chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product storage error, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Certified Medical Assistant reporting on behalf of a physician. This Certified Medical Assistant reported similar events for six patients. This is the third of six reports. A 6-month-old male patient received, on 05Sep2017 at 15:00, the third dose of PREVNAR 13 (NDC number: 00035197102, lot S35325, Expiry Date 31Jul2018) intramuscularly, in the left thigh at single dose, for immunization. Relevant medical history was unknown. Concomitant medications included PEDIARIX (Lot. 924Y3, Expiration date: 11Aug2019) intramuscular route in the right thigh; HIB, Lot. N003701 via intramuscular route in the left thigh; and rotavirus vaccine (Lot. G4434, Expiration date: 22Oct2018) orally. The patient previously received the first dose of PREVNAR 13 on 05May2017 and the second dose on 14Jul2017. There was temperature excursion of PREVNAR 13 due to power outage with a maximum temperature of  8.5 degrees Celsius and maximum of 1 hour out of range on 03Sep2017 at 1:55 am. The patient received the vaccine after the temperature excursion. On an unspecified date, the patient experienced fever. Clinical outcome was unknown at time of this report. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017396547 different patient, same product, same event.
Age: 24.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Hyperaesthesia, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A 24-year-old male patient of an unspecified ethnicity started to receive TRUMENBA (lot# s26985; Exp: 31Jan2019), via an unspecified route of administration on 12Aug2017 at 0.5 ml, single for immunisation. Medical history included allergy and exercise induced asthma; had history of high fever when gets a fever. The patient's concomitant medications were not reported. Given 12Aug2017 and worked out after vaccination. Patient experienced high fever of 104 Fahrenheit, body aches, headache, chills, skin sensitivity, Flu like symptoms. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A 24-year-old male patient of an unspecified ethnicity started to receive TRUMENBA (lot# s26985; Exp: 31Jan2019), via an unspecified route of administration on 12Aug2017 at 0.5 ml, single for immunisation. Medical history included allergy and exercise induced asthma; had history of high fever when gets a fever. The patient's concomitant medications were not reported. Given 12Aug2017 and worked out after vaccination. Patient experienced high fever of 104 Fahrenheit, body aches, headache, chills, skin sensitivity, Flu like symptoms. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the first of four reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot number: S43277, expiration date: Sep2018, NDC number: 0005197101), via an unspecified route of administration on an unspecified date at single dose for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as within the last 2 weeks), patient called into the office about experienced redness, swelling and a hard knot at the injection site lasting for several days. The nurse reported administering the product with possible quality issue to the patient. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400617 same reporter, drug and events, different patients; US-PFIZER INC-2017400618 same reporter, drug and events, different patients; US-PFIZER INC-2017400619 same reporter, drug and events, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the third of four reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 (NDC 0005-1971-01, LOT S43277), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shot is hurting and stinging, redness, swelling & hard knot at injection site lasting several days, adminstering product with possible quality issue and vaccine seems a lot thicker than normal all on an unspecified date with outcome of unknown. Nursesstated with the most recent lot number of PREVNAR 13 that patients had been complaining about the shot hurting and stinging. They also stated the vaccine seemed a lot thicker than normal. Four patients have called into the office about redness, swelling and a hard knot at the injection site lasting for several days. there were also bumps and immunization stinging. Sales representative stated onset was within the last 2 weeks with the most recent lot number.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 similar report from same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Product physical consistency issue, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the third of four reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 (NDC 0005-1971-01, LOT S43277), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shot is hurting and stinging, redness, swelling & hard knot at injection site lasting several days, adminstering product with possible quality issue and vaccine seems a lot thicker than normal all on an unspecified date with outcome of unknown. Nursesstated with the most recent lot number of PREVNAR 13 that patients had been complaining about the shot hurting and stinging. They also stated the vaccine seemed a lot thicker than normal. Four patients have called into the office about redness, swelling and a hard knot at the injection site lasting for several days. there were also bumps and immunization stinging. Sales representative stated onset was within the last 2 weeks with the most recent lot number.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 similar report from same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. This nurse reported similar events for 4 patients. This is the fourth of four reports. A patient of unspecified age, ethnicity and gender, started to receive PREVNAR 13 (Lot #: S43277, Expiration date: Sep2018,NDC number: 0005197101), via an unspecified route of administration on an unspecified date at single dose for routine immunization. The patient's medical history and concomitant medications were not reported. The patient called into the office about experienced redness, swelling and a hard knot at the injection site lasting for several days, on an unspecified date (reported as within the last 2 weeks). The nurse reported administering the product with possible quality issue to the patient.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 similar report from same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 17 year-old male patient received the first single dose of TRUMENBA via an unspecified route of administration in the left arm on 19Sep2016 for immunization. The patient medical history and concomitant medications were not reported. The patient's arm swelled up, injection site was hot to touch and he was in severe pain so he could not go to gym on an unspecified day in Sep2016. Outcome was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 08Sep2017 at single dose for immunization at doctor's office. Medical history included bronchiectasis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced pain and tenderness at the site. The patient reported that she read that you could have pain for a few days, but it has been about a week and she still has tremendous pain. The patient wanted to know if this was normal and how long will it last. The patient also reported that on an unspecified date, it has been difficult to sleep due to the pain from her left side. The patient has taken ibuprofen and she still has the pain consistently for about a week. The outcome of the event pain and tenderness at the site was not recovered while difficult to sleep was unknown. No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report received from a contactable nurse. A 65-year-old female patient received PREVNAR 13, intramuscular (upper right arm) on 07Sep2017 around 1400 at single dose for routine vaccination. Medical history included infection on right and left shoulder which started in May2017 where streptococcus A was the organism for both shoulders; surgery on right shoulder on 22MAY2017; surgery on the left shoulder on 25MAY2017 and hypothyroidism. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) at 0.112 ug daily for hypothyroidism which the patient has been taking for 38 years and 10th year booster of tetanus vaccine (manufacturer unknown) intramuscularly (left upper arm) on 07Sep2017 at unknown dose for immunization. On 07Sep2017, the patient noticed redness after the injection. The redness was small and what you would expect after an injection. The patient expected the initial reaction to be soreness and redness for day 1 or 2. On 13Sep2017 the patient reported that redness has doubled, hot at the site, and it being a little bit swollen. At the time of the report the patient noticed that redness was worse and pretty prominent. The patient also reported that there is no tenderness if she palpates the site. The outcome of the events was not recovered.
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist, based on the information received by Pfizer from Merck (Merck# 00573110). A 77-year-old male patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, in Jan2017, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date. Hives were resolved but came back about 6 weeks later and at repeated cycles, going away and coming back a few times. Outcome was unknown. No follow-up attempts possible. No further information expected.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Ear pain, Nausea, Pharyngitis, Pyrexia, Streptococcus test negative
Clinical narrative: Pt seen 9/12/17-C/O fever, nausea, ear pain x3 days. Pt taking Tylenol per chart notes Dr noted enlarged tonsils, erythematous tonsils, moist mucosa, no rashes Dx pharyngitis.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Tonsillar erythema, Tonsillar hypertrophy
Clinical narrative: Pt seen 9/12/17-C/O fever, nausea, ear pain x3 days. Pt taking Tylenol per chart notes Dr noted enlarged tonsils, erythematous tonsils, moist mucosa, no rashes Dx pharyngitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. came in stating that the injection site was swollen and painful to touch. No other Sxs.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient began with rash 24 hours after receiving vaccines. Swelling of left thigh also noted. Patient was instructed to use NEOSPORIN three times daily.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dry skin, Exfoliative rash, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Right deltoid, (R) arm, (R) forearm severely swollen red warm with dry scaly itchy red rash. Fever T100.1
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Right deltoid, (R) arm, (R) forearm severely swollen red warm with dry scaly itchy red rash. Fever T100.1
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: Pt has limited mobility of her right arm. She cannot move it fully forward, up, or backward. Pt has pain with movement. Can't lift things w/her right arm.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 19-year-old female patient who received BEXSERO. Concurrent medical conditions included allergy. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, injection site induration, injection site swelling and generalized urticaria were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site swelling and generalized urticaria to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO on left deltoid. The patient received allergy injections concomitantly but no further clarification was provided. The patient experienced an injection site reaction, described as a softball size, hard, red, raised reaction at the injection site, and hives all over her body. The patient was seen in the emergency room and discharged on the same day.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. developed rash on 9/15/17, went to ER on 9/18/17 and diagnosed w/shingles. Rash developed on left trunk.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Presyncope
Clinical narrative: This report was reported by a nurse via sales rep and described the occurrence of faint in a 17-year-old female patient who received BEXSERO. On an unknown date, the patient experienced BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced faint and presyncope. On an unknown date, the outcome of the faint and presyncope were unknown. It was unknown if the reporter considered the faint and presyncope to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The health care professional that patient received BEXSERO and became faint, almost passed out, and had to lay down. The patient recovered, left the office, and did not require any further medical intervention.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Piloerection
Clinical narrative: Patient said approximately one hour after receiving the immunization she felt "pins and needles" going down her arm. She also said the hair on her arm is standing up. She is still experiencing this effect 7 days later. MD recommended BENADRYL.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Father called public health on 9/15/17 to report that his daughter woke up this morning at 4:00 am, "with a fever of 101, body aches and sore arms". The father reported that TYLENOL was given and repeated 5 hours later due a fever of 100.6. Nurse questioned father regarding possible allergic reaction symptoms, father denied any wheezing, difficulty breathing or hives. Nurse instructed father if any of allergic symptoms occur to go to the ER. Nurse offered a home visit or office visit, father stated it was not necessary. Nurse encouraged increasing fluid intake, cold or warm packs to injection sites and using Ibuprofen or TYLENOL as needed. Nurse reported to the father that this form would be completed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Rash surrounding injection site. Was diagnosed with shingles. Given VALTREX and BACTRIM.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complains of severe arm pain redness and swelling.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain
Clinical narrative: Patient received the flu shot on 8/20/17, and reported that he started having chest pain on the left side especially when he bends down to pick up something. The adverse reaction happened a week after the patient received the vaccine. He is feeling better now. Per patient, he is negative for GERD or any heart conditions. He had received the flu shot in the past without any issues. Pt will be following up with MD soon. Symptoms are going away and he is feeling better.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Injection site bruising, Pain in extremity, Paraesthesia
Clinical narrative: Bruise at injection site, bruise under injection site, bruise on opposite arm, reddened palms, feeling of tingling in the area of the neck, occasional pain in a leg.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Rash, Skin burning sensation, Swelling
Clinical narrative: Within 10 minutes of getting the vaccination, She developed a rash on her arms and chest & face. She said it felt like her skin was on fire. She was given 10mg of Cetirizine. She denied wheezing or difficulty breathing. She stated that she felt swollen in her chest and neck, but no dysphagia or dysphonia, and no oropharyngeal swelling. Over the course of treatment she significantly improved and had only minor erythema of the skin remaining.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient called complaining of a red area, hot to touch, hard portion of the skin where injection was administered.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Extreme trembling, upset stomach, dizzy, extreme fatigue, diarrhea.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Extreme trembling, upset stomach, dizzy, extreme fatigue, diarrhea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disturbance in attention, Feeling abnormal, Insomnia, Night sweats
Clinical narrative: Thursday: Felt chills, difficult to concentrate/foggy brain, night sweats, couldn't sleep.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Pyrexia, Rash generalised
Clinical narrative: Got MMR Vaccine on 9/5/17. On 9/13/17 pt because lethargic and had a fever starting at 99.7 degrees. As the day went on fever got higher and higher. On 9/14/17 fever reached 103.7 degrees and Tylenol was given to pt. The fever leveled out between 101.3 degrees and 101.7 degrees. On 9/15/17 pt still had her fever so we contacted the nurse help line and they advised us to bring pt in. At the doctors they advised us that a fever is a known side effect of the MMR Vaccine. On 9/16/17 pt no longer had a fever. On 9/17/17 pt got a rash across her whole body. On 9/18/17 (Today) still has rash across her body.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Pt bruise and numbness in arm started day of injection. Bruise is still quite apparent and dark today (9/18). Pt reported numbness from injection site down to the fingers. Pt stated numbness stopped 5 days after injection.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Erythema, Malaise, Pyrexia, Tenderness
Clinical narrative: Patient called pharmacy describing tender red arm and fever of about 101. stated she generally wasn't feeling well. Instructed patient to take some ibuprofen or acetaminophen for the fever and to continue to monitor the injection site.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained of numbness in left cheek (under left eye socket to cheek bone area) which started approximately 30 minutes after the injection. After about 1.5 hours numbness eased but continued for about 3 hours total. Patient denied any weakness or paralysis in facial or arm muscles. No visual sign of drooping or irregular facial expressions, and grip was equal in both arms.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Coagulation test normal, Full blood count normal, Infertility, Laboratory test normal, Pregnancy
Clinical narrative: G5p2 37 year old female approximately 18 and a half weeks pregnant. Received the influenza vaccine the prior-year in 2010 due to working in the medical field. Received the influenza vaccine on October 10th 2011. Starting having large amounts of vaginal bleeding on October 11th 2011. Ended up having continuous bleeding with 16 units of blood delivered 9 in Long 9 oz female on October 19th. Ended up having to have a uterine embolization 12 hours after delivery with a D&C. I recently read the research article related to the possible connection to miscarriage and influenza during this time. I was unable to have any further children.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Surgery, Transfusion, Uterine leiomyoma embolisation, Vaginal haemorrhage
Clinical narrative: G5p2 37 year old female approximately 18 and a half weeks pregnant. Received the influenza vaccine the prior-year in 2010 due to working in the medical field. Received the influenza vaccine on October 10th 2011. Starting having large amounts of vaginal bleeding on October 11th 2011. Ended up having continuous bleeding with 16 units of blood delivered 9 in Long 9 oz female on October 19th. Ended up having to have a uterine embolization 12 hours after delivery with a D&C. I recently read the research article related to the possible connection to miscarriage and influenza during this time. I was unable to have any further children.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Blood test, Lymphadenitis, Mobility decreased, Musculoskeletal pain
Clinical narrative: Arm and shoulder became hot, swollen and painful the next day. By Saturday arm, neck and back were stiff and sore. Could not turn move neck and turn head. Went to emergency room Saturday for pain in arm, shoulder, neck and back. Was given medication in ER-- muscle relaxers and anti inflamatory medicine. Was told to follow up with my doctor if not better. Returned to family doctor Tuesday after a lump (cyst like ) thing was found above left color bone. Was given antibiotics at Family doctor. to see if we could get lump - inflammed lymph note down. If antibiotics don't work they want to do ultra sound and biopsy.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm and shoulder became hot, swollen and painful the next day. By Saturday arm, neck and back were stiff and sore. Could not turn move neck and turn head. Went to emergency room Saturday for pain in arm, shoulder, neck and back. Was given medication in ER-- muscle relaxers and anti inflamatory medicine. Was told to follow up with my doctor if not better. Returned to family doctor Tuesday after a lump (cyst like ) thing was found above left color bone. Was given antibiotics at Family doctor. to see if we could get lump - inflammed lymph note down. If antibiotics don't work they want to do ultra sound and biopsy.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Blood pressure decreased, Cold sweat, Consciousness fluctuating, Eye movement disorder, Pallor
Clinical narrative: Administered the listed vaccines in the following order; MENACTRA, VARIVAX, HAVRIX, and GARDASIL 9 on 9/18/17 at approximately 9:50 AM. After administration of GARDASIL 9, client sat in chair with eyes closed. Patient stated he was feeling "ok". When father asked client why his eyes were closed, client started to respond and immediately client's eyes began to roll and he became unresponsive. Client was warm, clammy with a pale greenish skin tone. Assessed client's vital signs BP 80/54, R 16, P-52 and applied ice pack to client's forehead and back of neck. Continued to assess client's alertness and orientation by verbal and physical stimulation. Client continued to come in and out of consciousness and was able to verbalize his full name and DOB. Client was given apple juice and assisted to recliner chair. Monitored client for approximately 10-15 minutes.  Reassessed client's vital signs and orientation. BP 101/68, R 16, P 68. Client was alert and oriented x3 and able to ambulate without difficulty. Client denied dizziness, headache, visual disturbances and nausea. Client stated he was "feeling better" and ambulated without assistance with father. Noted in medical chart that client is prone to fainting after vaccine administration and encouraged client and father to inform healthcare personnel of precaution prior to vaccinations. Client and father verbalized understanding, denied any questions or concerns and exited clinic.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Skin warm, Unresponsive to stimuli
Clinical narrative: Administered the listed vaccines in the following order; MENACTRA, VARIVAX, HAVRIX, and GARDASIL 9 on 9/18/17 at approximately 9:50 AM. After administration of GARDASIL 9, client sat in chair with eyes closed. Patient stated he was feeling "ok". When father asked client why his eyes were closed, client started to respond and immediately client's eyes began to roll and he became unresponsive. Client was warm, clammy with a pale greenish skin tone. Assessed client's vital signs BP 80/54, R 16, P-52 and applied ice pack to client's forehead and back of neck. Continued to assess client's alertness and orientation by verbal and physical stimulation. Client continued to come in and out of consciousness and was able to verbalize his full name and DOB. Client was given apple juice and assisted to recliner chair. Monitored client for approximately 10-15 minutes.  Reassessed client's vital signs and orientation. BP 101/68, R 16, P 68. Client was alert and oriented x3 and able to ambulate without difficulty. Client denied dizziness, headache, visual disturbances and nausea. Client stated he was "feeling better" and ambulated without assistance with father. Noted in medical chart that client is prone to fainting after vaccine administration and encouraged client and father to inform healthcare personnel of precaution prior to vaccinations. Client and father verbalized understanding, denied any questions or concerns and exited clinic.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/ rash at injection site.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain.
Age: 39.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Numbness in feet and hands beginning a week after the injection. Continued reoccurring numbness in both hands and feet then on Sunday April 16, 2017 I experienced face numbness for about an hour. During this time frame numbness would come and go periodically. On May 7th feet went numb and stayed numb until I was hospitalized on May 8th. On May 8th my hands went numb and then my face followed and stayed that way until IVIG treatments began at the hospital.
Age: 39.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness in feet and hands beginning a week after the injection. Continued reoccurring numbness in both hands and feet then on Sunday April 16, 2017 I experienced face numbness for about an hour. During this time frame numbness would come and go periodically. On May 7th feet went numb and stayed numb until I was hospitalized on May 8th. On May 8th my hands went numb and then my face followed and stayed that way until IVIG treatments began at the hospital.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age, medical history and concurrent conditions were not provided. On or about 27-OCT-2013 the patient was vaccinated with ZOSTAVAX, (route unknown) 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 30-AUG-2016 the patient was treated by a health professional in the Emergency Department for Ophthalmic Herpes Zoster. The patient has been prescribed oxycodone hcl/acetaminophen (PERCOCET) to attempt to manage and relieve her 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, pain and suffering, and other damages. Upon internal review Ophthalmic Herpes Zoster was considered to be medically significant.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Pt received vaccination while at clinic for routine monthly lab appointment. Medications & allergies were reviewed, Influenza screening & consent signed and VIS reviewed. Patient has never had reaction to the vaccination. Immunization was on a Friday and patient came into office the following Monday stating several hours after receiving the injection she had developed hives & itching affecting her abdominal region. She stated she took Benadryl 50mg orally and went to bed. The hives were nearly gone the next day and completely gone 2 days later. On the 3rd day after receiving the vaccination (Monday) she woke up with swollen lips. Patient denies food allergies or having come into contact with any products she has never used. Nephrologist was notified the day the reaction was reported and there were no orders given at that time. Patient stated she believes she has an allergy to cigarette smoke and is wondering if the smoke from recent wildfires in surrounding states may have caused the reaction. Patient will follow up with her Primary Care Physician.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pain
Clinical narrative: Patient given vaccine at around 1120 and came back about 9 hours later with a 101 fever, chills, body aches, fatigue, loss of appetite and nausea.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Pyrexia
Clinical narrative: Patient given vaccine at around 1120 and came back about 9 hours later with a 101 fever, chills, body aches, fatigue, loss of appetite and nausea.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram QT prolonged, Hypopnoea, Mobility decreased, Pyrexia
Clinical narrative: Patient experienced shallow breathing, fever and couldn't lift opposite arm (right arm).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Cellulitis VS reaction to vaccine. Erythema from left elbow to shoulder, warm, mild swelling - 7 1/2" L x 8" w.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: Cellulitis developed. Pain and warm to the touch morning after vaccination.  Patient had nausea and fever of 103.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Chest pain, Decreased appetite
Clinical narrative: Patient reported extreme pain on shoulder, back, chest and elbow on left side, possible hives on arm that are itching, loss of appetite and weakness and dizziness. Recommended patient to use BENADRYL and acetaminophen to help with symptoms and contact her primary care doctor on further treatment recommendations.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain
Clinical narrative: Patient reported extreme pain on shoulder, back, chest and elbow on left side, possible hives on arm that are itching, loss of appetite and weakness and dizziness. Recommended patient to use BENADRYL and acetaminophen to help with symptoms and contact her primary care doctor on further treatment recommendations.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Injection site pain
Clinical narrative: PATIENT STATES HE HAS HAD SHOULDER PAIN SINCE TIME OF INJECTION. WAS DIAGNOSED WITH RIGHT SHOULDER BURSITIS IN ED ON 9/17/2017.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Arm was swelling and turned red the next morning. She waited a couple of days and then went to the dr, who diagnosed her with cellulitis. She stated she remembered touching the immunization site after taking the trash to the compactor and without washing her hands.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: PATIENT COMPLAINS ABOUT A LITTLE SWELLING AT INJECTION SITE AND SORENESS IN THE RIGHT ARM. INSTRUCTED PATIENT THAT CAN BE A RESULT OF THE VACCINE. PATIENT DID NOT HAVE FEVER OR RESPIRATORY DISTRESS AFTER CONSULTATION.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, fatigue, headache; joint/muscle pain that has been ongoing for over 30 days. Treatment: patient was advised to continue Tylenol/Motrin PRN and hydrate/rest. Outcome: Fever, fatigue, headache subsided, but joint/muscle pain persisted-patient given exemption by MD, Acting Medical Director and advised to have an MMR titer drawn to see if there was any immunity retained.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asthenia, Bacterial test negative, CSF cell count increased, CSF glucose increased, CSF oligoclonal band absent
Clinical narrative: Patient presented with poor feeding, irritability, vomiting fever, weakness, decreased urine output that started 24-34 hours following administration of the vaccines. He was diagnosed with transverse myelitis by MRI and clinical findings and admitted to the pediatric intensive care unit at  Hospital.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF protein increased, Enterovirus test negative, Intensive care, Irritability, Myelitis transverse
Clinical narrative: Patient presented with poor feeding, irritability, vomiting fever, weakness, decreased urine output that started 24-34 hours following administration of the vaccines. He was diagnosed with transverse myelitis by MRI and clinical findings and admitted to the pediatric intensive care unit at  Hospital.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Polymerase chain reaction, Poor feeding infant, Pyrexia
Clinical narrative: Patient presented with poor feeding, irritability, vomiting fever, weakness, decreased urine output that started 24-34 hours following administration of the vaccines. He was diagnosed with transverse myelitis by MRI and clinical findings and admitted to the pediatric intensive care unit at  Hospital.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: Patient presented with poor feeding, irritability, vomiting fever, weakness, decreased urine output that started 24-34 hours following administration of the vaccines. He was diagnosed with transverse myelitis by MRI and clinical findings and admitted to the pediatric intensive care unit at  Hospital.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Possible cellulitis around injection.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effects occurred.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Pain all over her body started at nighttime, end up in ER, but released after.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pyrexia, Rash
Clinical narrative: COULD NOT MOVE ARM, RASH, LOW GRADE FEVER.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT STATES HER ARM BECOME VERY SORE, BRIGHT RED, AND EXTREMELY SWOLLEN. SHE FELT VERY SICK AND WAS IN BED FOR 2 DAYS. ONSET WAS AROUND 18 HOURS AFTER IMMUNIZATIONS WERE ADMINISTERED.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Activated partial thromboplastin time, Full blood count, International normalised ratio, Metabolic function test, Pain
Clinical narrative: Swelling of the L arm, treated symptomatically for pain with Tylenol, close monitoring.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Peripheral swelling, Prothrombin time, Ultrasound scan
Clinical narrative: Swelling of the L arm, treated symptomatically for pain with Tylenol, close monitoring.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Eye movement disorder, Fatigue, Immediate post-injection reaction, Increased upper airway secretion, Loss of consciousness
Clinical narrative: Immediately after vaccine was given, she lost consciousness. Arms and legs stiffened, eyes rolled back she had urinary incontinence and made gurgling sounds for a few seconds. Whole episode resolved after a few seconds. Felt fatigued afterward.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Musculoskeletal stiffness, Urinary incontinence
Clinical narrative: Immediately after vaccine was given, she lost consciousness. Arms and legs stiffened, eyes rolled back she had urinary incontinence and made gurgling sounds for a few seconds. Whole episode resolved after a few seconds. Felt fatigued afterward.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Asthenia, Cardiac disorder, Chills, Delirium
Clinical narrative: PATIENT RECEIVED THE VACCINE ON 9/15/2017 AT 9:00 AM AND BY 1:30 PM PATIENT WAS EXPERIENCING A FEVER OF 103 DEGREES WITH BODY ACHES AND CHILLS. BY 5:00 PM, HER HEAD AND STOMACH WERE EXTREMELY SORE AND HAD NAUSEA, ITCHING AND REDNESS OF THE INJECTED ARM AND HER HEART FELT WEIRD. HER FAMILY TOOK HER TO THE EMERGENCY ROOM AT 6:30PM AND SAID SHE WAS DELIRIOUS. THE ER GAVE HER FLUIDS AND MONITORED HER BP AND HEART, WHICH WAS EXTREMELY HIGH. THEY TOLD HER TO ICE HER ARM OVER THE WEEKEND AND TAKE TYLENOL FOR THE FEVER. TODAY SHE FEELS A LITTLE BETTER BUT HER BODY STILL FEELS WEAK AND SORE.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Heart rate increased, Hypertension, Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT RECEIVED THE VACCINE ON 9/15/2017 AT 9:00 AM AND BY 1:30 PM PATIENT WAS EXPERIENCING A FEVER OF 103 DEGREES WITH BODY ACHES AND CHILLS. BY 5:00 PM, HER HEAD AND STOMACH WERE EXTREMELY SORE AND HAD NAUSEA, ITCHING AND REDNESS OF THE INJECTED ARM AND HER HEART FELT WEIRD. HER FAMILY TOOK HER TO THE EMERGENCY ROOM AT 6:30PM AND SAID SHE WAS DELIRIOUS. THE ER GAVE HER FLUIDS AND MONITORED HER BP AND HEART, WHICH WAS EXTREMELY HIGH. THEY TOLD HER TO ICE HER ARM OVER THE WEEKEND AND TAKE TYLENOL FOR THE FEVER. TODAY SHE FEELS A LITTLE BETTER BUT HER BODY STILL FEELS WEAK AND SORE.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Nausea, Pain, Pyrexia
Clinical narrative: PATIENT RECEIVED THE VACCINE ON 9/15/2017 AT 9:00 AM AND BY 1:30 PM PATIENT WAS EXPERIENCING A FEVER OF 103 DEGREES WITH BODY ACHES AND CHILLS. BY 5:00 PM, HER HEAD AND STOMACH WERE EXTREMELY SORE AND HAD NAUSEA, ITCHING AND REDNESS OF THE INJECTED ARM AND HER HEART FELT WEIRD. HER FAMILY TOOK HER TO THE EMERGENCY ROOM AT 6:30PM AND SAID SHE WAS DELIRIOUS. THE ER GAVE HER FLUIDS AND MONITORED HER BP AND HEART, WHICH WAS EXTREMELY HIGH. THEY TOLD HER TO ICE HER ARM OVER THE WEEKEND AND TAKE TYLENOL FOR THE FEVER. TODAY SHE FEELS A LITTLE BETTER BUT HER BODY STILL FEELS WEAK AND SORE.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Vaccination site swelling
Clinical narrative: Patient stated that evening after receiving both vaccinations his left arm started to ache followed by swelling and redness (9/11/17). By 2 days after vaccination swelling and redness had spread from vaccination sites down to a few inches above his wrist. He came in to report the event to the pharmacy on 9/18/17 and the swelling and redness has receded to above the elbow. I counseled him that even though the reaction was getting much better he should still call his primary physician to report to them what happened as well to see if they would want to treat and so they could document the reaction to those 2 vaccinations.
Age: 72.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Upper left shoulder very painful.
Age: 72.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Calcinosis, Injection site reaction, Mobility decreased, Pain in extremity, X-ray abnormal
Clinical narrative: Upper left shoulder very painful.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Malaise, Pain in extremity, Skin warm
Clinical narrative: The arm the PNEMOVAX 23 was given became very sore and warm to the touch. She got very ill with flu like symptoms that evening. She woke up the next day a little better. I gave her an ice pack the day of the vaccination and told her if it got worse to call her physician. I called her the next day and that's when I found out she got sick.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bedridden, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: PATIENT REPORTS SEVERE FLU-LIKE SYMPTOMS BEGINNING APPROXIMATELY 12 HOURS FOLLOWING VACCINATION. STATES SHE WAS BEDRIDDEN FOR 2 DAYS WITH HEADACHE, BODY ACHES AND FEVER. SYMPTOMS GRADUALLY ABATED IN THE FOLLOWING DAYS.
Age: 5.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Arthropod bite, Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Starting 9/17 she got a welt in the shot site and it became red and painful fairly quickly, continued to get larger and spread and turn very hot to the touch. On 9/18 today there is now a small blister where the shot was given and her arm is swollen and very painful and some (minimal) itching.
Age: 5.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Starting 9/17 she got a welt in the shot site and it became red and painful fairly quickly, continued to get larger and spread and turn very hot to the touch. On 9/18 today there is now a small blister where the shot was given and her arm is swollen and very painful and some (minimal) itching.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Low grade fever, blistering rash on arms, legs, chest, stomach, and back beginning 14 days after vaccination.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Ill-defined disorder
Clinical narrative: CAN RESULT IN EXCESSIVE LOCAL OR SYSTEMIC CONCENTRATION OF ANTIGEN OR OTHER VACCINE CONSTITUENT.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site soreness at inj site requiring office visit. No redness or swelling noted on exam.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 inches below lowest site: warm, red, slightly swollen arm. She rested for 3 days and the swelling went down, warmth went away.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Patient had moderate swelling in the left upper arm and warm to touch. There is mild to warm erythema in the anterior, lateral, posterior and antecubital aspect of the upper arm. There was also orange peel induration in the posterior of the arm. Treatment of BENADRYL 25 mg Q6 hours. Ice pack on and off Q 20 minutes at a time.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pt reported soreness 9/14/17, soreness continued to progress and now has limited mobility of left arm. Reports soreness is from shoulder to upper part of elbow.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Swelling and inflammation of right upper arm almost immediately following injection lasting for two days at least. Pt also experienced pain in right upper arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pt received 2 vaccines on 09/12/2017 (FLUZONE HD on left arm and PNEUMOVAX 23 on right arm). Pt felt fatigue/flu like symptoms 2 hours after vaccination. She called her PCP, her PCP instructed her to go ER. ER visit(9/14)- there was redness and swelling on the right arm (upper arm to elbow in range) -provide pt with discharge instructions of apply BACTROBAN and TYLENOL/ice PRN- ER MD not sure if cellulitis vs. post injection site reaction. She called today to inform us of the events, she is doing better and swelling/redness is decreasing but still present. Apologized to the pt and asked if any further assistance or concerns are needed to let me know. Filed a VAERS report. Pt has receive pneumonia vaccine before but this reaction is first time. Lot: N004564 Exp:10/22/2018.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Culture urine, Eating disorder, Full blood count normal, Hypersomnia
Clinical narrative: It received vaccines 9-13-17 and developed fevers to 104 within 24 hrs. Fussy, not eating, sleeping all day.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia, Red blood cell sedimentation rate, Urine analysis normal
Clinical narrative: It received vaccines 9-13-17 and developed fevers to 104 within 24 hrs. Fussy, not eating, sleeping all day.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site nodule
Clinical narrative: (Rt) thigh pt has a knot 1 mm diameter no local tenderness or redness this was the place - where PEDVAX was given.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediate pain on injection, pain continues limited range of motion left arm/shoulder.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Neuralgia
Clinical narrative: Patient stated that she had nerve pain radiating up her head and neck after she received the shot. Note the injection was given high on her shoulder.