chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored VAQTA (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On an unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored ROTATEQ (dose, lot# and expiration date were not reported) orally. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager via a company representative referring to an about 9 or 10 year old female patient. There was no concomitant medication for the patient. The patient's medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with VARIVAX (strength, doses, lot#, expiration date and route were not reported) as chicken pox vaccine. In approximately 2012 (reported as around "9 or 10 years of age"), the patient developed shingles. The patient sought medical attention and treatment was given to the adverse event. The patient was recovered from shingles on an unknown date. The relatedness between shingles and VARIVAX was not reported. Additional information has been requested.
Age: 1.38
Sex: F
Vaccine: DTPPHIB, MMRV, PNC13
Symptoms: Swelling
Clinical narrative: Raised area on the left side of abdomen.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Muscle pain, spasm. tingling in arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 09 December 2015. This case involves a 67-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, were not reported) intramuscularly in left deltoid on 04 November 2015. Illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 04 November 2015, same day following the vaccination, the patient had developed stiffness and soreness in the arm. It was reported that symptoms were improving, but still present. No lab investigations were done and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Diet refusal, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 14 December 2015. Manufacturing report number: 2016SA098885. This case involves a female patient who was vaccinated with a dose of FLUZONE HD (injection) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on 29 September on an unspecified year. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient's arm got too much of pain and the patient was not able to move them without hurting, she is sick of her stomach, more tired, does not want to eat and added that there are so many other side effects which patient could not describe. It was reported that consumer wanted to get some information about a flu shot that she received and for how long side effects last. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 09 December 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, manufacturer: unknown, expiry date, dose, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced pain in shoulder. It was reported that, the patient refuses to receive another flu vaccination ever again. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event (event lasted for a month). List of documents held by sender: none.
Age: 69.0
Sex: U
Vaccine: FLUX
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 7 March 2016. Manufacture number: 2016120074 This case involves a 69-year-old patient (gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose number, route and site of administration were not reported.) on an unspecified date. Patient's medical history and concomitant medication was not reported. On an unspecified date post vaccination, the patient woke up very congested early in the morning and the phlegm was very thick. Lab data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Erythema, Pain in extremity, Urticaria
Clinical narrative: Patient was brought in by mom and stated that his arm was hurting. Patient's left & right arm had a red wheal. Patient was not feverish and mom stated he had not been feverish. Mom stated patient did not have any other symptoms other than his arm hurting and the redness.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left lower arm now has a warm, red bump where injection was administered, per mom. Patient was given Ibuprofen by mom for pain and swelling.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Vomiting
Clinical narrative: Fever, Vomiting, Red rash all over body lasting 3 days.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red rash and swelling around injection site.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt complaining of left arm swollen and red, warm to touch x1 day.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Rash resembling mild case of chickenpox. 8-10 red dots on face, trunk and legs. No fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 08-JUL-2016 from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history and concomitant medications are unknown. On an unknown date the patient was vaccinated with VARIVAX lot # L034368, expiration date 08-SEP-2017 which was improperly stored for the indication. The temperature was reported as 43 degrees Fahrenheit for 5 days (120 hours). There was no previous temperature excursion. The call was due to a "data logger." No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot# M004889, expiration date 25-JUL-2016, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the highest temperature of -11.4 Celsius degree for cumulative 4 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # M021124 with expiration date 02-FEB-2018, strength 25/0.5 (unit not provided), lot# M022531 with expiration date 23-FEB-2018, dose and route were not reported). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hour and 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cyanosis, Electrocardiogram normal, Electroencephalogram, Full blood count normal, Musculoskeletal stiffness
Clinical narrative: Turned dusky/blue twice within one week of receiving immunizations. Self resolved. Concern for possible seizure. Jul 29 2016 11:19AM At daycare, playing in saucer at daycare, went stiff at daycare. Face turned purple in color. Unresponsive, came out of it rather quickly. White face after that. First time this had ever had happened. NO food or drink when this happened. NO fevers or other signs of illness. Did have shots on Tuesday. No history in the family of seizures or heart rhythm issues. Sent to PCH for EEG, EKG, and CBC/ferritin. Preliminary EKG is normal and has normal CBC. Called and talked with mom about results. Will follow-up next week once results are back. Jul 29 2016 9:52AM Mom called in today said daycare said he had a possible seizure yesterday. Please call and see if wants to do follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Serum ferritin, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Turned dusky/blue twice within one week of receiving immunizations. Self resolved. Concern for possible seizure. Jul 29 2016 11:19AM At daycare, playing in saucer at daycare, went stiff at daycare. Face turned purple in color. Unresponsive, came out of it rather quickly. White face after that. First time this had ever had happened. NO food or drink when this happened. NO fevers or other signs of illness. Did have shots on Tuesday. No history in the family of seizures or heart rhythm issues. Sent to PCH for EEG, EKG, and CBC/ferritin. Preliminary EKG is normal and has normal CBC. Called and talked with mom about results. Will follow-up next week once results are back. Jul 29 2016 9:52AM Mom called in today said daycare said he had a possible seizure yesterday. Please call and see if wants to do follow up.
Age: 74.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Feeling abnormal
Clinical narrative: Initial unsolicited report received from a consumer via other company(pfizer) on 25 November 2015. This case involves a 74-years-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza vaccine)(batch number, route and site of administration, dose, dose in series were not reported) and also received a dose of PREVNAR 13 (batch number ,route and site of administration, dose, dose in series were not reported) on 3 November 2015. The patient hadn't had flu shot within last twenty years. The patient's medical history was reported as underactive thyroid. The patient's concomitant medication includes Thyroxine (75 mcg one a day) for Underactive thyroid. On 4 November 2015, one day following the vaccination, the patient felt lousy for 2-3 weeks. The patient's laboratory data and corrective treatment were not reported. The patient was recovering from the event ans was still lousy. List of documents held by sender: none. Follow up received from consumer on 24 December 2015. It was reported that the patient was recovered from the event without medical intervention.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 29-Jul-2016. This case involves a female (age not reported) patient who was vaccinated with a dose of DTaP vaccine (Lot number C4709AA, expiry date, dose and route of administration were not reported) in left leg, IPV (Lot number M1453, expiry date, dose and route of administration were not reported) in right leg, MMR (manufacturer Merck, Lot number M002418, expiry date, dose and route of administration were not reported) on left leg, and Varicella (manufacturer Merck, Lot number M002062, expiry date, dose and route of administration were not reported) on right leg on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, the patient developed fever. It was reported that one day later, the fever was 103.5 - 104.7 degree Fahrenheit. Other Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Numbness and difficulty moving legs from toes to thighs.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Hypoaesthesia, Pain in extremity, Paralysis
Clinical narrative: Numbness and difficulty moving legs from toes to thighs.
Age: 60.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt reports itching, red spots.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states she has redness/soreness/tenderness and warmth at the injection site since the day of the vaccine. It is now 6 days later and she reports the same symptoms. On 8/7/16 the patient reports having red spots develop and pain that woke her up in the night.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient developed cellulitis as diagnosed by her physician. Her physician believes it was from the PREVNAR 13 injection on 7/27/16. The redness is receding, but not completely yet (as of 8-8-16).
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient presented to health dept on 07/25/16 to receive immunizations. Hep A, Gardasil 9, and Bexsero administered. Patient calls in to health dept today, 08/08/16, c/o pain at injection site in right arm and generalized body aches. Patient denies c/o fever and denies c/o swelling or redness at injection site. She reports pain primarily at injection site at right arm and reports has been present since vaccination. Patient reports no ROM limitations. Called VFC on-call nurse, who advises pain at injection site can be common may take time to resolve. Also advises generalized body aches may or may not be related to vaccination. Patient called and reassured pain at injection site not uncommon and should resolve over time. Advised generalized body aches may or may not be related to vaccination. Advised to call our office back with any other questions or concerns or if would develop other sxs.  Patient voiced understanding.
Sex: F
Vaccine: DTAP, HEPA, TYP
Symptoms: Insomnia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Information has been received on 08-JUL-2016 from a registered nurse referring to a 61 year old female patient with allergy to iodine  crystals and nuts. On 24-JUN-2016 the patient was vaccinated with VAQTA lot # L009445,expiration 01-JUN-2017 intramuscular in the left deltoid for travel. Other suspect therapies included DIPTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (unspecified) (+) TE). Lot # 7RJ98 expiration 18-NOV-2018, intramuscular in the right deltoid administered on 24-JUN-2016. Concomitant therapies included VIVOTIF BERNA, Alprazolam, which was ordered on 20-JUN-2016 and unspecified as to which date it was administered, bupropion hydrochloride, estradiol, trazodone hydrochloride and vitamin D (unspecified). The patient reported that initially her arm (not specified which arm) did not hurt but progressively became more painful until she was not able to use her arm. The nurse reported the patient stated that her arm kept her up night after night but seemed to be improving on an unspecified date. On 04-JUL-2016 the patient sought treatment at an unspecified walk in clinic and was prescribed NAPROSYN 500 mg as needed to arm pain by an unknown healthcare provider. This is one of two reports by the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 60 years old male patient. The patient had no pertinent medical history, concurrent conditions and drug allergies. On 12-JUL-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU injection, 0.65 ml, subcutaneously, lot # L046893, expiration date 28-FEB-2017. The patient had no concomitant therapies. In approximately July 2016 (reported as "within 1 week of receiving vaccine"), the patient developed an "active case of shingles" (herpes zoster) and sought medical attention. The patient was prescribed a treatment of "VALTREX 1 gram three times per day for 1 week and an unspecified dosage of Gabapentin". No laboratory diagnostics were performed and no product quality complaint was involved. The outcome of herpes zoster and the causal relationship between herpes zoster and ZOSTAVAX were unknown. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9, intramuscularly (strength, site of administration, lot # and expiry date were not reported). On an unknown date, the patient experienced a strange feeling, like being out of it after the vaccination which lasted approximately 48 hours. The outcome of the event was reported by the physician as recovered. It was also reported that therapy was not discontinued and the event did not reappear after reintroduction. The relatedness between the event of the strange feeling, like being out of it and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot# reported as M007762, expiration date 07-FEB-2018, strength, dose and route were not expected). There was no previous temperature excursion. Digital data logger involved. The vaccine had been stored under the lowest temperature of 0.8 Celsius degree for cumulative 2 hours 41 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Patient reported on 8/02 that she had a fever since getting the vaccine. She states she is feeling better now, but she had a temperature of 102. Patient also had pain on her right side from her shoulder down to her right leg.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Swelling and redness and a hard bump on the arm that has persisted for 1 week. No fever.
Age: 5.0
Sex: F
Vaccine: DTOX
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: PATEINT WAS GIVEN DTAP IMMUNIZATION AT PUBLIC HEALTH DEPT 08/04/2016, PATIENT CAME INTO PCP OFFICE 08/06/2016 FOR TREATMENT OF CELLULITIS AND INFLAMMATION TO INJECTION AREA.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Injection site reaction, Myalgia, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse, via company rep[representative, refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The patient received their first dose of GARDASIL 9 on 19-JUL-2015 (reported as "07/19 last year") and the second dose of GARDASIL 9 on 21-JUL-2016 (doses, lot# and routes were not reported). On an unspecified time after receiving the second dose of vaccine, approximately in July 2016, the patient developed muscle pain in both legs, "high fever", and an unspecified injection site reaction. The outcome of the events was not reported. The relatedness between vaccination of GARDASIL 9 and muscle pain in both legs, "high fever", and an unspecified injection site reaction was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report concerning an unknown number of patients of an unknown gender and age was received from a medical assistance. The patient's concurrent conditions and medical history were not provided. On an unknown date, an unknown number of patients were vaccinated with ROTATEQ lot # L035636, expiration date 21-MAY-2017, besides, 15 patients were vaccinated with the same vaccine lot # L003694, expiration date 16-JUN-2017; both vaccines by oral route. It was reported that both lots of ROTATEQ were improperly stored before being administered to the patients. There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 08-JUL-2016 from a registered nurse. The nurse reported that an unspecified number of patients were vaccinated with PROQUAD lot # L042817 expiration date 26-APR-2017 or VARIVAX lot # L034367 expiration date 08-SEP-2017 that were improperly stored. The nurse reported the first temperature excursion occurred on 09-JUN-2016. Doses of the improperly stored vaccines were administered between 09-JUN-2016 and 08-JUL-2016. On 09-JUN-2016 the storage temperature was -10.7 degrees Celsius for hours. On 30-JUN-2016 the storage temperature was -12.5 degrees Celsius for 16 hours and 59 minutes. The storage temperature was -6.0 degrees Celsius for 24 hours at the time of the report. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a License Practitional Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reaction/allergies were not provided. On 28-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ Lot # K022993 with expiration date: 20-JUL-2016, (route of administration, strength and dose were not reported). Concomitant medication was not reported. No adverse effects were reported. No Product Quality Complain (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Gait disturbance, Headache
Clinical narrative: This spontaneous report was received from a 57 years old male patient, reporting on himself. The patient had no pertinent medical history or drug allergies/reactions. Concurrent conditions and concomitant therapies were not reported. On 26-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 Intramuscular, and ZOSTAVAX intramuscular. Dose, dose number, lot number, expiration date and anatomical location for both vaccines were not provided. The patient stated that "the pharmacist informed him that there was no problem with getting both vaccines together and that the information in the prescribing information concerning drug interactions had been changed". The patient upon the suggestion of the pharmacist received both injection, and the next day began to experience a fever of 100.4 (no units provided), body and joint aches from his ankles up to his neck. The patient also experienced swollen glands under his arm pits, sore and red testicles, headaches, tiredness, and difficulty walking due to the joint aches. On 28-JUL-2016, the patient saw his physician, who prescribed TYLENOL for the pain. The patient stated that although it was "somewhat better" he was still experiencing the symptoms and therefore the outcome of the events was reported as recovering. At the time of reporting the causality assessment between the events and the suspect therapies was not reported. There was not a product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Lymphadenopathy, Pain, Pyrexia, Testicular pain
Clinical narrative: This spontaneous report was received from a 57 years old male patient, reporting on himself. The patient had no pertinent medical history or drug allergies/reactions. Concurrent conditions and concomitant therapies were not reported. On 26-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 Intramuscular, and ZOSTAVAX intramuscular. Dose, dose number, lot number, expiration date and anatomical location for both vaccines were not provided. The patient stated that "the pharmacist informed him that there was no problem with getting both vaccines together and that the information in the prescribing information concerning drug interactions had been changed". The patient upon the suggestion of the pharmacist received both injection, and the next day began to experience a fever of 100.4 (no units provided), body and joint aches from his ankles up to his neck. The patient also experienced swollen glands under his arm pits, sore and red testicles, headaches, tiredness, and difficulty walking due to the joint aches. On 28-JUL-2016, the patient saw his physician, who prescribed TYLENOL for the pain. The patient stated that although it was "somewhat better" he was still experiencing the symptoms and therefore the outcome of the events was reported as recovering. At the time of reporting the causality assessment between the events and the suspect therapies was not reported. There was not a product quality complaint involved. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Gait disturbance, Insomnia, Malaise, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 25-Nov-2015. Manufacturer control number: 2015406514. This case involves a 94-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (Batch number: unknown) and PREVNAR13 (manufacturer: Pfizer, batch number: unknown) (dose, dose in series, route of administration were not reported for both vaccines) both in left arm on 21-Oct-2015 in the morning at 11:00 A.M. Patient had no illness at the time of vaccination and had medical history of chronic bronchitis, thyroid disorder and blood pressure. Patient had received Levoxyl (once a day) for thyroid, unspecified drug (once a day) for stomach and unspecified drug (low dose once a day) for blood pressure as concomitant medications. On 21-Oct-2015, few hours after vaccination, the patient experienced sickness, weakness, she could could hardly sleep and her arm was sore. On an unspecified date patient experienced difficulty in walking (when sitting could hardly get up and go). It was reported that patient had received flu shots, pneumonia shots and the shingles shot before and never had any bad reactions in the past. No laboratory investigations were performed and corrective treatment was not reported. On an unspecified date, patient recovered from the event of arm sore (duration: few days). At the time of this report patient had not recovered from events of sickness, weakness and difficulty in walking (when sitting can hardly get up and go) and the outcome of the event could hardly sleep was unknown. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal X-ray, Abdominal pain upper, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 17-year-old female patient who received BEXSERO. On 21st July 2016, the patient received the 1st dose of BEXSERO. On 28th July 2016, 7 days after receiving BEXSERO, the patient experienced stomach pain (serious criteria other: serious as per reporter). On an unknown date, the outcome of the stomach pain was recovering/resolving. The reporter considered the stomach pain to be possibly related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received the vaccine in her arm. The patient experienced extreme knife stabbing stomach pain after receiving BEXSERO. On 29th July 2016, the patient visited a doctor who ordered abdominal x-ray test. The results of abdominal x-ray was not provided.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eyelid oedema, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a physician on 30 November 2015. This case involves a 63-years-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI496AB, expiry date: 30 June 2016, dose, dose in series were not reported and site of administration was unknown) intramuscularly on 23 October 2015. The patient's illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergic to penicillin (PCN), Erythromycin, Percocet and had hypertension (HTN), Gastro esophageal reflux disorder (GERD). Concomitant medications were not reported. On 24 October 2015, one day following the vaccination, the patient had developed occular hyperemia with bloodshot eyes, tearing, drainage and swelling around the eyes with a sore throat. The patient had previously received many doses of FLUZONE QIV. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The patient had not recovered from all the events. List of documents held by sender: none. Follow-up information received from a physician on 21 January 2016. It was reported that the patient received 0.5 ml dose of FLUZONE QIV in left deltoid.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Peripheral swelling, Skin exfoliation, Urticaria
Clinical narrative: Initial unsolicited report received from pharmacist on 01 December 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number: U5022BA, expiry date: 29 April 2015, dose, dose in series, were not reported) on 29 November 2014. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination the patient had developed swollen arm, hot to touch at injection site, skin peeled at injection site like a sunburn and broke out in hives all over her body. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 30 year old female patient. None pertinent medical history, concomitant medications and drug reactions/allergies were reported. On unknown dates (reported as as a child), the patient was vaccinated with the first and the second dose of M-M-R II (dose, route, lot # and expiration date were not reported). The patient was unable to obtain her immunization record, so titers were drawn on 08-JUL-2016, and it showed that the patient was negative for immunity to mumps. As a result, the patient was administered the third dose of M-M-R II (lot L049314, albumin status rHA; dose, route and expiration date were not reported) on 21-JUL-2016. Titers have not been rechecked at the time of this report. It was also provided that the patient received an unspecified treatment of the adverse event. The outcome of the adverse event was unknown. The relatedness between the adverse event and M-M-R II was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, the mother of a 17 year old female. Medical history and concomitant medications were not specified. On 15-JUL-2016, the female received a fifth dose of GARDASIL intramuscularly. It was uncertain whether the vaccine was GARDASIL or GARDASIL 9. It was unspecified when the female received the other four vaccinations. No adverse effect was reported. Additional information is not expected as the mother refused to provided contact information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates starting on or after 09-JUN-2016, the patients were administered doses of improperly stored M-M-R II injection (lot#L028273, expired on 28-JUL-2017; lot#L037356, expired on 28-SEP-2017; lot#L035674, expired on 17-SEP-2017 (dose and route unknown). The vaccines were exposed under 11.1 Celsius degree for 4 hours 25 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from an unspecified reporter (working in a physician's office) via a company representative concerning a female patient of unknown age. There was no known medical history. It was unknown whether the patient had any drug reactions or allergies. The reporter stated that in 2013 and 2014, the patient was vaccinated with GARDASIL (dose, route of administration and lot number not reported). It was reported that on an unknown date, the patient started to experience seizures. The patient "was doing fine" before GARDASIL administration. It was reported that the patient sought medical attention (unspecified). The outcome of seizures was unknown. The relationship between vaccination with GARDASIL and the event was not provided. Upon internal review, the seizures were considered medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a field employee concerning an 11 year old female. Medical history and concomitant medications were unknown. On an unspecified date, the female received her first dose of GARDASIL 9. The physician mentioned that the female fainted after the first vaccination. The outcome of the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to two patients of an unknown gender and age. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (strength and route were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to six patients (ages and genders not specified). The patient's concurrent conditions, medical histories and concomitant medication use were not provided. On an unspecified date one patient was vaccinated with M-M-R II, (lot # unknown, expiration date 25-MAY-2016). The nurse reported that this patient was vaccinated with an expired dose of M-M-R II. No adverse effect was reported. The nurse also reported that on 02-JUN-2016 three patients were vaccinated with expired doses of PROQUAD (lot # K023861, expiration date 25-MAY-2016). A fourth patient was vaccinated with an expired dose of PROQUAD (lot #K023861, expiration date 25-MAY-2016) on 14-JUN-2016 and a fifth patient was vaccinated with expired dose of PROQUAD (lot #K023861, expiration date 25-MAY-2016) on 30-JUN-2016. No adverse effects were reported. The outcome of the expired products administered was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse refers to a 20-year-old patient of unknown age. No concurrent conditions or medical history were provided. On 28-JUL-2016, the patient was vaccinated with a pediatric 0.5 ml dose of VAQTA subcutaneously (strength, lot# and expiry date were unspecified). No concomitant medications were reported. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram, Fall, Fatigue, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Ascending paralysis that began with foot drop, severe fatigue, frequent falls, that lasted one month and is still causing falls and paralysis. He received inpatient IVIG treatment and PT/OT.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Peroneal nerve palsy
Clinical narrative: Ascending paralysis that began with foot drop, severe fatigue, frequent falls, that lasted one month and is still causing falls and paralysis. He received inpatient IVIG treatment and PT/OT.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Presyncope, Syncope
Clinical narrative: Syncopal episode consistent with vasovagal, immediately upon administration of HPV-9, which was shortly after administration in contralateral arm of TDaP. Prompt recovery. Then received MCV4.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: High fever which did not immediately respond to acetaminophen or ibuprofen. Chills, aches, and severe fatigue. Severe pain in arm at injection site; inability to move arm. At 36 hours after vaccine, dime-sized welt appeared two inches below injection site. At 48 hours, welt increased to size of an orange. At 72 hours, welt increased to size of a grapefruit.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: High fever which did not immediately respond to acetaminophen or ibuprofen. Chills, aches, and severe fatigue. Severe pain in arm at injection site; inability to move arm. At 36 hours after vaccine, dime-sized welt appeared two inches below injection site. At 48 hours, welt increased to size of an orange. At 72 hours, welt increased to size of a grapefruit.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Overdose
Clinical narrative: No adverse event reported with the patient. Patient received two ZOSTAVAX shots. 1 shot on 7-18-16 and 1 shot on 7-31-16.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported with the patient. Patient received two ZOSTAVAX shots. 1 shot on 7-18-16 and 1 shot on 7-31-16.
Age: 12.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swelling, redness, and warmth, and discomfort. Area measured 3 1/2 x 4 1/2 inch in diameter. Recommended to use ice pack x 20 minutes every hour, and ibuprofen for relief of discomfort and swelling. The area was improving, and not getting worse as reported by guardian.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test, Chest pain, Computerised tomogram, Dysphonia, Urticaria
Clinical narrative: Chest Pain (08/02/16); hives (08/03/16) ongoing; hoarseness (on 08/04/2016)-ongoing.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: X-ray
Clinical narrative: Chest Pain (08/02/16); hives (08/03/16) ongoing; hoarseness (on 08/04/2016)-ongoing.
Age: 68.0
Sex: M
Vaccine: HEPAB, PNC13, VARZOS
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Patient reported today (08/08/2016) that about 48-72 hours following his vaccine administration on 07/28/2016 that he had onset of 4-5/10 level back pain to the area of prior back surgeries. He described this pain as musculoskeletal in nature and that it radiated to the immediate area but with no neuropathic pain. He states that this pain has now almost completely resolved (now more than 1 week later). He has had an event like this previously with a flare of back pain, but it was caused by a fall and injury and this time he had no such injury. He is not sure if this is related to the vaccines he received or not.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Pt reports extreme dizziness with a rapid onset starting about 45 minutes after receiving vaccination. She states the dizziness lasted the rest of the day. She also complains of diarrhea the day after receiving vaccine.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Wife came into pharmacy and said his arm "knotted up" she described it as a edema like area than ran from his shoulder and down his arm.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Application site vesicles, Erythema, Pyrexia, Rash erythematous, Skin lesion
Clinical narrative: Fever started on morning of 08/06/2016, then mother noticed red rash/spots that started developing morning of 08/07/2016. Swelling and redness got worse as day went on. Came to physician's office today. Redness, swelling with bullae at the site of injection as well as scattered isolated popular lesions with surrounding erythema.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Swelling
Clinical narrative: Fever started on morning of 08/06/2016, then mother noticed red rash/spots that started developing morning of 08/07/2016. Swelling and redness got worse as day went on. Came to physician's office today. Redness, swelling with bullae at the site of injection as well as scattered isolated popular lesions with surrounding erythema.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: Extreme Fatigue.
Age: 1.69
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Injection site swelling, Pyrexia, Vaccination complication
Clinical narrative: Mom, called 8-5-16 at approx. 11am to report that her daughter,  was experiencing a reaction to the vaccines she received two (2) days ago.  Our records indicate that she obtained the HAVRIX and INFANRIX in her (R) vastus lateralis.  Mom reports that the (R) leg is twice its normal size, that there is a rash around the thigh and her fever last night was 101.8.  She has given Benadryl and Tylenol for treatment.  Reports temperature of 101.4 this am.  Employee states that she contacted her pediatrician, but no appointment was available and  was advised by her MD to go to Urgent Care or the ER.  She states she went to Urgent Care and was told that they would be unable to treat patient for the reaction and that she should come back to the Health Dept. for treatment.  Discussed situation with the mom and it was decided that she would go to Medical Center ER for further evaluation.  I spoke with mom at 2:00 pm the afternoon of 8/5/16 and she states that she was treated and advised if no improvement she was to go straight to a pediatric hospital in case it was infected.  Gave mom my cell number to contact me over the weekend if she needed to do so.  Spoke with mom 8-8-2016 at 10:50 am and mom reports that she is doing much better.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Extreme soreness, redness, swelling moving over a large portion of my upper arm. Using ice packs and taking BENADRYL.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Myalgia, Neuropathy peripheral, Pyrexia, Skin burning sensation
Clinical narrative: Patient presented to office today (08/08/2016) to report that she had an adverse reaction to her vaccine. She states that starting approximately 48 hours following her vaccine that she had fever (103 degrees F) with muscle/joint aches and neuropathy (burning pain to her skin) to her extremities and trunk. She describes the pain as severe enough to take ibuprofen for this consistently. The fever resolved within a day. The neuropathy to her extremities has also resolved and the muscle/joint aches are lessening. Her neuropathy to her trunk continues but is slowly improving.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Vaccination complication
Clinical narrative: Patient presented to office today (08/08/2016) to report that she had an adverse reaction to her vaccine. She states that starting approximately 48 hours following her vaccine that she had fever (103 degrees F) with muscle/joint aches and neuropathy (burning pain to her skin) to her extremities and trunk. She describes the pain as severe enough to take ibuprofen for this consistently. The fever resolved within a day. The neuropathy to her extremities has also resolved and the muscle/joint aches are lessening. Her neuropathy to her trunk continues but is slowly improving.
Age: 55.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: ITCH, RED, SWELLING PER PATIENT.