chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bronchitis, Incomplete course of vaccination, Pneumonia
Clinical narrative: Bronchitis; Inappropriate schedule of vaccine; Pneumonia; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cutaneous lupus erythematosus.   On 29th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In March 2019, 42 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the patient experienced bronchitis and incomplete course of vaccination. On an unknown date, the outcome of the pneumonia and bronchitis were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pneumonia and bronchitis to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in her left arm.  About 6 weeks later, the patient developed pneumonia and was lasted for about 5 weeks.  After pneumonia she had subsequent episodes of bronchitis. The patient was recovered from bronchitis till the time of reporting.  The age at vaccination for the 2nd dose was not applicable. It had been more than 6 months and the patient did not receive her 2nd dose of the Shingrix, which led to incomplete course of vaccination. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mononeuropathy, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: approx. 3/14/19 pt. complaint of burning and stabbing pain, right interior medial thigh DX: Mono-Neuropathy of anterior cutaneous branch of right femoral nerve  TX: high dose prednisone tapered over 1 month, gabapentin daily since time of DX, still taking gabapentin on 8/12/19 pt. still has episodes of moderate pain (aprox. 6 episodes per day, each lasting 2 minutes) each episode is described with burning stabbing pain
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: noticed swelling, redness, warmth, pain to L deltoid a day after receiving Tdap; also had flu-like symptoms with nightsweats and pain to the arm; by the 2nd day he took Ibuprofen and Tylenol for the pain but the pain and swelling persisted over the weekend.  reporting to facility today but still off; has not taken any more analgesics or antipyretics; has a bruise and redness to L deltoid
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Night sweats, Pain in extremity
Clinical narrative: noticed swelling, redness, warmth, pain to L deltoid a day after receiving Tdap; also had flu-like symptoms with nightsweats and pain to the arm; by the 2nd day he took Ibuprofen and Tylenol for the pain but the pain and swelling persisted over the weekend.  reporting to facility today but still off; has not taken any more analgesics or antipyretics; has a bruise and redness to L deltoid
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: FEVER, CHILLS, SWEATING, HEADACHE, MUSCLE ACHES
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Rash erythematous, Skin warm
Clinical narrative: Less than 24 hours post dose a red rash started.  Intitally the rash only covered a small area, approximately 2inch square.  The rash has spread  to approximately a 6inch x 3inch area and continues to be hot to the touch,  it feels  like the area of the rash is burning and tingling
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid redness, swelling and sore arm  for 3 days after second dose of shingrix
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pharmacist stated vaccine would go in back of arm subcutaneous and stated that since it is only injected in the skin layer it would be painful that evening. Vaccine given back of arm, about 1/2 way between shoulder and elbow. Had moderate pain that evening, some redness, site hot to touch. Next 3 days, fever up to 101.5, extreme fatique, swelling around site, redness growing to 6x3 in. Day 6-8 more redness, pain still present, fatigue, no fever. Still painful and red with signifcant oval "bump" under skin today. Pharmacy advised to go to dr. on Mon if not better.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pharmacist stated vaccine would go in back of arm subcutaneous and stated that since it is only injected in the skin layer it would be painful that evening. Vaccine given back of arm, about 1/2 way between shoulder and elbow. Had moderate pain that evening, some redness, site hot to touch. Next 3 days, fever up to 101.5, extreme fatique, swelling around site, redness growing to 6x3 in. Day 6-8 more redness, pain still present, fatigue, no fever. Still painful and red with signifcant oval "bump" under skin today. Pharmacy advised to go to dr. on Mon if not better.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Pharmacist stated vaccine would go in back of arm subcutaneous and stated that since it is only injected in the skin layer it would be painful that evening. Vaccine given back of arm, about 1/2 way between shoulder and elbow. Had moderate pain that evening, some redness, site hot to touch. Next 3 days, fever up to 101.5, extreme fatique, swelling around site, redness growing to 6x3 in. Day 6-8 more redness, pain still present, fatigue, no fever. Still painful and red with signifcant oval "bump" under skin today. Pharmacy advised to go to dr. on Mon if not better.
Age: 59.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Chills, Discomfort, Erythema, Nausea, Pain
Clinical narrative: day after patient reported chills, aches, nausea. 2 days after patient reports redness, swelling and warmth to L) arm, took Benadryl and had minimal benefit. 3 days after patient reports to clinic redness is milder per patient and measures 11.2cm X 9.1cm, slight warmth. Marked outline and recommended patient keep an eye on area and contact clinic if it grows or pain/swelling worsens, recommended Tylenol and ice to help with discomfort.
Age: 59.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: day after patient reported chills, aches, nausea. 2 days after patient reports redness, swelling and warmth to L) arm, took Benadryl and had minimal benefit. 3 days after patient reports to clinic redness is milder per patient and measures 11.2cm X 9.1cm, slight warmth. Marked outline and recommended patient keep an eye on area and contact clinic if it grows or pain/swelling worsens, recommended Tylenol and ice to help with discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: On 8-8-19, 5 YOM pt accompanied by parents presented for HAV, MMR, Varicella, IPOL and Dtap vaccines. Pt and parents counseled by Clinician and vaccines on right thigh administered by Clinician assistant (CA) and on the left thigh and upper arm side by clinician per parent's request. Pt's mother called on 8-11-19 and spoke to CA and per CA's report "Pt seen 8/8/19 for immunizations, pt mother called today to let us know Pt had red knot form on right leg at injection site, mother states knot is size of her fist. Recommended to take pt to urgent care of ER. Mother highly upset. Pt given DTaP and MMR in right leg." Pt's mother was tried to be contacted on 8-11-19 by covering clinician and on 8-12-19 by clinician that saw pt. Pt's mother did not answer and a message was left. She then returned call. She reports the pt developed redness and a knot of the size of her fist (pt's mother's fist) on the right thigh on 8-9-19 (day after vaccines administered). She stated the area is not tender or hard and there is no fluid-like sensation. She reported that the pt is not having any other symptoms like SOB. However, he is having itching at the site. She has been giving pt tylenol and benadryl. She reports, pt is able to move his leg and walk normally. When she called on 8-11-19 she was instructed to take her son the the ER but she refused. Instead, she called  her son's pediatrician and an ER doctor she knows on 8-11-19, and they told her to monitor an if no improvement to take her son to his pediatrician. She also reported pt has never had a reaction to vaccines. I went over the recommendations I gave her on the date of vaccination which included to take her son the ER in the event edema and/or erythema developed at the site of the injection, rash, difficulty breathing, chest pain, SOB, swelling of lips  or any other reaction and she verbalized understanding that day and today as well, she stated she did not take him to the ER because she is an ER nurse and "I know what they're gonna do at the ER." I insisted to take him to the ER but she refused and said she will follow up with her son's pediatrician tomorrow 8-13-19 if no improvement.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: This report describes a vaccination error. The IMOVAX rabies vaccine was injected into the quadriceps, which is not an acceptable site for administration of a rabies vaccine in adults. As explained in the prescribing information document for IMOVAX, for adults and older children, the vaccine should be injected into the deltoid muscle. There are no data demonstrating adequate immune response following injection of IMOVAX into quadriceps in adults. This vaccination error is serious because incorrect injection sites of rabies vaccine have been associated with failed prophylaxis, as explained in the prescribing information document for IMOVAX.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Nervousness, Vomiting
Clinical narrative: Pt vomited after administration, pt also was sweating and shaky, pt has previously fainted upon other vaccine administrations.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure on 8/6/19
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: arm soreness-4 days, fatigue, feeling tired, body aches, muscle soreness x 1.5 days- took Ibuprofen
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Influenza virus test negative, Pain, Vomiting
Clinical narrative: FLU LIKE SYMPTOMS AND SEVERE BODY ACHES. VOMITING AND HEADACHE ALSO OCCURRED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Influenza like illness, Rash, Scab
Clinical narrative: PT STATED THAT HE HAD FLU LIKE SYMTOMS, AND A RASH THAT APPEARED IN DIFFERENT AREAS OF THE BODY, BUT ONLY 1 BLISTER IN EACH AREA THAT CRUSTED OVER.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: When called patient about completing the series and doing the second vaccine, she stated that she had experienced a sore and swollen arm for 3 weeks after the vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Hyporesponsive to stimuli, Pallor, Syncope
Clinical narrative: Mother was not able to hold child due to back pain. Patient sat down in a chair by herself, holding the side of opening of the chair and holding mom's hand. Mother, stated patient would be able to sit by herself, patient agreed. Patient received Kinrix im and MMR sub was administered on left arm. Patient was repositioning to left side for administartion of varicella when she suddenly got of her chair start running and saying she needed to go to rest room. She was running to look for rest room. Mother guided her to the rest room in lobby. Mother was waiting when she noticed she was becoming loose and mother carried her in her arms. She entered immunization room and stated patient fainted. She was pale but warm to touch, semi responsive, head brought to her knees. Instantly she said she was ok. Varicella deferred until one month. Mother believes syncope might be stress related. This is the second time she fainted. First time fainted episode, 7/8/19  was after the ambulance had to take her grandfather to emergency room. Patient had medical evaluation 0n 7/8/19 at emergency room and a week later with private physician and all exams were negative. Mother was informed that she may have been got scared. 8/6/19 brother and patient didnot have any breakfast.  10.45 patient dismissed, alert, talkative and good color. Follow up with mother 8/7/19 mother in store. grandmother stated patient is doing fine. 7/7 and 7/9 telephone call to mother, child is doing fine.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Spike in blood pressure
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash
Clinical narrative: Existing rash worsened and MOC concerned it could be related to vaccines
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: patient started developing rash two days after vaccination. Went to doctor and was diagnosed with shingles 8-12-19.  Rash developed on left  side along bra strap line.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site mass, Injection site pruritus
Clinical narrative: Patient had a golf ball sized lump form at the injection site. The lump appeared bruised and dark in color. She also noted itching at the injection site. This has occurred since the vaccination 6 days ago. Currently the lump has turned to a pink color and has reduced in some size with itching every now and again.
Sex: M
Vaccine: FLUX
Symptoms: Death, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Happened at urgent care on 01/30/18. Patient received a flu vaccine that morning and stated he started feeling bad immediately. He went back to urgent care and was given a shot in the hip and sent home. He was found dead the next morning with no apparent cause.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient was inadvertently administered a dose of RECOMBIVAX and ROTATEQ/ Temperature: 47.5F; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not reported.   On 30-JUL-2019, the patient was inadvertently administered a dose of Hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (schedule, dose number, route and anatomical location of vaccination not provided; lot # R031052, expiration date: 03-JUN-2021) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (schedule and dose number not provided; lot #R029815, expiration date: 18-JUN-2020) both indicated as prophylaxis, that had been improperly stored (product storage error) at a temperature of 47.5 degrees Fahrenheit (°F) for a time frame of 2 hours and 45 minutes, as detected by a digital data logger. There was not a previous temperature excursion. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: swelling al injection site; Injection site pain; Injection site redness; the vaccines was given subcutaneously not intramusculary; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 92NA4, expiry date 22nd November 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 31st July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site erythema. The patient was treated with ranitidine hydrochloride and hydroxyzine hydrochloride (Hydroxizine). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 49 or 50 years old. The patient received Shingrix on right arm. The pharmacist reported that patient had received Shingrix and reported a local injection site reaction. Pain redness and swelling with a diameter of 6 inches around. The patient was seen by doctor's office that administered Shingrix and was prescribed hydroxizine and ranitidine. The patient went to pharmacy to pick up prescription and told the pharmacist what happened. The patient showed the pharmacist her injection site the pharmacist believed under further evaluation that the vaccine was given subcutaneously not intramuscularly, which led to wrong route of vaccination. The pharmacist stated that the redness began at the top of the tricep muscle and radiated down the arm. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: swelling al injection site; Injection site pain; Injection site redness; the vaccines was given subcutaneously not intramusculary; This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 92NA4, expiry date 22nd November 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 31st July 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site erythema. The patient was treated with ranitidine hydrochloride and hydroxyzine hydrochloride (Hydroxizine). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 49 or 50 years old. The patient received Shingrix on right arm. The pharmacist reported that patient had received Shingrix and reported a local injection site reaction. Pain redness and swelling with a diameter of 6 inches around. The patient was seen by doctor's office that administered Shingrix and was prescribed hydroxizine and ranitidine. The patient went to pharmacy to pick up prescription and told the pharmacist what happened. The patient showed the pharmacist her injection site the pharmacist believed under further evaluation that the vaccine was given subcutaneously not intramuscularly, which led to wrong route of vaccination. The pharmacist stated that the redness began at the top of the tricep muscle and radiated down the arm. The reporter did not consent to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Hives; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th July 2019, 2 days after receiving Shingrix, the patient experienced pruritus and hives. On 18th July 2019, the outcome of the pruritus and hives were recovered/resolved.   It was unknown if the reporter considered the pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The consumer on the line reported her husband woke up with hives on the underarm where he received the shot, a few hives on his body, and a whole bunch on his inner thighs and scrotum. The patient had itching on his palms, which woke him. The patient was travelling and initially thought maybe there were insects or bed bugs on the bed causing the itching. The patient went back to bed, the arm started clearing up and the itching on his palms as well, and when he got up there was no trace of anything. The reporter had no further information to provide for vaccine, lot number or expiry date was unknown. The responsible provider was unknown, it was the pharmacist on staff. The patient had no spleen. Consent provided to follow up with the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: total body eczema; This case was reported by a physician via call center representative and described the occurrence of eczema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In May 2019, 30 days after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was not recovered/not resolved.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The health care professional calling regarding self. The patient received Shingrix and approximately one month later the patient developed total body eczema.  The reporter did not consent to follow up. The physician was calling regarding himself, could not remember the injection site or the exact dates. Did not want to provide any further information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Needle issue
Clinical narrative: Needle reportedly broke during administration, vaccine material did not enter arm at full dose ("sprayed" elsewhere), however patient's arm became red and slightly raised at injection site following event suggesting some receipt of vaccine.  Need advice re: how to proceed - need to repeat dose #1 at full dose, and if so when?  Proceed to dose #2 at regular interval?
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: 4.5 x 5 cm area of mild erythema, no tenderness, no swelling.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Blood magnesium, Differential white blood cell count, Full blood count, Glomerular filtration rate, Heart rate increased
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Hypertension, Hypokalaemia, Injection site pain, Metabolic function test, Myalgia
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Myocardial necrosis marker, Pain in extremity, Platelet count, Troponin I
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Blood pressure increased, Blood test, Dyspnoea, Fear
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Frustration tolerance decreased, Hypertension, Hypokalaemia, Impaired driving ability, Injection site pain
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Lethargy, Loss of personal independence in daily activities, Malaise, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Product administered at inappropriate site, Respiratory distress, Vaccination complication
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain
Clinical narrative: severe L arm/shoulder pain rapid heart beat; went to Dr. office; they called 911; taken by EMTs to ER
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia, Seizure
Clinical narrative: Seizure without fever on day 9 after MMR vaccine given Seizure with fever on day 10 after MMR vaccine given
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills after 20 hours
Age: 71.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Blood pressure fluctuation, Faeces pale, Fatigue
Clinical narrative: erratic blood pressures, chronic fatigue, stomach pains, clay-colored stools
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Mother showed a picture on 8/6/19 that when the symptoms occurred she had a rash almost covering more than 1/2 of her right thigh with burn blisters which look like in the picture. When patient came in on 8/6/19 she did have better symptoms, rash looked better and the blisters were no longer there but you could see the marks of where the blisters were. Patient's right leg did look much better than the photo. Patient has a follow up appointment on 8/16/2019 with us at our clinic.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eyelid margin crusting, Nasal congestion, Ocular hyperaemia, Pyrexia
Clinical narrative: Stuffy nose fever both eyes swollen shut eyes red and tender yellow crust on the corner of the eyelids
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: Stuffy nose fever both eyes swollen shut eyes red and tender yellow crust on the corner of the eyelids
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; an inmproperly stored dose of PROQUAD was administered on 8/2/19; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.   On 02-AUG-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, dose number, route of administration and location of administration were not reported) (lot # R026351, expiration date 15-MAR-2020 and/or lot # S003171, expiration date: 30-JUL-2020); and on an unknown date, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, dose number, route of administration and location of administration were not reported) (lot # R010466, expiration date 10-APR-2020 and/or lot # R002056, expiration date: 22-JAN-2020). Both vaccines were administered for prophylaxis.   The vaccines were exposed to a temperature of -11.68 degree Celsius for 4 hours and 50 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Sex: F
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 currently 72 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.   On or about 16-APR-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a healthcare due to herpes zoster. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster was not reported. The reporter considered the herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: inappropriate schedule of vaccine; 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 a year after receiving Shingrix, the patient experienced adverse event. The patient was treated with acyclovir. 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 case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The pharmacist stated that, it was for something that happened after receiving the 1st dose. The condition was unknown for what the patient was taking for the Acyclovir. At the time of reporting, the patient was taking Acyclovir. The patient was due for the 2nd dose of Shingrix. The reporter wanted to know, was it okay for them to receive the 2nd dose while they were taking Acyclovir, the patient would be taking it for a month. No additional information was available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Hot flush, Nausea, Pain
Clinical narrative: Soreness and swelling,  then about 12 hours after vaccination: hot flash, nausea, spike in blood pressure, spike in  heart rate
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Soreness and swelling,  then about 12 hours after vaccination: hot flash, nausea, spike in blood pressure, spike in  heart rate
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Insomnia
Clinical narrative: Flulike symptoms, roughly 24 hours in duration: chills, fever, insomnia, headache, tiredness
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flulike symptoms, roughly 24 hours in duration: chills, fever, insomnia, headache, tiredness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: I have redness & swelling with pain and  warmth at injection site.  The area in question was considered "definitely not normal" and is 4 inches wide x 2.2 inches in height.  Raised slightly.  Painful.  Itching began today (8-12-2019).    I had my shot at the local Pharmacy.  I had redness and swelling at 22 hours and 36 hours.  Today is the third day. I was told to take Benadryl (I can only take children's liquid); put triamcinolone cream on it, and to ice it.  I was also told they want me to get the 2nd shot.  I'm concerned that the 2nd shot might be worse than this is.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms starting ~36 hrs after injection.  Aches in joints, muscles, congestion, cough, headache.  No fever.  This day 2 of symptoms that prevented me from going to work.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Flu like symptoms starting ~36 hrs after injection.  Aches in joints, muscles, congestion, cough, headache.  No fever.  This day 2 of symptoms that prevented me from going to work.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Immunization was given and turned red, within 3 min a mild hive formed. Zyrtec was given along with hydrocortisone cream on the site. Pt had NO respitory symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: it got very swollen and red/purple it was at least 4 cm in diameter. with ice packs it finally improving  still swelling under arm With #1 gardasil she was fine  She did have pain down her left arm  which is resolved
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MMR, MNQ, TDAP, UNK, VARCEL
Symptoms: Cold sweat, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: After immunization of the 6th vaccine (HPV9), patient head rolled down, eyes closed, skin was pale and clammy , and she was  non- responsive. Immunization nurse  began stimulation tactics by calling out her name and holding her head. A few seconds in, Patient was aroused and was oriented x 2 (Name and Place). Vitals signs taken, Patient escorted to exam room, and was examined by Physician. Patient was discharged and left facility without further incident with ER precautions
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient had extreme redness, itching, and redness spread down half of her arm to her elbow, and spread all around her arm. The rash worsened for several days after the vaccine and began to recede on Sunday 8/11/19.  Patient was advised by her MD to start loratadine 10mg tabs and ranitidine 150mg tabs. MD advised patient to wait full 6 months to obtain second dose of Shingrix, and to pre dose for several days prior to injection with loratadine and ranitidine.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site warmth, Swelling
Clinical narrative: Injection on 08/01/19.  Mother brought patient to clinic on 08/02/19 for evaluation of vaccine reaction in left arm.  Assessment indicated left upper arm with erythema 3"X3", inflammation and was warm to the touch.  RN counseled comfort measures and to see MD if reaction worsens or does not improve.  Parent called and said she took patient on to see MD on 08/02/19 after leaving the health Department and MD did not prescribe medication, but informed of comfort measures and told parent that the patient should have allergy testing.  Parent said the allergy testing  has not been scheduled yet.  Parent said that it took 7 days for the swelling and redness to go away.  No further complaints or problems.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Soreness in right arm at shot site:  immediately following shot and continuing at 4 days after shot Severe Fatigue: 12hr to 2 days after shot Fatigue: 2days to 4 days after shot Muscle aches: 12 hr to 2.5 days after shot Slight headache: 12 hr to 1 day after shot Tender skin: 12 hr to 1 day after shot Lack of alertness: 12 hr to 1 day after shot Fever (100+): 14hr to ~1 day after shot
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain of skin, Pyrexia
Clinical narrative: Soreness in right arm at shot site:  immediately following shot and continuing at 4 days after shot Severe Fatigue: 12hr to 2 days after shot Fatigue: 2days to 4 days after shot Muscle aches: 12 hr to 2.5 days after shot Slight headache: 12 hr to 1 day after shot Tender skin: 12 hr to 1 day after shot Lack of alertness: 12 hr to 1 day after shot Fever (100+): 14hr to ~1 day after shot
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered a sudden onset of red bumps and rash that spread on his body. Plaintiff was diagnosed with a rash like shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around July 11 2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     Shortly after receiving zoster vaccine live (ZOSTAVAX) approximately in July 2017, the pt suffered a sudden onset of red bumps and rash that spread on his body, the pt was diagnosed with a rash like shingles (rash vesicular). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. 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), 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not resolved. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The reporter considered the event to be disabling.
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 53 year old female patient. Her medical history, concurrent conditions and concomitant medications were not reported.     On or about 01-AUG-2017, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for the 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: 20.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Nodule, Peripheral swelling, Swelling
Clinical narrative: Swelling in arm; Knot in arm; This case was reported by a nurse and described the occurrence of swelling arm in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included LIVE VARICELLA VIRUS VACCINE (VARIVAX) for prophylaxis.   Previously administered products included Havrix pediatric with an associated reaction of accidental underdose (1st dose received on 21st June 2019 (batch number:K5FA5; expiry date:21st June 2021) intramuscularly).   On an unknown date, the patient received Bexsero and VARIVAX. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced swelling arm and local swelling. On an unknown date, the outcome of the swelling arm and local swelling were unknown.   It was unknown if the reporter considered the swelling arm and local swelling to be related to Bexsero.  Additional case details were reported as follows: On 22nd July 2019, reporter spoken with patient over phone. The patient had knot and swelling in other arm where Bexsero and Varivax was given. The patient stated that she did not have any problems with pediatric Hepatitis A dose that day. The patient was scheduled on 23rd July 2019 to be vaccinated with adult Hepatitis A vaccine. The reporter gave permission to follow up. This case had been linked to the case US2019118379, reported for same patient by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain on the lateral side of right biceps extending to about 3 inches past right elbow; This case was reported by a consumer via call center representative and described the occurrence of localised muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced localised muscle pain. On an unknown date, the outcome of the localised muscle pain was unknown.   It was unknown if the reporter considered the localised muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient after receiving vaccine experienced muscle pain on the lateral side of right biceps beginning approximately 4 inches below the injection site and extending to about 3 inches past right elbow. The patient was aware that one of the side effects of the vaccine was muscle pain.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: hurts from the injection site to the shoulder when she tries to push or pull using her left arm; The discomfort /forces her to stop using her arm; Injection site Pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced pain in arm and injection site discomfort. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site pain, pain in arm and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter had a consumer that called the pharmacy the next day after receiving the second dose of the Shingrix vaccine and described that the she was experiencing pain at the injection. The consumer recently contacted the pharmacy and indicated that it hurts from the injection site to the shoulder when she tried to push or pull using her left arm.  The discomfort she feels sometimes forces her to stop using her arm and use the other arm.  The reporter was unable to provide additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: lip swelling; tongue swelling; This case was reported by a physician via call center representative and described the occurrence of lip swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anaphylactic reaction, swollen tongue and lip swelling. Concomitant products included prednisone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced lip swelling and swollen tongue. On an unknown date, the outcome of the lip swelling and swollen tongue were unknown.   It was unknown if the reporter considered the lip swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional calling regarding a female patient in her seventies. The patient had a history of experiencing anaphylactic reactions with tongue and lip swelling. On an unknown date 5 months ago the patient received her first dose of Shingrix and approximately 30 days later she developed tongue and lip swelling no larynx involvement. The patient was treated with a 4 day course of prednisone and the events resolved. No emergency care was needed and no use of epinephrine. The reporter did not consent to follow up. The reporter did not had all the dates, treating physicians names, patient demographics.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report from contactable other HCP via Pfizer Sales Representative. This other HCP reported similar event for 3 patients. This is a 3rd of 3 reports.   A patient of unspecified age and gender started to receive 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.  The patient experienced syncope on an unspecified date with outcome of unknown.; 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 event syncope.,Linked Report(s) : US-PFIZER INC-2019341772 same drug/event/reporter, different patient;US-PFIZER INC-2019341787 same drug/event/reporter, different patient
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Tenivac was shipped on the wrong day and sat out in 100 F heat; temperature strip was green and ice was melted and vaccines minimally cold; Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone.  This case involves a 16 years old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number: U6265AAand expiry date: 19-Apr-2021) via intramuscular route in the left arm on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C (MENINGOCOCCAL A AND C VACCINE) on an unknown date.  It was a case of actual medication error due to product storage error temperature too high because Tenivac was shipped on the wrong day and sat out in 100 F heat.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by the sender: none.