chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Initial unsolicited report received from a pharmacist on 17 Oct 2016. This case is link with 2016SA191745 (same vaccine). This case involves a male patient (age was reported as 65 plus) who was vaccinated with a dose of Fluzone HD (batch number: UI620AD, expiry date and dose was not reported) via intramuscular route in right deltoid on 05 September 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as no known allergy and illness at time of vaccination was reported as none. Concomitant medications were not reported. On 06 September 2016, one day following the vaccination, the patients had red spots all over the body and itching. Patient visited healthcare professional who could not provide a diagnosis. Lab data was not reported and it was unknown if patient received corrective treatment. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Initial unsolicited report received from a pharmacist on 17 Oct 2016. This case is link with 2016SA191745 (same vaccine). This case involves a male patient (age was reported as 65 plus) who was vaccinated with a dose of Fluzone HD (batch number: UI620AD, expiry date and dose was not reported) via intramuscular route in right deltoid on 05 September 2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as no known allergy and illness at time of vaccination was reported as none. Concomitant medications were not reported. On 06 September 2016, one day following the vaccination, the patients had red spots all over the body and itching. Patient visited healthcare professional who could not provide a diagnosis. Lab data was not reported and it was unknown if patient received corrective treatment. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site infection, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) on 17-Oct-2016. This case involves a 68-year-old male patient who was vaccinated with FLUZONE HIGH DOSE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and with 0.5 ml single injection of PNEUMOVAX 23 via intramuscular route (batch number: L035687, expiry date: 16-Feb-2017, manufacturer: Merck; dose in series and site of administration were not reported) on 30-Sep-2016. The patient's pertinent medical history, drug allergy and concomitant medications were reported as none. On 01 Oct 2016, one day following the vaccination, the patient had pain at the Pneumovax injection site area that also looked infected and patient went to emergency room and was not admitted. On 03 Oct 2016, the patient went back to emergency room as reaction was spreading and getting worse. Patient was hospitalized on 03-Oct-2016 and was diagnosed as cellulitis on an unspecified date. The patient was still in hospital at the time of reporting. The patient's laboratory data was not reported. Patient received unspecified antibiotics as corrective treatment. The outcome of event was reported as not recovered. List of documents held by sender: none. Sender's Comments: Cellulitis at the injection site was reported after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE. Time to onset is compatible with the role of the vaccine. Further information on the patient's previous immunization history and tolerance, diameter of cellulitis, concurrent conditions and lab data to confirm alternative etiology/diagnosis etc. will be needed to completely assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Injection site infection, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) on 17-Oct-2016. This case involves a 68-year-old male patient who was vaccinated with FLUZONE HIGH DOSE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and with 0.5 ml single injection of PNEUMOVAX 23 via intramuscular route (batch number: L035687, expiry date: 16-Feb-2017, manufacturer: Merck; dose in series and site of administration were not reported) on 30-Sep-2016. The patient's pertinent medical history, drug allergy and concomitant medications were reported as none. On 01 Oct 2016, one day following the vaccination, the patient had pain at the Pneumovax injection site area that also looked infected and patient went to emergency room and was not admitted. On 03 Oct 2016, the patient went back to emergency room as reaction was spreading and getting worse. Patient was hospitalized on 03-Oct-2016 and was diagnosed as cellulitis on an unspecified date. The patient was still in hospital at the time of reporting. The patient's laboratory data was not reported. Patient received unspecified antibiotics as corrective treatment. The outcome of event was reported as not recovered. List of documents held by sender: none. Sender's Comments: Cellulitis at the injection site was reported after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE. Time to onset is compatible with the role of the vaccine. Further information on the patient's previous immunization history and tolerance, diameter of cellulitis, concurrent conditions and lab data to confirm alternative etiology/diagnosis etc. will be needed to completely assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 25-year-old female patient who received FLUARIX QUADRIVALENT (batch number C29T5, expiry date 30th April 2017). Co-suspect products included cephalexin unknown for product used for unknown indication. On 15th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 17th October 2016, the patient started cephalexin at an unknown dose and frequency. On 15th October 2016, 2 hrs after receiving FLUARIX QUADRIVALENT and not applicable after starting cephalexin, the patient experienced injection site erythema (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter) and injection site swelling (serious criteria other: as per reporter). In October 2016, the patient experienced skin disorder (serious criteria other: as per reporter). The action taken with cephalexin was unknown. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and skin disorder were unknown. The reporter considered the injection site erythema, injection site pain and injection site swelling to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the skin disorder to be related to FLUARIX QUADRIVALENT and cephalexin. Additional details were reported as follows: Within several hours after vaccination, the patient experienced redness, swelling and pain at the site. The patient was seen at the physician's office and prescribed cephalexin antibiotic which was started on 17th October 2016. The patient's mother called back to the pharmacy and noted the patient had developed bumps, but it was not clear if that was due to the antibiotic or due to FLUARIX QUADRIVALENT.
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 25-year-old female patient who received FLUARIX QUADRIVALENT (batch number C29T5, expiry date 30th April 2017). Co-suspect products included cephalexin unknown for product used for unknown indication. On 15th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 17th October 2016, the patient started cephalexin at an unknown dose and frequency. On 15th October 2016, 2 hrs after receiving FLUARIX QUADRIVALENT and not applicable after starting cephalexin, the patient experienced injection site erythema (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter) and injection site swelling (serious criteria other: as per reporter). In October 2016, the patient experienced skin disorder (serious criteria other: as per reporter). The action taken with cephalexin was unknown. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and skin disorder were unknown. The reporter considered the injection site erythema, injection site pain and injection site swelling to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the skin disorder to be related to FLUARIX QUADRIVALENT and cephalexin. Additional details were reported as follows: Within several hours after vaccination, the patient experienced redness, swelling and pain at the site. The patient was seen at the physician's office and prescribed cephalexin antibiotic which was started on 17th October 2016. The patient's mother called back to the pharmacy and noted the patient had developed bumps, but it was not clear if that was due to the antibiotic or due to FLUARIX QUADRIVALENT.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction, Dry eye, Eye irritation, Eye pruritus, Ocular icterus
Clinical narrative: My healthy eyes began to burn and feel dry and itchy about an hour after the flu shot.  They were really bad last night and I used cool compresses.  Today they look pink and yellowish tinted.   But feel better.  I don't know if the flu shot goes to my liver and that's why they look funny, or if it was just some weird reaction.  It has never happened before.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Pain in extremity, Pallor
Clinical narrative: Approximately 1 hour after receiving the flu shot, my daughter reported feeling dizziness and weakness and arm pain extending from her shoulder to her hand and tingling in her fingers. She also appeared pale. Gave her TYLENOL and clear fluids and continued to monitor her closely. At 11:00 PM, the weakness and dizziness had decreased, but she reported feeling extreme fatigue and the arm pain/tingling continued. At 7:00 AM, she still felt fatigued and pain in entire arm, but the tingling in her fingers has resolved. Antihistamines and MOTRIN given.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Approximately 1 hour after receiving the flu shot, my daughter reported feeling dizziness and weakness and arm pain extending from her shoulder to her hand and tingling in her fingers. She also appeared pale. Gave her TYLENOL and clear fluids and continued to monitor her closely. At 11:00 PM, the weakness and dizziness had decreased, but she reported feeling extreme fatigue and the arm pain/tingling continued. At 7:00 AM, she still felt fatigued and pain in entire arm, but the tingling in her fingers has resolved. Antihistamines and MOTRIN given.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Facial paralysis, Laboratory test, Nuclear magnetic resonance imaging brain
Clinical narrative: Left sided facial paralysis.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: Severe joint pain. Shoulders, elbows, wrists, knees. Weakness in arm given. No treatment, just Tylenol and Celebrex. Gradually getting better over 2 weeks. Still have weakness in arm although it is improving and still have right knee pain.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. An adult patient of an unspecified ethnicity and gender received PREVNAR 13 at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced injection site reaction to prevnar 13: the injection site had swelling and was red, the injection site had swelling and was red. The outcome of the events was unknown. The patient treated the patient with Benadryl and cold compression, and asked about any other suggestions. The reporter queried whether the vaccine has any preservative/additives.
Age: 73.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A 73 year old male patient of an unspecified ethnicity received, on 11Oct2016, the second dose of PREVNAR 13, (Lot. M51193, Expiration date: May2017, NDC number: 00005197102) intramuscularly, in the right arm, 0.5 ml, single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine (Manufacturer: Sanofi), received on same date of Pfizer vaccine, in the right arm. The patient previously received one other dose of PREVNAR 13 for immunization, on an unspecified date. On an unspecified date, the patient experienced sore arm and his body was achy. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Acne, Injection site reaction
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received, on an unspecified date, PREVNAR 13 single dose, for immunization. Relevant medical history included asthma, chronic kidney disease, high cholesterol, hypertension, and osteopenia. Concomitant medications were unknown. On an unspecified date, the patient experienced multiple pimple-like spots at injection site. Patient reported that it was not painful and no swelling was noted. Clinical outcome of the event was unknown at time of this report.
Age: 68.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This is a spontaneous report received from a contactable pharmacist via a Pfizer sales representative. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medication included influenza vaccine (unspecified trade name), via an unspecified route of administration in the other arm, the same unspecified day of PREVNAR 13, for immunisation. The patient experienced burning sensation while injection on an unspecified date with outcome of unknown.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Extra dose administered, Musculoskeletal pain, X-ray limb
Clinical narrative: This is a spontaneous report from a contactable other health care professional on behalf of a physician. A 66 years old male patient received the 2nd dose of PREVNAR 13 (Lot# M73332, Exp Date Jul 2017, NDC 0005-1971-01), intramuscular in the left arm, on 21Jul2016, at 0.5 ml single, for immunisation. Relevant medical history was none. Concomitant medications were not reported. The patient previously received 1st dose of PREVNAR 13 in 2001 for immunisation with no adverse effect. The patient experienced severe shoulder pain in Jul2016, 3-4 days after vaccination, with outcome of not recovered. The event was evaluated at physician office. The event worsened in the last 2 weeks. The patient underwent lab tests and procedures which included: blood work and x-ray of left shoulder on 20Oct2016.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Myalgia, Neck pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 84-year-old female patient of unspecified ethnicity started to receive PREVNAR; (lot number N16561, expiration date 30Sep2017), intramuscularly, in an unspecified deltoid, on 11Oct2016, at 0.5 ml, as single dose for immunization.  Medical history was reported as none.  Concomitant medications included: OMNISEPT, 300 mg two times a day, lidocaine 5% ointment (TRADE NAME UNSPECIFED), once a day, hydrocodone bitartrate, NORCO, every four hour as needed, PYRIDIUM, 200 mg, three times as day and RAPAFLO, 8 mg, once a day.  On 11Oct2016, the patient experienced sore neck, muscle pain in left quadriceps and could not walk.  The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. No treatment was received for the reported events.  The patient was recovering from sore neck, muscle pain in left quadriceps and could not walk at the time of reporting on 19Oct2016.  No causality was reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. An adult female patient of an unspecified age (reported as over 65) and race received, on an unknown date, PREVNAR 13 single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine. On an unspecified date, the patient experienced pain that prevented movement at the shoulder in the arm where was administered pneumococcal 13-val conj vac (dipht crm197 protein) (she received the flu shot in the other arm). She also had swelling in her hand. Clinical outcome was unknown at time of this report.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823,2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age an d gender not reported) who was vaccinated with a dose FLUZONE)(batch number:UI669AA, expiration date: 30 June 2017 and site of administration was not reported) intramuscularly, on an unspecified date (over the past month). Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medication was not reported. On an unspecified date (over the past month), following the vaccination, the patient had large red spot, warm to touch and raised hard spot. It was reported that the patient required emergency room or doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from pharmacist on 14 October 2016. This case involves 66- year-old female patient who was vaccinated with dose of Fluzone HD (Batch number: UI666AA, expiration date 13 April 2017, dose and route of administration was not reported) in left deltoid on an 14 October 2016. Patient Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects and medical conditions include latex and almond allergy and hypertension. Concomitant medication was reported as none. On 14 October 2016, 20 minutes following vaccination patient had tingling in her left middle finger lasting 10 minutes, now finger was slightly numb. Lab data reported as none. Corrective treatment was not reported. On 14 October 2016 patient recovered from tingling in her left middle finger. Outcome of other event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Initial unsolicited report received from a consumer on 14 October 2016. This case involves a female patient (age at event onset not reported) who was vaccinated with a dose of Fluzone QIV via intramuscular route (Batch number: UI678AB, expiry date: 30 June 2017; dose, dose in series and site of administration were not reported) on 06 October 2016. Information regarding patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at the time of vaccination were not provided. No further information regarding medical history was available. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 07 October 2016, one day (reported as within 24 hours) following the vaccination, the patient developed severe headache. Patient required emergency room (ER) visit and was hospitalized. Laboratory investigation was not reported. Corrective treatment was unknown. On unspecified date the patient was recovered from the event. The patient discharged from hospital on an unknown date and duration of hospitalization was reported as 5 days. List of documents held by sender: none. Sender's Comments: This poorly documented case of a patient had severe headache following INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine. Time to onset is compatible, but additional information regarding patient medical history, any history of migraine, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information role of vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site warmth
Clinical narrative: Initial unsolicited report received from nurse on 14 October 2016. This case involves female patient (age not reported) who was vaccinated with dose of Adacel (Batch number, expiration date, dose, site and route of administration was not reported) on April 2016. Medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had a large dark area around the upper arm; injection site was warm and feverish to the touch. Lab data and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal pain upper, Hyperhidrosis, Skin odour abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 16 October 2016. This case involves a patient (age at onset of event and gender not reported) who was vaccinated with Flu shot (batch number, expiry date of the product, route and site of administration, dose and dose in series were not reported) on an unspecified date. It was reported that the patient had been receiving flu shots every year. No further information regarding medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient started getting bad stomach pains, sweating profusely with sweat really smelling bad. It was reported that patient almost called the emergency. Laboratory data and corrective treatment were not reported. Patient was recovered from the events may be after a duration of about 45 minutes. The reporter's causality assessment was not reported but the pharmacy which the patient had called, 'didn't think it was was the injection'. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Viral infection
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 17 October 2016. This case is linked with 2016SA191698 (same batch number and same reporter). This case involves 31-year-old female patient who vaccinated with dose of Fluzone Qiv (Batch number: UI684AE, expiration date, dose, site and route of administration was not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had severe myalgia, viral infection and symptoms were only in leg. Lab data and corrective treatment were not reported. It was reported that patient received sought treatment for severe myalgia. Outcome of events was not reported. It was reported that patient was fine now. Upon internal review this case was considered as serious due to Important Medical Event: Viral Infection. List of documents held by sender: none. Sender's Comments: This case concerns 31 year old patient who received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED developed viral infection. Time to onset is not provided. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain and redness at injection site.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine given.  Pt was given pediatric 6-35 mos instead of adult dose. No adverse symptoms occurred. Pt was given influenza vaccine FLUZONE QUADRIVALENT on the next day by nurse per instructions.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Headache
Clinical narrative: Sharp headaches, Pain level 2-3 most all time with sporadic 20 minute pains of 8-10+ (pain scale of 1-10).
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphagia, Glossodynia, Lip swelling, Lymphadenopathy, Swollen tongue
Clinical narrative: Sore Tongue; swollen tongue; burning sensation on tongue; swollen lips; swollen glands; difficulty swallowing; no problems breathing; took 2 benadryl and 1 zyrtec, per "on call" doctor instructions.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Tongue discomfort
Clinical narrative: Sore Tongue; swollen tongue; burning sensation on tongue; swollen lips; swollen glands; difficulty swallowing; no problems breathing; took 2 benadryl and 1 zyrtec, per "on call" doctor instructions.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient returned about 2 days after shot. Rash in a circle around admin site. About 9.5" in diameter - slightly swollen. Not painful.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Bronchitis viral, Diverticulitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 59 year old female patient. The patient had a history of phlebitis of left upper leg. Her concurrent conditions included Lyme Disease. She was also allergic to unspecified sulfa drugs, lactose, shellfish, feathers, grasses, trees and dust mites. On 19-NOV-2015, the patient was vaccinated with a first dose of RECOMBIVAX HB injection, 1 ml, intramuscularly, lot # K020218, expiry date 24-OCT-2016 (site of administration was not reported). Concomitant therapies included aspirin (manufacturer unknown) and unspecified vitamins. On 05-JAN-2016, the patient received the second dose of RECOMBIVAX HB injection, 1 ml, intramuscularly, lot/batch # reported as L013051, expiry date 15-APR-2017 (site of administration was not reported). On an unknown date, the patient experienced diverticulitis and viral bronchitis and was hospitalized due to the events on an unknown date. She was treated with unspecified antibiotics at an unspecified hospital. The outcome of the events was not reported. The nurse stated that, on an unknown date, the patient was seen by an unspecified healthcare provider and was cleared to receive third dose of RECOMBIVAX HB. The relatedness between the events and RECOMBIVAX HB was not provided. Upon internal review, the event of diverticulitis was considered to be medically significant. Additional information is not expected, as there was no consent given to contact the reporter.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had redness and swelling at injection site for 2 days, beginning on the evening of vaccination date - also had slight fever and chills. No treatment.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, unable to lift arm in certain directions 3 weeks after flu shot.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, unable to lift arm in certain directions 3 weeks after flu shot.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: Injection site-pain, 1 inch welt, tingling down arm and joint pain in elbow and fingers.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling cold, Pyrexia, Tremor
Clinical narrative: Fever 102,chills, shaking, difficulty breathing.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Redness and swelling at injection site, fever, chills for 2 plus days. only local reaction remained on 10/26. No treatment.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Skin warm, Swelling
Clinical narrative: Allergic type reaction, swelling (baseball size), redness, hot skin, no anaphylaxis signs.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain
Clinical narrative: Patient complains of "significant" pain in deltoid from PNEUMOVAX shot on 9/29/16.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported upper arm pain and was treated in a urgent care clinic w/antibiotics and anti-inflammatory meds.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Flushing, Pharyngeal oedema, Tachycardia
Clinical narrative: Initial unsolicited report received from nurse on 13-Oct-2016. This case involves a female patient (unknown age) who was vaccinated with 0.5 ml dose of Fluzone QIV (batch number: UI625AA, expiry date: 30-JUN-2017, site of administration was not reported) via intramuscular route on 03-Oct-2016 at employee health room. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other vaccinations within 4 weeks and concomitant medications were reported as unknown. On 03-Oct-2016, within 10 minutes after receiving the vaccination, the patient became tachycardic with heart rate was greater than 130 bpm, Systolic blood pressure was 160, diastolic blood pressure was greater than 100 and patient also had flushing at chest and neck, felt tightness in chest and throat felt swollen. It was also reported that patient had no respiratory compromise. It was reported that the patient required emergency room or doctor visit and patient was seen by a physician in employee health. Laboratory investigations were reported as unknown. Corrective treatments includes 8 mg. of Decadron IM, and 50 mg. of Benadryl, followed by an additional dose of 50 mg. of Benadryl 6 hours later, and another 50 mg of Benadryl 6 hours after the second dose. On 04-OCT-2016, patient recovered from the all events within 48 hours of duration. Upon internal review, the case was considered as serious due to important medical event tachycardic with a heartrate greater than 130 bpm, flushing of her chest and neck, Systolic B/P was160, diastolic pressure was greater than 100, felt a tightness in her chest and throat felt swollen. Documents held by sender: none. Sender's Comments: In this case, the reported events and rapid onset of symptoms are consistent with hypersensitivity reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), immune status at the time of vaccination, medical history including allergies, concomitant medications, complementary investigations ruling out alternate etiology and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, the role of vaccine cannot be excluded.
Sex: U
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: Initial unsolicited report received from a physician on 15-Oct-2016. This case involves a patient (unknown age and gender), who was vaccinated with FLUZONE HD (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unknown date. The medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient had developed serum sickness and had a reaction. Lab test and the corrective treatment was not reported. The outcome of the events was not reported. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Mother stated the child developed a fever of 105 degrees between 2-3 pm on 10/25/16. She was accessed at the medical center and no problem identified per mother.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in the mouth, growing progressively stronger as time passes.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Erythematous patch (7x7 cm) with pain and swelling. Painful in evening after vaccination, painful and red the next morning, progressively getting bigger.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Ocular hyperaemia, Pruritus
Clinical narrative: ITCHING ON BACK. EYE RED. DIARRHEA.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Local swelling, Skin warm
Clinical narrative: Patient is stating that on the day he received his shot, he had localized swelling that progressed to his entire shoulder. He said it felt as if it had fever and the area bruised. Today, four days later, evidence of bruising still remains and patient claims fluid moved from shoulder into forearm.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: Sore throat, draining sinuses, body aches (2 hours later).
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a patient's mother via a company representative and refers to a 12 year old female patient. She did not have any pertinent medical history, drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, site, dose and route of administration were not reported). Concomitant vaccines included an unspecified influenza virus vaccine, administered at the same time the patient received GARDASIL 9. On the same day, after vaccination, she felt dizzy and lightheaded. The patient sought medical attention, she was taken back to the physician's office and sat down until she recovered. No treatment was given for the event and no lab diagnostic studies were performed. The outcome of the event was recovered on 17-OCT-2016. The relatedness between the event and GARDASIL 9 was not reported. Additional information is not expected due to lack of the reporter's contact details.
Sex: U
Vaccine: FLU4
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a child patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site cellulitis, injection site erythema, injection site abscess and injection site swelling. On an unknown date, the outcome of the injection site cellulitis, injection site erythema, injection site abscess and injection site swelling were recovering/resolving. The reporter considered the injection site cellulitis, injection site erythema, injection site abscess and injection site swelling to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of FLUARIX QUADRIVALENT in an unknown deltoid. The injection site was red, swollen and appeared as a cellulitis with an abscess. The physician did not have the charts at the time of reporting.  The physician denied any serious criteria concerns. The physician had limited information, but would have nurse call back with more details. This case was linked to case, US2016155828 as reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Injected limb mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received HAVRIX 1440 adult (batch number MB3Y2, expiry date 10th June 2018). Concomitant products included FLUZONE. On 4th October 2016, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) 1 ml. In October 2016, less than a month after receiving HAVRIX 1440 adult, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved. The reporter considered the injected limb mobility decreased to be probably related to HAVRIX 1440 adult. Additional details were provided as follows: At 12:20 hours, the patient received HAVRIX 1440 adult vaccine in her right deltoid and had difficulty in lifting arm. On the same day, the patient concomitantly received FLUZONE (batch number: UI664AA, expiry date: 6th April 2017) in her left deltoid.
Age: 61.0
Sex: F
Vaccine: FLUX, MNQ, PPV
Symptoms: Chills, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received MENVEO. Previously administered products included Pneumococcal Vaccine (adverse events) and influenza vaccine (no adverse events). Concomitant products included Flu Seasonal TIV Dresden (Influenza vaccine unspecified) and Pneumococcal vaccine. On 19th October 2016, the patient received MENVEO. On 19th October 2016, less than a day after receiving MENVEO, the patient experienced chills. On 20th October 2016, the patient experienced fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the chills and fever were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the chills and fever to be possibly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. On Wednesday 19th October 2016, the patient received MENVEO on right arm, at the age of 61 years, which led to inappropriate age at vaccine administration. The patient received Pneumococcal vaccine right arm and Flu Seasonal left arm. The reporter does not know the manufactures of the products or the names. The reporter stated that, because she has had a flu vaccine and pneumonia vaccine in the past, she only believes the side effects are related to the Meningitis vaccine. One day after receiving Meningitis vaccine, the patient experienced fever. The patient received Meningitis vaccine at the age of 61 years, which led to inappropriate age at vaccine administration. The patient had not notified her physician of the events, but was encouraged to do so.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Had a FLUZONE high dose PFS 2016-17 on October 14 at the pharmacy. In addition to the significant bruising, pain, swelling and large red mark at site of the injection where shot was given, (which were listed as likely side effects and are not at issue) I had a large spreading red welt a couple of inches below the injection mark and by the evening of October 16th also developed hives on my legs and arms. BENEDRYL relieved the symptoms of the hives on my arms and legs by morning. The large red welt continued for about a week. I do not have a known latex allergy, but I do have a history of developing hives as an allergic reaction to anti-inflammatories such as aspirin and MOTRIN. I had not taken any other medications during or before this time period nor am I aware of being exposed to any other allergens. My pharmacy has my allergy records on file. The injection site is still bruised and painful, but that is probably due to the lack of skill of the person who administered the shot rather than the drug.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Had a FLUZONE high dose PFS 2016-17 on October 14 at the pharmacy. In addition to the significant bruising, pain, swelling and large red mark at site of the injection where shot was given, (which were listed as likely side effects and are not at issue) I had a large spreading red welt a couple of inches below the injection mark and by the evening of October 16th also developed hives on my legs and arms. BENEDRYL relieved the symptoms of the hives on my arms and legs by morning. The large red welt continued for about a week. I do not have a known latex allergy, but I do have a history of developing hives as an allergic reaction to anti-inflammatories such as aspirin and MOTRIN. I had not taken any other medications during or before this time period nor am I aware of being exposed to any other allergens. My pharmacy has my allergy records on file. The injection site is still bruised and painful, but that is probably due to the lack of skill of the person who administered the shot rather than the drug.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Very painful with injection. Arm continued to get more sore & stiff. Can't move arm to certain degrees or use it for certain activities. Can't lay on arm affected as is painful. Doing ROM and advil to prevent stiffness. Notified dr and pharmacy of issue.  Going on for >3 WKs now. Will probably go to Dr next wk to seek PT therapy.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Very painful with injection. Arm continued to get more sore & stiff. Can't move arm to certain degrees or use it for certain activities. Can't lay on arm affected as is painful. Doing ROM and advil to prevent stiffness. Notified dr and pharmacy of issue.  Going on for >3 WKs now. Will probably go to Dr next wk to seek PT therapy.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: By 8:00 PM 10/24/1016. Fever 101 Temp. Chills. Muscle pain. Weak. Not hungry. Off and on headache. Treatment with aspirin, fever gone by next morning, muscle pain lasted all the next day, weakness lasted until 3rd day, still not 100%.
Age: 52.0
Sex: M
Vaccine: FLU4, HEP, HEPA, PNC10
Symptoms: Chills, Injection site swelling, Nausea, Vomiting
Clinical narrative: Pt had swelling at right arm injection site, 2x normal size plus pain in to right pectoral. Vomiting, nausea and chills.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Increased pain in arm/shoulder, limited range of motion.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Increased pain in arm/shoulder, limited range of motion.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm and surrounding area were red and swollen.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: ARM SWELL UP, WAS RED AND IT HURT. PATIENT SAID SHE TOOK BENADRYL AND WAS OK AFTERWARDS.
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site numbness in a female patient who received FLUARIX QUADRIVALENT (batch number CS979, expiry date 14th June 2017). Concomitant products included LEVAQUIN. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site numbness. On an unknown date, the outcome of the injection site numbness was unknown. It was unknown if the reporter considered the injection site numbness to be related to FLUZRIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient had numbness on the same arm where the injection was given. It was not known in which arm the vaccine was received. No additional details were known. This patient was going to visit the nurse the next day after reporting date for an appointment and the nurse practitioner said she would have more details then. The nurse practitioner reported minimal details for 3 different patients. All had the shot administered somewhere else within the hospital system but mentioned the events to this healthcare provider. She did not administer the vaccine. It is not known if CS979 is the exact lot number of the administered vaccine but she assumed it might be since it was the lot she had. She was also in a hurry to speak with Medical Information (MI) and was quickly providing information and now allowing all questions to be asked. This case was 1 of the 3 cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a adult female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the enlargement of lymph nodes to be unlikely related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date, within the previous couple of weeks from reporting date, the patient received FLUARIX QUADRIVALENT.  Side and site of injection was unknown. The patient experienced swollen lymph nodes under her arm. The swollen lymph nodes were specific to the opposite side that the patient received vaccine. It was reported that, issue described by the patient was going away and was returning at the time of reporting.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: Had large redness, pain and swelling. Rt upper forearm, had redness and bruising Left lower forearm times 2 days.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological examination normal, Paraesthesia
Clinical narrative: (L) arm tingling w/out weakness. Neuro exam WNL.