chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: Pt had seizure followed by cyanosis. FOC gave rescue breaths and called 911. Pt had 3-4 apneic events in ambulance lasting less than 10 seconds. Pt admitted overnight - observation - EEG/ECG.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Malaise
Clinical narrative: Pt. received Shingrix on 5/14/19 (L) Deltoid. Pt did not feel well on 5/15/19 no specific complaint "just off a little" On 5/16/19 pt noticed a 3 mm fluid filled blister 1-1 1/2 from injection site. Does not hurt or itch
Age: 59.0
Sex: M
Vaccine: MMR, TD
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient stated he felt "woozy", was moved to chair, and lost consciousness briefly.  Dr. made aware and was with patient until regained consciousness. 2 minutes.  No treatment necessary except cool compress
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Patient notified of symptoms of paresthesias that she has noticed. She is unsure if this is a side effect of the vaccine or other concerns. Reviewed potential side effects of the vaccine although paresthesias is not clearly noted in the information that I found. I suspect that this likely is a side effect. She states that she was going to try a chiropractic adjustment. Okay to do that at this point in time as long as it is only an adjustment to see if it does help with the paresthesias. It is okay to try Tylenol ibuprofen as well. The patient was instructed to notify me should this worsen or should she start noticing weakness of her legs such as concern for rare disorder such as Guillianne Barre. Please report this reaction to the VAERS. Patient was instructed to complete the series as planned at this point in time unless symptoms worsen or new symptoms arise.
Age: 1.33
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Crying, Irritability, Pyrexia, Tremor
Clinical narrative: Within 2 hours of immunization. fevers,  tremulousness, irritability. inconsolably  crying. no alternative source for fever on exam same day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Patient reported a headache, not being able to change her clothes without pain. The hair on her neck felt like needles and hurt. She felt run down even more than what the flu could do. Pain in her back. Very painful, couldn't move her arm for 48 hr. Patient reports aching all over when she touched anywhere on her body. She got the chills, was cold, and very tired all day on Saturday. Slept all day since it wore her out. She started to feel better on Monday 5/6/19.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported a headache, not being able to change her clothes without pain. The hair on her neck felt like needles and hurt. She felt run down even more than what the flu could do. Pain in her back. Very painful, couldn't move her arm for 48 hr. Patient reports aching all over when she touched anywhere on her body. She got the chills, was cold, and very tired all day on Saturday. Slept all day since it wore her out. She started to feel better on Monday 5/6/19.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Sudden hearing loss
Clinical narrative: He had sudden sensironeural hearing loss in his right ear two weeks after receiving the Shingirx.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Aphthous ulcer, Chapped lips, Lip swelling, Lymphadenopathy, Measles antibody
Clinical narrative: Init visit 5/8 notable for fine pink rash on face, neck arms and trunk as well as enlarged glandular tssue under jaw bilaterally. Tongue slightly swollen,apthious ulcer on tip. Mild cracking lip tissue. Treated with triamcinolone dental paste. 5/9 due to family concern that she was getting worse with more oral/lip swelling, pt examined in ER and given 2 mg Decadron and sent home. 5/9 I again saw her and noted that the lips were now cracked and swollen tongue was a bit more protrusive. Glandular swelling was bout the same. I gave her 6.25 mg of Benadryl here and sent her home on oral decadron 0.5 mg BID for 3 days. 5/13 and noted that the lip and tongue swelling w/improved eat. 5/16 lips healed rash gone NL mood.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test, Rash, Rash erythematous, Rubella antibody test, Swollen tongue
Clinical narrative: Init visit 5/8 notable for fine pink rash on face, neck arms and trunk as well as enlarged glandular tssue under jaw bilaterally. Tongue slightly swollen,apthious ulcer on tip. Mild cracking lip tissue. Treated with triamcinolone dental paste. 5/9 due to family concern that she was getting worse with more oral/lip swelling, pt examined in ER and given 2 mg Decadron and sent home. 5/9 I again saw her and noted that the lips were now cracked and swollen tongue was a bit more protrusive. Glandular swelling was bout the same. I gave her 6.25 mg of Benadryl here and sent her home on oral decadron 0.5 mg BID for 3 days. 5/13 and noted that the lip and tongue swelling w/improved eat. 5/16 lips healed rash gone NL mood.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Condition aggravated, Depression
Clinical narrative: Acute exacerbation of Depression
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: The area of concern on the right thigh is 5 inches by 6 inches. It is red, warm, and hard to the touch. Patient states it is not painful, however it is itchy. Patient was prescribed Banophen for itching. The patient will return 6/20/2019 for a recheck.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Rash
Clinical narrative: Rash started around 11am; covered extremities and trunk, some on face.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: RASH/rash on her leg; URTICARIA/itching rash all over; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  Started developing a rash on her leg the evening of 31-JUL-2017, then by 01-AUG-2017, had widespread urticaria - was seen by myself to confirm diagnosis.  Lab data  none   Other Medications  none known   Current Illnesses  severe right ankle sprain   History  none   Prior Vaccinations   VAERS data as of August 31 of 2017  The agency considered this event as non-serious.  Follow-up information has been received from the physician on 15-APR-2019, regarding a non-hispanic or latino white female patient. The patient's allergies included possibly latex and the patient was not pregnant at the time of vaccination.  It was unknown if the patient ever had an adverse event following any previous vaccine.  Follow-up information has been received from a physician on 06-MAY-2019. The patient's initials and date of birth were registered. It was confirmed that the patient's pre-existing physician diagnosed allergies included sensitivity to latex bandages. It was confirmed that since 31-JUL-2017 in the evening after receiving the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the first dose of hepatitis A virus vaccine inactivated (HAVRIX), an itchy rash all over began (urticaria). On 01-AUG-2017, the patient was seen at the clinic and was treated with hydroxyzine. On an unspecified date, the patient recovered from the event. At the time of reporting, the patient is 16 years old. The reporter considered the rash to be due to the latex sensitivity because of the latex exposure in (HAVRIX) pre-filled syringe vaccine, however he did not assess the relatedness between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Feeling abnormal, Hypoaesthesia, Myelitis transverse, Sensory loss
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antibody test, Blood folate normal, Blood glucose normal, Blood test, Blood test normal
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: C-reactive protein normal, CSF pressure normal, CSF test normal, Cauda equina syndrome, Diarrhoea
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Glycosylated haemoglobin normal, Hypoaesthesia, Lethargy, Lumbar puncture
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Peripheral sensory neuropathy
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan with contrast, Small fibre neuropathy, Vitamin B12 normal, X-ray normal
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Central nervous system lesion, Lumbar puncture normal, Nuclear magnetic resonance imaging spinal, Sensory disturbance
Clinical narrative: Pelvic and lower extremity sensory changes occurred on 1/8/19. Exam normal except mild sensory changes on 01/22/19, normal on 02/09/19. 02/06/19: 21x2x4mm longitudinal midline anterior spinal cord lesion. CSF
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm redness; Injection site tingling; Injection site pain; Malaise; Fatigue; Left arm swelling; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm. On an unknown date, the outcome of the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced  left arm redness, swelling, injection site pain and tingling, as well as overall malaise and fatigue.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site pain, Injection site paraesthesia, Malaise
Clinical narrative: Left arm redness; Injection site tingling; Injection site pain; Malaise; Fatigue; Left arm swelling; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm. On an unknown date, the outcome of the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced  left arm redness, swelling, injection site pain and tingling, as well as overall malaise and fatigue.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Left arm redness; Injection site tingling; Injection site pain; Malaise; Fatigue; Left arm swelling; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm. On an unknown date, the outcome of the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities, injection site tingling, injection site pain, malaise, fatigue and swelling arm to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced  left arm redness, swelling, injection site pain and tingling, as well as overall malaise and fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: bruising; swelling; pain; headache; nausea; fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site bruising, injection site swelling, injection site pain, headache, nausea and fever. On an unknown date, the outcome of the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever were recovered/resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient visited to physician for the issues and the physician did not provide any treatment mendication to the patient, but noted common side effects. The emergency room visit was required.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: bruising; swelling; pain; headache; nausea; fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site bruising, injection site swelling, injection site pain, headache, nausea and fever. On an unknown date, the outcome of the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever were recovered/resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient visited to physician for the issues and the physician did not provide any treatment mendication to the patient, but noted common side effects. The emergency room visit was required.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site bruising, Injection site pain, Injection site swelling, Nausea
Clinical narrative: bruising; swelling; pain; headache; nausea; fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site bruising, injection site swelling, injection site pain, headache, nausea and fever. On an unknown date, the outcome of the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever were recovered/resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site pain, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient visited to physician for the issues and the physician did not provide any treatment mendication to the patient, but noted common side effects. The emergency room visit was required.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event
Clinical narrative: No adverse effects were reported; The patient was inadvertently administered and adult 1 mL dose of VAQTA; This spontaneous report was received from a nurse regarding a patient of 1 year and 6 months old of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 15-MAY-2019, the patient was inadvertently administered an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, intramuscular, lot number R009799, expiration date 02-JUN-2019, for prophylaxis (product administered to patient of inappropriate age) No adverse effects were reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; The patient was inadvertently administered and adult 1 mL dose of VAQTA; This spontaneous report was received from a nurse regarding a patient of 1 year and 6 months old of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 15-MAY-2019, the patient was inadvertently administered an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, intramuscular, lot number R009799, expiration date 02-JUN-2019, for prophylaxis (product administered to patient of inappropriate age) No adverse effects were reported.
Sex: U
Vaccine: RV5, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: vomited once after administration resulting in a possible incomplete dose; vomited once after administration resulting in a possible incomplete dose; This spontaneous report as received from a nurse practitioner, refers to a 2 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R033253 expiration date 19-JUL-2020, per oral route for prophylaxis. On the same date (reported as "after administration"), the patient vomited once (vomiting), resulting in a possible incomplete dose.      At the time of the report, the outcome of vomiting was considered as recovered/resolved.   The reporter did not assess the causal relationship between vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: vomited once after administration resulting in a possible incomplete dose; vomited once after administration resulting in a possible incomplete dose; This spontaneous report as received from a nurse practitioner, refers to a 2 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R033253 expiration date 19-JUL-2020, per oral route for prophylaxis. On the same date (reported as "after administration"), the patient vomited once (vomiting), resulting in a possible incomplete dose.      At the time of the report, the outcome of vomiting was considered as recovered/resolved.   The reporter did not assess the causal relationship between vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).
Age: 62.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Rash near injection site. 5 Palms in size. Red. Itchy. Welts
Age: 62.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Injection site rash, Rash
Clinical narrative: Rash near injection site. 5 Palms in size. Red. Itchy. Welts
Age: 62.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Patient called the after hours covering physician sometime in the night after the vaccine was administered. She reported a rash on her right arm where the injection was given that extended onto her chest. Patient was advised to use benadryl cream. Folllow up phone call, voicemail, and message sent to patient today to check in, currently awaiting return call from pt.
Age: 62.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Injection site rash, Rash
Clinical narrative: Patient called the after hours covering physician sometime in the night after the vaccine was administered. She reported a rash on her right arm where the injection was given that extended onto her chest. Patient was advised to use benadryl cream. Folllow up phone call, voicemail, and message sent to patient today to check in, currently awaiting return call from pt.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Dizziness
Clinical narrative: Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Eye pain, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Insomnia, Myalgia
Clinical narrative: Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity, Palpitations, Pyrexia, Throat irritation
Clinical narrative: Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Feeling abnormal, Influenza like illness
Clinical narrative: Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Dyspnoea
Clinical narrative: muscle pain in shoulders, hips, lower mid back, finger joints, chills, nausea, uncontrollable shivering, upset stomach, breathing difficulties.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: muscle pain in shoulders, hips, lower mid back, finger joints, chills, nausea, uncontrollable shivering, upset stomach, breathing difficulties.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: localized swelling
Age: 2.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given two doses of the vaccine at the same time. One of the doses given was MMRV which is not supposed to be given under age 4. Mother advised to monitor for fever. It is unknown yet if she had any problems.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; on 04/29/2019, an adult patient received a pediatric dose of VAQTA; Information has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 29-APR-2019, the patient was vaccinated with a pediatric dose of hepatitis vaccine, inactivated (VAQTA) (lot# and expiration date unknown) intramuscularly for prophylaxis. There were no known adverse effects.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect were reported; patient was inadvertently administered one dose of expired VAQTA; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.  On 08-MAY-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) (anatomical location and route of administration were not provided, lot # N032753, with expiration date of 23-MAR-2019, which was valid) for prophylaxis. No adverse effects were reported. The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Asthenia, Cardiac pacemaker insertion, Dehydration, General physical health deterioration
Clinical narrative: This literature market report has been received from authors of a published article. An 85 year old male patient's adverse event was captured in this report. The patient's medical history and concomitant medication were not provided. The patient's concurrent condition included hypertension (HTN) and diabetes mellitus type 2(DM II).  On an unknown date during an annual visit, the patient was vaccinated with Zoster Vaccine Live(manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date when drive home, the patient began experiencing body aches. Within 2 days, the patient's pain worsened, and he became very weak. In emergency room (ER), the patient was found to be febrile with a white blood cell count (WBC) of 13 unites unknown. The patient was treated with ceftriaxone and admitted for a possible infection. Work up found no infection so antibiotics were not continued. Prednisone was added with no improvement. As no other reversible cause was found for the patient's symptoms, the patient was discharged after a few days to a subacute rehabilitation facility (SAR). Ten days later, the patient was readmitted with acute renal insufficiency. The patient was dehydrated and much weaker. The patient was again worked up with the only new finding being a pause in his heart rate. The patient remained weak despite pacer placement, so he was again discharged to SAR where he became quickly immobile. The patient continued to decline and was transferred out of state 2 months later to be closer to his son who could assist him with care oversight. The outcome of immobility was not recovered. The reporter considered immobility to be related to Zoster Vaccine Live (manufacturer unknown). This was a rare adverse effect of immunization that led to immobility in a previously independent patient. The event of immobility was considered to be serious due to disability and hospitalization. Upon internal review, immobility was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate abnormal, Immobile, Pain, Pyrexia, White blood cell count increased
Clinical narrative: This literature market report has been received from authors of a published article. An 85 year old male patient's adverse event was captured in this report. The patient's medical history and concomitant medication were not provided. The patient's concurrent condition included hypertension (HTN) and diabetes mellitus type 2(DM II).  On an unknown date during an annual visit, the patient was vaccinated with Zoster Vaccine Live(manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date when drive home, the patient began experiencing body aches. Within 2 days, the patient's pain worsened, and he became very weak. In emergency room (ER), the patient was found to be febrile with a white blood cell count (WBC) of 13 unites unknown. The patient was treated with ceftriaxone and admitted for a possible infection. Work up found no infection so antibiotics were not continued. Prednisone was added with no improvement. As no other reversible cause was found for the patient's symptoms, the patient was discharged after a few days to a subacute rehabilitation facility (SAR). Ten days later, the patient was readmitted with acute renal insufficiency. The patient was dehydrated and much weaker. The patient was again worked up with the only new finding being a pause in his heart rate. The patient remained weak despite pacer placement, so he was again discharged to SAR where he became quickly immobile. The patient continued to decline and was transferred out of state 2 months later to be closer to his son who could assist him with care oversight. The outcome of immobility was not recovered. The reporter considered immobility to be related to Zoster Vaccine Live (manufacturer unknown). This was a rare adverse effect of immunization that led to immobility in a previously independent patient. The event of immobility was considered to be serious due to disability and hospitalization. Upon internal review, immobility was determined to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: Breath holding, Cyanosis
Clinical narrative: Held their breath and turned blue; Held their breath and turned blue; This spontaneous report was received from a physician via company representative referring to multiple female infant patients of an unknown age. The patient's concurrent condition included rotavirus immunization. The patient's medical history, historical drugs, drug allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, oral for prophylaxis and rotavirus immunization. On an unknown date, infant patients held their breath (breath holding) and turned blue (cyanosis) during administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Physician reported that, this issue spontaneously resolved after administration was completed and also reported to field employee that this issue occurred more often in unspecified male infants, though it was clarified that both unspecified male infants and unspecified female infants may have been involved. Physician no longer administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to any patients due to the issue, and instead administered ROTARIX (manufactured by GlaxoSmithKline), and reported that no patients have experienced the same issue with ROTARIX. It was not clarified if this meant any patients who experienced the issue with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) completed their rotavirus vaccination series with ROTARIX. The outcome of breath holding, and cyanosis was reported as recovered. The causality of the events was related with respect to suspect therapy rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Amnesia, Axillary nerve injury, Cervical vertebral fracture, Concussion, Impaired work ability
Clinical narrative: This spontaneous report was received from a nurse who is a 42 year old male patient. Information on patient's pertinent drug reactions or allergies. The patient's medical history included chickenpox (when he was child) and intrinsic tremors. On 01-AUG-2018, the patient was vaccinated with VARIVAX via subcutaneous route (dose, strength unknown), (lot # N031003, expiry date: 03-NOV-2019) for prophylaxis. On 09-SEP-2018, the patient had a car accident (road traffic accident) and paralyzed his arm (monoplegia). He had axillary nerve damage (axillary nerve injury), fractured C6 and C7 (cervical vertebral fracture) and had concussion. The patient forgot a complete week due to the concussion and was out of work for 8 months (disability). The patient was treated in an unspecified emergency department and wore a soft collar until February 2019. The outcome of road traffic accident, monoplegia, axillary nerve injury, cervical vertebral fracture and concussion was recovered. Causality assessment was not provided. There was no product quality complaint associated with this report. The event concussion was determined to be serious due to disabling.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Monoplegia, Road traffic accident
Clinical narrative: This spontaneous report was received from a nurse who is a 42 year old male patient. Information on patient's pertinent drug reactions or allergies. The patient's medical history included chickenpox (when he was child) and intrinsic tremors. On 01-AUG-2018, the patient was vaccinated with VARIVAX via subcutaneous route (dose, strength unknown), (lot # N031003, expiry date: 03-NOV-2019) for prophylaxis. On 09-SEP-2018, the patient had a car accident (road traffic accident) and paralyzed his arm (monoplegia). He had axillary nerve damage (axillary nerve injury), fractured C6 and C7 (cervical vertebral fracture) and had concussion. The patient forgot a complete week due to the concussion and was out of work for 8 months (disability). The patient was treated in an unspecified emergency department and wore a soft collar until February 2019. The outcome of road traffic accident, monoplegia, axillary nerve injury, cervical vertebral fracture and concussion was recovered. Causality assessment was not provided. There was no product quality complaint associated with this report. The event concussion was determined to be serious due to disabling.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; Received an intramuscular dose of MMR II; This spontaneous report was received from a female pharmacist of unknown age referring to herself. The patient's concurrent conditions, medical history, drug reactions/allergies, concomitant drugs were not reported. On 30-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: Albumin status of rHA (recombinant human albumin), (lot # R000557; expiration date: 08-JAN-2020) via intramuscular route (incorrect route of product administration) for prophylaxis. No adverse effects (no adverse event) were reported. No product quality complaint involved.
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal
Clinical narrative: feeling like they were hit with a ton of bricks; This spontaneous report was received from a medical assistant regarding a female patient of an unknown age. The patient's concurrent condition included papilloma viral infection. The medical history, concomitant medication and drug allergies was not reported. On 06-MAY-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for papilloma viral infection via subcutaneous route (lot number: R027577, expiration date: 23-JUN-2021, dose: not reported). On an unknown date in May 2019 (reported as after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)), the patient experienced feeling like they were hit with a ton of bricks (feeling abnormal). The patient sought medical attention. The patient was not treated for the adverse event. The outcome of the event was unknown. The causality of the event with respect to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body pain; This spontaneous report was received from an employee and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in February 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 14-MAY-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 15-MAY-2019, the patient experienced fever (pyrexia) and body pain. The patient was not hospitalized and did not seek medical attention.  The patient took acetaminophen (TYLENOL) as a treatment. He stated he was "feeling better" but he had not completely recovered. He said he received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because it was a vaccination recommendation. The causal relationship between the occurred events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Laboratory test, Pyrexia, Rash generalised, Respiratory tract congestion
Clinical narrative: The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; The patient's parents brought him back to the physician's office with a rash all over his body, fever and congestion; This spontaneous report had been received from a nurse reporting a 13-month-old male patient. There was no information about the patient's medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  On an unspecified date, the patient was vaccinated with doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, indication, lot number and expiration date not reported) administered concomitantly. Sterile diluent injection used was also reported as suspect.  Subsequently, on an unspecified date (reported as seven days later), the patient's parents brought him to the physician's office with a rash all over his body (rash generalised), fever and congestion. It was reported that the physician was following up with laboratory tests to confirm whether this could be a case of measles, but the results were not provided. The outcome of the events and the causal relationship between the events and the suspect vaccines and sterile diluent were not reported. No product quality complaint (PQC) was reported due to the occurred.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Weak; Light headed/ Dizzy; Tired; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 72-year-old 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, less than a week after receiving Shingrix, the patient experienced weakness, light headedness and tiredness. On an unknown date, the outcome of the weakness, light headedness and tiredness were unknown.   It was unknown if the reporter considered the weakness, light headedness and tiredness to be related to Shingrix.  Additional details were provided as follows: The batch number and expiry date of Shingrix was not reported. One week ago, from the date of reporting, the patient received Shingrix and felt weak, light headed and tired. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash under arms/ Rash on breasts; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 4th May 2019, the patient received Shingrix. On 7th May 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: On the day of reporting, the patient developed a rash under both arms and breasts. No additional information was provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast tenderness, Tongue discomfort
Clinical narrative: burning sensation on her tounge; breast tenderness; tongue; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. On 26th April 2019, 1 days after receiving Shingrix, the patient experienced burning sensation, breast tenderness and tongue discomfort. On an unknown date, the outcome of the burning sensation and breast tenderness were not recovered/not resolved and the outcome of the tongue discomfort was unknown.   It was unknown if the reporter considered the burning sensation, breast tenderness and tongue discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. The day after patient received the vaccine, she developed a burning sensation on her tongue and breast tenderness (both breast). The reporter consented to follow up. There is a discrepancy with respect to the outcome of the events burning sensation and breast tenderness and the event tongue discomfort. In the database the outcome is reported as not recovered for both events, however in provided source document it is recovering/resoling. The outcome of the both events retains as per the database structural field. And the event tongue discomfort is reported in the structural field in the database, however there is no mention about the event tongue discomfort in the source document. Retain as per reported.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hypersensitivity; Hives; This case was reported by a pharmacist via call center representative and described the occurrence of hypersensitivity reaction in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced hypersensitivity reaction and hives. On an unknown date, the outcome of the hypersensitivity reaction and hives were unknown.   It was unknown if the reporter considered the hypersensitivity reaction and hives to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Vaccine facility, batch number and expiry date were not reported. The patient received a Tdap vaccine when they were a child and developed a hypersensitivity reaction that included hives. The reporter could not verify the manufacturer of the vaccine. The reporter does not have any further information to provide regarding the event.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Immediate post-injection reaction, Injection site erythema, Sleep disorder
Clinical narrative: red arm with red mark at injection site.; headaches; interrupted sleep; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th April 2019, immediately after receiving Shingrix, the patient experienced erythema of extremities, headache and sleep disturbance. On an unknown date, the outcome of the erythema of extremities was recovering/resolving and the outcome of the headache and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, headache and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm, intramuscularly and experienced a red arm with a big red mark at the injection site. The patient was experiencing headaches that were waking her up at night.  These side effects occurred immediately, however, the redness was less till the time of reporting, but still evident. The patients headaches are still unresolved. the discrepancy between the outcome reported in the structured field (recovering/resolving) and the outcome reported in the narrative (not recovered/resolved).