chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The message received from the commercial team that an adverse event following administration of Flulaval MDV had been reported a subsidiary of reported hospitalizations (including ICU) following the administration of Flulaval MDV to their employees. The reporter did not know how many employees received the vaccine. They have pulled all other MDVs from use. The reporter wanted to make you aware of this situation in case this is not an isolated event. The reporter asked is there a way to monitor this internally. This is 1 of 3 case having same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Pain is felt all the way down arm from the injection site; Fatigue; Shivering; Feels feverish; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019 18:00, the patient received the 1st dose of Shingrix. On 24th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm, fatigue, shivering and fever. On an unknown date, the outcome of the pain in arm, fatigue, shivering and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, shivering and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine left arm. The patient reported that she experienced immediate pain upon receiving the vaccine at 6:00 pm on day before reporting.   The patient said that the pain in her arm was as painful as period cramps. The pain in her arm progressively worsened throughout the night.   The pain was felt all the way down her arm from the injection site.   Less than a day after vaccination, the patient also experienced shivering, fatigue and feels feverish. The patient could barely get out of bed on day of reporting. The reporter did not consent to follow-up.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema
Clinical narrative: Injection site redness, which spread below the injection site, localized in the deltoid area; Injection site redness, which spread below the injection site, localized in the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA055A, expiry date unknown) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Menveo (intramuscular). On 24th September 2019, 1 days after receiving Menveo, the patient experienced injection site erythema and localized erythema. On an unknown date, the outcome of the injection site erythema and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and localized erythema to be related to Menveo.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient developed injection site redness, which spread below the injection site, localized in the deltoid area.  At the time of this report the event was reported as ongoing. The reporter consented to follow up. In the document outcome of event was reported as recovering, but in database its mentioned as not recovered, so kept as reported in database. As per sales data sheet reported batch number was changed from AMXA055A to AMVA055A.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Tongue discolouration, Vomiting
Clinical narrative: black tongue; nausea; vomitting; diarhea; tired; This case was reported by a other health professional via call center representative and described the occurrence of tongue black in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2020) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th September 2019, 1 days after receiving Shingrix, the patient experienced nausea, vomiting, diarrhea and tiredness. On 20th September 2019, the patient experienced tongue black. On 22nd September 2019, the outcome of the tongue black, nausea, vomiting, diarrhea and tiredness were recovered/resolved.   It was unknown if the reporter considered the tongue black, nausea, vomiting, diarrhea and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. On 20th September 2019, 2 days after receiving Shingrix, the patient experienced black tongue. On 22nd September 2019, all the symptoms were resolved. The reporter did not have other information available for this adverse event at this time. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pruritus, Urticaria
Clinical narrative: Welps on body and scalp; headache; body aches; fatigue; Itching along; This case was reported by a consumer via call center representative and described the occurrence of welts in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 23rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th September 2019, 2 days after receiving Shingrix, the patient experienced welts, headache, general body pain, fatigue and pruritus. On an unknown date, the outcome of the welts was recovering/resolving and the outcome of the headache, general body pain, fatigue and pruritus were unknown.   It was unknown if the reporter considered the welts, headache, general body pain, fatigue and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on left arm. The patient developed welts on her body and scalp and itching along with head and body aches and fatigue. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Non-Hodgkin's lymphoma
Clinical narrative: incorrect dosing schedule; This case was reported by a consumer via call center representative and described the occurrence of non-hodgkin's lymphoma in a 17-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced non-hodgkin's lymphoma (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the non-hodgkin's lymphoma was unknown.   It was unknown if the reporter considered the non-hodgkin's lymphoma to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Wife reported that her husband received the first dose of Shingrix about a year ago and then he was diagnosed with the 4th occurrence of Non-Hodgkins Lymphyoma for the 4th time in 17 years and his physician suggested that he not receive the second dose of Shingrix because of the concern that the chemo could render the vaccine ineffective. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Product administered at inappropriate site
Clinical narrative: erythema at injection site; warmth at the injection site; induration at the injection site; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2LL97, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In September 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site warmth, injection site induration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site induration were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that, the vaccine was not injected into the deltoid muscle, which led to  vaccine administered at inappropriate site. The vaccine was injected in the left arm below the deltoid.  The patient developed erythema and induration at the injection site and the injection site is warm to the touch. The erythematous area was approximately 8 cm x 5 cm in size. The reporter did not provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Swelling face
Clinical narrative: Swelling in face and neck; Swelling in face and neck; Generally itching; This case was reported by a physician via call center representative and described the occurrence of facial swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial swelling, neck swelling and pruritus. On an unknown date, the outcome of the facial swelling, neck swelling and pruritus were unknown.   It was unknown if the reporter considered the facial swelling, neck swelling and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient developed swelling in face and neck with generally itching after her first Shingrix. The chat was ended by the practitioner before further details could be clarified or obtained. No further details was provided. The reporter abruptly ended chat. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Pain at the injection site; Redness at injection site; Swelling at injection site; Striations running from the injection site to the back of arm and down arm; Bruising; Shoulder was painful; Shoulder had swelling; Feeling really lethargic; Feeling tired; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, less than a day after receiving Shingrix, the patient experienced lethargy and tiredness. On 18th July 2019, the patient experienced injection site pain, injection site erythema, injection site swelling, stretch marks, contusion, shoulder pain and swollen joints. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, stretch marks, lethargy, tiredness, contusion, shoulder pain and swollen joints were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, stretch marks, lethargy, tiredness, contusion, shoulder pain and swollen joints to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The pharmacist reported that the patient experienced pain, redness and swelling at the injection site. The patient also had striations running from the injection site to the back of her arm and down her arm. All the symptoms had resolved. The pharmacist reported that the patient experienced feeling really lethargic and tired. The day after vaccination, the patient noticed bruising, and her shoulder was also painful and had swelling.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Musculoskeletal pain, Skin striae
Clinical narrative: Pain at the injection site; Redness at injection site; Swelling at injection site; Striations running from the injection site to the back of arm and down arm; Bruising; Shoulder was painful; Shoulder had swelling; Feeling really lethargic; Feeling tired; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, less than a day after receiving Shingrix, the patient experienced lethargy and tiredness. On 18th July 2019, the patient experienced injection site pain, injection site erythema, injection site swelling, stretch marks, contusion, shoulder pain and swollen joints. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, stretch marks, lethargy, tiredness, contusion, shoulder pain and swollen joints were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, stretch marks, lethargy, tiredness, contusion, shoulder pain and swollen joints to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The pharmacist reported that the patient experienced pain, redness and swelling at the injection site. The patient also had striations running from the injection site to the back of her arm and down her arm. All the symptoms had resolved. The pharmacist reported that the patient experienced feeling really lethargic and tired. The day after vaccination, the patient noticed bruising, and her shoulder was also painful and had swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discomfort
Clinical narrative: Bad headache; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and injection site pain. On an unknown date, the outcome of the headache and injection site pain were recovered/resolved.   It was unknown if the reporter considered the headache and injection site pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter had a friend that received the Shingrix vaccine and experienced a bad headache and soreness at the injection site.  The reporter was unable to provide any additional details.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever; Arm was very swollen; Arm red; Arm was hot; A lot of pain; This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced fever, swelling arm, erythema of extremities, skin warm and pain. On an unknown date, the outcome of the fever, swelling arm, erythema of extremities, skin warm and pain were unknown.   It was unknown if the reporter considered the fever, swelling arm, erythema of extremities, skin warm and pain to be related to Tdap Vaccine.  Additional information received were as follows: The age at vaccination was not reported. The manufacturer, lot number and expiry date was unknown. The nurse on the line reported that she had a really strong reaction to Tdap 10 years ago. The patient experienced fever, her arm was very swollen, red, and hot and she had a lot of pain, which was more than normal. The reporter did not consent to follow-up. The caller did not had time to complete full safety report.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm getting really red; Arm getting really red; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 89-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information received were as follows: The age at vaccination was not reported. The nurse reported that the patient received an unknown flu vaccine on unknown date and experienced her arm getting really red and sore. Due to this prior experience she would like to get a split dose of an unspecified flu vaccine. The healthcare professional did not know what past flu vaccine the patient received and they had not decided what flu vaccine she would get this season.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: pain; discomfort; This case was reported by a nurse via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and discomfort. On an unknown date, the outcome of the pain and discomfort were unknown.   It was unknown if the reporter considered the pain and discomfort to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced lots of pain and discomfort after her first dose.  The nurse asked if Shingrix could be administered in the bottom instead of deltoid.  The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The message received from the commercial team that an adverse event following administration of Flulaval MDV had been reported a subsidiary of reported hospitalizations following the administration of Flulaval MDV to their employees. The reporter did not know how many employees received the vaccine. They have pulled all other MDVs from use. The reporter wanted to make you aware of this situation in case this is not an isolated event. The reporter asked is there a way to monitor this internally. This is 2 of 3 case having same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (101), body ache
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness heat around injection site, swelling of upper arm 2x size, hives on back, nausea, diarrhea, airway swelling.  Went to ER, Benadryl taken after shot. Upon arrival at ER, Pepcid, Decadron, Benadryl, Epi, Albuterol, repeat Benadryl, etc. 6-8 hour tx. Went home on high dose steroid pack 15 days.   9/11/19 trouble breathing, hives, upset stomach, albuterol and Benadryl worked, no hospital visit.   9/12/19, wheezing, tongue swelling, hives. Self medicated, Epi, albuterol, Benadryl. Ambulance transport to MedCenter. Pepcid, Decadron, repeat, etc. 6-8 stay?    9/29 facial, neck swelling with rash. GI upset, ER visit, Epi, Pepcid, Benadryl, Solumedrol. 4-5 hour hospital stay, placed on high dose steroid pack for 12 days.   10/7/19. Stopped antihistamine 10/5/19 to prepare for allergy testing. Swollen face, lips, hives, diarrhea. Took Zyrtec and Benadryl, so far, no ER visit.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Lip swelling, Nausea, Peripheral swelling, Rash
Clinical narrative: Swelling, redness heat around injection site, swelling of upper arm 2x size, hives on back, nausea, diarrhea, airway swelling.  Went to ER, Benadryl taken after shot. Upon arrival at ER, Pepcid, Decadron, Benadryl, Epi, Albuterol, repeat Benadryl, etc. 6-8 hour tx. Went home on high dose steroid pack 15 days.   9/11/19 trouble breathing, hives, upset stomach, albuterol and Benadryl worked, no hospital visit.   9/12/19, wheezing, tongue swelling, hives. Self medicated, Epi, albuterol, Benadryl. Ambulance transport to MedCenter. Pepcid, Decadron, repeat, etc. 6-8 stay?    9/29 facial, neck swelling with rash. GI upset, ER visit, Epi, Pepcid, Benadryl, Solumedrol. 4-5 hour hospital stay, placed on high dose steroid pack for 12 days.   10/7/19. Stopped antihistamine 10/5/19 to prepare for allergy testing. Swollen face, lips, hives, diarrhea. Took Zyrtec and Benadryl, so far, no ER visit.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Swelling face, Swollen tongue, Urticaria, Wheezing
Clinical narrative: Swelling, redness heat around injection site, swelling of upper arm 2x size, hives on back, nausea, diarrhea, airway swelling.  Went to ER, Benadryl taken after shot. Upon arrival at ER, Pepcid, Decadron, Benadryl, Epi, Albuterol, repeat Benadryl, etc. 6-8 hour tx. Went home on high dose steroid pack 15 days.   9/11/19 trouble breathing, hives, upset stomach, albuterol and Benadryl worked, no hospital visit.   9/12/19, wheezing, tongue swelling, hives. Self medicated, Epi, albuterol, Benadryl. Ambulance transport to MedCenter. Pepcid, Decadron, repeat, etc. 6-8 stay?    9/29 facial, neck swelling with rash. GI upset, ER visit, Epi, Pepcid, Benadryl, Solumedrol. 4-5 hour hospital stay, placed on high dose steroid pack for 12 days.   10/7/19. Stopped antihistamine 10/5/19 to prepare for allergy testing. Swollen face, lips, hives, diarrhea. Took Zyrtec and Benadryl, so far, no ER visit.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm and legs ached, felt tired and weak, sore muscles. NO rash, NO swelling, NO itching.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Drooling, Screaming, Vomiting
Clinical narrative: Client's mother contacted me and stated that the child had been screaming and vomiting since they had gotten home from getting the vaccinations, approximately an hour.  Client stated that child was also drooling.  Mother was concerned whether it was the vaccination or not.  Instructed mother to take child to see a physician for further examination.  Mother took child to Hospital to be evaluated.  Child was not given an IV fluids in the ER.  Child was discharged and mother was to continue monitoring child, make sure he takes some fluids, but he were to continue to vomit to bring him back in for IV fluids.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site erythema
Clinical narrative: Initially small redness around site continued to expand to larger area of arm 5 or 6 inches in the appearance of a band around the upper arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: arm swelled, ached, itched at site. Stomach hurt, soar muscles, NO rash
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Extreme nausea and vomiting, mild diarrhea.  Lasted for 18 hours.  Did not seek medical advice,  just waited it out.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Eye disorder, Eyelid margin crusting, Headache, Lymphadenopathy, Pain
Clinical narrative: Eyes started to film over after 4 hours, glands under my tongue started to swell, felt like I was hurting all over.  Showered, tyenol, went to bed.  During the night I woke and eyes crusted still, ached, headache, this morning somewhat better but hurt all over with a headache
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Myalgia, Swollen tongue
Clinical narrative: On evening after received vaccination, she experienced difficult to swallow, enlarged tongue., and muscle aches. She went to outpatient clinic and received Benadryl. She had fewer symptoms in the morning.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: pt states reaction site swollen, red.  Redness and irritation seem to be traveling from arm to back of neck.  Recommended pt apply ice, use tylenol or ibuprofen, contact dr if symptoms worsen or do not improve.
Sex: U
Vaccine: TDAP
Symptoms: Malaise
Clinical narrative: Been ill ever since; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, less than a day after receiving Tdap Vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was not recovered/not resolved.   It was unknown if the reporter considered the unwell to be related to Tdap Vaccine.  Additional information received were as follows: The age at vaccination was not reported. The patient received Tdap Vaccine so that the patient could be around the new grandson who was expected in February. The patient had some of the side effects but was still worth of it. The patient was ill ever since receiving Tdap Vaccine. The patient's youngest son, the baby's father also received Tdap Vaccine and also had some of the side effects.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: 9/29/19 Back of upper left arm started feeling itchy off and on. Thought it was a mosquito bite. 10/1/19 Site felt like it was burning a little and slightly swollen. Noticed there was a red rash an inch below injection site.  The rash  got bigger over the next few days and 5 blisters appeared. One of the blisters was larger.  It felt like I was being pinched at that spot.  10/7/19 Rash is almost gone. The blisters are now just red spots. No itchiness. A little soreness to touch.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 9/29/19 Back of upper left arm started feeling itchy off and on. Thought it was a mosquito bite. 10/1/19 Site felt like it was burning a little and slightly swollen. Noticed there was a red rash an inch below injection site.  The rash  got bigger over the next few days and 5 blisters appeared. One of the blisters was larger.  It felt like I was being pinched at that spot.  10/7/19 Rash is almost gone. The blisters are now just red spots. No itchiness. A little soreness to touch.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Laboratory test, Seizure
Clinical narrative: PT LEFT CLINIC AND WAS AT DRIVE THRU AND HAD A SEIZURE AMBULANCE HAD TO BE CALLED.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Eye pain, Injected limb mobility decreased, Malaise, Ocular hyperaemia
Clinical narrative: By 6 pm I was feeling sick/feverish - By 8 pm my eyes were red and bloodshot, which got worse as the night progressed; I also had the feeling like I was getting a cough in my chest but that did not materialize.  My eyes were sore and less red the next day, and I was fine after 48 hours.  A week after the shot my left arm hurt and was hard to lift just for the day.   **I don't know if I listed the correct flu vaccine that was used - I did not have that information
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: By 6 pm I was feeling sick/feverish - By 8 pm my eyes were red and bloodshot, which got worse as the night progressed; I also had the feeling like I was getting a cough in my chest but that did not materialize.  My eyes were sore and less red the next day, and I was fine after 48 hours.  A week after the shot my left arm hurt and was hard to lift just for the day.   **I don't know if I listed the correct flu vaccine that was used - I did not have that information
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in the shoulder, unable to lift arm without pain. She has been feeling this way for 13 days now. She expected the pain to wear away by now. No bruising
Age: 72.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Papule, Pruritus, Scab, Skin lesion
Clinical narrative: Patient tells me that she got the vaccine on Monday and on Saturday she began to have itchy lesions on her abdomen and then on her breast.   Patient did have a honey-colored crust over the breast lesion.  Patient reports the lesions on the abdomen have been improving.  She denies any fevers, chills, or sweats.  She does not report these lesions are painful.  She has been using Neosporin on the lesion on her breast.  She admits to traveling to her camp on Wednesday or Thursday of that week and does have a lot of insects including spiders in the cabin.  She does leave her closely on the floor in the closet and does question that this may be an insect bite.  Right breast:  Scattered raised and itchy papules on right breast at the 5 o'clock position  Right anterior abdomen in the right lower quadrant.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site rash, Nausea, Pain
Clinical narrative: Moderate rash at site of injection; significant headache, body aches, slight nausea.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came to the pharmacy today reporting a rash on his right lower leg.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform, Sinus congestion
Clinical narrative: stuffy sinuses; a measles-like rash; fever; This spontaneous report was received from a pharmacist and refers to a 36-year-old non-pregnant female patient. The patient's concurrent condition included drug reactions/ allergies to bupropion hydrochloride (WELBUTRIN) and citalopram. No information regarding the patient's pertinent medical history and concomitant therapies was provided.  On 16-AUG-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, lot # S014429 and expiration date 09-MAY-2021, subcutaneously (exact dose was not provided) for prophylaxis (reported as "needed booster for employment in the medical field"). On unspecified date in 2019, the patient experienced fever, stuffy sinuses and a measles-like rash. The outcome of sinus congestion, pyrexia and rash morbilliform was reported as recovered on 19-SEP-2019, when the patient came to the pharmacy. No causality assessment was provided by the reporter.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Headache, Hypoaesthesia, Impaired work ability
Clinical narrative: Arm numbness which progressed to hands, fingers, and legs; Tingling; Weakness; Headache; Feeling poorly; Out of work; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 40-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   In September 2019, the patient received FluLaval Tetra 2019-2020 season. In September 2019, couple of hours after receiving FluLaval Tetra 2019-2020 season, the patient experienced numbness, tingling, weakness, headache, feels poorly and inability to work. On an unknown date, the outcome of the numbness, tingling, weakness, headache, feels poorly and inability to work were not recovered/not resolved.   It was unknown if the reporter considered the numbness, tingling, weakness, headache, feels poorly and inability to work to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The director of pharmacy reported that the patient received the Flulaval vaccine on unknown deltoid on either 14th September 2019 or 15th September 2019. Within a couple hours of receiving the vaccine, the patient started feeling poorly. The symptoms continued to devolve over the next 5 days, and the patient experienced initial arm numbness which progressed to hands, fingers and legs. 5 days after the injection, the patient presented in the emergency room for evaluation and the neurology consult was unable to diagnose anything at the time. The patient was referred to outpatient neurology for follow up.  The patient was still experiencing headache, numbness, weakness, and was still out of work on leave as of the time of this call. The reporter consented to follow up. No further details available at the time of this call. The pharmacy consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Arm numbness which progressed to hands, fingers, and legs; Tingling; Weakness; Headache; Feeling poorly; Out of work; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 40-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   In September 2019, the patient received FluLaval Tetra 2019-2020 season. In September 2019, couple of hours after receiving FluLaval Tetra 2019-2020 season, the patient experienced numbness, tingling, weakness, headache, feels poorly and inability to work. On an unknown date, the outcome of the numbness, tingling, weakness, headache, feels poorly and inability to work were not recovered/not resolved.   It was unknown if the reporter considered the numbness, tingling, weakness, headache, feels poorly and inability to work to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The director of pharmacy reported that the patient received the Flulaval vaccine on unknown deltoid on either 14th September 2019 or 15th September 2019. Within a couple hours of receiving the vaccine, the patient started feeling poorly. The symptoms continued to devolve over the next 5 days, and the patient experienced initial arm numbness which progressed to hands, fingers and legs. 5 days after the injection, the patient presented in the emergency room for evaluation and the neurology consult was unable to diagnose anything at the time. The patient was referred to outpatient neurology for follow up.  The patient was still experiencing headache, numbness, weakness, and was still out of work on leave as of the time of this call. The reporter consented to follow up. No further details available at the time of this call. The pharmacy consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Toothache
Clinical narrative: toothache; Bad flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and toothache. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the toothache was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and toothache to be related to Shingrix.  Additional information received were as follows: This reporter was the patient's friend. The age at vaccination was not reported. Around 18th to 19th July 2019, the patient received Shingrix. The patient experienced bad flu-like symptoms for a week after the injection. As far as the reporter knows, the patient was still experiencing the toothache at the reporting date.
Sex: U
Vaccine: FLU4
Symptoms: Neurological symptom
Clinical narrative: Neurological events; This case was reported by a other health professional via sales rep and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown.   It was unknown if the reporter considered the neurological symptom to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter called to report adverse event due to unable to access database. The healthcare professional administered 10,000 vials of Flulaval vaccines to all employees.  The one of the patient developed neurological event. The reporter unable to provide patient details.  The healthcare professional reached out to the local health department. This matter went up to leadership at the healthcare professional. The reporter informed to medical Liason for that area and had been made aware. The reporter consented to follow up. This is 1 of the 3 linked cases reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discomfort, Injection site pain
Clinical narrative: Soreness at the injection site; Was really tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th August 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional case details were reported as follows: The reporter indicated that less than 2 months after receiving the first dose of the Shingrix vaccine she experienced soreness at the injection site that lasted for several days and was really tired the whole next day after receiving the vaccination. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Pain, Tremor
Clinical narrative: Very sore right arm at the injection site; Had body aches head to toe; Difficulty lifting her right arm above her shoulder; Shaking / Trembling; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019 14:00, the patient received the 2nd dose of Shingrix. In September 2019, 1 day after receiving Shingrix, the patient experienced general body pain and injected limb mobility decreased. On 26th September 2019 23:00, the patient experienced tremor. On 27th September 2019, the patient experienced injection site pain. The patient was treated with analgesic, nos (Analgesic). On an unknown date, the outcome of the tremor was recovered/resolved and the outcome of the injection site pain, general body pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the tremor, injection site pain, general body pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The reporter stated that she received an email from GlaxoSmithKline asking her to report any side effects that she may experience with her 2nd dose of Shingrix. The reporter stated that the email was in regards to her call on day before reporting inquiring if she should take her flu shot along with her Shingrix, but decided to only get her Shingrix injection. The patient got her Shingrix vaccine on day before reporting at 2 pm, she was fine till she went to bed, at 11 pm where she started shaking and trembling for about an hour. The patient did some slow breathing and put extra blankets on her and after an hour it went away.  When the patient got up in morning of day of reporting, 1 day after vaccination she had body aches head to toe, she went for a walk in the yard for ten minutes, and the aches are starting to diminish. The patient also reported experiencing a very sore right arm at the injection site and has difficulty lifting her right arm above her shoulder. The patient had to have someone help her out of her sweatshirt because her arm was so sore. The patient declined in providing her doctor's contact information, provided caller information on duration of side effects and using analgesics for pain from Shingrix consumer frequently asked question. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Swelling face
Clinical narrative: Facial swelling; Neck swelling; Generalized Itching; This case was reported by a physician via call center representative and described the occurrence of facial swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 7 days after receiving Shingrix, the patient experienced facial swelling, neck swelling and generalized pruritus. On an unknown date, the outcome of the facial swelling, neck swelling and generalized pruritus were unknown.   It was unknown if the reporter considered the facial swelling, neck swelling and generalized pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient developed swelling in face and neck and generalized itching about a week after first Shingrix dose. The reporter disconnected the chat prior to providing any additional patient details. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller was Glaxosmithkline medical information scientist reporting an adverse event that was reported to her by a physician. The caller stated that the patient developed fever and myalgia. The reporter requested to use the contact information for follow up with the healthcare professional. The caller was not able to verify a phone number for the healthcare professional.  The caller did not provide any additional information.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise
Clinical narrative: redness at injection site; felt ill; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   Previously administered products included Zostavax and Shingrix with an associated reaction of malaise (1st dose received on 24th July 2019, refer linked case US2019AMR176926).   On 25th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and feeling unwell to be related to Shingrix.  Additional information received were as follows: The caller was the patient. The patient felt ill and also developed redness at the injection site. The reporter did not consent to follow-up.  The caller did not provide any additional information.