chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 10-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for  herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 82 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 28-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 19-MAR-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 91 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 19-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 19-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare providedr for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 03-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster with complication; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles.  After the vaccination, the patient suffered a painful persistent rash, which was diagnosed as herpes zoster with complication. The patient continued to suffer the effect of herpes zoster; the outcome of the event was not recovered.  The causality between event and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: F
Vaccine: RV5
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation, Ocular hyperaemia
Clinical narrative: some spit/RotaTeq got into the healthcare professional's left eye. She immediately felt burning; The HCP's eye is a little pink; the patient spit and some spit/RotaTeq got into the healthcare professional's left eye; the patient spit and some spit/RotaTeq got into the healthcare professional's left eye; This spontaneous report was received from a Registered Nurse referring herself, a 42 year old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 24-MAY-2019, the nurse was administering rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R021650 with an expiration date on 27-MAY-2020, to a baby; however, the baby spat up (captured in MARRS: 1906USA001158) and some rotavirus vaccine, live, oral, pentavalent (ROTATEQ) got into the nurse left eye (accidental exposure to product and occupational exposure to product ). The nurse stated that she immediately felt burning (eye irritation), she flushed her eye with the wash system (total time flushing was unknown); however, the burning continued. It was additionally reported that on the same date, the nurse's eye was a little pink (ocular hyperaemia). It was specified that the nurse did not have vision changes.  At the reporting time, the nurse had not recovered from eye irritation and ocular hyperaemia.  The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events was unknown.; Sender's Comments:  US-009507513-1906USA001158:
Sex: U
Vaccine: MMR
Symptoms: Measles, Morbillivirus test positive
Clinical narrative: This spontaneous report was received from an unspecified reporter from the Department of Health, via company representative, referring to a child patient of unknown age and gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug allergies or reactions were not reported. On an unknown date, the patient received a dose of M-M-R II (strength, dose, route of administration, lot # and expiration date were unknown), for prophylaxis. On an unknown date, the patient contracted measles-like symptoms after receiving the vaccine. On an unknown date, the child was swabbed for the virus and the test came back positive for vaccine-strain measles. It was unknown by the reporter if treatment was given for the events. The outcome of the events was unknown. A causal relationship between the events and M-M-R II was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ear disorder, Emotional distress, Herpes zoster, Pain, Physical disability
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In or about September 2016, the pt was inoculated with ZOSTAVAX (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a physician for its intended purpose: the prevention of shingles. On an unknown date, shortly thereafter, the pt suffered from a severe rash. In or Around May 2017, she presented to a hospital for this injury and was diagnosed with shingles. Subsequently, and because of the shingles that the pt had because of ZOSTAVAX, she began having troubles with her ear (unspecified) and had a cyst on her spleen. As a direct and proximate result of Company's defective ZOSTAVAX vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, she 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. The outcome of the events was not recovered. The events were considered to be related to ZOSTAVAX. The events of shingles, troubles with her ear and a cyst on her spleen were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Spleen disorder, Splenic cyst
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In or about September 2016, the pt was inoculated with ZOSTAVAX (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a physician for its intended purpose: the prevention of shingles. On an unknown date, shortly thereafter, the pt suffered from a severe rash. In or Around May 2017, she presented to a hospital for this injury and was diagnosed with shingles. Subsequently, and because of the shingles that the pt had because of ZOSTAVAX, she began having troubles with her ear (unspecified) and had a cyst on her spleen. As a direct and proximate result of Company's defective ZOSTAVAX vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, she 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. The outcome of the events was not recovered. The events were considered to be related to ZOSTAVAX. The events of shingles, troubles with her ear and a cyst on her spleen were considered to be disabling.
Sex: M
Vaccine: RV5
Symptoms: Anal fissure, Haematochezia
Clinical narrative: This spontaneous report was received from a physician referring to a male patient of unknown age. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with ROTATEQ (strength, dose detail, lot # and expiration date were unknown) orally for prophylaxis. On an unspecified date, the patient developed blood in stool with one anal fissure after receiving ROTATEQ. It was unknown if the patient sought medical attention, or performed lab diagnostics/studies or was given treatment. The outcome of the events was unknown. The causality between the events and ROTATEQ was not provided. Upon internal review, blood in stool was determined to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Crohn's disease, Mumps antibody test negative
Clinical narrative: Information has been received from a physician referring to a 6 years old male patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the patient received 2 doses of M-M-R II (lot number, expiration date, dose, frequency, route unspecified) for prophylaxis. This patient was not administered a third dose of M-M-R II as he had Crohn's disease. It was undetermined if the Crohn's disease had manifested before or after receiving the vaccine. Blood work was done on the patient and tested negative for Mumps (Mumps antibody test negative). It was unknown if the treatment was given for the events. Outcome of the events was unknown. Causality assessment was not reported. Upon internal review, Crohn's disease was determined to be medically significant. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1906USA000289: Original Case : 1906USA000133.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: tested negative for Mumps; Information has been received from a physician referring to a 7 years old patient of unknow gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On an unknown date, the patient received 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number, expiration date, dose, frequency, route unspecified) for prophylaxis.   Blood work was done on the patient and they tested negative for Mumps (Mumps antibody test negative). It was unknown if the treatment was given for the event. Outcome of the event was unknown. Causality assessment was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000133:Original Case : 1906USA000133
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported.; one patient received one dose of MMR II intramuscular instead of subcutaneous; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions, and concomitant medications were not provided.     On 31-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscular instead of subcutaneous (incorrect route of product administration) (strength and anatomical location were not reported; lot number R019391 and expiration date 05-JUL-2020) for prophylaxis. No adverse effects reported.          Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: PROQUAD was inadvertently administered instead of the intended MMR II; VARIVAX was also adminstered along with the PROQUAD; No adverse affects reported; This spontaneous report was received from a licensed practical nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On an unknown date, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneously, with lot number R021101 and expiration date 20-JAN-2020, for prophylaxis  (dose, dose number and anatomical injection site were not reported), instead of intended measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number and expiration date)(wrong product administered). It was also reported that varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (dose, dose number, anatomical injection site, route of administration, lot number and expiration date were not reported) was also administered along with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (inappropriate schedule of vaccine administered). No adverse effects reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pain and swelling and hardness in the arm where the injection was given; pain and swelling and hardness in the arm where the injection was given; pain and swelling and hardness in the arm where the injection was given; Information has been received from a nurse via a field representative referring to a 70 years old female patient. The patient's concomitant medication, medical history, drug reactions or allergies were not reported.  On 29-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R033080 with expiration date on 06-JUN-2020, one shot of 0.5 milliliter, intramuscular in the deltoid of the left arm as Centers for Disease Control and Prevention (CDC) recommendation based on age. On the same date (reported as two hours after the injection), the nurse reported that the patient experienced pain and swelling and hardness in the arm where the injection was given after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. There was treatment given for the events. It was unknown if lab diagnostics or studies were performed. The patient called clinic to seek medical attention. The outcome of the events was reported as recovering. The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014297:
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; one M-M-R II dose was administered into deltoid; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.   On 02-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form, intramuscular into deltoid (lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; Administration of one dose of an expired vaccine; This spontaneous report was received from a registered nurse referring to a 25 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.   On 03-JUN-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number: N019923, expiration date: 28-APR-2019) intramuscularly, for prophylaxis (strength and dosage schedule were not reported). The vaccine was stored in the correct storage temperature range and no adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; one expired dose of VAQTA was administered to an unspecified patient; This spontaneous report was received from a registered nurse concerning to a unspecified patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.    On 31-MAY-2019, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) (route of administration was not reported, lot # R006342 and expiration date 21-APR-2019) for prophylaxis. No adverse effects reported.   This case is considered non-valid, as no patient identifiers were provided.  Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: Infantile spitting up; The patient spit and may not have received the full dose; This spontaneous report was received from a Registered Nurse referring to a pediatric patient of unknown gender and age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 24-MAY-2019, the baby patient was vaccinated with the nurse was administering rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot # R021650 with an expiration date on 27-MAY-2020, for prophylaxis; however, when the nurse was administering the vaccine to the baby patient, the baby spat up (infantile spitting up) and some rotavirus vaccine, live, oral, pentavalent (ROTATEQ) got into the nurse left eye (captured in: 1905USA013054); therefore, the patient may not have received the full dose (accidental underdose). It was specified that the nurse discussed the incident with the pediatrician.  The outcome of infantile spitting up was unknown. The causality assessment between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event was unknown.; Sender's Comments:  US-009507513-1905USA013054:
Age: 56.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effect reported; inadvertently administered PROQUAD (Lot#R008205/Exp:9/16/2019), instead of MMR II (Lot#Unknown/Exp:Unknown); inadvertently administered PROQUAD (Lot#R008205/Exp:9/16/2019), instead of MMR II (Lot#Unknown/Exp:Unknown); Information has been received from a medical assistant (also reported as a nurse) referring to a 56 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 31-MAY-2019,  the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R008205, expiration date:16-SEP-2019, therapy type: recombinant Human albumin (rHA), route, strength, dose and frequency were unknown) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, dose, frequency, route, lot#, therapy type and expiration date were unknown) (inappropriate age at vaccine administration and wrong vaccine administered). No adverse effect were reported.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: 25 Reasons to Avoid the GARDASIL Vaccine that Never Should Have Been Approved by the FDA; This spontaneous report has been received from a consumer via a company representative concerning a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient experienced adverse event (AE). The written AE information located on the website vaccineimpact.com in an article titled "25 Reasons to Avoid the GARDASIL Vaccine that Never Should Have Been Approved by the FDA". The outcome of adverse event is unknown. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain
Clinical narrative: pulsating ear pain/hurt; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 2nd dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was not recovered/not resolved.   It was unknown if the reporter considered the ear pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and in the evenining the patient got a pulsating pain in the right ear that continued to hurt. The patient asked was this normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Insomnia, Myalgia, Neuralgia
Clinical narrative: muscle pain; nerve pain; fingers tickling; unable to sleep; joint pain; shivering; pain in the arm; ears ringing; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 6 hrs after receiving Shingrix, the patient experienced muscle pain, nerve pain, tingling, sleeplessness, joint pain, shivering and pain in arm. In May 2019, the patient experienced ringing in ears. On an unknown date, the outcome of the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm were unknown.   It was unknown if the reporter considered the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient was repoter's wife. The patient received shingrix vaccine and after couple of hours the patient experienced Pain in the arm, 6 or 8 hours after joint pain, muscle pain shivering, nerve pain ,fingers tickleing at night unable to sleep and ears ringing  The patient asked whether ears ringing and the events reported were  common or not.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: muscle pain; nerve pain; fingers tickling; unable to sleep; joint pain; shivering; pain in the arm; ears ringing; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 6 hrs after receiving Shingrix, the patient experienced muscle pain, nerve pain, tingling, sleeplessness, joint pain, shivering and pain in arm. In May 2019, the patient experienced ringing in ears. On an unknown date, the outcome of the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm were unknown.   It was unknown if the reporter considered the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient was repoter's wife. The patient received shingrix vaccine and after couple of hours the patient experienced Pain in the arm, 6 or 8 hours after joint pain, muscle pain shivering, nerve pain ,fingers tickleing at night unable to sleep and ears ringing  The patient asked whether ears ringing and the events reported were  common or not.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Swelling
Clinical narrative: sore arm; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a adult patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown.   It was unknown if the reporter considered the pain in arm and swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she had experienced adverse events sore arm, swelling with Bexsero.  The health care professional also stated that it seemed to be higher incidence after 1st dose than 2nd dose. This case has been linked with case US2019GSK101167, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: stomach bothering; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 23rd May 2019, unknown after receiving Shingrix, the patient experienced fever. On 24th May 2019, the patient experienced abdominal discomfort. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the abdominal discomfort was unknown.   It was unknown if the reporter considered the fever and abdominal discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever and abdominal discomfort. The reporter advised patient to refer to the healthcare provider for patient care. The reporter stated to patient that safety department would be interested in learning more about the experience with the product.
Sex: M
Vaccine: UNK
Symptoms: Tetanus, Vaccination failure
Clinical narrative: Initial information received on 29-May-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 13 years old male patient who was diagnosed suspected tetanus with fully immunization, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious diagnosed suspected tetanus with fully immunization (tetanus) and vaccination failure following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. These event was assessed as medically significant. Relevant laboratory test results included: On an unknown date- Immunoglobulins: 1.7 iU/mL [tetanus Ig level before giving him tetanus immunoglobulin is protective] Final diagnosis was suspected tetanus with fully immunization. An unknown corrective treatment was received. The patient was recovering from tetanus as patient got better after treatment. Information on the batch number was requested. Documents held by sender: none.; Sender's Comments: This case concerns a 13 years old male patient who experienced tetanus after vaccination with ADACEL. The time to onset is unknown. Tetanus Ig level before giving him tetanus immunoglobulin is protective (1.7 IU/ml). Additional information regarding patient's past medical history, condition at the time of vaccination, concomitant medications excluding other predisposing etiologies, confirmatory lab reports confirming tetanus would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: PATIENT WAS GIVEN HIB AND SHE WAS TO RECEIVE MENINGOCOCCAL CONJUG.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Headache, Nausea, Pain
Clinical narrative: I only had a sore arm with the first vaccination in March 2019. With this second shot in June (about 11 weeks later), I began experiencing fever, body ache, fatigue and intense headache beginning about 24 hours following the vaccination and continuing for 36 hours. Nausea lasted from hour 30-36. These symptoms subsided. On day three, I began noticing an intermittent stabbing pain deep in my left eyeball. Coincidentally, in June 2018 I had an outbreak of shingles (my second) beginning in my left ear and running down my face into my chin area. If the eye pain continues today and does not lessen, I will see my eye doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I only had a sore arm with the first vaccination in March 2019. With this second shot in June (about 11 weeks later), I began experiencing fever, body ache, fatigue and intense headache beginning about 24 hours following the vaccination and continuing for 36 hours. Nausea lasted from hour 30-36. These symptoms subsided. On day three, I began noticing an intermittent stabbing pain deep in my left eyeball. Coincidentally, in June 2018 I had an outbreak of shingles (my second) beginning in my left ear and running down my face into my chin area. If the eye pain continues today and does not lessen, I will see my eye doctor.
Age: 47.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Cellulitis
Clinical narrative: Developed cellulitis, Patient was treated with IV Vancomycin, Clindamycin, ANCEF. Patient's cellulitis is resolving.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: A rash occurred on my left arm and chest, about days after my injection.  It is June 5, 2019 and it seems to be getting be getting a little better, for instance, from where it started in the middle of my chest (where I had a little bit of Shingles about 3 months after first  Shingrex shot)  but its continuing  to spread around towards my back, now.  Same on the arm, its starting to spread upwards towards my shoulder but not as bad as chest. Just been bathing it in alcohol in mornings, sometimes with Peroxide and using Gold Bond or Benadryl creams to sooth the itching. Hot showers as well but it dosent help the healing.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune disorder, Blood test normal, Cardiovascular autonomic function test normal, Computerised tomogram normal, Cytogenetic analysis normal
Clinical narrative: Within a week, my left leg began to have tremors.  Intermittent tripping began.  Headaches and head pressure followed, continuous to this day. Feeling of flulike symptoms without fever became continuous and have not stopped.  By June of 2012, my left leg began dragging.  My legs are still heavy. By 2013, I was completely disabled.  I discussed with many doctors immediately but was dismissed at every conversation.  IT IS NOT a coincidence.  The vaccine is responsible.  The doctors still have no concrete diagnosis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Disability, Electromyogram normal, Gait disturbance, Head discomfort, Headache
Clinical narrative: Within a week, my left leg began to have tremors.  Intermittent tripping began.  Headaches and head pressure followed, continuous to this day. Feeling of flulike symptoms without fever became continuous and have not stopped.  By June of 2012, my left leg began dragging.  My legs are still heavy. By 2013, I was completely disabled.  I discussed with many doctors immediately but was dismissed at every conversation.  IT IS NOT a coincidence.  The vaccine is responsible.  The doctors still have no concrete diagnosis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Limb discomfort, Nuclear magnetic resonance imaging normal, Paraparesis, Tremor
Clinical narrative: Within a week, my left leg began to have tremors.  Intermittent tripping began.  Headaches and head pressure followed, continuous to this day. Feeling of flulike symptoms without fever became continuous and have not stopped.  By June of 2012, my left leg began dragging.  My legs are still heavy. By 2013, I was completely disabled.  I discussed with many doctors immediately but was dismissed at every conversation.  IT IS NOT a coincidence.  The vaccine is responsible.  The doctors still have no concrete diagnosis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vestibular function test normal
Clinical narrative: Within a week, my left leg began to have tremors.  Intermittent tripping began.  Headaches and head pressure followed, continuous to this day. Feeling of flulike symptoms without fever became continuous and have not stopped.  By June of 2012, my left leg began dragging.  My legs are still heavy. By 2013, I was completely disabled.  I discussed with many doctors immediately but was dismissed at every conversation.  IT IS NOT a coincidence.  The vaccine is responsible.  The doctors still have no concrete diagnosis.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Approx 2 inch in diameter redness, pain, hot to touch at injection sight.  Pain lifting left arm. Average fever of 101.5 since day 1.  Only way to keep fever down is to alternate Tylenol and motrin every two hours.  Back pain and muscle aches.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Approx 2 inch in diameter redness, pain, hot to touch at injection sight.  Pain lifting left arm. Average fever of 101.5 since day 1.  Only way to keep fever down is to alternate Tylenol and motrin every two hours.  Back pain and muscle aches.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Arm pain and nausea for 3 days resulting in loss of function at work and home. Ongoing arm pain continuing but diminishing each day.  I would never have received this vaccination  if I had been aware of the side effects.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: I have mild flu-like symptoms. I am achy, have chills, am sleepy, have a bit of a headache and my arm hurts. The first dose only caused a bit of arm pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: I have mild flu-like symptoms. I am achy, have chills, am sleepy, have a bit of a headache and my arm hurts. The first dose only caused a bit of arm pain.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness, Moaning, Syncope
Clinical narrative: about 3 minutes after vaccinations given, client moaned, then fainted on the exam table. She closed her eyes for a few seconds and then woke up. cool pack applied to forehead and knees elevated while laying supine on exam table.  She was feeling better then, sat up, and fainted again. Cool pack applied again, knees elevated. Mom had some juice, so client drank some of that. Layed supine for about 15 minutes and then felt better. Assisted to walk home after.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Dyspnoea, Electroencephalogram normal
Clinical narrative: Seizure began at 11:30pm. He had been sleeping comfortably prior to that. He was seizing with jerking movements of both arms and legs. They also noted that his extremities were twitching. They also reported that during seizure activity, he seemed to be gasping for breath and called it "sharp inhalation" which lasted for about 5 minutes. Following the seizure, he was slightly groggy for about 10 minutes but had no other post ictal symptoms.  He did not have any precipitating factors except his parents note he had received his 6 mo vaccines earlier that day.    Patient has a past medical history of seizures 1 week following 4 month shots. Patient had multiple episodes of seizure like activity and was hospitalized and intubated at hospital. MRI, CT scan and EEG were reassuring. As was blood work. Hospital Course: Patient was seen in the ED and given tylenol suppository and IVF. Loaded with 20mg/kg of Keppra in the ED and then transferred to the floor for further workup. Then started on Keppra 10mg/kg BID. The patient had no further events during the entire inpatient course. Neurology was consulted and Dr informed the patient of the high likelihood of patient's presentation being an adverse reaction to DPT vaccine and that it was less likely primary epilepsy. A decision was made with parents' input to continue the baby on Keppra BID until outpatient appointment with Dr.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Endotracheal intubation, Muscle twitching, Nuclear magnetic resonance imaging normal, Seizure, Somnolence
Clinical narrative: Seizure began at 11:30pm. He had been sleeping comfortably prior to that. He was seizing with jerking movements of both arms and legs. They also noted that his extremities were twitching. They also reported that during seizure activity, he seemed to be gasping for breath and called it "sharp inhalation" which lasted for about 5 minutes. Following the seizure, he was slightly groggy for about 10 minutes but had no other post ictal symptoms.  He did not have any precipitating factors except his parents note he had received his 6 mo vaccines earlier that day.    Patient has a past medical history of seizures 1 week following 4 month shots. Patient had multiple episodes of seizure like activity and was hospitalized and intubated at hospital. MRI, CT scan and EEG were reassuring. As was blood work. Hospital Course: Patient was seen in the ED and given tylenol suppository and IVF. Loaded with 20mg/kg of Keppra in the ED and then transferred to the floor for further workup. Then started on Keppra 10mg/kg BID. The patient had no further events during the entire inpatient course. Neurology was consulted and Dr informed the patient of the high likelihood of patient's presentation being an adverse reaction to DPT vaccine and that it was less likely primary epilepsy. A decision was made with parents' input to continue the baby on Keppra BID until outpatient appointment with Dr.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vaccination complication
Clinical narrative: Seizure began at 11:30pm. He had been sleeping comfortably prior to that. He was seizing with jerking movements of both arms and legs. They also noted that his extremities were twitching. They also reported that during seizure activity, he seemed to be gasping for breath and called it "sharp inhalation" which lasted for about 5 minutes. Following the seizure, he was slightly groggy for about 10 minutes but had no other post ictal symptoms.  He did not have any precipitating factors except his parents note he had received his 6 mo vaccines earlier that day.    Patient has a past medical history of seizures 1 week following 4 month shots. Patient had multiple episodes of seizure like activity and was hospitalized and intubated at hospital. MRI, CT scan and EEG were reassuring. As was blood work. Hospital Course: Patient was seen in the ED and given tylenol suppository and IVF. Loaded with 20mg/kg of Keppra in the ED and then transferred to the floor for further workup. Then started on Keppra 10mg/kg BID. The patient had no further events during the entire inpatient course. Neurology was consulted and Dr informed the patient of the high likelihood of patient's presentation being an adverse reaction to DPT vaccine and that it was less likely primary epilepsy. A decision was made with parents' input to continue the baby on Keppra BID until outpatient appointment with Dr.