chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Haemorrhage, Poor quality drug administered
Clinical narrative: This spontaneous case, initially received on 19-Nov-2016, was reported by a non health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. At the time of the event the patient had Haemophilia B. Concomitant medication: Factor IX recombinant (Idelvion). Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for Indication not reported. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient developed bleed in leg after flu shot (Medically Significant, outcome: Recovered / Resolved). It was reported that the vials and connection seemed defective (outcome: Recovered / Resolved). Special circumstances: Poor quality drug administered.; Reporter's Comments: Reporter's assessment: The events were considered non-serious. The causality assessment for the event 'bleed in leg' was related as the patient thought that the 'bleed legs' was the result of flu shot.; Sender's Comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, bleeding/haemorrhage and product quality issue are unlisted. Causality: Not Related. Patient had underlying bleeding disorder for which he was receiving factor IX. There were issues with administration of this product, which may have resulted in bleeding. Vaccination is considered not causally attributable.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a non health care professional on 19 Oct 2016. This case involves a 58-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UF678AE, expiration date, dose not reported) via intramuscular route in the left deltoid on 04 Oct 2016. Patient medical history was not reported. Patient had no known allergies and illness at time of vaccination was reported as none. Any other vaccinations within 4 weeks of vaccinations were reported as none. Concomitant medication was not reported. On 04 Oct 2016, same day post vaccination; the patient experienced pain in arm radiating down arm and tingling and numbness in left arm. Lab data and corrective treatment was not reported. The patient was not recovered from the events. Follow-up information received from a non-health care professional on 18 November 2016. The patient had not received the FLUZONE QIV, patient had received FLUZONE QIV (batch number, expiry date, route, dose, dose in series were not reported) in an unknown site on an unknown date. This is not our product so there is no information on this. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pain
Clinical narrative: Initial unsolicited report received from healthcare professional (Regeneron Medical Specialist) on 03 November 2016. This case involves a 50-year-old male patient (age reported as In 50s) who was vaccinated with dose of INFLUENZA VACCINE (FLU SHOT) and one inection of ALIROCUMAB (Praluent injection) (batch number, expiration date, site and route of administration was not reported for both) on an unspecified date. Medical history and concomitant medication was not reported. On an unspecified date patient experienced "fatigue and felt achy" approximately six days after first Praluent injection and it was reported that patient received a flu shot "just prior to symptom onset. Lab data and corrective treatment were not reported. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dysphagia, Oropharyngeal discomfort
Clinical narrative: Initial unsolicited report received from a physician on 31 October 2016. This case involves 79-years-old male patient who was vaccinated with dose of FLUZONE HD (Batch number, expiry date, dose, dose number and site of administration was not reported) via intramuscularly on 31 October 2016. Patient's Illness at time of vaccination was reporter as none and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Any other vaccinations within 4 weeks of vaccination and concomitant medications were not reported. On 31 October 2016, two hours following vaccination patient experienced low grade temperature also had difficulty in swallowing and felt like a hand was pressing the throat. Patient requires ER/doctor visit and emergency room in case of allergic reaction. Lab data and corrective treatment were not reported. The Outcome of events was reported as unknown. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Gait disturbance, Local swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a consumer on 17 November 2016. This case involves a four-year-old male patient who was vaccinated with a dose of Fluzone Quadrivalent (batch number: unknown, expiration date, dose, site and route of administration were not reported) intramuscularly in the left leg on 15 November 2016. Patient's Illness at time of vaccination was reported unknown and Pre-existing physician diagnosed allergies, birth defects and medical conditions included no known allergy and gets big red areas from mosquito bites. It was reported that patient required emergency room or doctor visit. Concomitant medications were not reported. On 15 November 2016, same day following the vaccination, the patient developed localized swelling with redness which was warm and hot which progressed over two days (was now 6 inches in diameter) and started to limp. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pain in extremity, Skin warm
Clinical narrative: Initial unsolicited case received from a consumer (patient himself) on 17 Nov 2016. This case involves a 70 year old female patient who was vaccinated with a second dose of FLUZONE HD (Batch number: UI636AB, Expiry date: 27 Mar 2017, route of administration was not reported) in arm right site on 06 Sep 2016. The patient illness at the time of vaccination was reported as none and the patient had allergies to dust mites and ragweed, asthma and aortic valve leak, the patient was previously vaccinated with Fluzone HD one year before, and the patient any other vaccinations within four weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 06 Sep 2016, few hours after vaccination the patient right arm began to feel pain at the injection site and was painful for approximately one week and a week after receiving the vaccine the injection site began to itch and the patient stated that the itching is constant and on an unknown date the patient stated that when her arm is warm, the itchiness increases in intensity, and the patient stated there is nonvisible rash at site. The patient required emergency room or doctor visit. (Reported as she is making an appointment to see her physician) The patient lab tests were reported as none. The patient had taken Benadryl for the itching, and applies cortisone cream alternating with gold bond cream with lidocaine, and applies ice to the area. These methods give her temporary relief. The outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 18-NOV-2016. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUZONE HD batch number and expiration date not reported, intramuscularly, in left deltoid on an unspecified date (reported as October). Patient previous dose reported as unknown. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (reported as October), following the vaccination, the patient's left arm was swollen from the injection site to the elbow. Lab data and corrective treatment were not reported. On an unspecified date, the patient recoevered from the event (Back to normal after a week). List of documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Guillain-Barre syndrome, Mobility decreased, Pain in extremity
Clinical narrative: SORENESS IN LEGS, THEN BY 11-8 UNABLE TO WALK OR USE HANDS/ARMS/LEGS/FEET. DX WITH GUILLAIN BARRE SYNDROME.  STILL AT REHAB FACILITY 12-1-16.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Dizziness, Dysgeusia, Dyspnoea, Hypertension
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified). On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified). On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Severe swelling from elbow to shoulder, skin hot, tender and painful to touch, worsened throughout the day.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Loss of consciousness, Syncope
Clinical narrative: Two minutes after receiving the HPV vaccine, patient fainted. She was sitting on the Exam Table when she began to look weak. I was standing to her right, and leaned her onto me and then back on to the Exam table as she loss conciouisness. Patient was awake, alert and orientated with in 5 seconds after fainting.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Approximately 10 minutes after vaccination, patient vomited. Patient does have a history of vomiting so it is not clear if it was related to vaccination.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm is 19.5 cm at mid bicep (17 cm at mid bicep on the left). Swelling/redness and warmth extending inferiorly from site of vaccine at the Rt. deltoid and involved entire Rt upper arm. Only very mild tenderness.
Age: 0.75
Sex: M
Vaccine: FLU4, HEP
Symptoms: Body temperature increased
Clinical narrative: TYLENOL 102.7 R after vaccines.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site induration
Clinical narrative: Left deltoid 7x8 cm induration with bruising.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient is having extreme arm pain and spasms.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Asthenia
Clinical narrative: Pt brought to facility as transfer from another facility one day after receiving 2mo vaccinations c/o fever, stiffness, weakness, and loss of appetite. Pt found to have clinical sepsis of uknown etiology (all cultures have been negative to date and MRI showed no evidence of encephalopathy or meningitis) with end organ toxicity (transaminitis, AKI, anemia, and hypoglycemia to 20). Pt was admitted to PICU and placed on 7 day course of IV ceftriaxone, vancomycin, and acyclovir. Pt afebrile for last 5 days of admission, improved clinically, tolerated PO feeds, and activity back to baseline. Discharged on 12/1/16 with f/u appt with pediatrician on 12/5/16.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Coagulopathy, Culture negative, Cytogenetic analysis normal, Decreased appetite, Hypoglycaemia
Clinical narrative: Pt brought to facility as transfer from another facility one day after receiving 2mo vaccinations c/o fever, stiffness, weakness, and loss of appetite. Pt found to have clinical sepsis of uknown etiology (all cultures have been negative to date and MRI showed no evidence of encephalopathy or meningitis) with end organ toxicity (transaminitis, AKI, anemia, and hypoglycemia to 20). Pt was admitted to PICU and placed on 7 day course of IV ceftriaxone, vancomycin, and acyclovir. Pt afebrile for last 5 days of admission, improved clinically, tolerated PO feeds, and activity back to baseline. Discharged on 12/1/16 with f/u appt with pediatrician on 12/5/16.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Intensive care, International normalised ratio increased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Prothrombin time prolonged
Clinical narrative: Pt brought to facility as transfer from another facility one day after receiving 2mo vaccinations c/o fever, stiffness, weakness, and loss of appetite. Pt found to have clinical sepsis of uknown etiology (all cultures have been negative to date and MRI showed no evidence of encephalopathy or meningitis) with end organ toxicity (transaminitis, AKI, anemia, and hypoglycemia to 20). Pt was admitted to PICU and placed on 7 day course of IV ceftriaxone, vancomycin, and acyclovir. Pt afebrile for last 5 days of admission, improved clinically, tolerated PO feeds, and activity back to baseline. Discharged on 12/1/16 with f/u appt with pediatrician on 12/5/16.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Pyrexia, Sepsis, Thrombocytopenia, Transaminases increased, Ultrasound liver normal
Clinical narrative: Pt brought to facility as transfer from another facility one day after receiving 2mo vaccinations c/o fever, stiffness, weakness, and loss of appetite. Pt found to have clinical sepsis of uknown etiology (all cultures have been negative to date and MRI showed no evidence of encephalopathy or meningitis) with end organ toxicity (transaminitis, AKI, anemia, and hypoglycemia to 20). Pt was admitted to PICU and placed on 7 day course of IV ceftriaxone, vancomycin, and acyclovir. Pt afebrile for last 5 days of admission, improved clinically, tolerated PO feeds, and activity back to baseline. Discharged on 12/1/16 with f/u appt with pediatrician on 12/5/16.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Culture, Discomfort, Injection site erythema, Injection site reaction
Clinical narrative: Erythema, swelling, purulent drainage @ injection site.  Pt is elderly discomfort, noticed slight discomfort on day after vaccine, didn't pay much attention to it.  Site seen by family and they called for f/u care on 11/29.  Pt seen on 11/30 and dx with cellulitis and tx'd with doxycycline.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Purulent discharge
Clinical narrative: Erythema, swelling, purulent drainage @ injection site.  Pt is elderly discomfort, noticed slight discomfort on day after vaccine, didn't pay much attention to it.  Site seen by family and they called for f/u care on 11/29.  Pt seen on 11/30 and dx with cellulitis and tx'd with doxycycline.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood glucose, Electrocardiogram, Loss of consciousness
Clinical narrative: Pt loss consciousness for approximately 10 seconds upon administering Tdap and seasonal flu vaccine.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, MENB, VARCEL
Symptoms: Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling, joint pain in L shoulder. Not present prior to vaccination.  Using ibuprofen and ice to shoulder. Referal made to MD.  Con't to have symptoms 12/01/2016.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase, Arthralgia, Aspartate aminotransferase, Blood bilirubin, Blood glucose
Clinical narrative: Mom states patient started with joint pain about 2 weeks after 1st injection. 1st dose given 3/3/16, 2nd dose given 5/18/16.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein, Cytomegalovirus test, Full blood count, Metabolic function test, Spinal X-ray
Clinical narrative: Mom states patient started with joint pain about 2 weeks after 1st injection. 1st dose given 3/3/16, 2nd dose given 5/18/16.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test, Ultrasound abdomen
Clinical narrative: Mom states patient started with joint pain about 2 weeks after 1st injection. 1st dose given 3/3/16, 2nd dose given 5/18/16.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: 15 minutes p vaccine, began whelps to back. Was given Benadryl decadon, Pepcid and resolved in 30-45 minutes.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable consumer.  A female patient of unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 19Nov2016, as single dose for immunization. The patient's medical history and concomitant medications were not reported. On 22Nov2016, the patient experienced soreness around injection site following injection and rash around injection site. The outcome of soreness around injection site following injection and rash around injection site was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Sensory disturbance
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 90-year-old female patient of an unspecified race received  PREVNAR 13 on 21Nov2016 at single dose for immunisation.   The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient previously took PENUMOVAX 23 for immunisation when she was 82 years old.   The patient was unable to move her feet/lower extremities since an unspecified date in Nov2016 with unknown outcome and could not feel her feet, lower legs on 22Nov2016 with outcome of recovering. The patient had never complained of her feet before. The reporter said it was difficult to differentiate between generalized pain and if the symptoms were paresthesia.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Dizziness, Feeling of body temperature change, Headache
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer (the patient).  An 81-year-old female patient reported for herself that she received PREVNAR 13, via an unspecified route of administration on 21Nov2016 at single dose in right upper arm for immunisation .  No other vaccines were administered concomitantly or within 4 weeks. Medical history included blood pressure abnormal, type 2 diabetes mellitus, anxiety, insomnia, knee surgery and bilateral pneumonia in latter part of 2013.  The patient previously took pneumococcal vaccine in Jan 2014, and Flu shot every year. The patient reported that she never had pneumococcal 13-val conj vac (dipht crm197 protein) before. Concomitant medication included lisinopril (unknown manufacturer) started a year or more ago for blood pressure, metformin (unknown manufacturer) for type 2 diabetes started two years ago, sertraline hydrochloride (ZOLOFT) started taken at least 2 or 3 years ago for anxiety and insomnia (she took care of grandson and she got anxiety and could not sleep at night), atorvastatin (unknown manufacturer), tramadol (unknown manufacturer) for knees because knee surgery did not correct the problem. The patient experienced feeling hot and cold on 22Nov2016, chills on 23Nov2016, muscle weakness on 24Nov2016, muscle pain on 24Nov2016, dizzy on Nov2016, sweating on Nov2016, headache on 22Nov2016, no energy on Nov2016, flu like symptoms on Nov2016. All the events recovered at the end of  Nov2016. The events did not require a visit to emergency room or to physician office. The patient underwent lab tests and procedures which included nuclear magnetic resonance imaging  months ago to follow up on knee.  Therapeutic measures taken as a result of flu like symptoms included treatment with TYLENOL.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Influenza like illness, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer (the patient).  An 81-year-old female patient reported for herself that she received PREVNAR 13, via an unspecified route of administration on 21Nov2016 at single dose in right upper arm for immunisation .  No other vaccines were administered concomitantly or within 4 weeks. Medical history included blood pressure abnormal, type 2 diabetes mellitus, anxiety, insomnia, knee surgery and bilateral pneumonia in latter part of 2013.  The patient previously took pneumococcal vaccine in Jan 2014, and Flu shot every year. The patient reported that she never had pneumococcal 13-val conj vac (dipht crm197 protein) before. Concomitant medication included lisinopril (unknown manufacturer) started a year or more ago for blood pressure, metformin (unknown manufacturer) for type 2 diabetes started two years ago, sertraline hydrochloride (ZOLOFT) started taken at least 2 or 3 years ago for anxiety and insomnia (she took care of grandson and she got anxiety and could not sleep at night), atorvastatin (unknown manufacturer), tramadol (unknown manufacturer) for knees because knee surgery did not correct the problem. The patient experienced feeling hot and cold on 22Nov2016, chills on 23Nov2016, muscle weakness on 24Nov2016, muscle pain on 24Nov2016, dizzy on Nov2016, sweating on Nov2016, headache on 22Nov2016, no energy on Nov2016, flu like symptoms on Nov2016. All the events recovered at the end of  Nov2016. The events did not require a visit to emergency room or to physician office. The patient underwent lab tests and procedures which included nuclear magnetic resonance imaging  months ago to follow up on knee.  Therapeutic measures taken as a result of flu like symptoms included treatment with TYLENOL.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Blood culture positive, Decreased activity, Dyspnoea, Electrocardiogram, Hypophagia
Clinical narrative: Decreased activity, lethargy. Decreased oral intake, vomiting, difficulty breathing.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Laboratory test, Lethargy, Vomiting, X-ray
Clinical narrative: Decreased activity, lethargy. Decreased oral intake, vomiting, difficulty breathing.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Peripheral swelling
Clinical narrative: Whole arm became swollen, noticed taste in her mouth afterward.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Glossodynia, Seizure
Clinical narrative: Pt had seizure. Provided care and comfort. Made sure pt was better before leaving clinic. Rx: Triple mix for tongue sore.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: I did not observe the adverse event happen, but patient reported that a rash developed a few days after receiving the shingles (ZOSTAVAX) vaccine. He came back into pharmacy on 11-28-16 and reported the possible adverse reaction and showed the rash. It had small red bumps in the armpit area. It was all over that area plus a few inches further. Patient was not reporting any other effect or issue.
Age: 8.0
Sex: M
Vaccine: FLU4, HPV9, MENB
Symptoms: Activities of daily living impaired, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called in and informed nurse his arm was very sore, involving the entire shoulder. He canceled his usual activities due to this pain. Advised to use ice/cool therapy at site, and could take OTC mild pain reliever
Age: 6.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm with area of erythema and warmth distal to injection site left upper arm - area approx. 4 cm long x 2 cm across.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Pain in extremity, Pruritus, Pyrexia, Urticaria
Clinical narrative: Several hours after receiving a TDAP patient felt ill and developed a fever. The area where she had received her vaccine was itchy and patient had some pain with arm movement. She also developed large hives on the same arm which radiated to her shoulder. Treatment was cool compresses to the area, take an ALAVERT daily and use 1%  Hydrocortisone cream to the area 3-4 times a day.
Age: 48.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Large rash on arm at the injection site. Rash was approximately 6 in. long, 3 in. wide. Raised, Red bumps, sore, pain, and itchy.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported her arm was extremely red and swollen - more than usual after previous immunizations.
Age: 56.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Injection site redness, swelling & redness; Fever, chills, extreme all over body pain, headache.
Age: 56.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site redness, swelling & redness; Fever, chills, extreme all over body pain, headache.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect product storage
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 15 patients. This is 9th of 15 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient's medical history and concomitant medications were not reported. Pneumococcal 13-val conj vac (dipht crm197 protein) was exposed to 11 degrees Celsius for eight days. On an unspecified date the patient received pneumococcal 13-val conj vac (dipht crm197 protein) after temperature excursion. Pneumococcal 13-val conj vac (dipht crm197 protein) Lot#, Expiration date# and NDC# was provided (Lot# Q02071, Expiration date# Jan2018, NDC# 0005197101), however it was not confirmed if all patients were administered with the same Lot# or not. Sender's Comments: Linked Report(s): US-PFIZER INC-2016548681 Same drug/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Insomnia, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's parent). A female patient of unspecified age and race/ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient was very nauseous, throw up, dizzy, tired, sleep less at night all on unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cardiac arrest, Death, Dyspnoea, Immediate post-injection reaction, Syncope
Clinical narrative: Pt developed immediate SOB and syncope. Was hospitalized from 10/28/16 to 11/1/16 for cardiac arrest following Pneumovax. She then was readmitted 11/9/16 and died.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Death, Dyspnoea
Clinical narrative: Pt developed immediate SOB and syncope. Was hospitalized from 10/28/16 to 11/1/16 for cardiac arrest following Pneumovax. She then was readmitted 11/9/16 and died.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Decreased appetite, Grip strength decreased, Myalgia, Nausea
Clinical narrative: Sever Body Pains, muscle aches, unable to hold anything with hands, joint pains, nausea, loss of appetite.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Vaccination complication
Clinical narrative: Sever Body Pains, muscle aches, unable to hold anything with hands, joint pains, nausea, loss of appetite.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Rash erythematous, Rash pruritic, Throat irritation
Clinical narrative: Indurated, pruritic, red rash entire left arm (same arm injected with IIV) and then extending onto chest, scratchy throat starting minutes after shot and resolving with diphenhydramine, decadron.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient called our clinic today (12-01-2016) to report this adverse event. She states the problem is a result of the Tdap vaccine. Adverse Event: Leg pain. Pain has persisted off and on. Patient sought treatment at MD, Chiropractor and at hospital ER. Diagnosis: muscle spasms. Treatment has been muscle relaxers, physical therapy. Lumbar X-Ray was done.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site reaction, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Bright red rash from injection site down arm to elbow (approx.  4 inches x 5 inches); pt also said she has felt badly (fever, general malaise) reported 12/01/2016- assuming onset 11/29 or 11/30.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient has been experiencing prolonged pain in arm after vaccine. Also pain when raises arm or lifts anything, on 12/1/16 patient asked about when to take to help or if need to see doctor.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Electrocardiogram, Laboratory test, Neuralgia, Neuropathy peripheral
Clinical narrative: Severe pain localized in center of left shoulder. Would last 30 minutes and took my breath away. Lasted several weeks followed by pain of radial nerve localized on left arm, pain concentrated on left wrist. Had to wear splint to immobilize wrist. Total symptoms lasted 4 months and as of 12/1/16 still have some neuropathy in left hand.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, X-ray
Clinical narrative: Severe pain localized in center of left shoulder. Would last 30 minutes and took my breath away. Lasted several weeks followed by pain of radial nerve localized on left arm, pain concentrated on left wrist. Had to wear splint to immobilize wrist. Total symptoms lasted 4 months and as of 12/1/16 still have some neuropathy in left hand.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Pain, Pneumonia, Pyrexia
Clinical narrative: Described body ache that nite after receiving flu shot. Experienced fever the next day of 102 (10/12/2016) along with body ache. Had symptoms for about 8 days-went into MD/clinic at that time. Was found to have pneumonia. Antibiotics were prescribed.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Cyst, Drug administered at inappropriate site, Dyspnoea, Inflammation, Injected limb mobility decreased
Clinical narrative: Lot 157003 Given at facility - It already felt weird going in because I noticed it was placed too high, but could not stop it. I hoped it would be okay but within days, I could not move my arm and was in constant pain. Treatment with corticosteroid injection (had reactions of 2-3 word dyspnea, palpitation, nausea, three pillow orthopnea) and pain returned within two months. MRI revealed multiple cysts formed with dystrophy of all surrounding shoulder muscles. Received PT but still living with cysts and occasional flare of inflammation with related sever shooting pain and immobility.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site reaction, Nausea, Nuclear magnetic resonance imaging abnormal, Orthopnoea
Clinical narrative: Lot 157003 Given at facility - It already felt weird going in because I noticed it was placed too high, but could not stop it. I hoped it would be okay but within days, I could not move my arm and was in constant pain. Treatment with corticosteroid injection (had reactions of 2-3 word dyspnea, palpitation, nausea, three pillow orthopnea) and pain returned within two months. MRI revealed multiple cysts formed with dystrophy of all surrounding shoulder muscles. Received PT but still living with cysts and occasional flare of inflammation with related sever shooting pain and immobility.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: Lot 157003 Given at facility - It already felt weird going in because I noticed it was placed too high, but could not stop it. I hoped it would be okay but within days, I could not move my arm and was in constant pain. Treatment with corticosteroid injection (had reactions of 2-3 word dyspnea, palpitation, nausea, three pillow orthopnea) and pain returned within two months. MRI revealed multiple cysts formed with dystrophy of all surrounding shoulder muscles. Received PT but still living with cysts and occasional flare of inflammation with related sever shooting pain and immobility.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Red rash about 3 inches by 3 inches developed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site vesicles, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient said on the night of the injection she developed a large "blister" over the injection site. Her arm itched the next day. On 12/29 she presented to the pharmacy to show her reaction. Her entire upper arm from shoulder to elbow was dark red, warm to the touch, slightly swollen and tender. She wanted to point out that she has a flu shot every year, except the prior year and that this was the first time she had received the FLUZONE HIGH DOSE injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Patient said on the night of the injection she developed a large "blister" over the injection site. Her arm itched the next day. On 12/29 she presented to the pharmacy to show her reaction. Her entire upper arm from shoulder to elbow was dark red, warm to the touch, slightly swollen and tender. She wanted to point out that she has a flu shot every year, except the prior year and that this was the first time she had received the FLUZONE HIGH DOSE injection.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Wheezing
Clinical narrative: Heavy wheezing/headache. Wheezing lasted around 20 minutes. Headache at time of this email.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient complained of nerve pain of arms and legs. Had reaction later in the night of date of administration on 9/27/16 and had to seek medical attention by going to ER. Patient has discussed to primary care physician of adverse reaction and was referred to neurologist for further evaluation.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Localized hard knot in deltoid muscle, swelling of the entire arm and hand, pain in arm and shoulder area and scapula, temperature in arm.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria multiple episodes daily now for 1 week.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Asthma, Malaise, Vaccination complication
Clinical narrative: Woke up feeling ill. Thought it was my sinuses or that I might be catching a cold. Took my OTC's and went to work. On 12/01/2016 went to work feeling ill and ended up having an asthma attack.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain
Clinical narrative: PAIN IN UPPER LEFT SHOULDER/BACK (SAME SIDE AS SHOT WAS GIVEN IN THAT ARM).  PAIN REMAINED IN THAT AREA AND ALSO IN LOWER BACK FOR ALMOST 5 DAYS NOW.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site infection, Injection site streaking, Injection site swelling
Clinical narrative: STREAKING AND "INFECTION" NEAR THE INJECTION SITE. STREAKING ABOVE THE INJECTION. BUMP FELT AT SITE.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Fever/chills, redness and swelling at injection site.  Arm was very sore, hard to move it.  Took aleve for pain/swelling.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever/chills, redness and swelling at injection site.  Arm was very sore, hard to move it.  Took aleve for pain/swelling.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Pain, Pain in extremity, Palpitations
Clinical narrative: Pt. reported feeling dizzy, palpitations, sweaty hands, pain throbbing down arm to fingers and up to neck.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Same night as injection patient stated arm was sore and warm to touch. She left town early the next day (11/23) and went to Urgent Care. Patient states "arm mushroomed quickly" & Dr at urgent care could feel swelling and heat of arm through a sweater and coat. Arm was swollen from top of shoulder to elbow. She stated her symptoms were: itchy, hot, red, swollen, couldn't touch. Urgent care did cold compress, gave BENADRYL. Urgent care offered a steroid which she declined to receive. She did cold compress and BENADRYL for 3 & 1/2 days after her urgent care visit till the heat and swelling subdued.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction of L arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Injection pain was intense and felt like it hit something. Said it was painful injection and by evening she couldnt move arm at all and couldnt sleep due to pain. By next morning it was quite a bit better, sore bur much improved. Pt feels shot was too high. Some days are worse than others, some days not so bad. Pt did see her PA 3 weeks later and she said they could do PT. Pt denied because she didnt have time.  It is really bad now in shoulder and has decided to do therapy.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction L leg.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Right arm from sholder to elbow is red and hot to the touch.  Patient feels feverish and chills.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Gradually got worse after the shot.  Pain on the upper shoulder and when he lifts his arm to insert arm in sleeve or fix his belt he is in pain.
Age: 10.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Dizziness, Loss of consciousness, Nausea, Seizure
Clinical narrative: Dizziness, nausea, seizure and loss of consciousness.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Severe itchiness at the site of the injection, and a feeling of warmth at the site of injection.  The symptoms continued  on 12/1/16 at which time the patient contacted the immunizing pharmacy.  I (the pharmacist on duty) advised applying a cold pack and the taking of oral antihistamine.  Patient is well as of now.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain, X-ray
Clinical narrative: The day after my flu shot, noticed severe pain in my shoulder while picking up a bottle of laundry detergent. I also noticed limited mobility in the shoulder. The pain (both while the shoulder is in motion and while still) and the limited range of motion remain to this day.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient came to pharmacy saying that the very same day he recieved the shot, his arm got swollen and he came down with a high fever.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Experienced severe pain in upper arm/shoulder (left arm) about 3-5 days after injection-I am still experiencing pain and limited range of motion 3 months later. I am currently seeking medical help.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Skin warm
Clinical narrative: Patient developed spots on torso and felt a bit warm per mom on 11/29/16.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Fatigue, Pruritus, Rash generalised, Skin exfoliation
Clinical narrative: Hands-sore and itchy with skin peeling off generalized rash on body-small red spots. Very tired.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient received vaccine 11/28/16. Next day developed warm, tender hard, indurated area at site of shot; no fever, chills or night sweats just pain 5/10. Area of redness has not spread passed initial area of inflammation. Some pain when lifting arm.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient received vaccine 11/28/16. Next day developed warm, tender hard, indurated area at site of shot; no fever, chills or night sweats just pain 5/10. Area of redness has not spread passed initial area of inflammation. Some pain when lifting arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain
Clinical narrative: Flu shot given 11/16/16 on the (L) upper arm. She states she start feeling the pain over hr. later. The pain did not go away after a week. Took pain meds/warm compression on the site no relief. 2 wks past by no relief - she feels a knot on the (L) arm C/O muscles like being pull. Pain 7/10.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled up to elbow, took 3 days to return to normal.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Ear pain, Headache, Insomnia, Myalgia
Clinical narrative: Headache Pain in muscles, legs, arms stabbing pain in ears. Back pain still some pain in back could not sleep all night TYLENOL 1:00AM ALEVE 900AM.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Rash, itching, pain throughout whole body. No treatment reported/For 4 months.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Swelling (L) arm "size of her hand. LDT; tender to touch BENADRYL and ice.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not reported. On 23-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L001311, Expiration date: 06-JUL-2016 (Strength and dose were not reported) via intramuscular. No adverse experiences were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 20 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2015, the patients were vaccinated with improperly stored doses of VARIVAX lot # L001335 with expiration date 31-JAN-2017 (dose and route were not reported). It was stated that the temperature excursion was 74 F for 37 minutes. No previous temperature excursions were reported. It was stated that the call was made because a data logger. No adverse effects reported. There was not a product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This solicited report was received from an MR moderator, and refers to a 45 year old female enrolled in a Market Research Program. The patient's medical history, concomitant medications wand concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose number, dose, route of administration, lot number and expiry date not reported). After receiving the HPV vaccine, the patient fainted (syncope). The doctor's office called for an ambulance. At the time of the report, it was unknown if the patient had recovered from the event. The reporter did not provide a causality between fainting and therapy with GARDASIL 9. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Patient C/O acute (R) arm myalgia, which she contributes to the pneumonia vaccine. Pt. unable to lift affected arm without pain.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 17-NOV-2016 from a nurse. The nurse reported that on an unspecified date, a patient (age and gender not reported) received a dose of PEDVAXHIB (lot # M021594, expiration date 22-MAR-2019) and a dose of ROTATEQ (lot # M007301, expiration 19-NOV-2017) that were improperly stored. The temperature was 49.5 degrees Fahrenheit for 9 hours and 2 minutes. No previous temperature excursion were reported. No adverse effects were reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Eye pruritus, Headache, Throat irritation
Clinical narrative: 1 hour after developed eye itching, throat itching, dizziness, headache. Called and reported today.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased
Clinical narrative: Unable to move arm in certain directions. Saw Urgent Care. Saw Orthopedics Dr. received steroid shot. Orthopedics Dr. - surgery on 10/20/2016.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a 43 years old "MR" her moderator concerning her kids (The patients' age and gender were not provided). It was reported that the reporter was enrolled in a market research program. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patient's kids were vaccinated with a dose of varicella virus vaccine (manufacturer unknown) (lot #, expiration dates and dosages were not informed), (route was reported as injection). Concomitant therapies were not informed. On an unspecified date, the patients got rash after getting varicella vaccine (manufacturer unknown). At the time of the reporting, the outcome of rash was reported as unknown. The causal relationship between rash and varicella virus vaccine (VARIVAX) was not reported. Additional information has been requested.