chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Culture urine positive, Musculoskeletal disorder, Nausea, Pain
Clinical narrative: 90 min - 2 hrs after receiving vaccination patient developed severe nausea, near vomiting low back pain and generalized body aches. Severe pain in (L) arm with difficulty using arm. Intensity of symptoms gradually declined over next 24 hours with back pain persisting into 36 hour. Some nausea on Day 2. Symptoms completely resolved w/in 48 hours.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Urinary tract infection
Clinical narrative: 90 min - 2 hrs after receiving vaccination patient developed severe nausea, near vomiting low back pain and generalized body aches. Severe pain in (L) arm with difficulty using arm. Intensity of symptoms gradually declined over next 24 hours with back pain persisting into 36 hour. Some nausea on Day 2. Symptoms completely resolved w/in 48 hours.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient specifies that she received Tdap on the left arm on 2/26/18, 1:04pm. By 4:00pm, arm was red and warm to touch. It looks swollen, red and warm to touch.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Arm pain, soreness, headache, muscle aches, a little shivering, much fatigue and nausea.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain, soreness, headache, muscle aches, a little shivering, much fatigue and nausea.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient telephoned to report that the evening following her Tdap injection given on 3/23/18, the site was "painful and hot" over an area about the size of a half dollar. Over the next couple days the area covered entire upper deltoid area from the injection site to just above the elbow. She then followed up with her primary care provider on 3/26/18 and was told she had cellulitis and was given an antibiotic and told to take Benadryl. She reports she was told to call back for a possible steroid if symptoms not subsiding. She says the area still remains red and "itchy" and she has called her provider back today.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis
Clinical narrative: THE PATIENT RETURNED TO THE PHARMACY REPORTING LIGHT HEADEDNESS, DIZZINESS, SWEATING. THE PATIENT WAS CONCERNED ABOUT LOW BLOOD GLUCOSE. AFTER TESTING HIS GLUCOSE LEVEL IT WAS DETERMINED HE WAS NOT HYPOGLYCEMIC AT 142 BLOOD GLUCOSE LEVEL.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Rash erythematous
Clinical narrative: Half-dollar sized red rash on triceps area. Painful and inflamed. Rash was not at site of injection.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash, Rash pruritic, Varicella post vaccine
Clinical narrative: Pateint noticed a "bump" on the left  side of her neck and then the next day she noticed two more bumps: one on her right side of her neck and the other on her  lower right side of her back, above her waistline. Employee reports that these "bumps" are moderately itchy at site.  Patient placed on  valacyclovir 1 g three times a day for the next seven days to treat this to treat chickenpox.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Pt was given the wrong shot on 2-20-18. The M.A that checked for the M.A administering the shot is no longer allowed to sign for her. Only senior M.A's are allowed to check for the M.A that administer shot. Both M.A's were written up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 15th March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On 16th March 2018, the patient experienced urticarial rash, nausea, chills, headache and slight temperature. The patient was treated with BENADRYL and Cortisone (NOS). On an unknown date, the outcome of the injection site erythema and slight temperature were unknown and the outcome of the urticarial rash was recovering/resolving and the outcome of the nausea, chills and headache were recovered/resolved. It was unknown if the reporter considered the injection site erythema and slight temperature to be related to SHINGRIX. The reporter considered the urticarial rash, nausea, chills and headache to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the Nurse Practitioner. The patient details, lot number or expiry date was not provided. The healthcare professional reported that 1 day after the patient received a dose of SHINGRIX in left arm and developed urticarial rash approximately 7 cm wide, a mild headache, nausea, chills and a low grade temperature of 99 degrees Fahrenheit. Injection site now just red not raised anymore. The patient took BENADRYL and applied cortisone to area.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 15th March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On 16th March 2018, the patient experienced urticarial rash, nausea, chills, headache and slight temperature. The patient was treated with BENADRYL and Cortisone (NOS). On an unknown date, the outcome of the injection site erythema and slight temperature were unknown and the outcome of the urticarial rash was recovering/resolving and the outcome of the nausea, chills and headache were recovered/resolved. It was unknown if the reporter considered the injection site erythema and slight temperature to be related to SHINGRIX. The reporter considered the urticarial rash, nausea, chills and headache to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the Nurse Practitioner. The patient details, lot number or expiry date was not provided. The healthcare professional reported that 1 day after the patient received a dose of SHINGRIX in left arm and developed urticarial rash approximately 7 cm wide, a mild headache, nausea, chills and a low grade temperature of 99 degrees Fahrenheit. Injection site now just red not raised anymore. The patient took BENADRYL and applied cortisone to area.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site bruising, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash, injection site bruising and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and injection site bruising were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the rash to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a dose of SHINGRIX was inadvertently administered subcutaneously, which led to incorrect route of vaccination. The patient subsequently developed a rash, followed by bruising at the site of injection. The healthcare professional declined to provide patient's date of birth.
Age: 22.0
Sex: F
Vaccine: JEV1, SMALL
Symptoms: Blister, Pain, Rash pruritic
Clinical narrative: Blistering itchy rash on hands and feet/body aches.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX and sterile diluent (STERILE DILUENT). On an unknown date the patient experienced product storage error and no adverse event. The outcome of product storage error and no adverse event is unknown. The reporter considered product storage error and no adverse event to be not assessed to VARIVAX, PROQUAD and sterile diluent (STERILE DILUENT).
Sex: F
Vaccine: PPV
Symptoms: Gait inability, Guillain-Barre syndrome, Muscular weakness, Musculoskeletal disorder, Wheelchair user
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information regarding concomitant medications or concurrent conditions was provided. On or about 23-MAR-2015, the patient was admitted to the hospital for colitis and received treatment for the same. On or about 26-MAR-2015, the patient was administered PNEUMOVAX 23 at the hospital (dose, route, and lot # not provided). On or about 30-MAR-2015, she was readmitted to the hospital as a result of significant weakness in her legs. She was diagnosed with Guillain-Barre Syndrome during that admission to the hospital. The patient is now confined to a wheelchair and can no longer walk (also reported she lost most of the function in her legs). The lawyer claimed that the patient contracted Guillain-Barre Syndrome as a result of receiving the PNEUMOVAX 23 vaccine. The outcome of the Guillain-Barre Syndrome was not recovered. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Guillain-Barre Syndrome was considered disabling as the patient was confined to a wheelchair.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a non-contactable consumer. A patient of unspecified age, race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination the patient ended up in hospital with pneumonia. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: In the right arm RD possible cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of the right upper extremity.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cervical spinal stenosis, Choking, Diplegia, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and  swallowing. She has been to clinic 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG, Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but now it is gone. She has noted over the past week that she is choking on her food (solids worse than liquids). On exam she has a loss of sensation to the level her breast.   She was sent to hospital via ambulance 3/20/18 for direct admit to neurology They plan being aggressive on her treatment with IVIG,  High doses of steroids and Plasmapheresis. 9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days.she did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and  swallowing. She has been to clinic 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG, Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but now it is gone. She has noted over the past week that she is choking on her food (solids worse than liquids). On exam she has a loss of sensation to the level her breast.   She was sent to hospital via ambulance 3/20/18 for direct admit to neurology They plan being aggressive on her treatment with IVIG,  High doses of steroids and Plasmapheresis. 9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days.she did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Odynophagia, Pain in extremity, Polyneuropathy, Red blood cell sedimentation rate normal, Sensory loss
Clinical narrative: 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and  swallowing. She has been to clinic 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG, Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but now it is gone. She has noted over the past week that she is choking on her food (solids worse than liquids). On exam she has a loss of sensation to the level her breast.   She was sent to hospital via ambulance 3/20/18 for direct admit to neurology They plan being aggressive on her treatment with IVIG,  High doses of steroids and Plasmapheresis. 9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days.she did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Spinal osteoarthritis
Clinical narrative: 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and  swallowing. She has been to clinic 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG, Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but now it is gone. She has noted over the past week that she is choking on her food (solids worse than liquids). On exam she has a loss of sensation to the level her breast.   She was sent to hospital via ambulance 3/20/18 for direct admit to neurology They plan being aggressive on her treatment with IVIG,  High doses of steroids and Plasmapheresis. 9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days. She did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago but 2/9/18 pain and weakness in legs progressed to paralysis over weeks moving up from legs to involve upper extremities and swallowing. She has been to hospital 3 times. The 1st time 2-17-18 thru 2/24/18 and diagnnosed with Acute Inflammatory Polyneuropathy and severe stenosis at C5-C6. she was discharged back to prison after 5 days of IVIG,  Gabapentin 600 mg po qid and Zanaflex 4 mg po q6h prn for muscle spasms. 3/2/18 she was transported to hospital via ambulance with worsening of upper extremity weakness for treatment of Guillain-Barre Syndrome. She was again treated with IVIG X 5 days.she did well at first but now her condition worsening. She had some Achilles reflex bilaterally upon her return 2 weeks ago.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented to pharmacy 3/28/18 at approximately 3:30pm inquiring about whether the reaction on her arm was normal for after receiving a shingles vaccine. Pt has severe redness, warmth, and mild swelling of the upper left arm. I advised her that it could definitely be a result of receiving the vaccine but that she should follow up with the physician that wrote the prescription so he could evaluate her condition and determine whether or not she should continue with the series.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: On 03/28/18 the patient states he has pain in his arm since receiving his vaccination. The patient also states that the pain could also be due to his arthritis in his left arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Ecchymosis, Injection site pain, Malaise, Vertigo
Clinical narrative: MALAISE, WEAKNESS, VERTIGO LASTING 4-5 DAYS ALONG WITH  PAIN AT INJECTION SITE WITH  LARGE AREA OF ECCYMOSIS WHICH  HAS REMAINED ALMOST 3 WEEKS LATER.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Swelling, Tenderness
Clinical narrative: Patient reports swelling and redness on left arm at a location below the injection site. Noticed at about 24 hours after the shot was administered. Reports tenderness and inflammation (heat), not related to injection site pain. Has tried icing and benadryl but nothing has relieved the symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a consumer regarding a 14 year and 364 day old female patient. The patient concurrent conditions, medical histories, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9. It was reported that it was unknown if the patient was supposed to be getting the three dose or two dose regimen of HPV vaccination series with GARDASIL 9. The consumer reports that the patient was late for her second dose of GARDASIL 9 if she was supposed to get the three dose series (Inappropriate schedule of drug administration). No adverse effects reported. No product quality compliant (PQC) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about May 2016, the patient was treated by a physician and was diagnosed with painful herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a currently 25 years old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-DEC-1993, the patient was vaccinated with the first dose of M-M-R II, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. Subsequently on 13-DEC-1996, the patient was vaccinated with the second dose of M-M-R II, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. Then, on approximately 20-JAN-2018, the patient became pregnant with an approximately last menstrual period (LMP) of 06-JAN-2018 and an estimated delivery date (EDD) of 13-OCT-2018. On an unknown date in 2018 (reported as"while pregnant"), the patient had an "MMR titer" drawn and the results of the "MMR titer" showed that the patient "did not have immunity" (antibody test negative). Primary reporter reports the patient has not received any additional doses of M-M-R II since becoming pregnant. At the time of reporting, the pregnancy outcome was pending. The outcome of antibody test negative was unknown. The causal relationship between antibody test negative and M-M-R II was not provided.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Insomnia, Rash
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19-year-old (at the time of events, currently, 23-year-old) female patient with medical history of chickenpox in 2013 and concurrent condition of recurrent unspecified infections. On 16-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 lot # J013555 with expiration date on 02-MAY-2015, intramuscularly in the left arm as a prophylaxis of recurrent infections. On the same day, the patient received a dose of AFLURIA (reported as "Novartis branded influenza MDV TIRV 2V3 vaccine") in her right arm and no adverse reaction was reported in the right arm. On an unknown date in October 2014, the patient started having a rash and an unspecified allergic reaction in her left arm. On 18-OCT-2014, the patient was examined by a physician and was prescribed prednisone (manufacturer unknown), 60 mg on day 1, 40 mg on days 2 and 3, and 20 mg on days 4 and 5 to treat the allergic reaction. On 24-OCT-2014, the patient stated to the medical assistant that her arm was still bothering her and she was unable to sleep on her left side on unspecified dates in October 2014. The patient recovered from the events on unspecified dates. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 19-year old non-pregnant female patient. Patient had no pertinent medical history, drug reactions or allergies. Information regarding patient's concurrent conditions and past therapies were not reported. On 14-DEC-2017 the patient was vaccinated with first dose of GARDASIL 9 one injection via intramuscular route for human papilloma virus (HPV) prevention whose lot and expiry date were reported as unknown. The patient's concomitant medications included unspecified birth control pills. On 14-DEC-2017 reported as "immediately after vaccination" the patient started feeling dizzy and out of sorts (malaise). It was reported that patient's injection site was sore right after receiving the vaccination. No lab diagnostics or studies were performed and no medical attention was sought. The patient received an unspecified treatment for the adverse events. On 04-JAN-2018 reported as three weeks after vaccination, the patient's soreness was subsided. On an unspecified date, the patient's dizziness and malaise got subsided. The reporter stated that patient has not yet received the second dose in the HPV vaccination series that was due in February. The reporter did not provide the causal relationship with GARDASIL 9 vaccination. There was no product quality complaint (PQC) involved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Vertigo
Clinical narrative: Patient experienced vertigo. She also experienced redness at the site of injection. She went to the ER, they determined she was developing cellulitis at the site of injection.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Dad noticed a raised area on  patients left thigh yesterday. Since yesterday raised area has increased in diameter. Area is hard to touch.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Doctor ordered DTaP/Hib/IPV and patient received the PEDIARIX vaccine. Patients mother is aware.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Client received SHINGRIX vaccine on 3/22/2018 around 11:20 am. On 3/24/2018 around 9:00 am she noticed a pink/red rash on the medial part of her left upper arm underneath and to the side of injection site. The rash was about 1.5 inches wide by 6 inches in length and was blotchy and itchy. The rash lasted for about 36 hours and resolved on it's own. No medication or treatment was needed.
Age: 26.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, TDAP
Symptoms: Rash pruritic
Clinical narrative: Client reported having had itchy, painless rash on face, arms, hands, legs, and back for about 10 days, starting a couple days after vaccinations were given. Denies fever at time of rash. States that rash has resolved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient had high fever of 103 degrees the night of the vaccination. She also woke up the next morning with a really sore and swollen arm. The symptoms went away on its own after 2 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Muscular weakness, Pain
Clinical narrative: On going pain which began the days after injection and continuing until now. Arm of injection sore and weak around shoulder joint. There has been no numbness, tingling, or loss of function of arm. Patient treating pain and soreness with over the counter Aleve and mild exercise/physical therapy. Has not be troubling enough for patient to contact a Dr. or clinic for symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Swelling and redness warm to the touch-night of immunization-about golfball sized which worsened over night-contacted pharmacist at 3pm day after vaccination-instructed cool compress and Ibuprofen 600mg q 6 hours along with Loratadine 10mg which was readily available -after 3 hours swelling  went down. However, upper arm still red and warm to touch about 8"x6" oblong area-seen at walk in clinic and prescribed Doxycycline 100mg BID to prevent cellulitis spread.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Erythema, Pain, Paraesthesia oral, Swelling
Clinical narrative: REDNESS AND SORENESS AND SWELLING AS EXPECTED BUT WENT AWAY. BUT PT STILL HAS TINGLING IN THE LIPS AND CHAPPED. BUY AQUAPHOR OINTMENT AND BLISTEX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster pharyngitis
Clinical narrative: Development of herpes zoster in pharynx.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Pericarditis, Pleural effusion
Clinical narrative: Experienced chest pain on 11/30/2017, two days after vaccination, that was unbearable and had to call ER. Ended up with Pericarditis, left lung fluid build up and took about 2 months to slowly recover from the severe chest pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left thigh with erythema, edema, slight tenderness, warmth, noticed the next day by mom at 2 inches and by 24 hrs later was double size. They had only iced it prior to being seen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient began having painful rash on entirety of trunk.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pyrexia
Clinical narrative: Red arm, fever, cannot lift arm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: Patient reports arm pain at injection site and malaise for about a day or two following receipt of vaccine.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen, red, painful and warm to touch starting witching 12  hours of injection and still remarkable after 48 hours from injection time.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Arthralgia, Bone pain, Dizziness, Headache, Injection site pain
Clinical narrative: Moderate muscle/bone/joint ache/pain. Nausea. Dizziness. Moderate pain at injection site. Headache.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Moderate muscle/bone/joint ache/pain. Nausea. Dizziness. Moderate pain at injection site. Headache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had localized redness, sore and hot to the touch, and a bump under the skin at injection site - occurred the day after injection.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Dyskinesia, Electroencephalogram, Tic
Clinical narrative: About 12 hours later as we were eating breakfast the next morning, Patient's head tilted to the right and her right shoulder went up in a shrug like movement that was out of her control. This only continued and got worse within the week: several shoulder shrugs and head tilts also her hand would bend downward almost seizure like. Now to this day years later she still shrugs her shoulders out of nowhere for no reason at all. Sometimes she holds them (shoulders) up for a couple of seconds, other times it it just straight up and down.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Influenza, Injection site bruising, Peripheral swelling
Clinical narrative: Mild flu symptoms for a few days after injection. Swelling of right arm for 1 week, bruising below injection site  visible after 2 weeks.  Pain in right armpit after 3 weeks.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of axillary lymph nodes enlarged in a 57-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 5 days after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged and axillary lymph nodes enlarged was recovering/resolving and the outcome of the axillary lump was unknown. The reporter considered the axillary lymph nodes enlarges to be related to SHINGRIX. It was unknown if the reporter considered the axillary lump to be related to SHINGRIX. Additional details were provided as follows: At 09:45, the patient received the SHINGRIX vaccine in the left deltoid and developed a swollen lymph node under her left armpit approximately five days after the vaccination. It was a large, soft lump easily visible to the eye. It was 2 to 3 inches long and two inches wide. The swelling was significantly less on the reporting date although it was still visible. The reporter gave permission for her physician to be contacted and provided the contact details for the same. The call was transferred to Medical Information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a nurse call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 17th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. In January 2018, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired nurse practitioner. The patient received SHINGRIX in the left arm. The patient experienced pain and redness in left arm at injection site for first five and her arm was so sore that she could not sleep on that arm. The diameter of red spot was estimated by patient as 1 to 2 inches. The reported lot number (324KL) for SHINGRIX did not exist and was updated to 3Z4KL, according to sales database. For further tolerance to 2nd dose, refer linked cases US2018GSK050379. The patient was concerned about why her reactions would be different. The patient had PI.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX. On 14th March 2018, the patient received SHINGRIX. On 14th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site warmth and fever to be related SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced possible fever, warmth, redness, and a hardened area at the injection site. On 18th March 2018, the injection site was pink, warm, and hard. This adverse events were reported to medical information by a sales rep who received a voicemail with the reported events. Product and patient identifiers were not provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 dose series of ENGERIX B and completed the series. The patient underwent blood titer which came back negative, which led the patient to be a therapy non-responder. The patient's physician ordered 4th dose and the health care professional administered the patient a 4th dose of ENGERIX B after the titer was performed. The health care professional did not have patient's date of birth and vaccine information was not available.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 52-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). Concurrent medical conditions included shingles (experienced in 2014). On 2nd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2018, several hours after receiving SHINGRIX, the patient experienced fever, muscle pain, fatigue and lethargy. In February 2018, the outcome of the fever, muscle pain, fatigue and lethargy were recovered/resolved. The reporter considered the fever, muscle pain and fatigue to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the lethargy to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported no concomitant vaccine administration and no significant medication or medical history. The reported batch number of SHINGRIX CZ4KL did not exist and was updated to 3Z4KL as per sales data sheet. The patient received SHINGRIX in the left deltoid. The patient experienced a fever (99.8 degrees Fahrenheit), muscle aches and fatigue. Less than a week after receiving SHINGRIX, the patient experienced lethargy. About 4 pm, the patient experienced fatigue within on the day of vaccine administration. Fever was noted a few hours later, before he went to bed. The patient contacted the office by phone and TYLENOL was recommended. The symptoms were resolved after about 2.5 days.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Swollen (L) lymph node in neck.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Eye swelling, Urticaria
Clinical narrative: Pt started having swelling in eyes and hives on face around 4:00 pm. No breathing issues. Pt was given a small amount of BENADRYL around 4:00 pm. Swelling has gone down and hives have mostly subsided. Discussed allergic reaction to immunizations, will report, likely PROQUAD. Mom given BENADRYL at home, given dosing chart for weight, given steroids for 5 days and push fluids. Mom did give him a bath and will wash bedding as well. No current airway issues or spreading or urticarial, appears stable. Advised that if SOB or airway issues occur call 911 or to the ER, follow up as needed otherwise.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient experienced hives after receiving vaccines. Patient was seen by Dr after event and prescribed ORAPRED 15 mg/6 ml PO qd x 3 days advised to also take ALLEGRA 1 tsp daily.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient had Bell's Palsy. Patient was prescribed VALTREX 500mg (1 tab twice a day) and Triamcinolone 0.1% cream (Apply twice a day).
Sex: M
Vaccine: PPV, PNC, PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This spontaneous report as received from a pharmacist via Pfizer, Inc., (company reference number 2018096531) refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) OR pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (dose, dose number, lot #, expiry date and route of administration were not reported) for prophylaxis (the reporter wasn't sure if it is PREVNAR or PNEUMOVAX). On an unknown date, the patient experienced Guillain-Barre syndrome. The outcome of guillain-barre syndrome was unknown. The reporter's causality assessment between the event and the suspect therapy was not reported.  Upon internal review, Guillain-Barre syndrome was determined to be medically significant.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Flank pain, Herpes zoster, Laboratory test, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX vaccine (received in 2010). Concomitant products included ADVAIR, CYTOMEL, sertraline, CELEXA, estradiol, hydrochlorothiazide, NASONEX and SYNTHROID. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 6 days after receiving SHINGRIX, the patient experienced shingles (serious criteria hospitalization and disability) and flank pain (serious criteria hospitalization and disability). On 21st March 2018, the patient experienced rash (serious criteria hospitalization and disability). On an unknown date, the outcome of the shingles, rash and flank pain were not recovered/not resolved. The reporter considered the shingles, rash and flank pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included Citrulline and Allergy shots. The physician stated that she prescribed SHINGRIX for the patient. The patient received the vaccine at local pharmacy and she developed pain in her left flank. She was seen at the local emergency room and a full work up was performed and she was sent home. On 21st March 2018, 8 days after receiving SHINGRIX, a rash appeared and the patient was admitted to the hospital for 1 day for pain management. It was noted she had no other vaccines on the day of vaccination or 4 weeks prior was given. The physician had limited information on the actual vaccination administration since it was done at a local pharmacy. She doubted the patient would receive the 2nd dose given the circumstances with the 1st.