chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 17 year old female patient. She did not have relevant medical history, concomitant medications or drug history. It was reported that the patient had been receiving GARDASIL in a course of three injections over six months and that the first injection was administered on 18-OCT-2016. On 23-NOV-2016, the patient was vaccinated with the second dose of GARDASIL (lot # L007531, expiration date 04-NOV-2016) 0.5 ml for prophylaxis (route of administration was not reported). After she received the injection, it was discovered that the vaccine had already expired. At the time of this report, the patient had not experienced any adverse effect. The reporter stated that she did not have any relevant laboratory data. At the time of the report, it was unknown if the patient would continue GARDASIL, but the next injection was scheduled sometime in April 2018. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling jittery, Injection site discomfort, Injection site pain, Injection site pruritus
Clinical narrative: Information was received on 25-NOV-2016 from a pharmacist regarding a 70 year old female patient who received a PNEUMOVAX23 injection on 23-NOV-2016. The pharmacist reported that another pharmacist gave the injection. Medical history, concurrent conditions and concurrent medication were not reported. The pharmacist said the patient reported that late on the afternoon of 23-NOV-2016, she noticed redness running down the outside of her arm, not at the injection site, of course and she had a sore muscle. On 25-NOV-2016, the patient came to the pharmacy and the pharmacist documented that she still had a red rash from the top of her arm to the elbow, on the outside, that felt feverish, it was red, like a reaction, and itching, some pain and discomfort running down her arm, similar to that at the injection site. She had no trouble breathing nor had any other serious reaction but felt a little bit jittery. The pharmacist asked her to take BENADRYL for a couple of days. No further details were noted. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Information was received on 25-NOV-2016 from a pharmacist regarding a 70 year old female patient who received a PNEUMOVAX23 injection on 23-NOV-2016. The pharmacist reported that another pharmacist gave the injection. Medical history, concurrent conditions and concurrent medication were not reported. The pharmacist said the patient reported that late on the afternoon of 23-NOV-2016, she noticed redness running down the outside of her arm, not at the injection site, of course and she had a sore muscle. On 25-NOV-2016, the patient came to the pharmacy and the pharmacist documented that she still had a red rash from the top of her arm to the elbow, on the outside, that felt feverish, it was red, like a reaction, and itching, some pain and discomfort running down her arm, similar to that at the injection site. She had no trouble breathing nor had any other serious reaction but felt a little bit jittery. The pharmacist asked her to take BENADRYL for a couple of days. No further details were noted. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Information was received on 25-NOV-2016 from a pharmacist regarding a 70 year old female patient who received a PNEUMOVAX23 injection on 23-NOV-2016. The pharmacist reported that another pharmacist gave the injection. Medical history, concurrent conditions and concurrent medication were not reported. The pharmacist said the patient reported that late on the afternoon of 23-NOV-2016, she noticed redness running down the outside of her arm, not at the injection site, of course and she had a sore muscle. On 25-NOV-2016, the patient came to the pharmacy and the pharmacist documented that she still had a red rash from the top of her arm to the elbow, on the outside, that felt feverish, it was red, like a reaction, and itching, some pain and discomfort running down her arm, similar to that at the injection site. She had no trouble breathing nor had any other serious reaction but felt a little bit jittery. The pharmacist asked her to take BENADRYL for a couple of days. No further details were noted. Additional information is not expected.
Sex: M
Vaccine: IPV, MMR
Symptoms: Erythema, Nodule
Clinical narrative: Information had been received on 29-NOV-2016 from a consumer who reported that her son (age not reported) received M-M-R II vaccine in an unspecified thigh (unspecified date). At an unspecified time after receiving the M-M-R II, the consumer's son developed a "red knot near the MMRII injection site". The consumer stated that her son received an unspecified polio vaccine "at the same time as MMRII" (unspecified location of administration for the unspecified polio vaccine). The consumer reported that her son received PROQUAD (unspecified date/unspecified location of administration) an unspecified time after receiving M-M-R II. The consumer stated that her son developed a "knot" (no further clarifying information was provided) in an unspecified thigh at an unspecified time after receiving PROQUAD (unspecified date) (see MARRS# 1612USA005667). Outcome of events were not reported. This is one of two reports concerning the same patient. Additional information is not expected. Sender's Comments:  US-009507513-1612USA005667.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced "neurological problems", (specific problems unspecified). No product quality complaint (PQC) involved. The outcome of the event was unknown. The causal relationship between GARDASIL and the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 06-DEC-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were unknown) for prophylaxis and later recalled that she had previously received a dose of ZOSTAVAX (dose, route, lot number and expiration date were unknown) in the "previous year" (on unknown date of 2015), also reported as "the previous year". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored VAQTA (lot# M027879, expire date: 24-JAN-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for VAQTA was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004315: US-009507513-1612USA004316: US-009507513-1612USA004317: US-009507513-1612USA004318.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored RECOMBIVAX HB (lot#/ expire date: L048848/09-AUG-2018, lot#/ expire date: M032649/11-NOV-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for RECOMBIVAX HB was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA004317: US-009507513-1612USA003676: US-009507513-1612USA004316.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored GARDASIL 9 (lot#/ expire date: L036301/20-DEC-2017, lot#/ expire date: M024261/30-JUL-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for GARDASIL 9 was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA004317: US-009507513-1612USA004315: US-009507513-1612USA003676.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored M-M-R II (lot#/ expire date: M008589/16-FEB-2018, lot#/ expire date: M016234/31-MAR-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for M-M-R II was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA003676: US-009507513-1612USA004315: US-009507513-1612USA004316.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored ROTATEQ (lot#: M029252, expire date: 14-MAR-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for ROTATEQ was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003676: US-009507513-1612USA004316: US-009507513-1612USA004315: US-009507513-1612USA004317.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Diplopia, Immune system disorder, Malaise, Neuralgia
Clinical narrative: This spontaneous report was received from the grandmother of an 11 year old female patient.  Medical history and concomitant medications were not reported.  In 2012, the patient received her first dose of GARDASIL at age 11 (she was 15 years old at the time of this report).  The patient began "getting sick right after" receipt of the vaccine.  The grandmother clarified that the symptoms may have begun within a total timeframe of four months after the vaccination.  The patient's illness has progressively gotten worse over the years.  At the time of the report, the patient was bedridden and suffered from double vision, general pain and nerve pain and stated "her immune system is gone".  The patient sought unspecified medical care over the years.  In terms of treatment, the patient now received "home infusions on a consistent basis".  The outcome of the events was not recovered/not resolved.  The reporter stated she would like to "see us [Merck] in court for having this vaccine off the market".  The reporter also stated that three and a half weeks ago, a fried of her granddaughter's died (it was not clear from this statement whether the girls had received GARDASIL before her death) (see case #  1612USA005706). Bedridden was considered disabling by the reporter. Additional information is not expected as the reporter did not provide contact information. Sender's Comments:  US-009507513-1612USA005706.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from the grandmother of an 11 year old female patient.  Medical history and concomitant medications were not reported.  In 2012, the patient received her first dose of GARDASIL at age 11 (she was 15 years old at the time of this report).  The patient began "getting sick right after" receipt of the vaccine.  The grandmother clarified that the symptoms may have begun within a total timeframe of four months after the vaccination.  The patient's illness has progressively gotten worse over the years.  At the time of the report, the patient was bedridden and suffered from double vision, general pain and nerve pain and stated "her immune system is gone".  The patient sought unspecified medical care over the years.  In terms of treatment, the patient now received "home infusions on a consistent basis".  The outcome of the events was not recovered/not resolved.  The reporter stated she would like to "see us [Merck] in court for having this vaccine off the market".  The reporter also stated that three and a half weeks ago, a fried of her granddaughter's died (it was not clear from this statement whether the girls had received GARDASIL before her death) (see case #  1612USA005706). Bedridden was considered disabling by the reporter. Additional information is not expected as the reporter did not provide contact information. Sender's Comments:  US-009507513-1612USA005706.
Sex: M
Vaccine: MMRV
Symptoms: Nodule
Clinical narrative: Information had been received on 29-NOV-2016 from a consumer regarding a case for M-M-R II (MARRS# 1611USA014117). The consumer reported that her son (age unknown) received PROQUAD (unspecified date/unspecified location of administration) an unspecified time after receiving M-M-R II. The consumer stated that her son developed a "knot" (no further clarifying information was provided) in an unspecified thigh at an unspecified time after receiving PROQUAD (unspecified date). Outcome of event was not reported. This is one of two reports concerning the same patient. No further information is anticipated. Sender's Comments: US-009507513-1611USA014117.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Guillain-Barre Syndrome.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Expected some site pain on day of Flu Vaccine but continued to hurt and arm tightness increased and moved up into my shoulder. Today, is 2 months later and arm/shoulder hurt and I had no injury. I am doing ROM exercises on my own.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Nausea, Pain, Pain in extremity
Clinical narrative: Red and sore arm from injection area down to mid lower arm area for 2 days, then patient developed all over aches and some nausea for 2 more days bad enough to stay in bed mostly.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chills, Disturbance in attention, Feeling cold, Nasal congestion
Clinical narrative: Unable to focus, Cold Chills, sore throat, roof of mouth swollen, left nostril swollen, aches all over and elevated temperature.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pain, Palatal swelling
Clinical narrative: Unable to focus, Cold Chills, sore throat, roof of mouth swollen, left nostril swollen, aches all over and elevated temperature.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: Fever to 100.4F, neutropenia.
Age: 7.0
Sex: M
Vaccine: HEP, MMRV, TDAP
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: LOSS CONSCIOUSNESS AND FELL TO FLOOR HITTING HEAD ON FLOOR.  AWOKE WITHIN 15 SECONDS. PLACED SUPINE WITH FEET ELEVATED,  STAFF MEMBER CALLED AMBULAN B/P 100/60.  HR UPPER 50S REACHED 70S WITHIN A MINUTE OR TWO.  SAO2 100% RR 20.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Developed fever with chills and itching for both upper arms then rash development same night of vaccines given. Then that night/next day developed redness/edema/warmth/tenderness of both upper arms as well. Seen 12/12/16 in clinic, still with rash and redness but improving per mother, no treatment. No further fevers after night of 12/9/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Developed fever with chills and itching for both upper arms then rash development same night of vaccines given. Then that night/next day developed redness/edema/warmth/tenderness of both upper arms as well. Seen 12/12/16 in clinic, still with rash and redness but improving per mother, no treatment. No further fevers after night of 12/9/16.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: Right arm extremely sore in area where flu shot was administered.
Sex: U
Vaccine: HPV9, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Improperly stored doses were administered to the patients; No adverse effect; This spontaneous report was received from a Nurse Practitioner  (NP) concerning several unspecified patients (age and gender not specified). The NP reported that on unspecified dates several doses of improperly stored GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018) (dosage and route not specified) and PROQUAD (lot# M019232, expiration date 17-OCT-2017) (dosage and route not specified) were administered to unspecified patients.  The storage temperature for GARDASIL 9 was -0.1 degrees Celsius for 38 hours, 20 minutes, -1.67 Celsius for 2 minutes, and 9 Celsius for 13 minutes.  The storage temperature for PROQUAD was 11 degrees Fahrenheit for 15 hours 49 minutes.  No adverse effects were reported.  Additional information is not available. On 09-DEC-2016, a call was placed to the NP and went to voice mail.  A message was left requesting a return call from the NP.  Additionally, a request was made for patient identifiers and dates of vaccines. All telephone attempts to obtain follow-up have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1610USA002815: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of 0.5ml of improperly stored GARDASIL 9 either with lot number L040054 with expiration date of 26-DEC-2017 or L037554 with expiration date of 25-DEC-2017 (strenght and route of administration were not reported) for prophylaxis, which was stored at 1.1 celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA003033: US-009507513-1610USA003034: MERCK 1610USA003032: Mfr number.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age. Medical history and concomitant medications were not provided. On an unspecified date, the patient received ZOSTAVAX. The patient reported that she had "many problems" after receiving ZOSTAVAX.  She did not explain what "many problems" meant". The outcome of the "many problems" was unknown. Additional information is not expected as the patient did not provide contact information.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Death
Clinical narrative: This spontaneous report was received on 09-DEC-2016 from the grandmother of an 11 year old female who experienced adverse events after receiving GARDASIL (see case # 1612USA005619).  The reporter stated that in November 2016 (reported as three and a half weeks ago), a friend of her grandaughter's died.  It was unclear from the statement whether this girl received GARDASIL before her death.  Cause of death was not reported. Upon internal review, died was considered medically significant. Additional information is not expected as the reporter did not provide contact information. Sender's Comments: US-009507513-1612USA005619: Reported Cause(s) of Death: died.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse regarding a currently 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient's vaccination history included TDaP and unspecified flu vaccine. The patient's immunization records showed date in 1997, the patient received vaccination with first dose of PNEUMOVAX 23 from lot # 0906E (expiry date: 02-APR-1999), he received his second dose of vaccination from lot # 0691P (expiry date unknown) on an unknown date in 2005, and he received his third dose of vaccination from lot # 0895AA (expiry date unknown) in approximately 2012 (extra dose administered), (dose, and route unknown). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Pruritus, Swelling face, Throat irritation
Clinical narrative: Patient received the flu shot at 1500. By 1630 her throat started to itch and burn and her chest began to hurt. By 1920 she became short of breath and took a BENADRYL at 1930. When she presented to the emergency department at 2100, worsening facial itching, worsening facial swelling, and difficulty breathing. Patient was given BENADRYL, PEPCID, and SOLUMEDROL 125mg injection. Patient was discharged from the emergency department with improving symptoms at 2200.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Acute disseminated encephalomyelitis, Antibody test, Antinuclear antibody, Blood creatinine
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture, Blood glucose, Blood immunoglobulin G, C-reactive protein, CSF glucose
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: CSF oligoclonal band, CSF protein, CSF test, Cytology, DNA antibody
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Demyelination, Electrocardiogram pacemaker spike, Electrophoresis, Electrophoresis protein, Fungal test
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Glomerular filtration rate, Glycosylated haemoglobin, HIV antibody, HIV antigen, Histone antibody
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Immunoelectrophoresis, Immunology test, International normalised ratio, JC virus test, Lymphocyte count
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test, Mycobacterium test, Nuclear magnetic resonance imaging brain, Prothrombin time, Red blood cell sedimentation rate
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Rheumatoid factor, Treponema test, Varicella virus test
Clinical narrative: DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, MMRV, TD
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Patient has red, warm, swollen area to right upper arm. Area was outlined to see if swelling or redness increased. Patient's parent told that if symptoms got worse to follow up with ED.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient got small bumps on body and was diagnosed with chicken pox by an infectious disease doctor.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Fatigue, Flushing, Paraesthesia oral, Skin irritation, Throat irritation
Clinical narrative: Pt reports feeling very sudden onset of fatigue, flushed face, tongue "feels funny" and some irritation between ears and throat. Explains symptoms as similar reaction to when she eats walnuts. Tongue tingling resolved within about one hour. She went home and laid down and symptoms had resolved within several hours.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Depression, Fatigue, Headache
Clinical narrative: About an hour after injection patient started to feel very tired. As time went on she developed depression, extreme fatigue & headache.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a 12 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 12-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a 12 month old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 12-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a 13 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to a 13 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 19-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to 4 year old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 01-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse refers to 4 year old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored  M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided.  On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 07-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513 1610USA004339: US-009507513-1609USA014830.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 09-SEP-2016, the patient was vaccinated with M-M-R II lot # L036851 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with public funds. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient.The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Sex: M
Vaccine: PNC
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative.  A 45-year-old male patient of an unspecified ethnicity received PREVNAR (lot number unspecified), via an unspecified route of administration on an unspecified date as single dose for immunization.  Medical history included asthma from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  On an unspecified date, patient reported that he had a pretty bad reaction after vaccination that she reported as sore arms, fever and chills. The outcome of sore arms, fever and  chills was unknown.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Redness all over back of arm and down the forearm.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: To this day (12/12/16) I am having intermittent pain at the injection site in the muscle (two months after receiving the shot). The pain is sharp and lasts no longer than a few seconds. The occurrence is approximately 4 or 5 times a day. No other issues and no treatment received.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Administration site infection
Clinical narrative: Patient developed infection at site of administration.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Cellulitis, Injection site swelling
Clinical narrative: Patient reported arm swelling in the arm the vaccine was administered within 15 minutes of getting the vaccine, extending to shoulder, back and fingers. Patient's primary care provider dignosed cellulitis/bursitis and started the patient on anitibiotics. Patient reported feeling better within 24-48 hour of doctor visit.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: Facial swelling , mom giving Diphenhydramine 50 mg q 6 hours x 3 days.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Myalgia, Pain
Clinical narrative: Limited range of motion, deep muscle pain, sharp shooting muscle pain.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Limited range of motion, deep muscle pain, sharp shooting muscle pain.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient experienced localized swelling and redness, about the size of the palm of his hand, over his left bicep. He described it as mildly painful and developed approximately 24 hours after he received the vaccine. Pt elected to monitor for spreading before consulting his doctor. He was not experiencing any shortness of breath or reactions elsewhere.
Age: 90.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Dermatitis diaper, Injection site erythema, Injection site urticaria, Irritability, Pyrexia
Clinical narrative: Fever of 102 lasted over 24 hours, irritable, did not sleep well. Rash on diaper area. Large red welp at vaccine site on leg.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Fever of 102 lasted over 24 hours, irritable, did not sleep well. Rash on diaper area. Large red welp at vaccine site on leg.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 days after flu vaccine, patient developed a "golf ball sized redness at the area of the injection. Area was warm and hard to the touch. By the next day, the redness extended to covering most of the lateral upper arm. Patient was treated with BENADRYL and cool compresses. She did not require antibiotics. The area of redness resolved.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Irritability, Lethargy, Pyrexia
Clinical narrative: Dizziness, lethargy, fever, irritability.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypoaesthesia, Pain, Swelling, Vaccination site pain
Clinical narrative: Per patient report, site of vaccine became painful in evening. Patient went to hospital next day due to pain, swelling, and slight numbness. Patient was reportedly admitted and treated for cellulitis.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Mass, Pain in extremity, Skin warm
Clinical narrative: Patient received PREVNAR 13 and developed a hard lump (about the size of a fifty cent piece) that was red in color and hot to the touch. It made her arm hurt.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Tenderness
Clinical narrative: C/o (R) arm and body tenderness, malaise starting approx 12-16 hrs post vaccination.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt. was given 2 flu shots by mistake, 1st on 9/6/16. 2nd on 12/8/16.
Age: 70.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Had a dull ache at the injection site a month later. Can move arm fine but has on-off pain (left arm).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Administered vaccine in (R) deltoid. Went to push plunger and vaccine would not go in. I explained to patient I would need to stick her again and I changed site on (R) arm and then administered vaccine. No problem at that time. Pt unable to lift (R) arm.
Age: 5.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: The patient was given an adult dose of PNEUMOVAX 23. She was supposed to be given PREVNAR 13. She received a 0.5ml injection of the vaccine in her Right thigh. There were no adverse reaction, but she will have to have the immunization repeated.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of pain, swelling, and decreased function of arm where vaccination was received.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Two days after Dtap immunization given on right thigh, erythema, redness pain developed at injection site.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: FLUZONE given 11 am, pt called 3pm. Tongue swelling advised take BENADRYL if symptoms get worse seek medical attention.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Erythema multiforme, Serum sickness-like reaction
Clinical narrative: 11 days after MMR and VZV vaccines and on day 10 of Amoxicillin rash consistent with erythema multiforme minor vs. serum sickness like reaction.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Had shot at least 2 months ago and still feeling tingly, soreness at site of injection.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Total body urticaria/hives-esp B/L thighs-but also-arms, legs, upper trunk. Not soles, hands or face.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Pallor, Rash generalised
Clinical narrative: Presents to office with a 3.5 cm x 3 cm indurated light red, blanching area to right upper thigh. Day 11 post vaccine, last day of Amox, she developed a full body blanching maculopapular rash.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Presents to office with a 3.5 cm x 3 cm indurated light red, blanching area to right upper thigh. Day 11 post vaccine, last day of Amox, she developed a full body blanching maculopapular rash.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No TRX needed. MMR was given by CMA that was expired pt coming in 30 days for number 2 MMR.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No TRX needed. MMR was given by CMA that was expired pt coming in 30 days for number 2 MMR.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Local rash at injection site. Reported 2 days after administration.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram PQ interval prolonged, Electrocardiogram abnormal, Flushing
Clinical narrative: Left clinic after vaccine. Returned within 20 mins with complaints of facial flushing and fleeting dizziness.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site 7 days post injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis, sought care at an urgent care center and was placed on antibiotics.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: 3 hours after receiving vaccine, pt. became ill, tired, dizzy. Pt. did not feel like himself. Pt. was unable to maintain a conversation. Pt. was in bed for 24hr, not eating. Reaction lasted 36-48 hr. Full recovery.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Fatigue, Malaise
Clinical narrative: 3 hours after receiving vaccine, pt. became ill, tired, dizzy. Pt. did not feel like himself. Pt. was unable to maintain a conversation. Pt. was in bed for 24hr, not eating. Reaction lasted 36-48 hr. Full recovery.