chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Laboratory test, Loss of consciousness, Myocardial infarction, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a male physician of unknown age regarding himself via a company representative. No medical history and concurrent conditions were reported. On an unknown date approximately in 2011 (also reported as 5 years ago) the patient was vaccinated with a dose of VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in 2011 (also reported as the day after the injection) the patient became weak (hospitalization) and passed out (hospitalization) the physician was then taken to a hospital (unspecified duration of hospital stay) and was tested for a possible heart attack (hospitalization and medically significant). On an unknown date approximately in 2011 a hospital physician had stated to the reporting physician that he could have suffered a possible reaction to the VARIVAX injection. On an unknown date approximately in 2011 the patient underwent a magnetic resonance imaging (MRI) and an unspecified test (details unspecified) the results were not reported. It was reported that the patient sought medical attention but it was unknown if the physician received treatment for the event. The action taken with the therapy with VARIVAX was unknown. It was reported that after a few days after the incident the physician was recovering well and felt normal again with no other reactions. The outcome of syncope, myocardial infarction, vaccination complication and asthenia was reported as recovered. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review the event heart attack was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Syncope, Vaccination complication
Clinical narrative: This spontaneous report was received from a male physician of unknown age regarding himself via a company representative. No medical history and concurrent conditions were reported. On an unknown date approximately in 2011 (also reported as 5 years ago) the patient was vaccinated with a dose of VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in 2011 (also reported as the day after the injection) the patient became weak (hospitalization) and passed out (hospitalization) the physician was then taken to a hospital (unspecified duration of hospital stay) and was tested for a possible heart attack (hospitalization and medically significant). On an unknown date approximately in 2011 a hospital physician had stated to the reporting physician that he could have suffered a possible reaction to the VARIVAX injection. On an unknown date approximately in 2011 the patient underwent a magnetic resonance imaging (MRI) and an unspecified test (details unspecified) the results were not reported. It was reported that the patient sought medical attention but it was unknown if the physician received treatment for the event. The action taken with the therapy with VARIVAX was unknown. It was reported that after a few days after the incident the physician was recovering well and felt normal again with no other reactions. The outcome of syncope, myocardial infarction, vaccination complication and asthenia was reported as recovered. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review the event heart attack was considered to be medically significant. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that later that same evening her arm got swollen, red, and painful around the injection site. 8pm is an approximate time the patient reported her symptoms occurred the evening after she received the shot.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, Warmth and pain at injection site.  Noticed on subsequent admission to hospital for a different reason
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Skin discolouration
Clinical narrative: Approximately 5 minutes after receiving vaccines, patient's right arm turned red/purple color. Dr. and FNP assessed patient. Approximately 15 minutes after arm changed color it changed to red, the 10 minutes later color was back to normal. Vitals were normal.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site rash, Nausea
Clinical narrative: Patient reported fever, nausea and vomiting, and fatigue on 7/19/16 at approximately 13:12 via telephone call. The following day, 7/20/16, at approximately 09:27 (a.m.), patient reported nausea and vomiting subsided, new onset of reddened itchy rash around injection site. Provider notified and patient called in for appointment at 10:00 a.m. with her PCP. Called patient on 7/21/16 at 11:31 (a.m.) Pt's rash and other symptoms improving with BENADRYL as directed by provider.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Patient reported fever, nausea and vomiting, and fatigue on 7/19/16 at approximately 13:12 via telephone call. The following day, 7/20/16, at approximately 09:27 (a.m.), patient reported nausea and vomiting subsided, new onset of reddened itchy rash around injection site. Provider notified and patient called in for appointment at 10:00 a.m. with her PCP. Called patient on 7/21/16 at 11:31 (a.m.) Pt's rash and other symptoms improving with BENADRYL as directed by provider.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Patient received vaccine and later that night, stated her arm at inj site was "hard as a rock", reddened, has a rash, and arm is achy. Rash is raised, and is from elbow up 3-4 inches.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythema multiforme rash involving bilateral thighs.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Redness, irritation, and swelling around injection site. Pt saw MD, diagnosed with cellulitis. Treated with steroids and antibiotic.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Dizziness, Facial nerve disorder, Head discomfort, Headache
Clinical narrative: Initial unsolicited report received from a consumer on 11 July 2016. This case involves a 55-years-old female patient who was vaccinated with a dose of Imovax and a dose of Imogam (batch number, expiry date, site of administration was not reported) by intramuscularly on 07 July 2016. Illness at time of vaccination was reported as no and birth defects, medical conditions were not reported and Pre-existing physician diagnosed allergies included chemically sensitive. Concomitant medications were not reported. On 07 July 2016, few hours following the vaccination, the patient had experienced body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache, it also reported that headache pain is comparable to how felt when patient had a concussion. On 08 July 2016, after 24 hours following the vaccination, the patient had experienced difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in head, and tightness in the face, feel the nerves in mouth and nose. Laboratory investigations and corrective treatment were not reported. The outcome of the events body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache was reported as unknown because events comes and go and on 09 July 2016, after 36 hours the patient was recovered from the events difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in her head, and a tightness in the face, feel the nerves in mouth and nose. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Hot flush, Mastication disorder, Muscle spasms, Myalgia, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 11 July 2016. This case involves a 55-years-old female patient who was vaccinated with a dose of Imovax and a dose of Imogam (batch number, expiry date, site of administration was not reported) by intramuscularly on 07 July 2016. Illness at time of vaccination was reported as no and birth defects, medical conditions were not reported and Pre-existing physician diagnosed allergies included chemically sensitive. Concomitant medications were not reported. On 07 July 2016, few hours following the vaccination, the patient had experienced body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache, it also reported that headache pain is comparable to how felt when patient had a concussion. On 08 July 2016, after 24 hours following the vaccination, the patient had experienced difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in head, and tightness in the face, feel the nerves in mouth and nose. Laboratory investigations and corrective treatment were not reported. The outcome of the events body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache was reported as unknown because events comes and go and on 09 July 2016, after 36 hours the patient was recovered from the events difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in her head, and a tightness in the face, feel the nerves in mouth and nose. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Palpitations, Speech disorder, Tremor, Vibratory sense increased, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 11 July 2016. This case involves a 55-years-old female patient who was vaccinated with a dose of Imovax and a dose of Imogam (batch number, expiry date, site of administration was not reported) by intramuscularly on 07 July 2016. Illness at time of vaccination was reported as no and birth defects, medical conditions were not reported and Pre-existing physician diagnosed allergies included chemically sensitive. Concomitant medications were not reported. On 07 July 2016, few hours following the vaccination, the patient had experienced body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache, it also reported that headache pain is comparable to how felt when patient had a concussion. On 08 July 2016, after 24 hours following the vaccination, the patient had experienced difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in head, and tightness in the face, feel the nerves in mouth and nose. Laboratory investigations and corrective treatment were not reported. The outcome of the events body shaking, waves of hot flashes, heart palpitations, nausea, dizziness, burning muscles and joint pain and head feels heavy and patient had a headache was reported as unknown because events comes and go and on 09 July 2016, after 36 hours the patient was recovered from the events difficulty chewing, upper body spasms especially in the shoulders, couldn't focus patient eyes, blurry vision, it was a little hard to speak, vibrating sensation in her head, and a tightness in the face, feel the nerves in mouth and nose. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm swollen, red, hot from shoulder to elbow (13 cm x 10 cm), mildly tender to touch (deltoid area). (R) deltoid area 2 x 3 cm area pink, non-swollen, non-tender skin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (strength, dose and route of administration were unknown). The lot numbers were K011085 and L013063 with expiration dates of 08-AUG-2016 and 04-APR-2016 respectively. There were no concomitant therapies nor adverse effects reported. This case is one of two cases from the same reporter. 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 medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD subcutaneously (strength and dose were unknown). The lot number was L040415 with expiration date of 04-APR-2-17. There were no concomitant therapies nor adverse effects reported. This case is one of two cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot, dosing details not reported. It was reported that the patient had completed the recommended 3 dose vaccination series with RECOMBIVAX HB.  Concomitant medications were not reported. On an unknown date the patient had negative titers for Hepatitis B 'anti-HBs antibody negative'. The outcome of the event was not reported. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Asthma, Condition aggravated, Urticaria
Clinical narrative: Asthma symptoms began the evening of the day of the vaccine.  He required 2 rounds of oral Prednisone to get his asthma symptoms under control over the 2 weeks following the vaccine.  He also required daily oral allergy medication and frequent doses of Albuterol.  He also developed hives 1 week following the vaccine.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: 9 OUT OF 10 ON PAIN SCALE AT SITE OF INJECTION.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female non-pregnant patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated intramuscularly with an unknown dose of GARDASIL (3 dose series; lot # and expiry date were not reported), which was stored under potentially out of range temperature. The patient did not seek medical attention and no treatment was given. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site swelling
Clinical narrative: Leg swelling. Went to local ED area marked and instructed to observe. Swelling increased outside of marked area came into clinic following day antibiotics given.
Age: 8.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after receiving immunizations. 0840 At the initial assessment before immunizing mother stated that the patient has no history of fainting in the past and the patient had breakfast this morning. At or about 0843, the patient was administered the following vaccines: TDAP, MMR, VARICELLA, IPV. Upon completion, patient moved out of vaccination chair to another chair for observation. At or about 0848, we observed patient loss of consciousness with present jerky motions that lasted 2 or 3 seconds leaning and sliding her down to the wall. Patient's mother grabbed and held patient after she reached the floor and then stayed with her on the floor. After this episode, patient was fully awake. Had patient lay down and her feet were elevated. Patient was questioned by the Staff Nurse to see if she was injured. Patient was then given full assessment to ensure there were no injuries. Patient was found to have no injuries. Patient denies headache, nausea, or any other discomfort. After ensuring patient was stable, patient was ok to leave accompanied by her mother. Instructed mother to observe patient for any change on patient condition, if occurs then take the patient to the Emergency Room. Patient left the clinic accompanied by mother at 0930. 11:42 Staff Nurse called to check on condition of the patient and was told by mother that patient was doing good and had just finished eating. Mother was given telephone number of clinic and was told that we will call again later to check on patient and if any problems arise to get patient to the nearest Emergency Room. At 15:05 Staff Nurse called to check on patient again and mother stated daughter feels great. PHN Manager was informed of the situation.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Immediately following the injection my daughter felt dizzy, nauseous, weak and like she was going to pass out. The nurse gave her a ice pack for her head and we waited a few minutes. By the time we got home about 2:40 PM she had a severe headache, along with the above symptoms. The headache pain radiated back behind her ears when she sat up.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Nausea
Clinical narrative: Immediately following the injection my daughter felt dizzy, nauseous, weak and like she was going to pass out. The nurse gave her a ice pack for her head and we waited a few minutes. By the time we got home about 2:40 PM she had a severe headache, along with the above symptoms. The headache pain radiated back behind her ears when she sat up.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Immediately following the injection my daughter felt dizzy, nauseous, weak and like she was going to pass out. The nurse gave her a ice pack for her head and we waited a few minutes. By the time we got home about 2:40 PM she had a severe headache, along with the above symptoms. The headache pain radiated back behind her ears when she sat up.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Hyperhidrosis
Clinical narrative: After vaccine patient diaphoretic, no loc. lasting 15-20 min.
Age: 16.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via Pfizer Sales representative. A 16-year-old female patient of unspecified ethnicity received TRUMENBA at 0.5 ml single, MENACTRA and HPV9 all via an unspecified route of administration, on unknown date. Relevant medical history and concomitant medications were not reported. After the vaccination, on unknown date, the passed out for a few seconds. The outcome of the event was unknown.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a sales representative. An 18-year-old male patient received TRUMENBA at 0.5 ml, single and HPV9, both via an unspecified route of administration, on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient almost passed out on an unspecified date after vaccinations. He elevated his legs and felt better. The event was resolving at time of report.
Sex: F
Vaccine: PNC13
Symptoms: Kawasaki's disease
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative. A female patient in her 6th decade received PREVNAR 13 via an unspecified route of administration, on an unspecified date in 2015, about a year before the report, at 0.5 ml single. Medical history included ongoing lung disorder. Concomitant medications were not reported. The patient developed Kawasaki syndrome on an unspecified date in 2015, one or two months after vaccination. The event resolved on an unspecified date in 2015.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report obtained from a contactable health care professional through a Pfizer sales representative. A 16 year old female patient received, on an unspecified date, TRUMENBA 0.5 ml, single dose and MENACTRA. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient passed out for a few seconds. No further information provided.
Age: 0.76
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Peripheral swelling, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Child started with a rash and  fever in the evening on 7/20/16.  The child was seen in the office on 7/21/16 for a fever, T101 degree F.(Temporal) and a red, papular rash on his whole body The baby came back on 7/22/16 with the rash worse, his hands and feet were swollen, and temperature was 99.2F. He was started on ZYRTEC 2.5ml as needed on 7/21/16.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Pyrexia
Clinical narrative: Had PREVNAR 14 months ago. Had PNEUMOVAX yesterday and had local reaction within hours accompanied by fever.
Age: 9.0
Sex: M
Vaccine: HEPA, HPV9, MMRV, TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 2 inch wide by 4 inch long reddened & warm area on the back of patient's right arm, noticed while mother was bathing patient. c/o mild itching, denies pain. No treatment yet.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Laceration, Loss of consciousness
Clinical narrative: After second HPV child fell down off exam table and hit head on floor. Cut under left eye right below the brow. Child lost consciousness momentarily, ambulance was called and child was alert and active heading to the ER.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Immediate post-injection reaction, Laceration, Suture insertion
Clinical narrative: After second HPV child fell down off exam table and hit head on floor. Cut under left eye right below the brow. Child lost consciousness momentarily, ambulance was called and child was alert and active heading to the ER.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: After second HPV child fell down off exam table and hit head on floor. Cut under left eye right below the brow. Child lost consciousness momentarily, ambulance was called and child was alert and active heading to the ER.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Hypoaesthesia oral, Injection site pain, Injection site rash
Clinical narrative: 07/14/16-rash and pain at injection site-worsened. 07/15/16-Rash increased to bilateral arms, neck, face, head, ears, thighs and petechia. By midday 07/15/16--Also with numbness of lips and throat swelling without difficulty swallowing/breathing; mild cough and hoarse voice. 07/15/16-Approx. 1 PM- seen at ER-given prednisone, PEPCID and VISTARIL. Improved quickly.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Petechiae, Pharyngeal oedema
Clinical narrative: 07/14/16-rash and pain at injection site-worsened. 07/15/16-Rash increased to bilateral arms, neck, face, head, ears, thighs and petechia. By midday 07/15/16--Also with numbness of lips and throat swelling without difficulty swallowing/breathing; mild cough and hoarse voice. 07/15/16-Approx. 1 PM- seen at ER-given prednisone, PEPCID and VISTARIL. Improved quickly.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Pallor, Syncope
Clinical narrative: Child received 1st dose of HPV-9; in approx. 10 minutes, she told her mom she felt funny and fainted into mom's arms; child was pale, but responsive; after laying down for approximately 10 minutes with legs elevated, child recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Haematochezia, Haematuria, Immune thrombocytopenic purpura, Packed red blood cell transfusion
Clinical narrative: Case number PHHY2012US016081 is an initial literature report received on 20 Feb 2012. Authors described the risk of immune thrombocytopenic purpura after vaccination in children and adolescents. This case refers to a four-year-old female child. She was vaccinated with inactivated poliovirus vaccine (manufacturer and batch number: unknown), diphtheria-tetanus-acellular pertussis vaccine (manufacturer and batch number: unknown) and measles-mumps-rubella vaccine (manufacturer and batch number: unknown) on an unspecified date. Four weeks after receiving these vaccines, she developed immune thrombocytopenic purpura (ITP) complicated by hematochezia and hematuria requiring hospitalization and transfusion of packed red blood cell. The outcome of the event was not reported. Authors concluded that ITP is unlikely after early childhood vaccines other than MMR. Because of the small number of exposed cases and potential confounding, the possible association of ITP with hepatitis A, varicella, and tetanus-diphtheria-acellular pertussis vaccines in older children requires further investigation. Following internal review, this case has been identified as a duplicate of case B0781364A and will be deleted. All information will be kept in case B0781364A which stands as a case of record for this patient.
Age: 1.52
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: 7/13/16 HAVRIX vaccine administered. 7/14/16 mom called Triage Nurse - Pt has hives, instructed to give BENADRYL and monitor for dr and us. 7/16/16 seen in office, hives progressing.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Awoke in AM (7/22/16) with diffuse urticaria.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via other company Pfizer refers to over 100 patients of unknown age (both pediatric and adult) and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In MAY 2016 and JUNE 2016, the patients were vaccinated intramuscularly with unknown doses of PNEUMOVAX23 (lot # L022262, expiry date 05-NOV-2016) after temperature excursion included 192  hours total of refrigeration for a maximum temperature of 49.8 degrees Fahrenheit. The reporter confirmed that 7 doses of PNEUMOVAX23 were given in MAY 2016 and was unable to confirm how many doses were given in JUNE 2016. No patients received doses after 29-JUN-2016. The reporter's institution did not receive any report regarding any adverse events involving these patients. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: Pt. developed rash to abdomen within 3 hours of receiving vaccine. Was seen by dr. at clinic. Given DECADRON IM, hydrocortisone cream and TYLENOL. Pt was seen again the next day 9/28. Rash was gone. RN tried to contact 7/22 but no answer.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Activated partial thromboplastin time, Chest X-ray, Chest discomfort, Crying, Dyspnoea
Clinical narrative: Muscle aches and twitching 9pm 7-13-16. Crying in pain and chest discomfort by 11:15p. Shortness of breath. Given IVF and NSAIDS in the ED.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Muscle twitching, Myalgia
Clinical narrative: Muscle aches and twitching 9pm 7-13-16. Crying in pain and chest discomfort by 11:15p. Shortness of breath. Given IVF and NSAIDS in the ED.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Prothrombin time, Troponin
Clinical narrative: Muscle aches and twitching 9pm 7-13-16. Crying in pain and chest discomfort by 11:15p. Shortness of breath. Given IVF and NSAIDS in the ED.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. on unknown dates, the patients were vaccinated with a dose of VARIVAX (lot# L031068, expiration date 18-AUG-2017). The vaccines were exposed to a temperature of 17 Fahrenheit (F) for 55 hours. Digital data logger was involved. There was no previous temperature excursions. Product quality complaint (PQC) was not reported. No adverse effects were reported. A call was placed to the nurse that requested patient identifies, lot number, expiration date and date of vaccination. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin test positive, Urticaria
Clinical narrative: On 8/3/15 patient received PENTACEL and PREVNAR and developed hives. On 11/2/15 he received the same vaccines and within 10 minutes he developed hives, which generalized covering the buttocks, torso and upper extremities, prompting ER visit.
Age: 19.0
Sex: M
Vaccine: TYP, YF
Symptoms: Asthenia, Dizziness, Nausea, Syncope
Clinical narrative: While patient was standing at checkout counter, he experienced a new syncopal episode. Pt reports feeling nauseated, dizzy, and weak. Pt placed in reclining position, vital signs obtained, level consciousness assessed. Given water to drink and crackers to eat.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cyanosis, Paraesthesia, Urticaria
Clinical narrative: Within 1 hour developed hives and tingling and blue in hands.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives present 3 days after (7/14). Still present 7/22. Prednisone and BENADRYL given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Cough, Crying, Discomfort, Eye swelling
Clinical narrative: Hives present 3 days after (7/14). Still present 7/22. Prednisone and BENADRYL given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Injection site urticaria, Irritability
Clinical narrative: Hives present 3 days after (7/14). Still present 7/22. Prednisone and BENADRYL given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Malaise, Paraesthesia, Rash, Urticaria, Wheezing
Clinical narrative: Hives present 3 days after (7/14). Still present 7/22. Prednisone and BENADRYL given.
Age: 1.32
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Crying, Oral mucosal blistering, Rash
Clinical narrative: Increased crying, running temp>101 off and on, even though receiving Tylenol and now has spots on her arms, legs and mouth has blisters.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Fever, chicken pox rash.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Chills and fever.  Raised area at the injection site.  Site warm to touch.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Influenza like illness, Injection site rash
Clinical narrative: Lethargy, headache, numbness in limbs, flu-like symptoms without fever, rash in same arm as injection, under original injection site appeared 6 days post vaccine. Rash was itchy, blotchy, warm but not infected. Rash resolved within 2 days of appearance. Doctor visit one week post vaccine to evaluate rash and previous symptoms. Lethargy, body aches, numbness lasted ~ 3 days post injection. Caused patient to miss work for 2 days. This was part 2 of 2 of the vaccine. Same symptoms occurred after part 1 of the vaccine on 06/03/16, but slightly less severe. Patient recovered after ~ 8 days post second part of vaccine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth, Lethargy, Pain, Rash macular, Rash pruritic
Clinical narrative: Lethargy, headache, numbness in limbs, flu-like symptoms without fever, rash in same arm as injection, under original injection site appeared 6 days post vaccine. Rash was itchy, blotchy, warm but not infected. Rash resolved within 2 days of appearance. Doctor visit one week post vaccine to evaluate rash and previous symptoms. Lethargy, body aches, numbness lasted ~ 3 days post injection. Caused patient to miss work for 2 days. This was part 2 of 2 of the vaccine. Same symptoms occurred after part 1 of the vaccine on 06/03/16, but slightly less severe. Patient recovered after ~ 8 days post second part of vaccine.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash with small blisters on back of both hands.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Aphonia, Dizziness, Eye swelling, Eyelid margin crusting, Haemorrhage
Clinical narrative: Dizzy, headache, nausea, eyes started swelling under both eyes turned purple and sores with bleeding. Both eyes matted shut in the morning, sore throat, lost voice. Did not see a physician, symptoms lasted 10 days, bleeding under eyes lasted 4 days.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Nausea, Oropharyngeal pain, Skin discolouration, Skin ulcer
Clinical narrative: Dizzy, headache, nausea, eyes started swelling under both eyes turned purple and sores with bleeding. Both eyes matted shut in the morning, sore throat, lost voice. Did not see a physician, symptoms lasted 10 days, bleeding under eyes lasted 4 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Cough, Cystitis, Dizziness, Headache
Clinical narrative: Headaches, arthritis worse, sore throat, cough, dizziness and massive bladder infections. Increase in seizures too.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Seizure
Clinical narrative: Headaches, arthritis worse, sore throat, cough, dizziness and massive bladder infections. Increase in seizures too.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in to pharmacy 2 days after symptoms developed. She complained of swelling below (about 1 & 1/2 inches) where the immunization was administered, itching, and warmness to the touch in the area. She showed her doctor since she had an appointment after symptoms appeared. The doctor did not recommend any treatment, just if the swelling spread to come back and they may prescribe an antibiotic. I recommended Benadryl orally and hydrocortisone 1% topically to relieve the symptoms. (I felt the issue may have   been a bug bite or sting, but the patient was convinced that the problem was due to the immunization received.)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site reaction, Rash vesicular
Clinical narrative: Pt developed vesicular rash to R upper arm - area where vaccine was administered. Then developed subsequent cellulitis surrounding the rash. I am the provider who treated the rash and cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Decreased appetite, Gait disturbance, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Pain in the legs where vaccine was administered, swelling of the leg, fever of 102 degrees, lethargy, limping, not eating.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Pain in the legs where vaccine was administered, swelling of the leg, fever of 102 degrees, lethargy, limping, not eating.
Age: 69.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Dizziness, Fall
Clinical narrative: Patient felt dizzy and light headed. Was sitting when fell on floor. States she did not hit head. Leaning against counter with her back. Declined medical intervention.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Posture abnormal
Clinical narrative: Patient slumped over in her chair shortly following administration of the HPV vaccine. She was A&Ox2 and did not know where she was. She was transferred from the immunization room to the treatment room and placed supine with her lower extremities slightly elevated and a blanket placed over her. Vitals taken shortly after event and reassessed 10 minutes afterwards. Results forwarded to NP on site and patient was shortly met with and released by NP.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Induration, Peripheral swelling
Clinical narrative: Injected Arm Red, Turned Hard and Access Swelling. Dizziness, Headache -Lasted 4 Days. Itching.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Injected Arm Red, Turned Hard and Access Swelling. Dizziness, Headache -Lasted 4 Days. Itching.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Balance disorder, Body temperature increased, Chest pain, Dizziness, Fatigue
Clinical narrative: Roughly 1 hour after receiving vaccine pt had 99.2 F low grade increased temp (hers is normally 97 F). Following day pt complains of difficulty even lifting limbs (because of fatigue, but not inability to do so), difficulty keeping steady while standing, dizziness, and central moderate chest pain. Pt not on any immune system lowering conditions or meds. Pt not have sx of hemiplegic migraine such as numbness or paralysis (so migraine unlikely concern). Pt possibly experiencing acute cerebellar ataxia similar to what might occur with the virus itself. Evidence seems to show that this should resolve with time and no specific treatment is needed.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Mobility decreased
Clinical narrative: Roughly 1 hour after receiving vaccine pt had 99.2 F low grade increased temp (hers is normally 97 F). Following day pt complains of difficulty even lifting limbs (because of fatigue, but not inability to do so), difficulty keeping steady while standing, dizziness, and central moderate chest pain. Pt not on any immune system lowering conditions or meds. Pt not have sx of hemiplegic migraine such as numbness or paralysis (so migraine unlikely concern). Pt possibly experiencing acute cerebellar ataxia similar to what might occur with the virus itself. Evidence seems to show that this should resolve with time and no specific treatment is needed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient reported experiencing intense itching at the site and the surrounding area. When patient came in on 7/22/2016 morning, the site of injection appeared to be red and tender, including 2 inches surrounding the injection site. Instructed patient to take Benadryl for itching. Patient will call primary doctor for evaluation.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Eye swelling, Pruritus, Swelling face
Clinical narrative: Swollen face, swollen eyes, itchy bright red skin.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Mobility decreased, Pain in extremity
Clinical narrative: Cellulitis around site of injection. Arm very painful and could not move the arm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PATIENT REPORTED RED, ITCHY RASH SPREAD OUT ON HIS BACK. NO WEEPING AND PAIN.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Injection site rash, Somnolence
Clinical narrative: Sleepiness/Headache/Rash at the injection site.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling of injection site, more then 6 inches in diameter. Very sore and itchy. Very hot to the touch.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Periarthritis, X-ray
Clinical narrative: Frozen shoulder. First tenderness at injection site followed by increased area of pain and then shoulder stiffness and limited range of motion. Orthopedic eval, followed by PT.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Intussusception, Ultrasound scan, X-ray
Clinical narrative: Double intussusception (ileoileal, ileocecal), developed 5 weeks after vaccinations.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Left deltoid muscle pain. No relief.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M004116 with expiration date 12-OCT-2017, (dose number and route of administration were not provided). No adverse effects were reported. The vaccine experienced a temperature excursion of 30.9 F for 18 hours. There was a previous excursion of 48.9 F for 23 hours. No data logger was involved. Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Overdose, Product used for unknown indication
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report number 2016305571 for PREVNAR 13. This was originally reported by a registered nurse, and refers to a 66 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route, anatomical location lot # and expiration date were unspecified) and PREVNAR 13, (dose, dose number, route, anatomical location lot # and expiration date were unspecified). 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 physician referring to an unspecified number of patients of unknown age and gender. Information regarding medical history or concurrent conditions were not reported. On unknown dates, the patients were vaccinated with 5 improperly store doses of VARIVAX (which had the lot number of M002061, expiration date 12-JAN-2018 (dose, route and anatomical site of vaccination were not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. And there was not product quality complaint involved. This is one of two cases 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 registered nurse refers to 2 patients of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 2 patients were vaccinated with improperly stored VARIVAX, (lot# M002064 (expiry date: 12-JAN-2018) (dosage not reported). No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL lot #, dosing details and route unknown. Concomitant medications were not reported. On an unknown date the patient experienced syncope episode while in car driving home from physician's office. The physician reported that the patient's mother sought medical attention for the patient. The physician reported that the patient was monitored at emergency room as treatment. No treatment medication was given to the adverse event. It was reported that the patient's mother brought emergency room bill to physicians' office for implied payment. The outcome of syncope episode was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient noticed itchy red patch at injection site. Site is raised and about 2 inches long.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness, itchiness, and swelling at injection site. Reaction area covering approx 3.5 inches in diameter on right arm. Recommended BENADRYL due to likely allergic reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine on 7/20/16 came in 7/22/16 with redness, swelling and warmth at injection site.
Sex: M
Vaccine: HPV9
Symptoms: Contraindication to vaccination
Clinical narrative: Information has been received from a physician, via a company representative, concerning to a male patient of unknown age. Medical history, concurred conditions and concomitant therapies were not provided. On separate unknown dates the unspecified patient was vaccinated with the first two doses of GARDASIL 9. Route, concentration, dosage and lot number were not reported. The physician reported that on an unknown date, following the administration of the first two doses of GARDASIL 9, the patient started therapy with HUMIRA for an unknown reason. Physician did not provide any additional information. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a 32 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU, (route, dose, lot # and expiration date were not provided). On an unknown date, after ZOSTAVAX administration, the patient experienced severe arm swelling at the injection site. The patient was evaluated at an unspecified emergency room on an unspecified date. At the reporting time, the outcome of the event was unknown. The causality was not provided. Additional information has been requested.