chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction
Clinical narrative: This spontaneous report was received from a consumer and refers to a male patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported). No concomitant therapies were reported Weeks after getting vaccinated, on an unknown date, the patient complained of an inability to gain an erection. The outcome of the inability to gain an erection was unknown. The reporter did not explicitly provide causal relationship between the event and vaccination with the suspect vaccine. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer and refers to an unspecified number of female patients of unknown ages. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently, on unknown dates, the patients suffered adverse effects. The outcome of these adverse effects were unknown. The reporter considered adverse effects to be related to the vaccination with GARDASIL This is one of the several reports received from the same reporter Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Erectile dysfunction, Male sexual dysfunction, Mental disorder, Urinary incontinence
Clinical narrative: This spontaneous report was received from a consumer and refers to an unspecified number of male patients of unknown ages. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. On unknown dates, the patients were presented with "new physical and psychological problems". The patients, reportedly, could not perform sexually, with some describing the problem as "something is wrong down there." The reporter went further on to state that such patients needed help in order to cope with a dysfunctional male organ and/or a swollen or painful scrotum. Moreover, the embarrassment was given a note, when the patients could no longer achieve an erection or hold their bladder. The outcomes of the aforementioned events were unknown. The reporter did not explicitly state any causal relationship between the events and vaccination with the suspect vaccine with a notable exception to the event of male sexual dysfunction, which was considered to be related since it was believed that impotency was associated with GARDASIL. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.34
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23 March 2015. A 16-month-old female patient, whose medical history was reported as none and concomitant medications were not reported, had received third dose of DAPTACEL (Batch number, expiry date and dose number was not reported) in thigh right on 19 March 2015. On 19 March 2015, the patient had experienced red hive like spots on her back and right hip. It was also reported that the patient had previously received 2 doses of DAPTACEL vaccine. The patient had corrective treatment included BENADRYL. Lab investigations were reported as none. The patient had no illness at the time of vaccination, and no pre-existing diagnosed allergies and birth defects. At the time of this report, outcome of the event was resolved on an unspecified date. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 04 June 2015. No new information was provided. List of Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Obsessive-compulsive disorder
Clinical narrative: Initial unsolicited report received from a healthcare professional on 13 May 2015. A three years old patient, whose age, medical history and concomitant medications were not reported had received a first dose of DAPTACEL (batch number: C4645BA, expiry date: 05-NOV-2016 and dose was not reported), via Intramuscular route in left thigh on 09 December 2014. It was reported that the patient was seen in office on 12 May 2015 and patient's mother reported to doctor that her son had increased OCD behaviors after the DTaP vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Addendum 13-MAY-2015: upon second medical examination of the case at the time of internal review the following has been modified in this case: Significant correction has been completed to updated the patient age as 3 years in subject screen and narrative screen, updated the event coding "condition aggravated" in event screen, changed the narrative and corrected reporter information in reporter screen. Follow up information received from a healthcare professional on 17 September 2015. It was reported that patient had egg allergy and illness at time of vaccination was reported as Kohler's disease left foot. It was also reported that patient did not receive any other vaccinations 4 weeks prior. On 23 December 2014, fourteen days, after vaccination, the patient experienced increased OCD (obsessive-compulsive disorder) behaviors and condition aggravated. Patient was vaccinated and vaccine was purchased at private doctor's office/hospital. At the time of report, outcome of the events was not reported. Follow up information received from a healthcare professional on 23 November 2015. No additional information provided.
Age: 17.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a health professional referring to a 17-year-old female patient. Information about the patient's medical history and concurrent conditions was not provided. On 09-DEC-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L025208 expiration date: 07-JUL-2017 (administration route was not provided), which being pregnant. The patient became pregnant with Last Menstrual Period of 30-NOV-2015 and Estimated Delivery Date of 05-SEP-2016, initial exposure to (Oka/Merck) VARIVAX was at 1 week. The pregnancy outcome was pending. No adverse effects were reported. The outcome of exposure during pregnancy was unknown at the time of this report. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Blood iron decreased, Blood test, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient passed out.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Tonic clonic movements
Clinical narrative: Patient passed out.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP, VARCEL, DTAP, HEP, HEPA, HPVX, MEN, VARCEL
Symptoms: Seizure
Clinical narrative: Within 2 minutes of receiving 6 shots (HPV, Tdap, HEP A, HEP B, chicken Pox and Meningococcal) patient had 2 seizures.  Several nurses and Dr. were called in to give aide. He was given oxygen and his vital signs were monitored. It took about an hour for his vital signs to return to safe levels and for him to become fully coherent.
Age: 13.0
Sex: F
Vaccine: HPV9, FLUX
Symptoms: Blood test, Infectious mononucleosis, Platelet count decreased, Weight decreased
Clinical narrative: This spontaneous medically confirmed report (initial receipt 15-Apr-2016) concerns a 13-year-old female patient. On 14-Sep-2015, the patient received GARDASIL 9 injection (varicella vaccine live, confirmed not GARDASIL quadrivalent, batch number not provided) for the prevention of HPV. On an unspecified date in Nov-2015, the patient received unspecified flu medication (Influenza virus vaccine, manufacturer and batch number not provided). In January 2015 after receiving GARDASIL and flu vaccine, the patient started to 'work out' and started to lose weight, also in January 2016.  The patient was seen by an unspecified haematologist on an unspecified date and she had a low platelet count and mononucleosis. The outcome was not reported. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, mononucleosis (infectious), weight loss are unlisted. Thrombocytopenia is listed. Causality: Unrelated. Infectious mononucleosis is caused by Epstein-Barr virus (EBV) which is transmitted primarily via oropharyngeal secretions.  It can be associated with weight loss and thrombocytopenia. It is a common cause of viral pharyngitis especially particularly in young adults. Patient was in the age category in whom this illness is common. No immediate vaccine adverse events were reported and as there is a clear alternate causality for the reported event, causality is considered unrelated to vaccination.
Age: 13.0
Sex: F
Vaccine: HPV9, FLUX
Symptoms: Infectious mononucleosis, Platelet count decreased, Weight decreased
Clinical narrative: This spontaneous medically confirmed report (initial receipt 15-Apr-2016) concerns a 13-year-old female patient. On 14-Sep-2015, the patient received GARDASIL 9 injection (varicella vaccine live, confirmed not GARDASIL quadrivalent, batch number not provided) for the prevention of HPV. On an unspecified date in Nov-2015, the patient received unspecified flu medication (Influenza virus vaccine, manufacturer and batch number not provided). In January 2015 after receiving GARDASIL and flu vaccine, the patient started to 'work out' and started to lose weight, also in January 2016.  The patient was seen by an unspecified haematologist on an unspecified date and she had a low platelet count and mononucleosis. The outcome was not reported. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, mononucleosis (infectious), weight loss are unlisted. Thrombocytopenia is listed. Causality: Unrelated. Infectious mononucleosis is caused by Epstein-Barr virus (EBV) which is transmitted primarily via oropharyngeal secretions.  It can be associated with weight loss and thrombocytopenia. It is a common cause of viral pharyngitis especially particularly in young adults. Patient was in the age category in whom this illness is common. No immediate vaccine adverse events were reported and as there is a clear alternate causality for the reported event, causality is considered unrelated to vaccination.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Electroencephalogram normal, Feeling abnormal, Generalised tonic-clonic seizure, Migraine
Clinical narrative: Have had 9 grand mal seizures since vaccination. Have been sent to ER due to seizures. Have been tested for epilepsy. Am on seizure medication. Have had digestive problems since vaccination. Have been tested for abdominal pain -reduced diet.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Petit mal epilepsy
Clinical narrative: Have had 9 grand mal seizures since vaccination. Have been sent to ER due to seizures. Have been tested for epilepsy. Am on seizure medication. Have had digestive problems since vaccination. Have been tested for abdominal pain -reduced diet.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Electroencephalogram, Gastrointestinal disorder, Generalised tonic-clonic seizure, Laboratory test normal
Clinical narrative: Have had 9 grand mal seizures since vaccination. Have been sent to ER due to seizures. Have been tested for epilepsy. Am on seizure medication. Have had digestive problems since vaccination. Have been tested for abdominal pain -reduced diet.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Ultrasound abdomen
Clinical narrative: Have had 9 grand mal seizures since vaccination. Have been sent to ER due to seizures. Have been tested for epilepsy. Am on seizure medication. Have had digestive problems since vaccination. Have been tested for abdominal pain -reduced diet.
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Lethargy, Nausea, Seizure, Vomiting
Clinical narrative: 1-2 minutes after the injection I went into what the nurse un-officially diagnosed as a seizure, this went on for 10 seconds then I came back from it. Then after another 2-3 minutes I went into another episode which lasted 20 seconds. After coming to the second time I was nauseous and proceeded to vomit. I felt nauseous for the next 2-3  hours and 8 hours after the vaccine I still feel lethargic.
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site, Feeling abnormal, Incorrect route of drug administration, Lethargy, Loss of consciousness
Clinical narrative: 1-2 minutes after the injection I went into what the nurse un-officially diagnosed as a seizure, this went on for 10 seconds then I came back from it. Then after another 2-3 minutes I went into another episode which lasted 20 seconds. After coming to the second time I was nauseous and proceeded to vomit. I felt nauseous for the next 2-3  hours and 8 hours after the vaccine I still feel lethargic.
Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nausea, Seizure, Tension, Vomiting
Clinical narrative: 1-2 minutes after the injection I went into what the nurse un-officially diagnosed as a seizure, this went on for 10 seconds then I came back from it. Then after another 2-3 minutes I went into another episode which lasted 20 seconds. After coming to the second time I was nauseous and proceeded to vomit. I felt nauseous for the next 2-3  hours and 8 hours after the vaccine I still feel lethargic.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Condition aggravated, Joint swelling, Lethargy, Lip swelling, Migraine
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an approximately 12 year old female patient with migraine. Patient's medical history was not reported. On an unknown date, the patient had received first dose of GARDASIL 9. Patient received the second dose on 02-OCT-2015. On 08-APR-2016, the patient received her third dose of GARDASIL 9 (0.5 ml, lot #L026602, expiry date 19-OCT-2017). Concomitant therapies included naproxen. On unknown date, in approximately April 2016, the patient experienced swelling in her knees, elbows, ankles and also had some swelling in her lips following the third dose of GARDASIL 9. Patient also complained of lethargy and her migraine had worsened. Patient sought medical attention-she had a follow up visit with the physician on 04-APR-2016 because of the adverse events, following the third vaccination. The patient was given prednisone for a 2 weeks as treatment. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as recovering. The reporter did not assess the relatedness of the events with GARDASIL 9. The reporter considered the events to be serious due to disability. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an approximately 12 year old female patient with migraine. Patient's medical history was not reported. On an unknown date, the patient had received first dose of GARDASIL 9. Patient received the second dose on 02-OCT-2015. On 08-APR-2016, the patient received her third dose of GARDASIL 9 (0.5 ml, lot #L026602, expiry date 19-OCT-2017). Concomitant therapies included naproxen. On unknown date, in approximately April 2016, the patient experienced swelling in her knees, elbows, ankles and also had some swelling in her lips following the third dose of GARDASIL 9. Patient also complained of lethargy and her migraine had worsened. Patient sought medical attention-she had a follow up visit with the physician on 04-APR-2016 because of the adverse events, following the third vaccination. The patient was given prednisone for a 2 weeks as treatment. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as recovering. The reporter did not assess the relatedness of the events with GARDASIL 9. The reporter considered the events to be serious due to disability. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Decreased appetite, Fatigue, Headache
Clinical narrative: On day of vaccination; arm pain, malaise, fever (? temp), body aches - lasted 2 days. Then patient was well for 2 days - no residual symptoms. Then developed severe headache 4/20 - seen at our office - CT head normal - given TORADOL PO and told to f/u if needed. Seen in ER 4/22 for same headache, no fever, no N/V at that time. Seen again 4/25 for headache - not much change. Some fever to 101 , weak, tired, appetite fair. Still has headache.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: On day of vaccination; arm pain, malaise, fever (? temp), body aches - lasted 2 days. Then patient was well for 2 days - no residual symptoms. Then developed severe headache 4/20 - seen at our office - CT head normal - given TORADOL PO and told to f/u if needed. Seen in ER 4/22 for same headache, no fever, no N/V at that time. Seen again 4/25 for headache - not much change. Some fever to 101 , weak, tired, appetite fair. Still has headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right upper extremity.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of ROTATEQ, lot # L035276, expiry date 09-JUN-2017; lot # L002042, expiry date 28-JUL-2016; lot # L008996, expiry date 01-DEC-2016; lot # L013188, Expiry date 02-NOV-2016; lot # L027726, expiry date 10-MAY-2017 ad lot # K016263, expiry date 26-JUN-2016 (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Vaccination site inflammation
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 27 April 2015. This case is linked with case ID: 2015SA056122, 2015SA056123 (same vaccine). A patient (Demographics: unknown), whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (batch number: C4751AA, expiry date: 9 June 2017) via intramuscular route on April 2015. On unspecified date in April 2015, on the same day of vaccination the patient experienced large pink swelling, mild itching, area became red and hot to touch, Swelling was the size of golf ball. Patient required ER visit. Patient was treated with prednisone. Laboratory investigations were not reported. Upon medical review, the case was considered as serious due to important medical event: vaccination site inflammation and Vaccination site pruritus. At the time of the report, the outcome of the event was unknown. List of Documents held by Sender: None. Sender's Comments: Large injection site reactions including inflammation and pruritus are listed with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This case is not sufficiently documented. More information on the vaccination technique and exploring alternate etiologies like trauma, insect bite etc. would be helpful to further assess this case. Based on the information provided, the role of vaccine cannot be assessed.
Sex: U
Vaccine: DTAP
Symptoms: Vaccination site pruritus
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 27 April 2015. This case is linked with case ID: 2015SA056122, 2015SA056123 (same vaccine). A patient (Demographics: unknown), whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (batch number: C4751AA, expiry date: 9 June 2017) via intramuscular route on April 2015. On unspecified date in April 2015, on the same day of vaccination the patient experienced large pink swelling, mild itching, area became red and hot to touch, Swelling was the size of golf ball. Patient required ER visit. Patient was treated with prednisone. Laboratory investigations were not reported. Upon medical review, the case was considered as serious due to important medical event: vaccination site inflammation and Vaccination site pruritus. At the time of the report, the outcome of the event was unknown. List of Documents held by Sender: None. Sender's Comments: Large injection site reactions including inflammation and pruritus are listed with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This case is not sufficiently documented. More information on the vaccination technique and exploring alternate etiologies like trauma, insect bite etc. would be helpful to further assess this case. Based on the information provided, the role of vaccine cannot be assessed.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a healthcare professional (medical record provided) on 12-Aug-2015. This case is related to cases: 2015SA105654, 2015SA121736, 2015SA121739, 2015SA121741, 2015SA121742, 2015SA121743, 2015SA121744, 2015SA121745, 2015SA121746, 2015SA121747, 2015SA121748, 2015SA121749, 2015SA121750, 2015SA121751, 2015SA121752, 2015SA121753 (same lot number, same vaccine, same reporter). The individual patient identifiers were reported. This case is for the third patient out of 16 patients. A 19 months old female patient whose medical history and concomitant medications were not reported had received a dose of DAPTACEL (batch number: C4709AA, expiry date: 24-Feb-2017, dose details, route and site of administration were not provided) on 29-Jun-2015. On 30-Jun-2015, 1 day post vaccination, the patient developed a red knot at injection site which was a baseball size. It was reported that the symptoms were experienced for one to two weeks. Laboratory investigations and corrective treatment were not provided. At the time of this report, the patient recovered from the above mentioned event on an unspecified date. It was reported that the patient did not require any medical attention nor hospitalization. Documents held by sender: none. Follow up information received from a non health care professional on 14 September 2015. This case involve a 18 months old female patient who vaccinated with 0.5 ml intramuscular dose of DAPTACEL/DTaP Pediatric SDV in right thigh on 29 June 2015. On 30 June 2015, one day following vaccination, the patient experienced redness, knot was from swelling and it was hard underneath as well as warm to touch.
Age: 1.97
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional on 12 August 2015. This case is related to cases: 2015SA105654, 2015SA121736, 2015SA121739, 2015SA121740, 2015SA121741, 2015SA121742, 2015SA121743, 2015SA121744, 2015SA121745, 2015SA121746, 2015SA121747, 2015SA121748, 2015SA121749, 2015SA121751, 2015SA121752, 2015SA121753 (same lot number, same vaccine and same reporter). A twenty four months old female patient whose medical history and concomitant medications were not reported had received a dose of DAPTACEL (Pediatric SDV) (batch number: C4709AA, expiry date: 24 February 2017, dose, route and site of administration were not provided) on 06 July 2015. On 08 July 2015, 2 day post vaccination; the patient developed a red knot at injection site and 3-4 inch in size. It was reported that the patient did not require any medical attention or hospitalization. Laboratory investigations and corrective treatment were not provided. On unspecified date, the patient recovered from the above mentioned event (It was reported that few patients experienced the symptoms for a week while a few experienced the symptoms for one to two weeks). Follow up information received from a physician on 14 September 2015. The date of birth of the patient was provided. It was reported that 0.5 (unit not provided) dose of the vaccine was administered in the right thigh via intramuscular route. The patient developed a red knot at injection site which was 3-4 inches in diameter with redness and swelling. List of documents held by sender: none.
Age: 1.74
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional on 12 August 2015. This case is linked with 16 other cases 2015SA105654, 2015SA121736, 2015SA121739, 2015SA121740, 2015SA121741, 2015SA121742, 2015SA121743, 2015SA121744, 2015SA121745, 2015SA121746, 2015SA121747, 2015SA121748, 2015SA121749, 2015SA121750, 2015SA121751, 2015SA121752, (same reporter, vaccine, lot number and different lot number). A 23-month-old male patient, whose medical history and concomitant medication were not reported, had received a dose of DAPTACEL (pediatric SDV) (Batch number: C4709AA, expiry date: 24 February 2017, route and site of administration were not reported) on 4 June 2015. On 5 June 2015, one day after vaccination, the patient had developed cellulitis. In ER visit, the patient received antibiotics as a corrective treatment. It was reported that, the patient was fine; none required medical attention or hospitalization. Laboratory investigations was not reported. On an unknown date, the patient was recovered from the event ("It was unknown if the patient recovered within a week or in two weeks"). Upon internal review, company assessed the event cellulitis as serious and important medical event. Documents held by sender: none. Follow-up information received from a physician on 14 September 2015. This case involves a 21-month-old patient who had received 0.5 ml intramuscular dose of DAPTACEL vaccine in left thigh. Vaccine was administered at private doctor's office/hospital. On unspecified date, the patient developed a knot at injection site, redness/ whole thigh was red. It was reported that the knot at injection site was used to indicate the swelling. Sender's Comments: Follow-up information received on 14-September-2015 does not change the previous medical assessment: Cellulitis is listed with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible with a role of the vaccine. However, this case is poorly documented and no conclusion on the role of the vaccine can be drawn. Additional information on the site the patient developed cellulitis, complementary investigation results confirming the diagnosis of cellulitis, cleansing of the vaccine injection site, patient medical history (trauma, insect/animal bite, pathologies increasing the risk of cellulitis), as well as identification of the pathogen responsible for the event is needed to further assess this case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Chills, Feeling of body temperature change, Injection site urticaria, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (medical assistant) on 17 August 2015. A four-year-old female patient had received a fifth dose of DAPTACEL (manufacturer: Sanofi Pasteur LTD, batch number: C4780AA, expiration date: 23 July 2017, dose was not reported) intramuscularly in left deltoid, a fourth dose of IPOL (manufacturer: Sanofi Pasteur SA, batch number: L1001-1, expiration date: 14 July 2017, dose was not reported) subcutaneously in right triceps area on 13 August 2015. The patient also received a dose of PROQUAD (manufacturer: MSD, batch number: L014401, expiration date, dose and dose number were not reported) subcutaneously in left arm on 13 August 2015. Previously the patient received four doses of DAPTACEL and three dose of IPOL on an unspecified date. The patient did not have illness at the time of vaccination. The medical history and concomitant medication were not reported. On 13 August 2015, same day post vaccination, the patient experienced fever 102 (units not provided), chills, headache, body aches and temperature sensitivities for three days. On 17 August 2015, four days post vaccination, the patient developed hives around the injection site of DAPTACEL. Laboratory investigations were not performed. The patient received BENADRYL as a corrective treatment for local hives. The patient was advised to use ZYRTEC. On an unspecified date, the patient recovered from the events of fever, chills, headache, body aches and temperature sensitivities. The outcome of the event hives around the DAPTACEL injection site was unknown. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016164800) on 21 March 2016. This case involves a 71-year-old female patient who was vaccinated with a dose of Flu shot intramuscularly (batch number, expiration date and dose were not reported) in the right arm on an unspecified date in October 2015. The patients' medical history included Atrial fibrillation diagnosed around 20 years ago which was ongoing, fibromyalgia diagnosed 10 or 11 years ago, plantar fasciitis/achilles tendonitis: happens sporadically, slightly raised blood pressure diagnosed about 1 year ago. Illness at time of vaccination was reported as none. Concomitant medications were reported as none.On a unspecified date, right away following vaccination, the patient had experienced redness, swelling and soreness really bad. It was reported that adverse event following prior vaccination: most likely in the afternoon after 13:00. The patient did not required emergency room or doctor visit. Laboratory investigations was reported none. Corrective treatment were not reported. The patient was recovered from events. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016164800) on 21 March 2016. This case involves a 71-year-old female patient who was vaccinated with a dose of Flu shot intramuscularly (batch number, expiration date and dose were not reported) in the right arm on an unspecified date in October 2015. The patients' medical history included Atrial fibrillation diagnosed around 20 years ago which was ongoing, fibromyalgia diagnosed 10 or 11 years ago, plantar fasciitis/achilles tendonitis: happens sporadically, slightly raised blood pressure diagnosed about 1 year ago. Illness at time of vaccination was reported as none. Concomitant medications were reported as none.On a unspecified date, right away following vaccination, the patient had experienced redness, swelling and soreness really bad. It was reported that adverse event following prior vaccination: most likely in the afternoon after 13:00. The patient did not required emergency room or doctor visit. Laboratory investigations was reported none. Corrective treatment were not reported. The patient was recovered from events. List of documents held by sender: none.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # L017407, expiry date 15-AUG-2017; lot # L007560, expiry date 15-JUN-2017; lot # L011846, expiry date 16-JUN-2017, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient in his forties. Information regarding the patient's current conditions and medical history was not provided. On an unknown date in October 2015 and 07-APR-2016 the patient was vaccinated with RECOMBIVAX HB, dosing regimen, lot number unspecified) dose 1 and 2 respectively. No adverse events were reported. No laboratory tests were reported. No product quality complaint was involved. No further information was provided. 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 medical assistant refers to 5 patients of unknown age and gender. The patient's medical history was not reported. On unknown dates, the patient were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # reported as L007216, expiration date reported as 03-MAR-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 6.8 degrees Celsius for 5 hours 43 minutes. Data logger was involved. There were no previous excursion reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 27-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (lot # L004656, expiry date 11-FEB-2017 and lot # K021151, expiry date 02-NOV-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reported received from the same reporter.  Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11-year-old patient of unknown age. No information about the patient's medical history and concurrent conditions were reported. On 08-JAN-2016, the patient was vaccinated with an improperly stored, the first dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapies included Tdap and Meningococcal conj vaccine (unspecified). Administered doses was exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 14.0
Sex: U
Vaccine: FLU3, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 20-JAN-2016, the patient was vaccinated with an improperly stored, the third dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot #: K010215, expiration date on 05-MAY-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. No previous temperature excursion was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, Lot : L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Oral pruritus, Throat tightness
Clinical narrative: Patient c/o tightness feeling in his throat and itching to his mouth.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, lot number, expiration date and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. No previous temperature excursion was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, Lot #: L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The Patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #: L004743, expiration date on 01-JAN-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. Concomitant therapies were not provided. No previous temperature excursion was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, Lot #: L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCt-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) lot # L024122 expiration date 30-DEC-2016 (route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46 F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the 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 report was received from a healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCT-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored M-M-R II (lot K024035 expiry date 26-NOV-2016 and lot K004949 expiry date 04-APR-2016, route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the several reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding the multiple patient's concurrent conditions and medical history were not provided. The physician reported that multiple patients received RECOMBIVAX HB (Lot # J013394 with an expiration date on 25-AUG-2016) (dose and route were not reported). This vaccine was improperly stored. No adverse effects were reported. The storage temperature was 34F, the time frame: 120 hours and there was no previous excursion temperature. This is one of several reports received from the same reporter (MARRS # 1604USA008481). Additional information is not expects as the physician can not be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients unknown age and gender. Information regarding the multiple patient's concurrent conditions and medical history were not provided. The physician reported that multiple patients received GARDASIL (lot # K006960 with an expiration date on 19-FEB-2017) (dose and route were not provided). This vaccine was improperly stored. No adverse effects were reported. The storage temperature was 34 degrees F, the time frame: 120 hours and there was no previous excursion temperature. This is one of several reports received from the same reporter (MARRS # 1604USA010522). Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 03-NOV-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 14-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.