chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site swelling
Clinical narrative: Injection site got swollen after getting vaccine. Spoke to patient today (11/2/17), patient said she feeling better and swollen is better.
Age: 4.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Aggression
Clinical narrative: My child has received a flu vaccine which contained polyethylene Glycol and has had bad aggression issues which he had last year when receiving the flu shot and also when taking MIRALAX.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dysgraphia, Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: 11/1/17 - vaccine given at 0950 - experienced pain in (R) shoulder/arm. 11/2/17 - student C/O pain in arm/armpit, has pea sized red area at injection site that has a indurated area below surface that is felt. Student can't raise (R) arm above shoulder/head and it hurts to use his (R) hand to write, started yesterday.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 11/1/17 - vaccine given at 0950 - experienced pain in (R) shoulder/arm. 11/2/17 - student C/O pain in arm/armpit, has pea sized red area at injection site that has a indurated area below surface that is felt. Student can't raise (R) arm above shoulder/head and it hurts to use his (R) hand to write, started yesterday.
Age: 8.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: 11/1/17 - vaccine given at 0950 - experienced pain in (R) shoulder/arm. 11/2/17 - student C/O pain in arm/armpit, has pea sized red area at injection site that has a indurated area below surface that is felt. Student can't raise (R) arm above shoulder/head and it hurts to use his (R) hand to write, started yesterday.
Age: 1.42
Sex: M
Vaccine: MMR, PPV
Symptoms: Aphasia, Decreased eye contact, Gene mutation identification test positive, Malaise, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: High Fever, Rash, sick for months, loss of speech, loss of eye contact, loss of motor planning abilities.
Age: 1.42
Sex: M
Vaccine: MMR, PPV
Symptoms: Motor dysfunction, Pyrexia, Rash
Clinical narrative: High Fever, Rash, sick for months, loss of speech, loss of eye contact, loss of motor planning abilities.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Ear pain, Headache, Lip pruritus
Clinical narrative: Started at 1630 with severe arm and neck pain on L side, unable to turn head with pain. 1800 progressed to L ear pain with nausea and headache. 1900-1930 began an occasional cough that progressed to a more persistent cough with slight SOB. 2100 progressed to itching in both ears. 2200 progressed to an  itchy throat and at 2300  itchy lips with increased SOB and coughing. Self administered treatment:  Xopenex MDI at approx 2000.  Bendryl approx 2130.  Epi-Pen, Prednisone and Xopenex at 2300.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Nausea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Started at 1630 with severe arm and neck pain on L side, unable to turn head with pain. 1800 progressed to L ear pain with nausea and headache. 1900-1930 began an occasional cough that progressed to a more persistent cough with slight SOB. 2100 progressed to itching in both ears. 2200 progressed to an  itchy throat and at 2300  itchy lips with increased SOB and coughing. Self administered treatment:  Xopenex MDI at approx 2000.  Bendryl approx 2130.  Epi-Pen, Prednisone and Xopenex at 2300.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat irritation
Clinical narrative: Started at 1630 with severe arm and neck pain on L side, unable to turn head with pain. 1800 progressed to L ear pain with nausea and headache. 1900-1930 began an occasional cough that progressed to a more persistent cough with slight SOB. 2100 progressed to itching in both ears. 2200 progressed to an  itchy throat and at 2300  itchy lips with increased SOB and coughing. Self administered treatment:  Xopenex MDI at approx 2000.  Bendryl approx 2130.  Epi-Pen, Prednisone and Xopenex at 2300.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with VAQTA, intramuscularly for prophylaxis (dose, lot# and expiry date were not reported). On an unknown date the patient experienced incorrect dose administered and no adverse event. Follow up information has been received from a registered nurse concerning the 32 year old male patient. The patient had no illness at the time of vaccination and adverse event following a prior vaccination. On 12-JUL-2017, the patient was administered a pediatric dose of VAQTA (25U/0.5ml) intramuscularly in the left shoulder, lot# N012324 with expiry date 05-APR-2018. Company gave full dose (adult) vaccine to the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes zoster, Herpes zoster, Oral mucosal eruption, Post herpetic neuralgia, Vulvovaginal rash
Clinical narrative: This spontaneous report was received from a 74 year old female patient, referring to herself. The patient had no medical history, concurrent conditions nor concomitant therapy. On an unknown date (reported as several years ago), the patient was vaccinated with ZOSTAVAX (reported as "unspecified shingles vaccine") (dose, route, lot# and expiration date were not provided) for prophylaxis. On an unknown date, 5 years after the vaccination, she developed shingles rashes. The reporting patient mentioned that she developed rashes in her mouth, her back, and her vagina; the rashes lasted for an unspecified amount of time (The patient recovered from herpes zoster and genital herpes zoster on unknown date). Thereafter on an unspecified date, she developed post herpetic neuralgia in thoracic discs 8, 9 and 10, which she still had at the time of the report. Unspecified treatment was administered for the adverse events. The causal relationship between the above mentioned events and ZOSTAVAX was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX intramuscular (lot # M037655, expiration date: 29-NOV-2017, dose was not provided) for prophylaxis. Other suspect therapies included sterile diluent intramuscular (lot #, expiration date and dose were not provided) for prophylaxis. The patients did not experienced any adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 1-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14° C to -10° C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, drug, allergy history or concomitant medications. Approximately on October 2017 (reported as last week), the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that approximately on an unknown date in October 2017, the patient experienced "an outbreak with chickenpox". The patient was taking antivirals (unspecified details) as treatment for the event. The outcome of varicella was unknown. At the time of this report, the causality between the event and ZOSTAVAX was not reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. The patient's concurrent conditions, medical history were not reported. Concomitant therapy included sterile diluent (manufacturer unknown) (lot#, and expiration date were unknown). On an unspecified date in 2011, the patient was vaccinated with M-M-R II (lot#, expiration date, dose and route were unknown) for prophylaxis. Exactly 7 days later, on an unspecified date in 2011, the patient was vaccinated with VARIVAX (lot#, expiration date, dose and route were unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-OCT-2017 the patient was vaccinated with M-M-R II, therapy type: unknown, intramuscular injection, lot # N009775; expiry date: 20-SEP-2018 (dose, dose # and anatomical location unspecified) for prophylaxis. Concomitant therapies included sterile diluent. It was reported that the patient received a properly stored dose of M-M-R II, via intramuscular route instead of subcutaneously. No adverse reaction reported. No further information provided. Lot number lot # N009775; expiry date: 20-SEP-2018, is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-JAN-2009, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-FEB-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed prednisone and valacyclovir for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 31-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 02-NOV-2007, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-OCT-2009, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed FAMVIR and LIPODERM patches for the management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 1-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (DILUENT MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14 °C to -10 °C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (DILUENT MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 4-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (DILUENT MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14 °C to -10 °C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (DILUENT MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 4-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14° C to -10° C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient had a PREVENAR vaccine on 10/26/2017 and today she came into the pharmacy with a red, swollen arm that was hot to touch and it covered the majority of her arm. I had a NP in the clinic look at it and she was worried it may be cellulitis. Patient called her primary care doctor and went in to be seen. She was prescribed a steroid.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient had a PREVENAR vaccine on 10/26/2017 and today she came into the pharmacy with a red, swollen arm that was hot to touch and it covered the majority of her arm. I had a NP in the clinic look at it and she was worried it may be cellulitis. Patient called her primary care doctor and went in to be seen. She was prescribed a steroid.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received Influenza Virus Vaccine Inactivated Sanofi-Aventis lot number UI871AB the next day she noted a large bruise about 6-7 cm on site. The bruise was tender, swollen and itchy. She has not had any other symptoms and she notes that today she feels that the swelling is down and the tenderness and bruising is resolving.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Gave an Adult Hep B and should have given a Hep A.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Reports that two days post vaccine he developed a raised, red, itchy rash under his left armpit which progressed to right armpit, around beltline and into bilateral groin areas. Reports using over the counter Hydrocortisone cream. Has not seen a physician. Rash today noted under left armpit is pink 1" in length x 1/4" width; no drainage; reports small patch of rash in groin area but declines assessment of that rash. Reports no itching now and feels it is resolved.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Pain, Retching, Vomiting
Clinical narrative: Tired, took nap when got home. ~1:30pm body aches. Some loose stool.  ~4:pm vomiting. Vomited until dry heaves for an hour.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Injection site urticaria, Nasopharyngitis, Pyrexia, Urticaria
Clinical narrative: On 11/2/17 she ate poorly, fever of 100.4 during the day. Mother took her to Dr.'s office and Dr. said she thought it was a cold. Then on 11/2/17 around 8:30 pm., she developed 4 hives on left mid thigh which went away without Benadryl. No further rash or hives. Mother states child didn't seem to want to scratch area.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Back pain
Clinical narrative: I got a pneumonia vaccine yesterday. Approximately five minutes after receiving the shot I experienced severe pain in my lower back. I was driving at the time and managed to get to a parking lot. The pain subsided as quickly as it came on after about five minutes. It is now 24 hours later and I have had no other side effects.
Sex: U
Vaccine: FLU4
Symptoms: Product contamination physical
Clinical narrative: Noticed excessive particulate matter in influenza vaccine pre-filled syringes which does not resuspend upon agitation of the syringe. Contacted the manufacturer on 10/23/2017 requesting information on integrity of product. Have been told they are looking into it, have offered to provide product for evaluation. Hospital MD and Nurse, after observing product, have suspended all vaccination with product awaiting quality review and communication from manufacturer.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Impaired work ability
Clinical narrative: Got PREVENAR 13 shot on 23Oct2017. 24Oct2017 thru 27Oct2017 very ill-mild fever, chills, no appetite, extreme exhaustion, cold sores in nose and on lip and face, severe headache, nausea, site of injection red, swollen, painful entire arm. Lot S35324. Was not able to get out of bed for 3 days. Lost work days.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Nausea
Clinical narrative: Got PREVENAR 13 shot on 23Oct2017. 24Oct2017 thru 27Oct2017 very ill-mild fever, chills, no appetite, extreme exhaustion, cold sores in nose and on lip and face, severe headache, nausea, site of injection red, swollen, painful entire arm. Lot S35324. Was not able to get out of bed for 3 days. Lost work days.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: Got PREVENAR 13 shot on 23Oct2017. 24Oct2017 thru 27Oct2017 very ill-mild fever, chills, no appetite, extreme exhaustion, cold sores in nose and on lip and face, severe headache, nausea, site of injection red, swollen, painful entire arm. Lot S35324. Was not able to get out of bed for 3 days. Lost work days.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Swelling, Tenderness
Clinical narrative: 1 to 3 days (small residual after) with localized redness and swelling and tenderness, of entire-circumference mid-arm swelling (distal to deltoid site). 1 day after peak 2 days after.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient Called this morning reporting itching and rash on arms and legs. starting yesterday evening.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Had pain immediately following the injection 5/10 and is ongoing today. The pain radiates to her left shoulder blade. Reports it is an annoying and nagging pain. 48 hours after the injection she had a red rash over her trunk and on both arms. The rash was itchy. She took Benadryl for the rash and it resolved after two days.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Local reaction, Vaccination site reaction
Clinical narrative: Local reaction at vaccination site.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient has a rash at the injection site 11 days after the injection. The rash is the size of a quarter with a dark red spot in the middle. Pediatrician said no cause for concern.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Lymphadenopathy, Pain in extremity, Pallor
Clinical narrative: About 2 hours after vaccination became pale and dizzy. Approximately around 4-6hrs after vaccination that arm was incredibly sore and the evening of 10/31/2017 felt lymphadenopathy near collarbone and axillary region on left side.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling (11cmx7cm) & tactile warmth. Prescribed Benadryl, cetirizine & mupirocin. Also advised to apply a cool compress & elevate arm. Advised to RTC or go to ER if the redness extended the swollen area that was circled in office.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Complained muscle pain in the arm after 2 weeks, troubled in lifting arm upwards.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Back disorder, Back pain, Gait disturbance, Hypoaesthesia
Clinical narrative: After the shot in April starting to have severe back issues. Started by seeing my long time chiropractor and we treated it as a pinched nerve issue,  The pain radiated down the opposite side then the right side I am used to (left side) across my lower back,  down my hip to back of my knee. It has affected my walking as well as every day activity such as pulling my pants on to get dressed and putting my shoes on. This also created what I call a dead leg type issue where I was literally dragging my left leg at times. After a few chiro treatments went to family doctor. She put me on some muscle relaxers and had an xray done.  Still was not getting better 6 weeks later. Followed up with chiro has MRI done, Showed the pinched nerve on right side could not find a nerve pinched on the left. Still was having issues with lower back and leg. Went through many chiro visits as well as massage therapy treatments. I went from walking 13 plus miles comfortably to barely being able to walk one. It is now November and I still and having issues. I am still having everyday issues with bending my left leg, and it going dead leg on me, still having pain from lower back down hip to knee.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nerve compression, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: After the shot in April starting to have severe back issues. Started by seeing my long time chiropractor and we treated it as a pinched nerve issue,  The pain radiated down the opposite side then the right side I am used to (left side) across my lower back,  down my hip to back of my knee. It has affected my walking as well as every day activity such as pulling my pants on to get dressed and putting my shoes on. This also created what I call a dead leg type issue where I was literally dragging my left leg at times. After a few chiro treatments went to family doctor. She put me on some muscle relaxers and had an xray done.  Still was not getting better 6 weeks later. Followed up with chiro has MRI done, Showed the pinched nerve on right side could not find a nerve pinched on the left. Still was having issues with lower back and leg. Went through many chiro visits as well as massage therapy treatments. I went from walking 13 plus miles comfortably to barely being able to walk one. It is now November and I still and having issues. I am still having everyday issues with bending my left leg, and it going dead leg on me, still having pain from lower back down hip to knee.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: X-ray
Clinical narrative: After the shot in April starting to have severe back issues. Started by seeing my long time chiropractor and we treated it as a pinched nerve issue,  The pain radiated down the opposite side then the right side I am used to (left side) across my lower back,  down my hip to back of my knee. It has affected my walking as well as every day activity such as pulling my pants on to get dressed and putting my shoes on. This also created what I call a dead leg type issue where I was literally dragging my left leg at times. After a few chiro treatments went to family doctor. She put me on some muscle relaxers and had an xray done.  Still was not getting better 6 weeks later. Followed up with chiro has MRI done, Showed the pinched nerve on right side could not find a nerve pinched on the left. Still was having issues with lower back and leg. Went through many chiro visits as well as massage therapy treatments. I went from walking 13 plus miles comfortably to barely being able to walk one. It is now November and I still and having issues. I am still having everyday issues with bending my left leg, and it going dead leg on me, still having pain from lower back down hip to knee.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cardiac monitoring, Chest X-ray, Electrocardiogram, Laboratory test
Clinical narrative: Anaphylaxis.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Nodule, Skin warm, Swelling
Clinical narrative: Knot that is warm to the touch, red, and swollen. Counseled use of cold compress, since anti-inflammatory was not to be administered to patient.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 75 year-old female patient received the first dose of PREVNAR 13 (NDC number: 00005-1971-01, lot S35324, exp.date Aug2018) via intramuscular route in the right arm at 0,5ml single dose on 24Oct2017 13:00 and FLUZONE HIGH DOSE lot U1882AB, exp.date 21May2018 via intramuscular route In the left  arm at 0,5ml single dose. The patient had received one dose of influenza vaccine in 2009 but doesn't know how many she may have received before 2009. The vaccine  were administered in the pharmacy. On 26Oct2017 the patient had a lot of redness around injection site and the patient's arm was warm to the touch. The events were assessed as serious, medically significant. The outcome was not recovered. The patient used band aid.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "redness around injection site warm to the touch " cannot be fully excluded considering the known adverse event profile of PREVNAR 13.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: This is a spontaneous report from Pfizer sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose on 30Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date as soon as the patient got the vaccination, she had shooting pain and couldn't use my arm for 2 weeks. She called the nurse and doctor back they told her it would go away, just give it time. Anyway it was still hurting. They sent her to an orthopedic doctor and had her in physical therapy but somethings was not right. The outcome of the events was not recovered.
Sex: F
Vaccine: PNC13
Symptoms: Incorrect dose administered, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merck & Co., Inc. (reference number: 00628732). A 69-year-old female patient of an unspecified ethnicity received five doses of PREVNAR 13, via unspecified routes of administration on an unspecified dates at single doses, all given for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inappropriate dose of vaccine administered on an unspecified date. The event was further described as "she was vaccinated with PREVNAR 13 approximately 5 times". The patient mentioned that she did not develop an immune response after she was vaccinated. The outcome of the event was unknown.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Headache, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 05Oct2017 at single dose for immunization. Medical history included ongoing trigeminal neuralgia, peripheral neuropathy, diabetes mellitus and abdominal migraine and cluster headache because of the damage to cranial nerves. It was reported that the patient took a lot of other medications. On an unspecified date in Oct2017, the patient experienced productive cough, severe cough, low grade fever, sore throat and headache. No treatment was required/provided for the events. Outcome of the events was not recovered (also reported as probably worse than what when he started). No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Erythema, Limb discomfort, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 70-year-old patient of an unspecified gender received PREVNAR 13, single dose for prevention of pneumonia and influenza vaccine at unknown dose for immunization both via an unspecified route of administration on an unspecified date. Medical history included 'high blood' from an unknown date and unknown if ongoing. There were no reported concomitant medications. On an unspecified date, the patient reported swelling and tightening in arm where they give the shot, described by the patient like tightening your neck. The patient did not mind as a Flu shot was administered in that evening and was eased with an icepack. The next morning, the patient reported that it was still hurting, aching and the patient had pain, red hot, swelling and cannot event raise the arm. The patient stated that redness was not at the injection suite but was previously at the top of where the vaccine was given and was going down to the elbow described as "big redness". The outcome of the events 'cannot even raise the arm' and 'tightening in arm where they give the shot' was recovered: patient reported can raise the arm and no more tightness; all other events were unknown.
Age: 2.0
Sex: U
Vaccine: PNC13
Symptoms: Asthma
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merck & Co., Inc. A 31-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced asthma on an unspecified date. It was reported that patient was vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) at 2 years and 7 months and patient subsequently developed asthma. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Extra dose administered, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician reporting for his wife.  A 67-year-old female patient started received a second dose PREVNAR 13, via an unspecified route of administration on the right upper arm on 29Oct2017 12:00 at single dose and INFLUENZA VACCINE, via an unspecified route of administration on at unspecified dose both given as immunization at the pharmacy/drug store. Medical history included breast cancer and had lymph nodes removed from her right arm area on an unspecified date. Patient's family medical history was reported as none. Ongoing concomitant medication included rosuvastatin. The patient received as pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in Dec2015 as immunization, DPT in Apr2016 as immunization and had allergic reaction (unsure which ingredient in the DPT that patient was allergic to, but she's allergic to something in the vaccine) and varicella zoster vaccine in 2012 as immunization and had a reaction to the vaccine. It was reported that patient already received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in Dec2015 and then on 29Oct2017 was administered with second injection by mistake. The patient was supposed to receive PNEUMOVAX per standing protocol at the pharmacy. On 29Oct2017 (7-8 hours after receiving the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), patient experienced that the arm that was injected was painful and weak, had a fever, chills, stiff neck and swollen hand (on the arm where the injection was given). It was also mentioned that the following events "arm that was injected was painful and weak, fever, chills, stiff neck and swollen hand (on the arm where the injection was given" were still ongoing at the time of the report.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician reporting for his wife.  A 67-year-old female patient started received a second dose PREVNAR 13, via an unspecified route of administration on the right upper arm on 29Oct2017 12:00 at single dose and INFLUENZA VACCINE, via an unspecified route of administration on at unspecified dose both given as immunization at the pharmacy/drug store. Medical history included breast cancer and had lymph nodes removed from her right arm area on an unspecified date. Patient's family medical history was reported as none. Ongoing concomitant medication included rosuvastatin. The patient received as pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in Dec2015 as immunization, DPT in Apr2016 as immunization and had allergic reaction (unsure which ingredient in the DPT that patient was allergic to, but she's allergic to something in the vaccine) and varicella zoster vaccine in 2012 as immunization and had a reaction to the vaccine. It was reported that patient already received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in Dec2015 and then on 29Oct2017 was administered with second injection by mistake. The patient was supposed to receive PNEUMOVAX per standing protocol at the pharmacy. On 29Oct2017 (7-8 hours after receiving the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), patient experienced that the arm that was injected was painful and weak, had a fever, chills, stiff neck and swollen hand (on the arm where the injection was given). It was also mentioned that the following events "arm that was injected was painful and weak, fever, chills, stiff neck and swollen hand (on the arm where the injection was given" were still ongoing at the time of the report.
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients (couple). This is the first of two reports. An elderly male patient of unspecified ethnicity and age (reported as over 65 years) received PREVNAR 13 via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The patient experienced soreness, coughing and low grade fever on unspecified date. The patient complained and thought that he was going to get pneumonia after getting the shot a day after. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017472129 same drug/event, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients (couple). This is the second of two reports. An elderly female patient of an unspecified age (reported as over 65 years) and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness, coughing, and low grade fever. The patient complained and thought that she was going to get pneumonia after getting the shot a day after. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017472071 same drug/event, different patient.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, (lot number: T08483, expiry date: Sep2019), intramuscular (arm left) on 23Oct2017 at single dose to prevent pneumonia. The patient's medical history was not reported. Concomitant medication included influenza vaccine on 23Oct2017 (arm right) at unknown dose for immunization. On 23Oct2017, the day of vaccination, the patient got rash at the site that was about 50 cm and now it is recording at 220 cm.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Axillary pain, Injection site discolouration, Injection site erythema, Injection site rash, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 (lot number: S51635, expiration date: 31Oct2018), via an unspecified route of administration at deltoid left on 26Oct2017 14:00 at 0.5 ml, single dose for she was told anyone over 65 should get the pneumonia vaccine and influenza vaccine (manufactured by Sanofi Pasteur, lot number: UI883BA, expiration date: 25May2018), via an unspecified route of administration at deltoid left on 26Oct2017 at 0.5 ml, unknown frequency for it is that time of year when everyone is told to get it. Medical history included ongoing high blood pressure and ongoing gastrooesophageal reflux disease (GERD); both diagnosed a long time ago, maybe 20-30 years. The patient had no family history and relevant tests. Patient was taking other medications. On 27Oct2017, the patient experienced black and blue mark at site then on 30Oct2017, she experienced pain in her armpit and on 31Oct2017, patient noticed redness and is starting to have quite a large rash at the injection site, armpit gland is swollen and she felt a little itch. It was further reported that patient noticed redness and is starting to have quite a large rash at the injection site and her armpit gland is swollen. The patient asked if that could be a delayed reaction or something else. It was reported that the patient got senior flu shot at the same time so it could be the flu shot but the patient thought that the pneumococcal injection was the top one which the site where she was having the reaction. Patient has a black and blue mark at the site then redness started. It was reported that the black and blue mark is persisting and going through the normal progression, turning red then yellow. Patient just noticed the redness and rash about an hour or two ago. She felt pain in her armpit but noticed the swelling in morning. Patient just wanted to know if it was common 4 days later or she just thought any reaction would happen immediately. Outcome of the event felt a little itch was recovered on 31Oct2017 while outcome of other events was not recovered.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 (lot number: S51635, expiration date: 31Oct2018), via an unspecified route of administration at deltoid left on 26Oct2017 14:00 at 0.5 ml, single dose for she was told anyone over 65 should get the pneumonia vaccine and influenza vaccine (manufactured by Sanofi Pasteur, lot number: UI883BA, expiration date: 25May2018), via an unspecified route of administration at deltoid left on 26Oct2017 at 0.5 ml, unknown frequency for it is that time of year when everyone is told to get it. Medical history included ongoing high blood pressure and ongoing gastrooesophageal reflux disease (GERD); both diagnosed a long time ago, maybe 20-30 years. The patient had no family history and relevant tests. Patient was taking other medications. On 27Oct2017, the patient experienced black and blue mark at site then on 30Oct2017, she experienced pain in her armpit and on 31Oct2017, patient noticed redness and is starting to have quite a large rash at the injection site, armpit gland is swollen and she felt a little itch. It was further reported that patient noticed redness and is starting to have quite a large rash at the injection site and her armpit gland is swollen. The patient asked if that could be a delayed reaction or something else. It was reported that the patient got senior flu shot at the same time so it could be the flu shot but the patient thought that the pneumococcal injection was the top one which the site where she was having the reaction. Patient has a black and blue mark at the site then redness started. It was reported that the black and blue mark is persisting and going through the normal progression, turning red then yellow. Patient just noticed the redness and rash about an hour or two ago. She felt pain in her armpit but noticed the swelling in morning. Patient just wanted to know if it was common 4 days later or she just thought any reaction would happen immediately. Outcome of the event felt a little itch was recovered on 31Oct2017 while outcome of other events was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 169821, expiry date 31st January 2019). On 27th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, less than a month after receiving BEXSERO, the patient experienced fever (serious criteria disability and other: As per reporter), injection site warmth (serious criteria disability and other: As per reporter) and injection site swelling (serious criteria disability and other: As per reporter). In October 2017, the outcome of the fever, injection site warmth and injection site swelling were recovered/resolved. The reporter considered the fever, injection site warmth and injection site swelling to be almost certainly related to BEXSERO. Additional details were reported as follows: The reporter stated to a field representative that, the patient experienced a softball like mound at the injection site for BEXSERO that was warm to the touch. The reporter stated there was an intervention with KEFLEX. The symptoms resolved after about 1 week.
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Walking aid user
Clinical narrative: Mother called HD to report In evening patient was feeling dizzy and sweaty. No Fever. Went to bed when got up went to school. School called mother to pick child up due to being dizzy and needing help walking. Profuse Sweating but no fever. Instructed mother to call PCP for further instructions.