chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, PFIZER RXPATHWAYS. A contactable nurse reported that a 68-year-old female patient started to receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported), with route of administration and therapy dates unspecified at a single dose, for immunization; and sulfamethoxazole, with route of administration, therapy dates, dose, frequency and indication unspecified. Medical history included allergy to Iodide-containing products. The patient's concomitant medications were not reported. On an unspecified date, the patient had allergies with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and sulfamethoxazole. The action taken in response to the event was not applicable for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein); and was unknown for sulfamethoxazole. The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer via a sales representative. An elderly female patient received PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 24Aug2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced widespread pain in her body and general feeling of discomfort on25Aug2018. The outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: DTAP, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA251082 (Same reporter). This case involves Adult patient (age and gender not reported) who was treated with 0.1 ml dose of TUBERCULIN TEST [TUBERSOL] intradermally (Batch number: C5474BA and expiry date: 29-Oct-2020) for skin test. The vaccine MENACTRA, ADACEL, DAPTACEL and IPV (VERO) [IPOL] was also kept in refrig temp was up for 48 minutes to 9.2 C. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature was up for 48 minutes to 9.2 Celsius which was no longer viable. It was unknown if any adverse event was occurred or not following the vaccination. 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 the sender: None.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA251618. This case involves a 10-month-old patient (gender not reported) who received 0.25 ml of FLUZONE QUADRIVALENT batch number: UT6262MP on 31-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received Fluzone Quad 0.5 mL and 0.25 mL syringes after the 48 hours shipping, MA said they were still cool). 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 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves two months old female patient who was vaccinated with 0.25 ml dose of QUADRIVALENT INFLUENZA VACCINE (lot no UI983AA and Exp. Date 30-06-2019) via unknown route in the left thigh on 07-Sep-2018. The patients medical history not reported and No concomitants. No known reported symptoms. It was an actual medication error due to 0.25 ml of FLUZONE QUADRIVALENT was given to two months old female patient (drug administered to patient of inappropriate age). No any information about adverse event reported. 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.
Age: 45.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA255170 and 2018SA254040 (same reporter). This case involves a 45-year-old patient (gender not reported) who received a 0.5 mL expired dose of FLUZONE QUADRIVALENT (lot UI826AC and expiration date 30-Jun-18) once via intramuscular route in the right deltoid on 06-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event. 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.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from health care professional on 07-Sep-2018. This case is linked to cases 2018SA256129 and 2018SA255093 (same reporter). This case involves a four-years-old male patient who was vaccinated with a 0.5 ml dose of IPV (VERO) [IPOL] (Batch number : N1J45, expiration date : 05-Oot-2019, subcutaneously in right leg on 06-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. It was a case of actual medication error due to incorrect product storage. It was also reported that vaccine was exposed to temperature of 49.8 degrees F. The excursion lasted approximately 4 hours. It was unknown if the patient experienced any adverse event 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. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Papule, Rash, Urticaria
Clinical narrative: After 10 minutes of receiving both vaccines, patient develops urticaria (reddish and pale papules of 2-5 mm size, welts) rash in the face area, non tender, non vesicular, no fluctuation, no discharge.  After 20 minutes of a Dose a Bendryl, patient starts improving and requests to be discharged home.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Epistaxis, Pyrexia
Clinical narrative: Excessive cough, bloody nose, fever, chills.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest X-ray normal, Crying, Electrocardiogram normal, Malaise, Nausea
Clinical narrative: 1445 shots given child crying, mom at side. 1450 child did not feel well, laid back on exam table. 1455 child responded inappropriately to questions vital signs pulse 64  blood pressure  116/74. 1505 child still not responding appropriately to questions vital signs pulse 68 blood pressure 118/64 O2 Sat 99% 1510 EMS notified, mom told child if she did not feel well or felt queasy from the shots she needed to get up so they can go home and not trouble all these people, child was lying down with her head elevated 45 degrees, open her eyes and looked at her mom O2 sat 98%. 1520 EMS arrived child closed her eyes and than opened them in response to her name being called. 1530 EMS transported child to local hospital.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Speech disorder
Clinical narrative: 1445 shots given child crying, mom at side. 1450 child did not feel well, laid back on exam table. 1455 child responded inappropriately to questions vital signs pulse 64  blood pressure  116/74. 1505 child still not responding appropriately to questions vital signs pulse 68 blood pressure 118/64 O2 Sat 99% 1510 EMS notified, mom told child if she did not feel well or felt queasy from the shots she needed to get up so they can go home and not trouble all these people, child was lying down with her head elevated 45 degrees, open her eyes and looked at her mom O2 sat 98%. 1520 EMS arrived child closed her eyes and than opened them in response to her name being called. 1530 EMS transported child to local hospital.
Age: 10.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Unvaccinated patient presented for a well child check. It was determined that he had never received the pneumoccocal vaccine. Parents wished to start the patient on catch up vaccine schedule and it was determined that he would receive one dose of PCV-13 as he is 10 years old and never been vaccinated.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired product administered
Clinical narrative: Expired ROTARIX vaccine given( exp. 7/3/18). Remainder of Lot removed from stock. Mom/client had left clinic when event realized. Phone call to mom 9/13/2018 to notify of need to repeat dose. Arranged to RTC 10/3/2018 for this.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash, Injection site reaction, Urticaria
Clinical narrative: On Saturday 9/8/18 mom noticed a rash started to develop on the right thigh (tdap) and has been increasing in size and getting worse, currently there is a welt the size of a 1/2 dollar bill and multiple small welts surrounding the area. No fevers. Notified provider, who stated to administer Beandryl, Zyrtec. Told mom if itching to apply calamine lotion. She voiced understanding & will call back if no improvement.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Abdominal pain, Flushing, Pruritus
Clinical narrative: Patient received vaccines then later that day noticed itching as well as right sided abdominal pain and feeling flushed. Patient called and discussed this with care manager then was scheduled to follow up with provider on 9/14/18. After visit, provider stated that the Hepatitis A vaccine caused the reaction of itchiness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Decreased appetite, Diarrhoea, Hypersomnia, Vomiting
Clinical narrative: Patient received the flu vaccine on 9/11/18 and believes she is having a reaction. She states that she woke up on 9/13/18, took her thyroid and allergy medication, and laid back down. About 30 minutes later, she states that she "felt like I was on a boat", "off balance". She reports that she "threw up a little bit, mostly water" and had "a tiny bit of diarrhea". She states that she feels "a little better now", has been sleeping a lot, and has not eaten today "to be safe". She reports that she saw her dentist yesterday but denies receiving any medication/anesthesia during the visit. Discussed symptoms that require seeking immediate medical attention (hives, swelling of face/throat, difficulty breathing, fast heartbeat, dizziness, weakness, high fever, unusual behavior). She verbalized understanding.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 6 hours after injection, the patient experienced a rash on arms, legs and chest. The injection site had swollen to the size of an apple, was red and hot to touch. She took anti-histamines and the rash is gone. Site is still sore.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Dizziness, Heart rate increased, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: High fever, fast heartbeat, dizziness, light headedness, aches, unable to lift right arm persisting for 2 days.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Pain, Pyrexia, Vision blurred
Clinical narrative: Fever of 101.8. Body aches. Dizzy. Blurred vision.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Tingling to both left and right side of jaw and dizziness. Evaluated at Emergency Department.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Lip swelling, Oral herpes, Pain
Clinical narrative: Saturday 9/8/18 had the shingles booster shot. At 8am Sunday 9/9/18, felt miserable, and sore throughout the body. Felt bad most of the day, until 9 pm. Noticed swelling in the lip and a cold sore.  On Monday 9/10/18, noticed cold sore on lip and called primary care provider, their earliest available was Tuesday 9/11/18 at 8:15am, and the doctor prescribed Valtrex. Used the Valtrex to treat and the sore is still there on 9/12/18.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Patient stated that a rash formed on the site of injection the next day and it started spreading on body today.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Pt reported muscle spasm in left upper arm, neck and then back muscle spasms on r side of neck as well, but worse on left. Shooting pain radiating fromleft shoulder to vase of skull.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not provided. On 06-SEP-2018, the patient was vaccinated with an improperly stored PROQUAD (dose, route and anatomical location were not reported, lot number reported as R011216, expiration date 15-OCT-2019) for prophylaxis. The temperature and the time frame of the excursion was for 8 hours from 15 degrees to 46 degrees Fahrenheit (42.5 degrees Fahrenheit). There was no previous temperature excursion. The reporter also mentioned that the sterile diluent used to reconstitute PROQUAD did not undergo a temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-AUG-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician at a community health center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at an internal medicine office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2013, the patient was treated at the same internal medicine office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated at the same physician's office office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient received the first, second, third and fourth dose of PREVNAR 13, (lot number and expiration date unknown) all via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the physician reported that the 16 year old patient who completed her childhood series of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) recently had pneumonia. The physician was querying if the patient should receive a pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) now. The outcome of the event was unknown. The following information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Cold sweat, Confusional state, Feeling hot, Nausea, Pallor
Clinical narrative: Pt became hot, nauseated, clammy, loss of color in face, and somewhat confused. Pt was transferred to exam table to lay down, with cold cloth applied to head and feet up above heart. Pt was monitored by provider until she recovered fully. Pt took 5-10 minutes to recover from above symptomology. Pt's mom was told to follow up with this office with any concerns.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Fatigue, Influenza like illness, Muscle swelling, Myosclerosis
Clinical narrative: In addition to severe flu-like symptoms (which seem to be covered in the listed side effects, which resolved in about 10 days), I had the following: My whole shoulder muscle swelled up and became hard, itchy, and red; this lasted for about 10 days Severe fatigue and inflammation of both of my achilles tendons; this is ongoing I reported the Achilles' tendonitis to the pharmacist by phone and to my doctor by email when it did not resolve after 2 weeks. My doctor has prescribed rest , ice, and diclofenac gel, but my insurance is refusing to cover the gel.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Tendonitis
Clinical narrative: In addition to severe flu-like symptoms (which seem to be covered in the listed side effects, which resolved in about 10 days), I had the following: My whole shoulder muscle swelled up and became hard, itchy, and red; this lasted for about 10 days Severe fatigue and inflammation of both of my achilles tendons; this is ongoing I reported the Achilles' tendonitis to the pharmacist by phone and to my doctor by email when it did not resolve after 2 weeks. My doctor has prescribed rest , ice, and diclofenac gel, but my insurance is refusing to cover the gel.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Awoke next day with severe pain and stiffness in l knee; no injury.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Arthropod bite, Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Bump on L leg since receiving vaccinations at 15 months. Bump initially was red; then redness resolved, but firm mass remained under the skin. Mom state that lesion has had redness/swelling at intervals since July. Redness/swelling will only last for a small period of time/then resolves. Today mom got a call from daycare saying that he had had a bug bite and site was red/warm to touch and with a white spot on the center of the lesion. Mom says when she saw lesion at school today, it was "pulsing". Patient seems to have no pain on palpation of mass.There is only minimal redness on skin at present. 0.6 cm nodule/mass palpated under skin on L lateral thigh about 1.5 inches above knee. Minimal erythema on lesion. Very light blue color under skin.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Bump on L leg since receiving vaccinations at 15 months. Bump initially was red; then redness resolved, but firm mass remained under the skin. Mom state that lesion has had redness/swelling at intervals since July. Redness/swelling will only last for a small period of time/then resolves. Today mom got a call from daycare saying that he had had a bug bite and site was red/warm to touch and with a white spot on the center of the lesion. Mom says when she saw lesion at school today, it was "pulsing". Patient seems to have no pain on palpation of mass.There is only minimal redness on skin at present. 0.6 cm nodule/mass palpated under skin on L lateral thigh about 1.5 inches above knee. Minimal erythema on lesion. Very light blue color under skin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Generalised erythema, Peripheral swelling, Pruritus
Clinical narrative: Developed generalized erythema, swelling of fingers and itching. Epinephrine, BENADRYL and DECADRON. Admitted for overnight observation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Tremor
Clinical narrative: Shaking chills for 40 minutes, elevated temperature for 6 hours.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient had redness and swelling which traveled to her entire upper arm on 9/13/18. When she came to the pharmacy on 9/14/18 the swelling had gone down but her upper arm was red and hot to the touch. Advised patient to seek care by either primary care or urgent care.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Pt. sat in room for 7-8 mins post vaccine. Went to sit in lobby for rest of time. Front desk person states that after sitting she noticed, pt. head go back and he began shaking all over for 5-10 seconds. Nurse brought pt. back to room where he lied down and was given ice pack to cool down. Father stated - Pt was fine, but felt sick to his stomach and was light headed. Pt father stated he was fine and wanted to leave. We had patient sit for 10 mins longer until he and father stated he felt better and were ready to leave.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pain, Pruritus generalised, Swelling face
Clinical narrative: Last night at about 7:30 pm her face began to sting and burn. She began to itch all over, fleeting itching. This morning she woke up to a red, swollen face and still has the fleeting itching.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions known.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Developed painful, swollen red arm (at site of injection) by the next morning. Area worsened and unable to sleep due to pain in his arm. Seen on 9-13 at 1:15 PM. Area 10 x 11 cm, hot, erythematous and very tender to touch. No streaking. Full range of motion of arm. Started on KEFLEX 750 mg BID x 1 week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Developed painful, swollen red arm (at site of injection) by the next morning. Area worsened and unable to sleep due to pain in his arm. Seen on 9-13 at 1:15 PM. Area 10 x 11 cm, hot, erythematous and very tender to touch. No streaking. Full range of motion of arm. Started on KEFLEX 750 mg BID x 1 week.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dry mouth, Dyspnoea, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness (B) arms, (B) legs, mouth. Dry mouth, dizzy, short of breath.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Hypersensitivity, Influenza like illness, Injection site erythema
Clinical narrative: The day after the vaccine the patient reported she had flu like symptoms (achy and tired).  The reaction site was red and swollen.  She also stated she had a cough afterwards too.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: The day after the vaccine the patient reported she had flu like symptoms (achy and tired).  The reaction site was red and swollen.  She also stated she had a cough afterwards too.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Significant swelling in arm down toward mid forearm. Also warm to the touch and slightly red.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Swelling and pain at injection site (worse at 1 day after shot still bad at 3 days out). Tingle/itch in face developed at day 3. fever (unable to report reading for 24 hours).
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: The patient experienced numbness on part of her tongue after the immunization was given. The patient reported approximately ten minutes after administration that she was experiencing this. I gave her one 50 mg Diphenhydramine. I remained there for a 1.5 after the injection was given. I spoke with the patient before I left and she stated that she was fine but her tongue still "felt funny."
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Redness inflammation inner arm from shoulder area down to elbow.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Localized redness and swelling, painful with touch.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given KINRIX instead of individual doses. It was later discovered that patient was given KINRIX which is only for 4-6 year old patients. Call was placed to the state and we were informed that patient would not need to be revaccinated and that patient would not have any adverse reactions to vaccine. Advised on making sure proper labeling, protocols, verifications, and training are done to insure that this doesn't happen again.
Age: 9.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Abdominal X-ray, Abdominal pain, Allergy test, Blood test, Computerised tomogram abdomen
Clinical narrative: Patient started with severe abdominal pain the evening of 01/22/2018. She was crunched over into the fetal position crying and rocking back and forth. Pain continued to increase through the night. Patient was in severe pain for over 3 weeks. Many times begging for someone to take the pain away. She would lay in the fetal position and cry for hours. Multiple days of school were missed.
Age: 9.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Computerised tomogram pelvis, Crying, Loss of personal independence in daily activities, Scan with contrast, Ultrasound abdomen
Clinical narrative: Patient started with severe abdominal pain the evening of 01/22/2018. She was crunched over into the fetal position crying and rocking back and forth. Pain continued to increase through the night. Patient was in severe pain for over 3 weeks. Many times begging for someone to take the pain away. She would lay in the fetal position and cry for hours. Multiple days of school were missed.
Age: 9.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: X-ray with contrast lower gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Patient started with severe abdominal pain the evening of 01/22/2018. She was crunched over into the fetal position crying and rocking back and forth. Pain continued to increase through the night. Patient was in severe pain for over 3 weeks. Many times begging for someone to take the pain away. She would lay in the fetal position and cry for hours. Multiple days of school were missed.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Abnormal behaviour, Blood test, Confusional state, Disorientation
Clinical narrative: By 7:00 PM patient was acting erratically. She was unable to operate a phone or TV. She was wandering into other people's homes. She did not remember where her home was or what her family members looked like. Dr. drew blood and plans an MRI. He prescribed Donepezil and Trazadone.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Patient was a breech baby presentation external cephalic version ECV. Obstetrician tries to turn the baby into a head-down position by applying pressure on the mother's abdomen at 39 weeks early. At Hospital.
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse who referred to a 20-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-JUL-2018, the patient was vaccinated with the first dose of PROQUAD, recombinant human albumin (rHA), lot # N025926, expiration date 18-MAR-2019 (strength, dose and route of administration were not reported), for prophylaxis (drug administered to patient of inappropriate age). On 07-AUG-2018, the patient was vaccinated with the second dose of PROQUAD, recombinant human albumin (rHA), lot # R003294, expiration date 31-JUL-2019 (strength, dose and route of administration were not reported), for prophylaxis (inappropriate schedule of drug administration). A sterile diluent was used for reconstitution of the vaccines. No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2010, the patient was treated a medical services facility for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a medical clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at the same medical clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Vaccination failure
Clinical narrative: This spontaneous report was received from a male consumer and refers to his wife. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for shingles prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported, that the vaccination was failed and the patient had to have a booster vaccine in 60 days (vaccination failure). The outcome of the event was not reported. The causality for the event was not reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1809USA004485.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse, referring to an adult  patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2018, the patient was vaccinated with a pediatric dose instead of an adult dose of VAQTA, 25/0.5 (units not provided) intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Pyrexia, Rash
Clinical narrative: Patient's mother called 9/10 to state fever then rash. Fever first night - 101. Rash started 9/6 trunk - face no cough no conjunctivitis. Fever started the night of the vaccination 8/27/18 and rash started 9/6. Seen by a provider on 9/10 and mother reports provider stated it is a reaction to the vaccine, a mild measles case.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA, VARZOS
Symptoms: Dizziness, Headache, Hyperhidrosis, Injection site erythema, Musculoskeletal pain
Clinical narrative: Pt started w/symptoms in the evening vaccines were administered. Symptoms are musculoskeletal pain, sweats, headaches, dizziness redness on left deltoid. Recommended ibuprofen, increase fluid intake, rest review ER precautions.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Patient returned 20 minutes after receiving Hep A vaccine c/o hives on both arms. He was given IM BENADRYL 50 mg to txt hives F-up next day - he reported bothered by rash. Rec - he go to area clinic for treatment of rash.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: 10-28-2016 Patient came in with large painful rash on small of (L) lower back. Diagnosed with shingles. Prescribed Acyclovir. Resolved. Had both varicella vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 21-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015, the patient was treated at a physician's office for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 27-JUL-2016, the patient was inoculated with ZOSTAVAX at a market as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a doctor's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a family practice office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-SEP-2016, the patient was treated at a dermatology office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 28th February 2021) for prophylaxis. On 1st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache and injection site erythema. In September 2018, the patient experienced injection site warmth and injection site inflammation. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, headache, injection site erythema, injection site warmth and injection site inflammation were unknown. It was unknown if the reporter considered the injection site pain, headache, injection site erythema, injection site warmth and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: At 14:00 hours, the patient received SHINGRIX on left deltoid. The reporter experienced extreme soreness and redness at the injection site on the first day of vaccination. On the night after vaccination, the patient also experienced headache which resolved after taking TYLENOL. The patient woke up the next morning, and again had a headache. The patient took TYLENOL in the afternoon and the headache resolved. In September 2018, (less than a week after vaccination) since receiving the vaccination, the issue at the injection site had progressed such that now she had redness extending from the injection site all the way down to her elbow, and the area was very inflamed and hot. The symptoms were getting worse instead of resolving.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 78-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced rash and injection site reaction. On an unknown date, the outcome of the rash and injection site reaction were recovering/resolving. It was unknown if the reporter considered the rash and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX at 16.55 hours. The patient developed a rash or injection site reaction approximately one day after vaccination. (It was not specified if the rash occurred at injection site).