chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Erythromelalgia
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as nurse practitioner) via a company representative referring a 12 year old female patient. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patient was vaccinated with three series of GARDASIL 9 (route, anatomical location, lot number and expiration date were not provided) for prevention of HPV. Concomitant therapies were not provided. On an unknown date after the second dose of GARDASIL 9, the patient experienced bright red legs and pain. Subsequently, she was diagnosed with erythromelalgia. The patient sought for medical attention with rheumatologists, a blood test was performed (results were not provided) and steroids were used for treatment. Nevertheless, on an unspecified date 3 days after the third dose of GARDASIL 9, the symptoms were exacerbated. At the time of this report, the outcome of erythromelalgia was unknown. It was reported that there was no intervention to prevent serious criteria, the case did not involve cancer or overdose, the patient did not die, there was no hospitalization and no significant disability and none of the events were life-threatening. There was no product quality complaint (PQC) involved. The reporter did not provide a causality assessment between erythromelalgia and GARDASIL 9. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Had febrile seizure 3/5/16 - ER. Visit T-101.5 TYLENOL and ibuprofen given.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Had febrile seizure 3/5/16 - ER. Visit T-101.5 TYLENOL and ibuprofen given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Haematemesis, Lethargy, Loss of consciousness, Nausea, Pallor
Clinical narrative: On 3/2/16 Dtap (INFANRIX), Polio, and MMR were given mom reports child awoke next day very pale, wanting to vomit. Child passed out as she got to the bathroom, was out about 30-45 sec - threw up after coming around. Vomit was mucus and a tinge of blood- was lethargic rest of day ok the next day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rec'd DTaP and IPV at office visit on 03/02/16. (Rt) arm warm, red and swollen at site - started shortly after visit. Seen in office 03/04/16. Area 9 x 9 cm warm and indurated (Rt) upper arm noted. Afebrile tx with ibuprofen Q 6-8 hours x 48 hours; warm compresses; watch for 'streaking'.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hypersomnia, Injection site pain, Lymph node pain
Clinical narrative: Patient states injection site tenderness, neck and right axilla tenderness "lymph nodes" x 1 day, fatigue, increased sleeping. Sx resolved 3/7/16. Pt denies any further complaint.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Malaise, Pain, Walking aid user
Clinical narrative: This spontaneous report as received from a consumer referring to her 14 year old granddaughter The patient's concurrent and historical conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot number and expiration date were not provided) dose, route and anatomical location were not reported. The patient's concomitant medications were not provide. On an unknown date the reporter stated that the patient got really sick just after her doctor gave her the vaccine. She was fine until then. The reported stated that this is not a good drug and it was making lots of children sick and dying (reported in MARRS case #1603USA002747) and that the vaccine was not safe. On an unspecified date the patient also experienced pain and she was using a cane for an unspecified reason. At the time of the report, the outcome of malaise, gait disturbance and pain was unknown. This is one of two reports received from the same source. Additional information is not expected because no contact details were provided.
Age: 0.09
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Rcv'd vaccine 3-4-16 Rxn started on 3-5-16 went to urgent care and rcv'd BENADRYL and steroid - arm swollen from shoulder to elbows; picked here on 3-7-16 - S/s improved - Dr advised to continue BENADRYL/MOTRIN PRN.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV2, MNQ, TDAP
Symptoms: Asthenia, Disorientation, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: Case number PHHY2015US034074, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557084) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 360414) on 26 Mar 2015 with the follow-up information received from Quality Assurance Department (reference number: 360414) on 22 Apr 2015. This report refers to a 11-year-old female patient. Her historical conditions and concomitant medication were none. She was vaccinated with MENVEO (batch number: A14024) on right arm along with CERVARIX (other manufacturer and batch number: BF7A2) on left arm, FLULAVAL (other manufacturer and batch number: 9X3L3) on left arm and BOOSTRIX (other manufacturer and batch number: HP4XT) on right arm. On the same day at 12:15 pm, the patient had loss of consciousness for a few seconds, she had a drop off with hard sound on floor. She apparently had seizure movements for 2-3 seconds, apparently disoriented, excessive sweat, pale, partial recovery feeling but had weakness. Following the events the patient was referred to emergency for observation. Outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events was not reported. Seriousness of the events fall, loss of consciousness and convulsion were upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: A14024) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 360414) on 26 Mar 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 360414) on 22 Apr 2015: Updated MENVEO vaccine batch review report.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV2, MNQ, TDAP
Symptoms: Pallor, Seizure
Clinical narrative: Case number PHHY2015US034074, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557084) website on 16 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 360414) on 26 Mar 2015 with the follow-up information received from Quality Assurance Department (reference number: 360414) on 22 Apr 2015. This report refers to a 11-year-old female patient. Her historical conditions and concomitant medication were none. She was vaccinated with MENVEO (batch number: A14024) on right arm along with CERVARIX (other manufacturer and batch number: BF7A2) on left arm, FLULAVAL (other manufacturer and batch number: 9X3L3) on left arm and BOOSTRIX (other manufacturer and batch number: HP4XT) on right arm. On the same day at 12:15 pm, the patient had loss of consciousness for a few seconds, she had a drop off with hard sound on floor. She apparently had seizure movements for 2-3 seconds, apparently disoriented, excessive sweat, pale, partial recovery feeling but had weakness. Following the events the patient was referred to emergency for observation. Outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events was not reported. Seriousness of the events fall, loss of consciousness and convulsion were upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: A14024) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 360414) on 26 Mar 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 360414) on 22 Apr 2015: Updated MENVEO vaccine batch review report.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Case number PHHY2015US060340, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS ID 568660) on 12 May 2015 with a follow up information received from the quality assurance department (QA reference number: 371804) on 21 May 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to an 11-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14070, expiry date: Nov 2015) onto his right arm (right deltoid), GARDASIL (other manufacturer, batch number: K006960) onto his right arm, FLUARIX (other manufacturer, batch number: 9954H) onto his left arm and BOOSTRIX (other manufacturer, batch number 932Z9) onto his left arm; all vaccines administered on 03 Mar 2015. On 04 Mar 2015 after the vaccinations he had erythema and cellulitis at the site of vaccine. He was treated with KEFLEX and mupirocin. The final outcome of the events was unknown. The events were reported as non-serious, but the event cellulitis at the site of vaccination was upgraded based on available information in the source document. The causality of the event was not reported. Based on the documents review performed, it was concluded that the MENVEO batch M14070 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from the quality assurance department on 21 May 2015: QA reference number updated. Follow up information received from the quality assurance department on 16 Jun 2015: Batch summary and expiry date updated.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Chills, Cough, Diarrhoea
Clinical narrative: Immediate onset of abdominal pain, nausea, vomiting, watery diarrhea, fever to 103.6, rigors, weakness, fatigue, muscle aches, ear aches, sore throat, cough, headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Fatigue, Headache, Immediate post-injection reaction, Influenza virus test
Clinical narrative: Immediate onset of abdominal pain, nausea, vomiting, watery diarrhea, fever to 103.6, rigors, weakness, fatigue, muscle aches, ear aches, sore throat, cough, headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia, Streptococcus test
Clinical narrative: Immediate onset of abdominal pain, nausea, vomiting, watery diarrhea, fever to 103.6, rigors, weakness, fatigue, muscle aches, ear aches, sore throat, cough, headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Immediate onset of abdominal pain, nausea, vomiting, watery diarrhea, fever to 103.6, rigors, weakness, fatigue, muscle aches, ear aches, sore throat, cough, headache.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Fatigue, Nausea
Clinical narrative: Patient symptoms after vaccination were diarrhea and stomach pain. Pt states she is starting to feel bloated and pt is having more pain with movement and touch. Pt desribes the pain as dull and a level 4/10. Pt has had 2-3 epsisodes of diarrhea. Pt was c/o nausea and feeling fatigued. Denies fever, vomiting, cough, congestion, runny nose, chest pain, headache, loss of appetite.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Tenderness
Clinical narrative: Patient symptoms after vaccination were diarrhea and stomach pain. Pt states she is starting to feel bloated and pt is having more pain with movement and touch. Pt desribes the pain as dull and a level 4/10. Pt has had 2-3 epsisodes of diarrhea. Pt was c/o nausea and feeling fatigued. Denies fever, vomiting, cough, congestion, runny nose, chest pain, headache, loss of appetite.
Sex: U
Vaccine: HPV4
Symptoms: Death, Malaise
Clinical narrative: This spontaneous report was received from a consumer referring to an unspecified number of children of unknown ages and genders. No concurrent or historical conditions were reported. The reporting consumer stated that GARDASIL was making lots of children sick and dying. The reporter stated that her granddaughter got really sick just after her doctor gave her the vaccine, she considered that this was not a good drug and that the vaccine was not safe (reported on MARRS case # 1603USA002754). The reporter considered the adverse events were related to GARDASIL. This is one of two reports received from the same source. Additional information is not expected, because no contact details were provided.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm erythema, swelling.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Feeling abnormal, Full blood count normal, Influenza virus test negative
Clinical narrative: Within 24h after vaccines administration patient started "twitching" all over and eyes were in a daze, fever 100.6, foggy this lasted about 20 secs. after that had couple of similar episodes but were much shorter. Patient was seen at ER hospital and admitted to hospital, spinal tap, CT scan and EEG were done and were all normal. No anticonvulsant given.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lumbar puncture normal, Metabolic function test normal, Muscle twitching, Pyrexia
Clinical narrative: Within 24h after vaccines administration patient started "twitching" all over and eyes were in a daze, fever 100.6, foggy this lasted about 20 secs. after that had couple of similar episodes but were much shorter. Patient was seen at ER hospital and admitted to hospital, spinal tap, CT scan and EEG were done and were all normal. No anticonvulsant given.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed an injection site reaction to the Zostavax vaccine. The administration site became red, hard, and swollen.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Brain oedema, Delayed fontanelle closure, Nuclear magnetic resonance imaging, Swelling, Vaccination complication
Clinical narrative: Patient's soft spot swelled up and so did his temples. I was told by the ER staff at hospital his brain swelled due to a reaction of his vaccinations.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Patient reported a few red welts on her arm. They were not painful or itchy. Patient was instructed to ice the area.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Musculoskeletal pain, Pyrexia, Rash macular
Clinical narrative: Severe shoulder pain. Could not lift arm above head. Pain continued the next day followed by slight fever, swelling of ejection area, with blotchy hives. Hot to the touch. Pain and swelling starting to diminish 3 days after injection.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Urticaria
Clinical narrative: Severe shoulder pain. Could not lift arm above head. Pain continued the next day followed by slight fever, swelling of ejection area, with blotchy hives. Hot to the touch. Pain and swelling starting to diminish 3 days after injection.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Gingival swelling, Lymphadenopathy, Oropharyngeal pain, Stomatitis, Streptococcus test negative
Clinical narrative: Swelling of Lymph Nodes under left arm and under jaw, sore throat, irritation to mouth, swollen gums.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Pain in extremity
Clinical narrative: Patient experienced severe pain in left arm causing difficulty with tasks such as putting on a jacket and difficulty sleeping at night. Patient trying to treat w/ MOTRIN.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Sudden death
Clinical narrative: This spontaneous report was received from a consumer via a social media site concerning a female who on an unspecified date received GARDASIL. Concomitant medications and medical history were not provided. The reporter posted on the social media site. No further information was provided. Follow-up information was received on 04-MAR-2016 from a consumer via social media concerning a female who was reported to have received a dose of GARDASIL. It was reported: "The sudden death of a 12 year old girl... just hours after receiving the HPV GARDASIL vaccine has shocked the girl's family and sent local medical asking questions as [...]". No other information was provided. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Disturbance in attention, Dyskinesia, Irritability, Local reaction, Mental status changes
Clinical narrative: Local reaction to shot, altered mental state, irritability, involuntary movements, concentrating & focus difficulties, personality changes, extreme hyperactivity, very oppositional, mouth noises.  All of the above was witnessed by both parents and independently confirmed by special needs teacher.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Negativism, Personality change, Psychomotor hyperactivity
Clinical narrative: Local reaction to shot, altered mental state, irritability, involuntary movements, concentrating & focus difficulties, personality changes, extreme hyperactivity, very oppositional, mouth noises.  All of the above was witnessed by both parents and independently confirmed by special needs teacher.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Lymphadenopathy, Pallor
Clinical narrative: Patient first reported feeling lightheaded, feels like glands are swollen, pale facial color. After monitoring by nurse and visit with provider patient started to better 15 minutes later.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: Selling, discoloration (red/brown/yellow), and itching at injection site.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Immediate post-injection reaction, Pain, Type 1 diabetes mellitus
Clinical narrative: My daughter received a Tdap and Meningococcal boosters. She immediately started having severe headaches and body aches that lasted about 2 months off and on. Feb. 1st she was diagnosed with Type 1 diabetes.
Age: 9.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Headache, Injection site pain, Malaise, Nausea, Skin warm
Clinical narrative: Nausea, malaise, injection site tenderness.  Mom gave Motrin, which helped.  Early am 3/8/16 child reports headache and blurry vision.  Able to take PO fluids without difficulty.  Mom reports feels warm, like fever, but did not take temp.  Referred to urgent care.
Age: 9.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Vision blurred
Clinical narrative: Nausea, malaise, injection site tenderness.  Mom gave Motrin, which helped.  Early am 3/8/16 child reports headache and blurry vision.  Able to take PO fluids without difficulty.  Mom reports feels warm, like fever, but did not take temp.  Referred to urgent care.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Extra dose administered, Fatigue
Clinical narrative: Side effect: Mom stated since the last Saturday 5 March he hasn't been eating much and just seems tired/fatigue.  Course: Patients Mother brought son in for an annual physical and was told by the provider he was due for vaccines, Hep A Vaccine and meningococcal Vaccine.  Patients mother brought patient to Immunization Clinic. Immunization Clinic reviewed chart and shot record and administered meningococcal and Hep A on 17 Aug 2015. In Ahlta there was very minimal documentation of the history of vaccines. The mother did state she had the shot record in Aug.  Patient and mom returned to Immunization Clinic on March 2nd stating he needed to have the second Hep A shot from Aug 2015. There was only one Hep A shot recorded and documented in AHLTA at the time. The nurse administered a second Hep A vaccine.  Pts. mother was advised to come in at her soonest with a recent shot record so we could document the 2nd Hep A shot.  When the mom returned today 08 March 2016 the nurse noted there were already 2 Hep A vaccines given on 22 May 2010 and again on 22 Sep 2010.  So patient received 4 Hep A vaccines. Pts mother was notified and it was documented on the shot record and again in AHLTA.  DHA was called to advise on any possible adverse reactions to look for.  DHA Provider stated that luckily there should not be any reaction and research shows that they do not have any document adverse events for multiple Hep A vaccines. However, DHA recommended placing a VAERS report.  Patients mother was educated on PSR and VAERS report and that she may receive a call or something in the mail regarding the VAERS report.
Age: 36.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Headache
Clinical narrative: Severe heachache-- Advil, Aleve, caffeine.
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 23 February 2016. This case was linked with 2016SA037709 (same product and reporter). This case involves a three patients (gender was not reported) who was vaccinated with a intramuscular dose of Adacel (batch number U5298AA, expiration date, dose, dose in series were not reported, site of administration was reported as unknown) on February 2016 (reported as 11 February 2016 to 16 February 2016). Patient's medical history and concomitant medications were not reported. On an unspecified date in February 2016, one day (reported as next day) following the vaccination, patient developed redness and swelling about 2 inches. Lab data and corrective treatments were not reported. The patient was not recovered from event. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Trismus
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23 February 2016. This case involves a 39-year-old female patient who was vaccinated with a dose of ADACEL (batch number: C2455AA, expiry date: 06 July 2008, dose, dose in series, and site of administration were not reported) intramuscularly on 10 April 2006. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 April 2006, same day few hours following the vaccination, the patient had developed jaw pain, locked jaw. It was very painful to open her mouth. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the symptom lasted for 48 hours and the patient was recovered from the events. List of documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Pt received FLUMIST 3/4/16 and on 3/5/16 pt presented with hives all over. No SOB or respiratory distress noted.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Pt. was administered Tdap during routine PE 3/7. States he went home and arm was sore, red, and hot at injection site. Pt reports pain this morning in (L) arm only, is not able to work. Site feels hot to touch today, afebrile. Pt took TYLENOL last night and applied ice to site. Improvement in symptoms today.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Patient returned 2/29/16 to pharmacy with red, swollen arm - heat and pain reported by patient - redness approximately 6-8 inches across.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Rash erythematous
Clinical narrative: Next 48 hrs. very painful thru 72 hr, red rash (R) arm spread to under area of arm - recommended for flu and pneumonia given different intervals not together, too debilitating.
Age: 41.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Arthralgia, Fatigue, Muscular weakness, Musculoskeletal pain, Oropharyngeal pain
Clinical narrative: 10/19/15 pt called to report shoulder/joint pain. 10/2/15 Hep B vaccine IM right deltoid, 10/3/15 Stated had sore throat for 1 day. 10/5/15 Bilateral shoulder pain hard to raise arm over head. (R) shoulder arm felt weaker. Tired. Sharp pain at Hep B site Sun/Mon. Oct 4th/5th. Has lifted wts.
Age: 41.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Pain
Clinical narrative: 10/19/15 pt called to report shoulder/joint pain. 10/2/15 Hep B vaccine IM right deltoid, 10/3/15 Stated had sore throat for 1 day. 10/5/15 Bilateral shoulder pain hard to raise arm over head. (R) shoulder arm felt weaker. Tired. Sharp pain at Hep B site Sun/Mon. Oct 4th/5th. Has lifted wts.
Age: 1.2
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Developed shingles (VZV PCR (+)) diagnosed 2/29/16. Varicella vaccine administered 12/17/15.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Urticaria, Vomiting
Clinical narrative: Mom reports that approximately 45 minutes following injection of vaccines last Friday, patient developed diffuse body hives. On arrival home, approximately 1.5 hrs after injection, had several episodes of vomiting/diarrhea. Mom gave Benadryl x2 doses, unsure of dose amount for hives with improvement. Patient never developed wheezing or respiratory distress. No other treatments. Tmax 102.6 that evening. No fevers since that time. Mom also noted red, induration along left thigh where patient received injections. That area has become smaller and less tender. Mom has been massaging the area.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Dizziness, Pallor
Clinical narrative: After shots were given, pt transferred from examination table to a nearby chair when she started to feel lightheaded.  No LOC.  Pt was observed to be pale.  Vitals were taken with BP dropped from 119/76 to 95/65, pulse from 88 to 64.  Blood glucose 140.  No other associated symptoms including dyspnea, headaches, swelling or rash.  Pt was given some water.  Pt remained resting in chair and over the course of 15 minutes, regained color to her skin and report of dizziness resolving.  Pt was discharged home with mother with closed monitoring.  ER precautions signs given to mother.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased
Clinical narrative: Patient states that since he received his flu vaccine he has had trouble moving his right arm.  He was diagnosed with bursitis and has been seeing a chiropractor for help with movement.  He states he cannot move his arm above 90 degrees and has trouble with every day movements.  He stated the vaccine was given high in the arm.
Age: 10.0
Sex: F
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Erythema, Infection, Local swelling
Clinical narrative: Mom called stating during evening, noticed "big red spot that looked swollen on left arm" Also stated that patient was "scratching at it all night". Mom took child to ED next day and was told it was infection/possible reaction to shot and placed on 3 day course of cephalexin by ED. Scheduled appointment for follow-up with provider on 03/09/2016.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Patient called reporting a swollen arm and not feeling well.
Age: 19.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Loss of consciousness
Clinical narrative: Client began to feel clammy and said he felt lightheaded. While seated he lost consciousness. He was laid on the floor with feet elevated on a chair and regained consciousness. He was out for less than 30 seconds.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Neuralgic amyotrophy, Pain
Clinical narrative: 21 y/o M who presented to the ER with c/o left shoulder pain worsening over the last 3 1/2 weeks. Pain initially began after patient received anthrax vaccination. Located over the left shoulder/trapezius, described as "sharp" and "shooting" radiating to the neck and down the left arm and spine, rated as a 9/10 with paroxysms of pain. Over the last 3-4 days he notes shaking, numbness/tingling in the left arm below the shoulder. Patient was initially seen at his facility and treated for shoulder pain with NSAIDs and recommended PT however continued to worsen. On follow up case was discussed with Neurology and thought that symptoms were consistent with a neuralgic amyotrophy, patient was started on a 5 day prednisone burst. However again without any improvement and patient has now been seen in the ER and was started on Gabapentin. Patient reports finishing the steroids yesterday and ran out of Gabapentin this morning so hasn't taken any today. Xray left shoulder and C-spine series both normal. Denies any recent illnesses, F/C/N/V, SOB, chest pain.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia, Spinal X-ray normal, Tremor, X-ray limb normal
Clinical narrative: 21 y/o M who presented to the ER with c/o left shoulder pain worsening over the last 3 1/2 weeks. Pain initially began after patient received anthrax vaccination. Located over the left shoulder/trapezius, described as "sharp" and "shooting" radiating to the neck and down the left arm and spine, rated as a 9/10 with paroxysms of pain. Over the last 3-4 days he notes shaking, numbness/tingling in the left arm below the shoulder. Patient was initially seen at his facility and treated for shoulder pain with NSAIDs and recommended PT however continued to worsen. On follow up case was discussed with Neurology and thought that symptoms were consistent with a neuralgic amyotrophy, patient was started on a 5 day prednisone burst. However again without any improvement and patient has now been seen in the ER and was started on Gabapentin. Patient reports finishing the steroids yesterday and ran out of Gabapentin this morning so hasn't taken any today. Xray left shoulder and C-spine series both normal. Denies any recent illnesses, F/C/N/V, SOB, chest pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient given HPV vaccine and within a few seconds had a syncope episode. Vital signs taken, O2 per nasal cannula and Benadryl 25mg IM given. Patient recovered, discharged home with mother 1 hour later.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Baseball size red, itchy circle on right deltoid.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye inflammation, Headache, Lacrimation increased, Ocular hyperaemia, Pruritus
Clinical narrative: Extreme watering of eyes; blood shot eyes, inflamed eyes, headache, itching.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Nausea, vomiting, body aches, headaches.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Decubitus ulcer, Device related infection, Diplegia, Infection, Myelitis transverse
Clinical narrative: Started with losing bladder control, catheter in, week later had paralysis of legs.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Neuromyelitis optica, Nosocomial infection, Osteomyelitis, Plasmapheresis, Sepsis
Clinical narrative: Started with losing bladder control, catheter in, week later had paralysis of legs.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Spinal disorder, Surgery, Urinary incontinence
Clinical narrative: Started with losing bladder control, catheter in, week later had paralysis of legs.
Age: 19.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Neuralgia, Paraesthesia
Clinical narrative: Pain at injection site after vaccine administered, then progressively worsening pain over next 12 hrs. Erythema at site, trace edema, and tingling/nerve pain along left arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in 2016, reported as since 16-FEB-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# L023112, expiry date 24-DEC-2016; lot# L005292, expiry date 17-AUG-2016; lot# reported as L046506, expiry date 17-MAY_2017; lot# reported as L041629, expiry date 22-APR-2017; lot # L032761, expiry date 24-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporting nurse stated that the vaccines were exposed to a temperature excursion of 31.1 degrees Fahrenheit, for a cumulative time of 105 hours since 16-FEB-2016. No adverse effects were reported. There was no product quality complaint involved. This is on of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pharyngeal ulceration, Pyrexia
Clinical narrative: Patient developed redness and large swelling at site of injection. Since then she has been developing sores in mouth/throat, fevers on and off, severe fatigue. She relates this all back to the injection when sxs started.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Patient developed redness and large swelling at site of injection. Since then she has been developing sores in mouth/throat, fevers on and off, severe fatigue. She relates this all back to the injection when sxs started.
Sex: F
Vaccine: MMR
Symptoms: Differential white blood cell count normal, Extra dose administered, Hepatitis B surface antibody positive, Hepatitis viral test negative, Laboratory test normal
Clinical narrative: Information has been received from the authors in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficiency or recurrent infections in all three cases. This case refers to a female patient of unknown age. The patient had no history of immunodeficiency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2012, the patient was vaccinated with fourth dose of MMR (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in April 2015, measles, mumps, and rubella (MMR) titers were measured with the results showed positive mumps and rubella IgG titers yet negative measles IgG. Vaccination failure was reported. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR (manufacturer unknown). This report is linked to MARRS #1603USA004010 and #1603USA004011 (same literature link). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficiency or recurrent infections in all three cases. This case refers to a female patient of unknown age. The patient had no history of immunodeficiency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2012, the patient was vaccinated with fourth dose of MMR (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in April 2015, measles, mumps, and rubella (MMR) titers were measured with the results showed positive mumps and rubella IgG titers yet negative measles IgG. Vaccination failure was reported. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR (manufacturer unknown). This report is linked to MARRS #1603USA004010 and #1603USA004011 (same literature link). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 04-MAR-2016, the patient was vaccinated with an expired VARIVAX (Merck) injection (dose and route were not reported, lot # K002916 and expiry date 26-FEB-2016) (expired product administered). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist referring to a 64 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 12-FEB-2016, the patient was vaccinated with a dose of FLUZONE, then administered both a dose of ZOSTAVAX (lot # L034726, expiry date 09-DEC-2016) subcutaneously (dose, frequency unspecified) and a dose of Tdap (lot#, expiry date, dose, frequency, route unspecified) on 15-FEB-2016. Patient also started therapy with AUGMENTIN 875 mg twice daily (which she had been prescribed for an unspecified reason prior to receiving ZOSTAVAX) in the evening after receiving ZOSTAVAX, on 15-FEB-2016. Concomitant therapy included EPIPEN. The patient became "violently ill to her stomach," clarified as "extreme" nausea and vomiting after taking one dose of AUGMENTIN on 15-FEB-2016. The nausea and vomiting resolved on the following day 16-FEB-2016 and patient would continue therapy with AUGMENTIN. The patient called pharmacist for medical attention. No treatment was given for the event and no lab diagnostics studies performed. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Developed hives, pain in injection site, swelling at site. Treated with MEDROL dose pack, ice pack.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Malaise, Myalgia
Clinical narrative: Patient developed red itchy spot on injection site, 3-4 inches in size. Experienced malaise next day muscle pain. Fully recovered next day.
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Fatigue, Malaise, Pain
Clinical narrative: Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood cholesterol abnormal, Blood glucose abnormal, Blood thyroid stimulating hormone normal
Clinical narrative: Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bradyphrenia, C-reactive protein normal, Chest discomfort, Electrocardiogram normal, Fatigue
Clinical narrative: Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fibromyalgia, Full blood count normal, Gait disturbance, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Age: 62.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Red blood cell sedimentation rate normal, Thyroid function test normal, Thyroxine free normal, Tremor
Clinical narrative: Pain, fatigue. "Aerobic capacity has severely diminished" "chronic state of ill healthy".
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Activities of daily living impaired, Pain, Pain in extremity
Clinical narrative: Had HPV given on 12/14/15 initial stabbing pain. lasted for 3 days, slept through it, unable to go to school so pain. No swelling noted, ? red/warm, had sharp pain that radiated down the arm lasted 3 days, took ibuprofen without relief. No fever noted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 49.94 F, time frame: 15 minutes, unspecified date in October 2015) of ROTATEQ with lot/batch # K011562, expiry date 08-APR-2017 and lot/batch # J010265, expiry date 05-MAY-2017 (dose, dose number, vaccination site and route of administration not provided). There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oral herpes, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Since receiving vaccine I have been getting cold sores on average twice a month. More sever than prior to vaccine and up to three sores per event. Using acyclovir 5%. At time of vaccine arm turned warm and red, swelling and became painful this lasted 1 week.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cellulitis, Local swelling
Clinical narrative: Large swollen area (8.5 cm) after receiving 2 injections the day before. Dx with cellulitis. Rx: SEPTEA 200 mg 40 mg/5ml BIX x 10 days.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a Registered Nurse, and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patient was vaccinated with the 3rd dose series of RECOMBIVAX HB (dose, route of administration, anatomical location, lot # and expiration date were not provided) as a job requirement. Concomitant therapies were not reported. It was reported that the patient claimed she was not immune at the time of this report (hepatitis b surface antibody negative) It was uncertain if the patient was had titers drawn which showed negative immunity. No product quality issue was involved. Additional information has been requested.