chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: feeling pain; chills; fatigue; This case was reported by a physician via sales rep and described the occurrence of pain in a 54-year-old 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 a week after receiving Shingrix, the patient experienced pain, chills and fatigue. On an unknown date, the outcome of the pain and chills were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the pain, chills and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient described feeling pain from the Shingrix shot, chills and fatigue. The doctor called GlaxoSmithKline to inquire about the adverse event experienced by the patient and was told it would pass in 2-3 days. On the fourth day after the patient received the shot the doctor called the patient to inquire if the adverse event still persisted.  The patient said he felt better on the second day itself and he did not experience adverse event any more.
Sex: U
Vaccine: VARZOS
Symptoms: Compression fracture, Herpes zoster
Clinical narrative: Compression fracture; Shingles; This case was reported by a consumer via call center representative and described the occurrence of compression fracture in a elderly 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 compression fracture (serious criteria hospitalization) and shingles. On an unknown date, the outcome of the compression fracture and shingles were unknown.   It was unknown if the reporter considered the compression fracture and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix one and half year ago. Meantime, the patient was hospitalized for compression fracture and had attack of shingles. The reporter consented for follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity
Clinical narrative: Cold; Sore throat; left arm soreness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain.   On 18th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On 21st June 2019, the patient experienced sore throat. On 22nd June 2019, the patient experienced cold. On an unknown date, the outcome of the cold, sore throat and pain in arm were recovered/resolved.   It was unknown if the reporter considered the cold, sore throat and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient had some left arm soreness or achiness, which started about 2 hours after the injection and lasted about 2 to 3 days. The patient stated the soreness or achiness was like when you had a flu vaccine but she did not mention any name of the Flu vaccine she was referring.  3 days after receiving vaccination, the caller also stated that she developed a sore throat and then that weekend ( 4 days after) developed a cold which lasted about 10 days. The caller stated she did not know if the sore throat or cold was related to the vaccine but that her husband was also sick around the same time and when he was sick previously she got his cold as well. The reporter gave consent to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site; Redness at injection site; Pain at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Boostrix.  Additional information received were as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had redness, swelling and pain at the site of Injection with Boostrix. The reporter consented to follow up. The batch number was updated from 43E47 to 43E4T as per sales data sheet. This was one of the 6 cases, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Pain, Palpitations
Clinical narrative: chest tightness; generalized weakness; palpitations; body aches; This case was reported by a physician via call center representative and described the occurrence of chest tightness in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   The patient's past medical history included neck pain, shoulder pain and pain in arm.   On 21st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, 1 days after receiving Shingrix, the patient experienced general body pain. On 23rd August 2019, the patient experienced palpitation. On 27th August 2019, the patient experienced weakness generalized. On 3rd September 2019, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness, palpitation, weakness generalized and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chest tightness, palpitation, weakness generalized and general body pain to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that patient received Shingrix and experienced had body aches. On 23rd August 2019, 2 days after vaccination the patient experienced palpitations. On 27th August 2019, 6 days after vaccination, the patient experienced generalized weakness and on 3rd September 2019, 13 days after vaccination the patient experienced chest tightness. None of these symptoms have resolved at the time of reporting. The reporter had consented to follow up.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site infection, Injection site urticaria
Clinical narrative: injection site arm was red and hives. patient went to urgent care on Saturday night and was told the arm was infected and started doxycycline treatment. When it did not help, patient went to ER and was told it was anaphylactic reaction. patient was given Benadryl.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypoaesthesia, Lethargy, Somnolence, Swelling face
Clinical narrative: Patient states that within 24 hours of receiving the vaccine, she became tired and lethargic, fell asleep during the afternoon and when she awoke, the side of her face that she had been sleeping on was swollen and numb.  Patient states that the swelling has since reduced, but some swelling remains 72 hours after the vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: swollen red localized reaction
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Headache, Pain in extremity
Clinical narrative: PT CALLED IN AND ADVISED SHE FELT SHE REACTED TO ONE OF THE INJECTIONS, CLAIMING LEGS ACHING, GENERAL WEAKNESS, AND HEADACHE
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza, Insomnia
Clinical narrative: The night of the vaccine I had extreme restlessness and malaise and couldn't sleep whole night. The next day I had extreme chills, so bad I could barely stop shaking to use my computer for work. Also had a high fever of 103.5° and other symptoms similar to the worse case of the flu I used to get before I started getting annual flu shots years ago. Stiff neck, leg pains, sore skin, very tired, hard to think. Very debilitating and the worse reaction I've ever had to a vaccine. Also, the sorest my arm has ever been after a shot. On 3rd day I luckily feel  a little better. I do wonder this. I'm sure there was no one like me included in the clinical trials. About 1 1/2 months ago after being bitten by a bat, I had to undergo a three week series of rabies shots. With having such a severe reaction to the Shingles shot I wonder if that could have anything to do with it?
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Mental impairment, Musculoskeletal stiffness, Pain in extremity, Pain of skin
Clinical narrative: The night of the vaccine I had extreme restlessness and malaise and couldn't sleep whole night. The next day I had extreme chills, so bad I could barely stop shaking to use my computer for work. Also had a high fever of 103.5° and other symptoms similar to the worse case of the flu I used to get before I started getting annual flu shots years ago. Stiff neck, leg pains, sore skin, very tired, hard to think. Very debilitating and the worse reaction I've ever had to a vaccine. Also, the sorest my arm has ever been after a shot. On 3rd day I luckily feel  a little better. I do wonder this. I'm sure there was no one like me included in the clinical trials. About 1 1/2 months ago after being bitten by a bat, I had to undergo a three week series of rabies shots. With having such a severe reaction to the Shingles shot I wonder if that could have anything to do with it?
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness, Tremor
Clinical narrative: The night of the vaccine I had extreme restlessness and malaise and couldn't sleep whole night. The next day I had extreme chills, so bad I could barely stop shaking to use my computer for work. Also had a high fever of 103.5° and other symptoms similar to the worse case of the flu I used to get before I started getting annual flu shots years ago. Stiff neck, leg pains, sore skin, very tired, hard to think. Very debilitating and the worse reaction I've ever had to a vaccine. Also, the sorest my arm has ever been after a shot. On 3rd day I luckily feel  a little better. I do wonder this. I'm sure there was no one like me included in the clinical trials. About 1 1/2 months ago after being bitten by a bat, I had to undergo a three week series of rabies shots. With having such a severe reaction to the Shingles shot I wonder if that could have anything to do with it?
Age: 42.0
Sex: F
Vaccine: FLU4, IPV
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Headache, nausea, pain at IM injection site only
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray, Pyrexia, Respiratory syncytial virus test negative, Urine analysis
Clinical narrative: Pt was given shots on 9/5/19 and later that evening mom called and stated pt started to run a fever. Pt was taken to the ER and had a fever of 101-1'F. Pt was seen and Dr discussed with mom outcome of testing and what to watch for and when to bring back to Er.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Diet refusal, Encephalitis, Lethargy, Motor developmental delay, Muscle spasms
Clinical narrative: Immediate: High fever (100.4), Encephalitis: inconsolable high pitched screaming, lethargy, whimpering, refusal to nurse; She began having neurological symptoms. She started having involontary spasms, she started walking on her toes, stopped responding to her name, started having sensory processing issues and motor planning delays; regressed speech and social skills. She began occuptional and speech therapies and treatment is helping.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Neurological symptom, Pyrexia, Regressive behaviour, Screaming, Sensory processing disorder
Clinical narrative: Immediate: High fever (100.4), Encephalitis: inconsolable high pitched screaming, lethargy, whimpering, refusal to nurse; She began having neurological symptoms. She started having involontary spasms, she started walking on her toes, stopped responding to her name, started having sensory processing issues and motor planning delays; regressed speech and social skills. She began occuptional and speech therapies and treatment is helping.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Speech disorder developmental, Toe walking, Unresponsive to stimuli
Clinical narrative: Immediate: High fever (100.4), Encephalitis: inconsolable high pitched screaming, lethargy, whimpering, refusal to nurse; She began having neurological symptoms. She started having involontary spasms, she started walking on her toes, stopped responding to her name, started having sensory processing issues and motor planning delays; regressed speech and social skills. She began occuptional and speech therapies and treatment is helping.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Muscle spasms
Clinical narrative: I woke up with shivers, and a headache.  Earlier I had cramps in my legs and feet.  I took 1 500mg. Acetaminophen and put a blanket on.  I fell asleep what seemed like a few minutes, but I am not sure.  I woke up this morning feeling better.
Age: 56.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Mobility decreased, Pain, Pyrexia, Tremor
Clinical narrative: 3AM woke up with fever (~12 hours), severe body aches (lasted ~12 hours) and severe shaking. Patient states she was unable to move her arms, hands, legs and mouth  or speak for 5-8 minutes after waking up.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient experienced swelling and redness
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Aggression, Anger, Crying, Decreased appetite
Clinical narrative: 5/1 - Patient will not wake up from nap time at school. He is often the first kid to wake up from naps at school. Teacher notified me of this strange symptom. 5/2 - Same as above. Patient begins slight stuttering in the evening. 5/3 - Patient begins to stutter more. Cannot form sentences. Very irritable, lots of outbursts and tantrums. Can't seem to follow through on simple tasks and follow sequences. 5/4 - Stuttering gets worse. Big big emotions, screaming, crying.  Loss of appetite. This is unusual.  Same as above with follow through on tasks and sequences 5/5  - Stuttering is terrible. Same symptoms as above. 5/6 - Stuttering begins to get marginally better.  Trouble focusing and following through with simple tasks and sequences at school. 5/7 - Stuttering gets a little better.  5/8 - Stuttering is now much less than after initial shot. 5/9 - Mild stuttering  Complaints of stomach aches often after MMR shot. Diet has not changed. In general, the neurological symptoms lasted a week and a half. The focus and attention issues that came up after MMR has now subsided a little, but was severe post MMR shot and lasted nearly 4 months.  5/5 - Stuttering gets even worse. Volatile emotions. Appetite is unstable.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Disturbance in attention, Dysphemia, Emotional distress, Irritability, Screaming
Clinical narrative: 5/1 - Patient will not wake up from nap time at school. He is often the first kid to wake up from naps at school. Teacher notified me of this strange symptom. 5/2 - Same as above. Patient begins slight stuttering in the evening. 5/3 - Patient begins to stutter more. Cannot form sentences. Very irritable, lots of outbursts and tantrums. Can't seem to follow through on simple tasks and follow sequences. 5/4 - Stuttering gets worse. Big big emotions, screaming, crying.  Loss of appetite. This is unusual.  Same as above with follow through on tasks and sequences 5/5  - Stuttering is terrible. Same symptoms as above. 5/6 - Stuttering begins to get marginally better.  Trouble focusing and following through with simple tasks and sequences at school. 5/7 - Stuttering gets a little better.  5/8 - Stuttering is now much less than after initial shot. 5/9 - Mild stuttering  Complaints of stomach aches often after MMR shot. Diet has not changed. In general, the neurological symptoms lasted a week and a half. The focus and attention issues that came up after MMR has now subsided a little, but was severe post MMR shot and lasted nearly 4 months.  5/5 - Stuttering gets even worse. Volatile emotions. Appetite is unstable.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Somnolence, Speech disorder
Clinical narrative: 5/1 - Patient will not wake up from nap time at school. He is often the first kid to wake up from naps at school. Teacher notified me of this strange symptom. 5/2 - Same as above. Patient begins slight stuttering in the evening. 5/3 - Patient begins to stutter more. Cannot form sentences. Very irritable, lots of outbursts and tantrums. Can't seem to follow through on simple tasks and follow sequences. 5/4 - Stuttering gets worse. Big big emotions, screaming, crying.  Loss of appetite. This is unusual.  Same as above with follow through on tasks and sequences 5/5  - Stuttering is terrible. Same symptoms as above. 5/6 - Stuttering begins to get marginally better.  Trouble focusing and following through with simple tasks and sequences at school. 5/7 - Stuttering gets a little better.  5/8 - Stuttering is now much less than after initial shot. 5/9 - Mild stuttering  Complaints of stomach aches often after MMR shot. Diet has not changed. In general, the neurological symptoms lasted a week and a half. The focus and attention issues that came up after MMR has now subsided a little, but was severe post MMR shot and lasted nearly 4 months.  5/5 - Stuttering gets even worse. Volatile emotions. Appetite is unstable.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Depressed mood, Erythema, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient broke out in rashes across the right side of his body. The injection site was a baseball size bright red  hard lump and  hot to touch. His entire right inside  forearm was a raised red thickened bumpy skin with 5-6 puss leasions that was draining a clear fluid. Patient's torso was a bright red rash-and every time he exerts himself his rash carries up to the chest and acrosss entire back. This has been very hard on Patient he has become sad and withdrawn since getting this rash.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Injection site warmth, Pustule, Rash, Rash erythematous, Secretion discharge
Clinical narrative: Patient broke out in rashes across the right side of his body. The injection site was a baseball size bright red  hard lump and  hot to touch. His entire right inside  forearm was a raised red thickened bumpy skin with 5-6 puss leasions that was draining a clear fluid. Patient's torso was a bright red rash-and every time he exerts himself his rash carries up to the chest and acrosss entire back. This has been very hard on Patient he has become sad and withdrawn since getting this rash.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Skin hypertrophy, Skin lesion, Social avoidant behaviour
Clinical narrative: Patient broke out in rashes across the right side of his body. The injection site was a baseball size bright red  hard lump and  hot to touch. His entire right inside  forearm was a raised red thickened bumpy skin with 5-6 puss leasions that was draining a clear fluid. Patient's torso was a bright red rash-and every time he exerts himself his rash carries up to the chest and acrosss entire back. This has been very hard on Patient he has become sad and withdrawn since getting this rash.
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site rash, Varicella
Clinical narrative: Child presented to our clinic September 11 (12 days after vaccine) with symptoms consistent with a mild case of Chicken Pox.  She states symptoms appeared 3 days ago.  Child is afebrile, reports no pain.  Presents with disperse pruritic erythemic rash at approximately half dozen sites, as well as an indurated angry looking patch 4x6 cm at injection site.  Child appeared to be 'weary'.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Pt presented with bright red raised distorted area (approximately 4 -5 in) directly below the band-aid injection site. Pt reported no pain, fever, or itching. The application area of the circular "Inject-Safe" covering was also reactive, though not at all red.  I directed the patient to take a picture of the area and report the reaction to Family Physician, watch for changes or no improvement. Patient may be directed to take antihistamine prior to the 2nd Shingrix if no further complications. Pharmacist will also notify the FP  of this report
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Blood test normal, Burning sensation, Feeling hot, Grip strength decreased
Clinical narrative: My daughter began to complain of a burning/warming sensation primarily in her head but radiated throughout her chest and stomach areas.  Also stinging sensation in chest area, headaches, extreme weakness in entire body.  Her hands and fingers could not hold a fork for breakfast the following day after the vaccine.  We took her to Hospital ER (9-10).  They performed the whole works: blood, urine ( came back normal). Also performed an MRI on brain, which also came back normal.  she was discharged and told to take ibuprofen for pain as needed and to follow up with pediatrician.  Its been a week since her vaccine and her symptoms have not diminished but have remained in tact.  We are worried for her health and would like to know what went wrong.  We strongly believe this vaccine caused her body to react in this manner.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Headache, Magnetic resonance imaging brain normal, Pain, Urine analysis normal
Clinical narrative: My daughter began to complain of a burning/warming sensation primarily in her head but radiated throughout her chest and stomach areas.  Also stinging sensation in chest area, headaches, extreme weakness in entire body.  Her hands and fingers could not hold a fork for breakfast the following day after the vaccine.  We took her to Hospital ER (9-10).  They performed the whole works: blood, urine ( came back normal). Also performed an MRI on brain, which also came back normal.  she was discharged and told to take ibuprofen for pain as needed and to follow up with pediatrician.  Its been a week since her vaccine and her symptoms have not diminished but have remained in tact.  We are worried for her health and would like to know what went wrong.  We strongly believe this vaccine caused her body to react in this manner.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Burning sensation, Dyspnoea, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: My daughter began to complain of a burning/warming sensation primarily in her head but radiated throughout her chest and stomach areas.  Also stinging sensation in chest area, headaches, extreme weakness in entire body.  Her hands and fingers could not hold a fork for breakfast the following day after the vaccine.  We took her to Hospital ER (9-10).  They performed the whole works: blood, urine ( came back normal). Also performed an MRI on brain, which also came back normal.  she was discharged and told to take ibuprofen for pain as needed and to follow up with pediatrician.  Its been a week since her vaccine and her symptoms have not diminished but have remained in tact.  We are worried for her health and would like to know what went wrong.  We strongly believe this vaccine caused her body to react in this manner.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Palpitations, Paraesthesia, Vision blurred
Clinical narrative: My daughter began to complain of a burning/warming sensation primarily in her head but radiated throughout her chest and stomach areas.  Also stinging sensation in chest area, headaches, extreme weakness in entire body.  Her hands and fingers could not hold a fork for breakfast the following day after the vaccine.  We took her to Hospital ER (9-10).  They performed the whole works: blood, urine ( came back normal). Also performed an MRI on brain, which also came back normal.  she was discharged and told to take ibuprofen for pain as needed and to follow up with pediatrician.  Its been a week since her vaccine and her symptoms have not diminished but have remained in tact.  We are worried for her health and would like to know what went wrong.  We strongly believe this vaccine caused her body to react in this manner.
Age: 49.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site where VZV vaccine administered OTC  NSAIDs by patient and cold compress
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oropharyngeal pain, Pain, Rash
Clinical narrative: - large rash covering entire area between elbow and shoulder (appeared 1 hour after immunization), continuing thru 2 days later (and currently at time of this report) - body aches starting next day - soar throat starting next day  prednisone to treat rash, body aches/soar throat has subsided.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pruritus, Rash, Swelling, Swelling face
Clinical narrative: redness,  swelling, itchiness, and rash spreading to the chest,  back, and face. Also complained of an itchy throat.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Throat irritation
Clinical narrative: redness,  swelling, itchiness, and rash spreading to the chest,  back, and face. Also complained of an itchy throat.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; the patient received a dose of VARIVAX via the intramuscular route; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Concomitant therapy included sterile diluent (STERILE DILUENT). No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On 29-AUG-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) intramuscularly (lot # R035223, expiry date 04-DEC-2020) (exact dose was not reported) for prophylaxis.  No adverse effects were reported. The outcome of inappropriate route of vaccination and no adverse effects was unknown.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received their first dose of Gardasil on 12/7/2009 and the second dose of Gardasil on 1/4/2010; No adverse effect; This spontaneous report was received from a pharmacy technician refers to a 27 year old patient. Information about patient's concurrent condition, medical history, drug allergy/reaction, concomitant medication was not reported.   On 07-DEC-2009, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and on 04-JAN-2010, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route, anatomical location, lot/batch #, expiration date was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint was involved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site is red; Injection site swollen; Injection site painful; This case was reported by a consumer and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional case details were reported as follows: It was reported that the patient received Shingrix and her injection site was still red, Swollen and painful.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: -Swelling, Redness, Pain to vaccine site a day after vaccine given. -Patient was seen here on 9/5/19 for evaluation of Redness and swelling. -Patient started on Bactrim Suspension twice a day - Symptoms Resolved on 9/9/19 on F/U visit.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient c/o arm pain in right shoulder. Patient unable to complete range of motion with right arm without severe pain/
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Confusional state, Diarrhoea, Dizziness, Dysphagia, Fatigue
Clinical narrative: Received the Hepatitis B #2  vaccine at 3:30 pm. Went out to dinner with family around 6:30. When we arrived at the restaurant, we sat outside and I described that I "felt weird." My heart was racing, I was covered in goosebumps even though I was sitting in direct sunlight, and I felt dizzy. It felt that I had to try harder to swallow and it took longer to start breathing again after swallowing. I went into the bathroom at the restaurant and had really bad diarrhea. Another adult at the table asked if I had any medication allergies and I told her I couldn't have Cephalosporins or Penicillins. She asked if I needed an Epi Pen, but I got confused and told her that I couldn't have it because I was allergic to Penicillin (even though my normal self was aware they are completely different things). I felt like something awful was going to happen. I continued to be confused and she gave me Benadryl from her purse. A friend stayed with me for the next couple hours. I was exhausted and felt awful, but no more symptoms occurred.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Palpitations, Piloerection, Vaccination complication
Clinical narrative: Received the Hepatitis B #2  vaccine at 3:30 pm. Went out to dinner with family around 6:30. When we arrived at the restaurant, we sat outside and I described that I "felt weird." My heart was racing, I was covered in goosebumps even though I was sitting in direct sunlight, and I felt dizzy. It felt that I had to try harder to swallow and it took longer to start breathing again after swallowing. I went into the bathroom at the restaurant and had really bad diarrhea. Another adult at the table asked if I had any medication allergies and I told her I couldn't have Cephalosporins or Penicillins. She asked if I needed an Epi Pen, but I got confused and told her that I couldn't have it because I was allergic to Penicillin (even though my normal self was aware they are completely different things). I felt like something awful was going to happen. I continued to be confused and she gave me Benadryl from her purse. A friend stayed with me for the next couple hours. I was exhausted and felt awful, but no more symptoms occurred.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal
Clinical narrative: The patient was given the VIS form and stayed  in the room with me for 15 minutes since it was his first flu shot. Approximately 30 minutes later he returned to the area with another employee who stated he complained of feeling "fuzzy". I had him sit down and I asked him how he was feeling,He said he felt fine but he came back to see me because his fellow employee insisted. His blood pressure was 118/82. I asked him if he had eaten this morning and he said he only had been drinking coffee  and hadn't had enough sleep the night before. I gave him my protein bar and asked someone to get him some juice. I had him finish the protein bar and juice and retook his blood pressure ten minutes later and it was 118/-80. He said he felt much better and I told him to please come back if he was feeling poorly again. He didn't return.
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient experienced nausea, vomiting, fever,  loss of strength and energy.  Patient took ibuprofen for the fever on 09/10/19 and called pharmacy 09/11/19. Patient stated that he had gotten better and so far did not need to take any ibuprofen today.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Insomnia, Pain
Clinical narrative: Pt claims that as soon as she left the pharmacy, she experienced severe pain all over her body that kept her up all night, as well as GI upset. Says pain has remained constant. She called the pharmacy the morning of 9/11/19 to report it. RPh instructed her to contact her PCA and to seek medical attention if her pain gets worse or doesn't resolve in the next day.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient is fine. Patient was suppose to be given PCV13 and was given Pneumo23
Age: 10.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: he stated he could feel numbness in his R arm and hand an electrical shock. numbness and tingling in right bicep, down into the forearm, to the top of the hand, into thumb, index finger, middle finger which continued into the next day. NSAIDs, ice, elevation and rest for the symptoms
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: The injection site was swollen, red, hot, had small blisters and very painful. On 9/7/19 I saw  Dr. at Urgent Care. I was diagnosed with Shingles in that area only and prescribed Acyclovir, Amoxicillin, Doxycycline Monohydrate. As of 9/10/19 the blisters had dried up and the other symptoms had dissipated. The area is healed but the skin is darker.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood urea normal, Carbon dioxide normal, Full blood count normal, HIV test negative, Herpes zoster
Clinical narrative: The injection site was swollen, red, hot, had small blisters and very painful. On 9/7/19 I saw  Dr. at Urgent Care. I was diagnosed with Shingles in that area only and prescribed Acyclovir, Amoxicillin, Doxycycline Monohydrate. As of 9/10/19 the blisters had dried up and the other symptoms had dissipated. The area is healed but the skin is darker.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: The injection site was swollen, red, hot, had small blisters and very painful. On 9/7/19 I saw  Dr. at Urgent Care. I was diagnosed with Shingles in that area only and prescribed Acyclovir, Amoxicillin, Doxycycline Monohydrate. As of 9/10/19 the blisters had dried up and the other symptoms had dissipated. The area is healed but the skin is darker.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Laboratory test normal, Skin discolouration
Clinical narrative: The injection site was swollen, red, hot, had small blisters and very painful. On 9/7/19 I saw  Dr. at Urgent Care. I was diagnosed with Shingles in that area only and prescribed Acyclovir, Amoxicillin, Doxycycline Monohydrate. As of 9/10/19 the blisters had dried up and the other symptoms had dissipated. The area is healed but the skin is darker.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse 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 05-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # R002506, expiration date: 25-JAN-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of (7.7 degrees Fahrenheit) 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 hours 55 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
Age: 16.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Asthenia, Decreased activity, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: 1/16/19 Extreme fatigue, light headed, sore throat. Strep test, mono test, CBC & sick appointment with Dr., Pediatrician Platelet count 7,000 & very low WBC 1/17/19 CBC PLT 8,000 & very low WBC from 8:00 am appt. Dr Admitted to hospital under Dr., Hematologist at 4:00 pm At 6:00 pm CBC drawn results were PLT 10,000 & low WBC Diagnosed ITP resulting from MMR II vaccination 1/18/19 CBC drawn 6:00 am PLT 18,000 & WBC 3.9 discharged from hospital. No physical activities 1/21/19 CBC PLT 140,000 & WBC 4.61 Patient's symptoms from Jan. through May range from extreme tiredness, low energy & having a hard time focusing in school. He has not been able to participate in physical activities if his PLT are below 50,000 due to concern of internal bleeding. He plays Club Soccer at a high level year round along with High School soccer with the goal of being recruited & scholarship to play in college. He has to go weekly for bloodwork to see if his PLT counts are high enough each week to play. He has had to take Prednisone to increase PLT counts so he can participate in Club championship/state/regional games multiple times to ensure high enough counts & be able to play! His numbers have continued fluctuating & dropping down to 13,000 requiring Promacta prescription medicine to force his bone marrow to increase PLT production. Zofran also needed to deal with nausea from Promacta. He has been told his ITP could last 6 months to 5 plus years until his body re-sets itself & stops attacking his own PLT. We have his liver/organs checked each month to ensure the Promacta does not damage his liver & cause future health issues. This MMR vaccination has changed our son's life dramatically now & well into his future!
Age: 16.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Full blood count, Immune thrombocytopenic purpura, Loss of personal independence in daily activities, Mononucleosis heterophile test, Nausea
Clinical narrative: 1/16/19 Extreme fatigue, light headed, sore throat. Strep test, mono test, CBC & sick appointment with Dr., Pediatrician Platelet count 7,000 & very low WBC 1/17/19 CBC PLT 8,000 & very low WBC from 8:00 am appt. Dr Admitted to hospital under Dr., Hematologist at 4:00 pm At 6:00 pm CBC drawn results were PLT 10,000 & low WBC Diagnosed ITP resulting from MMR II vaccination 1/18/19 CBC drawn 6:00 am PLT 18,000 & WBC 3.9 discharged from hospital. No physical activities 1/21/19 CBC PLT 140,000 & WBC 4.61 Patient's symptoms from Jan. through May range from extreme tiredness, low energy & having a hard time focusing in school. He has not been able to participate in physical activities if his PLT are below 50,000 due to concern of internal bleeding. He plays Club Soccer at a high level year round along with High School soccer with the goal of being recruited & scholarship to play in college. He has to go weekly for bloodwork to see if his PLT counts are high enough each week to play. He has had to take Prednisone to increase PLT counts so he can participate in Club championship/state/regional games multiple times to ensure high enough counts & be able to play! His numbers have continued fluctuating & dropping down to 13,000 requiring Promacta prescription medicine to force his bone marrow to increase PLT production. Zofran also needed to deal with nausea from Promacta. He has been told his ITP could last 6 months to 5 plus years until his body re-sets itself & stops attacking his own PLT. We have his liver/organs checked each month to ensure the Promacta does not damage his liver & cause future health issues. This MMR vaccination has changed our son's life dramatically now & well into his future!
Age: 16.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Oropharyngeal pain, Platelet count decreased, Streptococcus test, White blood cell count decreased
Clinical narrative: 1/16/19 Extreme fatigue, light headed, sore throat. Strep test, mono test, CBC & sick appointment with Dr., Pediatrician Platelet count 7,000 & very low WBC 1/17/19 CBC PLT 8,000 & very low WBC from 8:00 am appt. Dr Admitted to hospital under Dr., Hematologist at 4:00 pm At 6:00 pm CBC drawn results were PLT 10,000 & low WBC Diagnosed ITP resulting from MMR II vaccination 1/18/19 CBC drawn 6:00 am PLT 18,000 & WBC 3.9 discharged from hospital. No physical activities 1/21/19 CBC PLT 140,000 & WBC 4.61 Patient's symptoms from Jan. through May range from extreme tiredness, low energy & having a hard time focusing in school. He has not been able to participate in physical activities if his PLT are below 50,000 due to concern of internal bleeding. He plays Club Soccer at a high level year round along with High School soccer with the goal of being recruited & scholarship to play in college. He has to go weekly for bloodwork to see if his PLT counts are high enough each week to play. He has had to take Prednisone to increase PLT counts so he can participate in Club championship/state/regional games multiple times to ensure high enough counts & be able to play! His numbers have continued fluctuating & dropping down to 13,000 requiring Promacta prescription medicine to force his bone marrow to increase PLT production. Zofran also needed to deal with nausea from Promacta. He has been told his ITP could last 6 months to 5 plus years until his body re-sets itself & stops attacking his own PLT. We have his liver/organs checked each month to ensure the Promacta does not damage his liver & cause future health issues. This MMR vaccination has changed our son's life dramatically now & well into his future!
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Patient called me this morning 9/11 to let me now that she started having reaction to the vaccine last night after receiving it from our store yesterday. Her arm started having swelling and a knot under the area where she received the shot. I told her to go to the dr and let us know what he said.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection and keeps swelling. Causing discomfort. Advised to take Benadryl and ice the area for swelling.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient has no record of adverse reactions to vaccinations or medications in the past. About 1 hour after the immunization, patient experienced severe itching, and redness at injection site in a 3" x 3". Patient experiences no pain during injection, nor pain afterwards. Only redness, heat, and itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: localized redness around injection site, appeared two days after injection
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Headache, Myalgia
Clinical narrative: Temperature between 99 to 100, constant vomiting and diarrhea for ~10 hours (diarrhea still on-going), muscle aches, joint aches, headache
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: Temperature between 99 to 100, constant vomiting and diarrhea for ~10 hours (diarrhea still on-going), muscle aches, joint aches, headache
Age: 24.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Confusional state, Disorientation, Immediate post-injection reaction, Musculoskeletal stiffness, Nausea
Clinical narrative: HPV vaccine administered without incident.  Immediately after Hepatitis B vaccine administration, pt requested to lay back.  Reclined and attempted to elevated legs, at which point patient stiffened.  Called for help, NP and MA responded immediately.  Pt began having  seizure like activity for approximately 30 seconds.  Sat up suddenly, confused and pale.  Ice packs applied to forehead and neck.  Pt reported feeling disoriented and nauseous. Remained in reclined position for approximately 20 minutes, reported feeling better.  Observed for additional 15 minutes.  Recommend she go home and rest, follow up with neurologist.  Left clinic in NAD.
Age: 24.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Pallor, Seizure like phenomena
Clinical narrative: HPV vaccine administered without incident.  Immediately after Hepatitis B vaccine administration, pt requested to lay back.  Reclined and attempted to elevated legs, at which point patient stiffened.  Called for help, NP and MA responded immediately.  Pt began having  seizure like activity for approximately 30 seconds.  Sat up suddenly, confused and pale.  Ice packs applied to forehead and neck.  Pt reported feeling disoriented and nauseous. Remained in reclined position for approximately 20 minutes, reported feeling better.  Observed for additional 15 minutes.  Recommend she go home and rest, follow up with neurologist.  Left clinic in NAD.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient said she got sick next day after receiving the vaccination with following symptoms: High fever and  rash on her right arm
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: HEADACHE, INJECTION SITE REDNESS & SWELLING, FEVER, SORE SHOULDER, SORE NECK
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: HEADACHE, INJECTION SITE REDNESS & SWELLING, FEVER, SORE SHOULDER, SORE NECK
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Skin mass, Type IV hypersensitivity reaction
Clinical narrative: Delayed type hypersensitivity reaction to aluminum component in Hepatitis A or B vaccine caused a subcutaneous nodule. patient had bump on left leg.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: BODY ACHES; HA; DIARRHEA; INJECTION SITE RED, SWOLLEN, HOT, TENDER
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain
Clinical narrative: BODY ACHES; HA; DIARRHEA; INJECTION SITE RED, SWOLLEN, HOT, TENDER
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on patient: It is mainly on his back spreading to his left and right axilla and  Upper and lower extremities.  It looks like chickenpox.  He is not complaining about itch or pain.  We did not give him anything for it since he did not complain.  The staff noticed when they were bathing him and felt the bumps on his back. It was hard to see initially bc of his skin color, so it was noticed 9/9/19 during his shower. It could have been there this past weekend, but possibly not noticeable yet.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure on 06/04/2019 - went to Medical Center