chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea/uncontrollable loose stools; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 6th August 2019 04:30, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 23 hrs after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that male patient received the first dose of Shingrix and 23 hrs after receiving Shingrix, the patient experienced diarrhea. The reporter stated that, the patient has not attempted to alleviate the symptoms with any treatment at the time of reporting. The reporter consented to follow up. The reporter granted permission for follow up
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Rash macular, Vaccine positive rechallenge
Clinical narrative: large red area on arm; blotchy area on arm; didn't feel well; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced large, red, blotchy area on her arm and did not felt good after receiving vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities, blotchy and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the erythema of extremities, blotchy and feeling unwell were unknown.   It was unknown if the reporter considered the erythema of extremities, blotchy and feeling unwell to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The reporter stated that an acquaintance of hers experienced a large, red, blotchy area on her arm after the first dose of Shingrix. The patient was feeling unwell after getting the vaccine. This is 2 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Rash macular
Clinical narrative: large red area on arm; blotchy area on arm; didn't feel well; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities, blotchy and feeling unwell. On an unknown date, the outcome of the erythema of extremities, blotchy and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, blotchy and feeling unwell to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported. The reporter stated that an acquaintance of hers experienced a large, red, blotchy area on her arm after the first dose of Shingrix. The patient was feeling unwell after getting the vaccine. The symptoms lasted about 2 weeks before resolving. This is 1 of the 2 cases reported by the same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Swelling / swelling worsening; Pain with movement / pain worsening; This case was reported by a physician via call center representative and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd June 2019, immediately after receiving Shingrix, the patient experienced swelling and pain upon movement. On an unknown date, the outcome of the swelling and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the swelling and pain upon movement to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient received their first dose two months ago and still had pain with movement and swelling. The symptoms started immediately and felt like they were worsening. The reporter gave permission to follow up
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Injection site pain, Pain
Clinical narrative: cellulitis; tenderness; aches; chills; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), injection site tenderness, pain and chills. The patient was treated with cefalexin (Cephalexine). On an unknown date, the outcome of the cellulitis, injection site tenderness, pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the cellulitis, injection site tenderness, pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The nurse reported that, the patient was diagnosed with cellulitis and within 2 days, experienced aches, chills, and injection site tenderness. The reporter reported that, the symptoms were still present as of day before reporting. The reporter stated that, 2 patients experienced reaction with same batch number(TT9BR), and was unusual from the facility's past experience with Shingrix. The reporter stated that, they were not going to use this batch any more. The reporter would fill out VAERS for patients who got a rash from Shingrix batch number (TT9BR). The reporter reported that, 2 out of 10 Shingrix doses resulted in a rash, they had 5 unused vaccines and had not heard back from 3 out of 10 Shingrix doses. The reporter consented to follow up. This case was 1 of the 3 linked cases.
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a patient of unknown age and gender received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had Guillain-Barre syndrome (GBS). Outcome was unknown. It was not clear if the event was resulting from the administration of pneumococcal 13-val conj vac (dipht crm197 protein) or due to another vaccine or a medication since the pharmacist had no information on that. Information on the batch number has been requested.; Sender's Comments: Current information is very limited and does not allow a full medically meaningful assessment, especially lack of complete medical history, concomitant medications, concurrent medical conditions and event details including time lag between the onset of the event and administration date of PREVENAR 13 and etiological workups. The event Guillain-Barre syndrome more likely represents an intercurrent medical condition unrelated to the use of  PREVENAR 13.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Blood test normal, Computerised tomogram head normal, Headache, Pyrexia
Clinical narrative: Overall weakness; Severe headache; Fever; Vomiting; This is a spontaneous report from a contactable Nurse via Pfizer sales representative.   A 20-years-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot: W95252; Exp 31Jan2020) , via an unspecified route of administration on 17Jul2019 16:15 at single dose for immunisation .  Medical history included hypercholesterolemia and familial hypercholesterolemia. Concomitant medication included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA).  The patient experienced overall weakness  on 17Jul2019 with outcome of recovered , severe headache on 17Jul2019 with outcome of recovered , fever  on 17Jul2019 with outcome of recovered , vomiting on 17Jul2019 with outcome of recovered.  The patient was hospitalized on 17Jul2019 because of all the reported events. During hospitalization the patient underwent lab tests and computerised tomogram of the head which gave normal results.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events weakness, headache, fever, vomiting.
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Overall weakness; Severe headache; Fever; Vomiting; This is a spontaneous report from a contactable Nurse via Pfizer sales representative.   A 20-years-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot: W95252; Exp 31Jan2020) , via an unspecified route of administration on 17Jul2019 16:15 at single dose for immunisation .  Medical history included hypercholesterolemia and familial hypercholesterolemia. Concomitant medication included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA).  The patient experienced overall weakness  on 17Jul2019 with outcome of recovered , severe headache on 17Jul2019 with outcome of recovered , fever  on 17Jul2019 with outcome of recovered , vomiting on 17Jul2019 with outcome of recovered.  The patient was hospitalized on 17Jul2019 because of all the reported events. During hospitalization the patient underwent lab tests and computerised tomogram of the head which gave normal results.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events weakness, headache, fever, vomiting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site rash, Pyrexia, Rash
Clinical narrative: Rash on left arm on bicep. From top of arm down per patient half way to elbow. She said she noticed yesterday morning after a shower, she had a headache, fatigue, fever and painful rash. She took some ibuprofen and slept. She says that symptoms have improved today but rash is still present though not as painful as yesterday.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Painful for 2 days after the shot on left arm where the injection was given. Diarrhea and fatigue on the fourth day. on the sixth day, the arm was red, tender, and spreading downward.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: two days later a rash developed on arms and legs Red, hives, itchy
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient that that she had a non stop headache for 48 hours after receiving the vaccination. Patient also stated that she had swelling, reddness, and itchyness at the injection site that resolved after 48 hours. Swelling began around 36 hours after receiving the shot but resolved in 12 hours.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Malaise, Pyrexia, Rash
Clinical narrative: extremely ill; rash; fever; fatigue; This case was reported by a other health professional via interactive digital media and described the occurrence of unwell in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 31st July 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced unwell, rash, fever and fatigue. The patient was treated with antihistamine (Antihistamines), esomeprazole magnesium (Nexium), ondansetron (Zofran), topical steroid nos (Steroid Cream), nsaid's and prednisone. On an unknown date, the outcome of the unwell was not recovered/not resolved and the outcome of the rash, fever and fatigue were unknown.   It was unknown if the reporter considered the unwell, rash, fever and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was pro vaccination but his daughter got a shot and had been extremely ill since. The reporter did the normal treatment antihistamines, Nexium, Zofran, rubbed the arm with alcohol, put a steroid cream on the rash, gave Non Steroidal Anti Inflammatory Drug for the fever, and marked the rash to determine the growth. The reporter found it very disturbing that this shot has caused her so many side effects and that she's completely fatigue 3 days later. The reporter talked to the nurse and then to the doctor and they said they have done everything aside from giving her prednisone to help her so try to ride it out and she should feel better in a week. The reporter was sure when she gets better it would just be a bad memory but she needed the booster shot.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Contusion, Hypoaesthesia, Joint range of motion decreased
Clinical narrative: Arm and joint pain that radiates through the shoulder to neck and arm, swelling, bruising, loss of joint motion, bursitis, adhesive capsulitis, muscle spasms, numb shoulder muscle, bicep tear. Radiating pain from shoulder joint down arm to elbow and hand. Tingling and minor numbness concentrated in pinky and ring finger, but also moving to the rest of the hand at times.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Musculoskeletal pain, Neck pain, Neurological examination normal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Arm and joint pain that radiates through the shoulder to neck and arm, swelling, bruising, loss of joint motion, bursitis, adhesive capsulitis, muscle spasms, numb shoulder muscle, bicep tear. Radiating pain from shoulder joint down arm to elbow and hand. Tingling and minor numbness concentrated in pinky and ring finger, but also moving to the rest of the hand at times.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal, Pain, Pain in extremity, Paraesthesia, Periarthritis
Clinical narrative: Arm and joint pain that radiates through the shoulder to neck and arm, swelling, bruising, loss of joint motion, bursitis, adhesive capsulitis, muscle spasms, numb shoulder muscle, bicep tear. Radiating pain from shoulder joint down arm to elbow and hand. Tingling and minor numbness concentrated in pinky and ring finger, but also moving to the rest of the hand at times.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Spinal X-ray abnormal, Swelling, Tendon rupture, X-ray limb abnormal
Clinical narrative: Arm and joint pain that radiates through the shoulder to neck and arm, swelling, bruising, loss of joint motion, bursitis, adhesive capsulitis, muscle spasms, numb shoulder muscle, bicep tear. Radiating pain from shoulder joint down arm to elbow and hand. Tingling and minor numbness concentrated in pinky and ring finger, but also moving to the rest of the hand at times.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Ear pain, Facial paralysis, Headache
Clinical narrative: Left facial paralysis, headache, left ear pain. Prescribed Prednisone and valacyclovir
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Left upper arm swollen, red, and warm.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt came in to facility 08/13/2019 with reports of itchy raised, reddened area at injection site that started 08/12/2019. Pt applied hydrocortisone cream to site at home with minimal effectiveness. Pt was prescribed  DiphenhydrAMINE HCl Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, 3 days and Amoxicillin-Pot Clavulanate Tablet, 875-125 MG, 1 tablet, Orally, every 12 hrs for 5 days.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Nausea, Pyrexia, Sluggishness
Clinical narrative: Dizzy, feverish, sluggish and nauseated
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Asthenia, Computerised tomogram, Flank pain, Food allergy
Clinical narrative: Second shot was on 4/22/2019. Had new anaphylactic  reaction to fish on  5/1/19.  had significant fecal motor weakness 5/13/1019,left flank pain for a week starting 6/2/2019. Left flank  swelling starting on 6/2/2019 and continuing until present
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Second shot was on 4/22/2019. Had new anaphylactic  reaction to fish on  5/1/19.  had significant fecal motor weakness 5/13/1019,left flank pain for a week starting 6/2/2019. Left flank  swelling starting on 6/2/2019 and continuing until present
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (on the scalp within the same time frame of receiving the vaccine).   On 27th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient fad rash prior to receiving the vaccine. The patient received her 1st dose of Shingrix within the same time frame of receiving the vaccine. It was not confirmed until after receiving the vaccine that it was shingles. On 31st July 2019, the patient was prescribed Valtrex.  The reporter stated that the vaccine after the symptoms of the rash had abated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Hypophosphataemia, Pyrexia
Clinical narrative: High fever, headache, Hypophosphatemia
Age: 60.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right anterior upper arm with swelling, redness, warm to touch causing discomfort.  Area swollen to approximately twice its normal size. Encouraged elevation for swelling and discomfort. OTC Benadryl PRN
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Headache, flu-like symptoms. fever (101 degrees), chills
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Lethargy, Pain in extremity
Clinical narrative: Day 1, sore arm.  Day 2 chills, fever to 101.4.  Day 3 OK, Day 4 lethargy, Day 5 chills, fever to 102.0, diarrhea, sore joints
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Day 1, sore arm.  Day 2 chills, fever to 101.4.  Day 3 OK, Day 4 lethargy, Day 5 chills, fever to 102.0, diarrhea, sore joints
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Pallor, Posture abnormal
Clinical narrative: Patient turned pale, and started tipping over, nurse laid her down and raised her legs, she came back to with in a few seconds
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenic purpura, Peripheral swelling, Platelet count decreased, Rash
Clinical narrative: idiopathic thrombocytopenic purpura; rash and swelling on her arm; rash and swelling on her arm; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or around 17-JUN-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), pt suffered from rash and swelling on her arm. She also suffered critically low platelet count shortly after receiving the vaccine and was diagnosed with idiopathic thrombocytopenic purpura that required various lengthy hospitalizations and continued treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to the vaccination. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, pt 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), she had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages  The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The reporter considered the events to be disabling.  Upon internal review, the event of idiopathic thrombocytopenic purpura was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2012, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration and lot# were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Blood test, Creatinine renal clearance, Discomfort
Clinical narrative: POLYARTHRALIGIA; This spontaneous report was received from a patient who is also a physician regarding himself. The patient's pertinent medical history included eczema and psoriasis. The patient had allergic rhinitis. The patient's concomitant medications included chlorthalidone, lisinopril, baby aspirin, atorvastatin, metformin, esomeprazole sodium (NEXIUM), sertraline, montelukast, olopatadine hydrochloride, fluticasone propionate (FLONASE), desloratadine, cromolyn, dupilumab (DUPIXENT), insulin glargine (TOUJEO), semaglutide (OZEMPIC), insulin lispro (HUMALOG), iron, multivitamin, cholecalciferol (VITAMIN D3), monthly allergy shots, a turmeric-ginger-pepper complex, CBD/THC and various topical medications for eczema and psoriasis. On 12-JUN-2019, the patient was vaccinated with the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose details, route, lot # and expiry date unknown) for booster shot/ prophylaxis. On 28-JUN-2019 (16 days after the injection), the patient had a sudden onset of polyarthralgia. The physician mentioned that his symptoms were "severe for 5 days and then tapered off". The patient visited two specialty physicians, on 01-2019 to his allergist and on 03-JUL-2019 to his nephrologist. Both  the specialty physicians performed "various blood tests and a Creatinine clearance test (lab details unspecified)" Physician further mentioned that he was not fully recovered and still had "discomfort in his right wrist, right hand and left ankle". The outcome of the event was recovering/ resolving. The reporter did not provide the causality assessment.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Ear discomfort, Influenza like illness, Interchange of vaccine products, Noninfective myringitis
Clinical narrative: flu like symptoms; ear drums burning; ear drums burning; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B vaccine (Trumenba) for prophylaxis.   In June 2019, the patient received the 2nd dose of Bexsero (intramuscular). On an unknown date, the patient started Trumenba at an unknown dose and frequency. In June 2019, several hours after receiving Bexsero, the patient experienced influenza-like symptoms, tympanic membrane inflammation and interchange of vaccine products. On an unknown date, the outcome of the influenza-like symptoms and tympanic membrane inflammation were recovered/resolved and the outcome of the interchange of vaccine products was unknown.   It was unknown if the reporter considered the influenza-like symptoms and tympanic membrane inflammation to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient's mother. In December 2018, the patient received 1st dose of Trumenba and in June 2019, the patient received 2nd dose of Bexsero, which led to interchange of vaccine products. The patient experienced flu like symptoms and ear drums burning the evening after the dose was given and that those symptoms were resolved in about 24 hours. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Patient noted that her tongue began to swell 3 hours or so after getting the injection. Also reports a slight fever that was not measured
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; administered improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), therapy type rHA, injection, lot # S003178 with expiration date on 30-JUL-2020 (the exact dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion of 6 to 14 (7.7) degrees Fahrenheit for 305 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. The sterile diluent  used to reconstitute the vaccines was stored properly.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-1907USA011351:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a currently 65 year old female patient. Her medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2017, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for the long term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        On an unknown date, Plaintiff was treated by a healthcare provider for the following injuries resulting from Plaintiff's zoster vaccine live(ZOSTAVAX) use: herpes zoster. Plaintiff bring this action on behalf of herself, claiming damages as a result of injury to herself, loss of consortium, loss of services and economic losses.  The outcome of herpes zoster was unknown.    The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Polymerase chain reaction positive, Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: rash onset 08/07/19; outcome: confirmed positive for varicella by PCR
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Chest X-ray, Chills, Electrocardiogram, Full blood count
Clinical narrative: I woke up in the middle of the night with sweats, shivering, nasua, and fever. My fever reached 103 and would not go down even with aspirin. I went to the emergency room and was admitted to the hospital for this TERRIBLE reaction. I had multiple tests and had an iv immediately after my arrival. I was very very sick. It took me weeks for my body to feel better. This sucked everything out of me and was related to the shingrix shot.  It is unknown whether I should take the 2nd shot. I don't want to have this happen again and my doctor said this is the worse reaction that he has ever seen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Metabolic function test, Middle insomnia, Nausea, Night sweats
Clinical narrative: I woke up in the middle of the night with sweats, shivering, nasua, and fever. My fever reached 103 and would not go down even with aspirin. I went to the emergency room and was admitted to the hospital for this TERRIBLE reaction. I had multiple tests and had an iv immediately after my arrival. I was very very sick. It took me weeks for my body to feel better. This sucked everything out of me and was related to the shingrix shot.  It is unknown whether I should take the 2nd shot. I don't want to have this happen again and my doctor said this is the worse reaction that he has ever seen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urine analysis
Clinical narrative: I woke up in the middle of the night with sweats, shivering, nasua, and fever. My fever reached 103 and would not go down even with aspirin. I went to the emergency room and was admitted to the hospital for this TERRIBLE reaction. I had multiple tests and had an iv immediately after my arrival. I was very very sick. It took me weeks for my body to feel better. This sucked everything out of me and was related to the shingrix shot.  It is unknown whether I should take the 2nd shot. I don't want to have this happen again and my doctor said this is the worse reaction that he has ever seen.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling, redness & warmth at injection site, size of a "tangerine" per employee
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: fever of 101.8 8 hours after vaccine fever if 106.0 24 hours after vaccine
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: 102 degree fever for 2 days. Redness/soreness in left upper arm away from the injection site. Fever abated, soreness has not
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Vaccine was administered to (L) thigh but moved during the procedure. On 8/9/19 he developed a fever to 103.1 24 hours after vaccine was given. On 8/10/19 the grandmother noticed redness around the injection site. Pt was prescribed Omnicef for 10 days. Mother may apply Benadryl topical cream if pt has itching @ this site.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen night arm. Warm to touch. Pt. did take Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Breath sounds abnormal, Cough, Oropharyngeal pain, Sneezing, Wheezing
Clinical narrative: 4yrold came in for WCC had proquad & kinnrix as part of his vaccine series. 20 min after shots developed sore throat, then cough, sneeze, returned to clinic was in clear distress w/ O2 sat 95%, breath sounds coarse & wheezing. Call 911. administered epi went to check on, resolved all symptoms 30 mis after epi
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No adverse reaction. Used a pediatric Needle to administer instead of adult needle. We need to reimonize We are going to readminister the vaccine with proper needle
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered a fourth dose of GARDASIL 9; the patient was administered the second dose on 08/08/2016 and the third dose on 10/24/2016; This spontaneous report was received from a pharmacist and refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported), on 08-AUG-2016, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) and on 24-OCT-2016, she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported), all for prophylaxis. On 15-JUL-2019, the patient was inadvertently vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; Death; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was not provided. On 17-APR-2018, the patient died. Information regarding cause of death and autopsy was not provided.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: Vision Loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 11-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in pharmacy. On an unspecified date, the patient experienced vision loss. On an unspecified date, the patient was treated by a physician for the event.  The outcome of the event of vision loss was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
Sex: U
Vaccine: FLUN3
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC HYPERSENSITIVITY; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine (live, attenuated)) (batch number KJ2502) once/single administration, via nasal route, on an unknown date. The patient had previously received 1 dose(s) of Flumist.     On an unknown date, the patient experienced allergic hypersensitivity (preferred term: Hypersensitivity).     The outcome of the event was unknown.    The event was considered non-serious.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; Diffuse body aches; Muscle aches; Feeling sick; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix. On 29th July 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: Within 24 hours the patient developed flu-like symptoms including a fever (maximum temperature reported as 101.8F), diffuse body aches, muscle aches, and feeling sick.  The patient was sent home from work by the physicians that she works with.  The patient took Ibuprofen and Tylenol for the symptoms, and symptoms resolved after approximately 48-72 hours. The reporter gave permission to follow up. This case had been linked to the case US2019142319, reported by same reporter. In the document onset date of events was reported as 30th July 2019, but as per narrative it was given as within 24 hrs. So onset date considered as 29 Jul 2019.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash "all over"; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 6th May 2019, the patient received Shingrix (intramuscular). On 8th May 2019, 2 days after receiving Shingrix, the patient experienced generalized rash. On 11th May 2019, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. 2 days after receiving Shingrix, the patient experienced rash all over, which lasted for 3 days and then resolved without treatment. The patient did not report this to the pharmacy until the reporting date. The reporter consented to follow up. The pharmacist granted permission for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated a coworker left a note at the pharmacy which outlined that the patient did not want to receive the 2nd dose of the Shingrix. The pharmacist believed that the patient experienced side effects from the 1st dose, but she was not sure what the patient experienced as the note did not specify further. The reporter consented to follow up. No further details provided during the call, but pharmacist granted permission for safety to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The reporter reported that about 3 days after receiving a dose of Shingrix, the patient experienced a shingles outbreak on his back about 2 inch by 4 inches.  The patient was seen by his physician and diagnosed with shingles and stated that it cleared up and resolved about one week later without treatment. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia
Clinical narrative: Heartburn; This case was reported by a pharmacist via call center representative and described the occurrence of heartburn in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th June 2019, 6 hrs after receiving Shingrix, the patient experienced heartburn. The patient was treated with omeprazole. On an unknown date, the outcome of the heartburn was unknown.   It was unknown if the reporter considered the heartburn to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on right deltoid. The patient had to take omeprazole to treat the heart burn. The reporter was unsure if the symptoms resolved. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine Administered at Inappropriate Site; pain at injection site; redness at injection site; swelling at injection site; hot to touch at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2019, the patient received Shingrix (subcutaneous). On 25th March 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The injection was given behind the left arm and was given subcutaneously, which led to intramuscular formulation administered by other route. The injection site was painful, red, hot to the touch, and swollen.  The symptoms were lasted for about 5 weeks and then resolved. The reporter gave permission to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash on upper torso and arm; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On an unknown date, less than a week after receiving Bexsero, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional details were provided as follows: The medical assistant stated that the patient was given the Bexsero and developed rash on upper torso and arm.  The patient was prescribed Benadryl to treat the rash. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever; Chills; Pain at the injection site; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the first of the two reports.  An 11-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had fever, chills, and pain at the injection site. The outcome of the events, 'fever', 'chills' and 'pain at the injection site', was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019341527 same reporter/drug/events, different patient