chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Muscular weakness, Musculoskeletal pain
Clinical narrative: pain in my right shoulder; weakness in my left shoulder; This case was reported by a consumer and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced shoulder pain and localized muscle weakness. On an unknown date, the outcome of the shoulder pain and localized muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and localized muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and weakness in my right shoulder right away after vaccination and had continued to the date of report which was three and half months since the vaccine was administered. The patient had been going to physical therapy with minimal positive results. No further information to offer other than what was in customer email.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: pain in my right shoulder; weakness in my left shoulder; This case was reported by a consumer and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced shoulder pain and localized muscle weakness. On an unknown date, the outcome of the shoulder pain and localized muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and localized muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and weakness in my right shoulder right away after vaccination and had continued to the date of report which was three and half months since the vaccine was administered. The patient had been going to physical therapy with minimal positive results. No further information to offer other than what was in customer email.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling
Clinical narrative: pain in my right shoulder; weakness in my left shoulder; This case was reported by a consumer and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced shoulder pain and localized muscle weakness. On an unknown date, the outcome of the shoulder pain and localized muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and localized muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and weakness in my right shoulder right away after vaccination and had continued to the date of report which was three and half months since the vaccine was administered. The patient had been going to physical therapy with minimal positive results. No further information to offer other than what was in customer email.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: muscle pain at the site; Fatigue; headache; upset stomach; muscle pain is now in both arms; It is affecting my life in an extraordinary way; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, immediately after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult per the vaccine indication. Immediately following the injection the patient experienced muscle pain at the site, fatigue, headache, upset stomach.  The muscle pain in both arms and continues to the date of reporting. The patient treated with Tylenol or Ibuprofen had no effect on the pain. The patient asked how can he get rid of this pain It was affecting my life in an extraordinary way.  The patient was afraid to get the 2nd dose for fear my symptoms would become worse. The patient asking for recommendation.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: muscle pain at the site; Fatigue; headache; upset stomach; muscle pain is now in both arms; It is affecting my life in an extraordinary way; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, immediately after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, headache, upset stomach, muscle pain and loss of personal independence in daily activities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult per the vaccine indication. Immediately following the injection the patient experienced muscle pain at the site, fatigue, headache, upset stomach.  The muscle pain in both arms and continues to the date of reporting. The patient treated with Tylenol or Ibuprofen had no effect on the pain. The patient asked how can he get rid of this pain It was affecting my life in an extraordinary way.  The patient was afraid to get the 2nd dose for fear my symptoms would become worse. The patient asking for recommendation.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Blister, Myalgia, Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: rash on chest, arms and left leg; Blisters on chest; experienced itching; Muscle ache; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix (received 1st dose, on an unknown date. For tolerece with 1st dose, refer linked case US2020AMR028692.).   On 23rd January 2020, the patient received the 1st dose of Shingrix (intramuscular) and Hepatitis A vaccine. On 24th January 2020, 1 days after receiving Shingrix and Hepatitis A vaccine, the patient experienced rash, blister, pruritus and muscle pain. Rechallenge with Shingrix was positive. Rechallenge with Hepatitis A vaccine was positive. On an unknown date, the outcome of the rash, blister, pruritus and muscle pain were unknown.   It was unknown if the reporter considered the rash, blister, pruritus and muscle pain to be related to Shingrix and Hepatitis A vaccine.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years.  Patient received the second dose of Shingrix and Hepatitis A vaccine at the same time. After receiving Shingrix, the patient experienced rash on chest, arms and left leg.  The patient also experienced itching, muscle ache and blisters on chest.  No further details were provided.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperaesthesia, Influenza like illness
Clinical narrative: whole left arm pain/left arm injection site pain; injection site sensation of warmth; sensitivity to touch; extreme body pain; extreme fatigue; flu-like symptoms; shivering; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent were unknown.   It was unknown if the reporter considered the pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced left arm injection site pain with injection site sensation of warmth with sensitivity to touch.  Then within 6 hours, the patient started to experience whole left arm pain with extreme body pain, with extreme fatigue with flu-like symptoms which included shivering.  The patient also reported he had lack of appetite. The reporter was consented to follow up. This case was linked with case US2020028078, reported by the same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pain in extremity
Clinical narrative: whole left arm pain/left arm injection site pain; injection site sensation of warmth; sensitivity to touch; extreme body pain; extreme fatigue; flu-like symptoms; shivering; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent were unknown.   It was unknown if the reporter considered the pain in arm, injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, shivering and appetite absent to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced left arm injection site pain with injection site sensation of warmth with sensitivity to touch.  Then within 6 hours, the patient started to experience whole left arm pain with extreme body pain, with extreme fatigue with flu-like symptoms which included shivering.  The patient also reported he had lack of appetite. The reporter was consented to follow up. This case was linked with case US2020028078, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular, Skin exfoliation
Clinical narrative: fever; rash surrounding his wrist; The rash had blistered; The rash had blistered and peeled; This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 03rd November 2019, received 1st dose. For tolerance of 1st dose refer case US2020AMR028715.).   On 29th January 2020, the patient received the 2nd dose of Shingrix. On 5th February 2020, 7 days after receiving Shingrix, the patient experienced fever, rash, blistery rash and peeling. The patient was treated with medication unknown (Topical Cream) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the fever was unknown and the outcome of the rash, blistery rash and peeling were not recovered/not resolved.   It was unknown if the reporter considered the fever, rash, blistery rash and peeling to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed a fever and a rash surrounding his wrist, where he normally wears his watch.  He removed the watch, but the rash began to move up the arm about 6-8 inches above the wrist. The size was about that of a dime.  The rash had blistered and peeled. This case was linked with case US2020AMR028715, reported by the same reporter for the same patient.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Events: Pain, Swelling, Fever, Localized redness of the skin Treatment: Went to PCP was treated and prescribed Benadryl, discussed with providers Outcome: after taking Benadryl, symptoms immediately were resolved
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash pruritic, Smear test, Varicella virus test positive
Clinical narrative: Patient started getting itchy, burning rash on frontal scalp 20-22 hours after receiving 2nd Shingrix dose.  Patient presented to my office on 2/5/2020 and viral culture was performed.  Viral culture was positive for VZV.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Lethargy, Nausea, Vomiting
Clinical narrative: PM on the day after vaccination(2/19/20) patient was lethargic, no fever or chills & injection sites wnl, early evening he was nauseated and vomited x1, did not seek medical attention and did not give any medication for symptoms. Today 2/26/20 Mom called in to report this, stating patient appears a little better but still lethargic according to Mom. Advised her to take patient to PCP and I will follow up with her tomorrow to see how he is doing.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal disorder, Pain in extremity, X-ray
Clinical narrative: Pain in arm and unable to use arm.Went to my primary care physician who referred me to orthopedic doctor.Dr did steroid injection and i have had no more pain since then .
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Per Patient-  Yearly flu vaccine received at facility flu clinic on 10/2/19 at 2:10 pm.  Noted injection to left arm felt more painful than prior immunizations.  RN administering injection stated "I can't push this because you're tense.  You need to relax".  Effort made to relax arm and injection was given.  Noted soreness/pain with movement approximatley 10 minutes after injection.  Bt 4 pm, the pain was severe enough to limit range of motion and activity.  Pain and limited ROM made physical activity/exercise not possible.  Symptoms persisted from this point on.  Nurse manager notified of symptoms after they continued for 2 weeks.  Employee Health also notified.  PCP notified and assessed shoulder pain at yearly visit, referred to Physical Therapy at that time (10/16/2019).  Outpatient Physical Therapy provided streching and strengthening exercises to be prefromed at home.  Exercises performed each day as instructed with no change in symptoms.  Presented to urgent care for severe pain on 11/18/2019.  X-ray performed & discharged with short course Prednisone.  Prednisone provided no releif of symptoms.  Appt. with PA at Dr. (ortho) office on 12/16/2019-Refered to Occupational Therapy.  Seven OT visits completed between 1/15/20-2/6/20 with no change in symptoms (pain, stiffness, decreased ROM).  Follow up orthopedic appt. approx. 1/26/20-MRI ordered.  MRI performed 2/3/2020.  Follow up with orthopedic surgeon on 2/14/2020.  One time Cortisone injection performed at this time.  Follow up scheduled 6 weeks out (not attended yet).  Some relief of symptoms noted, however, over head reaching motion still somewhat painful, in addition to reaching across body.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Per Patient-  Yearly flu vaccine received at facility flu clinic on 10/2/19 at 2:10 pm.  Noted injection to left arm felt more painful than prior immunizations.  RN administering injection stated "I can't push this because you're tense.  You need to relax".  Effort made to relax arm and injection was given.  Noted soreness/pain with movement approximatley 10 minutes after injection.  Bt 4 pm, the pain was severe enough to limit range of motion and activity.  Pain and limited ROM made physical activity/exercise not possible.  Symptoms persisted from this point on.  Nurse manager notified of symptoms after they continued for 2 weeks.  Employee Health also notified.  PCP notified and assessed shoulder pain at yearly visit, referred to Physical Therapy at that time (10/16/2019).  Outpatient Physical Therapy provided streching and strengthening exercises to be prefromed at home.  Exercises performed each day as instructed with no change in symptoms.  Presented to urgent care for severe pain on 11/18/2019.  X-ray performed & discharged with short course Prednisone.  Prednisone provided no releif of symptoms.  Appt. with PA at Dr. (ortho) office on 12/16/2019-Refered to Occupational Therapy.  Seven OT visits completed between 1/15/20-2/6/20 with no change in symptoms (pain, stiffness, decreased ROM).  Follow up orthopedic appt. approx. 1/26/20-MRI ordered.  MRI performed 2/3/2020.  Follow up with orthopedic surgeon on 2/14/2020.  One time Cortisone injection performed at this time.  Follow up scheduled 6 weeks out (not attended yet).  Some relief of symptoms noted, however, over head reaching motion still somewhat painful, in addition to reaching across body.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Lethargy, Swelling
Clinical narrative: Mother called clinic this morning and report that wear child received DTaP-IPV vaccine she has a large red and swollen bump and has been lethargic since last night. Mother encouraged to see child's pediatrician or emergency clinic if symptoms persist or become worse.Mother stated she has applied a cool compress to area and given child Tylenol.  Mother stated she would take child intro health care provider as soon as possible.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: immediate local reaction. raised, hard swelling at site of injection approx. 1" in diameter.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: patient had injection site rash; injection site ras with swelling; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly, lot # S026366, expiration date 17-SEP-2020 (exact dose and dose # were not provided) for prophylaxis. On the same day, the patient experienced injection site rash with swelling and was hospitalized on an unknown date. The outcome of the event was not provided.   The relatedness between suspect therapy and the events was not provided.
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional symptoms were reported; that a 5 year old patient was inadvertently administered GARDASIL 9; Information has been received from a medical assistant, referring to a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 21-FEB-2020, the patient was inadvertently administered 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route were unknown; lot # R025728 and expiration date 18-JUN-2021) (product administered to patient of inappropriate age). No additional symptoms were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Myalgia
Clinical narrative: had sore muscles all over; can barely walk; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain and walking difficulty. On an unknown date, the outcome of the muscle pain and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The case was reported by the sister of the patient. The patient received Shingrix and had sore muscles all over. She could barely walk. The reporter asked was this normal and what should she do.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling cold, Hyperaesthesia, Influenza like illness
Clinical narrative: injection site sensation of warmth; sensitivity to touch; injection site pain/whole left arm pain / arm soreness and tenderness; tenderness; extreme body pain; extreme fatigue; flu-like symptoms; feeling cold; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than an hour after receiving Shingrix, the patient experienced injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent were recovered/resolved and the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced injection site pain with injection site sensation of warmth with sensitivity to touch.  Then within 6 hours, the patient started to experienced whole left with extreme body pain, with extreme fatigue with flu-like symptoms which includes feeling cold.  The patient also reported lack of appetite. The reporter was consented to follow up. This case was linked with case US2020028081, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pain in extremity, Tenderness
Clinical narrative: injection site sensation of warmth; sensitivity to touch; injection site pain/whole left arm pain / arm soreness and tenderness; tenderness; extreme body pain; extreme fatigue; flu-like symptoms; feeling cold; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than an hour after receiving Shingrix, the patient experienced injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent were recovered/resolved and the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced injection site pain with injection site sensation of warmth with sensitivity to touch.  Then within 6 hours, the patient started to experienced whole left with extreme body pain, with extreme fatigue with flu-like symptoms which includes feeling cold.  The patient also reported lack of appetite. The reporter was consented to follow up. This case was linked with case US2020028081, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dyspepsia, Headache
Clinical narrative: headache; Stomachache; Digestive problems; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, stomach pain and digestion impaired. On an unknown date, the outcome of the headache, stomach pain and digestion impaired were unknown.   It was unknown if the reporter considered the headache, stomach pain and digestion impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed adverse reactions headache, stomachache, digestive problems.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Sudden hearing loss, Vision blurred
Clinical narrative: sudden hearing loss in her right ear; worsening vision in her right eye, described as vision being not as clear or precise as it used to be; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 2 weeks after receiving Shingrix, the patient experienced sudden hearing loss (serious criteria GSK medically significant) and blurred vision. The patient was treated with prednisone. On an unknown date, the outcome of the sudden hearing loss was not recovered/not resolved and the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the sudden hearing loss and blurred vision to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, but it could be 57 or 58 years old. Two weeks after vaccination, the patient experienced sudden hearing loss in her right ear for which she visited specialists and took a course of prednisone with no resolution. The patient also experienced worsening vision in her right eye, described as vision being not as clear or precise as it used to be. The reporter consented to follow up. Emergency room visit was required. No further details were available. This case had been linked with US2020033015, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: sudden hearing loss; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sudden hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the sudden hearing loss was unknown.   It was unknown if the reporter considered the sudden hearing loss to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced sudden hearing loss after getting a dose of Shingrix. No further details were available. This case had been linked with US2020033014, reported by same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: After having started a prescription for Diltiazem 120mg ER on Jan. 3, developed severely itchy, red skin rash, breaking out beginning Jan. 12. Had also received second Shingrix injection on Jan. 8 (no reaction to first shot, other than fever and aches on day after, same had occurred after the second dose). Rash was sufficiently alarming to cause a visit to urgent care (prescribed topical steroid cream and suggested using Benadryl) on Jan. 12; visited primary care doctor on Jan. 13 as rash continued to spread, covering trunk, arms and legs to knees. Doctor prescribed a course of oral prednisone plus continuing Benadryl. Itching stopped in a couple of days; rash gradually faded over 3 weeks. I had stopped Diltiazem on Jan. 12, on my own decision; primary care doctor agreed as did cardiologist on Jan. 13.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Herpes zoster, Nausea, Nightmare
Clinical narrative: I am 75 years old and have had shingles during 2019. On 02/06/20 I had the second Shingrix shot and about 8 hours later had a severe fever, frozen chills, nausea, exhaustion and nightmares.20 hours after the shot I was exhausted but recovering.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I am 75 years old and have had shingles during 2019. On 02/06/20 I had the second Shingrix shot and about 8 hours later had a severe fever, frozen chills, nausea, exhaustion and nightmares.20 hours after the shot I was exhausted but recovering.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient said she has an extremely sore and swollen arm. Wasn't aware this could happen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, fever, chills, muscle ache, nausea for 36 hours
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, fever, chills, muscle ache, nausea
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Laboratory test, Pathology test
Clinical narrative: Infant received vaccines morning of 2/20. At some point overnight between 2/20 and 2/21 the infant expired at home and was found deceased by his mother in the morning. We do not have further details but the death is being investigated by the Coroner's office.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Condition aggravated, Erythema, Injection site erythema, Injection site pain
Clinical narrative: 2-24-20 Child injured L hand with nail outside of home in the morning. Visited Health Department, received vaccinations as listed above.   2-25-20 child noted both hand at puncture site and L deltoid were sore and warm/red, applied ice packs 2-26-20 visited medical clinic per medical note: " Musculoskeletal: Normal range of motion and strength. Left deltoid has area of erythema surrounding injection site 8cm x 10cm. Warm to the touch, Left thenar eminence puncture site has surrounding erythema 3x4cm in size. Tender to the touch. Skin is warm, dry and pink, no rashes or lesions, no edema." Treatment: Vaccination reaction: cool packs to the site of injection. Benadryl 25mg at HS. Monitor site for worsening, Report to clinic if worsening.  Cellulitis of left hand: Keflex PO BID x 10 days. Report any further swelling, pain, drainage or worsening to the area. Follow up 2-28-20 if no improvement
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site warmth, Skin warm, Tenderness, Wound complication
Clinical narrative: 2-24-20 Child injured L hand with nail outside of home in the morning. Visited Health Department, received vaccinations as listed above.   2-25-20 child noted both hand at puncture site and L deltoid were sore and warm/red, applied ice packs 2-26-20 visited medical clinic per medical note: " Musculoskeletal: Normal range of motion and strength. Left deltoid has area of erythema surrounding injection site 8cm x 10cm. Warm to the touch, Left thenar eminence puncture site has surrounding erythema 3x4cm in size. Tender to the touch. Skin is warm, dry and pink, no rashes or lesions, no edema." Treatment: Vaccination reaction: cool packs to the site of injection. Benadryl 25mg at HS. Monitor site for worsening, Report to clinic if worsening.  Cellulitis of left hand: Keflex PO BID x 10 days. Report any further swelling, pain, drainage or worsening to the area. Follow up 2-28-20 if no improvement
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Seizure like phenomena, Syncope, Urinary incontinence
Clinical narrative: After receiving the Gardasil shot for the 2nd time- my son fainted, presented seizure like activity, lost consciousnesses, urinated o himself. These symptoms presented were more extreme the second time.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Several hours after Pneumovax 23 injection my entire deltoid muscle was severely swollen. I had a rash that covered my upper arm. That night I had severe chills. The next day my arm was swollen from my shoulder all the way down to my elbow with redness that covered my entire upper arm and into my left axillary area. The chills continued through the second. I am an RN and my arm looked so bad I thought I had cellulitis that had developed in the arm. Third day after my arm is still swollen and red although not quite as bad. I did seek medical help at a walk in clinic because I thought it was cellulitis. I will never take this infection again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I had my Shingrex (2nd one) vaccine and developed a fever of 101 with some arm soreness and muscle aches. It's worth it to avoid a Shingles outbreak but I felt this should be reported for better accuracy in how many people experience these side-effects.
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: My 12 year old daughter had a reaction to th HPV 9 shot. She received it 11/26/2019. Within 3 weeks, she started having low platelets. She was diagnosed with ITP 1/7/2020. This is currently an ongoing problem. Her body is continuing to make antibodies that are destroying her own platelets. She was a healthy, normal, active athlete before this shot.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Biopsy, Death, Diarrhoea, Graft versus host disease in gastrointestinal tract
Clinical narrative: Patient received the Fluarix Quadrivalent vaccination on 01/15/2020, approximately 6 months after his stem cell transplant. The next day he developed diarrhea that progressed over the weekend with abdominal pain and cramping requiring hospital admission. Upon admission he was found to have acute graft-versus-host disease (GVHD) of the GI tract, potentially incited by the immune activation from his influenza vaccination. Unfortunately the patient's GVHD was refractory to multiple lines of therapy and led to his death less than a month after presentation.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms
Clinical narrative: Patient received the Fluarix Quadrivalent vaccination on 01/15/2020, approximately 6 months after his stem cell transplant. The next day he developed diarrhea that progressed over the weekend with abdominal pain and cramping requiring hospital admission. Upon admission he was found to have acute graft-versus-host disease (GVHD) of the GI tract, potentially incited by the immune activation from his influenza vaccination. Unfortunately the patient's GVHD was refractory to multiple lines of therapy and led to his death less than a month after presentation.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: I had the first dose of the Shingrix vaccine. I was not told that the next day I would have pain so bad in my right shoulder that I could barely move my arm. I remain in a lot of pain 2 days after the shot. The pain makes it difficult to sleep or to function.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Extreme flu like symptoms. Fever of 100° - 24 hrs three days of reaction, close to making 911 call at 3:00 am, but waited it out until evening of Feb 12th. I live in rural area w/o urgent care facility. 1st injection 2 mos. prior or w/o adverse event. If so, would not have 2nd done.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Bowel movement irregularity, Chills, Diarrhoea, Dizziness
Clinical narrative: One week after receiving her annual influenza vaccination November 2017, patient experienced an acute onset of nausea and lightheadedness while standing, not associated with her usual groin/pelvic pain, eating, or sudden position change. Within 24-48 hrs she experienced lower extremity tremulousness "like a chill" affecting her from the waist down. Others were able to observe the shaking of her legs.  Over the next 8-10 hours, the tremors would last about 5-10 minutes, abate for 1-2 hrs, and then return without apparent stimulus.  She also noticed an icy-hot' sensation over various parts of her body at various times.  [Continued]  The distribution did not seem to follow a dermatomal pattern.  While the icy-hot' symptoms and pain seemed to slowly diminish in frequency, duration, and intensity over the 4-6 months, the bouts of nausea seemed to persist, with the additional onset of bowel and bladder symptoms.  Her stooling become irregular starting with explosive diarrhea then several days of constipation followed by several months of irregularity. She also experienced bouts of urinary urgency. During this time she lost over 15 lbs from anorexia due to her nausea.  Between Feb and Apr 2018, she experienced several bouts of "low blood pressure".  Her groin/pelvic pain seemed to diminish after a uterine infection was found and she was treated with Flagyl.  Her symptoms have been extensively evaluated by urology, rheumatology, neurology, urogynecology, and gastroenterology with no definitive diagnosis forthcoming. She began to experience an intense sandpapery', lightening-like sensation that radiated under her right ribs to her pelvic area, again not precipitated by movement or other identified activities.  This pain, and later lower back pain, decreased significantly with physical therapy.  She has been treated with magnesium and Vit D with some improvement. Bladder infusions with heparin, antibiotics, and lidocaine had only partial relief.  She underwent pelvic floor PT for several months, although does not complain of dyspareunia or other sexual dysfunction.  She has not experienced vaginal, ocular, or oral dryness.  Over the past two years, her symptoms have slowly improved, such that today, she experiences only an unusual transient (5-10 seconds) deep buzzing' sensation in her right abdomen if she lays on her right side or stomach and sharp pain in both her feet.  Working diagnosis: resolving small fiber neuropathy
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling of body temperature change, Groin pain, Hypotension, Nausea, Pain
Clinical narrative: One week after receiving her annual influenza vaccination November 2017, patient experienced an acute onset of nausea and lightheadedness while standing, not associated with her usual groin/pelvic pain, eating, or sudden position change. Within 24-48 hrs she experienced lower extremity tremulousness "like a chill" affecting her from the waist down. Others were able to observe the shaking of her legs.  Over the next 8-10 hours, the tremors would last about 5-10 minutes, abate for 1-2 hrs, and then return without apparent stimulus.  She also noticed an icy-hot' sensation over various parts of her body at various times.  [Continued]  The distribution did not seem to follow a dermatomal pattern.  While the icy-hot' symptoms and pain seemed to slowly diminish in frequency, duration, and intensity over the 4-6 months, the bouts of nausea seemed to persist, with the additional onset of bowel and bladder symptoms.  Her stooling become irregular starting with explosive diarrhea then several days of constipation followed by several months of irregularity. She also experienced bouts of urinary urgency. During this time she lost over 15 lbs from anorexia due to her nausea.  Between Feb and Apr 2018, she experienced several bouts of "low blood pressure".  Her groin/pelvic pain seemed to diminish after a uterine infection was found and she was treated with Flagyl.  Her symptoms have been extensively evaluated by urology, rheumatology, neurology, urogynecology, and gastroenterology with no definitive diagnosis forthcoming. She began to experience an intense sandpapery', lightening-like sensation that radiated under her right ribs to her pelvic area, again not precipitated by movement or other identified activities.  This pain, and later lower back pain, decreased significantly with physical therapy.  She has been treated with magnesium and Vit D with some improvement. Bladder infusions with heparin, antibiotics, and lidocaine had only partial relief.  She underwent pelvic floor PT for several months, although does not complain of dyspareunia or other sexual dysfunction.  She has not experienced vaginal, ocular, or oral dryness.  Over the past two years, her symptoms have slowly improved, such that today, she experiences only an unusual transient (5-10 seconds) deep buzzing' sensation in her right abdomen if she lays on her right side or stomach and sharp pain in both her feet.  Working diagnosis: resolving small fiber neuropathy
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pelvic pain, Pollakiuria, Sensory disturbance, Small fibre neuropathy
Clinical narrative: One week after receiving her annual influenza vaccination November 2017, patient experienced an acute onset of nausea and lightheadedness while standing, not associated with her usual groin/pelvic pain, eating, or sudden position change. Within 24-48 hrs she experienced lower extremity tremulousness "like a chill" affecting her from the waist down. Others were able to observe the shaking of her legs.  Over the next 8-10 hours, the tremors would last about 5-10 minutes, abate for 1-2 hrs, and then return without apparent stimulus.  She also noticed an icy-hot' sensation over various parts of her body at various times.  [Continued]  The distribution did not seem to follow a dermatomal pattern.  While the icy-hot' symptoms and pain seemed to slowly diminish in frequency, duration, and intensity over the 4-6 months, the bouts of nausea seemed to persist, with the additional onset of bowel and bladder symptoms.  Her stooling become irregular starting with explosive diarrhea then several days of constipation followed by several months of irregularity. She also experienced bouts of urinary urgency. During this time she lost over 15 lbs from anorexia due to her nausea.  Between Feb and Apr 2018, she experienced several bouts of "low blood pressure".  Her groin/pelvic pain seemed to diminish after a uterine infection was found and she was treated with Flagyl.  Her symptoms have been extensively evaluated by urology, rheumatology, neurology, urogynecology, and gastroenterology with no definitive diagnosis forthcoming. She began to experience an intense sandpapery', lightening-like sensation that radiated under her right ribs to her pelvic area, again not precipitated by movement or other identified activities.  This pain, and later lower back pain, decreased significantly with physical therapy.  She has been treated with magnesium and Vit D with some improvement. Bladder infusions with heparin, antibiotics, and lidocaine had only partial relief.  She underwent pelvic floor PT for several months, although does not complain of dyspareunia or other sexual dysfunction.  She has not experienced vaginal, ocular, or oral dryness.  Over the past two years, her symptoms have slowly improved, such that today, she experiences only an unusual transient (5-10 seconds) deep buzzing' sensation in her right abdomen if she lays on her right side or stomach and sharp pain in both her feet.  Working diagnosis: resolving small fiber neuropathy