chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Gait disturbance, Malaise, Muscular weakness
Clinical narrative: Patient started to feel unwell the day after he received the shot. he experienced muscle weakness, lower back pain, shoulder and  spine hurts on bending to pick up stuff. has pain in hands when he tries to make a fist. has knee pain and has difficulty walking. reported on Sunday the 27th of October.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Spinal pain
Clinical narrative: Patient started to feel unwell the day after he received the shot. he experienced muscle weakness, lower back pain, shoulder and  spine hurts on bending to pick up stuff. has pain in hands when he tries to make a fist. has knee pain and has difficulty walking. reported on Sunday the 27th of October.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swelling of right arm with high fever
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash erythematous
Clinical narrative: Patient reports having an outbreak of small red non pustular bumps on face and scalp 2 days after receiving the first shingles shot. Patient denies outbreak anywhere else on the body. Not accompanied by any other symptoms.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: When I move my left arm in many positions, my arm feels as if a needle is in it--sharp, intense pain. (There is no actual needle or other foreign body, just the feeling.)  This has persisted for two months.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Sensation of foreign body
Clinical narrative: When I move my left arm in many positions, my arm feels as if a needle is in it--sharp, intense pain. (There is no actual needle or other foreign body, just the feeling.)  This has persisted for two months.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: She developed a raised, hard, red, itchy bump at the injection site the day of the injection. She complained about it hurting and itching. By Saturday morning, the bump was 2 1/2 inches in diameter, warm to the touch, and she was in a lot of pain. We took her to the doctor who prescribed an antibiotic (Cephalexin) and 5ml of Zyrtec.  She recovered over the course of a week, but she still has discoloration- what looks like a large bruise at the site as of today (which is 3 1/2 weeks after the shot was given).  She does not have pain at the site any longer and it does not itch.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: She developed a raised, hard, red, itchy bump at the injection site the day of the injection. She complained about it hurting and itching. By Saturday morning, the bump was 2 1/2 inches in diameter, warm to the touch, and she was in a lot of pain. We took her to the doctor who prescribed an antibiotic (Cephalexin) and 5ml of Zyrtec.  She recovered over the course of a week, but she still has discoloration- what looks like a large bruise at the site as of today (which is 3 1/2 weeks after the shot was given).  She does not have pain at the site any longer and it does not itch.
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Erythema, Pruritus
Clinical narrative: ITCHING ON THIGHS AND ARMS,REDNESS ON NECK,FAINT FEELING
Age: 52.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Dyspnoea, Flushing, Pruritus, Rash
Clinical narrative: ITCHING ON THIGHS AND ARMS,REDNESS ON NECK,FAINT FEELING
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Mom suspects the reaction started the day after the shot but she saw the redness the morning of 10/10/19. No fevers, decrease in range of motion, or intense pain with direct palpation. Exam has shotty lymphadenopathy in jugulodigastric bilaterally and in left axilla but none in right axilla or supra/subclavicular.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Extensive confluent erythema on L thigh near injection site. Started 2 days ago. uUclear if just a reaction or if cellulitis. Presumption given for cephalexin antibiotic in case it does not improve on its own.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Laboratory test, Magnetic resonance imaging, Muscle atrophy, Muscular weakness
Clinical narrative: Said had severe diarrhea, vomiting, + weakness in legs. Went to ER ran test + nothing wrong MD has run several test, MRI's, etc + has said that is vaccine related. Showed muscled mass loss.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Said had severe diarrhea, vomiting, + weakness in legs. Went to ER ran test + nothing wrong MD has run several test, MRI's, etc + has said that is vaccine related. Showed muscled mass loss.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Crying, Feeling cold, Pain, Tremor
Clinical narrative: Within an hour of getting the shots I came home, added a hat and garden gloves to my winter jacket and began cutting down flowers in my garden to clear for winter. After about 20 minutes working in 43 degree temperature with wind, I felt "frozen" and rushed inside. I was so cold I began crying and then shriking in pain I was so cold. I was afraid the neighbors whould break in to see what was wrong. I was bent over just trying to get warm. Turned on my gas fireplace and turned up heat. Reaction lasted 1hr. Tried calling store and Dr. suggested 911, didn't like that idea... I laid down on the couch and covered myself with a warm blanket. I was still crying, shrieking, teeth chattering and shaking crazy
Age: 56.0
Sex: M
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Cellulitis, Culture throat, Influenza virus test negative, Local reaction, Pyrexia
Clinical narrative: Pt received vaccines in arm on 10/15 by 11 PM that night developed low grade temp, pt reported taking Tylenol that am and fever increased to 103 by that afternoon, on 10/17 had elevated fever and went to ER = (-) swab (-) meningitis (+) high WBC + local rx develop et treated with AIB and fluids - sent home 10/17 symptom subsided 10/20/19 Pt reported cellulitis per ER
Age: 56.0
Sex: M
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Pt received vaccines in arm on 10/15 by 11 PM that night developed low grade temp, pt reported taking Tylenol that am and fever increased to 103 by that afternoon, on 10/17 had elevated fever and went to ER = (-) swab (-) meningitis (+) high WBC + local rx develop et treated with AIB and fluids - sent home 10/17 symptom subsided 10/20/19 Pt reported cellulitis per ER
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Malaise
Clinical narrative: Redness + swelling + irritation on left arm where Shingrix was administered, area approximately 8" diameter. Pt required antibiotics for possible cellulitis. Pt. also experienced general malaise.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test normal, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Low grade Fever for 11 Days Large Neck muscles sore for 2 weeks Nearly Locked up at times
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Moderate swelling of (L) arm from above the elbow to shoulder with mild erythema. Pt reported mild pruritus. Ibuprofen 300MG Q6-PO PRN, BENADRYL 25MG twice daily PRN and Ice
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Dizziness, Electrocardiogram, Headache, Hyperhidrosis
Clinical narrative: Influenza vaccine given, patient presented to the ED immediately after c/o dizziness, double vision, headaches, nausea, and diaphoresis. Had EKG done, medications given Benadryl and Methylprednisone IVP. Observed and discharged home with prescription for prednisone and Diphenhydramine PRN.
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Influenza vaccine given, patient presented to the ED immediately after c/o dizziness, double vision, headaches, nausea, and diaphoresis. Had EKG done, medications given Benadryl and Methylprednisone IVP. Observed and discharged home with prescription for prednisone and Diphenhydramine PRN.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous, Rash macular, Skin lesion
Clinical narrative: Flu vaccine on 9/30/19 erythematous blotchy rash left upper arm - lesions were raised, discrete, but only surrounding vaccine site
Age: 65.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: -patients Right arm (deltoid) area became very warm & red -patient to the dr. office & had no fever, he was given a cephalosporin (he cannot remember which) -As of 10/28/19 he is starting to have some relief
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 8cm diameter area of edema & erythema (L) deltoid at site of influenza IM injection previous day.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Gastroenteritis, Pyrexia, Vomiting
Clinical narrative: More than 24 hours after receiving vaccines Patient began vomiting and fever. He was seen at facility who diagnosed him with gastroenteritis. Mom stated that this lasted a few hours.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasopharyngitis, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: URI cough, cold, congestion
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Had injection site soreness. Comes & goes, usually upon retiring for sleep - 11:30 & awakened within hour. Only cold "ice pak" numbs upper (L) arm, below shoulder, Only relief. Advil doesn't touch/affect, relieve pain.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: (L) deltoid became vey itchy immediately  (L) deltoid area became swollen area within 1 hour.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Dime size rash under injection site. Itching sensation low grade temp
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Fluzone given on left deltoid immediately after administration lump formed. patient complains of no itchiness. Lump size 4cm Appointment made for monitoring
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site irritation, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient returned to the pharmacy 10/28/19 around 5:00 pm stating she had a reaction. She described the site as burning & had 3 visible blistered, raised areas. Patient said she first noticed the irritation last night. After visibly inspecting the site, I suggested the patient contact her physician & go in for a visit.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site reaction
Clinical narrative: -site reaction occurred 24 hours after admin. was still present > 48 hours later - sore lower back
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site reaction, Urticaria
Clinical narrative: 3 inch x 3 inch welt at site and a knot
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Lacrimation increased, Lip swelling, Oropharyngeal pain
Clinical narrative: 10-22-19 Beginning at 5-45PM (Approx) Scratchy, sore, thick throat. Followed by itchy running eyes. 200am - Lips, eyes & face swollen, generalized itching on Limbs. Took 50mg Benedryl. Symptoms SL. Relieved 10-26 all symptoms gone. If I had not had Benedryl Avail. To me I would have driven myself to the E.R.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling face, Throat irritation, Throat tightness
Clinical narrative: 10-22-19 Beginning at 5-45PM (Approx) Scratchy, sore, thick throat. Followed by itchy running eyes. 200am - Lips, eyes & face swollen, generalized itching on Limbs. Took 50mg Benedryl. Symptoms SL. Relieved 10-26 all symptoms gone. If I had not had Benedryl Avail. To me I would have driven myself to the E.R.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Herpes zoster, Malaise, Pain, Rash
Clinical narrative: Got Shingrix shot (1st shot) on Oct 1st 2019. Had red bumps on neck on Sunday Oct 6th.  By next day had them on neck, chest and back. Went to urgent care on evening of Oct 8th. Dr at urgent care said I had shingles and prescribed anti viral meds. Went to my primary care physician the next day (Oct 9th). My Dr confirmed that I had Shingles. Not trying to be funny but I went out and got the Shingrix shot to PREVENT getting Shingles, not to get it.  2 Drs confirmed I had Shingles.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: Got Shingrix shot (1st shot) on Oct 1st 2019. Had red bumps on neck on Sunday Oct 6th.  By next day had them on neck, chest and back. Went to urgent care on evening of Oct 8th. Dr at urgent care said I had shingles and prescribed anti viral meds. Went to my primary care physician the next day (Oct 9th). My Dr confirmed that I had Shingles. Not trying to be funny but I went out and got the Shingrix shot to PREVENT getting Shingles, not to get it.  2 Drs confirmed I had Shingles.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives since date of injection
Age: 26.0
Sex: F
Vaccine: FLUA3
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Malaise, fever and body aches
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Injection site warmth
Clinical narrative: Painful, weakness to left shoulder and arm, warm at injection site, area firmer than surrounding tissue.  Symptoms have been ongoing since date of administration.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; a patient received improperly stored VARIVAX. DILUENT (S015772 2/15/2022) was stored properly; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 01-OCT-2019, the patient vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S011951, expiration date reported as 16-APR-2019, but upon internal validation established as 16-APR-2021; vaccine dosage detail not reported) for prophylaxis reconstituted with properly stored sterile diluent (lot # S015772, expiration date 15-FEB-2022) (product storage error). The storage temperature of varicella virus vaccine live (Oka/Merck) (VARIVAX) was -12.3 Celsius degrees for 6.05 hours. There was no previous temperature excursion. No adverse effects noted. No product quality complaints (PQC). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006992: US-009507513-1910USA007211: US-009507513-1910USA007203: US-009507513-1910USA007200: US-009507513-1910USA007348: US-009507513-1910USA007375:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect were reported; the syringe of PROQUAD dose was stored in the freezer for 6 days prior to being administered to the patient; the syringe of PROQUAD dose was stored in the freezer for 6 days; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 08-OCT-2019, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number S007813 and expiration date on 14-MAR-2021, for prophyaxis (dose, dose number, route of administration and anatomical injection site were not reported) was reconstituted and drawn into a syringe and this was stored on the freezer for 6 days (product storage error) prior to being administered to he patient on 14-OCT-2019 (poor quality product administered). The vaccine was reconstituted with a sterile diluent, with lot number R006344 and expiration date on 13-DEC-2020 (strength, dose, dose number, route of administration, anatomical injection site and indication were not reported). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; Received an expired dose of Vaqta; This spontaneous report was received from a pharmacist and refers to a 4 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 15-OCT-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # R024007, expiration date on 12-OCT-2019, for prophylaxis (strength, dosage, frequency and route were not reported) (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient received an improperly stored dose of PROQUAD (S008578, expiration 9/16/2020) on 10/15/2019; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patients' concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.      On 15-OCT-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S008578, expiration date: 16-SEP-2020) and sterile diluent (lot #: S007959, expiration date: 19-AUG-2021)  (strength, dose, frequency and route of administration were not provided) as prophylaxis (product storage error). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent were exposed to temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and 35 minutes, and 15  degrees Fahrenheit to 46  degrees Fahrenheit  (16.3  degrees Fahrenheit) for 44 minutes. No previous excursions were reported. The data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; Medical assistant states patient received 3 doses of GARDASIL 9 however, doses were a year apart; This spontaneous report was received from a medical assistant concerning a currently 30-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and past drugs or allergies were not reported.  On an unspecified date in 2017, 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); on an unspecified date in 2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration) and on 18-OCT-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (lot number 1602283 has been verified to be a valid lot number, expiration date reported as 15-AUG-2019, but upon internal validation established as 18-AUG-2021), (anatomical locations, strengths, doses, routes of administration and frequency were not reported for any of the doses; lot numbers and expiration dates of the first and second doses were not provided); all vaccines were administered as prophylaxis.  No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: She administered a dose of Proquad in error to a 10 and 1/2 month old baby.; no adverse effect reported; This spontaneous report has been received from a nurse and refers to a 10- and 1/2-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medication were not provided.   On an unknown date, the patient was vaccinated by error with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Product storage error
Clinical narrative: redness on her arm at the injection site; patient was administered one dose or improperly stored PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's current conditions, pertinent medical history, drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) of lot number S021740, expiration date was reported as 31-MAR-2021 but upon internal validation it was established as 25-MAR-2021 (dose, strength, frequency, route of administration were not reported) for prophylaxis (product storage error). On an unknown date, the patient experienced redness on her arm at the injection site (injection site erythema). There was no product quality complaint (PQC) present. The lot underwent the temperature excursion of 70 degree Fahrenheit in 16 hours time frame. There was no previous temperature excursion. The call was placed due to data logger. Outcome of the events was unknown. The reporter's causality assessment between the event injection site erythema and the suspect therapy was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (experienced zests several years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was over 50 years old at the time of reporting. The patient received both the doses of Shingrix. At the time of reporting, the patient came down with shingles, months after receiving 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Inappropriate schedule of product administration, Injection site erythema, Injection site swelling
Clinical narrative: vaccination failure; shingles; 3-5 small blisters; injected arm became very red; swollen and raised; feeling pain; itching on her left scapula; painful to touch; Drug dose administration interval too long; Fever and was "in bed for 5 days; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2018, the patient received the 1st dose of Shingrix. On 14th March 2019, the patient received the 2nd dose of Shingrix. On 14th March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2019, the patient experienced pain, pruritus and tenderness. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, injection site erythema, injection site swelling and fever. On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, pruritus, tenderness and drug dose administration interval too long were unknown and the outcome of the injection site erythema, injection site swelling and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus, tenderness, injection site erythema, injection site swelling and fever to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus and tenderness to be related to Shingrix.  Additrional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix was administered on right arm and the patient reported having much milder symptoms. She knew that she had received a vaccine but the symptoms were not nearly as bad. In mid-July 2019, the patient reported feeling pain and itching on her left scapula that became worse and worse and also painful to touch or if anything touched it.  The patient had 3-5 small blisters developed and broke out in that area and the patient, who was also a physician, suspected shingles. The patient was consulted with an infectious disease provider who diagnosed her with shingles. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Tenderness, Vaccination failure
Clinical narrative: vaccination failure; shingles; 3-5 small blisters; injected arm became very red; swollen and raised; feeling pain; itching on her left scapula; painful to touch; Drug dose administration interval too long; Fever and was "in bed for 5 days; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2018, the patient received the 1st dose of Shingrix. On 14th March 2019, the patient received the 2nd dose of Shingrix. On 14th March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2019, the patient experienced pain, pruritus and tenderness. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, injection site erythema, injection site swelling and fever. On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, pruritus, tenderness and drug dose administration interval too long were unknown and the outcome of the injection site erythema, injection site swelling and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus, tenderness, injection site erythema, injection site swelling and fever to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus and tenderness to be related to Shingrix.  Additrional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix was administered on right arm and the patient reported having much milder symptoms. She knew that she had received a vaccine but the symptoms were not nearly as bad. In mid-July 2019, the patient reported feeling pain and itching on her left scapula that became worse and worse and also painful to touch or if anything touched it.  The patient had 3-5 small blisters developed and broke out in that area and the patient, who was also a physician, suspected shingles. The patient was consulted with an infectious disease provider who diagnosed her with shingles. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Pain at injection site; Redness at injection site; blotchy at injection site; Itchiness at injection site; Fever; Fatigue; Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   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 injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The patient was a coworker. The age at vaccination was not reported. The reporter did not provide patient initial, date of birth or healthcare professional details. The patient received vaccine in unknown arm. The patient developed fever, pain at the injection site, aches, and fatigue. Patient also developed itchiness, redness, and blotches at the injection site. The patient's symptoms lasted for a few days before resolving. The reporter had limited information regarding this adverse event. The reporter consent to follow up. This case had been linked to the case US2019190821, reported by same reporter. For tolerance of 2nd dose of vaccine, refer case US2019AMR191514.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash macular
Clinical narrative: Pain at injection site; Redness at injection site; blotchy at injection site; Itchiness at injection site; Fever; Fatigue; Aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   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 injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site reaction, injection site itching, fever, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The patient was a coworker. The age at vaccination was not reported. The reporter did not provide patient initial, date of birth or healthcare professional details. The patient received vaccine in unknown arm. The patient developed fever, pain at the injection site, aches, and fatigue. Patient also developed itchiness, redness, and blotches at the injection site. The patient's symptoms lasted for a few days before resolving. The reporter had limited information regarding this adverse event. The reporter consent to follow up. This case had been linked to the case US2019190821, reported by same reporter. For tolerance of 2nd dose of vaccine, refer case US2019AMR191514.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash papular
Clinical narrative: shingles; Itching arm; Bumps under right arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and shingles.   On 17th October 2019, the patient received the 1st dose of Shingrix. On 20th October 2019, 3 days after receiving Shingrix, the patient experienced shingles, itchy upper limbs and papular rash. On an unknown date, the outcome of the shingles, itchy upper limbs and papular rash were unknown.   It was unknown if the reporter considered the shingles, itchy upper limbs and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid region. The patient stated that after vaccination experienced itching and bumps under her right arm and then developed shingles on the right side of the chest regions and then right side of her back. The patient consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash, Rash papular, Skin warm
Clinical narrative: Rash; rash was mildly raised, warm; This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced raised rash and skin warm. On an unknown date, the outcome of the raised rash and skin warm were resolved with sequelae.   It was unknown if the reporter considered the raised rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient developed a localized rash on his upper arm soon after receiving the vaccine. The patient had rash which was mildly raised, warm and lasted 2 to 3 weeks and was approximately 2 x 4 inches. The patient wanted to get 2nd dose. The reporter asked if it is safe to give the second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 21st October 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient completed a Shingrix 2 dose series in the past. Two days before the time of reporting, the patient was diagnosed with shingles 2 days. The patient received Valtrex last night. The patient's further details and product information not available. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: injection site pain; headache; vomited; nauseous; achy; chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, and influenza vaccine (INFLUENZA VACCINE), both via an unspecified route of administration on 22Oct2019 for immunisation at a pharmacy.  The patient medical history and concomitant medications were not reported.  The patient experienced injection site pain, headache, vomited, nauseous and achy chills. The outcome of headache was not recovered and of all other events was unknown. Course of events: She had injection site pain at time of the Prevnar vaccine. She then texted her daughter, a colleague, on 23Oct2019 asking if she should take acetaminophen or naproxen for headache since she just got that pneumococcal shot on 22Oct2019. She reported to have experienced to have "vomited, was nauseous, headache now, achy, chills last night."  Information on the lot/batch number has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Vomiting
Clinical narrative: injection site pain; headache; vomited; nauseous; achy; chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, and influenza vaccine (INFLUENZA VACCINE), both via an unspecified route of administration on 22Oct2019 for immunisation at a pharmacy.  The patient medical history and concomitant medications were not reported.  The patient experienced injection site pain, headache, vomited, nauseous and achy chills. The outcome of headache was not recovered and of all other events was unknown. Course of events: She had injection site pain at time of the Prevnar vaccine. She then texted her daughter, a colleague, on 23Oct2019 asking if she should take acetaminophen or naproxen for headache since she just got that pneumococcal shot on 22Oct2019. She reported to have experienced to have "vomited, was nauseous, headache now, achy, chills last night."  Information on the lot/batch number has been requested.
Sex: U
Vaccine: DTAP, DTAPIPV, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis reaction; Initial information received on 21-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 6 years old patient who experienced anaphylaxis reaction (anaphylactic reaction), while he/she received vaccines DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, VARICELLA ZOSTER VACCINE [VARICELLA VACCINE] and KINRIX.  The patient's past medical history included Food allergy with allergies pork/porcine and beef and Food allergy with allergies to gelatin. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect VARICELLA ZOSTER VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious anaphylaxis reaction (anaphylactic reaction) (Unknown latency) following the administration of VARICELLA ZOSTER VACCINE, DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE and KINRIX. This event was assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was anaphylaxis reaction.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for anaphylaxis reaction.  Information on the batch number was requested; Sender's Comments: This case involves a 6 years old patient who experienced anaphylaxis reaction (anaphylactic reaction), while he/she received vaccines DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, VARICELLA VACCINE (LIVE) and KINRIX. Time to onset is unknown with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be individually assessed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fever to 101.8, myalgias, headache, starting within 24 hours of 1st of series of Shingrix
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Itchy throat Tightness in throat Took Benadryl- one dose
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling with redness , tenderness , warm to touch , painful, swollen area is  large as the palm of my hand .
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Cellulitis - Area became red and hot.  Affected area expanded over the course of 2 days.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: Chest pain/discomfort, dizziness, and diaphoresis.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Hyperhidrosis, Streptococcus test
Clinical narrative: Chest pain/discomfort, dizziness, and diaphoresis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient had some pain at the injection site for 2 weeks and shooting pain down the arm to the hand
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Mother calls to report that patient had an itchy rash just on the right side (side of injection).  Slight fever.  Eating, drinking, and playing fine.  Dr. has instructed her to use Tylenol/Motrin for fever, Benadryl for the rash, rest and hydration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, UNK
Symptoms: Ear infection, Pyrexia, Rash
Clinical narrative: Patient started with a fever on 10/21/2019. On 19/22/2019, she was diagnosed with an ear infection. She started on amoxicillin, and by 10/25/2019 there was no improvement. The antibiotic was switched to Cefdinir, and started with a rash on 10/26/2019. On 10/28/2019 it has progresses to an entire body rash, including sole of the feet, and palm of the hands.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Myalgia, Peripheral swelling
Clinical narrative: Muscle aches and inability to move the arm for two days along with redness and swelling. Short course prednisone.  Tylenol prn - states allergy to Ibuprofen Ice
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Received a flu shot, administered by an RN at a Community Flu Outreach program.  The following day arm was sore and assumed it was flu shot.  Took off bandaid and noticed that it was up by my shoulder, much higher than is typical.  It's been three weeks now of shoulder and upper arm aches and pains. I  have trouble sleeping at night from the pain.  I've been taking a regiment of naproxen, acetamenaphin , and ibuprofen, along with warm heat before I go to bed, little of which has helped.  Called my doctor and she recommended continuing what I'm doing and it will go away.  it hasn't.  I have limited range of motion and soreness constantly now.  Have never had issues like this before the flu shot.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Chest discomfort, Dysgeusia, Dyspnoea, Salivary hypersecretion
Clinical narrative: Anaphylaxis Initial symptoms were hypersalivation and metallic taste in mouth. Then developed shortness of breath, tight chest and tongue swelling
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue
Clinical narrative: Anaphylaxis Initial symptoms were hypersalivation and metallic taste in mouth. Then developed shortness of breath, tight chest and tongue swelling
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Myocardial infarction, Pneumonia, Pulmonary oedema, Sepsis
Clinical narrative: heart attack; congestive heart failure; sepsis; pneumonia; edema of the lungs; viral infection; other injuries; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-JAN-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the clinic for routine health maintenance and for the prevention of shingles (herpes zoster). In early May 2018 (also reported as shortly after vaccination), the patient suffered a heart attack, congestive heart failure, sepsis, pneumonia, and other injuries and edema of the lungs as a result of viral infection caused by zoster vaccine live (ZOSTAVAX). These life-threatening conditions resulted in prolonged hospitalization and extensive medical history, excluding but not limited to a heart catheterization and a coronary angiogram. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, she suffered severe injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and suffered economic losses due to her inability to work. The patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence, she suffered serious, progressive, 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, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  The events of heart attack, congestive heart failure, sepsis, pneumonia, other injuries and edema of the lungs as a result of viral infection were considered to be disabling and life threatening. Upon internal review, the events of heart attack, congestive heart failure, sepsis, pneumonia and edema of the lungs were determined to be medically significant.