chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Anaphylactic shock, Asthenia
Clinical narrative: Patient went into an anaphylactic shock. Face turned blood red, patient had trouble breathing and tightness in his chest. I had to administer the shot of Epipen immediately and called 911 for further assistance. Patient was taken to the nearby ER for further examination. Patient came back to the pharmacy later that evening to let us know that he was feeling much better.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV, PPV
Symptoms: Anaphylactic shock, Chest discomfort, Dyspnoea, Erythema
Clinical narrative: Patient went into an anaphylactic shock. Face turned blood red, patient had trouble breathing and tightness in his chest. I had to administer the shot of Epipen immediately and called 911 for further assistance. Patient was taken to the nearby ER for further examination. Patient came back to the pharmacy later that evening to let us know that he was feeling much better.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Myalgia
Clinical narrative: Two days after vaccination patient reported severe diffuse muscle and bone pain that has persisted for 1 month duration
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: significant fatigue, chills, nausea, headache
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Myalgia
Clinical narrative: Two days after vaccination patient reported severe diffuse muscle and bone pain that has persisted for 1 month duration
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lethargy
Clinical narrative: First symptom was pain at shot site.  Woke up early in morning feeling a bit nauseous and chilled but not too bad.  very tired when walking dog at 7:30 a.m. and on way to work, heart seemed to be racing.  Was concerned but not overly so.  Have had a headache all day long and a bit nauseous and chilled throughout evening.  Fairly lethargic all afternoon, and left work early. 9:30 p.m. and head still aches. Arm still quite sore. Did not have any side effects with first shot except sore arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Palpitations
Clinical narrative: First symptom was pain at shot site.  Woke up early in morning feeling a bit nauseous and chilled but not too bad.  very tired when walking dog at 7:30 a.m. and on way to work, heart seemed to be racing.  Was concerned but not overly so.  Have had a headache all day long and a bit nauseous and chilled throughout evening.  Fairly lethargic all afternoon, and left work early. 9:30 p.m. and head still aches. Arm still quite sore. Did not have any side effects with first shot except sore arm.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Axillary pain, Decreased appetite, Fatigue, Headache
Clinical narrative: High fever, Headache, severe left arm pain radiating to shoulder down under armpit and left chest wall, severe swelling and redness at vaccine site, loss of appetite, fatigue, increase daytime sleepiness, increased weakness  Symptoms began approximately 28 hours after receiving vaccine.  Received flu shot the same day on same arm but flu shot was given slightly above where pneumonia shot was given (shots were given about 1 inch apart).  I asked nurse if it was ok to get both shots in same arm and was told it was fine.  I did not receive vaccine information sheets for either of the vaccinations I received and had to look up the information myself.  I reported my symptoms to my doctor on 10/15/19 at 9am and did not received response back.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Pyrexia, Somnolence, Vaccination site swelling
Clinical narrative: High fever, Headache, severe left arm pain radiating to shoulder down under armpit and left chest wall, severe swelling and redness at vaccine site, loss of appetite, fatigue, increase daytime sleepiness, increased weakness  Symptoms began approximately 28 hours after receiving vaccine.  Received flu shot the same day on same arm but flu shot was given slightly above where pneumonia shot was given (shots were given about 1 inch apart).  I asked nurse if it was ok to get both shots in same arm and was told it was fine.  I did not receive vaccine information sheets for either of the vaccinations I received and had to look up the information myself.  I reported my symptoms to my doctor on 10/15/19 at 9am and did not received response back.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: Chills, low-grade fever, joint pain, fatigue, reaction time delayed/much slower than usual
Age: 22.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash on both arms that lasts longer than 10 days and is growing worse if not helped by doctors. Very itchy sometimes.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Asthenia, Cough, Crying, Fatigue
Clinical narrative: April 8, 2019- gets a normal cold but body is unable to fight it and gets sicker than we have ever seen her; appears "defenseless."  Lasts for a week. April 16, 2019- gets severe flu symptoms with high fever and non-stop throwing up.  Immune system seems severely compromised. Lost 5-7 pounds and sick for a week. Thin and week for weeks after. May 16, 2019- in the evening, out of character panic and fit of crying along with a "desperate" need for food and water. Never observed this behavior in her, even as a young child. June 1, 2019- VERY sick again with extremely high fever (105-106). Severe chest cough. Never experienced either this level of fever or this severe a chest cough. Immune system seems very compromised. She is exhausted, loses weight again and remains week even after symptoms resolve more than a week later.  June 12, 2019- receive treatment plan to strengthen immune system. Hasn't been sick since. Still on that treatment plan now. (When she was little and got her Dtaps in a row, she developed a chronic cough that lasted for 6 months until we got a proper diagnosis and treatment).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Hunger, Immune system disorder, Influenza, Malaise, Nasopharyngitis
Clinical narrative: April 8, 2019- gets a normal cold but body is unable to fight it and gets sicker than we have ever seen her; appears "defenseless."  Lasts for a week. April 16, 2019- gets severe flu symptoms with high fever and non-stop throwing up.  Immune system seems severely compromised. Lost 5-7 pounds and sick for a week. Thin and week for weeks after. May 16, 2019- in the evening, out of character panic and fit of crying along with a "desperate" need for food and water. Never observed this behavior in her, even as a young child. June 1, 2019- VERY sick again with extremely high fever (105-106). Severe chest cough. Never experienced either this level of fever or this severe a chest cough. Immune system seems very compromised. She is exhausted, loses weight again and remains week even after symptoms resolve more than a week later.  June 12, 2019- receive treatment plan to strengthen immune system. Hasn't been sick since. Still on that treatment plan now. (When she was little and got her Dtaps in a row, she developed a chronic cough that lasted for 6 months until we got a proper diagnosis and treatment).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Panic reaction, Pyrexia, Thirst, Vomiting, Weight decreased
Clinical narrative: April 8, 2019- gets a normal cold but body is unable to fight it and gets sicker than we have ever seen her; appears "defenseless."  Lasts for a week. April 16, 2019- gets severe flu symptoms with high fever and non-stop throwing up.  Immune system seems severely compromised. Lost 5-7 pounds and sick for a week. Thin and week for weeks after. May 16, 2019- in the evening, out of character panic and fit of crying along with a "desperate" need for food and water. Never observed this behavior in her, even as a young child. June 1, 2019- VERY sick again with extremely high fever (105-106). Severe chest cough. Never experienced either this level of fever or this severe a chest cough. Immune system seems very compromised. She is exhausted, loses weight again and remains week even after symptoms resolve more than a week later.  June 12, 2019- receive treatment plan to strengthen immune system. Hasn't been sick since. Still on that treatment plan now. (When she was little and got her Dtaps in a row, she developed a chronic cough that lasted for 6 months until we got a proper diagnosis and treatment).
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash erythematous, Skin erosion
Clinical narrative: My 12 mo received the MMR+V on 10/14/19 and developed an awful rash on his buttocks on 10/15/19. Red, raw, and very painful.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Lip swelling, Oropharyngeal discomfort
Clinical narrative: 07:35 Flu shot given, 7:40am  starting feeling weak, dizzy and pressure in throat and puffy lips. Went to the ED immediately  and was put on IV of  Benadryl, decatron  and pepcide .  Observered for 2 hours then given  PO dose of decadron  when discharged and instructed to take the dose of decadron 48 hours after she left and benadryl  q6hours and pepcide q24 hours
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Rash
Clinical narrative: The Patient's Mother noticed a small rash once they got home from the office. The rash continued to increase in size; patient inadvertently received a third dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 6 years old female patient. The patient's concurrent condition included food (peanuts) allergy. Drug reactions/allergies included amoxicillin. The patient had no concomitant medications.  On 03-SEP-2019, the patient inadvertently received a third dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not reported) (lot# reported as Z002507, expiration date: 04-APR-2020) intramuscularly for prophylaxis (extra dose administered) because the medical record was not showing that she had received it already. After the third dose had been given, reconciliation of the medical record showed 3 doses. Lot # Z002507 is an invalid lot number for hepatitis a vaccine, inactivated.  On the same day, the patient's mother noticed a small rash once they got home from the office. The rash continued to increase in size. On 04-SEP-2019, the patient was seen by her physician. The patient was advised to be watched and go to urgent care if worsened or short of breath. No lab diagnostics/studies were performed. The mother did not report itching, hives or shortness of breath. Around 12-SEP-2019, the patient recovered from the event.   The causality assessment between hepatitis a vaccine, inactivated (VAQTA) and the event was not provided.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No adverse effects were reported.; Patient received improperly stored PNEUMOVAX 23.; This spontaneous report was received from a Vaccine coordinator referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 11-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # R033079 and expiration date 06-JUN-2020 for prophylaxis.       The administered dose of vaccine experienced the temperature excursion of minimum 32°F degrees Fahrenheit for and unknown time frame, and had no previous temperature excursion nor a digital data logger involved.; Sender's Comments:  US-009507513-1910USA010401:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: An adult patient received a pediatric dose of VAQTA; An adult patient received a pediatric dose of VAQTA; No known adverse effects; This spontaneous report was received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose and route of administration were not reported, lot number R030115 has been verified to be a valid lot number, and expiration date: 29-DEC-2019), indicated for prophylaxis (incorrect dose administered and underdose). No adverse effects were known.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA005274:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: received improperly stored vaccine; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) lot # S003865, expiration date: 08-AUG-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion at 32.5 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) lot # S007075, expiration date: 06-SEP-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose experienced the temperature excursions of 32.5 degrees Fahrenheit (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) lot # S003865, expiration date: 08-AUG-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Administered dose experienced the temperature excursions of 32.5 degrees Fahrenheit (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around March 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event vision loss was not recovered. The lawyer considered vision loss to be related to zoster vaccine live (ZOSTAVAX).   The event vision loss was considered by the lawyer as disability.  Upon internal review, the event vision loss was determined to be medically significant event.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; one pediatric dose inadverently administered; This spontaneous report was received from a health care professional regarding a 62-year-old non-pregnant female patient. The patient's relevant medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 11-OCT-2019, the patient was inadvertently vaccinated with one pediatric dose of VAQTA (strength, frequency and route not reported) lot # S005723 and expiry date :10-JUL-2020 for prophylaxis instead of an adult dose (product administered to patient of inappropriate age). No adverse effects were reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Serum sickness, Swelling
Clinical narrative: Swelling; redness; dimpling; serum sickness; This spontaneous report was received from a medical assistant referring to a 67-year-old female patient. Her concurrent conditions included gastrooesophageal reflux disease (GERD), hypertension, hyperlipidaemia, hypothyroidism, erythrocytosis, obesity and drug hypersensitivity to amoxicilline and demerol. Her historical drugs included amoxicilline and Demerol. Her drug reactions/allergies included allergy to amoxicilline and demerol. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, amlodipine, clobetasol propionate, olmesartan medoxomil and metformin.   On 08-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S021740 and expiration date: 25-MAR-2021) intramuscularly for prophylaxis. On 10-OCT-2019, the patient experienced serum sickness, erythema, injection site reaction and swelling. The patient had office visit and sought medical attention. It was unknown whether the patient was treated for the events and any lab diagnostics/studies were performed. The outcome of swelling, serum sickness, erythema and injection site reaction was reported as unknown. Causality assessment of the events were not provided. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 01-OCT-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012246 and expiration date: 10-FEB-2021) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (product storage error). No adverse effects were reported. The administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced temperature excursion at 68ºF for a time frame of eight hours. The previous temperature excursion occurred at 57ºF for 2 hours. The call was due to digital data logger. The outcome of the product storage error was unknown.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: The patient experienced diaphoresis; Pallor to the extremities; a cold sweat; He almost fainted; This spontaneous report was received from a nurse practitioner concerning an 11-year-old male patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). On the same date, the patient received diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA).  On the same unspecified date, when the patient began to walk out of the nurse practitioner's clinic, he almost fainted (presyncope). Additionally, the patient experienced diaphoresis (hyperhydrosis), pallor to the extremities (pallor) and a cold sweat. On the same date, the patient recovered from the abovementioned adverse events and about half hour later the patient could leave the clinic.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the abovementioned adverse events was not provided.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Hypoaesthesia, Immediate post-injection reaction, Insomnia
Clinical narrative: The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; Pain keep her up all night; Patient's left hand felt numb; Patient's left arm got very painful; This spontaneous information has been received from a registered nurse, concerning a 69-year-old female patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.    On 11-OCT-2019 the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (IM) in the left arm for prophylaxis (reported as routine) (lot number R018731 with expiration date on 27-FEB-2020). On the same date, immediately after getting the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, the patient's left arm  got very painful (vaccination site pain), and the pain kept her up all night (insomnia), and lasted approximately 10-12 hours after getting the vaccine. The patient's left hand felt numb (hypoaesthesia), and the patient had upper back, neck and chest pain. There was no lab diagnostics or studies performed and it was unknown if there was treatment given for the adverse events. The patient recovered from the abovementioned adverse events on 12-OCT-2019.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; The patient had upper back, neck and chest pain; Pain keep her up all night; Patient's left hand felt numb; Patient's left arm got very painful; This spontaneous information has been received from a registered nurse, concerning a 69-year-old female patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.    On 11-OCT-2019 the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (IM) in the left arm for prophylaxis (reported as routine) (lot number R018731 with expiration date on 27-FEB-2020). On the same date, immediately after getting the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, the patient's left arm  got very painful (vaccination site pain), and the pain kept her up all night (insomnia), and lasted approximately 10-12 hours after getting the vaccine. The patient's left hand felt numb (hypoaesthesia), and the patient had upper back, neck and chest pain. There was no lab diagnostics or studies performed and it was unknown if there was treatment given for the adverse events. The patient recovered from the abovementioned adverse events on 12-OCT-2019.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; Patient received improperly stored PNEUMOVAX 23.; This spontaneous report was received from a Vaccine coordinator referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # R033079 and expiration date 06-JUN-2020 for prophylaxis.      The administered dose of vaccine experienced the temperature excursion of minimum 32°F degrees Fahrenheit for and unknown time frame, and had no previous temperature excursion nor a digital data logger involved. No adverse events were reported.; Sender's Comments:  US-009507513-1910USA002523:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Felt lightheaded and dizzy; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix, the patient experienced dizziness. On 12th July 2019, the outcome of the dizziness was resolved with sequelae.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The patient stated that, on the day of vaccination she felt light headed and dizzy. These symptoms resolved. She did not have any further vaccine information for this adverse event. The patient consented to follow up. This case has been linked with case US2019183583, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Fatigue, Headache, Injection site erythema
Clinical narrative: Muscle pain cervical spine area; Headache; Fatigue; Not feeling well; Loss of energy; Pain; swelling; redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the muscle pain, headache, fatigue, feeling unwell and loss of energy were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy to be related to Shingrix.  Additional information received were as follows: The patient developed redness, swelling, and pain at the injection site located in the left deltoid. The symptoms resolved after few days. The patient went on to complain of muscle pain in the head and neck area, no energy and fatigue lasting over several weeks after the vaccination. The patient went and had blood work performed to determine the origin of the symptoms but the reporter did not have the results to report. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Muscle pain cervical spine area; Headache; Fatigue; Not feeling well; Loss of energy; Pain; swelling; redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the muscle pain, headache, fatigue, feeling unwell and loss of energy were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, headache, fatigue, feeling unwell and loss of energy to be related to Shingrix.  Additional information received were as follows: The patient developed redness, swelling, and pain at the injection site located in the left deltoid. The symptoms resolved after few days. The patient went on to complain of muscle pain in the head and neck area, no energy and fatigue lasting over several weeks after the vaccination. The patient went and had blood work performed to determine the origin of the symptoms but the reporter did not have the results to report. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 60 or 61 years. The reporter stated that her friend had the first Shingrix injection, sometime between July 2019 and August 2019 and experienced a bad reaction.   The reporter stated that the patient could not remember what the bad reaction was and had no further information. The patient consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: HPVX
Symptoms: Precancerous cells present, Smear cervix abnormal
Clinical narrative: Got precancerous cells/ pap smear was abnormal; This case was reported by a consumer via interactive digital media and described the occurrence of precancerous cells present in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced precancerous cells present. On an unknown date, the outcome of the precancerous cells present was unknown.   It was unknown if the reporter considered the precancerous cells present to be related to HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported the adverse event happened to someone they knew.  The patient got the HPV shots. The patient's pap came back abnormal months later and got precancerous cells. The reporter also stated nobody believed when they talked about this to peoples.      Lab Comments: On an unknown date, months later, the patient's pap came abnormal and showed Precancerous cells
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Myalgia, Neck pain, Product administered at inappropriate site
Clinical narrative: Pain at injection site; Mild flu-like symptoms; Mild fever; Sore neck; Generalized myalgia; Shot felt as though it went too high into their shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, flu-like symptoms, fever, neck pain and polymyalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 4 to 6 hours after administration of the vaccine, the patient started to experience symptoms.  He had pain at injection site with moderate intensity, mild flu like symptoms which included a mild fever, sore neck, generalized myalgia.  The patient also reported, that the shot felt as though it went too high into their shoulder but in the heart of their deltoid muscle, which led to vaccine administered at inappropriate site. The pharmacist was standing and he was sitting when the dose was administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at injection site; Mild flu-like symptoms; Mild fever; Sore neck; Generalized myalgia; Shot felt as though it went too high into their shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, flu-like symptoms, fever, neck pain and polymyalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 4 to 6 hours after administration of the vaccine, the patient started to experience symptoms.  He had pain at injection site with moderate intensity, mild flu like symptoms which included a mild fever, sore neck, generalized myalgia.  The patient also reported, that the shot felt as though it went too high into their shoulder but in the heart of their deltoid muscle, which led to vaccine administered at inappropriate site. The pharmacist was standing and he was sitting when the dose was administered. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain, Syncope
Clinical narrative: Syncope; Body aches; This case was reported by a nurse via sales rep and described the occurrence of syncope in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant) and general body pain. On an unknown date, the outcome of the syncope and general body pain were unknown.   It was unknown if the reporter considered the syncope and general body pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient went to the emergency room for treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: developed large red, hot swelling at injection site.; redness; hot; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day 12 hrs after receiving Shingrix, the patient experienced injection site swelling, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. A day and a half after receiving Shingrix, the patient developed large red, hot swelling at injection site.  The patient had lot of pain at first, and 2 and half days from injection he pain hadsubsided, but was still red, swollen and hot.  The patient was concerned as to whether or not to have the 2nd dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Hyperhidrosis, Laboratory test normal
Clinical narrative: Chest pains severe enough to cause her to sweat profusely; Sweat profusely; This case was reported by a consumer and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received Shingrix. On 8th October 2019, less than an hour after receiving Shingrix, the patient experienced chest pain and excess sweating. On an unknown date, the outcome of the chest pain and excess sweating were unknown.   It was unknown if the reporter considered the chest pain and excess sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was curious about how to report a potential side effect experienced by his wife. The day before the reporting date, the patient received Shingrix. Within 5 minutes of getting the Shingrix shot, the patient experienced chest pains severe enough to cause her to sweat profusely.  She was taken to the emergency room where they ran tests and were unable to find a cause.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site pain, Myalgia
Clinical narrative: Pain in injection site; Muscle aches; Upset stomach; Chills; This case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, muscle pain, upset stomach and chills. On an unknown date, the outcome of the injection site pain, muscle pain, upset stomach and chills were unknown.   It was unknown if the reporter considered the injection site pain, muscle pain, upset stomach and chills to be related to Shingrix.  Additional details were received as follows: The patient stated, she got the Shingrix injection the day before the reporting date. She experienced a bad side effects which included pain in injection site, muscle aches, upset stomach, chills. The patient did not think, she had a fever yet. She asked, how long these side effects would stay.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: headachy; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were unknown.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient stated, she did not like to provide the exact date of birth due to security reasons. The day before the reporting date, the patient got the Shingrix.  She felt tired and headachy and asked about the duration that, these events could last.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: pain in arm; redness; swelling; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, erythema and swelling. On an unknown date, the outcome of the pain in arm, erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced arm pain, redness and swelling that lasted almost 10 days on 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Flushing, Influenza like illness, Somnolence
Clinical narrative: sleepy; tiredness; weakness; fluish; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced sleepiness, tiredness, weakness and flushing. On an unknown date, the outcome of the sleepiness, tiredness, weakness and flushing were unknown.   It was unknown if the reporter considered the sleepiness, tiredness, weakness and flushing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was sleepy, tired, weak, fluish after receiving Shingrix.  The patient asked how long do the side effects of the Shingrix shot last. The pharmacist stated that the majority of solicited local adverse reactions and general adverse events seen with Shingrix had a median duration of 2 to 3 days. The patient asked if these symptoms were not normal. The patient asked if it was okay for to have the 2nd dose. Or could have milder symptoms the next time?
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red; Warm; This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. On 10th October 2019, 5 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated, she got first shingles shot on Saturday, last week. On the last night before the reporting date, the patient stated it started getting red and was warm.  It was not swollen, was no longer sore or not sore to the touch.  She asked should need to checkup and treatment be sought or just consider these events as common side effects of Shingrix vaccination. To this question, GlaxoSmithKline representative told her that, because each patient's clinical situation is unique, GlaxoSmithKline has no specific recommendations on adverse reaction management. GlaxoSmithKline recommends healthcare providers use their clinical judgment. Specific management of adverse reactions was not studied in the clinical trials of Shingrix and recommend that the patient should speak with the healthcare provider regarding this question as they were able to assist the patient.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feeling awful; This case was reported by a consumer and described the occurrence of feeling unwell in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On 11th October 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient had first Shingles vaccine the day before reporting. The patient had shingles vaccine and felt awful on day of reporting. The reporter requesting consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received Shingrix. In October 2019, 2 hrs after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient took the shingles shot about 2 hours ago and arm felt like it was swelling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Fever; Extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 17th October 2021) for prophylaxis.  On 10th August 2019, the patient received Shingrix. On 10th August 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were reported as follows: The healthcare professional reported that patient received an accidental 3rd dose of Shingrix, which led to extra dose administered. No side effects were reported.  The reporter gave permission to follow up.   Follow up information received from the pharmacist on 9th October 2019:   The patient demographic details was updated. The patient received 0.5 ml dose of vaccine intramuscularly. The patient came to pharmacy and asked to start new Shingrix series.  The patient said his doctor mentioned that there was a new shingles vaccine that recommend to get.  The patient said he never had the vaccine before.  The vaccine was processed and covered by insurance and given upon filling the consent form.  The reporter came upon vaccination from for the patient indicating that he already received two doses. On 10th August 2019, less than a day after vaccination the patient had fever. On 11th August 2019, the patient recovered from fever. The reporter considered the fever to be unlikely related to Shingrix. The VAERS information was updated.