chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a 30Jun2019 expired Menactra on 24Jul2019/ no side effects; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication.   On 24-Jul-2019, the patient received a second dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5917AA, expiry date 30-Jun-2019 via intramuscular route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that patient received a 30Jun2019 expired Menactra on 24Jul2019.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: the child was only supposed to receive 4 doses of Pentacel but the MA read the order wrong and misunderstood it; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that the child was only supposed to receive 4 doses of Pentacel but the MA read the order wrong and misunderstood it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On an unknown date, the patient received 5th dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: gave a patient expired Daptacel on 20May2019. The Daptacel had expired on 17May2019; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication.   On 20-May-2019, the patient received a fourth dose 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C52C6AA, expiry date 17-may-2019 via intramuscular route in left leg.  It was an actual medication error due to expired vaccine used.  It was reported that gave a patient expired Daptacel on 20May2019. The Daptacel had expired on 17May2019.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient refused more doses of Imovax and thought it was not needed; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that the patient refused more doses of Imovax and thought it was not needed.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received 1st dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incomplete course of vaccination  It was not reported if any adverse event occurred or not.  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.  Information on the batch number was requested  List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Eye pain, Headache
Clinical narrative: Flu-like symptoms:  body and joint ache, headache, fever/chills, sensitivity to touch,  sore  eyes and backache.  Symptom on-set morning of July 30, symptoms dissipated morning of August 1.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Tenderness
Clinical narrative: Flu-like symptoms:  body and joint ache, headache, fever/chills, sensitivity to touch,  sore  eyes and backache.  Symptom on-set morning of July 30, symptoms dissipated morning of August 1.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Patient complained of tingling sensation in lips.  She took Benadryl and sensation went away.  Patient is fine now.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient said her arm sore and ache and swollen from elbow and up also her arm feels hot
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported a rash on both arms 3 days after receiving Shingrix. Patient states that the rash is "definitely caused by Shingrix."
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Fever, chills, nausea, headache, fatigue lasted 3 days. Redness and swelling on most of upper arm, soreness from shoulder halfway down upper arm lasted 5  days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, fatigue lasted 3 days. Redness and swelling on most of upper arm, soreness from shoulder halfway down upper arm lasted 5  days.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Loss of consciousness
Clinical narrative: Affected individual donated plasma and then received the Twinrix vaccine.  The individual c/o pain with injection and lost consciousness for approx. 10 seconds.  He recovered almost immediately.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Erythema, Cellulitis of LUA- Keflex 500mg ordered
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: 2 days after vaccine Pediarix was administered, pt got hives (to right leg only) and erythema to right  leg, with small induration.  Patient was treated with Benadryl. Responded well to benadryl, hives went away.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: Last evening, became nauseated and vomited after eating chicken soup.  Mother stated that she had been feeling well other then her normal Headaches that she has routinely.  Has "normal allergies, runny nose, congestion from Hay fever"
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I got the injection about 9:00 AM Wednesday morning. 4 hours after the injection my shoulder and upper arm started getting sore.  An hour later I could not move my arm and if I tried to lift it, the pain was 10 on the 1 to 10 scale.  I left work at 2:00 and went home. The next morning I called the doctor's office and they told me to go to Urgent Care. I went, and left there with my arm in a sling and perscriptions for muscle relaxers, anti inflamatory and paid patches. The first 4 nights I could hardly sleep. It was hard to find a position that didn't hurt, and once I did fall asleep, I would roll over and the pain would wake me up.  On Sunday the pain started to subside, and each day after was a little better.  Today is Thursday, 8 days following the injection.  I still have pain when I move my arm in certain directions, but the pain now is only 1 - 2 on the 1 - 10 scale.   only occasionally wake up during the night after rolling over on that arm. I would think by now the pain would be gone.  The information sheet I was given on the vacine said extreme pain and restricted movement are possible but "very rare".  I certainly had both, and now, 8 days later, some effects are still with me.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Myalgia, Peripheral swelling
Clinical narrative: Swelling of arm, muscle ache and pouch developed (fluid like) and then proceeded to have skin turn red.  Pouch proceeded down arm and is continuing  on day 3
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Loss of consciousness, Nausea, Pain in extremity, Presyncope
Clinical narrative: He woke up with a painful arm from the vaccine. He complained of feeling dizzy and nauseous and then "blacked out."   It was determined to be a vasovagal reaction from the pain.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: Patient received the first dose of Shingrix on 7/14/19. The vaccine was mixed incorrectly (sterile water used as diluent instead of diluent that came prepackaged with vaccine). The patient was seen in the Emergency Dept at a local hospital the following day and diagnosed with Shingrix.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Product preparation error
Clinical narrative: Patient received the first dose of Shingrix on 7/14/19. The vaccine was mixed incorrectly (sterile water used as diluent instead of diluent that came prepackaged with vaccine). The patient was seen in the Emergency Dept at a local hospital the following day and diagnosed with Shingrix.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Loss of consciousness, Memory impairment, Pallor, Somnolence
Clinical narrative: Per patient's mom - patient complained about being very warm then lost consciousness for a few seconds. I was notified about the patient shortly after. symptoms: warmth, grogginess, pale, no recollection of walking from the IMZ area to the bench time: occurred within 5 minutes after injection outcome: approximately 10-15  minutes later, patient was noticeably better, smiling and left with her mom. Notes: Mom refused 911 said she'll monitor her daughter. Patient claimed this happened after blood drawn not too long ago.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Developed hives all over the body. Was prescribed steroid and helped.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face
Clinical narrative: Patient received her shingrix on 7/30/2019.  The patient called on 8/1/19 to report that she was getting some swelling in her cheek and she was breaking out with a rash on her arm and around her waist.  The patient was calling to ask the pharmacist what she could take to help with the rash because she was leaving for vacation tomorrow.  The patient was educated to watch for the rash and a bigger reaction since she has had shingles in the past.  The patient was glad the pharmacist warned her ahead of time to watch out for a reaction.  The patient was advised to take an antihistamine such as benadryl or zyrtec and she could also use a topical anti-itch like cortaid 10 or benadryl cream.  The patient was also advised to see her doctor if it was worsening and they could give her prednisone to help.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received shot on Friday night and was feeling fine for the next four or five days. Then on Tuesday afternoon she first started feeling itchy at the shot area and later it turned red and swollen and hard to the touch. She came to the pharmacy, spoke with the pharmacist and was advised to take some OTC Benadryl.  Today she reported the right arm area is soften, less red, less itchy and she thinks it is a lot better. However, the area still looked red and swollen and I encouraged her to call her primary care physician as per discussion during vaccination process. I encouraged patient to keep the shot area clean, continue OTC  Benadryl  and apply ice if needed. She is visiting with her primary care physician today to see if further treatment is needed.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: 2 hours after receiving vaccination she developed swelling and pain in right shoulder which the ER evaluation determined to be due to a large hematoma over the right deltoid.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cyanosis, Dizziness, Loss of consciousness, Nervousness, Pallor
Clinical narrative: Patient in clinic to receive meningococcal and tdap immunizations. Patient stated he was nervous, but tolerated injections well. Upon exiting to the clinic waiting room, patient became dizzy and sat down. After sitting down, patient passed out in the chair. Patient's mother called for help. RN responded and observed patient had lost consciousness. RN laid patient down, put his feet up, and attempted to arouse him. Patient regained consciousness immediately but was still very pale with blue tinged lips. RN instructed clerk to call 911. RN took patient BP and found it to be WNL at 116/74. RN continued to talk with patient. Patient admitted to not having anything to eat since breakfast. Patient stated he was feeling better but was not ready to sit up yet. Within a few minutes, patient no longer had blue tinged lips, and normal color began to return. Patient sat up, and RN gave him water and a snack. Patient tolerated water and snack well. Paramedics arrived on the scene. Paramedic assessed patient, found patient's vitals to be BP of 120/80, pulse in the 80s, and pulse oxygenation to be 96-97%. Paramedic had patient stand up and walk around, patient tolerated activity well. Paramedic gave recommendation that patient should be allowed to return home, but could be taken to the hospital if patient's mother felt it was necessary. Patient and mother returned home.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Skin rash that required treatment with topical steroids, stretched from site of injection across back
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: injection site pain; injection site warmth; arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date 3rd April 2021) for prophylaxis.   On 16th July 2019, the patient received Boostrix. On 22nd July 2019, 6 days after receiving Boostrix, the patient experienced injection site pain, injection site warmth and pain in arm. On an unknown date, the outcome of the injection site pain, injection site warmth and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth and pain in arm to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix on unknown arm. On 22 July 2019, the patient developed pain in arm, injection site pain, and injection site was warm to the touch. The all events were reported as ongoing. The reporter was consented to follow up. For all events onset date 21st July 2019 were updated as per source document event column, however in narrative it was reported as 22 July 2019.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: Hair started falling out in clumps; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th July 2019, 1 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: On Friday, the patient received Shingrix in left deltoid and on Saturday, her hair started falling out in clumps. The reporter was unable to provide any additional details. The reporter consented to follow up. This case was found to be duplicate of the case US2019132804. Case US2019132804 would be deleted and all the future corresponding information to the present case would be submitted to US2019132802 (case of record).
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter had several vials of the Shingrix product that were stored in the refrigerator and the vials froze, which led to incorrect storage of vaccine. The reporter was unable to provide any additional information.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Site became warm and painful within 4-5 hours,  and grew up to 4 inches in 2 days. Seen at urgent care 7/21/19, prescribed doxycycline. Fully recovered.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Heart rate increased, Pyrexia
Clinical narrative: PT C/O RAPID HEART BEAT/DIZZINESS/FEVER, DIZZINESS STARTED ABOUT TWO HOURS AFTER INJECTION AND THEN CONTINUED THE NEXT MORNING WHEN SHE WOKE UP, AND INCREASED HEAR BEAT, FEVER OF 100, SHE STATED THAT SHE HAD THE SAME ISSUE WITH HEART RACING WITH FIRST HPV THAT WAS GIVEN TWO MONTHS AGO, BUT SYMPTOMS RESOLVED. PT DID ALSO RECEIVE DEPO PROVERA INJECTION THE SAME DAY FOR CONTRACEPTIVE MAINTENECE.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash generalised
Clinical narrative: Rash all over body, pain at local injection site
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Genital rash, Headache, Musculoskeletal stiffness, Rash
Clinical narrative: Rash on right side of neck, left arm, left Breast, all around pubic area.  Headaches, stiff neck, and occasional shortness of breath.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Beginning the evening of the shot I started to feel extreme fatigue and muscle soreness. I went to bed and woke up with even worse soreness and fatigue. I took my temperature (via mouth) with a reading of 98.2 degrees Fahrenheit. It is 5:15 p.m. the day after the shot and I still feel extreme fatigue and whole body soreness.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Leg swelling and redness within 2 hours of injections, area of redness and swelling doubled within 2 hours of initial symptoms.  Child was taken to the ER, diagnosed with cellulitis and given IM penicillin.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccination - stated that she normally faints after getting blood drawn. Spoke to patient and she is doing okay.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: HEADACHE, FATIGUE, JOINT PAINT
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Localized erythema, swelling, tenderness.  Treatment: Cool compresses, NSAID Outcome: Unknown at this time.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Medical assistant gave DTaP to patient before noticing it had expired 2 months prior.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient experienced hives on her face and back. She is in the process of being treated for idiopathic hives, but had not had a significant outbreak in over a month. She described this particular events as pretty severe. The hives did not start to become a problem until the following night.  The hives resolved after 4 days. Patient was advised by her doctor to refrain from receiving the second dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Pt reports that after more than 24 hours after vaccine, her lips started to swell. Visibly looks "plump," but no respiratory problems. No new drugs or products being used during this period either. No reaction at time of vaccination.  Advised pt that if she has difficulty breathing to go to ER immediately, to evaluate if there were any medication/food/environmental changes to rule out other causes, and advised pt to f/u with doctor.  Pt said she has appointment with dermatologist in next few days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given MMRV and Varicella on the same day. No adverse reactions have been reported at this time. Parent notified of Immunization Error
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient received Kinrix for dose 2 of dtap and IPV vaccine
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately following immunization.  Recovered quickly
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Arthralgia, Bone pain, Decreased appetite, Exposure during pregnancy
Clinical narrative: currently 34 weeks pregnant, having large swelling at the injection site on my arm, it feels like there is a golf ball under my skin, it itches, burns and is bruised. I?ve had an upset stomach all day with no changes to diet, lack of appetite, extreme fatigue and my body is extremely sore. Every bone and joint in my body hurts as if I?ve got the flu. On top of all the my contractions have intensified since receiving the vaccine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: currently 34 weeks pregnant, having large swelling at the injection site on my arm, it feels like there is a golf ball under my skin, it itches, burns and is bruised. I?ve had an upset stomach all day with no changes to diet, lack of appetite, extreme fatigue and my body is extremely sore. Every bone and joint in my body hurts as if I?ve got the flu. On top of all the my contractions have intensified since receiving the vaccine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Pain, Uterine contractions during pregnancy
Clinical narrative: currently 34 weeks pregnant, having large swelling at the injection site on my arm, it feels like there is a golf ball under my skin, it itches, burns and is bruised. I?ve had an upset stomach all day with no changes to diet, lack of appetite, extreme fatigue and my body is extremely sore. Every bone and joint in my body hurts as if I?ve got the flu. On top of all the my contractions have intensified since receiving the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received shingrix vaccination on Tuesday and presented to pharmacy on Thursday with warm, red area. Treating with ice and tylenol, planning to follow-up with dr. if doesnt improve.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Around 5 pm the evening of injection, myalgia, joint pain, and muscle aches started.  By 8 pm, it felt like the flu:  fatigue, headache, shivering, fever, and overall achiness .  Next morning, 8 am: diarrhea, queasiness, continued myalgia, joint pain, muscle aches, fever, fatigue, headache, shivering (flu like symptoms and misery).  Took 2 pills of loperamide HCL at 10:30 am, and another at 11:30 am, which resolved the diarrhea.   Slept from 12:30pm to about 5pm.  By then, other symptoms started to subside.  By 8pm, queasiness and fatigue remained.  By morning of day 2, only sensitive stomach remained, which resolved itself by 2pm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Myalgia, Nausea, Pain
Clinical narrative: Around 5 pm the evening of injection, myalgia, joint pain, and muscle aches started.  By 8 pm, it felt like the flu:  fatigue, headache, shivering, fever, and overall achiness .  Next morning, 8 am: diarrhea, queasiness, continued myalgia, joint pain, muscle aches, fever, fatigue, headache, shivering (flu like symptoms and misery).  Took 2 pills of loperamide HCL at 10:30 am, and another at 11:30 am, which resolved the diarrhea.   Slept from 12:30pm to about 5pm.  By then, other symptoms started to subside.  By 8pm, queasiness and fatigue remained.  By morning of day 2, only sensitive stomach remained, which resolved itself by 2pm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Around 5 pm the evening of injection, myalgia, joint pain, and muscle aches started.  By 8 pm, it felt like the flu:  fatigue, headache, shivering, fever, and overall achiness .  Next morning, 8 am: diarrhea, queasiness, continued myalgia, joint pain, muscle aches, fever, fatigue, headache, shivering (flu like symptoms and misery).  Took 2 pills of loperamide HCL at 10:30 am, and another at 11:30 am, which resolved the diarrhea.   Slept from 12:30pm to about 5pm.  By then, other symptoms started to subside.  By 8pm, queasiness and fatigue remained.  By morning of day 2, only sensitive stomach remained, which resolved itself by 2pm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling hot, Gait disturbance, Housebound
Clinical narrative: The patient had a very sore arm the day after the vaccine. Two days after the vaccine the arm went limp. She got weaker, feeling very hot all over body, pain all over body, dizziness, had trouble walking, had trouble driving. She was homebound for 2 weeks. She is going to biochemical therapy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: The patient had a very sore arm the day after the vaccine. Two days after the vaccine the arm went limp. She got weaker, feeling very hot all over body, pain all over body, dizziness, had trouble walking, had trouble driving. She was homebound for 2 weeks. She is going to biochemical therapy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Two hours after the administration of the vaccine, at 12:00 pm on the 29th of July, a small bump started to form on the Patient's Lt deltoid near the administration site. The next day, the Mother of the Patient noticed that it was becoming larger, and that the bump was red and warm to the touch. The mother of the Patient reported the patient was given Motrin for her fever of 102 degrees Fahrenheit, and a warm compress for the pain and swelling. Bump on arm was 5x3 cm in area, on the 31st of July. Plan of action is to continue the care given by the mother. If it continues to become larger, the patient is recommended to seek further medical care.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine exp date 7.17.2019 (6 days expired)
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: area red and tender where shot was given.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Headache, Hyperhidrosis, Pain, Throat irritation
Clinical narrative: Patient came in this morning (8/1/19) and wanted to make me aware of adverse event.  She was questioning weather vaccine had pine, bolsom and azalea components in it. She tolerated first vaccine fine (4/3/19).   This time she said she had a headache all day (7/31/19) Had body aches and sweating (she said she was sweating currently and felt like she was hit by an 18 wheeler- about 9:30am today).  She said she had to take 4 extra strength Tylenol for the pain.  Also stated that her throat felt raw and she had trouble swallowing
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphagia, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Patient came in this morning (8/1/19) and wanted to make me aware of adverse event.  She was questioning weather vaccine had pine, bolsom and azalea components in it. She tolerated first vaccine fine (4/3/19).   This time she said she had a headache all day (7/31/19) Had body aches and sweating (she said she was sweating currently and felt like she was hit by an 18 wheeler- about 9:30am today).  She said she had to take 4 extra strength Tylenol for the pain.  Also stated that her throat felt raw and she had trouble swallowing
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Patient came in this morning (8/1/19) and wanted to make me aware of adverse event.  She was questioning weather vaccine had pine, bolsom and azalea components in it. She tolerated first vaccine fine (4/3/19).   This time she said she had a headache all day (7/31/19) Had body aches and sweating (she said she was sweating currently and felt like she was hit by an 18 wheeler- about 9:30am today).  She said she had to take 4 extra strength Tylenol for the pain.  Also stated that her throat felt raw and she had trouble swallowing
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: PATIENT SAID HIS ARM WAS SORE FOR A FEW DAYS AND THAT PAIN WENT AWAY.  HOWEVER, NOW WHEN HE LIFTS THE ARM HE HAD THE VACCINE IN, THERE ARE CERTAIN POSITIONS WHEN HE MOVES IT THAT FEEL LIKE A HOT NEEDLE IS BEING STUCK IN HIS ARM, HE SAID IF HE RUBS IT AFTER A WHILE THE PAIN GOES AWAY, BUT KEEPS RECURRING.  HE WILL DISCUSS WITH HIS MD AT UPCOMING OFFICE VISIT
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Fatigue, Headache, Skin swelling
Clinical narrative: 101 Degree temperature, headache, fatigue starting next day and lasting for 48 hours After 3 days red spot upper arm (NOT at injection site) which spread over next 3 days from upper arm to elbow and smaller areas on inner arm from elbow to wrist.  Skin was warm to touch and slightly swollen.  These symptoms begin to subside on the 7th day and redness was gone after 9 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 101 Degree temperature, headache, fatigue starting next day and lasting for 48 hours After 3 days red spot upper arm (NOT at injection site) which spread over next 3 days from upper arm to elbow and smaller areas on inner arm from elbow to wrist.  Skin was warm to touch and slightly swollen.  These symptoms begin to subside on the 7th day and redness was gone after 9 days.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: swollen arm, painful, warm to touch, sometimes itchy
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Aches and pains, fever,  tired
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Large red swollen circle on arm (about 3 inches by 2 inches) and between 1/4 inch and 1/2 inch raised.  Skin is red and hot to the touch in the swollen area.  No fever but general tiredness.  Pain in swollen area when raising or moving the left arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Large red swollen circle on arm (about 3 inches by 2 inches) and between 1/4 inch and 1/2 inch raised.  Skin is red and hot to the touch in the swollen area.  No fever but general tiredness.  Pain in swollen area when raising or moving the left arm.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness unilateral
Clinical narrative: Patient states 10 days after vaccination she experienced slight hearing loss in left ear.   Remains unresolved
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient came back in saying arm turned black/blue (like a bruise) and was extremely sore, she iced it and took Tylenol OTC but could barely get out of bed she stated
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: as per patient's daughter, patient reported feeling weak approximately 30min after receiving vaccine
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Febrile convulsion, Irritability, Screaming
Clinical narrative: Irritability,  screaming fits, febrile seizure
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Customer came to the window and said she received PPSV 23 yesterday and had a reaction.  Almost one-half of her upper arm was red and she had a small amount of swelling.  Pt stated she has been using ice on her arm and has also taken Tylenol.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Vomiting
Clinical narrative: caregiver called pharmacy 8-1-2019 and indicated pt had redness and irritation at injection site and pt had vomiting. indicated that  vomiting stoped. indicated to apply ice pack for redness & irritation and take nsaid and call dr tomorrow. also rph will contact dr tomorrow
Age: 88.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blister, Erythema, Papule, Peripheral swelling
Clinical narrative: PAPULES/ BLISTERS ON RIGHT ARM AND SWELLING/ REDNESS LEFT ARM
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever of 102 and shakes and chills
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site swelling, Malaise, Swelling
Clinical narrative: Bump on shoulder where given, swelling, some facial numbness,  overall unwell feeling for 2 days +  second dose of shingrix. No rxn; were experienced during first immunization.
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Dtap booster given to my 12 year old. Swelling and itching of the area shot was given. Medication: boostrix 0.5ml
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Flank pain, Herpes zoster, Laboratory test abnormal
Clinical narrative: I received the first of the two Shingrix shots on June 12, 2019. On June 15 I was beset by pain on my right flank, from mid back to navel. I went to my physician on June 20 as the pain had worsened. She found four shingles blisters and diagnosed the cause of the pain as shingles. She placed me on the anti viral med for a week and confirmed the diagnosis with lab results the next day. No more blisters appeared but the pain persisted for about 6 weeks.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Experienced muscle pain, felt tired and weak, headache and shivering after receiving Shingrix 50MCG injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills/fever, stomach upset, nausea, headache after dose of Shingrix given at 9:23 in morning and symptoms started at 9:30pm and resolved in morning
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rash
Clinical narrative: Developed (B) knee & ankle pain, abdominal rash 2 wks after MMR. Above symptoms cleared after 3 days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Pyrexia
Clinical narrative: flu like symptoms x 3 days  feverish Lethargic
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Peripheral swelling, Skin warm
Clinical narrative: Pt got Shingrix on 7/29/19, on 7/30 she felt flulike and had a headache. She also has a hot red swollen rm. We told her to take Tylenol & use ice packs.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt called office states (L)arm is swollen red warm to touch. Instructed to come to office for Dr to check arm. Comments: Pt. had pneumovax administered l deltoid yesterday during office visit.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site was moderately swollen and red in day one following immunization. Redness and swelling are significantly worse on day two and the site is warm to the touch. Patient is following up with primary care doctor.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Reaction to Bexsero red, itchy, warm to touch.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: fever; body aches; chills; myalgia; redness at the injection site; swelling at the injection site; hard at the injection site; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st May 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, chills and myalgia. On an unknown date, the patient experienced injection site erythema, injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site tenderness was unknown.   It was unknown if the reporter considered the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling, injection site induration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse was also the patient. The patient experienced fever, body aches, chills and myalgia. These symptoms lasted about 3 days. The patient was bad to the point that she had to stay home and skipped work. Less than 3 months after receiving Shingrix, the patient experienced the following symptoms at the injection site as redness, swelling, hard, tender. These local side effects lasted about a week and a half. The patient said that the injection hurt a lot as she was getting the injection.  The reporter did not give consent to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR136278.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pyrexia, Tenderness
Clinical narrative: fever; body aches; chills; myalgia; redness at the injection site; swelling at the injection site; hard at the injection site; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st May 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, chills and myalgia. On an unknown date, the patient experienced injection site erythema, injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site tenderness was unknown.   It was unknown if the reporter considered the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling, injection site induration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse was also the patient. The patient experienced fever, body aches, chills and myalgia. These symptoms lasted about 3 days. The patient was bad to the point that she had to stay home and skipped work. Less than 3 months after receiving Shingrix, the patient experienced the following symptoms at the injection site as redness, swelling, hard, tender. These local side effects lasted about a week and a half. The patient said that the injection hurt a lot as she was getting the injection.  The reporter did not give consent to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR136278.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Impaired work ability, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: fever; body aches; chills; myalgia; redness at the injection site; swelling at the injection site; hard at the injection site; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st May 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, chills and myalgia. On an unknown date, the patient experienced injection site erythema, injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site tenderness was unknown.   It was unknown if the reporter considered the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling, injection site induration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse was also the patient. The patient experienced fever, body aches, chills and myalgia. These symptoms lasted about 3 days. The patient was bad to the point that she had to stay home and skipped work. Less than 3 months after receiving Shingrix, the patient experienced the following symptoms at the injection site as redness, swelling, hard, tender. These local side effects lasted about a week and a half. The patient said that the injection hurt a lot as she was getting the injection.  The reporter did not give consent to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR136278.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: fever; body aches; chills; myalgia; redness at the injection site; swelling at the injection site; hard at the injection site; tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st May 2019, less than a day after receiving Shingrix, the patient experienced fever, general body pain, chills and myalgia. On an unknown date, the patient experienced injection site erythema, injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site tenderness was unknown.   It was unknown if the reporter considered the fever, general body pain, chills, myalgia, injection site erythema, injection site swelling, injection site induration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse was also the patient. The patient experienced fever, body aches, chills and myalgia. These symptoms lasted about 3 days. The patient was bad to the point that she had to stay home and skipped work. Less than 3 months after receiving Shingrix, the patient experienced the following symptoms at the injection site as redness, swelling, hard, tender. These local side effects lasted about a week and a half. The patient said that the injection hurt a lot as she was getting the injection.  The reporter did not give consent to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR136278.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Pain in extremity, Rhinorrhoea, Secretion discharge
Clinical narrative: Pain on left side - ankle, shin, thigh, + buttocks Most severe in morning Best relief came from an " Penetrating Pain Relief ointment" applied generously to areas mentioned above. Still have some pain on left side in areas mentioned 7/28/2019
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Laboratory test, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain on left side - ankle, shin, thigh, + buttocks Most severe in morning Best relief came from an " Penetrating Pain Relief ointment" applied generously to areas mentioned above. Still have some pain on left side in areas mentioned 7/28/2019