chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash vesicular, Viral rash
Clinical narrative: Viral exanthem; Small red spots began, continued in the following day spreading to most of body; Spots looked like chicken pox/ some spread and became large contagious rash; 1 year old patient received influenza vaccine; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2016US052268US-CHIRONMA-PHHY2016US052268).  This spontaneous report was received from a other health professional and refers to a 1-year-old male patient. The patient concurrent condition included ear infection. There was no information about the patient's concomitant therapies or medical history provided. On 23-FEB-2016, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (manufacturer unknown), influenza virus vaccine (unspecified) (manufacturer unknown), varicella virus vaccine live (oka/merck)(VARIVAX) (manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (manufacturer unknown) 1 dosage form (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for immunisation. On 05-MAR-2016, the patient experienced viral exanthem, small red spots began, continued in the following day spreading to most of body and spots looked like chicken pox/ some spread and became large contagious rash. The outcome of viral rash, rash vesicular and rash erythematous was reported as recovered/resolved. Causality assessment was not provided.   The events of a 1-year-old patient received influenza vaccine, viral exanthem, small red spots began, continued in the following day spreading to most of body and spots looked like chicken pox/ some spread and became large contagious rash were determined to be medically significant.; Sender's Comments:  625949:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I just get shingles again today/Several years ago I got shingles; Information has been downloaded from RA (US-GLAXOSMITHKLINE-US2019AMR227605).  This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.    On an unknown date, the patient was vaccinated with zoster vaccine live (manufacture unknown) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.  On an unknown date (reported as several years ago), the patient got shingles. On unknown dates, the patient got shingles again and experienced suspected vaccination failure. The outcome of suspected vaccination failure was unknown. The outcome of shingles was not recovered. The causality assessments between all events and zoster vaccine live (manufacture unknown) was unknown.  The agency considered the events shingles and suspected vaccination failure to be medically significant.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Measles post vaccine, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: He had a fever for 4 days after the shots , followed by diarrhea and a runny nose. About the 7th or 8th day after his shots I noticed a rash that started on his face / scalp that made it's way down his body and got so severe he had almost no white skin visible. It was confirmed by his pediatrician that it was vaccine strain measles.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient experienced no symptoms; incorrect product storage; This spontaneous report was received from healthcare worker and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.   On 14-MAY-2020, the patient was vaccinated with an improperly dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular (dose and frequency not provided, lot # reported as R028658 is NOT valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date 27-JUL-2021). The patient did not experience any symptoms.   The dose administered had been improperly stored (product storage error) at a temperature of 37 Fahrenheit (F) degrees for 3 hours. No previous temperature of excursion was reported and there was a digital data logger involved.
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal
Clinical narrative: pneumonia levels were low; indication for pnemovax23 was recurrent pneumonia; patient received a dose of Prevnar13 and later a dose of Pneumovax 23; This spontaneous report as received from a registered nurse refers to a 55 year old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.   In December 2015 the patient was administered a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).  Two years later, in December 2017 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dosage information, lot number and vaccination details were unknown)  for recurrent pneumonia.    In June 2020 (reported as: last week), the patient "had an unspecified blood test drawn and the result showed the patient's "pneumonia levels were low" (antibody test abnormal).  The nurse did not clarify this statement further.  The outcome of antibody test abnormal and the causality assessment with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) were unknown.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been downloaded from Agency (US-BEH-2014047225).   This spontaneous report was received from a healthcare professional and refers to a 63 year old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 16-SEP-2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided). On the same date, the patient was also vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (AFLURIA) (Lot # T58706), via intramuscular, for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided).   On 23-SEP-2014, the patient experienced shingles (herpes zoster).     At the time of reporting, the outcome of herpes zoster was reported as resolved on an unknown date.      The causal relationship among zoster vaccine live (ZOSTAVAX), influenza virus split virion 3v vaccine inactivated (AFLURIA) and the reported herpes zoster was not provided.  The reporter considered the herpes zoster as serious, medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Herpes virus infection, Herpes zoster, Herpes zoster cutaneous disseminated, Injection site rash
Clinical narrative: herpes zoster cutaneous disseminated; body temperature increased; pain; SHINGLES; injection site rash; shingles lesion; Information has been downloaded from Agency(US-GlaxoSmithKline-A1077948A) on 06-JUL-2020.  This spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history included chickenpox. The patient's concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, and prednisone. Information regarding the patient's historical drugs and drug allergies or reactions were not provided.  On 21-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, via subcutaneous as prophylaxis (concentration, dose, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported; lot number was reported as unknown). Other suspect therapies included belimumab (BENLYSTA) solution for injection, which was started on an unknown day in July 2013 via intravenous route for the treatment of systemic lupus erythematosus at a frequency reported as "VA" (strength, dose, and lot number were reported as unknown, expiry date was not reported).   On an unknown date in 2013 the patient experienced injection site rash and shingles lesion (herpes virus infection).  On an unknown day in July 2013, the patient experienced shingles (herpes zoster).  On 24-SEP-2014, the patient experienced herpes zoster cutaneous disseminated, pain, and increased body temperature. Her body temperature was 100 (units not provided) on an unknown date in 2014.  The action taken with belimumab (BENLYSTA) was not reported.   The outcome of herpes zoster, herpes zoster cutaneous disseminated, body temperature increased, and pain was reported as not resolved. The outcome of injection site rash and herpes virus infection was reported as unknown.        The reporter considered herpes zoster and herpes zoster cutaneous disseminated to be related to belimumab (BENLYSTA). The causal relationship between belimumab (BENLYSTA) ,and the occurrence of body temperature increased, pain, injection site rash, and herpes virus infection was reported as unknown.   The causal relationship between zoster vaccine live (ZOSTAVAX) and the occurrence of all the events was not reported.  The reporter/agency considered all the reported events to be medically significant and disabling/incapacitating events.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: herpes zoster cutaneous disseminated; body temperature increased; pain; SHINGLES; injection site rash; shingles lesion; Information has been downloaded from Agency(US-GlaxoSmithKline-A1077948A) on 06-JUL-2020.  This spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history included chickenpox. The patient's concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, and prednisone. Information regarding the patient's historical drugs and drug allergies or reactions were not provided.  On 21-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, via subcutaneous as prophylaxis (concentration, dose, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported; lot number was reported as unknown). Other suspect therapies included belimumab (BENLYSTA) solution for injection, which was started on an unknown day in July 2013 via intravenous route for the treatment of systemic lupus erythematosus at a frequency reported as "VA" (strength, dose, and lot number were reported as unknown, expiry date was not reported).   On an unknown date in 2013 the patient experienced injection site rash and shingles lesion (herpes virus infection).  On an unknown day in July 2013, the patient experienced shingles (herpes zoster).  On 24-SEP-2014, the patient experienced herpes zoster cutaneous disseminated, pain, and increased body temperature. Her body temperature was 100 (units not provided) on an unknown date in 2014.  The action taken with belimumab (BENLYSTA) was not reported.   The outcome of herpes zoster, herpes zoster cutaneous disseminated, body temperature increased, and pain was reported as not resolved. The outcome of injection site rash and herpes virus infection was reported as unknown.        The reporter considered herpes zoster and herpes zoster cutaneous disseminated to be related to belimumab (BENLYSTA). The causal relationship between belimumab (BENLYSTA) ,and the occurrence of body temperature increased, pain, injection site rash, and herpes virus infection was reported as unknown.   The causal relationship between zoster vaccine live (ZOSTAVAX) and the occurrence of all the events was not reported.  The reporter/agency considered all the reported events to be medically significant and disabling/incapacitating events.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash vesicular, Varicella virus test positive
Clinical narrative: Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Frustration tolerance decreased, Herpes zoster, Injection site pain, Injection site swelling
Clinical narrative: Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Insomnia, Rash
Clinical narrative: Patient presents with significant injection site pain and swelling to site for 3 days after injection. She developed an all-over maculopapular blistered rash on trunk, breasts, and lower extremities, clinically appears like chickenpox vs shingles. Extremely itchy and mildly painful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: High fever head ache arm sore neck ache
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 07/04/2020 @ 0900.  Awoke to left upper arm itching with swelling (at injection site), redness, and warmth. Every morning thereafter symptoms increased in severity. On 07/06 awoke with new symptoms including  a headache, low grade temperature, and nasal congestion. 07/07 - all symptoms got worse. Took a hot shower and took Tylenol. Awoke 07/08 and symptoms had improved. Symptoms today include - resolving nasal congestion, left upper arm with swelling, redness, and warmth.  No longer has a headache, fever, or itchiness.  Has not had any previous reactions to vaccinations. Stated her mother had a seizure within 5 minutes after Tdap vaccination and needed medication for her reaction. Patient denies and difficulty breathing, shortness of breath, or throat swelling. Reported today is the first day she is starting to feel better.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: 07/04/2020 @ 0900.  Awoke to left upper arm itching with swelling (at injection site), redness, and warmth. Every morning thereafter symptoms increased in severity. On 07/06 awoke with new symptoms including  a headache, low grade temperature, and nasal congestion. 07/07 - all symptoms got worse. Took a hot shower and took Tylenol. Awoke 07/08 and symptoms had improved. Symptoms today include - resolving nasal congestion, left upper arm with swelling, redness, and warmth.  No longer has a headache, fever, or itchiness.  Has not had any previous reactions to vaccinations. Stated her mother had a seizure within 5 minutes after Tdap vaccination and needed medication for her reaction. Patient denies and difficulty breathing, shortness of breath, or throat swelling. Reported today is the first day she is starting to feel better.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Headache, Pain, Pyrexia
Clinical narrative: cold sweats, fever, headache, overall soreness
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: After completion of vaccinations, patient passed out. Patient came back to very prompt and was evaluated by provider and deemed safe to return home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: left thigh edema, erythema mild tenderness.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Blood heavy metal test, Breast cyst, Hormone level abnormal, Insomnia, Tachyphrenia
Clinical narrative: insomnia, "racing thoughts"  seen in ER then admitted to psych ward at Mental Health Hospital "under parent's influence".  received treatment for 4 days, then discharged with no medical recommendations  current hormone disruption and breast cysts
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; received a dose of M-M-R II on 06/19/2020 and on 06/29/2020; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history,  drug reactions or allergies were not reported.   On 19-JUN-2020 and 29-JUN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (inappropriate schedule of product administration) (lot # S023654, expiration date not reported but upon internal validation established as: 30-JUL-2021; strength, dose, rout and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted using sterile diluent (manufacturer unknown). No known adverse effects. No further information was provided
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an currently 78-year-old female patient (pt). Information about concurrent condition, concomitant medication or medical history was not provided. On or about 16-SEP-2015, the pt was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine at her local pharmacy (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently on an unknown date, pt was treated by a provider for the following injuries resulting from Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. Pt claimed following damages as a result of Zoster Vaccine Live (ZOSTAVAX): injury to herself, loss of services and economic losses. The outcome of events was not provided. The causality was assessed as related by the lawyer and patient.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster
Clinical narrative: Patient was diagnosed with shingles; With in 5 days patient was having pain on side/back; With in 5 days patient was having pain on side/back; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030259).  This spontaneous report was received from an other health professional referring to a 71 years old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 17-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot # M032141, expiration date was not reported) (strength and dose number were not reported) 1 dosage form, subcutaneously and with influenza virus sag 3v vaccine inactivated (FLUVIRIN 2016/2017) (lot # 1620401, expiration date was not reported) (strength and dose number were not reported) 1 dosage form, intravenously for immunisation.    On 21-OCT-2016, within 5 days patient was having pain on side/back (back pain and flank pain). On an unknown date, patient was diagnosed with shingles (herpes zoster). The outcome of the events was unknown. The causality between the events and zoster vaccine live (ZOSTAVAX) was not reported. The causality between the events and influenza virus sag 3v vaccine inactivated (FLUVIRIN 2016/2017) was reported as not assessable.  The events back pain, flank pain and herpes zoster were considered to be medically significant by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Rhinorrhoea
Clinical narrative: intermittent headaches; soreness/aching; fatigue; chills; runny nose; sneezing; This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain, fatigue and chills. On an unknown date, the patient experienced runny nose, sneezing and headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain, fatigue, chills and headache were not recovered/not resolved and the outcome of the runny nose and sneezing were recovered/resolved.   It was unknown if the reporter considered the pain, fatigue, chills, runny nose, sneezing and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician confirmed that 12 days after dose of Shingrix the patient was still experiencing fatigue, chills, soreness and aching. The patient took three 600mg Advil tablets and that has helped his symptoms.  Additionally, he reports he experienced runny nose and sneezing for two days after dose 2, and has had intermittent headaches and denies intestinal symptoms. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: intermittent headaches; soreness/aching; fatigue; chills; runny nose; sneezing; This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain, fatigue and chills. On an unknown date, the patient experienced runny nose, sneezing and headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain, fatigue, chills and headache were not recovered/not resolved and the outcome of the runny nose and sneezing were recovered/resolved.   It was unknown if the reporter considered the pain, fatigue, chills, runny nose, sneezing and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician confirmed that 12 days after dose of Shingrix the patient was still experiencing fatigue, chills, soreness and aching. The patient took three 600mg Advil tablets and that has helped his symptoms.  Additionally, he reports he experienced runny nose and sneezing for two days after dose 2, and has had intermittent headaches and denies intestinal symptoms. No further details were provided.
Sex: F
Vaccine: MEN
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Allergic reaction; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced allergic reaction and sickness. On an unknown date, the outcome of the allergic reaction and sickness were recovered/resolved.   The reporter considered the allergic reaction and sickness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine and had allergic reaction and was sick for months because of it. Even though the patient had vaccinated all of children and would say be careful with Men B shot.
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic symptoms; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient reported to hospital with anaphylactic reaction. The reporter consented to follow up.
Sex: F
Vaccine: MEN
Symptoms: Crying, Dizziness, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: high fever/her fever shot up; severe body aches/entire body hurt/aching in pain; barely able to move/unable to really move; stiffness in her neck; felt faint/going to faint any time; red bump at the injection site; red bump at the injection site; couldn´t move her neck; crying; she was in bed for days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine and had reaction at injection site and spent several days after the shot and crying with high fever, severe body aches, barely able to move, stiffness in her neck and felt faint ant time she tried to get up out of bed. The patient had small red bumps at injection site. The patient took the first round and by the time and got her home she was bad.  When it came time for the second round even her doctor was not ok with her taking it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR118289:Same reporter
Sex: F
Vaccine: MEN
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Nuchal rigidity, Pain, Pyrexia
Clinical narrative: high fever/her fever shot up; severe body aches/entire body hurt/aching in pain; barely able to move/unable to really move; stiffness in her neck; felt faint/going to faint any time; red bump at the injection site; red bump at the injection site; couldn´t move her neck; crying; she was in bed for days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine and had reaction at injection site and spent several days after the shot and crying with high fever, severe body aches, barely able to move, stiffness in her neck and felt faint ant time she tried to get up out of bed. The patient had small red bumps at injection site. The patient took the first round and by the time and got her home she was bad.  When it came time for the second round even her doctor was not ok with her taking it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR118289:Same reporter
Sex: M
Vaccine: MEN
Symptoms: Diplegia, Paralysis, Sensory loss
Clinical narrative: paralized from his toes all the way up to his waist; Could not move a muscle; can't feel  pain/can't feel temperature; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis legs in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced paralysis legs (serious criteria GSK medically significant), paralysis voluntary muscle (serious criteria GSK medically significant) and loss of sensation. On an unknown date, the outcome of the paralysis legs, paralysis voluntary muscle and loss of sensation were not recovered/not resolved.   It was unknown if the reporter considered the paralysis legs, paralysis voluntary muscle and loss of sensation to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient had a sever reaction to the vaccine. He was paralized from his toes all the way up to his waist. The patient could not move a muscle.  The reporter states it was a miracle from God that he didn't die.  At 16 years of age, the patient had to relearn how to move his toes, one at a time and then to walk and run again. The patient still could not feel temperature or pain from waist down.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: fire-engine red" rash at injection site; fire-engine red" rash at injection site; fire-engine red" rash at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site burning, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site burning, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site burning, injection site erythema and injection site rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reported fire-engine red rash at injection site after Shingrix administration. The patient informed that pharmacist advised them to pre medicate with ibuprofen before next Shingrix dose. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuralgia, Pain in extremity
Clinical narrative: pain as a numbing sensation from the shoulder to her thumb; numbing sensation from the shoulder to her thumb; nerve pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, numbness in hand and nerve pain. On an unknown date, the outcome of the pain in arm, numbness in hand and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, numbness in hand and nerve pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain as a numbing sensation from the shoulder to her thumb, like nerve pain.  The pain began after receiving dose two of Shingrix and had worsened since it began. Consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Facial pain
Clinical narrative: Swelling on the right eye; Redness; Sore to the touch on the right cheek; This case was reported by a nurse via call center representative and described the occurrence of eye swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 1st dose of Shingrix. On 30th January 2020, 1 days after receiving Shingrix, the patient experienced facial pain. On 31st January 2020, the patient experienced eye swelling and erythema. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the eye swelling, facial pain and erythema were unknown.   It was unknown if the reporter considered the eye swelling, facial pain and erythema to be related to Shingrix.  Additional case details were reported as follows: One day after vaccination experienced the patient sore to the touch on the right cheek. On 31st January 2020, 2 days after receiving Shingrix the patient swelling on the right eye, redness. The patient went to urgent care and received a steroid shot and also prescription for steroids. The reporter consent to follow up. This case has been linked with case US2020115716, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115716:same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: Blistery rash; Rash looked like shingles; This case was reported by a consumer via call center representative and described the occurrence of blister in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date and no reaction experienced).   On 22nd June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd June 2020, 4 days after receiving Shingrix, the patient experienced blister and vesicular rash. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the blister and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in right arm. Reportedly four days later the patient developed a blistery rash approximately 1.5 inches long on the bottom of right ankle. The patient went to an urgent care and was told rash looked like shingles. The rash was not painful.  The reporter consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore on nose; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2020, 7 days after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On 1st July 2020, the outcome of the cold sores was recovered/resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and developed a cold sore on her nose, her HCP told her to take Valtrex and the sore was cleared up. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: had negative Hep-B titer results; 36 weeks pregnant female had negative Hep-B titer results; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 36-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Hepatitis B vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder and vaccine exposure during pregnancy. On an unknown date, the outcome of the therapy non-responder and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional case details were reported as follows: The age at vaccination was not applicable. The 36 weeks pregnant had negative Hep-B titer results and since plan on vaccination with Engerix-B, which led to therapy non-responder and vaccine exposure during pregnancy. The reporter consent to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Adverse reaction, Inappropriate schedule of product administration
Clinical narrative: Adverse reaction; second dose on the two month mark; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HAB (Twinrix).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced adverse reaction and drug dose administration interval too long. On an unknown date, the outcome of the adverse reaction and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Twinrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 2nd dose of vaccine later than recoomended interval, which led to lengthening of vaccination schedule. After second dose, the patient experienced adverse reaction and pharmacist wanted to know if this could be avoided by giving patient a third dose separately of Hepatits A (Havrix) and Hepatitis B (Engerix-B) vaccines instead of a combination Twinrix. The reporter consented to follow up. No Batch nor expiration dates for vaccines could be obtained by reporter. For patient no date of birth could be obtained.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort
Clinical narrative: GI issues have worsened; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal discomfort in a 22-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 22nd February 2019, the patient received Engerix B. On 22nd February 2020, 365 days after receiving Engerix B, the patient experienced gastrointestinal discomfort. Engerix B was continued with no change. On an unknown date, the outcome of the gastrointestinal discomfort was recovering/resolving.   It was unknown if the reporter considered the gastrointestinal discomfort to be related to Engerix B.  Additional information was provided as follows: The patient's GI issues had worsened in the past 6 months. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Swelling,  at the injection site.; tenderness at injection site; hot to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site tenderness and skin warm. On an unknown date, the outcome of the injection site swelling, injection site tenderness and skin warm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site tenderness and skin warm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced swelling, tenderness at the injection site. The arm was also hot to the touch. The reporter did not consent to follow up.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling and pain to site
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Headache, Pain
Clinical narrative: Severe Headache,  Chills, and Body Aches for 4 days
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Axillary pain, Burning sensation, Discomfort, Dry mouth
Clinical narrative: Patient received shot in left deltoid Thursday afternoon, by Friday she started getting "red, lumpy, bumpy, painful, burning, stabbing" feeling under armpit. Over the next week, bumps appeared at right shoulder, middle of upper back, and dry mouth/throat. She admits to taking Benadryl topically and by mouth, I let her know that the Benadryl likely caused dry mouth.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry throat, Erythema, Rash
Clinical narrative: Patient received shot in left deltoid Thursday afternoon, by Friday she started getting "red, lumpy, bumpy, painful, burning, stabbing" feeling under armpit. Over the next week, bumps appeared at right shoulder, middle of upper back, and dry mouth/throat. She admits to taking Benadryl topically and by mouth, I let her know that the Benadryl likely caused dry mouth.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash, Skin burning sensation, Skin lesion
Clinical narrative: Patient received shot in left deltoid Thursday afternoon, by Friday she started getting "red, lumpy, bumpy, painful, burning, stabbing" feeling under armpit. Over the next week, bumps appeared at right shoulder, middle of upper back, and dry mouth/throat. She admits to taking Benadryl topically and by mouth, I let her know that the Benadryl likely caused dry mouth.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The kinrix was given to early for the pt.  The DTap and the polio immunizations should have been given separately.  Pt did not have any adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001874: US-009507513-2006USA008951: US-009507513-2007USA001873:
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001874: US-009507513-2007USA001872: US-009507513-2006USA008951: