chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA006632.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006632:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer, the patient's son and refers to a 79-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2013, 4 years ago, the patient was vaccinated with ZOSTAVAX (dose, frequency, rout eof administration, lot# and expiration date were not reported) for prevention from shingles. On an unknown date, approximately in November 2017, reported as 3 weeks ago, the patient experienced a severe case of shingles. The outcome of herpes zoster was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (parent of the patient) for a patient enrolled in a Pfizer-sponsored program; this report regards events related to a product that is not involved in the program. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness afterward on an unspecified date with outcome of unknown. The next day she developed rash on her arm and on her face specifically the chin area where there was redness with outcome of unknown.  The reporter did not see this as being a side effect. Was it and if so would an OTC product be useful. Information on lot number has been requested.
Sex: F
Vaccine: PNC
Symptoms: Drug hypersensitivity, Iodine allergy
Clinical narrative: This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to an event reported in the patient's past medical history. A currently 66-year-old female patient of an unspecified ethnicity started to receive codeine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), PREVNAR (Lot number unknown), formaldehyde solution, lanolin, PLAQUENIL, via an unspecified route of administration from an unspecified date at an unspecified dose for unspecified indication. Medical history included latex allergy, shellfish allergy and nickel sutures allergy from unknown dates. The patient's concomitant medications were not reported. The patient experienced allergies to codeine, formaldehyde, ibuprofen, iodine, lanolin, PREVNAR, PLAQUENIL on an unspecified date. The action taken in response to the event for all the drugs were unknown. The outcome of allergies to codeine, formaldehyde, ibuprofen, iodine, lanolin, PREVNAR, PLAQUENIL was unknown. Pfizer is Marketing Authorization Holder of codeine and ibuprofen in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of codeine and ibuprofen has submitted the same report to the regulatory authority. The batch/lot number for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for two patients. This is the second of two reports. An infant patient of an unspecified age (below 2 year-old), race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization. The patient was fully vaccinated (unspecified number of vaccine doses). The patient medical history and concomitant medications were not reported. No underlying health conditions were present. The patient experienced recurrent pneumonia on an unspecified date. When antibody titers were tested , 6-7 of titers were below normal. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Linked Report(s): US-PFIZER INC-2017514614 same reporter/suspect product/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. An elderly female patient of an unspecified ethnicity received PREVNAR 13 (Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The elderly female patient had a very small body frame, with very little muscle mass on the upper deltoid injection site. The pharmacist was unable to get the patient to relax the small amount of deltoid muscle. The patient called back to the retail pharmacy that she was still experiencing pain at the injection site a week after the injection. The pharmacist advised the patient that she should follow up with her primary care doctor. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pain, Headache, Lethargy, Musculoskeletal stiffness, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 31 Oct 2017 and additional information received on the same date. This case involves a 43-year-old female patient who was vaccinated with 0.5 ml one dose of ADACEL (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 27 Oct 2017. The patient had allergies to sulfa (rash) and codeine (Nausea). Other medical history was not reported. Concomitant medications were not reported. (It was reported as Unknown if other vaccines were given at the time). On an unknown date, within few hours after the vaccination, patient developed severe headache, nausea, stiffness in neck and lethargy. On 31 Oct 2017 at midnight, four days after the vaccination (also reported as 3 days later), patient had a pounding headache, pain in her left eye, and she fainted at work, due to which the patient was brought to ER room and on an unknown date, the patient was hospitalized. Patient lab tests include an elevated ESR (erythrocyte sedimentation rate) level of 25. Corrective treatment was not reported. Outcome of all the events were unknown and details about hospitalization was not provided. It was reported as the patient treating MD determined patient reactions was related to receiving vaccine ADACEL. List of documents held by sender: none. Sender's Comments: Patient developed severe headache, nausea, stiffness in neck, lethargy and syncope after vaccination with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset was compatible. Patient's medical history was reported as allergy to sulfa and codeine but tolerance to previous vaccination was not provided. The events could be due to an underlying etiology that is unrelated to vaccination. Patient's medical condition at the time of vaccination should be assessed and all alternate infectious and non-infectious etiologies should be ruled out. Based upon reported information the role of the vaccine cannot be assessed.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate increased, Syncope
Clinical narrative: Initial unsolicited report received from a nurse on 31 Oct 2017 and additional information received on the same date. This case involves a 43-year-old female patient who was vaccinated with 0.5 ml one dose of ADACEL (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 27 Oct 2017. The patient had allergies to sulfa (rash) and codeine (Nausea). Other medical history was not reported. Concomitant medications were not reported. (It was reported as Unknown if other vaccines were given at the time). On an unknown date, within few hours after the vaccination, patient developed severe headache, nausea, stiffness in neck and lethargy. On 31 Oct 2017 at midnight, four days after the vaccination (also reported as 3 days later), patient had a pounding headache, pain in her left eye, and she fainted at work, due to which the patient was brought to ER room and on an unknown date, the patient was hospitalized. Patient lab tests include an elevated ESR (erythrocyte sedimentation rate) level of 25. Corrective treatment was not reported. Outcome of all the events were unknown and details about hospitalization was not provided. It was reported as the patient treating MD determined patient reactions was related to receiving vaccine ADACEL. List of documents held by sender: none. Sender's Comments: Patient developed severe headache, nausea, stiffness in neck, lethargy and syncope after vaccination with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset was compatible. Patient's medical history was reported as allergy to sulfa and codeine but tolerance to previous vaccination was not provided. The events could be due to an underlying etiology that is unrelated to vaccination. Patient's medical condition at the time of vaccination should be assessed and all alternate infectious and non-infectious etiologies should be ruled out. Based upon reported information the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Pain & swelling in her arm, also per husband appears to be a knot, she is going to dr today.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pain and weakness front of the shoulder from bicep to deltoid. Also is experiencing tingling that radiates to the wrist. The pain is waking the patient up at night.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Induration, Mass
Clinical narrative: Hard quarter sized lump reported 2 weeks after imm. Area is improving.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Oropharyngeal pain, Poor quality sleep, Swelling face
Clinical narrative: Sore throat and cough about four hours after. Slept poorly. Facial swelling next morning. Took a BENADRYL and felt much better in about a half hour.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Lymph nodes swelling and left neck pain.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, heat and swelling in left arm developed on Saturday, following shots given on Thursday.  Patient went to emergency room to have it checked Saturday morning, but reported no side effect present on Friday. Dr gave him Cephalexin 500mg QID for 7 days to treat symptoms.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Feeling cold, Headache
Clinical narrative: Abdominal pain, diarrhea, nausea, headache, sweats, freezing, no appetite.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Abdominal pain, diarrhea, nausea, headache, sweats, freezing, no appetite.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Feeling hot, Throat irritation
Clinical narrative: Patient says he was feeling well until received vaccine. He complained of feeling heated all over and burning throat that moved to his chest. Patient advised to see MD. Patient was examined by MD and was given MEDROL and benzonatate. Patient says MD did not confirm if this reaction was due to vaccine or not.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder regional pain.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Oral mucosal eruption
Clinical narrative: Patient developed bumps/rash around her mouth soon after leaving the provider's office (~30-40 minutes after vaccine administration). No other reported symptoms. She was asked to return for assessment. Given diphenhydramine 25mg IM. Symptoms completely resolved later the same day. Of note, patient receive influenza vaccination in 11/2019 with no complication (FLUZONE QUAD).
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Blood culture negative, Blood test, Electrocardiogram normal, Epidural blood patch, Hallucination
Clinical narrative: Mom states that patient woke up the next morning with fever, hallucinations. Mom took patient to hospital and the patient was hospitalized for 6 days. They did EKG, spinal tap, blood work and mom thought she was given HPV9, but it was FLULAVAL and BEXSERO that was given. Everything was normal and they feel it was a possible reaction to the vaccine, but it was not confirmed.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Lumbar puncture, Pyrexia
Clinical narrative: Mom states that patient woke up the next morning with fever, hallucinations. Mom took patient to hospital and the patient was hospitalized for 6 days. They did EKG, spinal tap, blood work and mom thought she was given HPV9, but it was FLULAVAL and BEXSERO that was given. Everything was normal and they feel it was a possible reaction to the vaccine, but it was not confirmed.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Bone pain, Dizziness, Erythema, Injection site warmth, Malaise
Clinical narrative: Patient says that he has not felt well since vaccine. Patient states that he felt heat at the injection site after receiving vaccine. Patient's face turned red and he felt dizzy. He also complained of bone pain. Patient is still feeling bad at this time.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Skin warm, Swelling
Clinical narrative: Pt complains of redness, swelling, and hotness of the arm, flu-like symptoms starting less than 24 hours after injection.
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain, Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 concomitantly with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines above described). No adverse effects were reported. Follow up information was received from a pharmacist on 04-NOV-2017. The patient was a male. He did not receive any other vaccinations within 4 weeks prior this vaccination, he had no illness at time of vaccination, no pre-existing physician diagnosed allergies, no birth defects, and no other medical conditions. On an unspecified dates, the patient experienced: arm swelled up due to pneumonia shot, rash and pain. The patient went to emergency room and was prescribed unspecified treatment for the events. Subsequently, on an unspecified date, the patient recovered.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-OCT-2017, the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, therapy type lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was also vaccinated with the first dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). 27 days later on 02-NOV-2017, the patient was vaccinated with her second doses of M-M-R II and VARIVAX. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who referred to a currently 23-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2010 (reported as when the patient was 16-year-old), the patient was vaccinated with a first dose of GARDASIL 9 (lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2017, the patient returned to the physician's office for the second dose of GARDASIL 9. No adverse effect was reported.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Patient was given the PNEUMOVAX 23 vaccine and experienced significant arm swelling, head pain, chills, and fever.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Patient received her PREVNAR 23 vaccine and developed cellulitis on the arm that the vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate reddening at injection site (post inoculation) that had spread to include entire (L) upper arm with reddening coursing past elbow at this point (12/03). This is 4 days post injection and steroids have been ordered as well as antibiotics for possible infection.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection administered via Subcutaneous on back on left arm. Red spot about the size of a baseball developed around site, the night the injection was administered. By the next day, redness, swelling, and itching down to the elbow occurred. The spot the size of the baseball has now turned purple. This lasted approximately a week. The injection was administered on 11-16-17 and today 12-04-17, the bruise is still present on the back of my arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood immunoglobulin G, Blood test abnormal, Diplopia, Electromyogram
Clinical narrative: Came down with double vision, poor balance and sensory symptoms. Diagnosed with Miller Fisher Syndrome, a subset of Guillain-Barre.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Miller Fisher syndrome, Sensory disturbance
Clinical narrative: Came down with double vision, poor balance and sensory symptoms. Diagnosed with Miller Fisher Syndrome, a subset of Guillain-Barre.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain
Clinical narrative: Patient developed increase right upper arm pain and redness surrounding injection site, started afternoon of Nov 29 2017. Pt denies right axillary involvement. Place on antibiotic doxycycline, patient states improving discomfort and redness diminishing as of morning of Nov 30 2017.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reported experienced increasing pain at L shoulder which started on or around Tues 10/17/17 in the AM. He had a flu shot at on 10/16/17. Starting on 10/17/17 he experienced L shoulder pain. He was unsure if this was related to the flu shot initially or was due to a work related incident such as moving a wheelchair or applying a tie down on a service vehicle.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Skin warm, Tenderness, Urticaria
Clinical narrative: Firm hives, felt hot to the touch. Sometimes hives felt itchy or tender. Hives were not gone by Monday, so I went back and was told to take BENADRYL. After first dose of BENADRYL, the hive isn't as firm and doesn't feel so warm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Even though patient has epilepsy she had not suffered a seizure in 6 years prior to receiving the GARDASIL vaccine. She had a seizure the next morning after receiving the vaccine.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 72-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with one shot of  PNEUMOVAX 23 lot# N022703 and expiration date 27-FEB-2019 (route of administration was not reported). On an unknown date, after receiving PNEUMOVAX 23, the patient experienced swelling between the shoulder and arm. On an unknown date, when the swelling went down, the area began to itch. The patient did not seek medical attention. The outcome of swelling between the shoulder and arm was recovered. The outcome of itching was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age who refers to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-NOV-2017, the patient was vaccinated with dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prevention of pneumonia. On the same day, the patient experienced pain and swelling at the injection site. The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of the events was reported as recovered on an unknown date in November 2017. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from the patient's mother referring to her 12 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-AUG-2016, the patient 12 year old, almost 13, was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 27-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2017, reported as "as of the date of this report", the patient had not received the third dose in the series, which was other than indicated in the prescribing information.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient in her 70s received PREVNAR 13, intramuscular, on an unspecified date, at 0.5 ml single, for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced pain and achiness in arm and severe cellulitis both on an unspecified date. The patient went to the doctor who prescribed BACTRIM. Outcome of the events was unknown. The reporter assessed the events as medically significant and related to pneumococcal 13-val conj vac (dipht crm197 protein). The information on the lot number has been requested. Sender's Comments: Current information is limited for fully medical assessment especially lack of details on the location and nature of cellulitis, site for vaccination and the time frame between the vaccination and the onset of the events. Considering the plausible time association, the technique issue during the vacation with PREVENAR 13 might have played a contributory role in triggering the occurrence of pain and achiness in arm and severe cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2017512487 same reporter/drug/event different patients.
Sex: U
Vaccine: FLUX, PNC13, FLU4, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A 10-month-old patient of an unspecified ethnicity and gender received the third dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose; and influenza vaccine, via an unspecified route of administration on an unspecified date, both for immunization. The patient's concomitant medications were not reported. It was reported that the patient had fever the day before and the parents gave TYLENOL which caused the fever to subside. This then prompted the administration of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient previously received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient experienced skin rash on an unspecified date. Outcome of the event was unknown. Follow-up activities initiated and information on the batch number has been requested.
Sex: U
Vaccine: FLUX, PNC13, FLU4, PPV
Symptoms: Pyrexia, Rash generalised, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer. A 10-month-old patient of an unspecified ethnicity and gender received the third dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose; and influenza vaccine, via an unspecified route of administration on an unspecified date, both for immunization. The patient's concomitant medications were not reported. It was reported that the patient had fever the day before and the parents gave TYLENOL which caused the fever to subside. This then prompted the administration of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient previously received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient experienced skin rash on an unspecified date. Outcome of the event was unknown. Follow-up activities initiated and information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. An infant patient of an unspecified age (below 2 year-old), race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunisation. The patient was fully vaccinated (unspecified number of vaccine doses). The patient medical history and concomitant medications were not reported. No underlying health conditions were present. The patient experienced recurrent pneumonia on an unspecified date. When antibody titers were tested, 6-7 of titers were below normal. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Linked Report(s) : US-PFIZER INC-2017514647 same reporter/suspect product/event, different patient
Sex: F
Vaccine: FLUX, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old female patient of an unknown race/ethnicity received TRUMENBA in Nov2017 at single dose via an unspecified route of administration for immunization. On the same date the patient received MENACTRA and influenza vaccine. On the same date the patient passed out. Patient's concomitant medications, medical conditions, and investigations were unknown. The information on the lot number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine contributed to the development of the reported event "passed out".
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Local reaction, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 21-year-old Asian female patient received the first dose of TRUMENBA, (Lot number: T41409 and Expiration date: Aug2019, NDC number: 0005-0100-10), intramuscular in left arm, on 29Nov2017 15:15 at 0.5 ml, single for prevention of Meningitis Group B. The patient received the vaccine through the protocol doctor for vaccines at a pharmacy. Medical history was reported as none. The patient's concomitant medications were not reported. No other vaccines were administered. The patient experienced muscle soreness in her entire body that began the night of 29NOV2017. She had a local reaction first and took Ibuprofen. She said that it was still sore today, but it felt like she did a lot of sit ups. The outcome of the event muscle soreness was recovering and for local reaction was unknown.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A 65 years old female patient of an unspecified age and ethnicity received on the same unspecified date PREVNAR 13 at single dose and influenza vaccine both via an unspecified route of administration for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little more tired and she felt like she was becoming sick on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLU3
Symptoms: Motor dysfunction, Pain in extremity
Clinical narrative: Initial unsolicited report received from pharmacist on 06-Oct-2017. This case involves 69 year old female patient who was vaccinated with a 0.5 ml one dosage of FLUZONE HIGH-DOSE (Batch number- UI812AB, expiry date, dose in series, site not reported) intramuscularly on an unknown date. Patient had a medical history COPD and had no known drug allergy. Concomitant medications were not reported. On an unknown date, four hours following vaccination patient had pain in the right and left hand and having difficulty grasping. No report of numbness or tingling. Pain started in the right hand and then began in the left hand a short time later. Laboratory investigations and corrective treatment were not reported. Outcome of the event was recovering as seen some improvement in the symptoms. follow-up information was received from pharmacist on 13-Nov-2017. The event outcome was recovered for both of the events on an unspecified date without any additional treatment.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Fatigue, Foetal hypokinesia, Headache, Injection site erythema
Clinical narrative: Initial solicited report received on 22 November 2017 from a Consumer. This is a prospective pregnancy registry case. This case involves a 33 year-old- female subject who had vaccine exposure during pregnancy and had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement. The medical history included: had previous flu vaccines and had developed hives after those vaccinations father's health status and age was not reported. The date of LMP was not reported. The estimated date of delivery was reported 17 December 2017. The subject's previous pregnancies were not reported. The subject maternal exposure drugs were not reported. The subject received a dose of FLUZONE INTRADERMAL QUADRIVALENT (route, site of administration and batch number not reported) on 20 November 2017. The subject stated that the reaction started the day of vaccination. She mentioned that she had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement the next day. This case was serious with the event of "did not feel any fetal movement" as considered as IME. It was not reported if the subject had treatment for infertility. The subject's family history of congenital abnormality was not reported. Prenatal testing included the subject was 36 weeks pregnant at the time of vaccination. On 22 November 2017, Ultrasound done and stated both were normal. The pregnancy was ongoing at the time of report. The outcome of events red, sore area at injection site, headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination was unknown at the time of report. List of documents held by sender: none. Sender's Comments: A 33-year-old female subject received a dose of study vaccine at 36 weeks of gestation. She had not felt fetal movements on day vaccination and decreased fetal movements the next day. On Ultrasound baby was normal. Based on data available, the sponsor assesses this event as not relate to study vaccine. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Ultrasound antenatal screen normal, Urticaria
Clinical narrative: Initial solicited report received on 22 November 2017 from a Consumer. This is a prospective pregnancy registry case. This case involves a 33 year-old- female subject who had vaccine exposure during pregnancy and had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement. The medical history included: had previous flu vaccines and had developed hives after those vaccinations father's health status and age was not reported. The date of LMP was not reported. The estimated date of delivery was reported 17 December 2017. The subject's previous pregnancies were not reported. The subject maternal exposure drugs were not reported. The subject received a dose of FLUZONE INTRADERMAL QUADRIVALENT (route, site of administration and batch number not reported) on 20 November 2017. The subject stated that the reaction started the day of vaccination. She mentioned that she had red, sore area at injection site, also experienced headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination, and had decreased fetal movement the next day. This case was serious with the event of "did not feel any fetal movement" as considered as IME. It was not reported if the subject had treatment for infertility. The subject's family history of congenital abnormality was not reported. Prenatal testing included the subject was 36 weeks pregnant at the time of vaccination. On 22 November 2017, Ultrasound done and stated both were normal. The pregnancy was ongoing at the time of report. The outcome of events red, sore area at injection site, headache, tiredness, hives across chest area, and did not feel any fetal movement that night following vaccination was unknown at the time of report. List of documents held by sender: none. Sender's Comments: A 33-year-old female subject received a dose of study vaccine at 36 weeks of gestation. She had not felt fetal movements on day vaccination and decreased fetal movements the next day. On Ultrasound baby was normal. Based on data available, the sponsor assesses this event as not relate to study vaccine. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Heart rate increased, Hypertension, Laboratory test
Clinical narrative: Severely swollen arm and shoulder, red, painful. Dizziness, elevated pulse up to 200, high blood pressure.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Swelling
Clinical narrative: Severely swollen arm and shoulder, red, painful. Dizziness, elevated pulse up to 200, high blood pressure.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Nausea, Unresponsive to stimuli
Clinical narrative: 0915 Injections administered - Pt. became light headed and nauseous. RN recommended for pt. to lay down. Pt. declined recommendation. 0920 pt. became unresponsive for approx. 30 seconds. RN laid pt down on exam table. Initial BP 108/64 Dr. expressed pt. within normal limits. 0925 BP 114/68 Pulse: 49 SpO2 99 room air. 0935 BP 116/62 Pulse: 52 SpO2 98 room air.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella lesions on face, trunk, arms.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Injection site pain, Pyrexia, Rhinorrhoea
Clinical narrative: Hx of asthma, fever after flu vaccine. Runny nose and cough; pt. C/O difficulty breathing and Mom gave 4 puffs albuterol with improvements. Fever 101.8; pain at injection site.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: Patient called her left arm (injection site) is swollen, red and hot when felt. She also said her arm is itchy and sore. I advised her to go to ER for evaluation.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Patient develop "rash" on upper left arm, few days after vaccination. She used NEOSPORIN on it  but did not seek medical advice until 11/24/17. She went back to Dr. who diagnosed it as shingles.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous, Scab
Clinical narrative: Patient develop "rash" on upper left arm, few days after vaccination. She used NEOSPORIN on it  but did not seek medical advice until 11/24/17. She went back to Dr. who diagnosed it as shingles.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphonia, Feeling hot, Throat tightness, Tremor
Clinical narrative: One hour after receiving the flu vaccine, face became hot and throat felt like it was tightening. Voice became hoarse, became chilled and began to shake. Vital signs taken and were normal. Given 25mg BENADRYL by mouth.
Age: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HIB administered after expiration date. Vaccine expired Nov 19, 2017 and was administered to pt Nov 21, 2017. MA that administered vaccine mistakenly read expiration date as Nov 17, 2019 as the manufacturer had date written on box as 19NOV17. Manufacturer was contacted, per CDC recommendation, vaccine will be re-administered. Provider has been made aware and will be contacting mother of the pt today to discuss. Discussed with MA who administered vaccine. I have seen this same error at 2 other facilities I have worked at outside of this company. ***There was no reaction to the vaccine.***
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Five hours after receiving the influenza vaccine, I felt very weak and tired, experienced a headache and body aches and chills. While in bed I experienced body sweats from my fever breaking. The entire next day, I continued to feel weak and tired and had a bad headache. I took ALEVE and decided to wait out the side effects hoping I would feel better soon. Today is day three following the injection and I am tired and a little weak. My headache is gone. Why would I experience such adverse effects?
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Five hours after receiving the influenza vaccine, I felt very weak and tired, experienced a headache and body aches and chills. While in bed I experienced body sweats from my fever breaking. The entire next day, I continued to feel weak and tired and had a bad headache. I took ALEVE and decided to wait out the side effects hoping I would feel better soon. Today is day three following the injection and I am tired and a little weak. My headache is gone. Why would I experience such adverse effects?
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Diarrhoea, Eye pruritus, Rash, Rash erythematous
Clinical narrative: Patient reports several episodes of diarrhea, scratchy throat, denies difficulty swallowing, but has a cough, has an obvious red facial rash, reports cough and itchy eyes.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Throat irritation
Clinical narrative: Patient reports several episodes of diarrhea, scratchy throat, denies difficulty swallowing, but has a cough, has an obvious red facial rash, reports cough and itchy eyes.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint stiffness, Nausea, Peripheral swelling
Clinical narrative: Patient experienced stiffness of joints day vaccine administered and also felt nauseous, symptoms have improved but now experiencing redness and swelling on feet. Counseled patient to keep an eye on these symptoms and to report to MD if not improved within 2 days or worsened. Also counseled to contact MD if sudden change in mood/behavior or high fever occurs.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5mL dose. Should have received 0.25mL dose. Patient had no adverse reaction following dosage error.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Started with Localized Swelling at injection site which migrated down entire length of arm down to wrist. Patient reported swelling was improving. No pain or itching.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscle injury, Myalgia, Pain in extremity
Clinical narrative: Since the patient received her flu vaccine on 10/19/17 she has had a sore arm from her shoulder all the way down through her forearm area. The patient states it feels like muscle soreness/damage. The patient states she has loss of range of motion from the soreness.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Corneal reflex decreased, Dry eye, Facial paralysis, Hypoaesthesia oral, Visual impairment
Clinical narrative: On Monday 11/20/17, Rt eye dry-noted at 8am, eye slow to blink, by 3pm Rt sided mouth droop, Rt eye not blink. Lips numb, Rt eye dry-vision worse. Went to Urgent Care. Neuro exam good except paralysis on Rt side face given script to start Prednisone and VALTRAX. Vaccine exp. date 7-6-2019. Not all symptoms have improved. At Urgent Care on 11-20-17, the Forehead had no paralysis but over next 24 hours the Forehead also on Rt side did show paralysis. Symptoms worsened first week, now today are better, but still slight droop in mouth, eye brow. Rt eye still slow to blink and focus able to not wear eye patch after 2 weeks. 50% better after 2 weeks. On 11/20/17 told I had Bells palsy.
Age: 70.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: 5 days after the immunisation, she developed an itch, it was tender to the touch; red, hot and lumpy (similar to a bee sting). She took BENADRYL and ALEEVE-Next day it was much better. No systemic reactions.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Lung infection, Pain in extremity, Skin infection
Clinical narrative: On Oct 6 2016 I went to Dr office for a Dog Bite that happened on Sept 29 2016. I started cephalexin 500mg on Sept 29 2016 I had the meds from previous took them 3 times a day for 7 days. On Oct 6 I went to Dr office because my leg hurt and was still swollen. Dr look at the wound and said he was giving me a shot and some more antibiotics. Nurse came in gave me two shots one on the upper left arm which was the tetanus shot. And one in the buttocks (ROCEPHIN) on right side. The tetanus injection hurt while injecting it. The next morning my upper arm hurt so bad like a deep bruise that lasted about 2 weeks. Then time wise is unknown but one morning I woke up not able to lift my left arm, that lasted about a week till I found the right antiflammatory drug. My relief came within an hour of taking CURAMED 750mg Healthy inflammation response after the arm incident my leg was still hurting went back to Dr he ordered a Doppler nothing showed up. Went back to Dr he ordered a vein specialist that Dr didn't find anything. In the  mist of all this I would go to the ER and urgent care. They couldn't help either. The urgent care gave me another round of antibiotics this time BACTRIM. So here we are a year later and I'm still hurting and I developed a lung infection, a skin infection on arms only. This is the third time I'm going.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound Doppler normal
Clinical narrative: On Oct 6 2016 I went to Dr office for a Dog Bite that happened on Sept 29 2016. I started cephalexin 500mg on Sept 29 2016 I had the meds from previous took them 3 times a day for 7 days. On Oct 6 I went to Dr office because my leg hurt and was still swollen. Dr look at the wound and said he was giving me a shot and some more antibiotics. Nurse came in gave me two shots one on the upper left arm which was the tetanus shot. And one in the buttocks (ROCEPHIN) on right side. The tetanus injection hurt while injecting it. The next morning my upper arm hurt so bad like a deep bruise that lasted about 2 weeks. Then time wise is unknown but one morning I woke up not able to lift my left arm, that lasted about a week till I found the right antiflammatory drug. My relief came within an hour of taking CURAMED 750mg Healthy inflammation response after the arm incident my leg was still hurting went back to Dr he ordered a Doppler nothing showed up. Went back to Dr he ordered a vein specialist that Dr didn't find anything. In the  mist of all this I would go to the ER and urgent care. They couldn't help either. The urgent care gave me another round of antibiotics this time BACTRIM. So here we are a year later and I'm still hurting and I developed a lung infection, a skin infection on arms only. This is the third time I'm going.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Local reaction, Nausea
Clinical narrative: Fevers, shaky, vomiting, nausea, dizziness 15-20 min. after injection. Injection site swollen and red. In ER - told it was local reaction.