chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: Have no desire to eat; Terrible vertigo/ Just moving my head at all while laying down caused the room to spin/ Unable to bend over; Nausea; Vomited; Unable to walk without assistance from fear of falling; Unable to walk without assistance from fear of falling; Was tired that night; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (and heavy in mind and body after receiving 1st dose, for tolerance refer case US2019AMR176889). Concomitant products included atorvastatin calcium (Lipitor).   On 25th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 26th September 2019, the patient experienced vertigo, nausea, vomiting, unable to walk and fear of falling. On 28th September 2019, the patient experienced decreased appetite. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite were unknown.   It was unknown if the reporter considered the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient stated, she was a normally healthy woman who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. On 25th September 2019 at night, the patient was tired. On the next morning, 1 day after receiving a dose of Shingrix, she had terrible vertigo, nausea and vomited. She was unable to walk without assistance from fear of falling. The patient felt that her head was just moving at all while laying down caused the room to spin. The next day on 27th September 2019, the symptoms were still present but less severe and the patient did not vomit.  On the third day (the day of reporting), 3 days after receiving a dose of Shingrix, she was experiencing moments of vertigo and did not have the desire to eat. The patient was unable to bend over and periodically no matter what she was doing, vertigo and nausea momentarily overwhelm her.  The patient stated, while dizziness was listed as a possible side effect, her reaction seemed severe and she was hoping the vertigo would abate shortly. She did call the pharmacy and they suggested her to take benadryl. The patient wanted to alert GlaxoSmithKline to her seeming over-reaction and wanted to receive information on to what to expect as the days passes. She would like to know if vertigo would going to stop or not.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Genital herpes/ herpes outbreaks/ had 3 separate outbreaks; This case was reported by a physician via sales rep and described the occurrence of genital herpes in a elderly 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, 14 days after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   The reporter considered the genital herpes to be unrelated to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported. The reporter stated that, the patient was seen in office last week on 16th September 2019.  The reporter was unsure of date of receiving Shingrix. Upon reviewing immunizations profile of patient, the reporter stated the 2nd dose of Shingrix needs to be given to the patient but they also mentioned that, the patient had an outbreak of genital herpes 2 weeks after receiving 1st dose of Shingrix. Exact onset date was not known. The patient also had three separate outbreaks after 2 weeks intervals subsequent to initial outbreak. The reporter did not think that, the event genital herpes outbreak was related to receiving Shingrix. The reporter agreed for follow up.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: cough; swelling at injection site; redness at injection site; pain at injection site; itching at injection site; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 25th September 2019, 1 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, injection site swelling, injection site erythema, injection site pain and injection site itching. On 27th September 2019, the patient experienced cough. On 27th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the cough, injection site swelling, injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, cough, injection site swelling, injection site erythema, injection site pain and injection site itching to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient reported that her fever went as high as 103. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. There was discrepancy in the outcome of the events cough, injection site swelling, injection site erythema, injection site pain and injection site itching reported in source document as recovering/ resolving and in argus it was reported as not recovered/ not resolved.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: cough; swelling at injection site; redness at injection site; pain at injection site; itching at injection site; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 25th September 2019, 1 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, injection site swelling, injection site erythema, injection site pain and injection site itching. On 27th September 2019, the patient experienced cough. On 27th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the cough, injection site swelling, injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, cough, injection site swelling, injection site erythema, injection site pain and injection site itching to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient reported that her fever went as high as 103. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. There was discrepancy in the outcome of the events cough, injection site swelling, injection site erythema, injection site pain and injection site itching reported in source document as recovering/ resolving and in argus it was reported as not recovered/ not resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Felt kind of wiped out; This case was reported by a pharmacist via call center representative and described the occurrence of worn out in an unspecified number of adult patients 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 worn out. On an unknown date, the outcome of the worn out was unknown.   It was unknown if the reporter considered the worn out to be related to Shingrix.  Additional case details were provided as follows: The age group was not reported but was selected as an adult as per Shingrix indication. No patient identifiers to provide or lot number and expiry date. The reporter stated that, everyone she knew just felt kind of wiped out after receiving Shingrix dose and she heard this when she was just talking to nurses and other staff members. No further details were provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue. The patient was treated with diphenhydramine hydrochloride + paracetamol (Tylenol Pm). On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not wish to provide dob, no vaccine information was available. The pharmacist who was a patient reported that he had fatigue the day after receiving a dose of Shingrix. Also took a tylenol pm the night after receiving the dose of Shingrix. The reporter did not consent to follow-up. The reporter did not wish to provide dob, no vaccine information was available.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: nurse given a patient one component from the Pentacel and not the other, no AE; Upon second medical examination of the case during internal review, a significant correction was performed on 04-Oct-2019 to update correct validity of case from non-valid to valid.  Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who was vaccinated with one component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number, expiration date, dose, route and site of administration was not reported) and not the other and not certain if that was the HIB portion or the DTAP IPV portion, on an unspecified date.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  No new information was received.  Addendum: 19-Aug-2019: The validity was corrected.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient's that received the diluent DTaP/IPV of the Pentacel, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA268503 (same reporter).  This case involves a 4 months old female patient who received 0.5 ml dose of diluent DTaP/IPV of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ101AAA and expiry date: 19Sep2020) via intramuscular route in the right thigh. This patient received the diluent of the DTaP/IPV which was the second dose of a DTaP and a IPV for this patient  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: patient received the diluent of the DTaP/IPVof pentacel, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA268491 (same reporter).  This case involves a 4 months old female patient who received 0.5 ml dose of diluent DTaP/IPV of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ101AAA and expiry date: 19Sep2020) via intramuscular route in the right thigh. This patient received the diluent of the DTaP/IPV which was the second dose of a DTaP and a IPV for this patient  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: upper arm burning, increased warmth, purpura; rest of the symptoms abated now, except purpura still visible lower forearm today
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood potassium
Clinical narrative: upper arm burning, increased warmth, purpura; rest of the symptoms abated now, except purpura still visible lower forearm today
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood sodium, Blood urea, Burning sensation, Carbon dioxide, Full blood count
Clinical narrative: upper arm burning, increased warmth, purpura; rest of the symptoms abated now, except purpura still visible lower forearm today
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein total, Purpura, Skin warm
Clinical narrative: upper arm burning, increased warmth, purpura; rest of the symptoms abated now, except purpura still visible lower forearm today
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Joint stiffness, Night sweats
Clinical narrative: Swelling at injection site, night sweats, itching at site.  Currently stiffness in joint, skin peeling on upper left arm, mostly resolved now.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: Swelling at injection site, night sweats, itching at site.  Currently stiffness in joint, skin peeling on upper left arm, mostly resolved now.
Age: 74.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Gastrointestinal disorder
Clinical narrative: had GI sx- diarrhea, upset stomach from 7pm-9pm. Both knees hurt on 10/07/2019
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site and entire shoulder, approx. 12 hrs. after injection I developed chills and a fever of 100.6.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: These occurred with both Shingrix vaccinations, but were worse with the second one. muscle pain, headache, chills, fever (100.5, second one but not first), tired (not sure if secondary to lack of sleep or vacillation) stomach pain, and nausea.  I am on Day 2,  and while  I still have symptoms they have lessened.  I have had cold sores  from about 1985 to early 2000s.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: These occurred with both Shingrix vaccinations, but were worse with the second one. muscle pain, headache, chills, fever (100.5, second one but not first), tired (not sure if secondary to lack of sleep or vacillation) stomach pain, and nausea.  I am on Day 2,  and while  I still have symptoms they have lessened.  I have had cold sores  from about 1985 to early 2000s.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Asthenia, Contusion, Erythema, Mobility decreased, Nausea
Clinical narrative: 1. Swelling - erythematous Patches 2. The pt was unable to lift her arm 3. Bruising in multiple areas of her Right arm. 4. Nausea, weakness
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Swelling
Clinical narrative: 1. Swelling - erythematous Patches 2. The pt was unable to lift her arm 3. Bruising in multiple areas of her Right arm. 4. Nausea, weakness
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Muscular weakness, Nausea, Pyrexia
Clinical narrative: 1. Swelling - erythematous Patches 2. The pt was unable to lift her arm 3. Bruising in multiple areas of her Right arm. 4. Nausea, weakness
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient is reporting ringing in his ears that lasted for about 14 days after he received vaccination.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site pain
Clinical narrative: Pain at injection site, bruising under the arm
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Bone pain, Myalgia, Pain
Clinical narrative: pt experienced whole body aches/muscle aches/ bone pain a few hours after receiving vaccines.  she self treated with around the clock ibuprofen and tylenol and the adverse reaction was resolved in 24 hours.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphonia, Muscle tightness, Throat irritation, Throat tightness
Clinical narrative: 2000 scratchy, full throat 2030 no voice, tightness in neck and throat took benedryl and zantac and relieved it
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Burning sensation, Fatigue, Injection site erythema
Clinical narrative: On Sept 18 I had the Shringrix vaccine. I started taking ibuprofen 400mg TID x 4 days immediately at the injection to mitigate skin reaction and pain. However, day 1 post vaccine (Sept 19) I got 3 inch reatcogenic site at injection site - red, hardening, and pain.  Also got malaise and feeling weak and tired. The latter symptoms lasted one day, but the skin reaction continued and then abated by Day 6 (Sept. 24).    However on day 11 (Sept 29), I developed pain (my typical shingle pain of muscle ache/bruising sensation) R  posterior pain at C6 (between scapula and spine).  On Day 12, Sept 30, the pain started to radiate from C6 right spinal area down the arm to top of R upper forearm.   At this sign I started Valtrex Sept 30, which worked 2 times prior when initiated to mitigate pain and later lesion development.  However, after 7 days on Valtex the pain got worse and persisted.  There were only 2 skin papules - one near elbow at top of R forearm started around 10/1   and one at top of R wrist started around 10/6.   At this date of reportin 10/8 I'm still experience mild-moderate my typical post-herpectic neuralgia (pain/ache.that feels like a deep brusing, from C6 spine down to wrist; at times worse and other times mild). I'm taking Neurontin 300mg capsules prn as they are very sedating to me. No relief from ibuprofen.    This pain distribution is the same as in May 2019 and December 2016 around C6 I'm concerned that the vaccine, Shingrix, triggered some neural - virus reaction. I'm reporting in case others also experience  their typical shingles pain in response to the vaccine. Thank you for considering and evaluation and assessing if labeling should be amended.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Malaise, Myalgia
Clinical narrative: On Sept 18 I had the Shringrix vaccine. I started taking ibuprofen 400mg TID x 4 days immediately at the injection to mitigate skin reaction and pain. However, day 1 post vaccine (Sept 19) I got 3 inch reatcogenic site at injection site - red, hardening, and pain.  Also got malaise and feeling weak and tired. The latter symptoms lasted one day, but the skin reaction continued and then abated by Day 6 (Sept. 24).    However on day 11 (Sept 29), I developed pain (my typical shingle pain of muscle ache/bruising sensation) R  posterior pain at C6 (between scapula and spine).  On Day 12, Sept 30, the pain started to radiate from C6 right spinal area down the arm to top of R upper forearm.   At this sign I started Valtrex Sept 30, which worked 2 times prior when initiated to mitigate pain and later lesion development.  However, after 7 days on Valtex the pain got worse and persisted.  There were only 2 skin papules - one near elbow at top of R forearm started around 10/1   and one at top of R wrist started around 10/6.   At this date of reportin 10/8 I'm still experience mild-moderate my typical post-herpectic neuralgia (pain/ache.that feels like a deep brusing, from C6 spine down to wrist; at times worse and other times mild). I'm taking Neurontin 300mg capsules prn as they are very sedating to me. No relief from ibuprofen.    This pain distribution is the same as in May 2019 and December 2016 around C6 I'm concerned that the vaccine, Shingrix, triggered some neural - virus reaction. I'm reporting in case others also experience  their typical shingles pain in response to the vaccine. Thank you for considering and evaluation and assessing if labeling should be amended.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Post herpetic neuralgia, Skin lesion
Clinical narrative: On Sept 18 I had the Shringrix vaccine. I started taking ibuprofen 400mg TID x 4 days immediately at the injection to mitigate skin reaction and pain. However, day 1 post vaccine (Sept 19) I got 3 inch reatcogenic site at injection site - red, hardening, and pain.  Also got malaise and feeling weak and tired. The latter symptoms lasted one day, but the skin reaction continued and then abated by Day 6 (Sept. 24).    However on day 11 (Sept 29), I developed pain (my typical shingle pain of muscle ache/bruising sensation) R  posterior pain at C6 (between scapula and spine).  On Day 12, Sept 30, the pain started to radiate from C6 right spinal area down the arm to top of R upper forearm.   At this sign I started Valtrex Sept 30, which worked 2 times prior when initiated to mitigate pain and later lesion development.  However, after 7 days on Valtex the pain got worse and persisted.  There were only 2 skin papules - one near elbow at top of R forearm started around 10/1   and one at top of R wrist started around 10/6.   At this date of reportin 10/8 I'm still experience mild-moderate my typical post-herpectic neuralgia (pain/ache.that feels like a deep brusing, from C6 spine down to wrist; at times worse and other times mild). I'm taking Neurontin 300mg capsules prn as they are very sedating to me. No relief from ibuprofen.    This pain distribution is the same as in May 2019 and December 2016 around C6 I'm concerned that the vaccine, Shingrix, triggered some neural - virus reaction. I'm reporting in case others also experience  their typical shingles pain in response to the vaccine. Thank you for considering and evaluation and assessing if labeling should be amended.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Headache, Influenza like illness, Mobility decreased
Clinical narrative: DONOR HAS COMPLAINTS OF FLU LIKE SYPMTOMS LIKE NAUSEA, WEAKNESS, JOINT PAIN, SWELLING, ITCHING, HEADACHES, LIMITED MOBILITY. DONOR SYMPTOMS HAVENT SUBSIDED, DONOR WILL SEEK MEDICAL ATTENTION.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pruritus, Swelling
Clinical narrative: DONOR HAS COMPLAINTS OF FLU LIKE SYPMTOMS LIKE NAUSEA, WEAKNESS, JOINT PAIN, SWELLING, ITCHING, HEADACHES, LIMITED MOBILITY. DONOR SYMPTOMS HAVENT SUBSIDED, DONOR WILL SEEK MEDICAL ATTENTION.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Bexsero vaccine was given on Monday 9/23/19. About 30-60 minutes following injection she started having nausea, swelling at injection site, discomfort at injection site and muscle VERY sore. This continued for the next two days, by Thursday 9/26/19 she wasn't nauseated any more, but injection site was very swollen, "about the size of a baseball". Swelling went down and patient left for a volleyball tournament over the weekend. Coach called on Saturday 9/28 because the shoulder/upper arm had hard red blotchy patches that were warm to the touch. Mom had coach bring her to UC, where the NP thought it was local reaction, gave steroid cream, which has helped some, red patches still there, but softening up, still itchy. I spoke w/ mom today, 10/8/19, Patient has recovered from response, no longer swollen, itchy or red. She did use steroid cream for several days and took about 2-3 days' worth of Zyrtec as well.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Rash macular
Clinical narrative: Bexsero vaccine was given on Monday 9/23/19. About 30-60 minutes following injection she started having nausea, swelling at injection site, discomfort at injection site and muscle VERY sore. This continued for the next two days, by Thursday 9/26/19 she wasn't nauseated any more, but injection site was very swollen, "about the size of a baseball". Swelling went down and patient left for a volleyball tournament over the weekend. Coach called on Saturday 9/28 because the shoulder/upper arm had hard red blotchy patches that were warm to the touch. Mom had coach bring her to UC, where the NP thought it was local reaction, gave steroid cream, which has helped some, red patches still there, but softening up, still itchy. I spoke w/ mom today, 10/8/19, Patient has recovered from response, no longer swollen, itchy or red. She did use steroid cream for several days and took about 2-3 days' worth of Zyrtec as well.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Patient reports, fever (slight), Painful lump to injection site x 1 day (since vaccination).
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Pt was having fainting like symptoms after he was at the work desk after the flu shot. Patient slightly fainted before he can call for help. Patient woke up and called for help and was having slight sweating. Patient?s breathing was normal and pulse was normal by the time we went there to help. Patient stated he was fine at that point and was checked again in 30 minutes. Patient  have had history of fainting after shots before.
Age: 94.0
Sex: U
Vaccine: ADEN_4_7, FLUA3
Symptoms: Erythema, Injection site pain, Pruritus
Clinical narrative: Note: Scheduled to see Dr. on 10/17/2019 for well-visit. No medical attn sought as of yet.   Fluad - Left Arm Pneumovax23 - Right Arm (System won't allow me to enter info in Box 17)  Itchiness started around 6pm into overnight, resulting in red patches all over body. Tried using ice/cold compress.  Believe it could be hives. No redness/itching around flu vax site, so could be related to Pneumovax. Pain at injection site of flu vax. Currently using calamine lotion and taking Benadryl.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: a bad case of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 12-APR-2012, the pt was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered a bad case of shingles. As a direct and proximate result of defective zoster vaccine live (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 zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The causality was related.  The event of bad case of shingles was considered to be disabling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Fever with chills, nausea accompanied with vomiting and loose stool, intense headache, dizziness, joint pain, sore throat
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever with chills, nausea accompanied with vomiting and loose stool, intense headache, dizziness, joint pain, sore throat
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: INJECTION SITE IS RED AND HOT ON TOUCH
Age: 28.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Computerised tomogram head, Dizziness, Fall, Head injury, Skin laceration
Clinical narrative: Patient was sitting for the immunizations, felt fine afterwards, got up and left. Patient was seated for approximately 5 min. Patient then proceeded to the restroom, where he finished utilizing and then as he was drying his hands felt lightheaded. Patient then fell backwards hitting his head on the floor. Patient was found by a coworker, who then ran to get help. Patient sustained a minor laceration and a skull fracture. Patient is currently being treated for this event.
Age: 28.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Skull fracture
Clinical narrative: Patient was sitting for the immunizations, felt fine afterwards, got up and left. Patient was seated for approximately 5 min. Patient then proceeded to the restroom, where he finished utilizing and then as he was drying his hands felt lightheaded. Patient then fell backwards hitting his head on the floor. Patient was found by a coworker, who then ran to get help. Patient sustained a minor laceration and a skull fracture. Patient is currently being treated for this event.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: INFANT HAD BLOODY STOOLS 2 WEEKS AFTER THE ORAL DOSE
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Didn't notice the child was given two shots of the IPOL  , physician made appointment to watch over patient didn't make the appointment nor answer the phone.... contacted our immunization coordinator successfully and lady which was not successful kept calling and email waiting for a response....
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Pyrexia, Tremor
Clinical narrative: Transient tremors and low-grade fever, no treatment no necessary.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Erythema, Urticaria
Clinical narrative: Pt's caregiver described the reaction as a "huge, red welp and bad bruising"
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: Vax - Shingrix (system won't allow me to enter in box 17)  Symptoms include teeth chattering chills, flu-like symptoms, fatigue, dizziness, poor balance, extreme tiredness, and inability to work. No medical attention sought. Waiting for symptoms to pass so that I can return to work. Warn everyone!
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness
Clinical narrative: Vax - Shingrix (system won't allow me to enter in box 17)  Symptoms include teeth chattering chills, flu-like symptoms, fatigue, dizziness, poor balance, extreme tiredness, and inability to work. No medical attention sought. Waiting for symptoms to pass so that I can return to work. Warn everyone!
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Injection site swelling
Clinical narrative: Felt initial pain at injection site (Left Deltoid) which persisted into night. Woke up at 3 am to get ready to go to work and had chills, body aching all over, increased pain in left upper arm with swelling in left upper arm and left hand/fingers (unable to remove ring). Took Tylenol followed by low dose ibuprofen. Called out of work. Had nausea, decreased appetite and headache all day on 10/3/19, had Fever 99.8 F, continued to take Tylenol. Had no cough, sore throat, shortness of breath or oral/facial angioedema.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Felt initial pain at injection site (Left Deltoid) which persisted into night. Woke up at 3 am to get ready to go to work and had chills, body aching all over, increased pain in left upper arm with swelling in left upper arm and left hand/fingers (unable to remove ring). Took Tylenol followed by low dose ibuprofen. Called out of work. Had nausea, decreased appetite and headache all day on 10/3/19, had Fever 99.8 F, continued to take Tylenol. Had no cough, sore throat, shortness of breath or oral/facial angioedema.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Diplopia, Dysstasia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: GBS- double vision, numbing of arms and legs, could not stand upright or walk
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture abnormal
Clinical narrative: GBS- double vision, numbing of arms and legs, could not stand upright or walk
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Epstein-Barr virus test, Full blood count, Lipids, Sinusitis, Thyroid function test
Clinical narrative: seasonal allergies; Information has been received from a medical assistant via a company representative referring to a 17 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 12-AUG-2019, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. S008151, expiration date : 20-NOV-2021; strength and dose were not reported), intramuscularly for routine vaccination. On 25-AUG-2019, the patient went to a minute clinic and was diagnosed with sinusitis and was given antibiotics, after he came into see the physician and was given an azithromycin (ZPAK). Two days after the azithromycin (ZPAK), he ended up with sinusitis again, the physician felt there might have been mono involved. On 01-SEP-2019, the patient experienced hives. On 04-SEP-2019, the patient came back to the office and was given diphenhydramine (BENADRYL). Hives were still coming and going. The patient did have seasonal allergies. The patient received lab diagnostics of complete blood count (CBC), lipid panel, thyroid panel and Epstein-Barr virus (EBV). All results were not provided. The outcome of the event was unknown. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: seasonal allergies; Information has been received from a medical assistant via a company representative referring to a 17 years old male patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 12-AUG-2019, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot No. S008151, expiration date : 20-NOV-2021; strength and dose were not reported), intramuscularly for routine vaccination. On 25-AUG-2019, the patient went to a minute clinic and was diagnosed with sinusitis and was given antibiotics, after he came into see the physician and was given an azithromycin (ZPAK). Two days after the azithromycin (ZPAK), he ended up with sinusitis again, the physician felt there might have been mono involved. On 01-SEP-2019, the patient experienced hives. On 04-SEP-2019, the patient came back to the office and was given diphenhydramine (BENADRYL). Hives were still coming and going. The patient did have seasonal allergies. The patient received lab diagnostics of complete blood count (CBC), lipid panel, thyroid panel and Epstein-Barr virus (EBV). All results were not provided. The outcome of the event was unknown. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported.; patient received extra dose of VARIVAX concomitantly with PROQUAD; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 24-SEP-2019, the patient received an extra dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot No. S005079 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 19-FEB-2021), concomitantly with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number and expiration date were not provided) for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-SEP-2019, the patient was inadvertently administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose and route of administration were not reported) (lot numbers involved: lot# S008692, expiry date 21-MAR-2021, lot# S019463, expiry date 24-JAN-2021, lot # R035222, expiry date 04-DEC-2020) for prophylaxis. All lot numbers of varicella virus vaccine live (oka/merck) (VARIVAX) were reconstituted with properly stored sterile diluent (STERILE DILUENT). The storage temperature was 27.1 Fahrenheit (F) during the time frame of 40 minutes. A digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.   On 10-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHa) (PROQUAD) lot # S009759, expiration date 27-SEP-2019 (dose, anatomical location and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. Administered dose of suspect vaccine experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.6F) for 56 hours and 40 minutes. Previous temperature excursion was reported as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.2F) for 10 minutes. Data logger was not involved. No adverse effects were reported.
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Alopecia, Blindness, Faeces discoloured, Nail growth abnormal, Pain in extremity
Clinical narrative: going blind in an unspecified eye; thyroid problems; hair falling out; nails stopped growing; pinching pain in legs, feet, and anal area; toe and anal pinching; toe and anal pinching; black stools; Recently received the "FLU vaccine on an unspecified date and then the shingles flared up; pinching pain in legs, feet; This spontaneous report was received from an 80-year-old male patient, who was referring to himself. The patient's pertinent medical history included heart attack and chronic allergies. He had no known drug reactions or allergies and no known concomitant medications.. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as vaccination. On an unknown date, he experienced unspecified thyroid problems, hair falling out, nail growth cessation, pinching pain in legs, feet and anal area, toe and anal pinching, black stools and also he stated that he was going blind in an unspecified eye. On an unknown date in May 2019, the patient was vaccinated with the first dose of zoster rgE vaccine (mammalian) (SHINGRIX) (dose, route of administration, lot number, expiration date and indication were not provided), and on an unknown date in July 2019, he was vaccinated with the second dose of zoster rgE vaccine (mammalian) (SHINGRIX). He stated, that after that, his symptoms improved for a while and became worse again. On an unknown date (reported as recently), he was vaccinated with an unspecified flu vaccine (dose, route of administration, lot number, expiration date and indication were not provided), and then shingles flared up. No treatment was given for the events and no lab diagnostics were performed. The patient sought medical attention. At the time of reporting, the outcome of the events was reported as not recovered. The relatedness between the events and the suspect vaccines was not reported. Upon internal review, the event of "going blind in an unspecified eye" was determined to be medically significant.
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Proctalgia, Thyroid disorder
Clinical narrative: going blind in an unspecified eye; thyroid problems; hair falling out; nails stopped growing; pinching pain in legs, feet, and anal area; toe and anal pinching; toe and anal pinching; black stools; Recently received the "FLU vaccine on an unspecified date and then the shingles flared up; pinching pain in legs, feet; This spontaneous report was received from an 80-year-old male patient, who was referring to himself. The patient's pertinent medical history included heart attack and chronic allergies. He had no known drug reactions or allergies and no known concomitant medications.. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as vaccination. On an unknown date, he experienced unspecified thyroid problems, hair falling out, nail growth cessation, pinching pain in legs, feet and anal area, toe and anal pinching, black stools and also he stated that he was going blind in an unspecified eye. On an unknown date in May 2019, the patient was vaccinated with the first dose of zoster rgE vaccine (mammalian) (SHINGRIX) (dose, route of administration, lot number, expiration date and indication were not provided), and on an unknown date in July 2019, he was vaccinated with the second dose of zoster rgE vaccine (mammalian) (SHINGRIX). He stated, that after that, his symptoms improved for a while and became worse again. On an unknown date (reported as recently), he was vaccinated with an unspecified flu vaccine (dose, route of administration, lot number, expiration date and indication were not provided), and then shingles flared up. No treatment was given for the events and no lab diagnostics were performed. The patient sought medical attention. At the time of reporting, the outcome of the events was reported as not recovered. The relatedness between the events and the suspect vaccines was not reported. Upon internal review, the event of "going blind in an unspecified eye" was determined to be medically significant.