chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Chills, Fatigue, Gastrooesophageal reflux disease, Headache
Clinical narrative: Patient developed hives, redness and swelling of her right upper arm around the vaccine site on 1/21/2016.  She had itching.  Mother treated with Zyrtec and Zantac.  Hives resolved and returned again on 1/25/16-1/26/16.  Mother called the pediatric office and was advised to treat with Benadryl. This seemed to help the hives and itching.  Rash remained- residual hives, swelling and induration.  On 1/27/16 she developed headache, nausea and stomach ache.  She had reflux but no vomiting.  She was tired and had chills but no fever.  She was seen in the doctors office on 1/29/16.  She was mildly ill appearing on exam.  Tired.  Non-focal exam.  Right upper arm with induration and a serpiginous rash and resolving hives.  No discrete wheal and flare.  Patient was treated with supportive care.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Patient developed hives, redness and swelling of her right upper arm around the vaccine site on 1/21/2016.  She had itching.  Mother treated with Zyrtec and Zantac.  Hives resolved and returned again on 1/25/16-1/26/16.  Mother called the pediatric office and was advised to treat with Benadryl. This seemed to help the hives and itching.  Rash remained- residual hives, swelling and induration.  On 1/27/16 she developed headache, nausea and stomach ache.  She had reflux but no vomiting.  She was tired and had chills but no fever.  She was seen in the doctors office on 1/29/16.  She was mildly ill appearing on exam.  Tired.  Non-focal exam.  Right upper arm with induration and a serpiginous rash and resolving hives.  No discrete wheal and flare.  Patient was treated with supportive care.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Nausea, Pruritus, Swelling, Urticaria
Clinical narrative: Patient developed hives, redness and swelling of her right upper arm around the vaccine site on 1/21/2016.  She had itching.  Mother treated with Zyrtec and Zantac.  Hives resolved and returned again on 1/25/16-1/26/16.  Mother called the pediatric office and was advised to treat with Benadryl. This seemed to help the hives and itching.  Rash remained- residual hives, swelling and induration.  On 1/27/16 she developed headache, nausea and stomach ache.  She had reflux but no vomiting.  She was tired and had chills but no fever.  She was seen in the doctors office on 1/29/16.  She was mildly ill appearing on exam.  Tired.  Non-focal exam.  Right upper arm with induration and a serpiginous rash and resolving hives.  No discrete wheal and flare.  Patient was treated with supportive care.
Age: 47.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Chills, Constipation, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache, fever, chills, muscle aches, shivers, constipation, sweating.
Age: 47.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Pyrexia
Clinical narrative: Headache, fever, chills, muscle aches, shivers, constipation, sweating.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Mobility decreased, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, reference number 2016066188) on 10-Feb-2016. This case involves a 75-year-old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported) on an unspecified date of September 2015. It was reported that, patient had received a flu shot 9 years ago and developed a low grade fever and a rash and her arms and fingers were so swollen she could not move them. As a child patient received penicillin and broke out with a real bad rash, tape allergy and was in the hospital for 9 days after her cesarean delivery. Concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced arm felt like it was going to fall off and a huge hive/rash with a fluid build up that was the size of her hand, hives and itched for 2 or 3 weeks. Patient had no laboratory investigation and corrective treatment were not reported. The outcome of events was recovered. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, reference number 2016066188) on 10-Feb-2016. This case involves a 75-year-old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported) on an unspecified date of September 2015. It was reported that, patient had received a flu shot 9 years ago and developed a low grade fever and a rash and her arms and fingers were so swollen she could not move them. As a child patient received penicillin and broke out with a real bad rash, tape allergy and was in the hospital for 9 days after her cesarean delivery. Concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced arm felt like it was going to fall off and a huge hive/rash with a fluid build up that was the size of her hand, hives and itched for 2 or 3 weeks. Patient had no laboratory investigation and corrective treatment were not reported. The outcome of events was recovered. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from non- healthcare professional on 15 February 2016. This case involves 4-year-old male patient who was vaccinated with fourth dose of IPOL (batch number- L1597-1, route of administration not reported) on left thigh, a fifth dose of Infanrix (manufacturer- GSK, batch number and route of administration not reported) on left thigh, a dose of Varicella (manufacturer- Merck, batch number and route of administration not reported) on right thigh, a dose of MMR (manufacturer- Merck, batch number and route of administration not reported) on right thigh on 12 February 2016. The patient's medical history and illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies was reported as unknown. Previously the patient had received three doses of IPOL vaccine and four doses of Infanrix vaccine on an unspecified date. The patient's concomitant medications were not reported. On 12 February 2016, same day following the vaccination, the patient had experienced red, swollen, itchy and warm to touch area at injection site on left leg. Laboratory data and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from Consumer on 16-Feb-2016. This case involves a 14-year-old female patient who was vaccinated with an intramuscular dose of TETANUS TOXOID (manufacturer: unknown and batch number was not reported) in left deltoid in 1968 on unspecified date. Illness at the time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects; medical conditions were reported as none. Other medical history and concomitant medications were not reported. In 1968 on unspecified date, after vaccination, patient had swelling and redness in the arm at injection site. She also had a fever. Lab test and corrective treatments were not reported. Patient was not recovered from the event. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: Received 2/1 - by 2/10 dvp 2-3 cm hard lump/induration at site of vaccine, pain 4 out of 10, also had rash 4 d post shot.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Epistaxis, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Pt developed nose bleeds, petechial rash, dx with ITP platelet 8,000 getting IVIG.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Left arm (deltoid) red, swollen, hot to touch. Patient complained of numbness and tingling down arm with pain.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Left arm (deltoid) red, swollen, hot to touch. Patient complained of numbness and tingling down arm with pain.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site swelling
Clinical narrative: Mom noticed bump on right thigh after vaccines given, mom denies any redness, no fever, still moving extremities.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-AUG-2015, the patient was vaccinated with improperly stored PROQUAD with lot number: L007230, expiry date 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Balance disorder, Feeling abnormal, Headache, Vomiting
Clinical narrative: Severe headache with vomiting 1 1/2 hr after vaccines. Then "foggy" and unsteady for 2 days. Day 3 getting better.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in arm radiating to shoulder and back and restricting range of motion. Prednisone plus phys therapy 2xweek thru 1/28/16. Still not resolved.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: As soon as she gave me the shot my arm hurt so bad I could not move it. I was told it is normal and would be sore 3 days. I was not able to lift my newborn with this arm. The next day I started to have a bruise that was very small and continued to grow for 4 wks. It started out looking like finger prints and by time it was done it was the whole area from my should to my elbow. My child is now 8 wks old and it has finally went away however I still have red blotches on that arm where they gave the shot as well as on my other arm. I called all 3 of my doctors and was told it is a normal reaction yet not one of them would see me in person. They just spoke with me over the phone.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash macular
Clinical narrative: As soon as she gave me the shot my arm hurt so bad I could not move it. I was told it is normal and would be sore 3 days. I was not able to lift my newborn with this arm. The next day I started to have a bruise that was very small and continued to grow for 4 wks. It started out looking like finger prints and by time it was done it was the whole area from my should to my elbow. My child is now 8 wks old and it has finally went away however I still have red blotches on that arm where they gave the shot as well as on my other arm. I called all 3 of my doctors and was told it is a normal reaction yet not one of them would see me in person. They just spoke with me over the phone.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Electromyogram, Impaired work ability, Injection site pain, Muscular weakness
Clinical narrative: Severe onset of right shoulder and arm pain. Then Oct.31, 2011 I develop right arm weakness in the hand and shoulder. The treatment included PT, massage, rest and steroids.  I have been unable to return to full time work due to ongoing symptoms and weakness.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve block, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe onset of right shoulder and arm pain. Then Oct.31, 2011 I develop right arm weakness in the hand and shoulder. The treatment included PT, massage, rest and steroids.  I have been unable to return to full time work due to ongoing symptoms and weakness.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis atopic, Eczema
Clinical narrative: Eczema on face, legs, arms.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: On Feb. 9, 2016  Pt. received the pneumonia vaccine and stated she had a lot of pain, redness and swelling afterwards. By Feb. 10th, pt. states "my left upper arm was swollen, red and hot to the touch, all the way down to my elbow, and including around the circumference of my entire upper arm." On Feb. 11th, about 10am, Pt came in to the facility to have arm assessed. The LVN assessed and subsequently said a doctor needs to see it. Dr.  examined my arm and determined cellulitis, caused by a bacterial infection, and ordered an oral antibiotic. After a few doses of the antibiotic the symptoms began to subside.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: On Feb. 9, 2016  Pt. received the pneumonia vaccine and stated she had a lot of pain, redness and swelling afterwards. By Feb. 10th, pt. states "my left upper arm was swollen, red and hot to the touch, all the way down to my elbow, and including around the circumference of my entire upper arm." On Feb. 11th, about 10am, Pt came in to the facility to have arm assessed. The LVN assessed and subsequently said a doctor needs to see it. Dr.  examined my arm and determined cellulitis, caused by a bacterial infection, and ordered an oral antibiotic. After a few doses of the antibiotic the symptoms began to subside.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Red rash approximately 6 inches in diameter slighty itch slighty warm.
Age: 1.56
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Gait disturbance, Injection site pain, Syringe issue
Clinical narrative: Extreme tenderness of bilateral thighs, right worse than left.  Would still walk, but limping.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, red and hot to the touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash diagnose as SHINGLES by MD (on 2/29/2016) treated with Valcyclovir.
Age: 16.0
Sex: F
Vaccine: FLUX, IPV, MEN
Symptoms: Cellulitis, Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Rash developed on L arm, warm erythematous, tender to palpation. Increased in size of 1 day. Seems to be cellulitis from vaccine.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Mild fatigue, erythemic anterior / lateral URE. Tenderness over injection site. NO LAD.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Chest X-ray, Dizziness, Dysarthria, Fatigue
Clinical narrative: Extreme fatigue, slurred speech, dizziness, excessive saliva.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Salivary hypersecretion
Clinical narrative: Extreme fatigue, slurred speech, dizziness, excessive saliva.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pneumonia, Pyrexia, Wheezing
Clinical narrative: Fever, cough wheeze and cxr showing RML pneumonia, insufficient response? Amoxicilin/clavulanate 1000 mg QID, Prednisone 20 mg every day, albuterol 180 mcg PRN.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Myalgia
Clinical narrative: 3-4 days after injection arm pain in deltoid diffuse lasted 5 months, still intermittent mild discomfort.
Age: 4.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Chest X-ray, Febrile convulsion, Pneumonia, Pyrexia
Clinical narrative: Son got a fever which caused a seizure that lasted about 5 minutes. 911 was called an son was taken to hospital vis ambulance. He remained at hospital until about 1:3am when he was discharged with febrile seizure and pneumonia. On Sun 2/28, around 3:30pm son started getting a fever and was taken to urgent care and we were sent to hospital ER right away. We were discharged about an hour later and told to keep his temperature down. Fever went away around midnight.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in whole right arm where shot was administered.  Could not move arm all day!  Severe pain!
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Body temperature increased, Febrile convulsion, Full blood count, Influenza A virus test
Clinical narrative: FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Influenza B virus test, Metabolic function test, Mycoplasma test
Clinical narrative: FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Culture, Febrile convulsion, Granulocyte count, Influenza virus test negative, Laboratory test normal
Clinical narrative: FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Lymphocyte count normal, Monocyte count increased, Mycoplasma test, Pyrexia, Seizure
Clinical narrative: FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
Age: 1.04
Sex: M
Vaccine: DTPIHI, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: FEBRILE SEIZURE; TEMP 104.7; 911 EMS/AMBULANCE/EMERGENCY DEPT. CARE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nausea, Rash, Urticaria
Clinical narrative: I now have shingles from getting the shingles vaccine.  Prior reactions were hives, benign rash and nausea.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Musculoskeletal pain, Neck pain, Rash
Clinical narrative: PT WAS VACCINATED ON RT DELTOID AT APPROX. 2PM AND LATER THAT NIGHT FELT ITCHING IN VACCINATION SITE, NEXT DAY HAD RASH AND AS DAYS PROGRESSED FELT SHOULDER AND RIGHT NECK PAIN. RASH WAS VISIBLE AT PHARMACY VISIT OF 2/26/2016 AND WAS TO SEE HER MD ON 2/29/2016.
Age: 62.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Immediate post-injection reaction, Insomnia, Musculoskeletal disorder, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Immediate pain, loss of use of right arm. Tingling of nerves arm drops down sometimes. Hard to sleep. Still having symptoms.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Malaise
Clinical narrative: Patient had previously rec. vaccine on 11/11/15 - forgot called patient on 2/26/16 - said fine and no problems. Patient stated called in sick to work day after vaccine.
Age: 1.01
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Given vaccine at 1:53 pm. Within 5 minutes patient developed urticaria lesion and ring of erythema around area of MMRV vaccine. No other symptoms. BENADRYL 4ml (1mg/kg) oral dose given. Observed for 30 minutes still warm to area with 1/2 dollar size erythema.
Age: 0.55
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 2/8/16 pt was given 2nd dose of flu too soon. 1st dose - given 1/27/16. 2nd dose - 2/8/16.
Sex: U
Vaccine: HPV4
Symptoms: Product use issue
Clinical narrative: This spontaneous report was received from a consumer referring to several unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with GARDASIL and due to unspecified physician's belief that the patients were in need for the product due to their participation in a homosexual lifestyle. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown demographics. The patients' concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored doses of GARDASIL 9 lot # K026247 and expiration date 29-JAN-2017, (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The GARDASIL 9 vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Infection, Injection site infection, Rash, Rash maculo-papular
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 16 month old patient of unknown gender. No information about patient's pertinent medical history, concomitant medications and the drug reactions or allergies were reported. On 28-JAN-2016, the patient was vaccinated with VARIVAX (Merck) injection (lot# L019127, expiration date 27-MAY-2017, dose and route of administration were not reported) in the right thigh. On the same day, the patient was also vaccinated with unspecified "Hib" vaccine (lot#, expiration date. dose, anatomical location and route of administration were not reported) and DTAP vaccine (lot#. expiration date, dose, anatomical location and route of administration were not reported) in another body area. On an unknown date in 2016 (reported as a couple of days later), the patient began to develop dots on the legs. On 09-FEB-2016, the patient was examined and had a macupapular rash, size 2 to 8 mm, over face, torso, arms, legs and peri-area. The patient's injection site for the VARIVAX (Merck) appeared to be developing a secondary infection. The treatment was given and included amoxicillin for a treatment of the VARIVAX (Merck) injection site injection site infection. During the visit, the patient was playful, happy, afebrile, with a good appetite  and energetic. No lab diagnostic studies were performed. The outcome of the events was unknown. The patient sought medical attention and was examined by a nurse practitioner. The reporter considered the event of a maculopapular rash, size 2 to 8 mm, over face, torso, arms, legs and peri-area to be related to VARIVAX (Merck), however the relatedness between this event and other suspect vaccines hib (manufacturer unknown) and DTAP. The relatedness between the events of dots on the legs, a secondary infection, injection site infection and the vaccination with VARIVAX (Merck), hib (manufacturer unknown) and DTAPT was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of unspecified patients. On unknown dates in 2015 and 2016 (over the past 3 months) the patient as vaccinated with an unspecified number of doses of GARDASIL (lot# K023432, expiration date 18-JUN-2016), which were improperly stored at 1 Centigrade for 48 hours (incorrect product storage). No adverse effect reported. There was no previous temperature excursion. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown demographics. The patients' concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored PNEUMOVAX 23 lot # L019836 and expiration date 24-MAR-2017, (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The PNEUMOVAX 23 vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 19-JAN-2016, the patient was vaccinated with incorrect stored ROTATEQ, (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ lot # L022447, expiration date 26-FEB-2017; lot number L027719, expiration date 28-APR-2017) orally (dose not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen
Clinical narrative: Information has been received from a nurse practitioner, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 31 years old female patient with no known pertinent medical history and no known drug allergies. On 21-JUN-2012, the patient was vaccinated subcutaneously with the first dose of 0.5 ml VARIVAX (Merck) (lot # not reported) on 21-JUN-2012. No concomitant medications were reported. It was reported that the patient was subsequently determined to be pregnant. The last menstrual period (LMP) was approximately on 31-MAY-2012 and the estimated date of delivery (EDD) of approximately 07-MAR-2013. A pre-natal ultrasound on 19-JUL-2012 revealed 7 week gestation. No problems reported. No treatment information was reported. The patient sought for medical attention via an office visit. It was reported that VARIVAX (Merck) was discontinued on 21-JUN-2012. Follow up information has been received from other nurse on 01-FEB-2016, who stated that the patient delivered a male infant. The patient had a vaginal delivery and the baby was normal. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L001626, expiration date 06-OCT-2016; lot number L016427, expiration date 13-APR-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 23-FEB-2016, the patient was vaccinated with incorrect stored ROTATEQ (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions were not reported. On 22-JAN-2016, the patient was vaccinated with incorrect stored oral, ROTATEQ (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Interchange of vaccine products, Product use issue
Clinical narrative: This spontaneous report was received from a 44 year old homosexual male consumer reporting on himself. His medical history and concurrent conditions were not reported. On an unknown date, the patient was initially vaccinated with GARDASIL, above the age of 26 and due to his physician's belief that he was in need for the product due to his participation in a homosexual lifestyle. Then he explained that his second dose on an unspecified date within the series was given with GARDASIL 9, (strength, dose, frequency, route, lot number and expiry dates for both vaccines were not provided). Concomitant medications were not reported. No adverse events were reported. The outcome of interchange of vaccine products and the causality between it and the vaccines were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K005429, expiration date: 15-APR-2016) (dose, route of administration and frequency were unspecified). Concomitant medications were not reported. It was stated that the temperature and time frame were 10 degrees F for 24 hours and that it had a previous temperature excursion of 9 degrees F for 5 days and 12 hours. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L036300, expiration date: 04-NOV-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dark red 6 1/2 mm long 3 1/2 mm (center circle) light pink 7.5 mm long 6.5 mm center layer/red circular bump on location site. Slightly warm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L020015, expiration date 16-AUG-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates from November 2015 to 25-FEB-2016, the patients were vaccinated with an unspecified number of doses of VAQTA lot # L014068, expiration date: 02-NOV-2017 and lot# L018499, expiration date: 25-FEB-2017 (dose and route of administration were not reported). Administered doses of VAQTA underwent temperature excursions at 46.72 Fahrenheit degrees, for 23 hours 49 minutes (0ver 3 month frame). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016, the patients were vaccinated with ROTATEQ lot # L013193, expiration fate 20-JAN-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received ROTATEQ that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32F and it was during the timeframe of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, the patients were vaccinated with VAQTA lot # L023232, expiration date 25-FEB-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received VAQTA that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32 F and it was during the time frame of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report was received from nurse via field representative, refers to an anonymous twin 15 months old boys. Medical history, concurrent conditions and concomitant medications were unspecified. On 15-FEB-2015, the twin boys were vaccinated with M-M-R II, 0.5 ml, single injection, subcutaneously. On 24-FEB-2015, one of the twin boys was seen by the infectious disease pediatrician, for an unspecified reason. The pediatrician diagnosed the child with measles. No treatment was given for the adverse event. The outcome of the event was unknown. Causality assessment was not provided. Therapy with M-M-R II was not reintroduced. No product quality complaint (PQC) was involved. No further information provided regarding the adverse effect. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of unspecified patients. On unknown dates in 2015 and 2016 (over the past 3 months) the patient was vaccinated with an unspecified number of doses of ROTATEQ (lot# L027726, expiration date 10-MAY-2017), which were improperly stored at 1 Centigrade for 48 hours (incorrect product storage). No adverse effect reported. There was no previous temperature excursion. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of over 65 years old. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. Approximately in February 2016 (reported as 2 weeks ago), the patient was vaccinated with ZOSTAVAX 0.65 ml (lot # and expiry were unknown) subcutaneously. Concomitant medications were not reported. Approximately in February 2016 (reported as following vaccination), the patient developed rash on the arm other than the ZOSTAVAX injected arm. On an unspecified date, the patient visited physician for rash, but no treatment was given to him. The outcome of rash was unknown. The relatedness of rash with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L029631 with expiration date of 14-AUG-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. Since 14-DEC-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L012038, expiration date 07-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, improperly stored doses of VARIVAX (Merck) lot # L026408, expiration date 15-JUL-2017 (dose and route of administration were not reported) were administered to the patients. The doses were under a temperature excursion of 22.5 degrees Fahrenheit for two and a half hours. There were no previous excursions. No data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L012838 with expiration date of 10-MAR-2018, lot# L030868 with expiration date of 09-JUN-2018, lot# L004740 with expiration date of 16-NOV-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blood test, Exposure during pregnancy, Gynaecological examination
Clinical narrative: Information has been received from a nurse practitioner for VARIVAX (Merck), a Pregnancy Registry product, concerning a 19 year old female patient with no medical history or drug reactions/allergies who on 24-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported) and a dose of Tdap (dose, route, lot # unspecified). Concomitant therapy included calcium carbonate and prenatal vitamins (unspecified). It was reported that 3 days after receiving the vaccines, on 27-NOV-2011, the patient learned that she was 5 weeks pregnant (LMP: 23-OCT-2011, EDD: 29-JUL-2012). Nurse practitioner reported that the patient was seen for the first prenatal check up on 17-JAN-2012 where it was confirmed that the patient was pregnant; a blood work was performed. The patient had been treated with prenatal vitamins. On 28-JAN-2016, a call was placed to the office, receptionist stated that the nurse practitioner was no longer working in the office, hence no further information is available. Additional information is not expected as all correspondence are received. Narrative has been updated.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Discomfort, Dizziness, Headache, Injection site erythema
Clinical narrative: Patient was not feeling well, had dizziness, fever, headache, nausea, loss of appetite, discomfort, redness and swelling the vaccine inj. site 1st 2 days, on 3rd day swelling of legs also.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Patient was not feeling well, had dizziness, fever, headache, nausea, loss of appetite, discomfort, redness and swelling the vaccine inj. site 1st 2 days, on 3rd day swelling of legs also.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L010598, expiration date: 16-AUG-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates from November 2015 to 25-FEB-2016, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL lot# K003520, expiration date: 20-NOV-2016 and lot# L016429, expiration date: 09-AUG-2017 (dose and route of administration were not reported). Administered doses of GARDASIL underwent temperature excursions at 46.72 Fahrenheit degrees, for 23 hours and 49 minutes (over 3 months frame). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Reporter reported GARDASIL with lot# L016429, which was not valid for GARDASIL. However, lot# L016429 is valid for GARDASIL 9. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses RECOMBIVAX HB (lot # L023387, expiration date: 22-JUN-2017, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Erythema, Hypersensitivity, Peripheral swelling, Rash
Clinical narrative: Patient was discharge from clinic, about 15 min. later, mom brought pt. back to clinic stating "he is having an allergic reaction to his shots". Pt. is coughing persistently, face is red and swelling was noted to face, chest, arms, legs and back. BENADRYL given and an albuterol treatment given. Pt's coughing resolved immediately after the albuterol treatment, his rash and hives improved after 30 min.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: Patient was discharge from clinic, about 15 min. later, mom brought pt. back to clinic stating "he is having an allergic reaction to his shots". Pt. is coughing persistently, face is red and swelling was noted to face, chest, arms, legs and back. BENADRYL given and an albuterol treatment given. Pt's coughing resolved immediately after the albuterol treatment, his rash and hives improved after 30 min.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L0101142 with expiration date of 24-SEP-2016, lot # L026728 with expiration date of 15-JAN-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, the patients were vaccinated with improperly stored doses M-M-R II (lot # L009544, expiration date: 19-MAR-2017, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Injection site reaction with cellulitis at injection site. Treated with 500mg KEFLEX.