chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown age. On 27-JUL-2017, the patients were vaccinated with VARIVAX for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 27-JUL-2017, the patients experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.   Sender's Comments: US-009507513-1709USA001606: US-009507513-1709USA001607:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 01-JAN-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2014, the patient was treated at a physician's office, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported similar events for 3 patients. This is the 2nd of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lightheadedness/dizziness on an unspecified date with outcome of recovered, weakness on an unspecified date with outcome of recovered. Event was described as lightheadedness, dizziness and weakness lasting 2-3 minutes after injection, resolved by lying down, given fluids and glucose tablet. Occurred in 3 patients of specific descent. Sender's Comments: Linked Report(s): US-PFIZER INC-2017379704 different patient, same product, same event; US-PFIZER INC-2017379978 different patient, same product, same event.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea and dizziness, followed by intense vomiting on and off for approx five hours.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Electroencephalogram, Hypotonia, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Seizure like activity, not responsive, stiffening of body and floppiness, blueness around lips fever earlier in day.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Seizure like activity, not responsive, stiffening of body and floppiness, blueness around lips fever earlier in day.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Localised infection, Skin infection
Clinical narrative: Infection of the skin/arm. Patient received cephalexin and is in good spirits as of a few hours after picking up and starting the cephalexin.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus
Clinical narrative: Itching in the back and hands for a couple days. Symptoms improved after taking Benadryl.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: Patient passed out after receiving vaccines. His eyes rolled to the back of his head several times before regaining consciousness. His face appeared very pale. After several minutes he sat up in a chair for 5 minutes and was given water and a Kitkat. He then left with his mother.
Age: 11.0
Sex: M
Vaccine: FLU4, IPV, MNQ, TD
Symptoms: Apnoea, Bradycardia, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Within 1 minute of receiving vaccine, patient became unresponsive, collapsed, seized, and experienced apnea and bradycardia. Placed in trendelleburg position, epinephrine given and patient became increasingly aware of surroundings, spoke with his father and heart rate O2 saturations rose, O2 never went below 92%. Note in regards to TD vaccine given above - two prior doses of Tdap vaccine had been given.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Persistent redness at the site of injection for more than 5 days, warm to touch and a little pain.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Muscle twitching, Pyrexia, Vertigo
Clinical narrative: Received injection on 9/1/2017 from a prescription written by Dr. on 8/16/2017. On 9/2/2017 @ around 6 pm spouse called and stated that the patient was experiencing vertigo, fever, and his muscles were beginning to twitch since 4 p.m. When asked if the fever was around the injection site, the answer was, "No, there is no fever, redness, or swelling where the shot was given."  Spouse was told that I was contacting Dr. and if husband gets worse, take him to emergency room or call 911. Called on-call doctor around 6 p.m. then at 6:15 pm called spouse and told her Dr. would be calling, but if worse, call 911. At 6:45 called spouse to see if doctor called her. She stated, 911 emergency was at the house. Follow-up 9/5/2017 and no answer @ 3:45 pm today.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: From patient comments "The site has gotten red, swollen, tender. It's also very itchy. She's tried some over-the-counter BENADRYL which hasn't helped much. She has never had a local reaction to a shot which she did pass out once when she was a child for an immunization. She denies any problems breathing and then she's aggravated from the wildfire smoke. No throat or mouth swelling." Physician exam: Skin warm and dry. Left upper arm over the deltoid there is very induration and erythema approximately 2 inches around surrounding the injection site. It is tender to palpation. It's tender to palpation inferior to this. There is no streaking. It is warm to the touch but not fluctuant. No lip or facial swelling.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: From patient comments "The site has gotten red, swollen, tender. It's also very itchy. She's tried some over-the-counter BENADRYL which hasn't helped much. She has never had a local reaction to a shot which she did pass out once when she was a child for an immunization. She denies any problems breathing and then she's aggravated from the wildfire smoke. No throat or mouth swelling." Physician exam: Skin warm and dry. Left upper arm over the deltoid there is very induration and erythema approximately 2 inches around surrounding the injection site. It is tender to palpation. It's tender to palpation inferior to this. There is no streaking. It is warm to the touch but not fluctuant. No lip or facial swelling.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Discomfort, Erythema, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Seen at Urgent care 8/27/17 and given Keflex 500 mg TID as well as a "steroid pill". On 8/28/17 phone advice given by RN to add Benadryl OTC and use ice pack as needed. Seen by PCP on 8/30/17: HPI 74-year-old female who presents today complaining of a reaction to the pneumonia vaccine. She had it on Friday and immediately started having erythema and pain in the arm by that evening. She started having discoloration and mottling of the arm. She notes that the swelling went away fairly quickly she has only taken 10 doses of Keflex and they gave her a 7 day course. She doesn't feel well on antibiotics so she is having some generalized discomfort and does not feel great but she doesn't have any  fever. She was having some chills initially. She did have some arm pain with this. Her redness started to resolve in 48 hours and took 72-96 hours to completely resolve. Suspect this is not cellulitis but was an acute inflammatory reaction to the pneumonia 23 vaccine.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Livedo reticularis, Pain in extremity, Skin discolouration, Swelling
Clinical narrative: Seen at Urgent care 8/27/17 and given Keflex 500 mg TID as well as a "steroid pill". On 8/28/17 phone advice given by RN to add Benadryl OTC and use ice pack as needed. Seen by PCP on 8/30/17: HPI 74-year-old female who presents today complaining of a reaction to the pneumonia vaccine. She had it on Friday and immediately started having erythema and pain in the arm by that evening. She started having discoloration and mottling of the arm. She notes that the swelling went away fairly quickly she has only taken 10 doses of Keflex and they gave her a 7 day course. She doesn't feel well on antibiotics so she is having some generalized discomfort and does not feel great but she doesn't have any  fever. She was having some chills initially. She did have some arm pain with this. Her redness started to resolve in 48 hours and took 72-96 hours to completely resolve. Suspect this is not cellulitis but was an acute inflammatory reaction to the pneumonia 23 vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Day 1: pain at injection site. Day 2: small red welt at injection site, still in pain when pressure applied to area. Day 3: large red, swollen welt at the injection site (~3 inches in diameter, circular). Night of Day 3 I drew a circle around the welt, and took 2 Benadryl before going to bed with the intent of seeking medical intervention on Day 4 if it got worse. Day 4: significant improvement in the welt, swelling went down and pain decreased. Day 5: slight redness in shape of welt (~3 inches in diameter), no pain.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was given flu shot at approximately 4:15pm on 9/5/17. Patient came back at 7:45pm (after getting off work) with a swollen area around the shot area. It was slightly red and sore (tender to touch). The swollen area was swollen more than usual post-shot swelling. She also stated that the area was itching badly. Pt reported no problems breathing or any other signs of allergic reaction. Patient reports getting flu vaccine for years previously with no adverse side effects. I advised patient to apply a cold compress to the area, take ibuprofen, and BENADRYL. I also told patient to seek medical attention if she begins to have any trouble breathing or worsening of any symptoms. Pt stated she was going straight home and would do that.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Peripheral swelling, Productive cough, Pyrexia
Clinical narrative: Patient's arm was swollen. He had flu like symptoms: fever of 102, coughing up green mucas, wheezing, body aches.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Secretion discharge, Wheezing
Clinical narrative: Patient's arm was swollen. He had flu like symptoms: fever of 102, coughing up green mucas, wheezing, body aches.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain, Peripheral swelling, Productive cough, Pyrexia
Clinical narrative: Flu like symptoms, body aches, fever of 102, coughing up green mucus, swollen arm.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Headache, fever, myalgias, swollen and painful arm surrounding injection site. Developed within 24 hours of injections.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient arm became red/swollen/hot/itching "day or two" after immunization, initially area was about the size of palm but continued to spread down her arm. The patient reports taking one dose of oral  diphenhydramine and using diphenhydramine topically. The primary care provider was contacted today when the patient brought reaction to the attention of the pharmacy. The PCP advised the patient to use a warm compress and scheduled an office appointment for tomorrow afternoon 9/6/17.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood test, Dysphagia, Swelling face
Clinical narrative: THE NEXT DAY AFTER RECEIVING THE VACCINATIONS, THE PATIENT EXPERIENCED FACIAL SWELLING & TROUBLE SWALLOWING PER VERBAL REPORT FROM DAUGHTER. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE THEY HAVE ADMITTED HER. THE DAUGHTER IS UNCLEAR OF WHAT TREATMENT/TESTS WERE PERFORMED FOR THE PATIENT.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Red rash, mild itching, swelling. went to md and given triamcinolone cream and Claritin.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Patient was informed afternoon of 09/04/2017 that they noticed her face / cheek swelling. Patient called Pharmacy staff 09/05/2017 approximately 1 pm informing staff pharmacist, her face has swollen significantly. She was advised to take BENADRYL. Patient called approximately an hour later and I spoke to her advising her to take BENADRYL, take her body temperature. I asked her if she was having difficulty breathing. The patient replied no and sounded very alert and coherent. I informed her I would call her 6 hours later and ask of her condition. I spoke to patient approximately 6 hours later. She informed me she was doing much better and her swelling improved with only 1 BENADRYL. I informed her the proper dose for allergic reactions was two capsules 2-3 times daily. I informed this was a sedating dose. I asked her to take two capsules tonight and if she woke up next morning completely cured to take another dose to be safe. If her conditioned worsened to call us or her doctor.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Bilateral bumpy rash on both arms.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. This case might have been reported by the sales representative previously however, no duplicate case was found. This case was linked to case US2017GSK135088, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. This case might have been reported by the sales representative previously however, no duplicate case was found. This case was linked to case US2017GSK135090, reported by the same reporter.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swollen and painful right arm, low grade fever 8-30-17 BENADRYL ordered, ice, elevation, acetaminophen seen by NP on 8/30/17and Dr. 8/31/17 Res reports improvement "No pain" 9/5/17, decreased swelling noted.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Describes shooting pain that occurs when raising arm up that persists 7 days and after vaccination. Pain has not gone away affecting pt range of motion.
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, unknown after receiving MENVEO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to MENVEO. Additional details were provided as follows: It was reported that the healthcare professional's account used to use MENACTRA. They tried MENVEO years ago and had some reactions of arm swelling. This case has been linked to the US2017GSK132045 and US2017GSK132044 reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to BEXSERO. Additional details were reported as follows: The health care professional was contacted by the patient regarding the rash that had appeared. The patient stated that, rash was showing for about 2 days. The patient didn't know if it was related to the suspect vaccine or not. The health care professional didn't want to be contacted. The representative had only this information regarding the event or product.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever, lethargic, no appetite.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Sore-warm arm-fever at 24 hrs past inj. Admitted to hospital.
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Red irritation around ZOSTAVAX injection site. Patient now feels better, but came in to report.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced localized rash around the injection site lasting 1-2 days. Area was swollen and warm to the touch with diameter of approx. 3-4 inches. Resolved without treatment in 1-2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed chicken pox (varicella) years after vaccination.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Severe chills; Fever, nausea.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Red, swollen, inflamed arm. Went to ER 2x and received antibiotics.
Age: 12.0
Sex: U
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain, tenderness to (L) upper deltoid persisted for 1 wk after shot. Treated for cellulitis.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Severe initial local swelling now with persistent moderate swelling of the subdeltiod bursae.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Nervousness, Pain in extremity
Clinical narrative: Received two vaccines at target pharm on 8/30/17 came into office on 8/3/17 w/pain in arm, feeling shaky and dizzy.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Mobility decreased, Pain, Rash erythematous
Clinical narrative: Pt received both vaccines in (L) arm. PNEUMOVAX higher and to the left. Next morning patient developed an odd, raised, red rash that was painful to the touch. He also said it was hard to lift arm and was painful in the armpit. Had taken ibuprofen without relief. Pt went to ER and received a MEDROL dose pack.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: #3 TWINRIX given too early. TWINRIX #1 on 3-24-17, #2 on 5-4-17. Left message with client she will need #3 TWINRIX repeated in January at correct interval.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Feeling hot, Head injury, Pallor
Clinical narrative: Patient counseled on vaccine to sit and wait at least 5-10 min after vaccine administered. Patient left right after administration. Patient found at exit window of office. At time of arrival to patient, patient awake and oriented but feeling light headed and hot. Skin also note to be pale. Grandmother and 2 staff members next to patient. Staff member states "she fell here at the check out window and hit head on the counter and then fell against the wall. She was unresponsive for approx. 15 sec." Patient moved to nearest exam room and assessed. Patient talking and responding appropriately. BP assessed at 1515 to be 70/44. Physician in room assessing patient. BP rechecked at 1520 to be 80/50. Advised to call if any change in condition.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient counseled on vaccine to sit and wait at least 5-10 min after vaccine administered. Patient left right after administration. Patient found at exit window of office. At time of arrival to patient, patient awake and oriented but feeling light headed and hot. Skin also note to be pale. Grandmother and 2 staff members next to patient. Staff member states "she fell here at the check out window and hit head on the counter and then fell against the wall. She was unresponsive for approx. 15 sec." Patient moved to nearest exam room and assessed. Patient talking and responding appropriately. BP assessed at 1515 to be 70/44. Physician in room assessing patient. BP rechecked at 1520 to be 80/50. Advised to call if any change in condition.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Left arm stiffness/neck stiffness for week after meningococcal B.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was a little sore the night after vaccine was administered. On 8/29/17 it was red from site of vaccination to elbow. Swollen in some area and a little warm to touch.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: On Sunday afternoon noticed redness and itch on inside of arm, from elbow to just below armpit. Also has edema on inside elbow.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 16-year-old female patient who received BEXSERO. The patient's past medical history included acne. Concomitant products included tetracycline. On 21st August 2017, the patient received the 2nd dose of BEXSERO. On 23rd August 2017, 2 days after receiving BEXSERO, the patient experienced rash. On 24th August 2017, the patient experienced hives. On 25th August 2017, the patient experienced lip swelling. The patient was treated with prednisone. On an unknown date, the outcome of the rash, hives and lip swelling were not recovered/not resolved. The reporter considered the rash and lip swelling to be possibly related to BEXSERO. It was unknown if the reporter considered the hives to be related to BEXSERO. Additional details were provided as follows: The case was reported by the patient's mother. The patient received MVI (multivitamins) concomitantly. The reporter denied any allergies for the patient. The patient received BEXSERO in left shoulder. On 23rd August 2017, within 72 hours of receiving the vaccine the patient had a rash that started on her back, then moved to her front and then down her legs. The reporter stated, the patient was seen at the physician office. On 24th August 2017, 3 days after vaccination the patient experienced rash-hives and the physician did not believe the issues were related to the vaccine and prescribed a prednisone dose pack for the patient that she began yesterday from the date of reporting. On 25th August 2017, 4 days after vaccination, the patient had swollen lips the morning and the reporter reported that her daughter was worse. The patient received no other vaccines on the day of reporting or 4 weeks prior to this vaccine. The reporter also noted it comes and goes.
Sex: F
Vaccine: MMR, PPV, MMR, PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report has been received from a female physician of unknown age via a company representative referring to herself. Information about concurrent condition, concomitant medication and medical history was unknown. On 09-AUG-2017, the patient was administered the M-M-R II (dose, route, lot# and expiration date were not reported) and PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported) for prophylaxis, in the same syringe without any DILUENT. The patient did not seek medical attention and there was no treatment. No adverse effect was reported.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Full blood count, Muscle spasms
Clinical narrative: Initial unsolicited report received from a physician on 25-AUG-2017. This case involves a 55-year-old female patient who was vaccinated with a dose of ADACEL (batch number: U5593AA, expiry date, dose and dose in series were not reported) via intramuscularly in the left deltoid and TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07-AUG-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 09-AUG-2017, two days after vaccination, patient experienced left arm muscle spasms, arm weakness, dizziness and nausea which continued till the time of reporting. As previous medication, patient took tetanus vaccine and had previous similar reactions but the symptoms hadn't lasted this long. Physician did not know any information regarding previous reactions to tetanus vaccine since patient could not provide any further information regarding the reactions which had happened. Patient required visit to hospital emergency room. Lab tests were not reported. As corrective treatment, patient received muscle relaxant and PEPCID. Outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial unsolicited report received from a physician on 25-AUG-2017. This case involves a 55-year-old female patient who was vaccinated with a dose of ADACEL (batch number: U5593AA, expiry date, dose and dose in series were not reported) via intramuscularly in the left deltoid and TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07-AUG-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 09-AUG-2017, two days after vaccination, patient experienced left arm muscle spasms, arm weakness, dizziness and nausea which continued till the time of reporting. As previous medication, patient took tetanus vaccine and had previous similar reactions but the symptoms hadn't lasted this long. Physician did not know any information regarding previous reactions to tetanus vaccine since patient could not provide any further information regarding the reactions which had happened. Patient required visit to hospital emergency room. Lab tests were not reported. As corrective treatment, patient received muscle relaxant and PEPCID. Outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Muscle spasms, Nausea
Clinical narrative: Initial unsolicited report received from a physician on 25-AUG-2017. This case involves a 55-year-old female patient who was vaccinated with a dose of ADACEL (batch number: U5593AA, expiry date, dose and dose in series were not reported) via intramuscularly in the left deltoid and TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07-AUG-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 09-AUG-2017, two days after vaccination, patient experienced left arm muscle spasms, arm weakness, dizziness and nausea which continued till the time of reporting. As previous medication, patient took tetanus vaccine and had previous similar reactions but the symptoms hadn't lasted this long. Physician did not know any information regarding previous reactions to tetanus vaccine since patient could not provide any further information regarding the reactions which had happened. Patient required visit to hospital emergency room. Lab tests were not reported. As corrective treatment, patient received muscle relaxant and PEPCID. Outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Dizziness, Muscle spasms, Muscular weakness, Nausea
Clinical narrative: Initial unsolicited report received from a physician on 25-AUG-2017. This case involves a 55-year-old female patient who was vaccinated with a dose of ADACEL (batch number: U5593AA, expiry date, dose and dose in series were not reported) via intramuscularly in the left deltoid and TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07-AUG-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On 09-AUG-2017, two days after vaccination, patient experienced left arm muscle spasms, arm weakness, dizziness and nausea which continued till the time of reporting. As previous medication, patient took tetanus vaccine and had previous similar reactions but the symptoms hadn't lasted this long. Physician did not know any information regarding previous reactions to tetanus vaccine since patient could not provide any further information regarding the reactions which had happened. Patient required visit to hospital emergency room. Lab tests were not reported. As corrective treatment, patient received muscle relaxant and PEPCID. Outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 4-month-old female patient who received PEDIARIX (batch number 7275T,  expiry  date  16th  September  2019).  Co-suspect  products  included  ROTARIX  lyophilized  formulation  (batch  number  LL773, expiry date 19th February 2019). Concomitant products included PEDVAXHIB and PREVNAR 13. On 17th August 2017, the patient received the 2nd dose of PEDIARIX and ROTARIX lyophilized formulation. In August 2017, 20 hrs after receiving PEDIARIX and ROTARIX lyophilized formulation, the patient experienced hives (serious criteria other: as per reporter). The patient was treated with BENADRYL. In August 2017, the outcome of the hives was recovered/resolved. The reporter considered the hives to be unlikely related to PEDIARIX and ROTARIX lyophilized formulation. Additional details were provided as follows: The patient's birth weight was 5lbs. 13oz. The patient required an emergency room visit. The patient was treated with BENADRYL at follow up visit with reporting pediatric office.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 4-month-old female patient who received PEDIARIX (batch number 7275T, expiry date 16th September 2019). Co-suspect products included ROTARIX lyophilized formulation (batch number LL773, expiry date 19th February 2019). Concomitant products included PEDVAXHIB and PREVNAR 13. On 17th August 2017, the patient received the 2nd dose of PEDIARIX and ROTARIX lyophilized formulation. In August 2017, 20 hrs after receiving PEDIARIX and ROTARIX lyophilized formulation, the patient experienced hives (serious criteria other: as per reporter). The patient was treated with BENADRYL. In August 2017, the outcome of the hives was recovered/resolved. The reporter considered the hives to be unlikely related to PEDIARIX and ROTARIX lyophilized formulation. Additional details were provided as follows: The patient's birth weight was 5 lbs 13 oz. The patient required an emergency room visit. The patient was treated with BENADRYL at follow up visit with reporting pediatric office.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Blacked out seconds after injection , sweating, nausea, weakness, tiredness, i urinated on myself.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Urinary incontinence
Clinical narrative: Blacked out seconds after injection , sweating, nausea, weakness, tiredness, i urinated on myself.
Age: 11.0
Sex: M
Vaccine: TTOX
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Lymphangitis
Clinical narrative: Redness and swelling at injection site; cellulitis and lymphangitis.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored VARIVAX (lot # M035142 with expiration date of 03-AUG-2018; strength, dosage, frequency and route unspecified) for prophylaxis which was reconstituted with sterile diluent(STERILE DILUENT). Sterile diluent (STERILE DILUENT) was not involved in the temperature excursion. No adverse effects were reported. Temperature was from -14 to -10 degree C (-13.9 degree C) for 2 hours (frozen vaccine). There was no previous excursion. This is one of 4 cases received from the same reporter.; Sender's Comments: US-009507513-1709USA001898: US-009507513-1709USA001897: US-009507513-1709USA001896:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 13 year old male patient. The patient had no concomitant medications, medical history or drug reactions/allergies. On 06-NOV-2004 and 15-JUL-2009, the patient was vaccinated with a dose of VARIVAX subcutaneously for vaccination (prophylaxis) (dose, lot # and expiration date were unknown) respectively. On an unknown date in 2017 (reported as an unknown recent date), the patient developed a case of shingles. The patient was prescribed acyclovir 800mg orally four times daily for 7 days. At the time of the report, the patient's condition was unknown. The nurse declined Varicella-Zoster Virus (VZV) packet since the patient had been receiving treatment. The causality between the shingles and VARIVAX was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age. In October 2016, the patients were vaccinated with VARIVAX lot # M025870 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist referring to a 62 year old female patient. The patient had no pertinent medical history. He took tetracycline before and experienced unknown reaction. Concomitant therapies included acyclovir. On 23-AUG-2017 the patient received ZOSTAVAX, 0.65 ml, subcutaneous  (lot # M042851/ exp. date 18-JAN-2018) and reconstituted with sterile diluent (manufacturer unknown), (lot # M010689/ exp. date 11-MAR-2018) for prevention of shingles. On 23-AUG-2017 in the evening, the patient experienced itching at the injection site, and itching worsened during the night. No treatment was given for the event. No lab performed. Pharmacist was contacted by the patient on 24-AUG-2017. No further information was provided.  The outcome of injection site pruritus was unknown.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-AUG-2017, the patient was vaccinated with one dose of RECOMBIVAX HB 2.5/0.5 (unit unspecified) (route unspecified) from lot # N002914, expiration date: 04-NOV-2019 and one dose of VAQTA (strength, dose, and route unspecified) from lot# M036459, expiration date: 18-JAN-2018; for prophylaxis, that were improperly stored. No adverse effects reported. The vaccines were exposed to a temperature of 28.6 Fahrenheit (F) for a time frame of 115 minutes. Previous temperature excursion was 32F to 35 F for 225 minutes. The call was because of a data logger. No product quality complaint involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to an unspecified number of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M041182 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA012368.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 28-AUG-2017 the patient was vaccinated with VARIVAX lot # M041513 for prophylaxis. Other suspect therapies included ZOSTAVAX. Concomitant therapies included sterile diluent (STERILE DILUENT). On 28-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered and no adverse event to be not related to ZOSTAVAX and VARIVAX. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Mumps antibody test negative
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 46 year old female patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions was not reported. Concomitant therapies included sterile diluent (DILUENT MRK) injection, lamotrigine(LAMICTAL), omeprazole(PRILOSEC), acetaminophen, butalbital, caffein(FIORICET), metaxalone, gabapentin, venlafaxine hydrochloride(EFFEXOR) and aripiprazole(ABILIFY). In approximately 2007, reported as "about 10 years ago", the patient was vaccinated with a dose of M-M-R II (dose, strength, indication, route, lot number and expiration date were not provided); however, despite of this, on an unknown date, the patient's titers for mumps came back negative. On 29-AUG-2017, the patient recived an expired booster dose of M-M-R II, lot # L020189 and expiration date 03-JUN-2017 (dose, strength and route were not provided) for prophylaxis. The patient did not received  treatment for the events but sought medical attention at the physician's office. The outcome of the patient and the causality assessment were not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # N014980 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1709USA001647:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # M037643 with expiry date 01-SEP-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK INJ) for prophylaxis. No adverse effects reported. The administered dose experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for a time frame of 1 hour 9 minutes. There was no previous temperature excursions. The call was because of data logger. There was no Product Quality Complaint (PQC) involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 31-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD (lot # N010114 with expiry date 24-SEP-2018 and lot # N012489 with expiry date 17-OCT-2018) (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK INJ) for prophylaxis. No adverse effects reported. The administered doses experienced a temperature excursion of -9 degree Celsius to 8 degree Celsius for a time frame of 2 hours. There was no previous temperature excursions and data logger was not involved. There was no Product Quality Complaint (PQC) involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 31-AUG-2017, the patient was vaccinated with M-M-R II, lot # M042846 with expiration date on 21-OCT-2018, for prophylaxis. Other suspect therapies included VARIVAX lot # N012488 with expiration date on 20-APR-2019 and sterile diluent (STERILE DILUENT). On 31-AUG-2017, 3 months 10 days after onset of therapy the patient experienced accidental overdose. No adverse effects were reported. Product quality complaint was not involved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 25-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M037655 for prophylaxis. Other suspect therapies included sterile diluent. On 31-AUG-2017 the patient experienced injection site erythema and injection site pain. On an unknown date the patient experienced injection site warmth and adverse event. The outcome of adverse event was unknown. The outcome of injection site erythema, injection site warmth and injection site pain was reported as not recovered/not resolved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-MAY-2017 the patient was vaccinated with ROTATEQ lot # M040268 for prophylaxis. On 16-MAY-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937: US-009507513-1709USA001553: US-009507513-1708USA003630: US-009507513-1709USA001554:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 24-MAY-2017 the patient was vaccinated with ROTATEQ lot # M040268 for prophylaxis. On 24-MAY-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937: US-009507513-1709USA001552: US-009507513-1708USA003630: US-009507513-1709USA001554.