chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MEN, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: the patient may have had a seizure; Immediately after receiving these vaccinations, the patient fainted; This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were unknown. On an unknown date in approximately July 2019 (reported as about 3 months ago), the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly (exact dose, dose number, anatomical location, lot # and expiration date were not reported) for routine vaccination (prophylaxis), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (formulation, exact dose, dose number, route of administration, anatomical location, indication, lot # and expiration date were not reported) and a dose of meningococcal vaccine (unspecified, reported as meningitis vaccine)(manufacturer unknown) (formulation, exact dose, dose number, route of administration, anatomical location, indication, lot # and expiration date were not reported). On that same day, immediately after receiving these vaccinations, the patient fainted and might had a seizure. The patient did not receive any treatment for the events and it was unknown if she had any lab diagnostics or studies performed. It was stated that within few minutes after she fainted, the patient completely recovered from the events. The causality assessment was not provided.    Upon internal review, the events of the patient fainted and had a seizure were determined to be medically significant.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: SHE FELT ACHY; Just lousy; Pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml. On an unknown date, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, pain and unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, pain and unwell were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain and unwell to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient reported pain at injection site for a period of 24 hours. The patient took tylenol.  The patient reported that she felt achy and just lousy after receipt of vaccine. The symptoms resolved within 24 hours.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Rash
Clinical narrative: Mild rash on right arm; Pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Concomitant products included PARACETAMOL (TYLENOL).   On 4th October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. On 4th October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. In October 2019, the patient experienced rash. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the injection site pain and rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received the vaccine in left arm. The patient received Fluarix Quadrivalent 2019-2020 season within a few minutes of administration patient complained of pain at injection site the soreness lasted for 3-4 days and she experienced a mild rash on right arm. The patient did mention that she took tylenol prior to receiving the vaccine. This case linked with US2019AMR185904, reported by same reporter.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Tenderness
Clinical narrative: Pt received flu vaccine with the proper technique and was fine after but called next day (according to Rph on duty) saying she had some tenderness in the area, a common side affect, however they followed up and pt felt better the day after.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no reaction - patient should have been administered a TDAP
Age: 13.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Fatigue, Loss of consciousness, Pain in extremity, Syncope
Clinical narrative: Child is an immigrant. He presented to the clinic with his mother and family friend requesting vaccinations be given so child can start school. Mother did not have a copy of the child's immunization record. It was determined that child would start immunization schedule over and mother was in agreement. Mother denied any previous issues with vaccines and initially reported that the child had not received any immunizations in the past 4 weeks. Child was to be given 7 immunizations. After administering the 4 listed above to the left arm, he fainted while sitting in chair. He was out for approximately 20 seconds. After being stimulated with an ammonia capsule and verbal stimuli, patient awakened and was carried to an exam table where he laid down. He appeared to be very tired for about 5 minutes after fainting and just wanted to rest with his eyes closed. No signs/symptoms of an allergic reaction were found. He would respond to questions appropriately  and open his eyes when requested. Respirations were even and unlabored. His vitals were taken routinely and all were within normal limits. After 5-7 minutes, patient returned to baseline. He sat up, began smiling and laughing. When asked orientation questions he answered all appropriately. A small, fine tremor to bilateral lower extremities was noted, but subsided after patient sat up and began talking . He ate a granola bar and drank 8 oz of water. Child did complain of left arm soreness, but no dizziness or headache. After immunizations were given the mother reported that the child did receive a flu vaccine 2 weeks ago, but was unsure of which kind. She denied patient receiving any other vaccines at that time. The remaining 3 immunizations were not given at this visit. When he left the clinic, he had returned 100% to baseline. His gait was balanced and he was alert and oriented X4, respirations even and unlabored. We advised mother that patient should receive future immunizations at a clinic where a doctor is on sight in case the fainting occurs again. Mother verbalized understanding.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Rash
Clinical narrative: headache for 2 days, joint pain: mostly shoulders 2 days,   2 days after getting vaccination got a full body rash that lasted 2.5 days
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Barium enema
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Blood test, Computerised tomogram, Crying, Decreased appetite
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Food poisoning, Headache, Heart rate increased, Injection site erythema
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Loss of personal independence in daily activities
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise, Mobility decreased, Nausea, Retching
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 9//27/2019: Day of the Tdap injection 12:30 pm: Stomach ache, back pain, pain at the injection site as well as injection site feeling hot and red. 3:00 pm: continued symptoms from 12:30 pm   9/28/2019:  All day: Back and side pain, pain at the injection site, swelling of the right arm where the injection was, joint pain, and difficulties using the right arm. There was nausea and feelings of being weak around 10:00 pm until 4:00 am.    9/29/2019:  4:00 am drying heaving, nausea, vomiting, back pain, struggling with feeling weak, and difficulties in staying asleep. Difficulties all day with feeling ill. I thought that I had food poisoning and did not realize it was connected to the Tdap immunization.    9/30/2019:  All day: I had to miss work because I was weak, vomiting, gland swelling, headaches, heart rate increased, having severe cramping in my stomach, back pain, side pain, and struggling to get out of bed all day. Again I thought it was due to my alleged food poisoning the day previously.    10/01/2019 to 10/15/2019: Coninutes struggling with severe cramping, diaherra, crying spells, lack of appetite, back pain, nausea, feeling week, and struggling with sleeping.    10/16/2019: I continued to have symptoms and talked with the (PA). PA took blood and urine for analysis.
Age: 13.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client was outside of acceptable age range for immunization
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Nausea after the first dose in late June.  Vomiting after second dose in October.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Headache, Lip injury, Loss of consciousness
Clinical narrative: Patient sat on exam table to receive vaccine in right thigh.  Child relaxed and compliant.  After vaccine stood up unaided form exam table and passed out - fell forward and hit his head on the floor.  Immediately laid down on the floor by staff and he regained consciousness.  Ice pack applied to forehead and mouth - teeth cut into lip with impact of fall.  Evaluated by MD, vital signs taken and given pedialyte popsicle to suck on.  As he improved, sat up and then taken to car in a wheel chair.  Vomited x1 4 hours later at home.  Complained of headache and some nausea since the fall and was re evaluated in the office on Monday 10/21 for concussion.  Currently following the concussion protocol with limited activity and school attendance.  to be re evaluated in office 10/29 or sooner if worsening symptoms.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient sat on exam table to receive vaccine in right thigh.  Child relaxed and compliant.  After vaccine stood up unaided form exam table and passed out - fell forward and hit his head on the floor.  Immediately laid down on the floor by staff and he regained consciousness.  Ice pack applied to forehead and mouth - teeth cut into lip with impact of fall.  Evaluated by MD, vital signs taken and given pedialyte popsicle to suck on.  As he improved, sat up and then taken to car in a wheel chair.  Vomited x1 4 hours later at home.  Complained of headache and some nausea since the fall and was re evaluated in the office on Monday 10/21 for concussion.  Currently following the concussion protocol with limited activity and school attendance.  to be re evaluated in office 10/29 or sooner if worsening symptoms.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pyrexia, Sensitive skin
Clinical narrative: Fever, skin sensitivity, fatigue
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client age was not in the appropriate range for immunization.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Urticaria
Clinical narrative: WIDESPREAD URTICARIA       ALSO WITH COUGHING AND DYSPNEA THE DAY BEFORE WHICH RESOLVED AFTER VENTOLIN USE X 1
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Feeling hot, Injection site pain, Lip swelling, Malaise
Clinical narrative: Started w/general mild malaise, throat clearing, scratchy throat, mild nasal congestion, generalized body warmth, site soreness. Progressed to mouth and lips feeling fuller and prickly, then mouth lip tightness. The submandibular area of mouth became puffy. Then progressed to true swelling of submandibular area.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Mouth swelling, Nasal congestion, Paraesthesia oral, Swelling, Throat irritation
Clinical narrative: Started w/general mild malaise, throat clearing, scratchy throat, mild nasal congestion, generalized body warmth, site soreness. Progressed to mouth and lips feeling fuller and prickly, then mouth lip tightness. The submandibular area of mouth became puffy. Then progressed to true swelling of submandibular area.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed itchiness at site of injection approx 3hrs after vaccination. The following day (10/16/19) redness and swelling developed and itching continued. 2 days post vaccination, large red area developed around injection site ad swelling and itchiness continued. On 10/22/19, pt reports that itchiness and swelling has resolved. Redness still exists at site of where band aid was placed over injection site.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Pallor, Pulse abnormal, Syncope
Clinical narrative: Patent had syncope after vaccination. Patient assisted to ground. Cool cloth on forehead. Fan place closed to client. Vitals taken. Pulse rapid, weak, thread. Color pale. Respirations even. Nursing staff stayed with patient until she felt better. Vitals stable. Sitting up on exam table. Nursing staff observed patient for approx. 30 minutes after episode. Parents by bedside. Mother states patient has had syncope in the past with immunizations.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Orthosis user, Pain in extremity, Trigger finger
Clinical narrative: Trigger finger on right hand;  shot was in right arm with no redness.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patient called on 10/20 and said that she had a fine grain rash and was itchy all over her body.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm, overall sore muscles, tired
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Pt states she developed arm redness, itchy rash around injection site that
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Induration, Skin warm
Clinical narrative: 60 mm top to bottom. 90 mm left to right. Discomfort, redness, hard, and warm to touch.  Referred to Provider evaluation and develop continue plan of care.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: & flu-like illness
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient called to report on 10/22/19 following vaccination on 10/20/19. She reported that she was experiencing upset stomach without vomiting. She also reported that the injection site area was red and rashy, and that she was experiencing pruritis around the injection site. At this time she has spoken via telephone with her provider but has not been seen in person by a provider or had any interventions.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: rash and redness around injection site
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: Extreme left shoulder/arm pain that was prolonged and traveled down left arm. Initially thought it was normal reaction to vaccine but it persisted several weeks after injection which prompted doctor visit 10/21/19 for evaluation. No arm injuries prior to event.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given 3rd Hep B at 4 month appt. No adverse effects. CDC was contacted and stated that it is a valid dose.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Interstitial lung disease
Clinical narrative: In ability to breathe well even after taking meds.  A form of Interstitial lung disease.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Redness, swelling, and bruising.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Muscle tightness, Pain
Clinical narrative: Patient states that he started experiencing leg cramps approximately 2 days after receiving his flu shot. He explains that the muscles in the backs of his legs and up into his butt feel very tight. Eventually they loosen up, but it is very painful he states.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Rash macular
Clinical narrative: 3 days after vaccine woke up complaining of foot pain in L foot, not wanting to bear weight.  Became more red and swollen around foot later in day, as well as faint macular rash on BLE; similar even in 2018 season, where foot pain and refusal to bear weight on same leg in which he received the flu vaccine
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: 3 days after vaccine woke up complaining of foot pain in L foot, not wanting to bear weight.  Became more red and swollen around foot later in day, as well as faint macular rash on BLE; similar even in 2018 season, where foot pain and refusal to bear weight on same leg in which he received the flu vaccine
Age: 65.0
Sex: M
Vaccine: FLU3, FLU4, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not have any adverse reaction. Pt had a high dose flu shot administered and also had a flulaval quadrivelant shot administered instead of the intended pneumovax vaccine. Pt was monitored s/p realizing error in injecting for 30 minutes without an adverse reaction and advised to call if he has adverse reaction occur while at home. Pt later reported he did not have an adverse reaction.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Large swollen hot knot on left shoulder
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Urticaria
Clinical narrative: Sore upper arm, headache, nauseous, hives, tired, shivering
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administering an improperly stored GARDASIL 9; This spontaneous report was received from a physician via office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-SEP-2019, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614897, expiration date not reported, but upon internal validation established as 20-SEP-2021) (dose number and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 32.2 degrees Fahrenheit for 4 hours 18 minutes. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/reaction and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) one dose (strength, frequency, route were unknown) lot # S003865, expiry date: 08-AUG-2020 for prophylaxis. On an unknown date, the patient recived improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) vaccine (product storage error). The outcome of product storage error was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered VAQTA on 23-SEP-2019 (Lot R021233 Exp 05-SEP-2019) that was expired; No adverse effects; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's current conditions, medical history, concomitant medications, drug reactions or allergies were unknown by the reporter.    On 23-SEP-2019, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (units not reported) for prophylaxis, lot #R021233 and expiration date on 05-SEP-2019 (expired product administered) (frequency was not reported).
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac disorder, Herpes zoster, Lung disorder, Pain
Clinical narrative: shingles; heart and lung problems; lung problems; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 29-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In May 2014, the pt was diagnosed with painful and debilitating shingles and heart and lung problems thereafter, caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered severe injuries and life-long disabilities not present prior to using the Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition and suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt 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 of the Company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered.  The events of shingles, heart and lung problems were considered to be disabling.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013316:
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 female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-SEP-2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for herpes zoster. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a healthcare professional for shingles. The outcome of the event was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: the inadvertent administration ofan expired dose of ROTATEQ; This spontaneous report was received from a nurse via a company representative and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 16-OCT-2019, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R002806, expiration date 29-SEP-2019, orally (dose was not reported) for prophylaxis.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 30-SEP-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In July 2015, the pt was diagnosed with painful and debilitating shingles caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered severe injuries and life-long disabilities not present prior to using the Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of their condition and suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt 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 of the Company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered.  The event of shingles was considered to be disabling.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012054:
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a physician via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and now the patient experienced rash on the face.  This is 3 of 4 cases reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient received 2 on schedule doses of Shingrix 1st dose 18th September 2018, and 2nd dose received on 19th January 2019.  The patient reported that they believed they had the Shingles at the time of administration of the second dose. There was no clear timeline between diagnosis and administration of the 2nd dose as the patient did not report the event until 9 months later. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: pain; fever; fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient stated that received the first dose of the Shingrix vaccine in his right deltoid of the arm and had experienced injection site pain, fever and fatigue. Additional information were unspecified. The patient did not consent to follow up.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site pain, Joint stiffness, Paraesthesia
Clinical narrative: Patient initially experienced pain in the right shoulder and numbness and tingling of middle fingers on right hand. Patient reported 10/21/19 that he is still experiencing stiff joints of his right middle fingers when making a fist. Patient also reports that his condition is slowly improving.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received two flu shots this season. No adverse events noted.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dehydration, Feeling abnormal, Influenza like illness
Clinical narrative: Got a flu shot 10/9 and soon after had sore throat, tightness, N/V, malaise, sensation that she might have diarrhea. She looked acutely ill to ER with chills. No hives or SOB. Gave her GI cocktail, IV fluids and treated her for UTI vs. Pyelo as UA had lots of WBC on UA. Felt "pretty terrible" for 24 hours. Sore throat felt great after she left ER. Had flu like symptoms and weak from N/V and dehydration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Oropharyngeal pain, Pyelonephritis, Urinary tract infection
Clinical narrative: Got a flu shot 10/9 and soon after had sore throat, tightness, N/V, malaise, sensation that she might have diarrhea. She looked acutely ill to ER with chills. No hives or SOB. Gave her GI cocktail, IV fluids and treated her for UTI vs. Pyelo as UA had lots of WBC on UA. Felt "pretty terrible" for 24 hours. Sore throat felt great after she left ER. Had flu like symptoms and weak from N/V and dehydration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, White blood cells urine positive
Clinical narrative: Got a flu shot 10/9 and soon after had sore throat, tightness, N/V, malaise, sensation that she might have diarrhea. She looked acutely ill to ER with chills. No hives or SOB. Gave her GI cocktail, IV fluids and treated her for UTI vs. Pyelo as UA had lots of WBC on UA. Felt "pretty terrible" for 24 hours. Sore throat felt great after she left ER. Had flu like symptoms and weak from N/V and dehydration.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient complains of left shoulder pain times 2 days after receiving flu shot at Pharmacy and denies any trauma or injury and no reactions to previous vaccines. Inability of ROM outward, forward, backward without severe pain. Patient applied dry heat and took ibuprofen on October 15th 2019 without relief of symptoms.  Patient was referred to PT and RX oxycodone.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, body aches, chills, extremely sore and red injection site.  With this 2nd dose, there were less symptoms (with the first injection, I was also very fatigued with severe headache plus the other symptoms listed), symptoms were much less severe, and lasted only a day (lasted 3 days with 1st injection).
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: Headache, body aches, chills, extremely sore and red injection site.  With this 2nd dose, there were less symptoms (with the first injection, I was also very fatigued with severe headache plus the other symptoms listed), symptoms were much less severe, and lasted only a day (lasted 3 days with 1st injection).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pt stated that her L arm started to get very warm and swell 10/14/19 afternoon.  Pt stated that she tried  hot packs  to help with the swelling and tenderness but it did not help, started to use Ice packs.  Husband wanted her to go Monday night to the ER due to swelling of arm.  Tues arm was swollen up into the shoulder area and down to the elbow  and all the way around her arm.  Pt continues to Ice  arm. Wed  pt called and wanted to be seen. swelling had gone  down  but not away still in area above elbow. site was red and warm to the touch.   Pt was tx with Triamcinolone Acetonide Cream BID for 7 days
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Disorientation, Dizziness, Headache
Clinical narrative: Developed considerable chills in mid afternoon after the a.m dose, then temperature of 103 by early evening.   103 fever lasted for hours, then late evening, began to drop to 101.  Headache, body aches, light headedness/off balance.  Disoriented.   Awful chills began again throughout the night.    The following morning; (22nd), fever remained at 101 - then late morning, the  fever was gone, though still off balance and somewhat lightheaded.    Body aches remain as well as headache.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Developed considerable chills in mid afternoon after the a.m dose, then temperature of 103 by early evening.   103 fever lasted for hours, then late evening, began to drop to 101.  Headache, body aches, light headedness/off balance.  Disoriented.   Awful chills began again throughout the night.    The following morning; (22nd), fever remained at 101 - then late morning, the  fever was gone, though still off balance and somewhat lightheaded.    Body aches remain as well as headache.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm extremely sore even after three weeks
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Patient described waking up 2 days after getting the flu shot with bilateral lower extremity weakness. Her symptoms have now improved to near baseline.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Differential white blood cell count, Full blood count, Joint swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: Swelling in left arm and left elbow. The arm was hot and swollen to touch with some edema. Seen in ED and received 125 mg of Solu-Medrol and was discharged with a 3-day dose of steroids.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm
Clinical narrative: Swelling in left arm and left elbow. The arm was hot and swollen to touch with some edema. Seen in ED and received 125 mg of Solu-Medrol and was discharged with a 3-day dose of steroids.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Vomiting
Clinical narrative: Pt had Pneumococcal 23 and Fluad given on 10/15/19 in separate arms. For the next 24 hours Pt had 4 episodes of emesis and a headache. Pt did bland diet and fluids and was fine after 24 hours. No other reactions noted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Influenza, Malaise
Clinical narrative: 9 hours after injection, I began having uncontrollable chills followed by extreme aching in my muscles, sever headache, and nausea. In other words, symptoms of the flu itself. As I am writing this on October22nd, I still feel week and unwell.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: 9 hours after injection, I began having uncontrollable chills followed by extreme aching in my muscles, sever headache, and nausea. In other words, symptoms of the flu itself. As I am writing this on October22nd, I still feel week and unwell.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Joint swelling, Peripheral swelling, Rash
Clinical narrative: Patient developed a rash 4 days after receiving the flu vaccine. The following evening he developed knee swelling and pain with progression to limping. He then developed swelling in hands and around eyes on 10/21. Almost all resolved by time of eval in PCPs office.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling of eyelid
Clinical narrative: Patient developed a rash 4 days after receiving the flu vaccine. The following evening he developed knee swelling and pain with progression to limping. He then developed swelling in hands and around eyes on 10/21. Almost all resolved by time of eval in PCPs office.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Immune system disorder, Lymph node pain, Vaccination complication
Clinical narrative: Patient in our clinic with multiple small tender lymph nodes in left axilla. Provider advised it is likely an immune response from flu shot, and to return to clinic in 2 weeks if not resolved, or come in sooner if worsens.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed hives and then the hives increased & she sought medical treatment from initially Urgent Care and then her PCP. She received a steroid shot which alleviated the hives.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Localised infection
Clinical narrative: Pt received Flu Vaccine on 10/8/2019. C/O area becoming infected. Treated in the ED.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Limb mass
Clinical narrative: 9.5. - received varicella vaccine in L arm, some redness, warmth 9.6. - site with increased redness, swelling and itching at site, took benadryl 9.7 - underside of L arm was red swollen, hot and had a lump, was seen at urgent care and given script for prednisone and told to take for several days if symptoms were no better 9.8. - symptoms were no better so starting taking prednisone, states symptoms were better that evening.