chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000110: US-009507513-1704USA000068: US-009507513-1704USA000112.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of PEDVAXHIB for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000110: US-009507513-1704USA000111: US-009507513-1704USA000068.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70 year-old male patient received PREVNAR 13 (lot R45377, expiry date 01Dec2017, NDC 00005197102) intramuscular in the right deltoid on 12Dec2016 at 0.5 ml single for immunization. Medical history included ongoing arthritis, ongoing diabetes, ongoing gout. Concomitant medications included ongoing glipizide 10 mg tablet since Jun2016 at 10 mg twice a day oral for diabetes, ongoing colchicine 0.5 mg tablet since 27Mar2017 at 0.5 mg twice a day oral for gout, ongoing gabapentin 600 mg tablet since Apr2014 at 600 mg thrice a day oral and indomethacin . The patient experienced sore and numb arm on an unspecified date. No laboratory works were done. The patient was not recovered from the reported events.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. This  physician reported for three patients. This is the third of three patients. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot R19477, Exp. Date Jan2018, NDC number 100009260230), via an unspecified route of administration on 11Mar2017 at 0.5 ml, single in the arm for immunisation. The patient medical history was not reported. Concomitant medication included ZOMIG. The patient experienced pink patch distal to injection site and pain on top of left shoulder on abduction on 12Mar2017 and lump noticed at site of injection on left upper arm on 13Mar2017. The outcome of the events was unknown. All the events were considered non serious and related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness and redness at site of injection; headache-soreness and redness has continued for three days, so far.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on the face.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding an 88 year old female patient. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was vaccinated in error with an expired dose of ZOSTAVAX vial 19400 Plaque-forming unit (PFU) (dose was not reported) subcutaneously (lot number: L037791; expiration date: 30-DEC-2016) for prophylaxis. The patient was also administered sterile diluent injection (strength and dose were not reported) subcutaneously (lot number: L035498; expiration date: 01-MAY-2018). Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an adult female medical assistant, reporting on herself. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-MAR-2017, the patient was vaccinated with an expired dose of VAQTA 25/0.5 (unit not provided) injection (lot # L045713, expiration date 14-JAN-2017, 0.5 ml; site and route of administration were not provided). The medical assistant also reported that the expired dose of VAQTA was a pediatric dose, rather than an adult dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. Their concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M033905 with expiry date 20-JUL-2018 (exact dose and route of administration were not reported). The administered doses were exposed to the temperature between 6 and 14 degrees Fahrenheit for 1 hour and 10 minutes and to the temperature between 15 and 46 degrees Fahrenheit for 2 hours and 10 minutes. Previous temperature excursions included exposure to the temperature between 15 and 46 degrees Fahrenheit for 10 hours and 40 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. None pertinent medical history was reported. The patient's concurrent conditions included penicillin allergy. On 27-MAR-2017, the patient was vaccinated with a dose of PROQUAD (lot # M018635, expiration date 11-OCT-2017, subcutaneously in the thigh; dose was not reported for prophylaxis. Concomitantly, on the same date, the patient was vaccinated in the other thigh with a dose of KINRIX. In March 2017 (it was reported that the patient's mother noticed the reaction on 29-MAR-2017), the patient developed swelling, redness, tenderness and warmth to the touch at the PROQUAD injection site. The patient sought medical attention via physician office visit. The reporter stated that ibuprofen and warm compresses were suggested for treatment of the symptoms. None lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and PROQUAD was not provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a physician on 17-Mar-2017. This case involves a 50-year-old female patient who was vaccinated with first dose of ADACEL (Batch number: U5552AA, expiry date, dose form frequency and route of administration not reported) in the left deltoid on 03-Mar-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as seizure disorder. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-Mar-2017, the same day following the vaccination, the patient developed pain in left arm and shoulder. The patient visited the physician due to the events. Relevant laboratory investigations and corrective treatment was not reported. The outcome of the events was reported as unknown. List of documents held by the sender: None.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had local pain and swelling in the arm from the vaccine. Had a localized site reaction. Patient was instructed to put ice on the injection site,and to take benadryl and Ibuprofen to help with the local reaction to the vaccine. Patient received the vaccine on 4/1/17 and said he woke up on 4/2/17 to pain and swelling from the vaccine. Patient on 4/3/17 went an saw a physician and they gave him Ibuprofen (NSAID) to help with the reaction. Patient had improved from Sunday, 4/2/17 since he was seen in the pharmacy.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Decreased appetite, Dyspnoea, Eructation, Eye discharge
Clinical narrative: Per husband started that day c/o GI upset N/V and belching(gas) called ambulance at home could not breathe but pt belched and felt better did not go to hospital. For two week thereafter c/o off and on fever, muscle aches, GI upset, not eating well. Lost 5-6lbs total weight, third week no symptoms feeling better, fourth week (last 2 days) c/0 off and on fever, muscle aches and eye red with exudate.  Has never seen a doctor at this point per husband. Referred patient to a doctor NOW since only fever and muscle aches are noted on VIS given to patient at time of visit.  No mention of OTC meds by husband. he was "all over the place with symptoms" and I had to struggle to get him on a time line. ASAP physician with evaluation and possible blood work was my suggestion to patient since I am not a physician and we have NO physician on site. Told husband I would be reported a VAERS to the CDC and that he needed to go to the doctor with his wife now.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Myalgia, Nausea, Ocular hyperaemia, Pyrexia, Vomiting
Clinical narrative: Per husband started that day c/o GI upset N/V and belching(gas) called ambulance at home could not breathe but pt belched and felt better did not go to hospital. For two week thereafter c/o off and on fever, muscle aches, GI upset, not eating well. Lost 5-6lbs total weight, third week no symptoms feeling better, fourth week (last 2 days) c/0 off and on fever, muscle aches and eye red with exudate.  Has never seen a doctor at this point per husband. Referred patient to a doctor NOW since only fever and muscle aches are noted on VIS given to patient at time of visit.  No mention of OTC meds by husband. he was "all over the place with symptoms" and I had to struggle to get him on a time line. ASAP physician with evaluation and possible blood work was my suggestion to patient since I am not a physician and we have NO physician on site. Told husband I would be reported a VAERS to the CDC and that he needed to go to the doctor with his wife now.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Weight decreased
Clinical narrative: Per husband started that day c/o GI upset N/V and belching(gas) called ambulance at home could not breathe but pt belched and felt better did not go to hospital. For two week thereafter c/o off and on fever, muscle aches, GI upset, not eating well. Lost 5-6lbs total weight, third week no symptoms feeling better, fourth week (last 2 days) c/0 off and on fever, muscle aches and eye red with exudate.  Has never seen a doctor at this point per husband. Referred patient to a doctor NOW since only fever and muscle aches are noted on VIS given to patient at time of visit.  No mention of OTC meds by husband. he was "all over the place with symptoms" and I had to struggle to get him on a time line. ASAP physician with evaluation and possible blood work was my suggestion to patient since I am not a physician and we have NO physician on site. Told husband I would be reported a VAERS to the CDC and that he needed to go to the doctor with his wife now.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rash erythematous
Clinical narrative: Before lunch time on 3-31-17 Mother called the health dept.  The child got up on 3-31-17 with a red rash covering neck, arms, legs and back. Encouraged to consult pcp and ER visit if mom felt necessary. Mom denied difficulty breathing or any other issue. I called mom at 3:40 pm and rash was improving. I called mom on 4-3-17 and mom reports rash was gone by 4-1-17.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: Patient reported that she had a hypertensive event a few days following the vaccine. She did not say if the doctors thought it was vaccine related, but reported it happened within a few days of receiving the vaccine.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Feeling of body temperature change, Headache, Injection site erythema, Injection site mass
Clinical narrative: Fever, body aches, hot/cold, headache, fatigue, redness/swelling/lump at site of injection.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, body aches, hot/cold, headache, fatigue, redness/swelling/lump at site of injection.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist (who is also the patient) via a company representative. The patient was a female "over 50 years old". Medical history included shingles in 2013 (reported as four years prior to receiving ZOSTAVAX). Concomitant medications were not provided. She had no drug reactions or allergies. On 02-MAR-2017, the patient received ZOSTAVAX to prevent shingles (route and lot # not provided). The patient reported that she had shingles four years prior to receiving the vaccine, which was other than indicated in the prescribing information. After receiving ZOSTAVAX, later that day, she developed itching and swelling up and down her arm that received the ZOSTAVAX vaccine. She continued to have these symptoms for several days. She did not received treatment for the events. The events resolved. The reporter did not rate causality. Additional information is not expected as the patient did not provide consent to follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of an unknown age or gender. There was no information about the patient's concurrent conditions, medical history, concomitant medication, drug reactions or allergies. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD with a Lot number of M038860 and an expiration date of 13-MAR-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14 °F (-14 degrees Celsius (°C) to -10°C) range for a time frame of 4 hours and 40 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. No information regarding the patient's concurrent conditions, medical history or concomitant therapies was provided. On 08-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 (formulation, route of administration were not provided, lot # M003659, expiration date 20-SEP-2017) for prophylaxis. On 15-NOV-2016, the patient was vaccinated with a dose of GARDASIL (formulation, route of administration were not provided, lot # K011562, expiration date: 08-APR-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea
Clinical narrative: This spontaneous report as received from a 50 year old male patient refers to himself. The patient's medical history was not reported. On 24-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot # and dose were not reported) for prophylaxis. Concomitant therapies included LIPITOR. On 27-MAR-2017, the patient experienced diarrhoea and chills. He took "PEPTO BISMOL tablets" for 2 days as treatment and recovered on 29-MAR-2017. The patient did not seek medical attention. He considered diarrhoea and chills to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 2 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 30-MAR-2017, the patient was vaccinated with a dose of M-M-R II lot # L009545, expiration date on 19-MAR-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis, however no adverse events reported. No product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Vaccine for Children (VFC) coordinator refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206, expiration date 27-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 degrees Celsius for 36 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact. Sender's Comments: US-009507513-1704USA000476.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Vaccine for Children (VFC) coordinator refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M037770, expiration date 01-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 degrees Celsius for 36 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact. Sender's Comments: US-009507513-1704USA000270.
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age, race and ethnicity, received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced itching in his back, it looked like chicken pox but it wasn't chicken pox in that area. Antibiotic treatment was required. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, reported similar events for herself and her husband. This is the second of two reports. A male patient of unspecified age received PREVNAR 13 via an unspecified route of administration at single dose on an unknown date for pneumonia immunization. On an unknown date the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On an unknown date the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When was in so much pain, could not sleep and  took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient recovered completely. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017016070 same drug/event, different patient.
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, reported similar events for herself and her husband. This is the second of two reports. A male patient of unspecified age received PREVNAR 13 via an unspecified route of administration at single dose on an unknown date for pneumonia immunization. On an unknown date the area that patient got shot in started to bruise about two inches around and then further out, it became blazing hot and it was at least 6 inches around that came to be really hot and swollen. It lasted a week and finally went to the doctor. On an unknown date the patient also experienced little patch, where it has swollen and turned red, the colour was not returned to normal. When was in so much pain, could not sleep and  took couple of TYLENOL. The doctor prescribed a cream, Triamcinolone for the itching when the swelling had come down and the pain had started to go away. The patient recovered completely. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017016070 same drug/event, different patient.
Sex: F
Vaccine: PNC13, TTOX
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An elderly (around 70 year old) female patient of an unspecified ethnicity received PREVNAR 13 at single dose in one arm, TETANUS VACCINE in the other arm, both intramuscular on an unspecified date one year before this report for immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced arm swelled up all the way down to her elbow on an unspecified date with outcome of unknown. The nurse knew that swelling was an adverse reaction, but this swelling was much more significant: the woman's arm swelled up all the way down to the her elbow.
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative who reported the same event for 2 patients. This is for the 1st of 2 reports. A patient of an unspecified age, race and gender received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a lump underneath the injection spot since an unspecified date with unknown outcome. Sender's Comments: Linked Report(s): US-PFIZER INC-2017142905 same reporter/drug/event different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site mass
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative who reported the same event for 2 patients. This is for the 2nd of 2 reports. A patient of an unspecified age, race and gender received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a lump underneath the injection spot since an unspecified date with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017142827 same reporter/drug/event different patient.
Sex: M
Vaccine: FLUX
Symptoms: Death, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (manufacturer report number- 2017101323) on 20-MAR-2017. This case involves a male patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced fever. On an unspecified date, patient died (reported as dropped dead). The cause of death was not reported. Patient's lab data and corrective treatment were not reported. The events outcome was reported as fatal. It was unknown whether autopsy was performed or not. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with flu shot had fever and died. Case is poorly documented, latency post vaccination is not provided, detailed medical history, past vaccination history and concomitant medication are unknown. Results of laboratory analysis and autopsy report are not provided. Additional information is required to fully assess role of the vaccine in reported event.; Reported Cause(s) of Death: Fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Electrocauterisation, Epistaxis, Heart rate increased
Clinical narrative: Blood pressure extremely high with high pulse rate. 3 nosebleeds that required 2 visits to ER, because of high BP. Then had nose cauterized. Went to cardiologist to get BP and PR under control. Still trying to get it regulated. No problem prior to vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: Blood pressure extremely high with high pulse rate. 3 nosebleeds that required 2 visits to ER, because of high BP. Then had nose cauterized. Went to cardiologist to get BP and PR under control. Still trying to get it regulated. No problem prior to vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Diet refusal, Influenza, Productive cough, Pyrexia, Respiratory syncytial virus infection
Clinical narrative: 12/10/15 he got vaccinated, 6 days later 12/16/15 started getting congested 2 days later 12/18/15 was congested with fever of 103.00 would not and could not breastfeed and was throwing up milk and phlegm. 12/18/15 went to doctor's, sent us home said it was the flu. 1 day later 12/19/15 went to ER since the symptoms were getting worse, they sent us home said it was the flu. 12/20/15 took him back to ER fever was 103.2 still symptoms and they admitted him for positive RSV.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Respiratory syncytial virus test positive, Respiratory tract congestion, Vomiting
Clinical narrative: 12/10/15 he got vaccinated, 6 days later 12/16/15 started getting congested 2 days later 12/18/15 was congested with fever of 103.00 would not and could not breastfeed and was throwing up milk and phlegm. 12/18/15 went to doctor's, sent us home said it was the flu. 1 day later 12/19/15 went to ER since the symptoms were getting worse, they sent us home said it was the flu. 12/20/15 took him back to ER fever was 103.2 still symptoms and they admitted him for positive RSV.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Extreme pain in right thigh-swelling-redness in 6 hrs-"injection was given in right thigh" next day-swelling extreme-extreme pain for 5 days-fever broke in 6 days-this date still very sore.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Hip fracture, Laboratory test, Pneumonia
Clinical narrative: By 6/27/15 she had pneumonia shortly after, a stroke pneumonia 2 more times. In late Jan 2017 or early Feb, a broken hip, then pneumonia. She is coming home tomorrow 3/31/17.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain upper, Flushing, Hypotension, Mouth swelling, Nausea
Clinical narrative: Swelling in the mouth, flushing, stomach pain, nausea and vomiting. Hypotension. Epinephrine auto injector administered by clinic nurse. EMS called. IV fluid administered by EMS. Alert and stable before transport to ER.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Vomiting
Clinical narrative: Swelling in the mouth, flushing, stomach pain, nausea and vomiting. Hypotension. Epinephrine auto injector administered by clinic nurse. EMS called. IV fluid administered by EMS. Alert and stable before transport to ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching at and around the injection site.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Injection site rash, Irritability, Rash
Clinical narrative: Rash on face & legs, fussy. Temp of 100.5 on 4/2/17.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTED PAIN, SWELLING, REDNEESS AND FEVER AT REACTION SITE.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: Shortly after adminstering vaccinations patient felt dizzy. She had a seat on the bench by pharamcy for 15 minutes. After 15 minutes she felt fine and left the store with her parents.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a  female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2009, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 03-MAR-02017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). No adverse effect were reported. No additional information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dehydration, Exposure during pregnancy, Viral infection
Clinical narrative: Initial unsolicited pregnancy report received from a health care professional (medical assistant) on 11 Aug 2016. This case involves a 17-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number U5186AA, expiration date 14 Mar 2017, dose and site of administration were not reported) via intramuscular route on 11 Aug 2016. Pregnancy information of last menstrual period (LMP) was 01-Jun-2016 and estimated delivery date was not reported. Patient's medical history and concomitant medication was not reported. Mother's health during pregnancy, specify risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. It was a case of vaccine exposure during pregnancy. At the time of this report, the patient did not experience any adverse events. Treatment for infertility were not reported. Follow up information received from health care professional on 20-Mar-2017. This case involve 18-year-old patient. Patient's smoking history, alcohol history was reported as none. Patient had two previous pregnancy, one is current pregnancy and one miscarriage. Patient had one spontaneous abortions prior to 20 weeks gestation. On an unspecified date, post vaccination, the patient had experienced viral illness and dehydration. On an unspecified date, the patient was hospitalized. Outcome of the events was not reported. Documents held by sender: none. Sender's Comments: A 17 year old pregnant patient experienced viral illness and dehydration after vaccination with MENACTRA. Time to onset was unknown. The events are unlisted with the vaccine. No medical history or concomitant medication have been reported. Additional information regarding patients concurrent medical condition, concomitant medication and medical history with previous vaccinations is required. There could be a possibility of alternate etiology for the events due to some underlying medical condition during pregnancy. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eyelid margin crusting, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 20-MAR-2017. This case involves a female patient (Onset age unknown) who was intramuscularly vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose were not reported) in an unknown site on an unknown date of OCT-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as allergy to mushroom and Illness at the time of vaccination was reported as not provided. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient's eyes became irritated and crusty and she was sick for a couple of days and also had fever, red and crusty eyes, and was sick for a few days on previous vaccination. The patient also had a previous vaccination with FLUZONE HD 2 years ago. The patient did not required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bedridden, Burning sensation, Guillain-Barre syndrome, Migraine
Clinical narrative: Textbook GB symptoms but mild as I was not paralyzed or on respirator. I have recurring problems still. Burning hands, feet, legs, arm, weakness, at times my body burns everywhere, horrible migraines as well. There was a time I thought I might die, my neuro system is wrecked. I get extra weak and bedridden at times.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological symptom
Clinical narrative: Textbook GB symptoms but mild as I was not paralyzed or on respirator. I have recurring problems still. Burning hands, feet, legs, arm, weakness, at times my body burns everywhere, horrible migraines as well. There was a time I thought I might die, my neuro system is wrecked. I get extra weak and bedridden at times.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Dyspnoea, Urticaria
Clinical narrative: Patient developed a welt on arm and went to doctor about trouble breathing--had bronchitis and was giving antibiotic and inhaler--drew marker around welt to see if it got better/worse 04/02/2017.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin mass
Clinical narrative: Erythema and swelling on her right arm, hard knots under the skin.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Electromyogram normal, Injected limb mobility decreased, Injection site mass, Joint swelling
Clinical narrative: Swelling in elbow, into upper back, severe shoulder joint pain. Unable to lay on right side. Her pain and swelling persisted for two months before she sought treatment. She has been diagnosed with lymphedema and had a palpable mass at the site of injection. After several sessions of physical therapy, she has only regained 60% use of her right arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphoedema, Nerve conduction studies normal, Swelling, X-ray limb normal
Clinical narrative: Swelling in elbow, into upper back, severe shoulder joint pain. Unable to lay on right side. Her pain and swelling persisted for two months before she sought treatment. She has been diagnosed with lymphedema and had a palpable mass at the site of injection. After several sessions of physical therapy, she has only regained 60% use of her right arm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: itchy rash on chest and back consistent with urticarial. Given steroids and Benadryl.
Age: 55.0
Sex: F
Vaccine: FLUC4, HEPA, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt reported swelling and redness in upper left arm, with redness distributed over the lateral aspect of the upper arm from elbow to shoulder. Pt visited clinic 4/3/2017 to report reaction and said that swelling and redness were improving. She did not experience any itching, though she did take Tylenol for pain. Pt was planning on getting a TST at an urgent care so I encouraged pt to discuss the reaction with her provider.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report was received from a 65-year-old male consumer with no pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. Historical vaccine include: Approximately on 01-FEB-2017 reported as "six weeks prior", the patient received a dose of PNEUMOVAX 23 for prophylaxis (dose, route, lot number, expiration date, and frequency were unspecified); and subsequently, on 13-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX on his left arm, therapy route reported as "vaccine", dose and frequency reported as "one-time vaccine" (strength, lot number, and expiration date were not provided) for prophylaxis (reported as shingles). Afterward, on 15-MAR-2017, the patient had a reaction at the injection site and additionally, the patient reported that he experienced irritation and swelling "around the size of a golf ball", in the injection site. The patient sought unspecified medical attention but no laboratory tests or diagnostic procedures were performed, however, it was reported that the patient received an unspecific treatment. At the time of this report, it was unknown whether the patient recovered or not from the adverse events. The causal relationship between the therapy with ZOSTAVAX and the adverse events were not provided. No product quality complaint was involved. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician concerning an approximately one year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 27-MAR-2017 (reported as today), the patient was vaccinated with one dose of VARIVAX (strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis and with one dose of PROQUAD (strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions or drug allergies were not reported. On 25-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and dose were not reported) administered subcutaneously (lot # M033904 expiration date: 20-JUL-2018) for prophylaxis. A sterile diluent (lot # and expiration date were unknown) was used to reconstitute the dose. According to the reporter, VARIVAX was exposed to the following temperature excursion: 2 hours between 6 degrees Fahrenheit (F) and 14 F. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA014489:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 28-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength and dose were not reported) administered subcutaneously (lot # M042498 expiration date: 17-APR-2018) for prophylaxis. An sterile diluent (lot # and expiration date were unknown) was used to reconstitute the dose. According to the reporter, PROQUAD was exposed to the following temperature excursion: 73 minutes between 6 degrees Fahrenheit (F) and 14 F. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013987.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Agitation, Anger, Burning sensation, Erythema, Induration
Clinical narrative: This is a spontaneous report from a contactable physician. A 70-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Expiry Date Mar2018, NDC # 0005197102, UPC # 100009468481) intramuscular at 0.5 ml, single on 23Mar2017 for immunisation, PLAVIX via an unspecified route of administration at 75 mg, from an unspecified date to an unspecified date for an unspecified indication. Medical history included chronic obstructive pulmonary disease (COPD), Heart valve disorders, solitary pulmonary nodule, blood cholesterol. Concomitant medication included alendronate sodium, levothyroxine, metoprolol, oxybutynin, pravastatin, prednisone, sertraline, budesonide, SYMBICORT, trazodone, VENTOLIN HFA, zolpidem. On 24Mar2017 the patient experienced injection site was slightly hemorrhagic, whole arm was full red, slightly indurated. On an unspecified date the patient experienced burning sensation. Course of events: Physician stated that the patient came back with a huge hemorrhagic around the whole arm on the right hand side: injection site was slightly hemorrhagic but then her whole arm was full red, slightly indurated and she was also complaining of burning sensation. The patient started to develop all the symptoms on the following day. The patient is very agitated and angry. The physician told her it could be anything. Hemorrhagic was quite a lot, it went from arm to forearm. Skin of the patient was slightly indurated because she was older. Normally their skin is loose and handy so this particular area where the hemorrhage is indurated and burnt. The outcome of the events was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Skin haemorrhage
Clinical narrative: This is a spontaneous report from a contactable physician. A 70-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Expiry Date Mar2018, NDC # 0005197102, UPC # 100009468481) intramuscular at 0.5 ml, single on 23Mar2017 for immunisation, PLAVIX via an unspecified route of administration at 75 mg, from an unspecified date to an unspecified date for an unspecified indication. Medical history included chronic obstructive pulmonary disease (COPD), Heart valve disorders, solitary pulmonary nodule, blood cholesterol. Concomitant medication included alendronate sodium, levothyroxine, metoprolol, oxybutynin, pravastatin, prednisone, sertraline, budesonide, SYMBICORT, trazodone, VENTOLIN HFA, zolpidem. On 24Mar2017 the patient experienced injection site was slightly hemorrhagic, whole arm was full red, slightly indurated. On an unspecified date the patient experienced burning sensation. Course of events: Physician stated that the patient came back with a huge hemorrhagic around the whole arm on the right hand side: injection site was slightly hemorrhagic but then her whole arm was full red, slightly indurated and she was also complaining of burning sensation. The patient started to develop all the symptoms on the following day. The patient is very agitated and angry. The physician told her it could be anything. Hemorrhagic was quite a lot, it went from arm to forearm. Skin of the patient was slightly indurated because she was older. Normally their skin is loose and handy so this particular area where the hemorrhage is indurated and burnt. The outcome of the events was unknown.
Sex: M
Vaccine: MENB
Symptoms: Chills, Influenza
Clinical narrative: This is a spontaneous report from a contactable customer communicated to a sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single for Protection against Neisseria meningitides serogroup B.  The patient medical history and concomitant medications were not reported.  The patient experienced flu symptoms like chills on an unspecified date with outcome of unknown.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2017051212) on 20-Mar-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS VACCINE AND TOXOID (Tetanus Toxoid) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date following vaccination (Latency unknown), the patient experienced allergy to tetanus vaccines and toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient got cellulitis at injection site.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Immune system disorder, Sinusitis, Syncope
Clinical narrative: Light headed and faint 5 minutes after vaccine.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Within an hour I experienced rapid heartbeat and elevated blood pressure, I don't have blood pressure problems. This lasted about 8 hrs afterwards.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Tenderness
Clinical narrative: PATIENT C/O TENDERNESS AND SWELLING, INSTRUCTED TO APPLY WARM COMPRESS.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Headache, Palpitations, Vertigo, Vision blurred
Clinical narrative: Symptoms included blurred vision, headache, feeling of heart racing, feeling of difficult breathing, vertigo.  Symptoms improved while laying.  Treatment given has been antihistamine.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events/Flu vaccine given in error.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tremor
Clinical narrative: Patient reports that her arm has been shaking since she received her vaccination. (Right arm).