chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pain
Clinical narrative: diarrhea; flu like symptoms; soreness; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 20th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th June 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On 21st June 2019, the patient experienced diarrhea. On an unknown date, the outcome of the influenza-like symptoms, pain and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The day before reporting day, the patient received her 2nd dose of Shingrix.  The patient stated that she started experiencing all the side effects on the same day except diarrhea. The reporter mentioned flu like symptoms and soreness specifically. There is a discrepancy with respect to the outcome of events flu like symptoms and soreness. In source document it was reported as recovering/resolving and the narrative stated the events were not recovered. The outcome captured as per narrative information. Also the vaccination date was reported in source document as 1st July 2019 (future date) but in the narrative it was 20th June 2019. The vaccination date captured as per narrative. As per narrative it seems that patient also experienced diarrhoea which was not specifically reported. We have raised query for the same however we have capture diarrhoea event in the case conservatively since no reply received from the reporting team.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Injection site pain
Clinical narrative: no energy; soreness at injection site; joint pain; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced loss of energy, injection site pain and joint pain. On an unknown date, the outcome of the loss of energy, injection site pain and joint pain were recovered/resolved.   It was unknown if the reporter considered the loss of energy, injection site pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The patient experinced side effects to the Shingrix vaccine. Consent to follow up was requested.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pruritus, Product administered at inappropriate site
Clinical narrative: at the injection site, she has a giant lump which is growing; keeps getting bigger and itching; way lower than the deltoid, not in the muscle, but closer to her elbow, specifically a few inches above her elbox; This is a spontaneous report from a contactable consumer who reported for herself, a 57-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration 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. At the injection site, she has a giant lump which was growing. Upon further discussion, it started this morning and kept getting bigger and itching. She said the injection was given a week ago and given "way lower than the deltoid, not in the muscle, but closer to her elbow, specifically a few inches above her elbox." Her kids who were pharmacists pointed it out to her that the injection site was "very low" on the arm. It was given at a store, not at the doctor's office. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Deafness, Meningitis, Pyrexia
Clinical narrative: Meningitis; drug ineffective; High fever; Total hearing loss; This is a spontaneous report from a Pfizer sponsored program Prevnar 13. A Contactable Pediatric Nurse reported the niece.  A 15-18 month old female patient of an unspecified age received 2 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for pneumococcal immunisation, not prescribed by the reporting nurse.  The patient medical history and concomitant medications were not reported.  The patient only had 2 doses of PREVNAR and she was in daycare; at age 15-18 months she got high fever and was taken to hospital and was in hospital for a length of time (1 or 2 weeks). She was diagnosed in hospital with meningitis and then later (2-3 months) 2-1 months with total hearing loss that was linked to the meningitis and high fever. The outcome of the events was unknown.  The reporting nurse was actually not sure if PREVNAR was 7 or 13.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Body ache; Had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across; Had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across; Nausea; Fatigues; This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number: AL8468, expiration date: 01Feb2021), via an unspecified route of administration on 18Jun2019 at a single dose for vaccination purposes. Medical history included ADHD. Concomitant medication included methylphenidate hydrochloride (CONCERTA 27 mg tablet) for ADHD. On 19Jun2019, the patient had nausea, body ache and fatigues and then he had redness and swelling at injection site and it wasn't smaller area it was probably a good 15 cm down the arm. The redness on the area was about 15 cm elongated 8 cm across. Nausea, body ache and fatigues started first and by the evening he had the redness and swelling. The physician asked if the should ahead for the second dose or not. Treatment for the events included ibuprofen and Benadryl. The events recovered on an unspecified date.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender receive pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) , 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 reported soreness in the arm for two days. The pharmacist stated that this is a typical occurrence and the pharmacist sees a lot of patients.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Pain
Clinical narrative: Pain; Fatigue; Redness at injection site with Trumenba use.; This is a spontaneous report from a contactable physician via a sales representative.  A patient of unknown age and gender received a single dose of meningococcal group b rlp2086 (TRUMENBA) on an unknown date for immunization. Medical history and concomitant medications were not reported. The patient experienced pain, fatigue and redness at injection site on an unknown date. Patient had fatigue for a few days and was now OK. Outcome of pain and redness at injection site was unknown.
Age: 9.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Adacel at the age of 9; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine years old patient (gender not reported) who was vaccinated with a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number, Exp. Date, dose, route and site of administration not reported on an unknown date.  The patient's past vaccination(s) included MENINGOCOCCAL VACCINE received at age of 2 years, 5 years and 8 years and DAPTACEL for immunization. Concomitant medications not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Cough, Ear infection, Haemoglobin increased, Neutrophil count decreased, Rhinorrhoea
Clinical narrative: 1/29/18: runny nose, occasional cough vomiting: 1x; has been 3 times  per month, past 3 months CBC: WBC 3.9, Hgb 165, ANC: 1300; ear infection. All symptoms fully resolved. Normal CBC 2/12/18
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: 1/29/18: runny nose, occasional cough vomiting: 1x; has been 3 times  per month, past 3 months CBC: WBC 3.9, Hgb 165, ANC: 1300; ear infection. All symptoms fully resolved. Normal CBC 2/12/18
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: Fever of 103, lethargic, went to urgent care, was sent to the hospital to monitor fever. Was sick for 2 weeks. Received another flu vaccine on 1/10/2013 and similar reaction occurred. Nothing was done by medical staff, other than monitoring.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Patient received the Shingrix vaccine into the left deltoid at approximately 10:30am, after 30 minutes the vaccination site got hot and red and started to spread to a maximum of 5 1/2" in diameter.  The patient who is also recovering from a hip replacement was put on Doxycycline hyclate 100mg BID for 7 days as a preventative measure to ensure she wasn't at risk for a systemic infection as a result of a possible cellulitis infection. The doxycycline was only taken for a total of 2 days as the patient has experienced severe reflux from the antibiotic and has discontinued the antibiotic and will follow up with her provider in a few days.  After taking Doxycycline for a few days the swelling and redness has gone down and the patient has been advised to continue using Benadryl cream and/or hydrocortisone cream with Aveeno w/ colloidal oatmeal to help with itching.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Her arm became painful, red and swollen.  The next day she went swimming a developed a hive rash to her entire upper torso that lasted for a few hours.  She does have a history of developing hives when swimming but mom states it was much worse post her injection. Her pain lasted several days and still has a small lump at the injection site.  The injection site is no longer tender to the touch.  There is also a band-aid "tattoo" at the site of where the bandaid was placed.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin reaction, Urticaria
Clinical narrative: Her arm became painful, red and swollen.  The next day she went swimming a developed a hive rash to her entire upper torso that lasted for a few hours.  She does have a history of developing hives when swimming but mom states it was much worse post her injection. Her pain lasted several days and still has a small lump at the injection site.  The injection site is no longer tender to the touch.  There is also a band-aid "tattoo" at the site of where the bandaid was placed.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: NOT A LISTED ADVERSE EVENT BUT PATIENT GOT THE SHINGLES APPROXIMATELY 1 MONTH INTO GETTING THE VACCINE. PATIENT WAS TOLD THIS IS NOT A LIVE VACCINE AND SHOULD NOT GIVE HER SHINGLES BUT WILL REPORT IT.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm, acute nausea, headache.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dizziness, Eye movement disorder, Headache
Clinical narrative: Bilateral hip ache  Upper back (across both scapular?s) stiffness  Upper neck, base of skull stiffness Headache,  Dizziness Eye tracking disturbance Sore arm at site of injection, unable to perform ROM left arm For all symptoms, Acetaminophen every 4 hrs.  Cool compress to site of Inj. And rest
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Bilateral hip ache  Upper back (across both scapular?s) stiffness  Upper neck, base of skull stiffness Headache,  Dizziness Eye tracking disturbance Sore arm at site of injection, unable to perform ROM left arm For all symptoms, Acetaminophen every 4 hrs.  Cool compress to site of Inj. And rest
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Aldolase normal, Antiacetylcholine receptor antibody, Antinuclear antibody, Antinuclear antibody positive, Arthralgia
Clinical narrative: Since 7-15-2016 I experienced pain and weakness in joints and ankles, and difficulty walking. This progressed over the next few months into sever pain and weakness in the ankles, knee, toes, elbow, wrist and fingers. Sometimes including pain in my face. I was unable to walk without a cane. I was unable to open a car door. I fell 2/2017 and broke my wrist. 04/30/2017 I fell and broke L1 vertebrae. These falls were sudden and without reason except my ankles gave out. Physically therapy was conducted for my wrist, back and ankle stability between March and December 2017. My wrist and back improved, however ankle stability has not improved. To this day I cannot but on a pair of pants without leaning against a support. I cannot walk a set of stairs without a railing.  Sometimes my wrists give out without notice causing me to drop items. I cannot stand for more than 5 minutes without sitting. This constant pain and weakness continues to this date.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone decreased, Dysstasia, Electromyogram normal
Clinical narrative: Since 7-15-2016 I experienced pain and weakness in joints and ankles, and difficulty walking. This progressed over the next few months into sever pain and weakness in the ankles, knee, toes, elbow, wrist and fingers. Sometimes including pain in my face. I was unable to walk without a cane. I was unable to open a car door. I fell 2/2017 and broke my wrist. 04/30/2017 I fell and broke L1 vertebrae. These falls were sudden and without reason except my ankles gave out. Physically therapy was conducted for my wrist, back and ankle stability between March and December 2017. My wrist and back improved, however ankle stability has not improved. To this day I cannot but on a pair of pants without leaning against a support. I cannot walk a set of stairs without a railing.  Sometimes my wrists give out without notice causing me to drop items. I cannot stand for more than 5 minutes without sitting. This constant pain and weakness continues to this date.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Facial pain, Fall, Full blood count normal, Gait disturbance, Joint instability
Clinical narrative: Since 7-15-2016 I experienced pain and weakness in joints and ankles, and difficulty walking. This progressed over the next few months into sever pain and weakness in the ankles, knee, toes, elbow, wrist and fingers. Sometimes including pain in my face. I was unable to walk without a cane. I was unable to open a car door. I fell 2/2017 and broke my wrist. 04/30/2017 I fell and broke L1 vertebrae. These falls were sudden and without reason except my ankles gave out. Physically therapy was conducted for my wrist, back and ankle stability between March and December 2017. My wrist and back improved, however ankle stability has not improved. To this day I cannot but on a pair of pants without leaning against a support. I cannot walk a set of stairs without a railing.  Sometimes my wrists give out without notice causing me to drop items. I cannot stand for more than 5 minutes without sitting. This constant pain and weakness continues to this date.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Lumbar vertebral fracture, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Parasitic test, Spinal X-ray abnormal
Clinical narrative: Since 7-15-2016 I experienced pain and weakness in joints and ankles, and difficulty walking. This progressed over the next few months into sever pain and weakness in the ankles, knee, toes, elbow, wrist and fingers. Sometimes including pain in my face. I was unable to walk without a cane. I was unable to open a car door. I fell 2/2017 and broke my wrist. 04/30/2017 I fell and broke L1 vertebrae. These falls were sudden and without reason except my ankles gave out. Physically therapy was conducted for my wrist, back and ankle stability between March and December 2017. My wrist and back improved, however ankle stability has not improved. To this day I cannot but on a pair of pants without leaning against a support. I cannot walk a set of stairs without a railing.  Sometimes my wrists give out without notice causing me to drop items. I cannot stand for more than 5 minutes without sitting. This constant pain and weakness continues to this date.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Vitamin D, Walking aid user, Weight bearing difficulty, Wrist fracture, X-ray limb abnormal
Clinical narrative: Since 7-15-2016 I experienced pain and weakness in joints and ankles, and difficulty walking. This progressed over the next few months into sever pain and weakness in the ankles, knee, toes, elbow, wrist and fingers. Sometimes including pain in my face. I was unable to walk without a cane. I was unable to open a car door. I fell 2/2017 and broke my wrist. 04/30/2017 I fell and broke L1 vertebrae. These falls were sudden and without reason except my ankles gave out. Physically therapy was conducted for my wrist, back and ankle stability between March and December 2017. My wrist and back improved, however ankle stability has not improved. To this day I cannot but on a pair of pants without leaning against a support. I cannot walk a set of stairs without a railing.  Sometimes my wrists give out without notice causing me to drop items. I cannot stand for more than 5 minutes without sitting. This constant pain and weakness continues to this date.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Patient presented to the pharmacy on 7/8/2019 at approximately 2:15 pm to show a rash as a result of the Shingrix vaccination. The rash was round and red and about 3 inches in diameter.  The patient complained of itchiness and warmth in the area of the rash, but no pain. This rash showed up at some time on 7/6/2019 after receiving the shot on the afternoon of 7/5/2019.  The patient stated the rash had not grown in size since it appeared.  No additional adverse events were reported. The patient was advised to call her PCP and report the event and see if any office visit or medications were needed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: Patient reported to pharmacy with welts on her arm and stated that she had pain and itching on the arm she had taken the shot.  I observed the welts and informed her to go to her doctor and advised her to take Ibuprofen for the pain and cortisone for the itching.  She has an appointment on the next day so she would see him then.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dry skin, Fatigue
Clinical narrative: Felt feverish, extremely tired, legs ached, stomach ached, legs ached, very thirsty.  Throat felt raw, skin felt very dry. Not hungry at all. Later in the week, diarhea, one 1/2 day. Really took 3 weeks before I felt like myself. I usually have a good amount of energy, but had to rest a few times a day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Thirst, Throat irritation
Clinical narrative: Felt feverish, extremely tired, legs ached, stomach ached, legs ached, very thirsty.  Throat felt raw, skin felt very dry. Not hungry at all. Later in the week, diarhea, one 1/2 day. Really took 3 weeks before I felt like myself. I usually have a good amount of energy, but had to rest a few times a day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Dizziness, Dysarthria, Heart rate increased, Hypoaesthesia
Clinical narrative: PATIENT EXPERIENCED SWELLING, TIGHTNESS AT INJECTION SITE.   WITHIN THE NEXT 24 HOURS HE EXPERIENCED ELEVATED PULSE RATE, ELEVATED GLUCOSE, NUMBNESS IN LEFT ARM, SLURRED SPEECH, AND DIZZINESS.  HE WENT TO THE HOSPITAL ON 7/6/19 AND WAS RELEASED.  HE IS TO FOLLOW UP WITH HIS PCP 7/9/19
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: PATIENT EXPERIENCED SWELLING, TIGHTNESS AT INJECTION SITE.   WITHIN THE NEXT 24 HOURS HE EXPERIENCED ELEVATED PULSE RATE, ELEVATED GLUCOSE, NUMBNESS IN LEFT ARM, SLURRED SPEECH, AND DIZZINESS.  HE WENT TO THE HOSPITAL ON 7/6/19 AND WAS RELEASED.  HE IS TO FOLLOW UP WITH HIS PCP 7/9/19
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Mobility decreased, Neuralgia, Pain, Pain in extremity
Clinical narrative: Sore arm, limited mobility as lifting her arm is too painful, difficulty sleeping due to pain. Patient indicated that it started since she got immunized and it is still not resolved. Patient is taking Gabapentin for the nerve pain.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling to Right deltoid
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: PT CAME IN ON 7/7/19 TO PICK UP RX AND SHE INFORMED ME OF HER REACTION TO THE SHOT. IT STARTED A DAY OR TWO AFTER AND HER ARM BECAME VERY SORE, EXTREMELY TENDER TO THE TOUCH, SWELLING, REDNESS (THAT STARTED TO SPREAD UNDER HER ARM) AND THEN PAIN IN THE ARM FOR QUITE AWHILE .
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: FIRST DOSE OF SHINGRIX VACCINE INADVERTANTLY GIVEN SUBCUTANEOUSLY, EVEN THOUGH IT SHOULD HAVE BEEN INTRAMUSCULAR.  LOCAL SITE REACTION INCLUDES REDNESS AND HEAT.  DISCUSSED PAIN ALLEVIATION WITH PATIENT AND WILL FOLLOW UP WITH HER PCP.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood pressure increased, Cold sweat, Dyspnoea, Heart rate increased, Hypotonia
Clinical narrative: Father stated patient passed out on the way to the truck while walking, put in wheelchair and brought to clinic, Patient presented to clinic, clammy, no muscle tone, unable to bear weight on legs, trembling, shaking and stating she could barely breathe. Elevated heart rate, elevated BP. Dr, administered an Epi-Pen, patient placed on 2L O2 and sent to Emergency room
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness, Tremor, Weight bearing difficulty
Clinical narrative: Father stated patient passed out on the way to the truck while walking, put in wheelchair and brought to clinic, Patient presented to clinic, clammy, no muscle tone, unable to bear weight on legs, trembling, shaking and stating she could barely breathe. Elevated heart rate, elevated BP. Dr, administered an Epi-Pen, patient placed on 2L O2 and sent to Emergency room
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: patient came back to pahrmacy to pick up rx and complained that her arm is red and sore, redness was about 2 inches wide.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post shingles neuropathy; Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 78-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 08-JUN-2018, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles and post shingles neuropathy resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles and post shingles neuropathy was unknown.   Upon internal review, post shingles neuropathy was considered to be medically significant.  The reporter considered shingles and post shingles neuropathy to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Headache, Musculoskeletal stiffness
Clinical narrative: Very sore arm. Fever 100.3 for 24 hours. Severely sore muscles all over for 24 hours. Very stiff neck for 6 hours. Ache all over. Weakness. Severe headache for 12 hours. Diarrhea x 2 and GI distress for 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm. Fever 100.3 for 24 hours. Severely sore muscles all over for 24 hours. Very stiff neck for 6 hours. Ache all over. Weakness. Severe headache for 12 hours. Diarrhea x 2 and GI distress for 24 hours.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Computerised tomogram head, Dehydration, Differential white blood cell count
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Full blood count, Headache, Hypersensitivity, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Pain, Pain in extremity, Urine analysis
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Vomiting
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Monoplegia, Vomiting
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Abdominal pain upper, Computerised tomogram head, Dehydration, Headache, Impaired work ability
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 79.0
Sex: F
Vaccine: UNK, VARZOS, UNK, UNK, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Left shoulder and arm were very painful immediately following the injection, left arm could not be moved voluntarily without great effort and pain, arm numb through hand. Headache, took Tylenol ten minutes after injection given. Stomach upset vomited throughout night. No sleep all night. mid morning husband insisted I go to emergency room. Could not move arm to get dressed, went in night clothes. Was in hospital until 6:17 pm. Great pain in head and stomach, dehydration so it took five tries to get intravenous line in to administer benedryl, saline, anti nausea etc. Slept with help of anti nausea medication all evening, night and through 2 p.m. on the 5th. Slept again from 6 p.m. through the night on the 6th. On 6th, left arm swelled up and became red from elbow to shoulder. Got benedryl over the counter and that reduced the allergic reaction somewhat. On 7th and 8th, arm less swollen, still reddened. Slept most of the afternoon on 8th probably as result of benedryl.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised, Skin warm, Swelling
Clinical narrative: PT SAID HER SYMPTOMS STARTED ON 07-06-2019 , PAIN, HOT, SWOLLEN AND ITCHY ARM,   PT WAS ADVISED TO TAKE BENADRYL ON 07-07-2019.  ON 07-08-2019 SHE WENT TO URGENT CARE SINCE HER BODY HAD STARTED TO ITCH EVERYWHERE.   SHE WAS ADVISED BY URGENT CARE TO STAY ON BENADRYL.  AND TO MAKE A FOLLOW UP VISIT HER REGULAR PCP
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site mass, Joint range of motion decreased
Clinical narrative: Patient experienced lump in her upper left arm with decreased range of motion 2 days after vaccination. Patient did not report event to the pharmacy because she thought it would get better. Vaccination was given on 6/12/2019 and reported to the pharmacy 7/8/2019; pt will follow up with her PCP on her upcoming appointment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: First dose on 4/17 (in same facility).  Around 3:30-4pm started feeling bad, bad headache, drained then it got worse.  In the evening started feeling nauseous and dizzy.  By bedtime patient had chills.  Patient woke up at 3-4am with fever and couldn't sleep. Took Tylenol but did not help much.   Patient went back to bed to sleep.   There was a lot of pain in arm which lingered for more than 1 day.   Contacted clinic on 7/1 but they did not take information just specified lot number was different from first dose.   Husband had vaccine at same time with no issues. By Monday issues resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: First dose on 4/17 (in same facility).  Around 3:30-4pm started feeling bad, bad headache, drained then it got worse.  In the evening started feeling nauseous and dizzy.  By bedtime patient had chills.  Patient woke up at 3-4am with fever and couldn't sleep. Took Tylenol but did not help much.   Patient went back to bed to sleep.   There was a lot of pain in arm which lingered for more than 1 day.   Contacted clinic on 7/1 but they did not take information just specified lot number was different from first dose.   Husband had vaccine at same time with no issues. By Monday issues resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site rash
Clinical narrative: RASH ON ENTIRE RIGHT UPPER ARM,  DIARRHEA
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Brain oedema, Computerised tomogram head abnormal, Generalised tonic-clonic seizure, Immediate post-injection reaction, Leukocytosis
Clinical narrative: Immediately after vaccines developed fevers, 2 days after vaccines had 30 min Tonic-clonic seizure. Since then has continued to have monthly GTC seizures.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Lumbar puncture normal, Pyrexia, White blood cell count increased
Clinical narrative: Immediately after vaccines developed fevers, 2 days after vaccines had 30 min Tonic-clonic seizure. Since then has continued to have monthly GTC seizures.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced joint aches, swelling and pain at injection site within 15 minutes after administration, and a headache that persisted for 2 weeks. Patient reported these after they resolved but did report using 800mg of advil to treat pain with little to no relief.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Injection site pain, Neck pain
Clinical narrative: Patient experienced shoulder pain in arm of injection site- has improved throughout the day. He awoke at 4:30 am on the 3rd of July with the pain.  Also, patient noted experiencing a shock or zapping pain which lasted for about 10 seconds and would resolve behind both ears and back of neck.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Lip swelling, Pain
Clinical narrative: The patient called today to express concern over a reaction to the immunization given on 7/5. The patient stated he has flu-like symptoms and body aches the day after receiving the immunization which subsided that evening. The patient called this morning (7/8) to express concern over a swollen lip that he thought might be associated with the immunization as well. The swelling started on the left upper lip then proceeded to encompass the whole lip shortly thereafter. The patient was instructed that, though unlikely, this could be associated with the immunization and was instructed to take OTC benadryl to reduce the swelling. The patient was also instructed to seek emergency medical attention if his symptoms worsened.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Nausea, Photophobia, Syncope, Tinnitus
Clinical narrative: Patient first described tinnitus and vertigo within 3 minutes of vaccination. The patient and her mother were instructed to sit down, but they went into the bathroom. They emerged from the bathroom about 5 minutes later, and the patient's mother said that the patient had fainted. The patient was laid on her back and given ice packs. The patient said that she didn't remember fainting. The patient described being nauseous and sensitive to fluorescent light. At this time, the patients heart rate was 200 beats per minute. There were no signs of urticaria and her breathing was normal. 5 minutes later, her heart rate had decreased to 150 beats per minute. After 10 minutes of lying down, the patient was asked to sit upright. She reported feeling "back to normal." Her pulse at this time was down to 120 beats per minute. After sitting for 5 minutes, the patient was able to stand on her own and walk out of the store.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Vertigo
Clinical narrative: Patient first described tinnitus and vertigo within 3 minutes of vaccination. The patient and her mother were instructed to sit down, but they went into the bathroom. They emerged from the bathroom about 5 minutes later, and the patient's mother said that the patient had fainted. The patient was laid on her back and given ice packs. The patient said that she didn't remember fainting. The patient described being nauseous and sensitive to fluorescent light. At this time, the patients heart rate was 200 beats per minute. There were no signs of urticaria and her breathing was normal. 5 minutes later, her heart rate had decreased to 150 beats per minute. After 10 minutes of lying down, the patient was asked to sit upright. She reported feeling "back to normal." Her pulse at this time was down to 120 beats per minute. After sitting for 5 minutes, the patient was able to stand on her own and walk out of the store.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: PATIENT HAD SHINGRIX SHOT IN LEFT ARM AT AROUND 10AM.  SHE RETURNED THIS AFTERNOON AROUND 5PM WITH RED SPLOTCHES ON MOSTLY LEFT ARM BUT ALSO HAD ONE ON THE RIGHT ARM.  SHE BELIEVES IT IS FROM THE SHOT. SHE STATES THAT SHE IS VERY SENSITIVE TO VACCINATIONS
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pruritus
Clinical narrative: pt had itching at site. no raised bump, no swelling, no difficulty breathing, no swelling of tongue, lips, or face, no hives.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Dysstasia, Hyperhidrosis, Lymphadenopathy
Clinical narrative: I went to the Opera hours after receiving the vaccination (standing room) and after an hour of the show I could barely stand. And all the rough the next two days I suffered from sweats, chills, aches body, cramps in my muscles especially arms and hands, and I had a swollen gland type pain in my left armpit.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: I went to the Opera hours after receiving the vaccination (standing room) and after an hour of the show I could barely stand. And all the rough the next two days I suffered from sweats, chills, aches body, cramps in my muscles especially arms and hands, and I had a swollen gland type pain in my left armpit.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Headache, Heart rate increased, Heart rate irregular, Pyrexia
Clinical narrative: Headache, increased pulse rate, 100.2 fever, irregular heart beat. Shaking, weakness
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Headache, increased pulse rate, 100.2 fever, irregular heart beat. Shaking, weakness
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Headache, increased pulse rate, 100.2 fever, irregular heart beat. Shaking, weakness
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Joint stiffness, Nasopharyngitis, Pyrexia, Sinus congestion
Clinical narrative: 06/06/2019: Cold symptoms. Mild fever, sinus congestion.  06/17/2019: Joint stiffness and inflammation in right ankle, bilateral knees, bilateral hands/fingers, bilateral elbows and back.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Got the shingrix vaccine on June 24th. Had a lot of side effects that came and eases but on 6/27 my arm started hurting more and more and feeling hot at injection area and a few inches away. I have lost the strength in my left arm and shoulder. The pain is bad, Advil, Tylenol have little effect. Ice helped some but my arm can not lift up from elbow up to and including my shoulder. So painful. It's now 7 days and no relief. I wish I had never gotten the shot. I feel like my muscle is damaged. I haven't gone to my doctor because he will want to give me cortisone shot and afraid of those side effects.called company but got nurse that read leaflets to me.
Age: 40.0
Sex: U
Vaccine: UNK
Symptoms: Hot flush, Sleep disorder, Somnolence
Clinical narrative: I received a tetnus shot and have had several side effects: drousyeness, hot flashes, sleep disturbances, and possible headaches (started yesterday) since receiving the shot.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Eye swelling, Fatigue, Headache, Malaise
Clinical narrative: Patient reported feeling sick 24 hours after vaccination. Symptoms include dizziness, headache, extreme fatigue, and swollen eyes. These symptoms last for 7 days
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Patient reported feeling sick 24 hours after vaccination. Symptoms include dizziness, headache, extreme fatigue, and swollen eyes. These symptoms last for 7 days
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: VERY SORE ARM / SHOULDER Pt went to ER
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately after Menactra & Adacel. (+) dizziness & headache headache persistent 4 days after episode
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Diarrhoea, Hypersensitivity, Pyrexia, Throat irritation
Clinical narrative: Patient felt an allergic reaction coming on in the evening after the shot. Throat was itching, hacking cough, mild fever, diarrhea Went to ER on 7/8/19 and was prescribed prednisone 40 mg x 5 days and OTC Pepcid 20 mg.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: 01/03/2019 Received Shingrix #1. 01/06/19 2 -2"x3" oval irritated areas on abdomen noted, no blistering. 04/07/19 Numerous blisters on Adb, chest, back, moved to arms and hands. Itchy. TNTC 04/26/19 Dr. tx with Certizine and Ranitadine. Itching improved some. 05/23/19 Dr. with Derm consult dx: possible Bullous Pemphigoid reaction tx with Steriod burst x 3 over next six weeks. blisters improve while on steriods return with weaning of steriods. Discontinued Steriods during third course due to a developing tremor in hand.  June ER visit given Hydroxyzine and Doxepin. Further documentation pending Dermatology visit on 7/12/2019. Hx of chicken pox aprx. 12 y.o.