chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient States her arm has been hurting since the administration of the vaccination and has had a limited range of motion since getting the vaccine. She has had significant pain, and has not had relief with over the counter medications.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme pain, redness and swelling of entire upper arm after injection.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain, slightly swollen, develop lump approx. 2 cm on right deltoid.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain, swelling and redness on upper arm.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test, Facial paralysis
Clinical narrative: Development of Left sided BELL'S PALSY within hours of the HPV vaccine (1st dose).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 29-MAR-2018, the patient was vaccinated with expired VAQTA lot # M039202 with expiration date 11-MAR-2018, for prophylaxis (dose and route of administration were not reported). No adverse symptoms were reported. It was stated that the vaccine did not have any temperature excursion prior to administration.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Genital swelling, Hypersensitivity, Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received PREVNAR 13 for immunization at single dose on 23Feb2018, via an unspecified route of administration. On 24Feb2018 the patient experienced itching and swelling of the right foot with outcome of recovered on 25Feb2018, on 26Feb2018 the patient experienced swelling of the genitals, swelling of the right side of the face both with outcome of recovered on 28Feb2018, on unknown date swelling of the lower lip, the first episode recovered on 28Feb2018, then the event reoccurred on 02apr2018 and the outcome was recovered. He went to the emergency room on 25Feb2018 and was told it was an allergic reaction to the vaccine. The patient took some antihistamine and put ice. Information on the batch number has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received PREVNAR 13 for immunization at single dose on 23Feb2018, via an unspecified route of administration. On 24Feb2018 the patient experienced itching and swelling of the right foot with outcome of recovered on 25Feb2018, on 26Feb2018 the patient experienced swelling of the genitals, swelling of the right side of the face both with outcome of recovered on 28Feb2018, on unknown date swelling of the lower lip, the first episode recovered on 28Feb2018, then the event reoccurred on 02apr2018 and the outcome was recovered. He went to the emergency room on 25Feb2018 and was told it was an allergic reaction to the vaccine. The patient took some antihistamine and put ice. Information on the batch number has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 103.3 which developed within 24 hours of getting vaccines. Mom advised to give Tylenol. When Tylenol was given fever came down within an hour.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Severe red rash or hives symptoms on my upper torso. My chest down to my rib cage, then on my back down past to the middle of my back. There is extreme itching sensation, maddening. There is no water blister or ooze, from the rash. Also on my arms to lesser extent. 4-3-18 My doctor observed the symptoms. He did not have any positive comments. I was given an injection of some type of steroid, and recommended to apply some type of topical cream. I have been applying generic BENADRYL with some mild results. Itchiness, still persists, and 5 to 6 hours I have to re-apply more cream.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Erythema, Injection site erythema, Musculoskeletal pain, Nausea
Clinical narrative: Vomiting with nausea beginning evening of 4/3/18  (4-5X ), fever (undocumented), redness at site and spreading down arm, pain radiating to shoulder and back.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting with nausea beginning evening of 4/3/18  (4-5X ), fever (undocumented), redness at site and spreading down arm, pain radiating to shoulder and back.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Erythema, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: Vomiting with nausea beginning evening of 4/3/18  (4-5X ), fever (undocumented), redness at site and spreading down arm, pain radiating to shoulder and back.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Second dose of MMR and Varicella but first dose given combined - vaccine was given on 03/28/18 with a small reaction (rash) at time of vaccine and larger rash on both legs in days after vaccination as reported by mother.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling on the left bicep area: red, raised, painful, warm, fever and chills. Patient returned for the PPD reading and informed us of the swelling and pain to her left upper arm. Ice pack wrapped around her arm. Keflex Rx (1 TID #30) given to patient.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Swelling on the left bicep area: red, raised, painful, warm, fever and chills. Patient returned for the PPD reading and informed us of the swelling and pain to her left upper arm. Ice pack wrapped around her arm. Keflex Rx (1 TID #30) given to patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pyrexia
Clinical narrative: 02Mar, the night after vaccination, pt had right arm pain at the site of injection. On the following day, 03 Mar, pt noted arthralgias and fever to 101.3F that resolved with acetaminophen. No cutaneous findings.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: None at this time. Administration happened within the current hour. PROQUAD given at the same time as VARIVAX, separate sites. PROQUAD should have been MMR vaccine only.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None at this time. Administration happened within the current hour. PROQUAD given at the same time as VARIVAX, separate sites. PROQUAD should have been MMR vaccine only.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, VARCEL
Symptoms: Cold sweat, Dizziness
Clinical narrative: Approx. 5-10 minutes after vaccine administration client became lightheaded and clammy; reported feeling better within 5 minutes of lying flat; no recurrence of adverse symptoms after resting supine x 15 minutes; vital signs remained stable; left clinic feeling well with no return of complaints.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after injection was applied Pt's arm became red to site appx'  2 inches across with a small dime size lump at center. Area red hot slight swelling and hot to touch.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Pain, Pain in extremity
Clinical narrative: Pt states no reaction immediately after administration. She was sleeping that night, and then around 3 am she woke up with severe muscle aches. She said that she was too weak and in pain to get up out of bed. She laid awake in bed until about 6 am and then was able to get up and take some acetaminophen. As of today (2 days post vaccine) she still has pain in her arm but generalized muscle aches have subsided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: 3 hours after receiving the vaccine, my arm became increasingly painful and stiff. I was unable to raise it from my side and was in unbearable pain. I iced it and took ibuprofen every 3 hours for 24 hours. It is now 34 hours after the vaccination and I am able to move my arm now, but still have a lot of pain raising it over my head.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Reported feeling lightheaded approx. 10 minutes after vaccines; rested supine x 20 minutes; BP and  HR monitored while lying down; returned to baseline after 20 minutes; reported feeling better after lying supine first 5 minutes; left clinic with mother reportedly feeling well/good condition; no loss of consciousness or alteration in mental status.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: Pt reported an outbreak of genital herpes after receiving vaccine. Said she had not had an outbreak in years and felt it was the vaccine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Approx 1 hour after injection developed soreness and slight swelling at injection site. Approx 11 hours after injection - awoke at 06:00 on 3/23 with headache. Approx 18 hours after injection - 13:00 on 3/23, began experiencing unusual fatigue.  Approx 19 hours after injection - 14:00 on 3/23, experienced acute muscle soreness, especially in low back. Approx 19.5 hours after injection - 14:30 on 3/23, felt chilled, shivering, clothing touching skin was mildly painful. Approx 23 hours after injection - 18:00 on 3/23, came home from work and checked temperature - 99.8. Still experiencing all other symptoms listed above, took a nap for approx 30 minutes. Approx 25 hours after injection - 20:00 on 3/23, fever at 100.9. approx 26 hours after injection - 21:00 on 3/23, fever at 101.4. Approx 27 hours after injection - 22:00 on 3/23, fever at 101.9. All other symptoms continuing. Went to bed. Felt hot in the bed, but shivering. Restless sleep, awoke approximately 03:00 on 3/24 drenched in sweat, but feeling better. Approx 36 hours after injection - awoke 07:00 on 3/24, all symptoms gone except pain & swelling at injection site. This gradually diminished over 2 days.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain of skin, Poor quality sleep
Clinical narrative: Approx 1 hour after injection developed soreness and slight swelling at injection site. Approx 11 hours after injection - awoke at 06:00 on 3/23 with headache. Approx 18 hours after injection - 13:00 on 3/23, began experiencing unusual fatigue.  Approx 19 hours after injection - 14:00 on 3/23, experienced acute muscle soreness, especially in low back. Approx 19.5 hours after injection - 14:30 on 3/23, felt chilled, shivering, clothing touching skin was mildly painful. Approx 23 hours after injection - 18:00 on 3/23, came home from work and checked temperature - 99.8. Still experiencing all other symptoms listed above, took a nap for approx 30 minutes. Approx 25 hours after injection - 20:00 on 3/23, fever at 100.9. approx 26 hours after injection - 21:00 on 3/23, fever at 101.4. Approx 27 hours after injection - 22:00 on 3/23, fever at 101.9. All other symptoms continuing. Went to bed. Felt hot in the bed, but shivering. Restless sleep, awoke approximately 03:00 on 3/24 drenched in sweat, but feeling better. Approx 36 hours after injection - awoke 07:00 on 3/24, all symptoms gone except pain & swelling at injection site. This gradually diminished over 2 days.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Approx 1 hour after injection developed soreness and slight swelling at injection site. Approx 11 hours after injection - awoke at 06:00 on 3/23 with headache. Approx 18 hours after injection - 13:00 on 3/23, began experiencing unusual fatigue.  Approx 19 hours after injection - 14:00 on 3/23, experienced acute muscle soreness, especially in low back. Approx 19.5 hours after injection - 14:30 on 3/23, felt chilled, shivering, clothing touching skin was mildly painful. Approx 23 hours after injection - 18:00 on 3/23, came home from work and checked temperature - 99.8. Still experiencing all other symptoms listed above, took a nap for approx 30 minutes. Approx 25 hours after injection - 20:00 on 3/23, fever at 100.9. approx 26 hours after injection - 21:00 on 3/23, fever at 101.4. Approx 27 hours after injection - 22:00 on 3/23, fever at 101.9. All other symptoms continuing. Went to bed. Felt hot in the bed, but shivering. Restless sleep, awoke approximately 03:00 on 3/24 drenched in sweat, but feeling better. Approx 36 hours after injection - awoke 07:00 on 3/24, all symptoms gone except pain & swelling at injection site. This gradually diminished over 2 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain, itching and swelling of left deltoid extending to elbow. Symptoms decreased with antihistamine and cold packs.
Age: 38.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Asthenia, Blood bilirubin increased, Body temperature increased, Chills, Fatigue
Clinical narrative: Patient received vaccination with TdaP and hepatitis B vaccine in left deltoid at same visit. The night after injection she developed injetion site soreness, fatigue, body aches, HA, chills, generalized weakness, nausea. Worsened over the next day and developed per patient up to 105F and on 4/4/18 early am she presented to ER for eval.  Labs revealed WBC 20, slight elevation of serum bili. Patient felt better after IVF and analgesics/anti-pyretics. Rapid flu test neg. Patient was feeling improved but still slight malaise by evening of 4/4.
Age: 38.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Headache, Influenza virus test negative, Injection site pain, Malaise, Nausea
Clinical narrative: Patient received vaccination with TdaP and hepatitis B vaccine in left deltoid at same visit. The night after injection she developed injetion site soreness, fatigue, body aches, HA, chills, generalized weakness, nausea. Worsened over the next day and developed per patient up to 105F and on 4/4/18 early am she presented to ER for eval.  Labs revealed WBC 20, slight elevation of serum bili. Patient felt better after IVF and analgesics/anti-pyretics. Rapid flu test neg. Patient was feeling improved but still slight malaise by evening of 4/4.
Age: 38.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Pain, White blood cell count increased
Clinical narrative: Patient received vaccination with TdaP and hepatitis B vaccine in left deltoid at same visit. The night after injection she developed injetion site soreness, fatigue, body aches, HA, chills, generalized weakness, nausea. Worsened over the next day and developed per patient up to 105F and on 4/4/18 early am she presented to ER for eval.  Labs revealed WBC 20, slight elevation of serum bili. Patient felt better after IVF and analgesics/anti-pyretics. Rapid flu test neg. Patient was feeling improved but still slight malaise by evening of 4/4.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Death, Influenza, Respiratory distress, Septic shock
Clinical narrative: Patient received immunizations on 2/8/18. She presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away the same day, presumably from Influenza B.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Redness expanding in two inch circumference around injection site, soreness, hard lump under skin, fever, injection site sensitive to touch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Rash
Clinical narrative: Moderate pain at injection sight. Moderate to sever muscle aches and pain. Fatigue lasting 36 hours. Rash on chest and abdomen beginning 24 hours later.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Pain, Pruritus
Clinical narrative: 02-24-18 Slight dizziness in the morning. It went away within about 2 hours. 04-04-18 Noted stinging and itching just above my belt line, right side. A pink colored egg-shaped area appeared at this site, approximately 11 cm long by 6 cm wide. This felt and looked the same as when shingles began on my left side, in 1987. I had my wife photo the affected area on 04-04-2018 with my phone.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Mom called on the 20th and said there was redness on his (L) thigh when he received his vaccine. "Red spot" she said she noticed it a week before and the spot is smaller. The area was erythematous and has associated pruritus, but no drainage from the site or swelling resolving with intervention. Expect to resolve in the next couple of days. Mom has not returned.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX. On 21st March 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. This case was reported by the patient. The patient received SHINGRIX vaccine on the left arm subcutaneously rather than intramuscular route, which led to incorrect route of vaccine administration. The patient's arm had a sore spot approximately the size of a silver dollar where the vaccine was administered, just above the elbow on back side of the left arm. This case was linked to case US2018049217, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (experienced shingles in December 2017). Concurrent medical conditions included sulfonamide allergy. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th March 2018, 2 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, rash and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash and pain in arm were recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, rash and pain in arm to be probably related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The patient's concomitant medications included blood pressure medicine and thyroid medicine. At 16:00 hours, the patient received SHINGRIX in left deltoid. The patient developed a swelling, rash and pain around the injection site, which radiated to the whole arm.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started 4/3 - 4/4. Slight redness and became worse with swelling, itching, more redness. No fever. (L) delt. warm to touch. No open areas or drainage. Prescribed BENADRYL 4/4/18.
Age: 32.0
Sex: M
Vaccine: DTP, FLUX, PPV
Symptoms: Abdominal pain, Adrenocortical insufficiency acute, Blood pressure decreased, Condition aggravated, Gastrointestinal disorder
Clinical narrative: This literature case, initially received on 26-Mar-2018, was reported by other health professional, concerning a 32-year-old, adult, male patient. The patient's current condition included recurrent idiopathic pericarditis and persistent hypotension (since unspecified dates). It was reported that, the patient was admitted in hospital with persistent hypotension. During hospitalization, the patient was examined and examination revealed elevated ACTH (Adrenocorticotropic hormone), low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. The patient's therapy included hydrocortisone, 20 mg in the morning and 5 mg at night as well as fludrocortisone 0.05 mg daily. The patient was counseled on the use of emergency dexamethasone injection pens. One month after discharge, patient had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. On an unspecified date, the patient was administered with INN flu vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect products- Tdap and pneumococcal vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). Six hours after immunization, the patient developed fever, myalgia, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 degree Celsius and hypotension of 88/54 (results not reported) with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 l of normal saline and stress-dose IV (intravenous) hydrocortisone for 24 hours. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalized. Patient was discharged home with steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient had recovered from the events (abdominal pain, vomiting, hypotension, hyponatraemia and hyperkalaemia). Outcome of the other events adrenal crisis, fever, myalgia and hypotension was not reported. The reporter assessed this case as serious due to hospitalization. The reporter assessed the causality between events and suspect vaccine as related, as the vaccine can cause gastrointestinal symptoms in adult at a incidence of 6.5 percent and also the patient developed febrile illness with vomiting after receiving all the three vaccines (influenza, Tdap and pneumococcal vaccine) at once which resulted in adrenal crisis.
Age: 32.0
Sex: M
Vaccine: DTP, FLUX, PPV
Symptoms: Hyperkalaemia, Hyponatraemia, Hypotension, Intensive care, Myalgia
Clinical narrative: This literature case, initially received on 26-Mar-2018, was reported by other health professional, concerning a 32-year-old, adult, male patient. The patient's current condition included recurrent idiopathic pericarditis and persistent hypotension (since unspecified dates). It was reported that, the patient was admitted in hospital with persistent hypotension. During hospitalization, the patient was examined and examination revealed elevated ACTH (Adrenocorticotropic hormone), low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. The patient's therapy included hydrocortisone, 20 mg in the morning and 5 mg at night as well as fludrocortisone 0.05 mg daily. The patient was counseled on the use of emergency dexamethasone injection pens. One month after discharge, patient had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. On an unspecified date, the patient was administered with INN flu vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect products- Tdap and pneumococcal vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). Six hours after immunization, the patient developed fever, myalgia, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 degree Celsius and hypotension of 88/54 (results not reported) with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 l of normal saline and stress-dose IV (intravenous) hydrocortisone for 24 hours. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalized. Patient was discharged home with steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient had recovered from the events (abdominal pain, vomiting, hypotension, hyponatraemia and hyperkalaemia). Outcome of the other events adrenal crisis, fever, myalgia and hypotension was not reported. The reporter assessed this case as serious due to hospitalization. The reporter assessed the causality between events and suspect vaccine as related, as the vaccine can cause gastrointestinal symptoms in adult at a incidence of 6.5 percent and also the patient developed febrile illness with vomiting after receiving all the three vaccines (influenza, Tdap and pneumococcal vaccine) at once which resulted in adrenal crisis.
Age: 32.0
Sex: M
Vaccine: DTP, FLUX, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: This literature case, initially received on 26-Mar-2018, was reported by other health professional, concerning a 32-year-old, adult, male patient. The patient's current condition included recurrent idiopathic pericarditis and persistent hypotension (since unspecified dates). It was reported that, the patient was admitted in hospital with persistent hypotension. During hospitalization, the patient was examined and examination revealed elevated ACTH (Adrenocorticotropic hormone), low DHEA-S, positive ACTH stimulation test and positive 21-hydroxylase antibody consistent with autoimmune Addison disease. The patient's therapy included hydrocortisone, 20 mg in the morning and 5 mg at night as well as fludrocortisone 0.05 mg daily. The patient was counseled on the use of emergency dexamethasone injection pens. One month after discharge, patient had normal sodium and potassium levels and a renin level of 3.0 ng/mL/h. On an unspecified date, the patient was administered with INN flu vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and non-company suspect products- Tdap and pneumococcal vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). Six hours after immunization, the patient developed fever, myalgia, abdominal pain and vomiting that prevented intake of oral steroids. In the emergency department, vital signs revealed fever of 39.5 degree Celsius and hypotension of 88/54 (results not reported) with hyponatraemia and hyperkalaemia. Upon admission to the intensive care unit for adrenal crisis, he received 4 l of normal saline and stress-dose IV (intravenous) hydrocortisone for 24 hours. The patient's gastrointestinal symptoms quickly resolved after steroid administration and his sodium and potassium normalized. Patient was discharged home with steroid regimen and was instructed to triple his home steroid regimen with any future vaccinations. The patient had recovered from the events (abdominal pain, vomiting, hypotension, hyponatraemia and hyperkalaemia). Outcome of the other events adrenal crisis, fever, myalgia and hypotension was not reported. The reporter assessed this case as serious due to hospitalization. The reporter assessed the causality between events and suspect vaccine as related, as the vaccine can cause gastrointestinal symptoms in adult at a incidence of 6.5 percent and also the patient developed febrile illness with vomiting after receiving all the three vaccines (influenza, Tdap and pneumococcal vaccine) at once which resulted in adrenal crisis.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: At site of injection (left arm sub-q) pt presents area of 4 inches height and 2 1/2 inches wide redness, swelling, heat and soreness that presented evening after received injection. As of 2 days after injection, pt is ok with no MD appointment required. Pt. reports flu-like symptoms the day after received vaccine and pt. feels still recovering. Sx of aches (muscle aches) weakness and fatigue.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: At site of injection (left arm sub-q) pt presents area of 4 inches height and 2 1/2 inches wide redness, swelling, heat and soreness that presented evening after received injection. As of 2 days after injection, pt is ok with no MD appointment required. Pt. reports flu-like symptoms the day after received vaccine and pt. feels still recovering. Sx of aches (muscle aches) weakness and fatigue.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling
Clinical narrative: At site of injection (left arm sub-q) pt presents area of 4 inches height and 2 1/2 inches wide redness, swelling, heat and soreness that presented evening after received injection. As of 2 days after injection, pt is ok with no MD appointment required. Pt. reports flu-like symptoms the day after received vaccine and pt. feels still recovering. Sx of aches (muscle aches) weakness and fatigue.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Fine diffuse macular rash mostly on face and trunk. No vesicles.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At site of injection pt. presents with area (on left arm sub-q) of 6 inches height and 4 inches wide, redness, swollen, hot to touch and soreness. Pt had flu-like symptoms the day after vaccine for 24 hours of chilling and felt warm to touch and aches.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: At site of injection pt. presents with area (on left arm sub-q) of 6 inches height and 4 inches wide, redness, swollen, hot to touch and soreness. Pt had flu-like symptoms the day after vaccine for 24 hours of chilling and felt warm to touch and aches.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 80-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown). On 17th January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and injection site pain. On an unknown date, the outcome of the injection site reaction and injection site pain were recovered/resolved. The reporter considered the injection site reaction and injection site pain to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient experienced a typical injection site reaction including soreness at the injection site. No intervention or hospitalization was required. This case has been linked to US2018051271 and US2018051276, reported by same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 80-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date unknown). On 17th January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and injection site pain. On an unknown date, the outcome of the injection site reaction and injection site pain were recovered/resolved. The reporter considered the injection site reaction and injection site pain to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient experienced a typical injection site reaction including soreness at the injection site. No intervention or hospitalization was required. This case has been linked to US2018051271 and US2018051276, reported by same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye pain, Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, BYSTOLIC, AMBIEN CR and COQ10. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On 22nd March 2018, the patient experienced erythematous rash. On 24th March 2018, the patient experienced eye pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, erythematous rash, eye pain and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythematous rash, eye pain and painful rash to be related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX on the left deltoid. There was a spot on his scalp that started hurting. Three days after vaccination, the patient noticed the beginning of a red rash on his face and there were more patches of red rash. Five days after vaccination, he started getting bubbles on his eyelid and his eye started hurting a stabbing pain. On 25th March 2018, the patient went to the emergency room and it was confirmed that he had Shingles and some of it was in his eye. All of this was on the left side of his head and face, the same side that the patient received SHINGRIX. He started taking VALTREX to treat the shingles on the same day. Physician contact details were provided.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, BYSTOLIC, AMBIEN CR and COQ10. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On 22nd March 2018, the patient experienced erythematous rash. On 24th March 2018, the patient experienced eye pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, erythematous rash, eye pain and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythematous rash, eye pain and painful rash to be related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX on the left deltoid. There was a spot on his scalp that started hurting. Three days after vaccination, the patient noticed the beginning of a red rash on his face and there were more patches of red rash. Five days after vaccination, he started getting bubbles on his eyelid and his eye started hurting a stabbing pain. On 25th March 2018, the patient went to the emergency room and it was confirmed that he had Shingles and some of it was in his eye. All of this was on the left side of his head and face, the same side that the patient received SHINGRIX. He started taking VALTREX to treat the shingles on the same day. Physician contact details were provided.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye pain, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, BYSTOLIC, AMBIEN CR and COQ10. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On 22nd March 2018, the patient experienced erythematous rash. On 24th March 2018, the patient experienced eye pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, erythematous rash, eye pain and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythematous rash, eye pain and painful rash to be related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX on the left deltoid. There was a spot on his scalp that started hurting. Three days after vaccination, the patient noticed the beginning of a red rash on his face and there were more patches of red rash. Five days after vaccination, he started getting bubbles on his eyelid and his eye started hurting a stabbing pain. On 25th March 2018, the patient went to the emergency room and it was confirmed that he had Shingles and some of it was in his eye. All of this was on the left side of his head and face, the same side that the patient received SHINGRIX. He started taking VALTREX to treat the shingles on the same day. Physician contact details were provided.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, BYSTOLIC, AMBIEN CR and COQ10. On 19th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On 22nd March 2018, the patient experienced erythematous rash. On 24th March 2018, the patient experienced eye pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, erythematous rash, eye pain and painful rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythematous rash, eye pain and painful rash to be related to SHINGRIX. Additional details were reported as follows: At 12:30, the patient received SHINGRIX on the left deltoid. There was a spot on his scalp that started hurting. Three days after vaccination, the patient noticed the beginning of a red rash on his face and there were more patches of red rash. Five days after vaccination, he started getting bubbles on his eyelid and his eye started hurting a stabbing pain. On 25th March 2018, the patient went to the emergency room and it was confirmed that he had Shingles and some of it was in his eye. All of this was on the left side of his head and face, the same side that the patient received SHINGRIX. He started taking VALTREX to treat the shingles on the same day. Physician contact details were provided.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pain, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 58-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 24th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 18 hrs after receiving SHINGRIX, the patient experienced hives. On 24th March 2018, the patient experienced injection site muscle pain. The patient was treated with BENADRYL and CORTAID. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site muscle pain was recovering/resolving. The reporter considered the hives and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The hives was resolving and then reoccurring. The patient had attempted to use BENADRYL and topical CORTAID to manage. On 24th March 2018, 1 hour after receiving SHINGRIX, the muscle pain occurred in 6 inch radius injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 58-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 24th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 18 hrs after receiving SHINGRIX, the patient experienced hives. On 24th March 2018, the patient experienced injection site muscle pain. The patient was treated with BENADRYL and CORTAID. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site muscle pain was recovering/resolving. The reporter considered the hives and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The hives was resolving and then reoccurring. The patient had attempted to use BENADRYL and topical CORTAID to manage. On 24th March 2018, 1 hour after receiving SHINGRIX, the muscle pain occurred in 6 inch radius injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 58-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 24th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 18 hrs after receiving SHINGRIX, the patient experienced hives. On 24th March 2018, the patient experienced injection site muscle pain. The patient was treated with BENADRYL and CORTAID. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site muscle pain was recovering/resolving. The reporter considered the hives and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The hives was resolving and then reoccurring. The patient had attempted to use BENADRYL and topical CORTAID to manage. On 24th March 2018, 1 hour after receiving SHINGRIX, the muscle pain occurred in 6 inch radius injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. Concomitant products included PREVACID, ZETIA, Metformin, TRICOR and estradiol. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site warmth, fever, chills and nausea. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and injection site warmth were recovering/resolving and the outcome of the fever, chills and nausea were recovered/resolved. The reporter considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. The reporter considered the fever, chills and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced swelling and redness described as extreme measuring of 3.75 inches in diameter at injection site. The patient experienced soreness, extreme pain and hot to touch also described for the injection site. The swelling caused difficulty getting her shirt on. The patient experienced low grade fever. Photos of the injection site reaction were available which were from 30, 50 and 72 hour time points.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. Concomitant products included PREVACID, ZETIA, Metformin, TRICOR and estradiol. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site warmth, fever, chills and nausea. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and injection site warmth were recovering/resolving and the outcome of the fever, chills and nausea were recovered/resolved. The reporter considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. The reporter considered the fever, chills and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced swelling and redness described as extreme measuring of 3.75 inches in diameter at injection site. The patient experienced soreness, extreme pain and hot to touch also described for the injection site. The swelling caused difficulty getting her shirt on. The patient experienced low grade fever. Photos of the injection site reaction were available which were from 30, 50 and 72 hour time points.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Nausea, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old female patient received a single dose of TRUMENBA (Lot Number: R45100:Expiry date: Jul2018) on 02Apr2018 at 09:50 for immunisation. The patient medical history was not reported. Concomitant medication included DEPO-PROVERA 150 mg/ml to keep from being or getting pregnant. On 02Apr2018, immediately after she got the shot, the patient experienced nausea, dizziness and ringing in ears. Lab work was done on an unknown date. Outcome of nausea, dizziness and ringing in ears was unknown.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Laboratory test, Nausea, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old female patient received a single dose of TRUMENBA (Lot Number: R45100:Expiry date: Jul2018) on 02Apr2018 at 09:50 for immunisation. The patient medical history was not reported. Concomitant medication included DEPO-PROVERA 150 mg/ml to keep from being or getting pregnant. On 02Apr2018, immediately after she got the shot, the patient experienced nausea, dizziness and ringing in ears. Lab work was done on an unknown date. Outcome of nausea, dizziness and ringing in ears was unknown.