chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunology test normal, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Malaise, Nerve injury
Clinical narrative: Day after vaccine, had 3 minutes of severe vertigo,  and for several hours felt like I had a virus. Within a few weeks I often felt very ill, as if I had a virus. But symptoms would come and go. By May 2018 I had developed tingling in all extremeties and head, and continued to feel very ill often. After many tests and several doctors (primary care, a new primary care, vascular, neurology (2 different neurologists), provider at Neurology diagnosed me July 17, 2019 after reviewing all MRIs, blood work, et al. His diagnosis is that my symptoms are caused by the Shingrix vaccine, that the nerve damage creating the tingling sensations are not permanent but will take another 18-24 months to clear. I have now gone 85 days without feeling ill as if I have a virus. The tingling is constant, but has reduced since May of 2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Toxicologic test normal, Ultrasound scan normal, Vaccination complication, Vertigo
Clinical narrative: Day after vaccine, had 3 minutes of severe vertigo,  and for several hours felt like I had a virus. Within a few weeks I often felt very ill, as if I had a virus. But symptoms would come and go. By May 2018 I had developed tingling in all extremeties and head, and continued to feel very ill often. After many tests and several doctors (primary care, a new primary care, vascular, neurology (2 different neurologists), provider at Neurology diagnosed me July 17, 2019 after reviewing all MRIs, blood work, et al. His diagnosis is that my symptoms are caused by the Shingrix vaccine, that the nerve damage creating the tingling sensations are not permanent but will take another 18-24 months to clear. I have now gone 85 days without feeling ill as if I have a virus. The tingling is constant, but has reduced since May of 2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitamin B12 normal
Clinical narrative: Day after vaccine, had 3 minutes of severe vertigo,  and for several hours felt like I had a virus. Within a few weeks I often felt very ill, as if I had a virus. But symptoms would come and go. By May 2018 I had developed tingling in all extremeties and head, and continued to feel very ill often. After many tests and several doctors (primary care, a new primary care, vascular, neurology (2 different neurologists), provider at Neurology diagnosed me July 17, 2019 after reviewing all MRIs, blood work, et al. His diagnosis is that my symptoms are caused by the Shingrix vaccine, that the nerve damage creating the tingling sensations are not permanent but will take another 18-24 months to clear. I have now gone 85 days without feeling ill as if I have a virus. The tingling is constant, but has reduced since May of 2018.
Age: 15.0
Sex: F
Vaccine: MMR, MNQ, TDAP, VARCEL, MMR, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient presented to the health department to get updated immunizations for school.  The nurse that she saw was RN at Health Department.  The nurse did not do the screening checklist for contraindications to vaccines, which resulted in not asking if the patient was pregnant.  The patient was actually 16 weeks pregnant with a due date of 02/11/2020.  On 08/23/2019, the patient was counseled and advised to see her OB/GYN as soon as possible.  She was instructed to take of copy of the vaccines that were given to her doctor
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Migraine, Mobility decreased
Clinical narrative: Patient reports extreme fatigue upon waking day after injection; states she couldn't get out of bed until 4pm; Also, she reports a migraine headache, and she emphasized it was not a 'regular' headache (tension).
Age: 1.08
Sex: M
Vaccine: HEPA, HPV9, MMR, VARCEL
Symptoms: Pyrexia, Respiratory symptom, Wrong product administered
Clinical narrative: HPV was given in error instead of Prevnar vaccine. Mom states child has had fever and upper respiratory symptoms since 2 days after vaccination.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Facial paralysis, Muscle twitching, Partial seizures
Clinical narrative: Pt. reported by mother to have had a focal seizure, (R) side of face, 1 hour after receiving Tdap shot. Reported that pt had another focal seizure approx. 24 hrs later. (R) side of face with twitching and drooping with second seizure. Fully recovered without further seizure activity since.  Mom spoke with pt's Neurologist who suggested to her that seizure activity could have been triggered by vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Mobility decreased, Pain in extremity, Vomiting
Clinical narrative: arm pain(on a (1-10) pain  scale I give it a 9)  , shivering, fever, chills, severe vomiting, was in bed for 4 days.  Missed three days of work.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness transient, Corrective lens user
Clinical narrative: Loss of vision/crystal vision--needed to wear special glasses for 2 weeks until vision was restored to normal
Age: 77.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Breast pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: In less than an hour after injections, got sudden chills, severe headache, muscle ache, nausea. Tried to relieve headache with cold compresses and Alleve.  Finally took codeine after 6 hours and got relief.   Headache and body aches continued in the morning, relieved with Alleve but right breast continued to be exceptionally sore and rashed.  This breast had radiation in 2015. The initial questionnaire asked if I had undergone radiation.  Is this an adverse effect?  Why is the question on the sheet?
Age: 77.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Rash
Clinical narrative: In less than an hour after injections, got sudden chills, severe headache, muscle ache, nausea. Tried to relieve headache with cold compresses and Alleve.  Finally took codeine after 6 hours and got relief.   Headache and body aches continued in the morning, relieved with Alleve but right breast continued to be exceptionally sore and rashed.  This breast had radiation in 2015. The initial questionnaire asked if I had undergone radiation.  Is this an adverse effect?  Why is the question on the sheet?
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RED, HOT SWOLLEN AREA OF INJECTION FOR A FEW DAYS.  AFTER 6 DAYS SHE TOOK BENADRYL AND FELT BETTER. NEXT DAY WOKE UP AREA SWOLLEN HOT AND PURPLE. WENT TO DOCTOR AND THEY SAID IT WAS CELLUTIS AND THEY PUT HER ON AN ORAL ANTIBIOTIC, CEPHALEXIN.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient work up the morning after receiving the vaccine (morning of 8/23/19) with redness and swelling in his Right Arm about 5 cm in diameter around the vaccine site. The area was firm and hot to the touch and painful upon palpating. We administered Benadryl, to no noticeable effect. By the morning of 8/24, the affected area had spread to about 11 cm  (at this point, we outlined the affected area in order to monitor its progress), the area was still firm and hot to the touch and painful upon palpating. By the afternoon of 8/25/2019 the area had spread to about 14 cm with the same presentation. Patient was able to perform normal day-to-day activities with no impairment and showed no signs of fever of other adverse reaction. The area was treated with ice (8/23 & 8/24) and then gentle heat (8/25 through present). As of the morning of 8/26/2019 the area is showing some improvement, most noticeable around the perimeter. The initial affected area is still hot to the touch, but pain upon palpating is decreased and the skin is not as tight.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: PT CAME IN WITH PARENT, IMMUNIZATION RECORD CHECKED AND SHOWED PT WAS DUE FOR 12 YEAR VACCINATIONS (TDAP AND MCV4), PT'S MOM NOW HAS CHILDREN BACK AND REPORTS PT HAD GOTTEN THE SAME IMMUNIZATIONS PREVIOUSLY AT ANOTHER CLINIC AND THEY HAD NOT UPDATED
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu like symptoms with fever and chills for two days plus large area of pain swelling and redness 3X5 inches at injection site for 4 days
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms with fever and chills for two days plus large area of pain swelling and redness 3X5 inches at injection site for 4 days
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: hingles  vaccine was on Friday 8/23. Patient reported about 3 hours after the vaccine he  began to have muscle and joint pain, 103 fever and a pounding headache. Patient  reports the symptoms have disappeared since last night 8/25.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Constant electric skin pulses throughout all of my body. On certain days, more than others days. Did not realized it was the vaccine until August 4-6, 2019. Vent to my Internist on 8/7/2019. Went to Neurologist on 8/8/2019. Will have EMG on 9/11/209 (upper Body) and 9/19/2019 (Lower Body) Results for EMG on 9/23/2019.
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Complications of transplanted heart, Coordination abnormal, Grip strength decreased, Hypoaesthesia
Clinical narrative: she had a stroke; Cardiac Allograft Vasculopathy; Cardiac Allograft Vasculopathy; Hand tremors; lack of coordination; could not grab things; numbness in the hands and head; This is a spontaneous report from contactable pharmacist via Pfizer sales representative. A 71-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in May2019 at single dose for immunization.  Medical history included open heart surgery and CV (Cardiovascular) history.  The patient's concomitant medications were not reported.  The patient experienced hand tremors, lack of coordination, could not grab things, numbness in the hands and head, she also mentioned that she had a stroke (CVA (Cardiac Allograft Vasculopathy)) after four weeks of the administration of pneumococcal 13-val conj vac (dipht crm197 protein), all in 2019 and with outcome of unknown.; Sender's Comments: Stroke manifested as tremors,  lack of coordination,  could not grab things,  numbness in the hands and head represents an coincidental occurrence; Cardiac allograft vasculopathy is attributable to the underlying cardiac conditions, both of which are not related to the vaccination with PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: she had a stroke; Cardiac Allograft Vasculopathy; Cardiac Allograft Vasculopathy; Hand tremors; lack of coordination; could not grab things; numbness in the hands and head; This is a spontaneous report from contactable pharmacist via Pfizer sales representative. A 71-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in May2019 at single dose for immunization.  Medical history included open heart surgery and CV (Cardiovascular) history.  The patient's concomitant medications were not reported.  The patient experienced hand tremors, lack of coordination, could not grab things, numbness in the hands and head, she also mentioned that she had a stroke (CVA (Cardiac Allograft Vasculopathy)) after four weeks of the administration of pneumococcal 13-val conj vac (dipht crm197 protein), all in 2019 and with outcome of unknown.; Sender's Comments: Stroke manifested as tremors,  lack of coordination,  could not grab things,  numbness in the hands and head represents an coincidental occurrence; Cardiac allograft vasculopathy is attributable to the underlying cardiac conditions, both of which are not related to the vaccination with PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects; Improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician refers to a patient of unknown age and gender. Patient's medical history, concomitant therapies and concurrent conditions were not reported. On 14-AUG-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, frequency were not reported) (lot # R027063 and expiry date 20-SEP-2020) via subcutaneous route for prophylaxis (Product storage error). The vaccine experienced a temperature excursion at 70 Fahrenheit (F) with a time frame of 4 days. There was no previous temperature excursion. It was reported that this call was due to a data logger. No adverse effects were reported  Furthermore, no product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; A patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 22-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R004439 with an expiration date on 12-AUG-2019, for prophylaxis (dose, route of administration, and anatomical location were not reported). No known adverse effects were experienced by the patient.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: redness; pain; swelling; discoloring of the injection site; skin with raised red bubbles that look shingles; itchy; developed a little area of itchy red raised blisters; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient stated that the arm blew up and was red and swollen for day. The patient also developed a little area of itchy red raised blisters near the vaccination site. The patient asked could the reaction be shingles. The patient was not a healthcare professional. The patient had pain, redness and swelling and discoloring of the injection site for over 2 weeks. The patient also had a patch of skin with raised red bubbles that look like pictures of seen of shingles. The patch of skin was near injection site. The patient concern was could have developed Shingles from the vaccine. The reporter was not able to provide the answer and recommended to speak with healthcare provider regarding shingles.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: redness; pain; swelling; discoloring of the injection site; skin with raised red bubbles that look shingles; itchy; developed a little area of itchy red raised blisters; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient stated that the arm blew up and was red and swollen for day. The patient also developed a little area of itchy red raised blisters near the vaccination site. The patient asked could the reaction be shingles. The patient was not a healthcare professional. The patient had pain, redness and swelling and discoloring of the injection site for over 2 weeks. The patient also had a patch of skin with raised red bubbles that look like pictures of seen of shingles. The patch of skin was near injection site. The patient concern was could have developed Shingles from the vaccine. The reporter was not able to provide the answer and recommended to speak with healthcare provider regarding shingles.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pruritus
Clinical narrative: itching / itching all over her body; pain left scapula; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included major depression.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced generalized pruritus and scapula pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus and scapula pain were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and scapula pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient never had chickenpox (off label use) but received Shingrix. The patient stated that since getting the vaccine, she had developed itching all over her body and pain in the left scapula. The patient stated that she started taking Benadryl for the itching and it helped some. The patient did not provide any additional details. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: body aches; swelling; elevated heart rate; elevated blood pressure; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan and rosuvastatin calcium (Crestor).   On 12th August 2019, the patient received the 1st dose of Shingrix .5 ml. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, heart rate increased and increased blood pressure. On an unknown date, the outcome of the injection site pain and injection site swelling were resolved with sequelae and the outcome of the heart rate increased and increased blood pressure were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, heart rate increased and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all of the most common symptoms. The patient had pain, swelling and tenderness at the injection site. The patient's blood pressure and heart rate also elevated.
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had 1 dose 3 years ago and never received a 2nd dose; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 14Aug2019, this case now contains all required information to be considered valid.   This is a follow-up spontaneous report from a Pfizer-sponsored program (Call Center for HCPs). A contactable pharmacist reported that a 20-year old male patient received as immunization the first dose of meningococcal group b rlp2086 (TRUMENBA) at single dose, on an unspecified date (3 years before this report) but never received a 2nd dose.   The information on the lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Sick relative
Clinical narrative: Sick; received her first TRUMENBA dose in Jun2018; she did not come back for her second dose; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration in Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The healthcare professional asked if they need to restart the two-dose series. The patient received her first meningococcal group b rlp2086 dose in Jun2018. She did not come back for her second dose, which was due in Dec2018. The patient is in the office for sick visit on 20Aug2019. Outcome of the event sick was unknown.   Information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: flu-like symptoms; pain at injection site; This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms and pain at injection site on an unspecified date. The outcome of the events were unknown.
Sex: U
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: had numbness/tingling on feet and legs; had numbness/tingling on feet and legs; nerve pain by neck; headache; This is a spontaneous report from a contactable physician.    A 19-years-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient on an unknown date  had numbness/tingling on feet and legs  with outcome of unknown , had nerve pain by neck  on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown. The reported events were considered non serious.   The information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was given Prevnar 13 and got Guillain-Barre syndrome; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given pneumococcal 13-val conj vac (dipht crm197 protein) and got guillain-barre syndrome on an unspecified date with outcome of unknown.; Sender's Comments: There is no plausible mechanism to establish a causal relationship between the occurrence of the event "guillain-barre syndrome" and the administration of the suspect vaccine in the individual case.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Injection site bruising, Injection site pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: The injection site on left arm was too high.  It was not 3 fingers below the shoulder.  The patient felt pain during the injection, which she thought was unusual.  Next, on night of injection and night of day 2 of injection, she experienced high fever (102 F).  There was redness on the arm, and she bruising at injection site.  She discussed experience with MD office when she was getting a routine vit b 12 shot, and the staff informed her that injection site was too high.  She reported the error to pharmacy on 8/26.  The pharmacist apologized for the error and advised the patient to monitor for shoulder pain, that is common with this type of error.  On 8/26, the bruise was still evident, redness/swelling in deltoid area was not present, shoulder pain was not evident, and patient was able to rotate shoulder as usual.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Fever, chills, nausea, tiredness, pain and redness at injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, tiredness, pain and redness at injection site
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Sore arm at injection site, low grade fever (100.5), body aches, nausea, headache, vomit 1x. Used Tylenol and Advil. Most severe first night,  starting about 6 hours post vaccination and continuing through night into the next morning/afternoon. I was able to resume activities 27 hours post vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Sore arm at injection site, low grade fever (100.5), body aches, nausea, headache, vomit 1x. Used Tylenol and Advil. Most severe first night,  starting about 6 hours post vaccination and continuing through night into the next morning/afternoon. I was able to resume activities 27 hours post vaccine.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient received pediatric dose of Hep A and should have received adult dose of Hep A
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Swelling of the Lips, applied aquaphor was tolerated and continued for 1 month.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: Blinding headache, nausea, disorientation, dizzy, fatigue, minor arm pain. This lasted for 24 hours. Couldn't move, tried to sleep, but too much head pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Blinding headache, nausea, disorientation, dizzy, fatigue, minor arm pain. This lasted for 24 hours. Couldn't move, tried to sleep, but too much head pain.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head, Eye pain, Headache, Vomiting
Clinical narrative: Patient developed a headache and vomiting after his basketball camp the day after his Gardasil was received. He developed severe pain in his right eye
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Syncope, Vomiting
Clinical narrative: Patient was laying on exam table approximately 5 minutes after HPV 9 injection reported feeling like fainting, very weak. Brother of patient came out of room calling for help. Per mother of child patient fainted few seconds. In the presence of nurse and medical assistants patient conscious reported feeling very lightheaded. Patient vomited clear content.  Patient was keep on supine position, BP not detectable at first check. As patient tolerated was prompt to sitting position, drank water and given crackers. BP detectable 90/50. Patient monitored for the following 15 minutes until stable to leave.  Patient  accompanied by mother and 2 brothers at all time. Left clinic walking to commute home by private vehicle.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Swelling of the lips., unknown treatment, etc
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Nausea, Vaccination complication
Clinical narrative: The patient is a 66 year old female who presents with a complaint of adverse reaction to Shingrix. Recieved first dose of shingrix on Friday morning (3 days ago) and has experienced a headache, nausea, and a large area of erythema around the injection site and progressing to the inner part of the upper arm that is itching.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Injection site pain, Limb discomfort
Clinical narrative: Pt stated that during injection it felt as if the needle was moved/wiggled while in arm and painful.  A "burning" sensation traveled into her forearm area.  She was provided with ice which provided some relief. She was not light headed or dizzy.  Her arm was still uncomfortable when she left the pharmacy approximately 20 minutes after injection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Depressed level of consciousness, Loss of consciousness, Nausea
Clinical narrative: Menactra given. Patient waited 10 minutes after immunization.  Patient was observed walking to chair and sat for another minute. Patient stated she felt fine. Patient walked to exit with mother and was waiting at checkout. Patient stated she suddenly felt nauseous and then told mother she felt like she was going to pass out. Mother supported patient and lowered her to floor. Mother stated patient lost consciousness for 2-3 seconds. Patient checked by Dr. BP 100/58. Patient taken back to room via Wheelchair  and rested on table for 10 minutes. Patient then sat up and rested for 10 more minutes. Patient stated she felt like this several times in past with kidney stones but did not lose consciousness. Patient drank water, stated she may have been dehydrated. After standing and walking a few minutes, patient felt fine and walked to car with mother.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness
Clinical narrative: Patient stated he was dizzy about 5 minutes after injection. He then had mild confusion that lasted approximately 20 minutes.
Age: 56.0
Sex: M
Vaccine: DTAP, FLUC4
Symptoms: Headache, Joint swelling, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Low grade fever, swollen shooulder, swollen wrist and hands, headache, neckache arm pain
Age: 56.0
Sex: M
Vaccine: DTAP, FLUC4
Symptoms: Pyrexia, Swelling
Clinical narrative: Low grade fever, swollen shooulder, swollen wrist and hands, headache, neckache arm pain
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Gait disturbance
Clinical narrative: Flu-like symptom beginning 48 hours after injection and lasting 10 days.  Fever, chills, body aches, lethargy, loss of appetite, diarrhea, loss of strength.  Initially unable to sit up in bed without assistance.  Walking un-steady for 2 days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Flu-like symptom beginning 48 hours after injection and lasting 10 days.  Fever, chills, body aches, lethargy, loss of appetite, diarrhea, loss of strength.  Initially unable to sit up in bed without assistance.  Walking un-steady for 2 days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu-like symptom beginning 48 hours after injection and lasting 10 days.  Fever, chills, body aches, lethargy, loss of appetite, diarrhea, loss of strength.  Initially unable to sit up in bed without assistance.  Walking un-steady for 2 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Impaired work ability, Induration
Clinical narrative: My are is sore, has a red circle about 3.5 inches around and is hard and hot to the touch.  I have a fever, chills, body aches, headache and nausea. It has been almost 48 hours since my vaccination and i am unable to work or perform my normal routine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: My are is sore, has a red circle about 3.5 inches around and is hard and hot to the touch.  I have a fever, chills, body aches, headache and nausea. It has been almost 48 hours since my vaccination and i am unable to work or perform my normal routine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: My are is sore, has a red circle about 3.5 inches around and is hard and hot to the touch.  I have a fever, chills, body aches, headache and nausea. It has been almost 48 hours since my vaccination and i am unable to work or perform my normal routine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Patient presented to pharmacy on 8-26-19.  Her right arm was swollen.  Redness at the site of injection that was warm and hot to the touch.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient experienced pain in upper arm, back shoulder and neck areas.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Urticaria
Clinical narrative: Within 2 hours of receiving the vaccine patient described diffuse itching and broke out in hives on her face, neck, and arms.  She continued to have diffuse itching, and rash and was evaluated in the clinic today, August 26 where she had ongoing outbreaks of pruritic lesions on arms, legs, neck, hair line and waistline despite using Benadryl every 4 hours I put her on a prednisone taper starting August 26 and she will use some topical triamcinolone
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects; improperly stored MMR II was administered; This spontaneous report has been received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 14-AUG-2019 the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant human albumin (rHA)) (M-M-R II), for prophylaxis, subcutaneously (strength, dose, dose number, frequency and anatomical site of vaccination were not reported; lot number R027063 and expiration date on 20-SEP-2020)  The doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to a temperature excursion of above of  70 degress Fahrenheit (°F) for a timeframe of 4 days, which was recorded by a digital data logger. There was not a previous temperature excursions. In addition, no adverse effects or product quality complaints were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Death, Pyrexia
Clinical narrative: The patient developed a fever, was hospitalized at an unspecified hospital for an unspecified length of time; The patient "eventually died" on an unspecified date several years ago. Cause of death: unknown; This spontaneous report was received from the pharmacist via a company representative, referring to a 16-year-old female patient. The patient's current conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date (reported as "several years ago"), the patient received unidentified Merck hpv vaccine administered (name and lot for prophylaxis (dose, strength, lot# and expiration date were not reported) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, strength, lot# and expiration date were not reported). The patient was vaccinated at the clinic of an unspecified physician, not at a pharmacy.   On an unspecified date (reported as "several years ago"), the patient developed a fever, was hospitalized at an unspecified hospital for an unspecified length of time and received an unknown type of treatment. On an unknown date, the patient eventually died from an unknown cause. It was unknown if an autopsy was performed.   At the time of this report, the causality assessment between the unidentified Merck hpv vaccine administered (name and lot number not provided) and the events, were not reported. The reporter considered the event of fever to be life threatening.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Immediate post-injection reaction, Ophthalmic herpes zoster
Clinical narrative: shingles in eye; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Right after the patient got the Shingrix vaccine, she got shingles in her eye a year and a half ago and she was still struggling with it and now the patient requires cataract surgery. The reporter did not consent to follow-up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Pt presented to office with generalized flat rash to trunk and back 7 days after receiving Bexsero. She has not had fever, this was her first dose, she is current on all other vaccinations and has had no prior reactions. She reports the rash really does not itch or hurt. No soa, no wheezing, no tongue swelling.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Pyrexia, Urticaria, Visual impairment
Clinical narrative: Patient developed a fever the evening of 8/20. Fever spiked at 100 degrees. Overnight she developed widespread hives and took benadryl 50mg at 4 AM on 8/21 and at 7:30 AM on 8/21. Patient reported the reaction to the pharmacy on 8/21 and pharmacy contacted Dr. office. Office advised patient to continue benadryl 50mg every 4 to 6 hours and contact office if not improving or getting worse. Pharmacist advised this information to patient and was going to give patient a follow-up call on 8/22. Patient arrived at pharmacy early on 8/22 with prescriptons from ER for EpiPen 0.3mg and Prednisone 60mg  daily for 5 days. Patient reported that on the evening of 8/21 she was having difficulty walking, visual disturbances, and spreading of hives to feet & face. She had a friend accompany her to the ER where she was treated and released. Patient was given instruction from ER to follow up with Dr. Patient filled rx for prednisone and declined rx for epipen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Influenza, Lethargy, Pain
Clinical narrative: Per pt, experienced symptoms of the flu (tiredness, fever, pain, lethargy, chills)
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Per pt, experienced symptoms of the flu (tiredness, fever, pain, lethargy, chills)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Nausea, Pain, Rash
Clinical narrative: Blistering erythematous rash on trunk along the T4 dermatome, symptoms of fatigue, nausea, and aches. Prescribed Valtrex for seven days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Blistering erythematous rash on trunk along the T4 dermatome, symptoms of fatigue, nausea, and aches. Prescribed Valtrex for seven days.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Immunisation, Underdose
Clinical narrative: Pediatric dose of vaccine was accidentally given to patient instead of adult dose. An additional dose of pediatric dose was given in order to equal the adult dose.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever of 101.8 at highest for 36 hours, head pain, eye sensitivity, severe muscle joint pain, severe chills, fatigue, appetite loss. Worse symptom was profuse and urgent bouts of  urination every 30-60 minutes for about 24 hours straight . I also had bad heart palpitations for about 24 hours.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Micturition urgency, Myalgia, Palpitations, Photophobia, Pyrexia
Clinical narrative: Fever of 101.8 at highest for 36 hours, head pain, eye sensitivity, severe muscle joint pain, severe chills, fatigue, appetite loss. Worse symptom was profuse and urgent bouts of  urination every 30-60 minutes for about 24 hours straight . I also had bad heart palpitations for about 24 hours.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: localized rash on upper left arm, approximately 5 inches in diameter. recommended diphenhydramine for rash and acetaminophen if needed for pain/fever
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Nausea
Clinical narrative: First injection of Shingrix just had sore muscle for about a week.  Second injection about ten hours late became fatigued, slightly nausous, chills, fever and joint aches and pains.  Felt like flu symptoms.  Day 2 had the same side effects.  Took day off work.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First injection of Shingrix just had sore muscle for about a week.  Second injection about ten hours late became fatigued, slightly nausous, chills, fever and joint aches and pains.  Felt like flu symptoms.  Day 2 had the same side effects.  Took day off work.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Muscular weakness
Clinical narrative: patient states her arm has felt "tired" since 2 days post injection
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Albumin CSF decreased, Antibody test negative, Antibody test positive, Antinuclear antibody
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Antinuclear antibody positive, Antiribosomal P antibody, Aspartate aminotransferase normal, Basophil count decreased
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Basophil percentage decreased, Blood HIV RNA below assay limit, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium decreased, Blood chloride increased, Blood creatinine normal, Blood glucose decreased, Blood immunoglobulin G decreased
Clinical narrative: 5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.