chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Sepsis
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus three neonate patients developed sepsis. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of sepsis and vaccine exposure in utero as serious and important medical event. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Biopsy, Culture wound, Exposure to vaccinated person, Granuloma, Infection transmission via personal contact
Clinical narrative: This unsolicited case was received from a literature on 16-Jun-2015. This case is linked to cases: 2015SA089691 and 2015SA082627 (same literature). Abstract: Although naturally occurring smallpox virus was officially declared eradicated in 1980, concern for biological warfare prompted the Government in 2002 to recommend smallpox vaccination for select individuals. Vaccinia, the smallpox vaccine virus, is administered into the skin, typically on the upper arm, where the virus remains viable and infectious until the scab falls off and the epidermis is fully intact - typically 2-4 weeks. Adverse events following smallpox vaccination may occur in the vaccinee, in individuals who have contact with the vaccinee (i.e., secondary transmission), or in individuals who have contact with the vaccinee's contact (i.e., tertiary transmission). In June 2014, two cases of inadvertent inoculation of vaccinia and one case of a non-viral reaction following vaccination occurred. This includes the first reported case of shaving as the likely source of autoinoculation after contact transmission. This paper describes the diagnosis and treatment of these cases, the outbreak investigation, and steps taken to prevent future transmission. A male patient (age not reported) who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) on an unspecified date. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The medical history and concomitant medications were not reported. On an unspecified date, the patient developed four crusted papules on the left upper arm and he reported to the clinic on 13-Jun-2014. The first papule appeared 5 days after he had received a tattoo at the same location. He noted that his roommate, who was vaccinated three weeks prior with smallpox vaccine had not kept his vaccination site covered at all times and had mistakenly used the patient's towel. He was referred for a dermatologic evaluation, which included a biopsy and wound culture. On an unspecified date, there was a contact transmission of vaccinia and inadvertent inoculation. The patient developed granulomatous inflammation which was typical of a tattoo reaction and necrotic keratinocytes which was suggestive of an infectious process. Polymerase Chain Reaction (PCR) suggested non-variola orthopox DNA which was consistent with the diagnosis of contact transmission of the vaccinia. At the time of this report, the outcome of the event was unknown. Documents held by sender: yes.
Sex: M
Vaccine: SMALL
Symptoms: Inflammation, Orthopox virus infection, Orthopoxvirus test positive, Papule, Polymerase chain reaction positive
Clinical narrative: This unsolicited case was received from a literature on 16-Jun-2015. This case is linked to cases: 2015SA089691 and 2015SA082627 (same literature). Abstract: Although naturally occurring smallpox virus was officially declared eradicated in 1980, concern for biological warfare prompted the Government in 2002 to recommend smallpox vaccination for select individuals. Vaccinia, the smallpox vaccine virus, is administered into the skin, typically on the upper arm, where the virus remains viable and infectious until the scab falls off and the epidermis is fully intact - typically 2-4 weeks. Adverse events following smallpox vaccination may occur in the vaccinee, in individuals who have contact with the vaccinee (i.e., secondary transmission), or in individuals who have contact with the vaccinee's contact (i.e., tertiary transmission). In June 2014, two cases of inadvertent inoculation of vaccinia and one case of a non-viral reaction following vaccination occurred. This includes the first reported case of shaving as the likely source of autoinoculation after contact transmission. This paper describes the diagnosis and treatment of these cases, the outbreak investigation, and steps taken to prevent future transmission. A male patient (age not reported) who was unvaccinated and exposed to vaccinia virus via contact transmission with a patient, who was vaccinated with ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co., route was not reported) on an unspecified date. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The medical history and concomitant medications were not reported. On an unspecified date, the patient developed four crusted papules on the left upper arm and he reported to the clinic on 13-Jun-2014. The first papule appeared 5 days after he had received a tattoo at the same location. He noted that his roommate, who was vaccinated three weeks prior with smallpox vaccine had not kept his vaccination site covered at all times and had mistakenly used the patient's towel. He was referred for a dermatologic evaluation, which included a biopsy and wound culture. On an unspecified date, there was a contact transmission of vaccinia and inadvertent inoculation. The patient developed granulomatous inflammation which was typical of a tattoo reaction and necrotic keratinocytes which was suggestive of an infectious process. Polymerase Chain Reaction (PCR) suggested non-variola orthopox DNA which was consistent with the diagnosis of contact transmission of the vaccinia. At the time of this report, the outcome of the event was unknown. Documents held by sender: yes.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. This case is for 25 stillbirths. The exposure to Tdap vaccine was in utero. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was fatal. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Death neonatal, Foetal exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. This is a case for 2 neonate patients (gender: unknown). The patients were exposed to Tdap vaccine in utero. The patients died on an unspecified date. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was fatal. Documents held by sender: none.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 2nd of 4 reports. Only 2 cases are serious. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in the deltoid on an unspecified date. PREVNAR 13 was the only vaccine given. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness after the vaccine was given. The patient called the office and returned for an office visit to see the doctor for the occurred events. It was unknown with what the cellulitis the patient may have been treated. The outcome of the events was unknown. Based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the events, redness and cellulitis, the Company cannot completely exclude that the suspect drug PREVNAR 13 contributed to the development of the reported events.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 1st of 4 reports. Only 2 cases are serious. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in the deltoid on an unspecified date. PREVNAR 13 was the only vaccine given. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness after the vaccine was given. The patient called the office and returned for an office visit to see the doctor for the occurred events. It was unknown with what the cellulitis the patient may have been treated. The outcome of the events was unknown. Based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the events, redness and cellulitis, the Company cannot completely exclude that the suspect drug PREVNAR 13 contributed to the development of the reported events.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Pallor
Clinical narrative: Baby was in car seat in waiting room became very pale head turned to the side eyes rolled back and she required stimulation to respond. This happened 2-3 times once removed her from car seat she returned to hugging. We did send to ER via ambulance for further evaluation baby was fine and back to herself in the ER. Heart rate & resp. remained normal the entire episode.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Inflammation
Clinical narrative: Inflammatory reaction.
Age: 0.39
Sex: F
Vaccine: DTOX, HIBV, IPV, RVX, UNK
Symptoms: Abdominal pain upper, Crying, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Fever, Vomiting, Diarrhea, inconsolable crying, stomach pain, and unusual fussiness.
Age: 0.39
Sex: F
Vaccine: DTOX, HIBV, IPV, RVX, UNK
Symptoms: Vomiting
Clinical narrative: Fever, Vomiting, Diarrhea, inconsolable crying, stomach pain, and unusual fussiness.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles, Varicella post vaccine
Clinical narrative: Chicken pox outbreak on neck AND Measles bumps on back and shoulder and forearm.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of PNEUMOVAX23 (single dose vials) were given to unspecified patients on unspecified dates (incorrect product storage). NO adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1507USA00113, 1507USA001114 and 1507USA001115 (same reporter link). 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 pharmacist refers to an  unspecified number of patients of unknown age and gender with no pertinent medical history and drug reactions reported. On unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not reported) that were improperly stored. Concomitant therapy was not reported. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unkonwn age and gender with no pertinent medical history and drug reactions reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) that were improperly stored. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender with no pertinent medical history and drug reactions reported. On an unknown dates, the patients were vaccinated with doses of VAQTA (dose, route, lot number and expiration date were not reported) that were improperly stored. No adverse effect was reported. This is one of several cases received from the same source.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Aggression, Disorientation, Emotional disorder, Fatigue, Irritability
Clinical narrative: Increased aggression w/ sibling and peers (2 wks after and presently). Increased irritability (2 days after and presently). Obsessive, emotional, meltdowns for no reason, fatigued, disoriented, socially withdrawn, speaks less clearly and sometimes out of context, socially unaware and not receptive to cues (2-3 wks after and presently).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Obsessive-compulsive disorder, Social avoidant behaviour, Speech disorder
Clinical narrative: Increased aggression w/ sibling and peers (2 wks after and presently). Increased irritability (2 days after and presently). Obsessive, emotional, meltdowns for no reason, fatigued, disoriented, socially withdrawn, speaks less clearly and sometimes out of context, socially unaware and not receptive to cues (2-3 wks after and presently).
Age: 0.36
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4-month-old patient of unknown gender. No information on patient's medical history or concomitant conditions was provided. On 22-DEC-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008680, dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly stored (Oka/Merck) VARIVAX (dose, route and site of administration were not reported, lot # K008819, expiration date 19-JUN-2016. No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 11-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported), lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 10-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported, lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly stored (Oka/Merck) VARIVAX (dose, route, and site of administration were not reported, lot # K008819, expiration date 19-JUN-2016. No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly  stored (Oka/Merck) VARIVAX (dose, route and site of administration were not reported, lot # K008819, expiration date 19-JUN-2016). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 22-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVASX (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner reefers to a 4 Months old patient of unknown gender. No information on patient's medical history or concomitant medication was provided. On 23-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 19-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB, lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route were unknown. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Intussusception, Irritability, Peripheral swelling
Clinical narrative: Swelling of hands and feet, colic/fussy, intussusception. No tx, sent straight to ER.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with an improperly stored doses of ROTATEQ (lot number, strength, dose and route were not reported). No adverse effects was reported. The outcome of the patients event was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent conditions and historical medication. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB  (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No pertinent medical history drug reactions or allergies and concomitant medications were reported. On 30-JUN-2015, the patient was vaccinated with an expired dose of M-M-R II, dose: 0.5 ml, once, subcutaneously, expiration date: 14-JUN-2015 (lot # not reported). No adverse effect was reported. 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 Registered Nurse refers to an unspecified number of patients ("less than 10") of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse events were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's medical history, concomitant therapy and concurrent conditions provided. On unknown date in August 2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot#, expiration date and site of vaccination were not provided). On 09-JUN-2015, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, lot# K005083, expiration date 04-NOV-2016, intramuscular (site of vaccination was not provided). No adverse event was reported. Additional information has been requested.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Full blood count normal, Metabolic function test normal, Pyrexia, Seizure
Clinical narrative: Received 6 mo DTaP, Polio, Hep B, PCV-13 and Rotavirus -> had seizure within 12 hours of vaccines. Few hours later -> had 2nd seizure. 1st documented fever was after 2nd seizure.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health care worker concerning unknown number of patients of unknown demographics. On unspecified dates, the patients were inadvertently vaccinated with improperly stored LIQUID PEDVAXHIBZ (dose, route, lot number and expiration date were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.14
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 7 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 14-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Rash
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. The wife of the patient reported this adverse event to the pharmacist. Patient's concurrent conditions, concomitant medication and medical history were not provided. ON 28-MAY-2015, the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot # and expiry date were not provided). "Three to four days later", on approximately 31-MAY-2015, the patient broke out in an unspecified rash under of his under arms. The patient then had unspecified neck and back pain (since an unspecified date of 2015). The patient had sought for medical attention by his wife speaking to pharmacist. The events were improved with unspecified therapy. The pharmacist reported that the patient was recovered and the rash had gone away (on an unspecified date of 2015). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 14-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K004541; exp. date: 04-DEC-2016 (dose, strength and route of administration were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 22-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K000074 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a healthcare professional refers to unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route, frequency and lot # unspecified). No concomitant medications were reported. On an unknown date unspecified patients received doses of improperly stored MMRII or ROTATEQ oral (related case). Patient did not experience any adverse effects. No further information was provided. There was no Product Quality Complaint (PQC) involved. The outcome of incorrect product storage was unkonwn. This case is linked to: 1507USA000919. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown demographics. The pertinent medical history and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot# K025761, Expiry: 08-JUN-2016; Lot# K022444, Expiry: 13-MAY-2016) (number of doses unspecified). No adverse effects were reported. The reporter enquired about the temperature excursions. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Overdose
Clinical narrative: This spontaneous social media report was received via "Question From MerckVaccines.com Technical Assistance" web page, from a 64 year old female patient in relative good health, who was reporting on herself. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with two doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) one in each arm (lot #, expiration date, vaccination route and dose were not reported). 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 health care worker refers to unspecified patients of unknown demographics. The pertinent medical history and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K005177, expiry: 10-APR-2016; lot # L004654, Expiry: 11-FEB-2017; Lot #K009758, Expiry: 08-JUL-2016)(number of doses unspecified). No adverse effects were reported. The reporter inquired about the temperature excursions. The is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. No information regarding the patient's relevant medical history, concomitant medications and drug reactions or allergies was not reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided). On an unspecified date, the patient experienced syncope. The patient sought medical attention by visited a doctor. The outcome of syncope was unknown. The relatedness between the event and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No information regarding the patient's relevant medical history, concomitant medications and drug reactions or allergies was not reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). On an unspecified date, the patient experienced swollen joints. The patient sought medical attention by visited a doctor. The outcome of swollen joints was unknown. The relatedness between the event and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a child of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of (Oka/Merck) VARIVAX (lot #, expiry date, dose and route unknown). There was no concomitant medication reported. On an unknown date, after receiving the dose of (Oka/Merck) VARIVAX, the patient developed a "rash" on an unspecified location. The outcome of rash was unknown. It was also reported the patient's mother (currently pregnant with gestation unspecified) then contracted the rash. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patient's medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified  number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVAX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. ON 28-APR-2015, a male patient of unknown age received (Oka/Merck) VARIVAX (lot number K108963, expiration date 15-OCT-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age an gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVAX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the date of 06-APR-2015 and 30-APR-2015. On 17-APR-2015, a male patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age an gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVAX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the date of 06-APR-2015 and 30-APR-2015. On 17-APR-2015, a male patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received immunization of polio (IPV) and Pediarix on same date; should have received Prevnar instead of polio; no adverse affects known.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient described a red bump and circle at injection site and a lighter red circle around that.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Blood test, Crying, Dyskinesia, Insomnia, Irritability
Clinical narrative: Low grade fever, fussy, crying incolsable, not sleeping for long periods. Jerking and twitching.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Low grade fever, fussy, crying incolsable, not sleeping for long periods. Jerking and twitching.
Age: 1.36
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Crying, Erythema, Irritability
Clinical narrative: WITHIN TWO HOURS OF VACCINATIONS PATIENT BECAME RED BEGINNING ON THE EARS SPREADING TO ALL EXTREMITIES AND ONE SPOT ON HER BACK. PATIENT BECAME FUSSY & CRYING. RETURN TO PHYSICIAN'S OFFICE @ 1:15P.M. WHERE PATIENT WAS GIVEN BENADRYL & TOLD MOTHER TO FOLLOW UP ON MONDAY. INSTRUCTED TO GO TO NEAREST ER WITH CHANGES IN BREATHING &/OR JOINT SWELLING.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Autoimmune disorder, Computerised tomogram, Diplopia, Eyelid ptosis, Immunology test
Clinical narrative: MYSATHENIA GRAVIS (AUTOIMMUNE DISORDER). Double vision, ptosis(drooping of the eyelid).
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Myasthenia gravis, Nuclear magnetic resonance imaging, Positron emission tomogram
Clinical narrative: MYSATHENIA GRAVIS (AUTOIMMUNE DISORDER). Double vision, ptosis(drooping of the eyelid).