chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Ultrasound abdomen abnormal, Urine output decreased, Vomiting
Clinical narrative: PT PRESENTED TO ER WITH INCONSOLABLE CRYING AND VOMITING, LOSS OF APPETITE, DECREASED URINE OUTPUT, FEVER AND MUCOID BLOODY STOOL IN ER. WAS HAVING COUGH CONGESTION FOR 3 DAYS. ULTRASOUND DONE SUGGESTED INTUSUSSCEPTION. CONTRAST ENEMA WAS DONE.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Dehydration, Malaise, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Fever that got up to 105.4 and  malaise.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling, redness, induration.
Age: 4.0
Sex: F
Vaccine: DTP, IPV, MMRV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Induration, redness, swelling.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Rash, Rash papular, Rhinorrhoea
Clinical narrative: Patient had erythematous papular rash that started on face and spread to involve trunk associated with mild rhinorrhea and cough.
Age: 14.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient's arm progressively lost range of motion through the day and he described shooting pain down his arm. After school (15:00), he could extend his arm minimally, he could not lift his arm over his head, and  said it was not like the usual pain after other shots he's had in the past. I looked at his shoulder and realized the injection site was very high on his shoulder and not consistent with landmarks for IM injections for the deltoid. I called pediatrician, who said to ice the shoulder and give ibuprofen. We gave the ibuprofen two days and he still has problems with range of motion.
Age: 14.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient's arm progressively lost range of motion through the day and he described shooting pain down his arm. After school (15:00), he could extend his arm minimally, he could not lift his arm over his head, and  said it was not like the usual pain after other shots he's had in the past. I looked at his shoulder and realized the injection site was very high on his shoulder and not consistent with landmarks for IM injections for the deltoid. I called pediatrician, who said to ice the shoulder and give ibuprofen. We gave the ibuprofen two days and he still has problems with range of motion.
Sex: U
Vaccine: MENB
Symptoms: Injection site swelling, Pyrexia, Viral infection
Clinical narrative: This case was reported by a physician via other and described the occurrence of viral infection in a 18-year-old patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced viral infection (serious criteria hospitalization), injection site swelling (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the viral infection, injection site swelling and fever were unknown. It was unknown if the reporter considered the viral infection, injection site swelling and fever to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The GSK medical affairs physician in the Vaccines group had given a BEXSERO promotional speaker program and during the program one of the physician attendees mentioned an adverse event in one of her patients who received BEXSERO. The physician after the program said that she had not reported the adverse event. She asked to call her office the next day to get more details, however on call he was told the physician would call him back. The physician had not called back. The reporter did not know the exact dates of vaccination. The patient developed injection site swelling and very high fever, therefore went to the Emergency Room of a hospital. The patient was hospitalized overnight for observation. Discharge diagnosis was viral infection. At the time of reporting, the patient had not returned for 2nd dose of BEXSERO.
Age: 71.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness on the site of injection the day after. Forming a big ring and so itchy. Patient took some BENADRYL today and felt better.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4, MENB, MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Patient has a huge circle the size of a softball on left arm, it's super hot, and redness began about 7 hours after administration.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to 1-year-old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-APR-2016, the patient was vaccinated with VARIVAX (lot # L049536; expiry date 08-DEC-2017, dosage information not provided) for prophylaxis. Concomitant medications were not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 07-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then the patient's symptoms were resolved, on an unknown date in 2016. Causality assessment was not provided. Follow-up information has been received on 28-JUN-2016, from the physician referring to the female patient. The patient had no pre-existing allergies, birth defects or medical conditions. On 26-APR-2016 at 10:30 am, the patient was vaccinated in the right lower extremity with the first dose of VARIVAX. It was reported that the patient was also vaccinated in the lower left extremity with the fourth dose of PREVNAR (lot # M59350), intramuscularly, on 26-APR-2016. at 10:30 am. The patient had no illness at the time of vaccination. The reporter stated that 10 days post vaccination, on 07-MAY-2016 at 11:45 am, the patient was noted to have cellulitis at and around the site of vaccine in the right lower extremity. No relevant tests were performed. The outcome of the event was reported as recovered on 08-MAY-2016, after 10 day course of treatment with KEFLEX. Vaccination site cellulitis was considered to be medically significant by the physician. Follow-up information has been received on 02-FEB-2017, from the physician. The reporter stated that she had not received the lot check she had requested in June 2016. The reporter also stated: "When I first requested this lot check, I was told it may take 3 months. It has been 8 months, and I have not heard anything back from the company". The lot check was performed initially as multiple patient case but in this follow up, the physician requested the lot check information. This is one of several reports received from the same reporter. 1606USA004939 and 1606USA004940. Additional information has been requested. Sender's Comments: US-009507513-1606USA004939: US-009507513-1606USA004940: US-009507513-1605USA005112: MERCK 1606USA004938:Mfr number.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Fatigue, Headache
Clinical narrative: Severe fatigue; extreme pain at injection site and left shoulder. Unable to move it for two days. Headache, Loss of sleep. Day 2-heart palms.; stomach pain; NO redness or swelling at injection site; pain in joints muscles everywhere! In physical therapy still! PT says 12-18 months more. Difficulty with dressing/undressing. Certain movements cause excruciating pain in left shoulder. Contd aching pain at injection site. Have had X-ray and two MRI's.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Severe fatigue; extreme pain at injection site and left shoulder. Unable to move it for two days. Headache, Loss of sleep. Day 2-heart palms.; stomach pain; NO redness or swelling at injection site; pain in joints muscles everywhere! In physical therapy still! PT says 12-18 months more. Difficulty with dressing/undressing. Certain movements cause excruciating pain in left shoulder. Contd aching pain at injection site. Have had X-ray and two MRI's.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray limb
Clinical narrative: Severe fatigue; extreme pain at injection site and left shoulder. Unable to move it for two days. Headache, Loss of sleep. Day 2-heart palms.; stomach pain; NO redness or swelling at injection site; pain in joints muscles everywhere! In physical therapy still! PT says 12-18 months more. Difficulty with dressing/undressing. Certain movements cause excruciating pain in left shoulder. Contd aching pain at injection site. Have had X-ray and two MRI's.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This spontaneous report was received from a currently 61 years old male patient regarding himself. The patient's medical history included sleep apnoea syndrome. The patient had no drug reactions/allergies. Concurrent conditions information was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # reported as 00006-4963-41), (dose, dose number, frequency and expiration date were not provided), for prophylaxis. Concomitant therapies included atorvastatin (EVERSTAIN). On an unknown date (reported as several weeks later), the patient experienced Bell's Palsy (facial paralysis). Furthermore, it was stated that in the weeks following the vaccination with ZOSTAVAX he felt numbness on one side of his face and sought medical attention. Prednisone (manufacturer unknown) was prescribed as treatment. Moreover, on an unspecified date the patient was sent to an unspecified neurologist who on an unspecified date conducted a nuclear magnetic resonance imaging (MRI) (results unknown) and a spinal tap (results unknown) for further studies. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of facial paralysis was reported as slowly recovering but has not yet fully recovered. The causal relationship between ZOSTAVAX and facial paralysis was not provided. Upon internal review facial paralysis was determined as medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a currently 61 years old male patient regarding himself. The patient's medical history included sleep apnoea syndrome. The patient had no drug reactions/allergies. Concurrent conditions information was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # reported as 00006-4963-41), (dose, dose number, frequency and expiration date were not provided), for prophylaxis. Concomitant therapies included atorvastatin (EVERSTAIN). On an unknown date (reported as several weeks later), the patient experienced Bell's Palsy (facial paralysis). Furthermore, it was stated that in the weeks following the vaccination with ZOSTAVAX he felt numbness on one side of his face and sought medical attention. Prednisone (manufacturer unknown) was prescribed as treatment. Moreover, on an unspecified date the patient was sent to an unspecified neurologist who on an unspecified date conducted a nuclear magnetic resonance imaging (MRI) (results unknown) and a spinal tap (results unknown) for further studies. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of facial paralysis was reported as slowly recovering but has not yet fully recovered. The causal relationship between ZOSTAVAX and facial paralysis was not provided. Upon internal review facial paralysis was determined as medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from a currently 61 years old male patient regarding himself. The patient's medical history included sleep apnoea syndrome. The patient had no drug reactions/allergies. Concurrent conditions information was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # reported as 00006-4963-41), (dose, dose number, frequency and expiration date were not provided), for prophylaxis. Concomitant therapies included atorvastatin (EVERSTAIN). On an unknown date (reported as several weeks later), the patient experienced Bell's Palsy (facial paralysis). Furthermore, it was stated that in the weeks following the vaccination with ZOSTAVAX he felt numbness on one side of his face and sought medical attention. Prednisone (manufacturer unknown) was prescribed as treatment. Moreover, on an unspecified date the patient was sent to an unspecified neurologist who on an unspecified date conducted a nuclear magnetic resonance imaging (MRI) (results unknown) and a spinal tap (results unknown) for further studies. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of facial paralysis was reported as slowly recovering but has not yet fully recovered. The causal relationship between ZOSTAVAX and facial paralysis was not provided. Upon internal review facial paralysis was determined as medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Fall, Seizure, Tremor
Clinical narrative: Patient was sitting on the table & seized up, fell to his side and started shaking. Approximately 1-2 minutes after the vaccine was injected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 13-JAN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 lot number M043987 expiration 30-JUN-2018 or lot number M036161 expiration 06-MAY-2018 that was exposed to a temperature excursion for 48 hours. The pharmacist was not sure which of the 2 lot numbers was the administered dose. The temperature excursion was reported as greater than 46F through less than or equal to 77F range for 48 hours. No adverse effects were reported. No further information was reported. Lot number M043987 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent.) Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-JAN-2017 the patient was vaccinated with VARIVAX (lot # M013068, expiration date 14-APR-2017, route and site of administration were not reported) 0.5 ml for prophylaxis. It was reported that the STERILE DILUENT was used to reconstitute VARIVAX. A "volume of 0.55ml of STERILE DILUENT was used to reconstitute and only 0.5ml was withdrawn from the VARIVAX vial post reconstitution and administered to the patient, not the entire contents". The deliverable volume of the STERILE DILUENT vial ranged from 0.62 mL to 0.83 mL with an average deliverable volume of 0.7 mL. Additional information is not expected because there was no consent for further contact.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-NOV-2011, the patient was vaccinated with a dose of VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that VARIVAX dose was administered in less than 28 days after patient received live influenza nasal spray (name and manufacturer unspecified). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse and refers to unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications and pertinent medical history. On an unknown date, the patients were vaccinated with  improperly stored doses of GARDASIL 9, lot number  M028323 and expiration date 26-SEP-2018 (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32F (0 Celsius) and highest 36F (2.2 Celcius) for 4 hours due to a data logger issue. No previous temperature excursion was reported.  No adverse effects were reported. No product quality complaint was involved. 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 nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses (in the temperature between 14-46F (-9 to 8 degrees Celsius) for 1 hour and 3 minutes and in 14-46F for 1 hour and 4 minutes) of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004711.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to the three patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, also reported "since ZOSTAVAX was approved", the patients experienced shingles after vaccination. Moreover, the physician said she was not impressed with the efficacy of the product. The outcome of the adverse events was unknown. The relatedness between vaccination with ZOSTAVAX and the adverse events was not reported. Additional information is not expected because there was no consent for a follow up with the physician.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) and refers to an approximately 14 year old female patient. The patient had no pertinent medical history, concomitant medications and no drug reactions or allergies. On an unknown dates in 2014, the patient was vaccinated with GARDASIL injection, intramuscularly, 3 injections at 0, 2 months and 6 months (dose, anatomical location, lot # and expiry date were not specified) for prophylaxis. On an unknown date in 2016, the patient started having severe headaches. On an unspecified date, the patient sought medical attention. The physician ordered magnetic resonance imaging (MRI) (results were not provided) for the patient and placed her on therapy with acetaminophen (+) butalbital (BUPAP) 50-100 mg daily. The outcome of the event was reported as recovered on an unspecified date. The mother reported that the patient was no longer experiencing headaches and was doing well. The reporter did not provide the causality assessment between the event and GARDASIL. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Cyanosis, Dyspnoea, Respiratory arrest
Clinical narrative: Information has been received from a healthcare professional via agency concerning a 12 month old male patient. The patient's medical history included no health conditions or allergies. Concomitant medications and past drug history were unknown. On 06-FEB-2017 morning, the patient was vaccinated with M-M-R II (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis and received 3 other "standard 12 month vaccines" which might have included Haemophilus influenzae type b (HIB) and DTaP based on the guidelines but could not confirm the other vaccine names. On 06-FEB-2017, the parents called 911 for what looked to the emergency medical technician (EMT) to the he had had an anaphylactic reaction like if someone was allergic to peanuts and was having a peanut reaction or like the reaction her dad had to penicillin. When the EMT arrived, the child was in "bad shape", not breathing and his lips turned blue. The standard life-saving medications were given including administering epinephrine, oxygen and IV. The patient was being transported via ambulance to the hospital at the time of the call and he "should be fine" per the EMT. At the time of report, the patient's blood pressure and oxygen levels were good. As of 07Feb2017, it is unknown if the patient continues MMR II and the other unknown vaccines and the trouble of breathing, anaphylactic reaction, "bad shape", not breathing and lips turning blue were improving. The "EMT" thought the patient should be fine but he would be further evaluated at the hospital. Causality between the event and M-M-R II was unknown. The reporter considered the event anaphylactic reaction to be medically significant and life-threatening. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (above 46F but below 77F with a maximum temperature of 50F for 3 hours 15 minutes plus a second excursion between 32F and 36F, to 35 F for 3.5 minutes) doses of ROTATEQ (orally, lot # M026315, expiration date 26-JAN-2018; dose was not reported) for prophylaxis. No adverse effects and no previous excursion were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1702USA004609.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (above 46F but below 77F with a maximum temperature of 50F for 3 hours 15 minutes plus a second excursion between 32F and 36F, to 35 F for 3.5 minutes) doses of VAQTA (lot # M036459, expiration date 18-JAN-2018; dose and route of administration were not reported) for prophylaxis. No adverse effects and no previous excursion were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1702USA003970.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the medical assistants and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature above 46F but below 77F for 3 hours) doses of RECOMBIVAX HB (lot # M037248, expiration date 21-FEB-2019; dose and route of administration were not reported) for prophylaxis. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004698: US-009507513-1702USA003256.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the medical assistants and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature above 46F but below 77F for 3 hours) doses of ROTATEQ (orally, lot # M016238, expiration date 07-DEC-2017; dose was not reported) for prophylaxis. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003256: US-009507513-1702USA004697.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses (in the temperature between 14-46F (-9 to 8 degrees Celsius) for 1 hour and 3 minutes and in 14-46F for 1 hour and 4 minutes) of PROQUAD (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The call was made because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001367:
Age: 70.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: This is an initial report of an AE, received on 01 Feb 2017, for Protein Sciences FLUBLOK. Subject, a 70 year old female received FLUBLOK Intramuscular on 05 Jan 2017. On an unspecified date in 2017, after receiving FLUBLOK, the subject reported having an allergic reaction to the left side of her face and nostrils that included redness and swelling. It was unknown if any corrective treatment was provided. At the time of the report, it was unknown the outcome of the event. Medical history for the subject included egg allergy. The subject had received FLUBLOK in the past with no events. Concomitant medications were not reported.
Sex: F
Vaccine: MNQ, TYP
Symptoms: Cough, Decreased appetite, Diarrhoea, Headache, Injection site reaction
Clinical narrative: Initial unsolicited report received from a physician under reference number PVX201606-000542 on 24 January 2017. This case involves a 12 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) and VIVOTIF (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination, the patient had developed Persistent cough, Soft tissue swelling on MENACTRA injection site, Slight cold that got worst very fast, Decreased appetite, Fever, Nausea, Headache, and Diarrhoea. Laboratory investigations were not reported. No corrective treatment was reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: MNQ, TYP
Symptoms: Nasopharyngitis, Nausea, Pyrexia, Soft tissue swelling
Clinical narrative: Initial unsolicited report received from a physician under reference number PVX201606-000542 on 24 January 2017. This case involves a 12 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) and VIVOTIF (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified time following the vaccination, the patient had developed Persistent cough, Soft tissue swelling on MENACTRA injection site, Slight cold that got worst very fast, Decreased appetite, Fever, Nausea, Headache, and Diarrhoea. Laboratory investigations were not reported. No corrective treatment was reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Approximately 10 minutes after employee was given immunization she states she was feeling dizzy. She laid down on exam bed for approx. 5 min. and then sat in chair with no change in dizziness. Denied any other symptoms.
Age: 16.0
Sex: F
Vaccine: MNQ, UNK, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-02-06.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2017-02-05.
Age: 1.08
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash
Clinical narrative: She broke out in spots, which cleared up within a day, then came back worse and more pronounced a week later.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Idiopathic thrombocytopenic Purpura.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: SWELLING AND ERYTHEMA.
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 a multiple, unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot# M015931 with an expiration date 30-MAR-2018, lot# M027637 with an expiration date 02-JUN-2018 and lot # M011667 with an expiration date 08-MAR-2018 for prophylaxis (dose and route of administration were not reported). Administered doses of M-M-R II experienced the temperature excursion between 46 and 77 degrees Fahrenheit for 2 hours and 15 minutes and between 27 and 36 degrees Fahrenheit for an undetermined length of time. No adverse effects were reported. A digital data logger was involved. There were more than 10 previous multiple excursions. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004706.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-APR-2014, the patient was vaccinated with a dose of PROQUAD subcutaneously, batch# J011124, expiration date 05-SEP-2015. On 03-OCT-2016, the patient was vaccinated with a dose of PROQUAD subcutaneously, lot# L033698, expiration date 28-FEB-2017.  On 24-JAN-2017, the patient was vaccinated with a dose of PROQUAD subcutaneously, lot # L033698, expiration date 28-FEB-2017. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (albumin status: recombinant human albumin), subcutaneously, lot # M033215 with expiry date 09-JAN-2018 (exact dose was not reported). The dose was exposed to the temperature higher than 46 degrees Fahrenheit but lower than 77 degrees Fahrenheit for 36 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were noted. 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 refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M018957 with an expiration date 22-NOV-2017, lot# M031807 with an expiration date 02-APR-2018, lot# M031807 with an expiration date 02-APR-2018, lot# M025568 with an expiration date 07-NOV-2017, lot# M006112 with an expiration date 16-NOV-2017 and lot # M038717 with an expiration date 24-APR-2018 for prophylaxis (doses were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion between 32 to 36 degrees Fahrenheit for 600 hours, 24 but less than 32 degrees Fahrenheit for one hour and over 46 but less than 77 degrees Fahrenheit for 45 minutes. A digital data logger was involved. there were more than 10 previous temperature excursions. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010803.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Migraine, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the first of two reports. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 01Nov2016 at single dose for meningitis immunisation. The patient medical history and concomitant medications were not reported. Within 15 minutes of getting the injection; the patient had migraine and stiffness of both hands. This lasted for about half an hour. The outcome was recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056141 same reporter/drug, different patient US-PFIZER INC-2017056141.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Migraine, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age and ethnicity received the 2nd dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for meningitis immunization. The patient medical history and concomitant medications were not reported. The patient previously took TRUMENBA dose 1 on an unknown date. The patient experienced stiffness of both hands and migraine after getting the shot and lasted for about 30 minutes. The outcome was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056092 same reporter/drug, different patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Condition aggravated, Hypotension, Multiple organ dysfunction syndrome, Pyrexia, Seizure
Clinical narrative: 4 year old boy with complicated medical condition-autism, seizure disorder, microcephaly - received 4 year old vaccines at regular check up. Was in good health at the visit. Following day, had a fever, then began having seizures -> status epilepticus later admitted to hospital where he went into hypotensive shock and multi organ failure. Currently in critical condition.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Shock, Status epilepticus
Clinical narrative: 4 year old boy with complicated medical condition-autism, seizure disorder, microcephaly - received 4 year old vaccines at regular check up. Was in good health at the visit. Following day, had a fever, then began having seizures -> status epilepticus later admitted to hospital where he went into hypotensive shock and multi organ failure. Currently in critical condition.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Activities of daily living impaired, Asthenia, Dyspnoea, Loss of consciousness, Muscular weakness
Clinical narrative: Started experiencing blackouts, whole body weakness, shortness of breath, muscle aches after HPV vaccine. Got so weak couldn't open door.  Went back to doctor repeatedly who said it couldn't be vaccine.  However, when tried to do gymnastics, muscles so weak, clavicle started popping out of sternum (which they said was impossible but did a few times.)  Had to quit gymnastics the following month after the vaccine because no longer could do hand stand or bars etc. 2 years later better but she struggles to do 2 push ups and shakes a lot doing that. She can't do gymnastics which was her life long dream.  Even though we went to doctor and said this is what happened they always tried to attribute to something else that they could never discover what that something else was.  They didn't even tell me there was this vaccine reporting system!
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Myalgia
Clinical narrative: Started experiencing blackouts, whole body weakness, shortness of breath, muscle aches after HPV vaccine. Got so weak couldn't open door.  Went back to doctor repeatedly who said it couldn't be vaccine.  However, when tried to do gymnastics, muscles so weak, clavicle started popping out of sternum (which they said was impossible but did a few times.)  Had to quit gymnastics the following month after the vaccine because no longer could do hand stand or bars etc. 2 years later better but she struggles to do 2 push ups and shakes a lot doing that. She can't do gymnastics which was her life long dream.  Even though we went to doctor and said this is what happened they always tried to attribute to something else that they could never discover what that something else was.  They didn't even tell me there was this vaccine reporting system!
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Thirst, Type 1 diabetes mellitus, Urinary incontinence, Weight decreased
Clinical narrative: Began losing bladder control and developing thirst. 30 days after had lost a lot of weight had excessive thirst, no energy and no bladder control.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red circle shaped in appearance rash near site of injection.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Acute shoulder pain.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash at vaccination site and neck.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received on 19-JAN-2017 from a female medical assistant referring to a 32-year-old female. The medical assistant reported the female patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. It was reported that the patient who received doses of M-M-R II during childhood (dates unspecified; Lot numbers and expiration dates not reported) has "inadequate titers." The indication reported for the M-M-R II was "Prevention of Measles, Mumps, and Rubella". The medical assistant reported the patient had seen an unspecified allergist on an unspecified date who performed lab work on unspecified dates and the lab work results show that the patient "needed a MMRII trigger dose". The patient had no hospitalization for the adverse experience. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 19-JAN-2017 from a nurse who reported that VARIVAX (lot# M035141, expiration 03-AUG-2018) was shipped to her office on 06-JAN-2017. It was supposed to arrive by 10-JAN-2017 but it did not arrive until 11-JAN-2017. During that extra day in transit, it was exposed to unknown temperatures. A dose of this VARIVAX was administered subcutaneously to a patient (gender and age not reported) on 18-JAN-2017. Temperature excursion was unknown and time frame was one day. There was no previous temperature excursion. Call was not because of a "data logger". No known adverse effects. All of the data listed was reconfirmed with the reporter. No further information provided. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 23-year-old male patient, who was a pharmacist's nephew. The patient's current conditions included asthma. No information on the patient's concomitant medications, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with VARIVAX injection (dose, route of administration, lot # and expiry date were not reported) for routine. On an unknown date, after receiving VARIVAX, the patient was in contact with the reporter's father, who had shingles. It was confirmed that the reporter's father did not receive ZOSTAVAX. An unspecified time after the patient had contact with the reporter's father, he developed chickenpox. The outcome of chickenpox was reported as recovered on an unknown date. The relatedness between the event of chickenpox and VARIVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011679.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (concentration, dose, route and anatomical place of vaccination were not provided). Subsequently, in November 2016, the patient inadvertently received a second dose of PNEUMOVAX 23 (concentration, dose, route and anatomical place of vaccination were not provided). Nevertheless, no  adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with an improperly stored dose of VAQTA (lot number M033611 and expiration date 02-MAR-2018, dose and route were not reported) for prophylaxis. The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003523:Original Case: 1702USA001003; US-009507513-1702USA003522:Original Case: 1702USA001003; US-009507513-1702USA001003:Original Case: 1702USA001003; US-009507513-1702USA003521:Original Case: 1702USA001003.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L035127, expiration date:14-SEP-2017, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 14 and 46 Fahrenheit degrees for 3 hours. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003697.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of M-M-R II (albumin status: recombinant human albumin, rHA) (involved lot numbers: L007577 with expiration date at 05-MAR-2017 and M016233 with expiration date at 31-MAR-2018; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA000822.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of PROQUAD (albumin status: recombinant human albumin, rHA; lot # M031942 with expiration date at 27-DEC-2017 and lot # M031566 with expiration date at 24-DEC-2017) (lot # reported as M0299598 with expiration date at 10-DEC-2017 and unknown albumin status) (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA000822: US-009507513-1702USA004066: US-009507513-1702USA004068.