chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Diarrhoea, Dizziness, Erythema, Headache
Clinical narrative: This is a spontaneous report from a contactable physician (reporting for daughter) from a Pfizer-sponsored program 2017 Trumenba non-operationalized research. An  18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA via an unspecified route of administration, on 06Jan2017, single dose for immunization. Relevant medical history and concomitant medications were not reported. After the first dose of meningococcal group B vaccine on 06Jan2017, the patient experienced redness (10 cm), swelling, pain, malaise, headache, nausea, dizziness, fever to 102 degree F, muscle and joint ache, and diarrhea. Outcome of the events was unknown. The information on the batch number has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician (reporting for daughter) from a Pfizer-sponsored program 2017 Trumenba non-operationalized research. An  18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA via an unspecified route of administration, on 06Jan2017, single dose for immunization. Relevant medical history and concomitant medications were not reported. After the first dose of meningococcal group B vaccine on 06Jan2017, the patient experienced redness (10 cm), swelling, pain, malaise, headache, nausea, dizziness, fever to 102 degree F, muscle and joint ache, and diarrhea. Outcome of the events was unknown. The information on the batch number has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician (reporting for daughter) from a Pfizer-sponsored program 2017 Trumenba non-operationalized research. An  18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA via an unspecified route of administration, on 06Jan2017, single dose for immunization. Relevant medical history and concomitant medications were not reported. After the first dose of meningococcal group B vaccine on 06Jan2017, the patient experienced redness (10 cm), swelling, pain, malaise, headache, nausea, dizziness, fever to 102 degree F, muscle and joint ache, and diarrhea. Outcome of the events was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Pain, Polyuria, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received TRUMENBA, 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 patient experienced high fever, body aches, dizziness, fatigue and polyuria, all on unspecified date. The outcome of the events was unknown. Information regarding batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017546610 same reporter, product and event; different patient.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Pain, Polyuria, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is a second of two reports. A patient of unspecified age, ethnicity and gender, received TRUMENBA, 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 patient experienced high fever, body aches, dizziness, fatigue and polyuria on an unspecified date. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017544111 Same reporter, similar events in different patients".
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable other HCP (Pharmacy Intern) calling on behalf of the pharmacist reported same events for 2 patients. This is Report 2 of 2 for the wife, a 65-year-old female patient. A 65-year-old female patient received PREVNAR 13 (Lot # S43277, Expiry Date Sep2018, NDC # 0005197102) intramuscular at 0.5mL, single at left arm on 11Dec2017 for immunization, given at Pharmacy/Drug Store under standing orders. No medical history to report. Patient's Medical History (including any illness at time of vaccination): None. Concomitant vaccination included ZOSTAVAX (Merck, Lot # N020945, Expiry date 26Oct2018) subcutaneous at right arm on 11Dec2017 for immunization. The patient's left arm has been swollen for a week primarily at the injection site on an unspecified date with outcome not recovered. Reporter seriousness for left arm swollen was reported as medically significant. Reporter stated the 2 patients received the vaccines around the same time and their reactions were pretty severe. The reporter considered the event was related to the study medication PREVNAR 13. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of "swollen for a week primarily at the injection site" cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. Linked Report(s): US-PFIZER INC-2017546967 same reporter/drug/event, different patient.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacy Intern calling on behalf of a Pharmacist reported similar events for 2 patients, this is report 1 of 2, for a 68-year-old male patient that: A 68-year-old male patient received PREVNAR 13 (Lot # S43277, Expiry Date Sep2018, NDC # 0005197102) intramuscular at 0.5mL, single at left arm on 11Dec2017 for immunization, given at Pharmacy/Drug Store under standing orders. Patient's medical History was unknown. Concomitant medication included chlorhexidine oral 15 ml, 2x/day from 11Dec2017 and ongoing, and Rosuvastatin 20mg once daily from Sep2016 and ongoing. Concomitant vaccination included ZOSTAVAX (Merck, Lot # N020945, Expiry date 26Oct2018) subcutaneous at right arm on 11Dec2017 for immunization. The patient's left arm has been swollen for a week primarily at the injection site on an unspecified date with outcome not recovered. Reporter seriousness for left arm swollen was reported as medically significant. Reporter stated the 2 patients received the vaccines around the same time and their reactions were pretty severe. The reporter considered the event was related to the study medication PREVNAR 13. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported event. Linked Report(s): US-PFIZER INC-2017546863 same reporter/drug/event, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Chest pain, Fatigue, Insomnia, Poor quality sleep
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer-sponsored program. A 78-year-old male patient received second dose of PREVENAR 13 via an unspecified route of administration, in Nov2017, single dose, for immunization. Relevant medical history included logging accident years ago, operation on his neck (before receiving the second dose), and the patient also can't lose weight (but that was because of his other meds) before all of this. Concomitant medications included injections for cholesterol (unspecified drug). The patient previously received PREVENAR 13 in 2016 (last year) for immunization. It was reported that the patient already received a dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) one year ago and he received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) about a month ago. On 19Dec2017, the patient has been having some chest pain and tightness of chest. It was also reported that his sleep has not been on key lately and that the patient has been having trouble sleeping lately and was tired. It was reported that the chest pain comes and goes, sitting makes it better but the patient doesn't know if it's just his chest muscles because he didn't sleep properly. Outcome of the event sleep has not been on key lately/ has been having trouble sleeping and fatigue was not recovered while it was unknown for the other events.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient received PREVNAR 13 (NDC number: 00005197102; Lot T08483; Expiry Date: Sep2019) on 19Dec2017 at 0.5ml single intramuscular, for immunization (over 65 doctor recommended). The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling at injection site on 19Dec2017. Outcome of the events was not recovered, patient still had redness and swelling at the injection site. Pharmacist considered the event redness and swelling at injection site related to pneumococcal 13-val conj vaccine.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Local reaction, Rash macular, Urticaria
Clinical narrative: Within 10 minutes of vaccination patient developed urticaria and small, pink blanchable macules. First noticed on (R) arm with what more appeared as a local reaction. The diffuse truncal rash occurred. Given BENADRYL and improved.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Patient received flu shot 12/15/17, by that eve he had red dots all over his body. Saturday had hives all over and injection site was red and larger than a silver dollar in size per mom. Symptoms were managed at home with ZYRTEC by 12/18/17, hives and itching were gone with only a few red dots remaining. Denies fever or SOB over wkend.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Influenza virus test negative, Injection site pain, Oral disorder, Pyrexia, Swelling
Clinical narrative: Patient developed fever up to 104 and tenderness on his right thigh. With diffuse swelling or tenderness of 5 cm x 5 cm. He developed oral lesions 2 days later. 12/19/17 well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Tenderness
Clinical narrative: Patient developed fever up to 104 and tenderness on his right thigh. With diffuse swelling or tenderness of 5 cm x 5 cm. He developed oral lesions 2 days later. 12/19/17 well.
Age: 74.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Lip swelling
Clinical narrative: Pt stated his lip (upper) became swollen the morning after receiving both flu and pneumonia vaccines. Pt took ZYRTEC on own then took BENADRYL later in the day. On 12-16-17, Pt lip has improved some per patient.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Peripheral swelling, Swelling face
Clinical narrative: Swelling around face, eyes, backs of legs that presented morning after vaccine administration; went to doctor and was given steroid shot which resolved.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient called approx. 3 PM 12/18/17 and said he has pain in his shoulder area where injection was given. ADVIL or TYLENOL relieves pain or soreness but keeps coming back.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Heart rate increased, Hot flush, Insomnia, Nausea
Clinical narrative: 11/20/17- 4:15 pm - Had Nausea and Diarrhea. For the next two days couldn't sleep more than 3 hours each night and had night sweats, hot flashes and increased heart rate. On day three took KLONIPIN 0.25mg to sleep. Pt states it took 10 days for symptoms to subside.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Night sweats
Clinical narrative: 11/20/17- 4:15 pm - Had Nausea and Diarrhea. For the next two days couldn't sleep more than 3 hours each night and had night sweats, hot flashes and increased heart rate. On day three took KLONIPIN 0.25mg to sleep. Pt states it took 10 days for symptoms to subside.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Urticaria
Clinical narrative: Swelling around both eyes and hives on face. Reaction was noticed by parent at approximately 11:00 a.m. Patient was administered Children's Benadryl 10ml by mouth and observed in clinic an additional 20  minutes and rechecked by clinic staff prior to leaving office.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Patient developed a warm round rash at the injection site. This developed the following day and was about 3 inches in diameter. She was also slightly feverish the day following the immunization.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 year old male patient with Kawasaki's disease. The patient's drug reactions/allergies and concomitant medication were not reported. On 22-NOV-2017, the patient was vaccinated in the left arm with an improperly stored dose of PROQUAD, lot number: N008825 (expiration date: 12-SEP-2018), dose 1, intramuscularly, for prophylaxis (strength and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: -9.4C for 10 hours - Previous temperature excursion: -8.9C for 8 hours and 51 minutes. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 2-month-old patient of unknown gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 18-DEC-2017, the patient was inadvertently vaccinated with PNEUMOVAX 23 (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse symptoms were reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received a second flu shot 2 months after the first.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient said a rash of 2 to 3 inches occured around the injection sight and lasted for 14 days. Also a month later Patient had 1 or 2 spots of unknown breakouts on her back and wondered if this was causeded by the shot or a moist heating pad she was using for pain relief. Referred patient to her doctor if the symptoms persist.
Age: 80.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to office with pain, redness and swelling at the injection site. Advised cold/heat compresses, Tylenol, topical hydrocortisone cream and arm elevation.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Vaccine administered on 12/21/2017, on 12/26/2017 patient presented with a fever up to 101 degrees F, symptomatically treated at home by mom and dad with otc antipyretics. On 12/28 patient presented to the office with a measles-like rash.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Periarthritis
Clinical narrative: Pt developed increasing pain and stiffness in left shoulder over the course of month after vaccination and developed adhesive capsulitis of left shoulder.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Chills, Headache, Inflammation, Pruritus
Clinical narrative: Severe rash, chills, headache, itching, burning. Still causing inflammation and lesions 11-28-17 thru 12-22-17.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin lesion
Clinical narrative: Severe rash, chills, headache, itching, burning. Still causing inflammation and lesions 11-28-17 thru 12-22-17.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant via company representative, refers to a 69 year old female patient. The reporter stated that the patient was allergic to latex, amoxicillin, and potassium. There was no information about the patient's medical history provided. On 25-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 dose reported as 1 rod inserted (site, route of administration, lot # and expiration date were not reported) for prevention of pneumococcal disease. Concomitant therapies included the flu shot. On 25-OCT-2017, the patient experienced injection site pain and redness from her left biceps down to her triceps. The patient sought no medical attention. No treatment was given for adverse events. The outcome of injection site pain and injection site erythema was unknown at the time of this report. The relatedness between the events and PNEUMOVAX 23 was unknown. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient was treated with KEFLEX 500 mg three times a day for 7 days. No laboratory diagnostics were performed. On an unknown date, the patient had recovered from the adverse events. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1712USA013805.
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient was treated with KEFLEX 500 mg three times a day for 7 days. No laboratory diagnostics were performed. On an unknown date, the patient had recovered from the adverse events. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1712USA013805.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66 year old female patient with blood cholesterol abnormal, diabetes mellitus and hypertension. The patient had no known allergies (NKA). On 28-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # N022704, expiration date: 27-FEB-2019, for prophylaxis (dose # and route of administration were unknown). Concomitant medications were not reported. On an unspecified date in 2017, the patient experienced "pain in the arm all the way to her neck" along with "swelling and redness in the arm". The patient was taking acetaminophen (TYLENOL) for the pain, and was also recommended by the pharmacisto to take ibuprofen (MOTRIN). At the time of reporting, the patient had not recovered from the adverse events. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a currently 21 year old patient of unknown gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates (reported as "7-10 years ago"), the patient was vaccinated with the first and the second dose of GARDASIL for prophylaxis at unspecified age (route of administration, lot# and expiration dates were unknown). The nurse stated that it was unknown what interval was between first dose and second dose of GARDASIL. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient had not sought any treatment, and no laboratory diagnostics were performed. At the time of reporting, the outcome of the adverse events was unknown. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1712USA000628:
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient had no pertinent medical history, drug reaction or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route of administration, lot # and expiration date were unknown). Concomitant therapies included unspecified blood pressure and thyroid medications. On an unknown date, the patient developed extreme swelling of the arm where the vaccine was administered, and the injection site was red, hot to the touch and hard. The symptoms spread to the patient's collarbone on the morning after receiving the vaccine. The patient had not sought any treatment, and no laboratory diagnostics were performed. At the time of reporting, the outcome of the adverse events was unknown. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1712USA000628:
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 27-Oct-2017. This case involves a 72-year-old female patient, who was vaccinated with 0.5ml dose of FLUZONE HD frequency: once(batch number, expiry date and dose in serise were not reported) in left arm via intermuscular route on 22-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, (reported as that night) following the vaccination, the patient's developed a red lump towards her elbow that it was about 4 inches around it was hot and painful to the touch. Laboratory data was not reported. The patient received corrective treatment with Steroid Cream. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a pharmacist and consumer on 27-Oct-2017. This case involves a 79-year-old female patient, who was vaccinated with a 0.5 ml of dose of FLUZONE HD intramuscularly once (batch number: UI877AA, expiry date, dose, dose in series, route, and site of administration were not reported) on 25-Oct-2017. The patient's medical history and concomitant medication were unknown. Also reported that patient does not have any chronic illness or allergies. On an unknown day, two days following the vaccination, the patient developed right shoulder pain and cannot lift the arm. Lab data and corrective treatment was not reported. Outcome of all the events were not recovered. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Initial unsolicited report received from pharmacist on 27-Oct-2017. This case involves 71-year-old female patient who was vaccinated with 0.5 ml once dose of FLUZONE HD (Batch number, expiration date, dose was not reported) via intramuscular route in right deltoid on 26 Oct 2017. Medical history was not reported. Stated patient has no known allergies. Patient did not receive any other vaccines. On 26 Oct 2017, same day following the vaccination, the patient experienced oval shaped, red spot that was around injection site and on 27 Oct 2017, one-day post vaccination, the spot is extending lower on arm. Lab data and corrective treatment were not reported. The patient's event outcome was unknown. List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Skin haemorrhage
Clinical narrative: Initial unsolicited report received from a nurse on 02-Nov-2017. This case involves a 74-year-old male patient, who was vaccinated with booster dose of 0.5 ml of TYPHIM VI once (batch number: M15722M, expiry date, dose in series and administration site were not reported) via intramuscular route on 31-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's developed scratching his hands so badly they are bleeding again. The patient was previously vaccinated with Typhim VI on an unspecified day. Laboratory data was not reported and corrective treatment included CORTISONE, Diphenhydramine hydrochloride (Benadryl). Outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Localized swelling redness tenderness started +/- 8hrs after vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient got PNEUMOVAX 23 shot 12/19/17 in the morning. By evening the arm was swollen, red and itchy from shoulder to elbow. It was uncomfortable to lift. Patient was advised to take Ibuprofen, BENADRYL and a cold compress.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient called, said he had shoulder pain from injection site up to shoulder.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Pt had some pain the day after the injection. 48 Hours after the injection, the patient had continuous pain in the arm, and could not raise his arm laterally without excruciating pain. Since Sunday the 24th, the patient's pain had decreased a bit, and can move his arm with a better range of motion, but still does not have normal range of motion. Patient was using ice on the site, along with heating pads. Patient also used TYLENOL, but neither the TYLENOL, ice, or heating pads helped.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pt tolerated vaccine well, later complains of shoulder pain for last 6 weeks since vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Inj. given at 3:52 PM. Fever of 102.7, chills, achy joints at night. In AM pt. has red, raised hives all over legs and itching. Tx: BENADRYL.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Inj. given at 3:52 PM. Fever of 102.7, chills, achy joints at night. In AM pt. has red, raised hives all over legs and itching. Tx: BENADRYL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Cyanosis, Erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a 67 year old female consumer referring to herself. The patient had no pertinent medical history. The patient's drug reactions/allergies included sulfa drugs and penicillin. Concomitant therapies included rosuvastatin calcium (CRESTOR) and valsartan (DIOVAN). On 27-NOV-2017 at 11 a.m., the patient was vaccinated in the arm with one injection of PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 27-NOV-2017, about 2 hours after vaccination, the patient's face began to turn red (erythema) and the arm that received the injection turned blue (cyanosis), crawling red (erythema) and began to swell from her shoulder to her elbow. The patient reported that the injection site turned hard (injection site induration), became a warm lump (injection site warmth, injection site mass) and it was painful (injection site pain). She also experienced unspecified elevated blood pressure after noticing the symptoms. The patient visited an urgent care outpatient medical facility where a physician prescribed a topical cream for the arm swelling; additionally she used warm compresses all night. No laboratories or diagnostic test were carried out. The patient reported that she did not sleep well (poor quality sleep) the night of 27-NOV-2017 because of the painful swelling in her arm that received the PNEUMOVAX 23 injection. At the time of the report the swelling had decreased and the red color (erythema) had turned to pink (recovering); however, the outcome of blood pressure increased, injection site pain, injection site warmth, injection site mass, injection site induration, cyanosis and poor quality sleep was not reported. The reporter did not assess the relatedness of the adverse events with PNEUMOVAX 23.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Poor quality sleep
Clinical narrative: This spontaneous report was received from a 67 year old female consumer referring to herself. The patient had no pertinent medical history. The patient's drug reactions/allergies included sulfa drugs and penicillin. Concomitant therapies included rosuvastatin calcium (CRESTOR) and valsartan (DIOVAN). On 27-NOV-2017 at 11 a.m., the patient was vaccinated in the arm with one injection of PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 27-NOV-2017, about 2 hours after vaccination, the patient's face began to turn red (erythema) and the arm that received the injection turned blue (cyanosis), crawling red (erythema) and began to swell from her shoulder to her elbow. The patient reported that the injection site turned hard (injection site induration), became a warm lump (injection site warmth, injection site mass) and it was painful (injection site pain). She also experienced unspecified elevated blood pressure after noticing the symptoms. The patient visited an urgent care outpatient medical facility where a physician prescribed a topical cream for the arm swelling; additionally she used warm compresses all night. No laboratories or diagnostic test were carried out. The patient reported that she did not sleep well (poor quality sleep) the night of 27-NOV-2017 because of the painful swelling in her arm that received the PNEUMOVAX 23 injection. At the time of the report the swelling had decreased and the red color (erythema) had turned to pink (recovering); however, the outcome of blood pressure increased, injection site pain, injection site warmth, injection site mass, injection site induration, cyanosis and poor quality sleep was not reported. The reporter did not assess the relatedness of the adverse events with PNEUMOVAX 23.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date,  the patient was mistakenly vaccinated with a pediatric dose of RECOMBIVAX HB (strength, dose number, dose, administration route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On unspecified dates, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # N016185 and expiration date of 31-JUL-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 23 hours. Vaccine was reconstituted with properly stored  sterile diluent (MERCK STERILE DILUENT). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1712USA013911: US-009507513-1712USA013912:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On unspecified dates, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # N016185 and expiration date of 31-JUL-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 23 hours. Vaccine was reconstituted with properly stored  sterile diluent (MERCK STERILE DILUENT). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1712USA013912: US-009507513-1712USA001694:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On unspecified dates, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # N016185 and expiration date of 31-JUL-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 23 hours. Vaccine was reconstituted with properly stored sterile diluent (MERCK).  No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1712USA001694: US-009507513-1712USA013911.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase MB increased, Catheterisation cardiac, Chest discomfort
Clinical narrative: 68 y/o male who received influenza vaccine on 11/8/17 in clinic who developed malaise, retrosternal burning, burping, nonbloody emesis, diaphoresis and 8/10 chest discomfort for which he presented to an hospital for on 11/9/17 where EKG was reported to show inferior Q waves and slight ST elevation, with 1 mm ST elevation with inferior leads. Underwent cardiac catheterization and PCI on 11/9/17. Per hospital report, on 11/9/17, initial lab work was as follows: troponin I 130, CMP WNL, AST 262, ALT 52. On 11/10/17 troponin I was 61.90 and then 38.60. On 11/10/17, CK MB 143.3 and 64. Patient was initiated on atorvastatin 80mg daily (previously on simvastatin 20mg daily), metoprolol tartrate 12.5mg BID, ticagrelor 90 mg BID and was discharged from the hospital the following day. Aspirin 325 mg once, Metoprolol 12.5 mg bid, Ticagrelor 90 mg BID.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram Q wave abnormal, Electrocardiogram ST segment elevation, Eructation, Hyperhidrosis, Malaise
Clinical narrative: 68 y/o male who received influenza vaccine on 11/8/17 in clinic who developed malaise, retrosternal burning, burping, nonbloody emesis, diaphoresis and 8/10 chest discomfort for which he presented to an hospital for on 11/9/17 where EKG was reported to show inferior Q waves and slight ST elevation, with 1 mm ST elevation with inferior leads. Underwent cardiac catheterization and PCI on 11/9/17. Per hospital report, on 11/9/17, initial lab work was as follows: troponin I 130, CMP WNL, AST 262, ALT 52. On 11/10/17 troponin I was 61.90 and then 38.60. On 11/10/17, CK MB 143.3 and 64. Patient was initiated on atorvastatin 80mg daily (previously on simvastatin 20mg daily), metoprolol tartrate 12.5mg BID, ticagrelor 90 mg BID and was discharged from the hospital the following day. Aspirin 325 mg once, Metoprolol 12.5 mg bid, Ticagrelor 90 mg BID.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test normal, Nausea, Percutaneous coronary intervention, Troponin I increased, Vomiting
Clinical narrative: 68 y/o male who received influenza vaccine on 11/8/17 in clinic who developed malaise, retrosternal burning, burping, nonbloody emesis, diaphoresis and 8/10 chest discomfort for which he presented to an hospital for on 11/9/17 where EKG was reported to show inferior Q waves and slight ST elevation, with 1 mm ST elevation with inferior leads. Underwent cardiac catheterization and PCI on 11/9/17. Per hospital report, on 11/9/17, initial lab work was as follows: troponin I 130, CMP WNL, AST 262, ALT 52. On 11/10/17 troponin I was 61.90 and then 38.60. On 11/10/17, CK MB 143.3 and 64. Patient was initiated on atorvastatin 80mg daily (previously on simvastatin 20mg daily), metoprolol tartrate 12.5mg BID, ticagrelor 90 mg BID and was discharged from the hospital the following day. Aspirin 325 mg once, Metoprolol 12.5 mg bid, Ticagrelor 90 mg BID.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Typical pain at injection site within a few hours, but about 12 hours after injection I had near fainting, nausea, severe shaking/chills, headache. Developed a fever about an hour later. In the morning I felt much better, but still weak, queasy and head-achy. The second morning (about 48 hours after the injection) I was back to nearly normal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Pyrexia, Tremor
Clinical narrative: Typical pain at injection site within a few hours, but about 12 hours after injection I had near fainting, nausea, severe shaking/chills, headache. Developed a fever about an hour later. In the morning I felt much better, but still weak, queasy and head-achy. The second morning (about 48 hours after the injection) I was back to nearly normal.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Depressed level of consciousness, Hypoacusis, Pallor
Clinical narrative: Client became pale after 4th vaccination. Client wanted to lay against wall in office. Placed client on floor in side lying position. Client remained conscious. Client stated "I felt as if I were going to pass out and could not hear well out of ears". Client's facial color very pale. Blood pressure 116/83 pulse 81, SPO2 97 percent on room air. Client remained conscious. After laying on floor, color returned to face and client began to feel better. Monitored client for 15 plus minutes. Vitals 140/92 pulse 93. Client has history of hypertension. Client stated feeling normal prior to leaving clinic.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt. states that on Friday 12/22/2017 he became ill, vomiting, chills, aches, had to have someone drive him home from work. Injection site was warm and hot. Also notes that it was sore with a raised warm area and a "hard lump" was noted in arm.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: Pt. states that on Friday 12/22/2017 he became ill, vomiting, chills, aches, had to have someone drive him home from work. Injection site was warm and hot. Also notes that it was sore with a raised warm area and a "hard lump" was noted in arm.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration, Pain
Clinical narrative: Induration redness pain warmth.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Approximately 15 minutes after Hepatitis B injection given employee was working on donor floor and started to have symptoms. She started with generalized warmth, headache and nausea. Employee taken to office and cool compresses applied and lab jacket removed. Employee's vitals taken 126/71, heart rate 71. Employee then started with dizziness, lower extremities elevated. Vital signs taken again 117/66, heart rate 78. Employee states stomach feeling better at this time.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient complained of a lot of pain and stiffness in her hands and legs. She said it started the day after the vaccines and lasted about 3 days. She said it finally went away on its own.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of arm from above shoulder, down to elbow, beginning on 12/16 and continuing until 12/18. Was given prednisone, orally, for 3 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: Painful swollen muscle area, red around muscle, itching in area of redness.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-NOV-2017, the patient was vaccinated with VARIVAX improperly stored (dosage, route of administration and frequency were not reported) lot # M033214 and expiration date: 13-JUL-2018, indicated for prophylaxis, together with an unspecified sterile diluent (manufacturer unknown) lot#: N015632, expiration date: 18-FEB-2019. The vaccines did not have any previous temperature excursions not recorded by a data logger. The vaccines were stored in a temperature of -14C for 4 hours. There was no adverse effect reported. This is one of several reports from the same source (MARRS # 1712USA013685, MARRS # 1712USA013689). Sender's Comments: US-009507513-1712USA013685: US-009507513-1712USA013689.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 01-DEC-2017, the patient was vaccinated with M-M-R II lot # M040558 and expiration date of 06-OCT-2017, intramuscularly for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). No adverse effects were reported.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions have been noted to this combination of flu shots given in error. The manufacturer was contacted and the clinical services RN said to expect no adverse reaction. Patient's MD was contacted. Patient was contacted and felt fine. She had no concern and no adverse reaction whatsoever.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site reaction, Muscular weakness, Pain in extremity
Clinical narrative: Patient subsequently developed pain to the right arm with associated numbness and muscle weakness. She developed weakness of grasp and decreased sensation from the deltoid muscle into the digits of the right hand.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory loss
Clinical narrative: Patient subsequently developed pain to the right arm with associated numbness and muscle weakness. She developed weakness of grasp and decreased sensation from the deltoid muscle into the digits of the right hand.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Approximately 2 hours after vaccination, arm became very sore. By 6 hours later, had decreased ROM in that arm--unable to lift arm above 90 degrees. This soreness and decreased ROM continued, but got better over months. Took ibuprofen and used ice to area x 1st few weeks. Still has soreness and occasional "jolt" to area of injection. Unable to sleep on right side without soreness.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Full blood count, Malaise, Pain, Pyrexia
Clinical narrative: Fever, pain, feeling ill  went to ER. Diagnosed with Cellulitis, treated with Antibiotics. No further information available.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Fever, pain, feeling ill  went to ER. Diagnosed with Cellulitis, treated with Antibiotics. No further information available.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PATIENT STATE BACK OF ARM AND PROCEEDING DOWN ARM TOWARD ELBOW, AREA ALSO SWOLLEN AND WARM TO TOUCH. AS REDNESS AND SWELLING RESOLVED, AREA CHANGED TO ITCHING.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Swelling of R upper arm and pain severe enough to prevent patient from moving his arm beyond neutral position. No cardiovascular or nervous system compromise.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Blood test normal, Chest X-ray normal, Feeling abnormal, Hyperhidrosis
Clinical narrative: STARTED FEELING POORLY SHORTLY AFTER INJECTION. BY 5:20PM DRY HEAVES, NAUSEOUS, AND DIAPHORETIC. SENT TO ER BY DR FOR IV AND MEDS. PRESENTED IN ER WITH SAME SYMPTOMS AND CRAMPY UPPER ABDOMEN. NO CHEST PAIN OR SHORTNESS OF BREATH. GIVEN IV'S, PEPCID, BENADRYL AND ZOFRAN. ABDOMEN BENIGN. CHEST X-RAY CLEAR. BLOOD WORK NORMAL. SENT HOME AROUND MIDNIGHT THE SAME DAY. NO FURTHER SYMPTOMS.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Retching
Clinical narrative: STARTED FEELING POORLY SHORTLY AFTER INJECTION. BY 5:20PM DRY HEAVES, NAUSEOUS, AND DIAPHORETIC. SENT TO ER BY DR FOR IV AND MEDS. PRESENTED IN ER WITH SAME SYMPTOMS AND CRAMPY UPPER ABDOMEN. NO CHEST PAIN OR SHORTNESS OF BREATH. GIVEN IV'S, PEPCID, BENADRYL AND ZOFRAN. ABDOMEN BENIGN. CHEST X-RAY CLEAR. BLOOD WORK NORMAL. SENT HOME AROUND MIDNIGHT THE SAME DAY. NO FURTHER SYMPTOMS.