chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Caesarean section, Exposure during pregnancy, Human chorionic gonadotropin increased, Ultrasound scan vagina normal
Clinical narrative: No adverse event - Patient inadvertently received LAIV during pregnancy on 15 Dec 2015. 34 y/o female. G3 P2. LMP - 15 Aug 2015. Follow up at OB and GYN Clinic. Final EDC - 21 May 2016. Pregnancy outcome: healthy baby boy delivered by C-section. Birth weight: 3675 grams. Apgars: 9/9.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Needle issue, Pain, Pain in extremity
Clinical narrative: 9/30/15 Needle broke in right shoulder during flu vaccine at my physician's office. Right arm was sore immediately after. My right arm got progressively sore and increasingly limited in range of motion. During the next three months right arm had become extremely painful during movement and sleep. I was unable to reach up, behind me, or across my body. 12/30/15 Returned to primary care physician's office. PA prescribed Naproxen and physical therapy. 1/14/16 went to an orthopedic specialist. He ordered x-rays. Doctor diagnosed 'Adhesive Capsulitis' in my right shoulder. Prescribed a cortisone shot. 2/11/16 Follow up with orthopedic specialist. No improvement in range of motion and I was in constant pain. Received 2nd cortisone shot. 4/7/16 Orthopedic specialist decided to discontinue physical therapy and I was told the adhesive capsulitis will now just have to run its course. During the period of 1/7/16 to 4/1/16 I had 20 physical therapy sessions. To date, right arm still has not returned to full function and I still experience fairly constant pain daily, especially during the night.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray
Clinical narrative: 9/30/15 Needle broke in right shoulder during flu vaccine at my physician's office. Right arm was sore immediately after. My right arm got progressively sore and increasingly limited in range of motion. During the next three months right arm had become extremely painful during movement and sleep. I was unable to reach up, behind me, or across my body. 12/30/15 Returned to primary care physician's office. PA prescribed Naproxen and physical therapy. 1/14/16 went to an orthopedic specialist. He ordered x-rays. Doctor diagnosed 'Adhesive Capsulitis' in my right shoulder. Prescribed a cortisone shot. 2/11/16 Follow up with orthopedic specialist. No improvement in range of motion and I was in constant pain. Received 2nd cortisone shot. 4/7/16 Orthopedic specialist decided to discontinue physical therapy and I was told the adhesive capsulitis will now just have to run its course. During the period of 1/7/16 to 4/1/16 I had 20 physical therapy sessions. To date, right arm still has not returned to full function and I still experience fairly constant pain daily, especially during the night.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 63-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included ADVAIR unknown for asthma. The patient's past medical history included hypertension, premature ventricular contractions and gastrooesophageal reflux disease. Concurrent medical conditions included drug allergy (FORADIL, CELLCEPT and ACTEMRA). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and ADVAIR at an unknown dose and frequency. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine and ADVAIR, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reactions to be related to Seasonal Influenza vaccine and ADVAIR. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have any relevant family history. The patient did not have any relevant drug history and history of drug or alcohol abuse.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Discomfort soon after receiving vaccine. Progressively worse. By 11/7 very limited range of motion and pain. Saw primary Dr. Referred to orthopedic. Received cortisone shots physical therapy medication, tried hot and cold to help pain. Both shoulders. Flu vaccine given in right arm. Left shoulder arm affected due to over use (compensating for right shoulder arm). To date, still problems with certain movements.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Repetitive strain injury, X-ray limb
Clinical narrative: Discomfort soon after receiving vaccine. Progressively worse. By 11/7 very limited range of motion and pain. Saw primary Dr. Referred to orthopedic. Received cortisone shots physical therapy medication, tried hot and cold to help pain. Both shoulders. Flu vaccine given in right arm. Left shoulder arm affected due to over use (compensating for right shoulder arm). To date, still problems with certain movements.
Age: 65.0
Sex: F
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Blister, Local swelling, Pain, Rash
Clinical narrative: Customer stated - had 1/2 inch raised area behind arm with 4 inch in diameter rash with blisters and severe pain.
Age: 65.0
Sex: F
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Injection site induration, Pain in extremity, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Customer stated - had 1/2 inch raised area behind arm with 4 inch in diameter rash with blisters and severe pain.
Age: 83.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Fall, Feeling abnormal, Muscular weakness, Tremor, Urinary incontinence
Clinical narrative: He received influenza immunization at local pharmacy.  Approximately three to four hours after injection, he felt chilled and noted shaking in bilateral arms.  He states that his legs were weak, such that he fell while walking to the restroom.  His son helped him get back to bed and he was able to go to sleep.  He reports episode of urinary incontinence during the night, which is unusual occurrence for him.  He states the next morning he was able to rise and weight bear, though he did not quite feel like himself for a couple of days.
Age: 83.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Fall, Feeling abnormal, Muscular weakness, Tremor
Clinical narrative: He received influenza immunization at local pharmacy.  Approximately three to four hours after injection, he felt chilled and noted shaking in bilateral arms.  He states that his legs were weak, such that he fell while walking to the restroom.  His son helped him get back to bed and he was able to go to sleep.  He reports episode of urinary incontinence during the night, which is unusual occurrence for him.  He states the next morning he was able to rise and weight bear, though he did not quite feel like himself for a couple of days.
Age: 83.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Urinary incontinence
Clinical narrative: He received influenza immunization at local pharmacy.  Approximately three to four hours after injection, he felt chilled and noted shaking in bilateral arms.  He states that his legs were weak, such that he fell while walking to the restroom.  His son helped him get back to bed and he was able to go to sleep.  He reports episode of urinary incontinence during the night, which is unusual occurrence for him.  He states the next morning he was able to rise and weight bear, though he did not quite feel like himself for a couple of days.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Erythema, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Administered adacel and pneumovax 23 injections in the same arm, in different locations of deltoid muscle, Wednesday 05/18/2016.  Provided pt with appropriate VIS sheets and counseled patient that may have a sore arm for several days after the injections. Had patient remain in store for 20 minutes after giving injection to watch for allergic reaction.  After 20 minutes, patient reported that she felt fine.  Patient called pharmacy friday 05/20/16 to check on other meds, pharmacist checked in with patient to see how her arm was feeling and she reported no pain at that time.  Patient called pharmacy on Monday 05/23/16 stating that her arm was red, swollen, and painful.  Pharmacist on duty suspected a typical injection reaction and instructed patient to let us know if it was still hurting in a few days.  Patient called 05/26/16 stating that her arm was still painful.  When asked to describe the pain she said it was shooting from her wrist to her neck, but not getting any worse.  She had not been using any tylenol or ibuprofen for the pain.  This pharmacist recommended that she try some ibuprofen for the pain and inflammation and to let us know if the pain did not get better.  Patient said she would try that and let us know Saturday/Sunday 05/28-29 if still not better.  **Update Tuesday 05/31/16 patient has not contacted pharmacy regarding any further issues.**
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after receiving HPV 9 vaccine in right bicep patient became unconscious. He had already received MENACTRA and Hep A about 5 minutes earlier without incident.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Cellulitis, Diarrhoea, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Fever (37.8), Vomiting and diarrheas, site of administration became red , hot and hard and patient developed a cellulitis in the right arm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever (37.8), Vomiting and diarrheas, site of administration became red , hot and hard and patient developed a cellulitis in the right arm.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event. Patient received invalid vaccination. Got a pediatric hep A vaqta 0.5mL, should have received hep A 1.0 mL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine given IM not SQ called CDC and is valid and does not need to be repeated.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: The patient said he came down with a sore throat, cough, fever.  He presented a prescription for an antibiotic today 5/31/16, saying that the dr. gave it to him because he still wasn't better.  We tried to explain that the symptoms probably weren't related to the immunization, but the patient insists they were.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Speech disorder
Clinical narrative: Patient was administered IMZ at approximately 1:55 pm. Within 2 minutes patient motioned she was in distress. Face turned red and patient exhibited signs of difficulty breathing. Patient could not talk. At approximately 2 PM 911 called and EPIPEN administered. Patient  was layed on floor with knees up. Cold compresses were applied. Paramedics arrived within 5 minutes she was transported to medical facility for treatment at approximately 2:05 PM.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Laboratory test normal, Syncope
Clinical narrative: Syncope x3 times, hospital admission required.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Local redness, warmth.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Injection site red and swollen. pt had vomiting and diarrhea x one day. acting fine today 05/31/2016.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling
Clinical narrative: Patients daughter called in to pharmacy stating that patient was claiming of a swollen elbow (elbow appears purple). The area where the shot was admistered is not painful.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: SWOLLEN, WARM, PAINFUL SPOT ON ARM NEAR DELTOID.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Seen for a wellness visit 05/24/2016 vaccines administered Left Deltoid KINRIX and Right Deltoid PROQUAD. Within 24 hours of administration of KINRIX Left Deltoid only with redness/warmth and rash. Patient taken to emergency room 05/25/16. HPI: (4 year old male came to the ER for L. upper arm redness and warmth s/p getting his shots yesterday. Rash started today.)
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Influenza like illness
Clinical narrative: Patient received PREVNAR 13 and influenza vaccines and 4 days later had reaction. Transferred by ambulance to ED. Flu-like symptoms.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073720 and US2016073723, reported by the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L044475, expiration date on 30-May-2017, lot # M004116, expiration date on 25-OCT-2017 and lot # M003659, expiration date on 20-SEP-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. 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 Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored doses of M-M-R II lot number reported as L040961, expiration date on 19-OCT-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot #K008931, expiration date 04-MAR-2017; Lot #K01574, expiration date 08-APR-2017, (dose, frequency and route of administration were not reported). There was no adverse effect reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of two reports received 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 referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L013203, expiration date: 28-JAN-2017 (dose, frequency and route of administration were not reported). There was no adverse effect reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-MAY-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 with unspecified Lot No. and expiration date: 19-MAR-2016 (dose and route of administration were not reported). No concomitant therapy was provided. No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: This spontaneous report was received from a consumer, who received the information from her 14 year old daughter, referring to a 14 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 29-NOV-2013, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). The patient's concomitant medications were not reported. It was stated by the reporter, that immediately after being administered the dose of GARDASIL, the patient fainted. Furthermore, she experienced shaking through the episode. The patient was "out" for a brief period of time. Due to it, she was attended by her mother, a nurse and her pediatrician. At the time of the report, the outcome of tremor and syncope were unknown. The causality between the adverse events and vaccination with GARDASIL was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Acne, Injection site discolouration, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative, referring to a 13 year old female patient. The patient's medical history or concurrent conditions were not reported. On 19-JAN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, anatomical site of vaccination, lot number and expiration date were not provided). On 21-JUL-2015 and on 24-MAY-2016 the patient received the second and third doses of GARDASIL 9 respectively (inappropriate schedule of vaccine administered). Information regarding concomitant medication was not reported. On 19-JAN-2015, the patient developed an acne-like a rash around the injection site and also had changes in her skin pigmentation around the injection site. Treatment was not given for the adverse events. The patient did not seek for medical attention. There was no intervention to prevent serious criteria, significant disability or incapacity, hospitalization or prolonged. Additionally, there was not life threatening and there was not product quality complaint involved. It was also reported that therapy with GARDASIL 9 continued. At the time of reporting, the outcome of application site acne, injection site discoloration and vaccination site rash was unknown. The causality assessment between the events and therapy with GARDASIL 9 was not provided. 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 healthcare worker concerning nine unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the nine patients were vaccinated with improperly stored doses of VARIVAX with lot # L013066 and expiration date: 14-APR-2017 (dose and route of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. The temperature reported was 12.20 F. The time frame reported was 838 hours and 59 minutes. There was no previous temperature excursion and no digital data logger reported. No Product Quality Complaint (PQC) was involved. 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 an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored dose of ROTATEQ orally, lot # L037574, expiration date on 30-JUL-2017, lot # L035511, expiration date on 21-MAY-2017 and lot number reported as: L033694, expiration date on 16-JUN-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: This solicited report was received from a physician concerning unspecified number of patients of "all" ethnicities of unknown age and gender enrolled in a market research program. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with GARDASIL or with GARDISIL 9 (dose, strength, frequency, route of administration and lot number were not provided). On unknown dates, "almost all patients (95%)" experienced pain and burning at the injection site. On unknown dates, the patients recovered with sequelae from the pain and burning at the injection site. At the time of reporting, therapy with GARDASIL 9 and GARDASIL was continued. The reporting physician considered the event to be related to GARDASIL 9 and GARDASIL. It was reported that the AE diminished after stopping suspected therapy and that the AE re-appeared after restarting suspected therapy (conflicting information). Additional information is not expected since physician did not give consent to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, and refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions and drug reactions/allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were reported. It was reported that, on an unknown date (reported as "two years later"), the patient developed shingles. No product quality complaint was involved. At the time of reporting, the outcome of shingles was unknown. Additionally, the relatedness between the event and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a 25 years old female consumer concerning her. The patient had none pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 12-MAY-2016 the patient was vaccinated with her second dose of unidentified Merck hpv vaccine (name and lot number not provided), intramuscular. On the next day, the patient found that she was pregnant. No other symptoms were reported. The last menstrual period and estimated delivery date were not reported. The patient did not seek medical attention, no treatment was given for the event and none laboratory diagnostic studies were performed. At the time of reporting, the patient was 2-3 weeks pregnant. The pregnancy outcome was pending. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient intended to be vaccinated with a dose of ZOSTAVAX (route, dose, lot # and expiration date unknown), at the ZOSTAVAX vaccination clinic, however, the pharmacist was uncertain whether the patient had received a valid dose of ZOSTAVAX. Recently the patient came to the pharmacy, stating that on different unspecified dates, the patient developed 8 to 10 separate cases of shingles. No lab diagnostics studies were performed and no treatment was given for the event. The patient had an active case shingles at this time of reporting. The causal relationship between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information is not expected, as there is no consent to contact the pharmacist.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Gout
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. The patient had a medical history of gout. On 25-MAY-2016 the patient was administered a dose of ZOSTAVAX (lot #, dose and route were not provided). On 26-MAY-2016 (reported as "a day later"), the patient experienced a "flare up" of his gout in his foot. It was reported that treatment would require a corticosteroid shot in unspecified foot on an unspecified date. The outcome of the event and causality were not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Pt experienced rash all over one day after getting ZOSTAVAX.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Full blood count normal, Metabolic function test normal, Nausea, Urine analysis normal
Clinical narrative: Nausea, vomiting, diarrhea, urticaria identical to but more severe than her usual nut allergy sx. Nut allergy is not listed as a contraindication.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, urticaria identical to but more severe than her usual nut allergy sx. Nut allergy is not listed as a contraindication.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Pt. reported significant soreness (L) deltoid area on 5/25/16 - no redness or swelling. Also was nauseated and lightheaded - all resolved after 3-4 days.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Left shoulder/axillary region swelling/tender significant pain (L) arm with decreased range of motion secondary to pain.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Left shoulder/axillary region swelling/tender significant pain (L) arm with decreased range of motion secondary to pain.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored doses of GARDASIL lot # K011325, expiration date on 30-APR-2017 and lot # K010215, expiration date on 05-MAY-2017 (dose was not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction - swelling, pain, redness at injection site.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073723 and US2016073731, reported by the same reporter.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.  It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073720 and US2016073731, reported by the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown date, the patient was vaccinated with the improperly stored dose of ROTATEQ (orally, lot # K016261, expiration date on 23-JUN-2016; dose was not reported). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 7 days. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from one company via another company refers to a 50 year old female patient. The patient's concurrent conditions, past medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route not provided). Concomitant therapies were not provided. It was reported that, the patient was allergic to vaccine. The outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was not provided. 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 referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with the improperly stored dose of ROTATEQ (orally, lot # K016261, expiration date on 23-JUN-2016; dose was not reported). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 34 degrees Fahrenheit for 7 days. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 12-MAR-2016, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 20-MAY-2016, reported as today, the patient was vaccinated in the pharmacy with the second dose in the series, which was GARDASIL 9 injection (dose, route of administration, lot# and expiry date were not reported). There was no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Skin tightness
Clinical narrative: Rec'd 'KINRIX' at O.V. on 05-25-16. C/from mom on 5-27-16 to report s/s began 5-26-16, erythema and edema 3 x 2 1/2" to (Rt) arm. C/o tightness. No fever or streaking. Seen at PCN on 5/28/16. Tx = continue MOTRIN and BENADRYL prn.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with the improperly stored dose of RECOMBIVAX HB lot number reported as M000442, expiration date on 31-MAR-2018 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions 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 as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (incorrect product storage) (lot # L029472, expiry date 08-AUG-2017 (lot # L045953, expiry date 17-NOV-2017) (lot #L041207, expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the VARIVAX experienced a temperature of 12.1 degrees centigrade for a time frame of 1 hour, 38 minutes. It was reported that the VARIVAX was back in range. It was reported that the VARIVAX experienced no previous temperature excursion. This case was reported due to a data logger. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. It was reported that the patient was administered an expired dose of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016) on 19-MAY-2016. No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 23 year old female patient. The concurrent condition, medical history and concomitant medication was not reported as none. On 23-MAY-2016, the patient was vaccinated with VARIVAX (lot # 1002215, Expiry: 21-JAN-2017) 0.5 ml, subcutaneous. On 24-MAY-2016, the patient experienced rash on her left leg. She sought medical attention by contacting the pharmacist. No lab tests were done. She applied hydrocortisone cream on the rash. The outcome of rash was reported as not resolved. The causality was unspecified. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Laboratory test normal, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 61 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with ZOSTAVAX. On an unknown date in 2016 (reported as a couple of days after vaccination), she felt "pins and needles as well as numbness" over unspecified portion of her body. On 30-APR-2016, she was seen in emergency room and was diagnosed with "paresthesia and a possible reaction to ZOSTAVAX". She was not hospitalized. At the time of reporting unspecified "labs were good" and the patient was still "feeling weird body feeling" (not recovered). The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 03-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (dose and route were not reported, lot #K011562, expiration date 04-APR-2017). On 09-OCT-2015, the patient was vaccinated with the second dose of GARDASIL (dose and route were not reported, lot #K011562, expiration date 04-APR-2017). On 12-JAN-2016, the patient was vaccinated with the third dose of GARDASIL (dose and route were not reported, lot #K010215, expiration date 05-MAY-2017). There was no adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On 24-MAY-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L030587, Expiry: 10-FEB-2017). The vaccine was stored at 42.8 F for 9 hours. There were no previous temperature excursions. There were no adverse effects. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On 24-MAY-2016, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L030587, Expiry: 10-FEB-2017). The vaccine was stored at 42.8 F for 9 hours. There were no previous temperature excursions. There were no adverse effects. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age, but possibly a newborn. The patient's medical history and past drug history were unknown. On either 05-MAY-2016 or 06-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot # L039660 with expiration date 04-FEB-2018), via injection (dose and exact route were not reported), which had previously undergone a supported temperature excursion. Concomitant medication was not reported. As of 06-MAY-2016, it was unknown if the patient continued to take RECOMBIVAX HB. The outcome of receiving the RECOMBIVAX HB that had undergone a temperature excursion was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.92
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On 24-MAY-2016, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot # L038501, Expiry: 16-AUG-2018). The vaccine was stored at 27.98 F for 1 hour and 13 minutes. There were no previous temperature excursions. There were no adverse effects. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and genders. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (lot#, dose and route unknown) which was possibly improperly stored under the temperature of possibly 8 F for 1 year. Data logger was reported as no. No symptoms was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications were not provided. On 23-NOV-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) (lot # L033698, expiration date 28-FEB-2016) (route, strength, dosage and frequency were unreported) and a dose of VARIVAX (Merck) lot #K010439 and expiration date 28-FEB-2017 (route, strength, dosage and frequency were unreported). No adverse effect reported. No product quality complaints were reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 69 year old male patient. The patient had no pertinent medical history, no drug reactions or allergies. On 23-MAY-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneously, lot # L035506, expiry date 16-DEC-2016. Concomitant therapies included lisinopril (manufacturer unknown), atorvastatin and zolpidem tartrate (manufacturer unknown). In approximately May 2016 (reported as unspecified time after receiving ZOSTAVAX), the patient experienced red spots all over his body that were itchy. There were no lab diagnostic studies performed. The patient took BENADRYL (also reported as manufacturer unknown) as treatment. The outcome of red spots all over his body that were itchy was reported as not recovered at the time of the report. The patient called the pharmacist to seek medical attention. The relatedness between the event and the suspect therapy was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 69 year old female patient. There was no pertinent medical history or drug reaction reported. On 09-MAY-2016, the patient was vaccinated with ZOSTAVAX lot # L035505 with expiration date of 16-DEC-2016 (dose, route of administration were not reported). Concomitant medication was unspecified. On 10-MAY-2016, the patient developed a hardened, painful area at the injection site that was about the size of a quarter. At an unspecified time following the administration, in May 2016, the patient experienced dizziness. On 11-MAY-2016, the hardened, painful area had increased to 3 inches in diameter. The patient sought medical attention via a phone call to the pharmacy. No lab diagnostics study was performed. At the time of reporting, the patient was not recovered from the events. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient received a dose of sterile diluent injection (strength, dose, frequency, route of administration, lot# and expiry date were not reported) when she was supposed to receive a dose of ZOSTAVAX. The nurse reported that the patient was not vaccinated with ZOSTAVAX, as she received only the sterile diluent. There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-NOV-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which were improperly stored for 50 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 40 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.