chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PPV, VARCEL
Symptoms: Developmental delay, Disturbance in social behaviour, Ear infection, Ear tube insertion, Gene mutation identification test positive
Clinical narrative: Patient fell asleep on the way home from her vaccinations. She woke up within an hour or so. Around 3:00pm she spiked a fever of 104.4 so I gave her Tylenol. 4-6 hours later I gave her Motrin and a luke warm bath. Her fever remained high for 3 consecutive days and eventually breaking by day 4. I continued alternating the motrin/tylenol during this time as medical professionals in my family suggested. During that time, she began banging her head like she was in pain, screaming a very loud pitch sound I had never heard before and just wasn't "herself" The fever broke, but her behaviors continued. Within 4-6 weeks she lost all words, eye contact, and socialization. Her behaviors remained the same and I then took her into her Pediatrician. Her doctor referred us to a Ped Neurologist where they then began tests. She began to have chronic ear infection and tubes were placed in July 2018 by Dr at the Medical Clinic.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PPV, VARCEL
Symptoms: Head banging, Language disorder, Pain, Pyrexia, Screaming
Clinical narrative: Patient fell asleep on the way home from her vaccinations. She woke up within an hour or so. Around 3:00pm she spiked a fever of 104.4 so I gave her Tylenol. 4-6 hours later I gave her Motrin and a luke warm bath. Her fever remained high for 3 consecutive days and eventually breaking by day 4. I continued alternating the motrin/tylenol during this time as medical professionals in my family suggested. During that time, she began banging her head like she was in pain, screaming a very loud pitch sound I had never heard before and just wasn't "herself" The fever broke, but her behaviors continued. Within 4-6 weeks she lost all words, eye contact, and socialization. Her behaviors remained the same and I then took her into her Pediatrician. Her doctor referred us to a Ped Neurologist where they then began tests. She began to have chronic ear infection and tubes were placed in July 2018 by Dr at the Medical Clinic.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PPV, VARCEL
Symptoms: Sleep disorder
Clinical narrative: Patient fell asleep on the way home from her vaccinations. She woke up within an hour or so. Around 3:00pm she spiked a fever of 104.4 so I gave her Tylenol. 4-6 hours later I gave her Motrin and a luke warm bath. Her fever remained high for 3 consecutive days and eventually breaking by day 4. I continued alternating the motrin/tylenol during this time as medical professionals in my family suggested. During that time, she began banging her head like she was in pain, screaming a very loud pitch sound I had never heard before and just wasn't "herself" The fever broke, but her behaviors continued. Within 4-6 weeks she lost all words, eye contact, and socialization. Her behaviors remained the same and I then took her into her Pediatrician. Her doctor referred us to a Ped Neurologist where they then began tests. She began to have chronic ear infection and tubes were placed in July 2018 by Dr at the Medical Clinic.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Hypotension
Clinical narrative: Lightheadedness, fatigue, borderline low blood pressure
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Local reaction
Clinical narrative: Mild localized reaction with induration 48 hrs after vaccines were given in reaction to ProQuad and Kinrix vaccinations.
Age: 3.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: My son was given his dtap and polio vaccines 9 days before he turned 4. So now he might have to have them again.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Facial pain, Injection site pain, Myalgia, Nausea
Clinical narrative: I developed the typical symptoms beginning about 8 hours after the shot.  Soreness at injection sight, muscle aching throughout my body, nausea and feeling feverish.  However, beginning about 8 hours after the shot my nose began turning red and throbbing with pain.  It looked/looks like a severe sunburn, however I haven't been out in the sun for more than a few minutes.  I received the Vaccine on Monday, 9-9-19.  It is now Friday, 9-13-19 and my nose is finally getting a little better.  It is less red and less sore.  I returned to the Pharmacist who administered the Vaccine and she said she had never heard or seen this before.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I developed the typical symptoms beginning about 8 hours after the shot.  Soreness at injection sight, muscle aching throughout my body, nausea and feeling feverish.  However, beginning about 8 hours after the shot my nose began turning red and throbbing with pain.  It looked/looks like a severe sunburn, however I haven't been out in the sun for more than a few minutes.  I received the Vaccine on Monday, 9-9-19.  It is now Friday, 9-13-19 and my nose is finally getting a little better.  It is less red and less sore.  I returned to the Pharmacist who administered the Vaccine and she said she had never heard or seen this before.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Rash erythematous, Rash macular
Clinical narrative: I developed the typical symptoms beginning about 8 hours after the shot.  Soreness at injection sight, muscle aching throughout my body, nausea and feeling feverish.  However, beginning about 8 hours after the shot my nose began turning red and throbbing with pain.  It looked/looks like a severe sunburn, however I haven't been out in the sun for more than a few minutes.  I received the Vaccine on Monday, 9-9-19.  It is now Friday, 9-13-19 and my nose is finally getting a little better.  It is less red and less sore.  I returned to the Pharmacist who administered the Vaccine and she said she had never heard or seen this before.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rhinalgia
Clinical narrative: I developed the typical symptoms beginning about 8 hours after the shot.  Soreness at injection sight, muscle aching throughout my body, nausea and feeling feverish.  However, beginning about 8 hours after the shot my nose began turning red and throbbing with pain.  It looked/looks like a severe sunburn, however I haven't been out in the sun for more than a few minutes.  I received the Vaccine on Monday, 9-9-19.  It is now Friday, 9-13-19 and my nose is finally getting a little better.  It is less red and less sore.  I returned to the Pharmacist who administered the Vaccine and she said she had never heard or seen this before.
Age: 41.0
Sex: F
Vaccine: HEPA, MMR, TYP
Symptoms: Arthralgia, Blood test, Chills, Headache, Inflammatory marker test
Clinical narrative: 9 days after vaccine administration (5/15/19), developed fairly acute onset of headache, chills and malaise.  Over the subsequent 4 days she developed  worsening arthralgias, starting in distal medium joints that progressed to generalized arthralgias to the point that she had difficulty ambulating.  On 5/20/19 admitted to hospital for 24 hr observation and started on a 6 week course of steroids.  She had to cancel her planned overseas trip for which she received the vaccinations in the first place. She went on to a complete recovery of her symptoms over the subsequent weeks of treatment with steroids and has no permanent sequelae or persistent symptoms.
Age: 41.0
Sex: F
Vaccine: HEPA, MMR, TYP
Symptoms: Malaise
Clinical narrative: 9 days after vaccine administration (5/15/19), developed fairly acute onset of headache, chills and malaise.  Over the subsequent 4 days she developed  worsening arthralgias, starting in distal medium joints that progressed to generalized arthralgias to the point that she had difficulty ambulating.  On 5/20/19 admitted to hospital for 24 hr observation and started on a 6 week course of steroids.  She had to cancel her planned overseas trip for which she received the vaccinations in the first place. She went on to a complete recovery of her symptoms over the subsequent weeks of treatment with steroids and has no permanent sequelae or persistent symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: Radiating pain from joints. Extreme fatigue Lightheadedness Not able to continue giving lecture
Age: 67.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: On 9/12/19 around 4 pm the client developed redness, swelling, pain at injection site (right deltoid area) and  pain upon moving right arm.  Per the client the redness was about the size of her palm and the swelling went from her upper arm down to her elbow. She took an Ibuproten last night for pain. This morning the client states her arm isn't as red, swollen or as  painful.  She still has pain upon movement of her arm. The client was encourage to contact her doctor especially if her symptoms became worse.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: Very tired one day after injection. Next day (second day after vaccine) started having aches in joints mostly on left side of body?knee, ankle, wrist. Then muscles aches on left.. Tingling started in left foot and left hand, traveled up leg. Over the next few days knee and ankle on right side had aches, and tingling spread to both feet, shins, hands, face including eyelids, inside eyes, inside mouth, side of face. Swelling developed behind left knee which primary care doctor thought could be popliteal cyst from possible arthritis in left knee irritated by immune response to vaccine. Now can?t bend left knee easily. as too painful. Now three and a half weeks out, most joint aches are gone except for left knee but tingling has continued, moving to different parts of body including face, especially eyelids, feet, hands, legs.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Swelling, Synovial cyst
Clinical narrative: Very tired one day after injection. Next day (second day after vaccine) started having aches in joints mostly on left side of body?knee, ankle, wrist. Then muscles aches on left.. Tingling started in left foot and left hand, traveled up leg. Over the next few days knee and ankle on right side had aches, and tingling spread to both feet, shins, hands, face including eyelids, inside eyes, inside mouth, side of face. Swelling developed behind left knee which primary care doctor thought could be popliteal cyst from possible arthritis in left knee irritated by immune response to vaccine. Now can?t bend left knee easily. as too painful. Now three and a half weeks out, most joint aches are gone except for left knee but tingling has continued, moving to different parts of body including face, especially eyelids, feet, hands, legs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient called to let us know that he arm that she had gotten her shingrix shot in was red, and hot radiating down from the injection site to her elbow. She did not notice this reaction until Friday morning and got the vaccine on Wednesday evening.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Electromyogram, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: The onset of pain occurred almost immediately, the pain worsened and continued in the following days. The pain was a burning, aching and throbbing sensation that took over my left shoulder. As the days progressed my range of motion and strength in my left arm was severely limited. It became difficult to put on clothes and sleep on my left side. I saw my PCP and was given Celebrex, I went to a chiropractor for soft tissue laser treatments to reduce the pain and inflammation. I was admitted to Hospital on March 9,2019 due to a total loss of function on my left arm and extreme pain from my shoulder down to my left hand and across the left side of my chest. I was prescribed steriods.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscular weakness
Clinical narrative: The onset of pain occurred almost immediately, the pain worsened and continued in the following days. The pain was a burning, aching and throbbing sensation that took over my left shoulder. As the days progressed my range of motion and strength in my left arm was severely limited. It became difficult to put on clothes and sleep on my left side. I saw my PCP and was given Celebrex, I went to a chiropractor for soft tissue laser treatments to reduce the pain and inflammation. I was admitted to Hospital on March 9,2019 due to a total loss of function on my left arm and extreme pain from my shoulder down to my left hand and across the left side of my chest. I was prescribed steriods.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: The onset of pain occurred almost immediately, the pain worsened and continued in the following days. The pain was a burning, aching and throbbing sensation that took over my left shoulder. As the days progressed my range of motion and strength in my left arm was severely limited. It became difficult to put on clothes and sleep on my left side. I saw my PCP and was given Celebrex, I went to a chiropractor for soft tissue laser treatments to reduce the pain and inflammation. I was admitted to Hospital on March 9,2019 due to a total loss of function on my left arm and extreme pain from my shoulder down to my left hand and across the left side of my chest. I was prescribed steriods.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Client experienced malaise, achiness, and headache that lasted until the next day. Client also experienced a fever of 104 for approximately 5 hours; unrelieved by Tylenol.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: About 3.5 hours after the shot was administered patient experienced body aches congestion headache and slight fever lasted the entire next day and by thursday morning had resolved/gone away. Also patient complained of a very sore arm.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Photopsia, Pruritus
Clinical narrative: Patient stated that 1 hr after immunization she developed a headache and vision problems (blurred vision and flashing) that lasted approx. 3 hours. Also reported a line under injection site that was red, hot, and itchy and had burning pain in the area. She stated rash was slowly diminishing.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Vision blurred, Visual impairment
Clinical narrative: Patient stated that 1 hr after immunization she developed a headache and vision problems (blurred vision and flashing) that lasted approx. 3 hours. Also reported a line under injection site that was red, hot, and itchy and had burning pain in the area. She stated rash was slowly diminishing.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received one improperly stored dose of PROQUAD; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  Since 12-JUL-2019, vaccines had a temperature excursion.  On 14-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot number S008570 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 5 degrees Celsius (C)  for more than 30 days. The excursion ended on 05-SEP-2019. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received one improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  Since 12-JUL-2019, vaccines had a temperature excursion.  On 14-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot number S008570 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 5 degrees Celsius (C)  for more than 30 days. The excursion ended on 05-SEP-2019. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient received an improperly stored PROQUAD; This spontaneous report was received from a nurse concerning a 4 year old male patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 12-AUG-2019 and on 13-AUG-2019, the vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced two temperature excursions each date respectively. On 19-AUG-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # R026722, expiration date 17-MAR-2020) or (lot # R023499, expiration date 13-FEB-2020) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of -14°C to -10°C (-11.91 C, multiple) for 8 hours, as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a 3-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 28-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R006221 with expiration date 29-FEB-2020 or R029517 with expiration date 14-OCT-2020 (reported as 14 of unknown month 2020) (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect product storage). The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported.  On 12-AUG-2019 and 13-AUG-2019, administered doses of vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-11.91 C) for 8 hours. There was no previous temperature excursion. Digital data logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster meningitis, Polymerase chain reaction positive, Rash
Clinical narrative: Patient is 16 year old female who is hospitalized with VZV Meningitis; This spontaneous report was received from a physician referring to a 16-year-old female patient. The patient's past medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot/batch, expiry date not reported) when she was a child for prophylaxis. The physician reported that the patient was in hospital with VZV meningitis (varicella zoster virus meningitis (herpes zoster meningitis)) documented on polymerase chain reaction (PCR) with a rash on her left arm for several weeks that was painful. The physician believed that VZV meningitis was not classic, but vaccine associated zoster. The patient was having an immune work-up. The physician was planning to test the cerebrospinal fluid (CSF) and see if this was a wild type or vaccine strain. The outcome of the event herpes zoster meningitis was not reported. The reporter considered the event herpes zoster meningitis to be related to varicella virus vaccine live (Oka/Merck)(VARIVAX).  Upon internal review, the event herpes zoster meningitis was determined to be medically significant.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: redness on injection site; swelling on injection site / huge knot; Injection site knot; neck swelling; neck pain; neck stiffness; This case was reported by a nurse and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Previously administered products included Keflex, Naproxen and Simvastatin.   On 8th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th March 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient experienced redness, swelling on injection site. After vaccine the patient reported a huge knot and redness neck stiffness. The patient complained of neck swelling and pain
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Swelling
Clinical narrative: redness on injection site; swelling on injection site / huge knot; Injection site knot; neck swelling; neck pain; neck stiffness; This case was reported by a nurse and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   Previously administered products included Keflex, Naproxen and Simvastatin.   On 8th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th March 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, neck swelling, neck pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The patient experienced redness, swelling on injection site. After vaccine the patient reported a huge knot and redness neck stiffness. The patient complained of neck swelling and pain
Sex: M
Vaccine: UNK, UNK
Symptoms: Hepatitis A, Incomplete course of vaccination
Clinical narrative: Heptatis A infection; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of hepatitis a in a male patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult and Havrix adult at an unknown dose. On an unknown date, several years after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced hepatitis a and incomplete course of vaccination. On an unknown date, the outcome of the hepatitis a and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the hepatitis a to be related to Havrix adult.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine years ago and experienced hepatitis A. Till the time of reporting the patient had not received the booster dose, which led to incomplete course of vaccination. The patient stated that the health department told her to just get the booster vaccination, but the centers for disease control (CDC) told to get the Havrix series again. This case has been considered as medication error associated with adverse event. This case has been linked with case US2019158421, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Extensive swelling of vaccinated limb, Injection site swelling, Swollen tongue
Clinical narrative: Raised bump at injection site / golf ball size; Swollen tongue; Cough; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 28th August 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, swollen tongue and cough. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the injection site swelling, swollen tongue and cough were unknown.   It was unknown if the reporter considered the injection site swelling, swollen tongue and cough to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. On the reporting date, the patient informed the pharmacist that after an unspecified time after the injection, she experienced a raised bump on the injection site that turned into golf ball size, which led to extensive swelling of vaccinated limb. The patient also experienced a swollen tongue and cough. The patient went to an emergency department and was given Benadryl and prednisone, monitored for 2 hours, and sent home. The reporter consented to follow up. The emergency room visit required.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Blood test, Gait disturbance, Injected limb mobility decreased, Laboratory test
Clinical narrative: My left arm hurt a great deal all the time for 2 weeks after getting the vaccine on Jan. 15, 2019, with stiffness beginning in my both my arms. I woke up around the date of  Jan. 25, 2019 and could not left myself up from my bed because my arms were too weak and I couldn't lift them up. I had to roll out of bed and crawl to a chest of drawers to pull myself up using the knobs.   Along with that, my hips and legs became stiff and painful. By Jan. 31 and shortly before that date, I had trouble walking and could only take small steps. After taking Prednisone 10mg  starting May 13, 2019 I felt as I could finally walk and move well.  On this date of 9-13-19 I still feel a lot of pain in my arms and legs and the pain comes and goes.  A rheumatologist confirmed  on July 29, 2019 that I have Polymyalgia. I've tapered off to 7 mg a day of Prednisone but still feel the symptoms, although I can get out of bed easier and walks outside a few times a week when the pain isn't severe.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: My left arm hurt a great deal all the time for 2 weeks after getting the vaccine on Jan. 15, 2019, with stiffness beginning in my both my arms. I woke up around the date of  Jan. 25, 2019 and could not left myself up from my bed because my arms were too weak and I couldn't lift them up. I had to roll out of bed and crawl to a chest of drawers to pull myself up using the knobs.   Along with that, my hips and legs became stiff and painful. By Jan. 31 and shortly before that date, I had trouble walking and could only take small steps. After taking Prednisone 10mg  starting May 13, 2019 I felt as I could finally walk and move well.  On this date of 9-13-19 I still feel a lot of pain in my arms and legs and the pain comes and goes.  A rheumatologist confirmed  on July 29, 2019 that I have Polymyalgia. I've tapered off to 7 mg a day of Prednisone but still feel the symptoms, although I can get out of bed easier and walks outside a few times a week when the pain isn't severe.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity
Clinical narrative: My left arm hurt a great deal all the time for 2 weeks after getting the vaccine on Jan. 15, 2019, with stiffness beginning in my both my arms. I woke up around the date of  Jan. 25, 2019 and could not left myself up from my bed because my arms were too weak and I couldn't lift them up. I had to roll out of bed and crawl to a chest of drawers to pull myself up using the knobs.   Along with that, my hips and legs became stiff and painful. By Jan. 31 and shortly before that date, I had trouble walking and could only take small steps. After taking Prednisone 10mg  starting May 13, 2019 I felt as I could finally walk and move well.  On this date of 9-13-19 I still feel a lot of pain in my arms and legs and the pain comes and goes.  A rheumatologist confirmed  on July 29, 2019 that I have Polymyalgia. I've tapered off to 7 mg a day of Prednisone but still feel the symptoms, although I can get out of bed easier and walks outside a few times a week when the pain isn't severe.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint stiffness, Magnetic resonance imaging
Clinical narrative: My left arm hurt a great deal all the time for 2 weeks after getting the vaccine on Jan. 15, 2019, with stiffness beginning in my both my arms. I woke up around the date of  Jan. 25, 2019 and could not left myself up from my bed because my arms were too weak and I couldn't lift them up. I had to roll out of bed and crawl to a chest of drawers to pull myself up using the knobs.   Along with that, my hips and legs became stiff and painful. By Jan. 31 and shortly before that date, I had trouble walking and could only take small steps. After taking Prednisone 10mg  starting May 13, 2019 I felt as I could finally walk and move well.  On this date of 9-13-19 I still feel a lot of pain in my arms and legs and the pain comes and goes.  A rheumatologist confirmed  on July 29, 2019 that I have Polymyalgia. I've tapered off to 7 mg a day of Prednisone but still feel the symptoms, although I can get out of bed easier and walks outside a few times a week when the pain isn't severe.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal stiffness, Myalgia, Nerve conduction studies, Pain in extremity
Clinical narrative: My left arm hurt a great deal all the time for 2 weeks after getting the vaccine on Jan. 15, 2019, with stiffness beginning in my both my arms. I woke up around the date of  Jan. 25, 2019 and could not left myself up from my bed because my arms were too weak and I couldn't lift them up. I had to roll out of bed and crawl to a chest of drawers to pull myself up using the knobs.   Along with that, my hips and legs became stiff and painful. By Jan. 31 and shortly before that date, I had trouble walking and could only take small steps. After taking Prednisone 10mg  starting May 13, 2019 I felt as I could finally walk and move well.  On this date of 9-13-19 I still feel a lot of pain in my arms and legs and the pain comes and goes.  A rheumatologist confirmed  on July 29, 2019 that I have Polymyalgia. I've tapered off to 7 mg a day of Prednisone but still feel the symptoms, although I can get out of bed easier and walks outside a few times a week when the pain isn't severe.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Client complained of achiness, malaise, headache that started that night and went into the next day. Client complained of a fever of 101 that lasted approximately 5 hours; unrelieved by Tylenol. Client had a golf ball sized swollen lymph found on 9/12/19 by client; was resolving on 9/13/19 at 8:45 am when examined by M.D. and nurse (myself), no longer visible, just slightly swollen and tender to the touch.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Tenderness
Clinical narrative: Client complained of achiness, malaise, headache that started that night and went into the next day. Client complained of a fever of 101 that lasted approximately 5 hours; unrelieved by Tylenol. Client had a golf ball sized swollen lymph found on 9/12/19 by client; was resolving on 9/13/19 at 8:45 am when examined by M.D. and nurse (myself), no longer visible, just slightly swollen and tender to the touch.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash
Clinical narrative: pt came in with rash at injection site reaction
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Pt reported "sore, red, warm, puffed out" area 2.5in x 4in "moving down on inside of arm."
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site mass, Lethargy, Pain in extremity, Urticaria
Clinical narrative: Patient received the vaccine on 9/7/19 and started getting chills that evening.  The next morning the patient noticed painful welts on arms and a lump around the injection site.  Patient has been lathargic the following the 5 days.  The pharmacy left a message with the patient physician to make them aware of the fact that patient and the physician followed up with the patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Beginning the evening of the vaccine, she developed a small erythematous wheal. This has progressed over the intervening 2 days to encompass a large area, ~10cm in length, 6cm in width around the area of injection. it is hot, and tender. Skin is mildly edematous.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time, Angiogram, Balance disorder, Blood calcium, Blood creatine phosphokinase
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase MB, Blood culture, Blood glucose, Blood magnesium, Blood phosphorus
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone, Cardiac function test, Chest X-ray, Computerised tomogram head, Diarrhoea
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Differential white blood cell count, Disorientation, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fibrin D dimer, Full blood count, Glycosylated haemoglobin, Heart rate increased, Lipids
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging brain, Metabolic function test, Pain, Pain in extremity, Prothrombin time
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Scan with contrast, Speech disorder, Swallow study, Troponin
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: I had a sore arm and body aches and a mild fever and mild diarrhea from 8/7/19 to 8/8/19  On the evening of 8/13/19 I felt extremely tired, so went to bed around 9 pm. I woke up in the middle of the night to go to the bathroom but was unsteady. Went back to sleep and woke up late around 7:40 am, and was disoriented. My wife tells me I shaved with toothpaste, and when I spoke it was gibberish. She took me to a minor emergency place where they started doing tests. Was there from 10:30 am to around 4 pm. then was transferred to hospital for further evaluation and more tests.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Malaise, Pain in extremity, Rash, Urticaria
Clinical narrative: Pateint States extreme overall body malaise and fatigue as well as pain in upper right extremity. Injection site was right deltoid. There is also presence of an approximately six inches in diameter welt/rash in area just distal and medial to the injection site in the deltoid.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Myalgia
Clinical narrative: pt came in today with a 1 inch by 1/2inch yellowing-bruise on her arm - she said it was there the next day after her flu shot- arm doesn't hurt to move - muscle hurts a little
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain, Rash, Urticaria
Clinical narrative: Pateint presented with an approximately 4 to 6 inch in diameter rash/welt in upper left extremity. It was distal and medial to the injection site in the left deltoid. She also stated the area to be more painful than expected.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Chills, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: chills, fever (101.8), muscle cramps, shivering, headache, body aches
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of product administration, Swelling, Tenderness
Clinical narrative: Intramuscular formulation administered by other route; Tenderness; Redness; Swelling; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 4th July 2019, 30 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tenderness, erythema and swelling. On 3rd September 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the tenderness, erythema and swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the tenderness, erythema and swelling to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. Approximately 30 minutes after the injection, the patient experienced tenderness, redness, and swelling. After 36 hours, the symptoms resolved. The patient received 2nd dose of Shingrix, was not administered intramuscularly because she didn't even feel the vaccine going into her muscle, which led to inappropriate route of vaccine administration. The patient experienced no local site reaction at all. The reporter consented to follow up. The reporter could follow-up with the patient directly.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site; Swelling at injection site; Joint pain; Body aches; Upset stomach; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, 10 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years. The patient experienced pain at injection site, swelling at injection site, joint pain, body aches, upset stomach, fatigue and headache about 10 hours after the dose. The reporter asked to remain anonymous and did not provide demographics. This case has been linked with US2019161261, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Pain at injection site; Swelling at injection site; Joint pain; Body aches; Upset stomach; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, 10 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, joint pain, general body pain, upset stomach, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years. The patient experienced pain at injection site, swelling at injection site, joint pain, body aches, upset stomach, fatigue and headache about 10 hours after the dose. The reporter asked to remain anonymous and did not provide demographics. This case has been linked with US2019161261, reported by same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 353S5, expiry date 31st May 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 1st April 2019).   On 24th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 1 day after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vesicular rash was recovering/resolving.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient had a generalized vesicular rash that started 24 to 48 hours after the Shingrix vaccination.  The patient was improving and was being treated with antiviral medications. The reporter consented to follow up and provided contact details.