chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Slow response to stimuli
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around 15 to 16 years of age). Previously administered products included ZOSTAVAX (received around September 2017). On 9th February 2019, the patient received the 1st dose of SHINGRIX. On 9th February 2019, 4 hrs after receiving SHINGRIX, the patient experienced injection site swelling, shivering, feeling hot, pain in arm and malaise. On 10th February 2019, the patient experienced activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy. In February 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy were recovering/resolving and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased, loss of energy and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient never received chicken pox vaccine. On Friday around 2 pm, the patient received 1st dose of SHINGRIX on an unknown arm as recommended by physician. Six hours after receiving SHINGRIX, the patient experienced Shivering, feeling feverish and malaise. One day after receiving SHINGRIX, the patient was unable to perform normal functions (basically lay on the couch all day and evening) all day, experienced muscle weakness which led slow response to move legs to walk, extreme fatigue, extreme malaise, Pain (unable to lift injected arm above shoulder level as it was very painful to try to lift it) and no energy. The appetite of patient was normal. On 11th February 2019, the patient's condition was pretty much back to normal, injected arm still stiff, minimal pain raising arm fully up (which was unable to do yesterday). The patient asked are adverse events more pronounced or serious to response to 2nd shot or attenuated. Clarification raised to clarify discrepancy about GSK receipt date.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm and product supply issue were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm after receiving 1st dose. The patient has not been able to receive the 2nd dose due to the shortage of the vaccine. The reporter did not provide any additional details regarding this patient or event.
Age: 58.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Crying, Immediate post-injection reaction, Incorrect route of product administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: The injection was placed very high on my shoulder. It immediately radiated pain into my upper arm and when the pharmacist injected the vaccine it hurt even more. By 5:00pm I was unable to lift my arm. I was unable to feed myself due to the pain. I placed ice on the injection site and took ADVIL throughout the night I was awake and in pain to the point of crying. I appear to be experiencing SIRVA (shoulder injury related to vaccine administration). I received the Hep A first dose in my left arm and have the expected tenderness one expects when receiving a vaccine. It is nothing even close to the inability to raise my arm and the pain radiating into my hand I am experiencing in my right shoulder.
Age: 58.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Insomnia, Loss of personal independence in daily activities, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: The injection was placed very high on my shoulder. It immediately radiated pain into my upper arm and when the pharmacist injected the vaccine it hurt even more. By 5:00pm I was unable to lift my arm. I was unable to feed myself due to the pain. I placed ice on the injection site and took ADVIL throughout the night I was awake and in pain to the point of crying. I appear to be experiencing SIRVA (shoulder injury related to vaccine administration). I received the Hep A first dose in my left arm and have the expected tenderness one expects when receiving a vaccine. It is nothing even close to the inability to raise my arm and the pain radiating into my hand I am experiencing in my right shoulder.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient said it was her second dose of the series. Her left arm became very red and spread to the elbow. Patient went to her doctor who prescribed medication to treat reaction.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported severe pain in left arm the night after her injection. The pain has been decreasing each day. She took one dose of OTC ADVIL or ALEVE the night the pain started.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Monoplegia, Pain in extremity, Presyncope
Clinical narrative: Pt developed some presyncopal symptoms, but did not pass out. She shortly afterwards developed right arm numbness and paralysis. She had intact deep tendon reflexes. Was sent home to observe, but they went to the ED that night due to her symptoms persisting and developing some arm pain. Was thought that she had a conversion disorder. Her symptoms gradally improved over the following week, having totally resolved a week later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling, redness at injection site. Mild flu-like symptoms for 24 hours. (Aches, chills, fever of 100).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling, redness at injection site. Mild flu-like symptoms for 24 hours. (Aches, chills, fever of 100).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called to report that she experienced an extreme injection site reaction - approximate size is 4 inches by 5 inches on left arm. Arm is extremely swollen, red, and warm to touch. Discussed with patient over the counter remedies and also counseled her to seek additional medical treatment if it does not self-resolve.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Severe myalgia, fever, upset stomach, dizziness, headache, red swollen injection site. Lasted 36 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe myalgia, fever, upset stomach, dizziness, headache, red swollen injection site. Lasted 36 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient states she developed a rash on her chest 02/01/2019 which she describes as "chicken pox looking".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Very sore at injection site for 3 days, severe lethargy for 36 hrs and slight fever and flu symptoms for 24 hrs.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Immediate post-injection reaction, Seizure, Syncope
Clinical narrative: Pt first received the Nexplanon implant and then about 5 min after received her flu vaccine.   Immediately after receiving the flu vaccine she fainted and then had a seizure that lasted 15-20 seconds. Pt was transported by EMS to the emergency room and was later cleared and sent home.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient reports pain in arm and weakness in shoulder that has been ongoing since vaccination in October.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Nausea, Vaccination site nodule, Vaccination site pain
Clinical narrative: Vertigo, sweating, nausea for two hours starting early morning day after vaccine. The 3 inch square red breakout, knot, and very sore around vaccine site. For at least 5 days after vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo, sweating, nausea for two hours starting early morning day after vaccine. The 3 inch square red breakout, knot, and very sore around vaccine site. For at least 5 days after vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Death
Clinical narrative: This spontaneous report was received via voicemail from a field representative who learned of this adverse event from a nurse practitioner referring to a 17 year old patient of an unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "a couple of years ago"), the patient died from  an unspecified cause It was unknown if an autopsy was performed or not. The causality assessment was not provided at the time of the report.; Reported Cause(s) of Death: on an unspecified date a couple years ago, the patient died from an unspecified cause.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Malaise, Mobility decreased, Paralysis, Speech disorder
Clinical narrative: The morning after receiving the flu vaccine the patient woke up not feeling well. She got out of bed and walked and then became "paralyzed, frozen". She said she was unable to move or speak. She also developed a cough. She notified us on 02/16/2019 that this had occurred, but was not experiencing that side effect any more. She said she just had a cough and had started taking cold medication.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Electromyogram, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Progressive muscular numbness and weakness hospitalized for 8 days then treated at rehab hospital (currently still hospitalized at rehab hospital).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site haemorrhage, Injection site induration
Clinical narrative: Mom states on the 12th pt began with a "white bump" to the injection site. Bump worsened to the point of a "knot under the skin" and the "bump bleeding on and off" with redness around area per mom reported on 2/20 via phone call to the clinic. Mom instructed to come in to an office visit. CPNP found pt to have cellulitis of the right thigh and prescribed BACTRIM and BACTROBAN ointment. Mom presented with pictures of area which CPNP noted pt to have had a vesicle at the injection site. Mom says pt was playing last night and area opened and blood and "white stuff came out." Per CPNP open sore noted with surrounding redness, firm. No discharge now.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site nodule, Injection site swelling, Injection site vesicles
Clinical narrative: Mom states on the 12th pt began with a "white bump" to the injection site. Bump worsened to the point of a "knot under the skin" and the "bump bleeding on and off" with redness around area per mom reported on 2/20 via phone call to the clinic. Mom instructed to come in to an office visit. CPNP found pt to have cellulitis of the right thigh and prescribed BACTRIM and BACTROBAN ointment. Mom presented with pictures of area which CPNP noted pt to have had a vesicle at the injection site. Mom says pt was playing last night and area opened and blood and "white stuff came out." Per CPNP open sore noted with surrounding redness, firm. No discharge now.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: No adverse event
Clinical narrative: No adverse reaction reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at the site of injection - redness described as 4 inches in diameter over phone.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral
Clinical narrative: Evening of same day receiving PNEUMOVAX 23---had temp of 100.0, redness and edema around upper arm down to mid forearm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Arthralgia, Bone pain, Gait inability, Mobility decreased
Clinical narrative: Extreme pain, more than i ever experiened in right hip, could not walk, talk or get out of bed.  After self care and patience i started to walk and by late morning i felt good. This repeated for about 4 nights including any time i sat for longer than an hour. Morning extreme pain has diminished but i am left with a deep constant pain in my left hip bone. Its a deep bone pain. I put two and two together, after my first SHINGRIX vaccine i had the same sort of pain in my left shoulder/arm. That pain is also a deep bone pain. I have gain my movement ability in both areas but i still have the bone pain. Luckily i am a movement oriented person and can deal with this pain but i am mad about it. I am sure it is the vaccine that caused it. It took till the second shot to identify this!
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperthyroidism, Monocyte count abnormal, Pain, Pyrexia
Clinical narrative: This time the shivering, fever and aches were more severe than the first time. Since then he is being treated for hyperthyroid and his monocytes count is not in the normal range. He is taking methimazole for the thyroid and has to have more blood labs next week to check thyroid levels and monocytes again.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Osteoarthritis, Product administered at inappropriate site, X-ray limb abnormal
Clinical narrative: Placement of injection was too high in the deltoid.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Pruritus, Rash generalised, Rash morbilliform
Clinical narrative: Patient developed a full body 'measles like' rash and causes him discomfort. He's itchy.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Screaming, Skin discolouration
Clinical narrative: This spontaneous report has been received from a consumer who saw the information online posted by the patient's mother regarding to a 2-day old male patient. The patient's concurrent condition, medical history, drug allergies and concomitant therapies were not reported. On an unspecified date in 2012, the patient was vaccinated with RECOMBIVAX HB (lot number, expiration date, route of administration, dose and anatomical location of vaccine were not reported) for prophylaxis. On an unspecified date in 2012, after his parents took him to home, he was screaming on and off for 20 hours; therefore, the patient began to turn red (erythema) and purple in his face (skin discoloration). The patient was taken to the emergency room and afterwards he seemed to be recovered from the events. The causality assessment between all the events and RECOMBIVAX HB was unknown. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA000943; US-009507513-1902USA001350.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a currently 17 year old female patient. There were not patient's medical history, concurrent conditions and concomitant therapies. On 06-AUG-2018, the patient was vaccinated with VAQTA intramuscularly, lot # R013858, expiration date: 12-JUN-2019, for vaccination (strength, dosage and frequency were not provided). The reporter stated that on an unknown date, the patient experienced headache that lasted for one month. Therefore, the patient saw an unspecified healthcare professional regarding the headache who prescribed unknown treatment. The patient's conditions was currently resolved. There were not laboratories diagnostics performed. The reporter did not provide causality assessment between the event and VAQTA.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Influenza virus test negative, Myalgia, Neck pain, Presyncope, Pyrexia
Clinical narrative: Presyncope, neck pain, myalgias, fever.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Insomnia, Loss of personal independence in daily activities, Nausea
Clinical narrative: Sore arm for 12 hours (Like a golf ball had been injected inside the muscle). Nausea. Insomnia. Body aches. Cold extremities. Lack of energy for about 16 hours after onset of symptoms, I could not perform any ordinary activities--it felt like a bad case of flu.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Sore arm for 12 hours (Like a golf ball had been injected inside the muscle). Nausea. Insomnia. Body aches. Cold extremities. Lack of energy for about 16 hours after onset of symptoms, I could not perform any ordinary activities--it felt like a bad case of flu.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling/redness right upper arm from shoulder to elbow with 2 nickel-sized blisters present at top portion of area; presented to office 2/20/2019 at 1:00pm; given instructions to take KEFLEX susp 250mg/5ml: 10mls po q 8hrs x 10days; follow-up in office 24-48 hrs.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Blister, Erythema, Papule, Polymerase chain reaction, Scab
Clinical narrative: Small papule noted to buttocks 2/14/19. Numerous lesions started 2/17/19, erythematous papules, some progressing to vesicles and then crusting. Lesions to trunk, extremities, face, diaper area. Lesions at various stages when seen 2/18/19. Recommended symptomatic care. Returned 2/20/19 for VZV PCR for typing.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Skin lesion, Varicella virus test
Clinical narrative: Small papule noted to buttocks 2/14/19. Numerous lesions started 2/17/19, erythematous papules, some progressing to vesicles and then crusting. Lesions to trunk, extremities, face, diaper area. Lesions at various stages when seen 2/18/19. Recommended symptomatic care. Returned 2/20/19 for VZV PCR for typing.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Neuralgia, Pain in extremity, Tremor
Clinical narrative: Severe nausea, shaking, dizziness, nerve pain and arm soreness that lasted several days.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Differential white blood cell count, Full blood count, Metabolic function test, Mobility decreased, Pain in extremity
Clinical narrative: Arm soreness wasn't noticeable and now has gotten increasingly worse. Unable raise left arm.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Arm soreness wasn't noticeable and now has gotten increasingly worse. Unable raise left arm.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Patient had shoulder pain that began immediately after vaccine administration - lasted at least until 12/18/2018 and possibly longer although records are not available. Vaccination site was confirmed and the clinic believes that administration was correct.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction occurred, Pt was called to come back for adult dose.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Approximately 3 days after recieving vaccine pt notes a diffuse red rash that was warm and encompassed the arm about 3-6 inches below the site of injection. Injection site not appearently involved, but no other changes present that woul warrant said reaction. Patient still had a milder version of the rash when she presented to the pharmacy on 2/20/19. Pt was reffered to MD for evaluation and to rule out other causes.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: His arm became very puffy and red. Itchy.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncope- Pt fainted in seated position. Responded to light tapping on cheeks shortly after. Pt was given a cup of water and began to feel better. Pt was advised to have someone pick her up. She left the pharmacy with a friend at 245pm (over half hour later). Pt states she was feeling fine and was advised to seek medical attention if fainting and/or swelling of lips/tongue/throat were to occur. Pt was also advised to have friend stay with her for rest of the day, so that someone was watching over her. Pt confirmed that she understood instructions provided as stated above.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I have been suffering from constant pain in my dominant left arm, since I received the shot. At first the pain was manageable with some Tylenol. but the last two weeks, the pain has been excruciating and unbearable. I have taken Tylenol, Advill, Alleve. to help with the pain. Then my pain medication was upped to Tylenol 3 with codiene and also Ibruprofen 600. That also did not relieve my pain. I can hardly get out of bed now. I have tried using, rest, ice, compression, and elevation. I have an appoint to see my general practioner to see what can be done.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Injection site pain, Pain, Pallor
Clinical narrative: Pt reported on 2/11/2019 that ever since she got the second injection on 10/29/2018 that her left mid-deltoid has hurt down into her elbow. Pt stopped by clinic on 2/14/2019 and further reported that the pain is only with certain movements like putting on jackets and carrying things. It is a sharp pain that goes from mid-deltoid to elbow with those movements, and only when she moves it specific directions or lifts or moves stuff. A specific example was when hunting and carrying her gun. It aches when laying on it certain ways, but no numbness or tingling. At this point she also reported that she has chronic shoulder arthritis and that it had recently been worse. She also has a small non-painful pale bump that pt reports was not there prior to the immunization. Denied any red or pain at the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt reported on 2/11/2019 that ever since she got the second injection on 10/29/2018 that her left mid-deltoid has hurt down into her elbow. Pt stopped by clinic on 2/14/2019 and further reported that the pain is only with certain movements like putting on jackets and carrying things. It is a sharp pain that goes from mid-deltoid to elbow with those movements, and only when she moves it specific directions or lifts or moves stuff. A specific example was when hunting and carrying her gun. It aches when laying on it certain ways, but no numbness or tingling. At this point she also reported that she has chronic shoulder arthritis and that it had recently been worse. She also has a small non-painful pale bump that pt reports was not there prior to the immunization. Denied any red or pain at the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain
Clinical narrative: Nausea, chills, aches and pains, overall feeling like flu.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Patient claimed to have a rash that started the day after the reaction and progressed. Patient finally saw the doctor on 1/3/2019 and was prescribed a steroid shot and a steroid dose pack. Patient was given the shot again on 2/20/2019 and given ranitidine 150mg, cetirizine 10mg and hydroxyzine 10mg for the reaction.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo, with accompanying vomiting (once).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Granuloma annulare, Rash, Rash erythematous
Clinical narrative: Rash developed approximately 1 week following the 2nd SHINGRIX vaccination. First appeared on legs and then spread to back. Flat, red, no pain or itching. Large areas. PC physician believes it to be an adverse reaction to the 2nd SHINGRIX innoculation. Treated with steroid ointment for 7 days. Treatment was ineffective.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient was administered the 2nd dose for SHINGRIX on 02-16-19. Patient came back a couple hours later having swelling at the injection site and sore arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Altered state of consciousness, Chills, Fatigue, Headache
Clinical narrative: Same day, approx. 9pm, experienced extreme fatigue. Approx. 1am during that night, experienced full on flu symptoms. Including: chills, muscle aches, massive headache, so much so, I could not get up for aspirin. Fading in and out of brief periods of sleep, all night. Approx. 830am took 2 aspirins and slept about an hour. It helped and I thought it was over. My stomach started cramping and making all sorts of gurgling noises shortly after noon. Then I had very unpleasant bathroom visits (many). At one point almost passed out. Got thru that and began the chills and body aches again! My husband had his right before me and he had NO complications. I am nervous that I will go thru this again during the booster. Seems my body did not like this AT ALL!
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Myalgia, Pain
Clinical narrative: Same day, approx. 9pm, experienced extreme fatigue. Approx. 1am during that night, experienced full on flu symptoms. Including: chills, muscle aches, massive headache, so much so, I could not get up for aspirin. Fading in and out of brief periods of sleep, all night. Approx. 830am took 2 aspirins and slept about an hour. It helped and I thought it was over. My stomach started cramping and making all sorts of gurgling noises shortly after noon. Then I had very unpleasant bathroom visits (many). At one point almost passed out. Got thru that and began the chills and body aches again! My husband had his right before me and he had NO complications. I am nervous that I will go thru this again during the booster. Seems my body did not like this AT ALL!
Age: 26.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Asthenia, Blood test, Seizure, Syncope
Clinical narrative: About 3 hours after administration of 3 shots, PT got seizure and fainted. 911 came and checked blood pressure which was in normal range. He was very feeble and couldn't open the eyes. They took him to hospital upon PT's request.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site joint pain, Injection site rash, Irritability, Oedema peripheral
Clinical narrative: On 2/19/19, patient presented back to pediatrician's office with rash over bilat lower extremities, left ankle with larger erythematous raised patch, scattered rash on hand, toe, ear; Edema over the knee bilat, right greater than left; right knee painful to touch; irritability and excessive crying.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous
Clinical narrative: On 2/19/19, patient presented back to pediatrician's office with rash over bilat lower extremities, left ankle with larger erythematous raised patch, scattered rash on hand, toe, ear; Edema over the knee bilat, right greater than left; right knee painful to touch; irritability and excessive crying.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Lt deltoid swelling x3 days. Warmth around the arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Periorbital swelling, Rash erythematous, Rash generalised
Clinical narrative: Patient woke up on 2/19/19 with raised, red rash all over body. She sought medical treatment from her primary care Dr. and was advised to take BENADRYL. She then reported to pharmacy to choose correct BENADRYL. She took 1st BENADRYL dosage 02/19 PM. Patient was contacted 02/20/2019 to follow up, and indicated that she woke up with rash, and swelling around eyes, but no itching. She had just taken another dosage of BENDARYL, and will follow up with pharmacy later in the day.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Heart rate increased, Influenza like illness, Injection site pain
Clinical narrative: Pt reports having SOB, increased heart rate, pain and swelling at the site of injection. Pt also describes FLU like Sx, chills and congestion.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Respiratory tract congestion
Clinical narrative: Pt reports having SOB, increased heart rate, pain and swelling at the site of injection. Pt also describes FLU like Sx, chills and congestion.
Age: 36.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: C/O pain swelling/numbness in right arm shoulder after receiving vaccines.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash is located on the arms, legs, and on the torso anterior and posterior. Rash developed over 2-3 days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Pt states she still has soreness and a lump at the site of vaccine.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site macule, Injection site warmth, Local reaction
Clinical narrative: Right deltoid -> localized injection site reaction. "Erythematous, macular, pink, warm to touch."
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Rash
Clinical narrative: 10 days past reaction: 2/15/19 noticed rash across abdomen. 2/16/19 rash from chest down to feet with swollen lymph nodes back of head/neck area. Joint pain. Only treatment OTC anti-inflammatory medication.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: high fever of 103; Chills; severe headache; shaking; This spontaneous report was received from a physician via Pfizer refers to a male patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) along with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis on the same day (strength, dose, route, frequency, indication, lot number, expiry date unspecified). The patient had severe reaction to it. On an unknown date, the patient experienced high fever of 103 (pyrexia), shaking (tremor), severe headache and chills.  The reporter was presuming meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) was causing the reaction since quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was given at the office. The patient had to be sent to another office location on the same day at least 15-20 minute later to receive meningococcal b rfhbp vaccine (e. coli) (TRUMENBA). The patient started to have the reaction about an hour after the initial quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine was administered, that is why she was presuming meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) caused the reaction. The outcome of pyrexia, tremor, headache and chills was unknown. The reporter causality was unknown for the event pyrexia, tremor, headache and chills to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a 27-year-old female patient. The patient's pertinent medical history included gastrooesophageal reflux disease and her drug reactions or allergies included an adverse reaction to an unspecified over the counter decongestant. The patient's concomitant medications included omeprazole. On 28-DEC-2018, the patient was vaccinated with a first dose of VARIVAX subcutaneously, lot # N014632, expiration date 11-MAY-2019 (dose and site of administration were not reported) for prophylaxis and reported no adverse events. On 29-JAN-2019, the patient received a second dose of VARIVAX subcutaneously, lot # R019235, expiration date 04-JUL-2020 (dose and site of administration were not reported). On 30-JAN-2019, the patient experienced redness, warmth, itching and mild pain at the injection site. The patient called a physician office for medical consultation. The events were treated on unspecified dates with an unspecified around the clock anti-histamine and an unspecified anti-inflammatory medication. No lab diagnostics or studies were performed. The outcome of the events was reported as recovered on 03-FEB-2019. The causality between the events and suspect vaccine was not reported. Sender's Comments: US-009507513-1902USA004146: US-009507513-1902USA006029.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a 27-year-old female patient. The patient's pertinent medical history included gastrooesophageal reflux disease and her drug reactions or allergies included an adverse reaction to an unspecified over the counter decongestant. The patient's concomitant medications included omeprazole. On 28-DEC-2018, the patient was vaccinated with a first dose of VARIVAX subcutaneously, lot # N014632, expiration date 11-MAY-2019 (dose and site of administration were not reported) for prophylaxis and reported no adverse events. On 29-JAN-2019, the patient received a second dose of VARIVAX subcutaneously, lot # R019235, expiration date 04-JUL-2020 (dose and site of administration were not reported). On 30-JAN-2019, the patient experienced redness, warmth, itching and mild pain at the injection site. The patient called a physician office for medical consultation. The events were treated on unspecified dates with an unspecified around the clock anti-histamine and an unspecified anti-inflammatory medication. No lab diagnostics or studies were performed. The outcome of the events was reported as recovered on 03-FEB-2019. The causality between the events and suspect vaccine was not reported. Sender's Comments: US-009507513-1902USA004146: US-009507513-1902USA006029.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 66-year-old male patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th February 2019, less than a day after receiving SHINGRIX, the patient experienced tinnitus and tremor of hands. On an unknown date, the outcome of the tinnitus and tremor of hands were unknown. It was unknown if the reporter considered the tinnitus and tremor of hands to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, while leaving the pharmacy the patient experienced tinnitus. The patient also experienced shaking hands.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paralysis
Clinical narrative: Paralyzed neck and extreme pain.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from an office manager on behalf of a physician, and refers to a 38 year old female patient. The patient had no concomitant medications, concurrent conditions, drug reactions, allergies or historical conditions. On 18-JAN-2019, the patient was vaccinated with M-M-R II lot # R000551, expiration date 08-JAN-2020, subcutaneously as prevention of measles, mumps and rubella, which was diluted with MERCK STERILE DILUENT. On 29-JAN-2019, the patient developed a generalized rash all over her face and body. She sought medical attention by calling the physician, however, she did not receive any treatment for the event. No laboratory tests were carried out. By the time of this report, the patient had not recovered from the event. Causality assessment was not reported.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug allergies were not reported. On unknown date in April 2017, the patient was vaccinated with one dose of PROQUAD (rHA), lot # M042498 with expiration date on 17-APR-2018 (strength, route and anatomical side of the injection were not reported) and one dose of VARIVAX lot # M039378 with expiration date on 20-SEP-2018 (strength, route and anatomical side of the injection were not reported) (Inappropriate schedule of vaccine administered). No adverse effects was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse referring to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patients were vaccinated with an unknown number of improperly stored dose of ROTATEQ, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  The administered doses of the vaccine experienced a temperature excursion of above 47 Fahrenheit degrees for 27 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 12-FEB-2019, the patient was vaccinated with M-M-R II subcutaneous, lot # R002930 and expiration date 31-JAN-2019 (dosage schedule, anatomical location were not reported). On the same day, the patient received a first dose of M-M-R II, however the dose das expired on 30-JAN-2019 (expired product administered). The outcome of expired product administered was unknown.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 18 year old patient of unknown age. The patient's concomitant medications included diluent MRK. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 04-JAN-2019, an 18 year old patient was vaccinated with PROQUAD rHA, subcutaneously, lot # R017802 and 19-DEC-2019 for prophylaxis (dose was not reported) (product use issue). The outcome of product use issue was unknown.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: PATIENT WAS VACCINATED ON FRIDAY AND WOKE UP MONDAY MORNING WITH A VERY SORE RIGHT ARM AND COULD HARDLY MOVE IT. PATIENT'S ARM WAS HOT TO THE TOUCH.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, and rash from injection site to elbow.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Muscular weakness
Clinical narrative: Employee experienced dizziness upon waking the morning after the vaccine. She had some muscle weakness, headache, and fatigue throughout the morning.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever 101. Nausea, Headache, and body aches per pt states symptoms started at night and states still continued to this morning 02/21/2019. Pt advised to continue to Tylenol and Motrin and push fluids if symptoms worsen please call office.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache
Clinical narrative: Shivers and feeling cold from 10-3 am. Painful headache came on at 3 am.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, MMR, VARCEL
Symptoms: Activated partial thromboplastin time normal, Full blood count normal, Petechiae, Platelet count normal, Prothrombin time normal
Clinical narrative: Patient developed petechiae on neck, face.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dyspnoea, Fatigue, Sneezing, Vision blurred
Clinical narrative: Vaccines given on 02/19/18 at 9:15 AM. Began sneezing at 9:45 AM. At noon pt reported feeling very fatigued, left eye had blurred vision, then became SOB. She was at school and called father to come get her. Went to ER and was given steroid shot and BENADRYL. Was monitored for 4 hours then released.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Tenderness
Clinical narrative: Patient reporting generalized fatigue and wrist tenderness that started almost immediately after vaccination was received and has yet to resolve as of 2/20/2019.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Vaccination site swelling
Clinical narrative: "I noticed a swelling, redness, itching at the site of the vaccination. It was getting bigger as the day went by....I am still feeling some pain, and itching (2/21/2019 @1019 a.m.)."
Age: 19.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HPV9, IPV, TYP, DTAP, HEP, HEPA, HPV9, IPV, TYP
Symptoms: Amenorrhoea, Menstruation irregular
Clinical narrative: I stopped having periods. I had 3 periods in less than 3 years and then went on birth control for 4 years. Prior to shots, my periods lasted 8 days, after the shots and with BC, they lasted 2 days. Once BC was stopped, I had one period after 3 months then conceived my son. After his birth, I didn't have another period for 2 years. Then after one period in October 2016, I conceived my daughter. As it stands, she is 18 months old and I have yet to have another period
Age: 19.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HPV9, IPV, TYP, DTAP, HEP, HEPA, HPV9, IPV, TYP
Symptoms: Amenorrhoea, Maternal exposure before pregnancy
Clinical narrative: I stopped having periods. I had 3 periods in less than 3 years and then went on birth control for 4 years. Prior to shots, my periods lasted 8 days, after the shots and with BC, they lasted 2 days. Once BC was stopped, I had one period after 3 months then conceived my son. After his birth, I didn't have another period for 2 years. Then after one period in October 2016, I conceived my daughter. As it stands, she is 18 months old and I have yet to have another period
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 18 years old patient of unknown gender. Information about concomitant medications, medical history and drug reactions was not provided. On an unknown date, the patient was administered with an adult dose of RECOMBIVAX HB (route, lot number and expiration date were not reported) for prophylaxis (incorrect dose administered). No adverse effects were reported.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable Nurse. A 33-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient also started to receive amoxicillin (manufacturer unknown), buprenorphine (manufacturer unknown), ibuprofen (manufacturer unknown) and hydrocodone (manufacturer unknown), all via an unspecified routes of administration from unspecified dates of therapy at unspecified doses for unspecified indications. Medical history included allergies: sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced allergies: pneumococcal, hydrocodone, ibuprofen, amoxicillin, buprenorphine on an unspecified date. The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was not applicable while unknown for amoxicillin, buprenorphine, ibuprofen and hydrocodone. The outcome of the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), ibuprofen, buprenorphine and amoxicillin in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), ibuprofen, buprenorphine and amoxicillin has submitted the same report to the regulatory authorities. The information on the lot number and expiration date has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dry skin, Pain
Clinical narrative: Day after vaccine very tired, diarrhea. Dry scaly tiny bumps on entire left shoulder. It traveled across my chest between the bottom of my neck to top of breasts and my right shoulder. Dr. doesn't want me to get the second dose. I still have it only it is getting much better. I had a HZV (zoster) vaccine on Oct. 30, 2009. I got shingles Sept. 16, 2015 on my right side, on my back, under my shoulder blade. Stabbing pains, but no skin outbreak. I went to the clinic and saw Dr.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Pain, Pain in extremity
Clinical narrative: First - achy, fever, chills x2 days. 2nd dose - painful arm, short of breath chest tight x 1 day fever began, chills achy x 2 days. Fever 100.5.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First - achy, fever, chills x2 days. 2nd dose - painful arm, short of breath chest tight x 1 day fever began, chills achy x 2 days. Fever 100.5.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin lesion, Skin warm, Swelling
Clinical narrative: 02/21/2019 PATIENT REPORTS REDNESS AND SWELLING TO RIGHT BUTTOCKS. MOM REPORTS THAT HE HAD HIS MENINGOCOCCAL VACCINE 02/19/2019. LESION TO RIGHT BUTTOCK 5X5 CM AREA WITH WARMTH AND REDNESS NOTED. DENIES TTP AT SITE. COLOR: FLESH COLOR. GENERAL APPERANCE LOCALIZED. INFECTIOUS SIGNS: WARMTH, ERYTHEMA AND SWELLING. CELLULITIS: ADMINISTERED ROCEPHIN 1 GRAM IM IN OFFICE TODAY (02/21/19). PRESCRIBED CEPHALEXIN 500MG. INSTRUCTED MOM TO APPLY WARM COMPRESSES TO THE AREA 2-3 TIMES PER DAY. MAY TAKE TYLENOR OR MOTRIN OTC AS NEEDED FOR PAIN. RTC IF S/S'S ARE NO BETTER, SOONER IF NEEDED. CARE INSTRUCTIONS GIVEN.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced fevers, slight chills, and a sore, red hardened area (roughly 5" in diameter) at and surrounding the vaccine site injection. General malaise and soreness of the arm lasted several days- a week. Still experiencing some malaise.