pain. Felt like muscle in upper left arm was weakened, cannot sustain left arm weight or move left arm without intense pain. Went back to doctor's office. PA-C prescribed methylprednisolone, 4 mg, (MEDROL DOSEPACK). Took 6 tablets at 2pm. Later used pulleys to force left arm to move. Pain still intense. Next day, pain not so intense & had some range of motion. Arm improved but little range of motion. Heat has helped.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; a patient was administered a dose of improperly stored VAQTA; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 19-NOV-2019, the patient was vaccinated with a improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose number, dose, frequency, route of administration and anatomical location was not reported) for propylaxis (lot#: S007770, expiration date: 24-JUL-2020) (product storage error). The temperature excursion was below 36 degrees Fahrenheit (31.8 degrees Fahrenheit) for a total time frame of 15 minutes. There were no previous temperature excursions. The call was due to a data logger. No adverse symptoms and no product quality complaints reported.
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure increased, Condition aggravated, Product administered to patient of inappropriate age
Clinical narrative: Patient age: 83 years old; he received third dose of GARDASIL 9 on 12/8/2019 and noted his blood pressure went way up, 165/100; This spontaneous report was received from a male patient of 83-year-old reporting on himself. His current condition included hypertension. The patient's pertinent medical history, concomitant medications, and drug allergies or reactions were not reported.  On an unspecified date, his dermatologist advised him to have a series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) completed. So, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age). The patient did not experienced any symtoms with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 08-DEC-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, route, anatomical location, lot number, and expiration date were not reported), and he noted his blood pressure went way up to 165/100 (units not provided) (blood pressure increased) where typical measure is 130/85 (units not provided). The patient sough for medical attention.        At the time of the report, the patient had not recovered from the blood pressure increased   The causality assessment between the aforementioned event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  was not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Vaccination failure
Clinical narrative: Suspected vaccination failure; patient who received Shingrix and then had Shingles.; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included lyme disease.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 15th July 2019, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had no previous history of shingles, immunosuppressive disease or treatment. On 2018, the patient received both doses of Shingrix at an unknown pharmacy. On 15th July 2019, the patient was diagnosed with shingles and was clinically diagnosed by the reporter, but no PCR confirmation. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles in the same dermatome where the injection was given; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient was return within 3 months with a case of shingles in the same dermatome where the injection was given. At the time of reporting, the reporter did not have specific patient information. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with case US2019AMR208357, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Dyspepsia, Fatigue, Feeling abnormal
Clinical narrative: felt foggy; Exhausted; Sore throat; Upset Stomach; Vomiting; Stomach ache; Indigestion; Body ache; Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 7th November 2019, 1 days after receiving Shingrix, the patient experienced headache. On 8th November 2019, the patient experienced sore throat, upset stomach, vomiting, stomach pain, indigestion and general body pain. On 9th November 2019, the patient experienced feeling abnormal and exhaustion. On 10th November 2019, the outcome of the headache and sore throat were recovered/resolved. On an unknown date, the outcome of the upset stomach, vomiting, stomach pain, indigestion, general body pain, feeling abnormal and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the headache, sore throat, upset stomach, vomiting, stomach pain, indigestion, general body pain, feeling abnormal and exhaustion to be related to Shingrix.  Additional details were provided as follows: On Tuesday, the patient received Shingrix in right arm. On Thursday, she experienced a headache. On Friday, 2 days after Shingrix vaccination, she had a sore throat and headache. On the same night, she experienced upset stomach, stomach ache, vomiting, indigestion and entire body was aching. On Saturday, 3 days after Shingrix vaccination, everything continued and she also felt foggy and exhausted. On Sunday, 10th November 2019, sore throat and headache were gone, but everything else continued. The patient stated, aching still comes and goes. The patient did not consent to follow-up. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Oropharyngeal pain, Pain, Vomiting
Clinical narrative: felt foggy; Exhausted; Sore throat; Upset Stomach; Vomiting; Stomach ache; Indigestion; Body ache; Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 7th November 2019, 1 days after receiving Shingrix, the patient experienced headache. On 8th November 2019, the patient experienced sore throat, upset stomach, vomiting, stomach pain, indigestion and general body pain. On 9th November 2019, the patient experienced feeling abnormal and exhaustion. On 10th November 2019, the outcome of the headache and sore throat were recovered/resolved. On an unknown date, the outcome of the upset stomach, vomiting, stomach pain, indigestion, general body pain, feeling abnormal and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the headache, sore throat, upset stomach, vomiting, stomach pain, indigestion, general body pain, feeling abnormal and exhaustion to be related to Shingrix.  Additional details were provided as follows: On Tuesday, the patient received Shingrix in right arm. On Thursday, she experienced a headache. On Friday, 2 days after Shingrix vaccination, she had a sore throat and headache. On the same night, she experienced upset stomach, stomach ache, vomiting, indigestion and entire body was aching. On Saturday, 3 days after Shingrix vaccination, everything continued and she also felt foggy and exhausted. On Sunday, 10th November 2019, sore throat and headache were gone, but everything else continued. The patient stated, aching still comes and goes. The patient did not consent to follow-up. No further details were provided.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Nasal congestion, Nausea
Clinical narrative: This morning mom noticed erythematous wheals at the right deltoid (the site of injection) and perioral area. He also had a fever, nausea and vomited once this morning. On examination, he had nasal congestion and clear rhinorrhea in addition to the rash described above. Both of his sisters also had fever and sore throat but no rash. He and his sisters were diagnosed with viral upper respiratory infections
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Rhinorrhoea, Urticaria, Viral upper respiratory tract infection
Clinical narrative: This morning mom noticed erythematous wheals at the right deltoid (the site of injection) and perioral area. He also had a fever, nausea and vomited once this morning. On examination, he had nasal congestion and clear rhinorrhea in addition to the rash described above. Both of his sisters also had fever and sore throat but no rash. He and his sisters were diagnosed with viral upper respiratory infections
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This morning mom noticed erythematous wheals at the right deltoid (the site of injection) and perioral area. He also had a fever, nausea and vomited once this morning. On examination, he had nasal congestion and clear rhinorrhea in addition to the rash described above. Both of his sisters also had fever and sore throat but no rash. He and his sisters were diagnosed with viral upper respiratory infections
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, and body aches. lasting 2 hours. Headache lasting 8 hours states "splitting" H.A.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Pain, Paraesthesia, Walking aid user
Clinical narrative: Fatigue, numbness, tingling, pain, needed to use walker in 2018,  now needs to use wheelchair currently.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Wheelchair user
Clinical narrative: Fatigue, numbness, tingling, pain, needed to use walker in 2018,  now needs to use wheelchair currently.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site swelling, Lip swelling, Urticaria
Clinical narrative: Pt experienced extreme swelling at the injection site, hives and swelling of his lips. He was administered 30mg of liquid Benadryl & kept for observation for 45+min until symptoms began to resolve. Pt was released w/ EpiPen in hand.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Mobility decreased, Pain, Pruritus, Skin warm
Clinical narrative: PATIENT DESCRIBED PAIN AND SWELLING A FEW HOURS AFTER ADMINISTRATION. THE AREA TURNED ITCHY AND WARM TO THE TOUCH. PER PATIENT, THE AREA WAS ALSO SWOLLEN AND HARD. THE FIRST NIGHT SHE WAS NOT ABLE TO MOVE HER ARM BUT ON 12/12/19 SHE WAS ABLE TO GET BETTER RANGE OF MOTION. NOTIFIED PATIENT TO TRY TAKING BENADRYL OR ZYRTEC TO DECREASE THE SYMPTOMS THE LOOK TO BE AN ALLERGIC REACTION AT SITE OF INJECTION. NOTIFIED HER TO SEEK MEDICAL ATTENTION AS SOON AS POSSIBLE IF SYMPTOMS DO NOT RESOLVE OR GET WORSE. WILL CALL PATIENT TO FOLLOW UP TODAY TO SEE HOW SHE IS DOING.