chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 10-MAY-2012 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 15-OCT-2013, the patient was treated at a health care facility for a painful rash that was diagnosed as Herpes Zoster with ophthalmic complication (a strain of shingles that has spread into the eye and caused vision loss). On or about 05-DEC-2013, the patient was treated at the same facility for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia, a chronic and permanent condition involving nerve damage and pain that occurs as a residual effect of shingles. While shingles and post-herpetic neuralgia are an incurable conditions, the patient has been prescribed VALTREX to manage his symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, the events of Painful rash diagnosed as Herpes Zoster with ophthalmic complications (a strain of shingles that has spread into the eye and caused vision loss) were determined to be medically significant. The event of treated for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia was considered to be disabling. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009733.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 10-JAN-2013 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-DEC-2015 the patient was treated for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 22-JAN-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2016, the patient was treated by his physician at a Medical Center for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is being complained and alleged that the patient was inoculated with a dose of ZOSTAVAX on or about 23-MAR-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAY-2015, the patient was treated by a physician at a physician's office for a painful rash that was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration) on or about 07-APR-2010, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2013, the patient was treated for a painful rash that was diagnosed as shingles. On or about 21-OCT-2014, the patient was treated at the same facility for symptoms that had worsened. The patient was diagnosed with post herpetic neuralgia, a painful and chronic condition involving nerve damage as a residual effect of multiple shingles outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016 the patient was treated for a painful rash, which was diagnosed as shingles. On or about  23-JUN-2016 the patient was treated again for ongoing and worsening symptoms, at which time she was given the additional diagnosis of post-herpetic neuralgia. Post-herpetic neuralgia is a chronic condition resulting from nerve damage caused as a residual effect of severe shingles. On or about 16-SEP-2016 the patient was treated again for a new outbreak of herpes zoster. Although shingles is an incurable viral condition, the patient was prescribed pregabalin (LYRICA) and gabapentin (NEURONTIN) for management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 13-JUL-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAY-2016 the patient was treated for a painful rash which was diagnosed as shingles with post-herpetic neuralgia. Post-herpetic neuralgia is a chronic condition resulting from nerve damage as a residual effect of severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 13-JUN-2015 by a physician, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 29-FEB-2016, patient was treated by physician for an ongoing painful rash and persistent nerve pain which was then diagnosed as shingles. On or about 31-MAR-2016, patient was treated again by physician for continuing and worsening symptoms of shingles outbreaks. Although shingles is an incurable viral condition, patient was prescribed valacyclovir (VALTREX) for management of her symptoms and future outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site cellulitis, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Company representative. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 11Apr2017 at 0.5 ml, single in the upper left arm for immunisation . Vaccine Lot number and expiration date were not provided.  The patient medical history and concomitant medications were not reported. After vaccination on Apr2017 the patient experienced initially very tender large area around the injection that became swollen, hot to touch, chills, the whole upper left arm became swollen and bright to the color and resulted in cellulitis. The patient received treatment  with antibiotics for cellulitis. The outcome of the events was unknown.; Sender's Comments: Based on the compatible temporal association, the event "cellulitis/whole upper left arm become swollen and bright to the color" is assessed as related to PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Company representative. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration on 11Apr2017 at 0.5 ml, single in the upper left arm for immunisation . Vaccine Lot number and expiration date were not provided.  The patient medical history and concomitant medications were not reported. After vaccination on Apr2017 the patient experienced initially very tender large area around the injection that became swollen, hot to touch, chills, the whole upper left arm became swollen and bright to the color and resulted in cellulitis. The patient received treatment  with antibiotics for cellulitis. The outcome of the events was unknown.; Sender's Comments: Based on the compatible temporal association, the event "cellulitis/whole upper left arm become swollen and bright to the color" is assessed as related to PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Measles post vaccine
Clinical narrative: Basic attenuated measles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth and pain around injection site and radiating away from injection site.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Headache, Infection, Pain
Clinical narrative: Burning, redness and swelling like a balloon. Put ice on it 3/9/2017; went to dr and they diagnosed with infection. Treated with cephalexin better after 2 weeks; 4/20/2017 pain started; wrapped it in ice; red mark returned and it felt hot; fever, arm swelled; headache, went to hospital - now on bactrim Ds and  cephalexin.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: Burning, redness and swelling like a balloon. Put ice on it 3/9/2017; went to dr and they diagnosed with infection. Treated with cephalexin better after 2 weeks; 4/20/2017 pain started; wrapped it in ice; red mark returned and it felt hot; fever, arm swelled; headache, went to hospital - now on bactrim Ds and  cephalexin.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Opisthotonus, Seizure like phenomena, Tremor
Clinical narrative: About 10 minutes after HPV vaccine administered, patient had a witness seizure-like episode (likely convulsive vasovagal syncopal event). Patient standing, eyes rolled back, leaned back, arms stiff and shaking, unresponsive. Brief (10 seconds), no urine or stool incontinence, no post-ictal period. Similar reaction with 1st HPV vaccine per mom.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: About 10 minutes after HPV vaccine administered, patient had a witness seizure-like episode (likely convulsive vasovagal syncopal event). Patient standing, eyes rolled back, leaned back, arms stiff and shaking, unresponsive. Brief (10 seconds), no urine or stool incontinence, no post-ictal period. Similar reaction with 1st HPV vaccine per mom.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itchiness.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient noticed her arm was red and had pain associated with it the day after administration. She had been moving her arm around post administration even noting that she had done some cleaning at her daughter's house. She had no  symptoms until around mid-day on 4/20/2017.  Upon presentation to the pharmacy, she had a red area on her arm above the elbow and extending inward toward bicep, below administration site. It was red, warm, and some swelling, with no apparent reaction at site of the administration. She reported no hives, fever, dizziness or trouble breathing.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt came to pharmacy on 4/21/17 showed are inside of arm near elbow was swollen, red and hurt not near the injection site. Pt went to dr they said it was cellulitis and may or may not have been from the injection said there is many possible reasons that it could have occured. pP got rx for keflex on 4/21/17.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swollen Arm, Fever, Aches & Pains, Headache.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Large red area below injection site almost down to elbow.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in both shoulders after both shots given within 4-5 hours can't lift arm up over head.
Sex: F
Vaccine: HEPA, PPV
Symptoms: Feeling hot, Injection site bruising, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a female patient who received HAVRIX. Co-suspect products included BEXSERO, MENACTRA and PNEUMOVAX. On 1st April 2017, the patient received the 1st dose of HAVRIX. On 6th April 2017, the patient received BEXSERO. On 4th April 2017, the patient received MENACTRA vaccine. On 1st April 2017, the  patient received PNEUMOVAX. On 2nd April 2017, 1 days after receiving HAVRIX and not applicable after receiving BEXSERO, the patient experienced injection site bruising. On 9th April 2017, the patient experienced feeling hot. On an unknown date, the outcome of the injection site bruising and feeling hot were recovering/resolving.  It was unknown if the reporter considered the injection site bruising and feeling hot to be related to HAVRIX. It was unknown if the reporter considered the feeling hot to be related to BEXSERO. Additional details were reported as follows: The reporter was notified regarding the patient who was a new GSK employee. The patient received 1st dose of HAVRIX in left deltoid and experienced injection site bruising. On 9th April 2017, 3 days after receiving BEXSERO and 8 days after receiving HAVRIX, the patient felt feverish. It was unknown if the reporter considered the feeling hot to be related to MENACTRA and PNEUMOVAX as well. It was unknown if the reporter considered the injection site bruising to be related to MENACTRA as well. No other information was provided. Follow up was denied by the reporter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received KINRIX and PROQUAD in left thigh on 4-14-17. By 7:30 that evening had redness where vaccines were administered. Saturday 4-15-17 patient still had redness and thigh was painful. Sunday 4-16-17 there was a 6 inch wide red, hot, swollen painful area. Had knee pain (L) and left toes felt "funny". Went to urgent care - said it was vaccine reaction. Instructed to do BENADRYL and ibuprofen.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Pt started to have pain and itching 4 days after vaccination. The following day the injection site became red and swollen . Pt used cold compress, antihistamine, and corticosteroid cream to self treat. Pt went to see physician and determined there was no infection and given prescription for ibuprofen.
Age: 37.0
Sex: M
Vaccine: ANTH, IPV
Symptoms: Deep vein thrombosis
Clinical narrative: DVT developed the day following anthrax and polio immunizations.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient took 1st oral typhoid pill in a.m. Reported a rash, and within 3 hours had trouble breathing. Called 911. Paramedic gave BENDARYL. ER gave pt. IV steroid. Placed on BENADRYL of 80 and discharged.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm upper muscle, red swollen. Length of swelling shoulder to 1 inch above elbow.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Periarthritis, X-ray
Clinical narrative: (L) shoulder pain onset after injection. Has continued 7 6 months. Developed adhesive capsulitis - steroid injection and now in PT.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site induration, Malaise, Pain
Clinical narrative: Vaccine administered around 10:30 am, patient felt pain was fine until 5 pm then pt. felt the whole left arm numb, ring and middle fingers numb, loss of feeling. Got sick about 6:30 pm. No fever, no swelling, just felt hard at injection site. Only took ibuprofen. Pt. called PCP and came in to see PCP and was advised to ER and given TORADOL, ZOFRAN and muscle relaxant.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Sensory loss
Clinical narrative: Vaccine administered around 10:30 am, patient felt pain was fine until 5 pm then pt. felt the whole left arm numb, ring and middle fingers numb, loss of feeling. Got sick about 6:30 pm. No fever, no swelling, just felt hard at injection site. Only took ibuprofen. Pt. called PCP and came in to see PCP and was advised to ER and given TORADOL, ZOFRAN and muscle relaxant.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Hepatitis A vaccine administered approximately 12:15 pm on 4.19.17. Upon awakening on 4.20.17 pt. reports BLE pruritic macular rash, spreading from hands superiorly to mid bicep. BLE macular rash knee to thigh.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema peripheral, Pain, Rash
Clinical narrative: Left arm tenderness, erythema, rash, edema, body aches, joint pain. Treated: BACTIM DS BID x 10 days, Mupirocin 2% ointment.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Left arm tenderness, erythema, rash, edema, body aches, joint pain. Treated: BACTIM DS BID x 10 days, Mupirocin 2% ointment.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back injury, Computerised tomogram head normal, Electrocardiogram normal, Head injury, Hyperhidrosis
Clinical narrative: I was restless and had trouble falling asleep the night I had the shingles vaccine. Suddenly, I was sweating and felt that I had a fever. I got up to get some water and fainted, hitting my head and sacrum/coccyx area. I went to the ER the next morning and had a head CAT scan, x-ray of my lower spine and an EKG. All tests negative.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Initial insomnia, Pyrexia, Restlessness, Spinal X-ray normal, Syncope
Clinical narrative: I was restless and had trouble falling asleep the night I had the shingles vaccine. Suddenly, I was sweating and felt that I had a fever. I got up to get some water and fainted, hitting my head and sacrum/coccyx area. I went to the ER the next morning and had a head CAT scan, x-ray of my lower spine and an EKG. All tests negative.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Altered state of consciousness, Asthenia, Dyspnoea
Clinical narrative: Sudden abdominal pain, shortness of breath on day after vaccine was administered. Felt like was going to pass out/weak  - patient was seen by Dr. in office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: Patient given TDaP and MENACTRA in right arm. Patient developed redness and swelling in upper arm extending to axilla. It was warm to touch. Area measures 7cm X 6cm tender to touch.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pt. has had pain/muscle pain at injection site greater than 5 mo without relief. Pt. unable to completely lift arm.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. has had pain/muscle pain at injection site greater than 5 mo without relief. Pt. unable to completely lift arm.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given MenB when she due for meningococcal.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cough, Malaise, Rash
Clinical narrative: 15 minutes after vaccine given call by nurse, because child was not feeling ok, he said that he felt like coughing after vaccine given in upper part of left arm (HPV). Mother noticed rash. His lungs and heart ok. This morning he was not feeling well and sent to ER.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother brought in child on 04/20/17 at 11am to show this Nrsing superv. extension of the injectable site redness and swelling. Child is afebrile w/no other C/O any acute discomfort. (R) arm (upper deltoid is swollen and red 31/2 x 31/2). This Nrsg. Superv advised mom to apply Ice, NEOSPORIN to the skin and contact MD/PED or go to the nearest ED if gets worse. Nrsg. Superv. T.C. 4/21/17 mother reported much improvement w/Ice and NESPORIN ointment.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Skin warm, Swelling
Clinical narrative: Noticed next day (Saturday) swelling size of peach near muscle - warm to touch Urgent Care->Prednisone, BENADRYL, Hydrocortisone.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: Face has been hot, red and swollen since vaccine administered.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Fall, Immediate post-injection reaction, Syncope
Clinical narrative: Fainted after vaccination given. Fell from chair to the floor after Hepatitis A vaccine in (L) deltoid and HPV GARDASIL 9 in (R)r deltoid. IM - immediately fainted after 2nd vaccine. No injury.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient, presented to clinic 4/10/17 for complete physical and immunizations. Pt returned to clinic today 4/13/17 due to (L) lateral thigh swollen and erythematous and plus or minus tendered; given cold compress, TYLENOL and MOTRIN as needed for pain.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Dry skin, Mouth breathing, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: Peeling dry, flaking, scaling skin. Large raised dark bumps on arms, legs, and back. Large red raised bumps on face. Trouble breathing through nose, onset of loud snoring. Went to primary DR and sent to dermatologist. Dermatologist prescribed 2 topical creams. Face cream caused skin to lighten on areas where applied. Body cream did minimize the appearance of large bumps.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Snoring
Clinical narrative: Peeling dry, flaking, scaling skin. Large raised dark bumps on arms, legs, and back. Large red raised bumps on face. Trouble breathing through nose, onset of loud snoring. Went to primary DR and sent to dermatologist. Dermatologist prescribed 2 topical creams. Face cream caused skin to lighten on areas where applied. Body cream did minimize the appearance of large bumps.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Musculoskeletal pain, Nausea, Pyrexia, Tremor
Clinical narrative: She said that she started to have a headache, fever, and nausea. She also said that her shoulder hurt quite bad. She said she was shaking.  She said she thought she was shaking from the pain in her shoulder.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, lack of appetite, diarrhea, dehydration, fever ranging from 100-102
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Patient states she came down with shingles, nerve pain in back, was treated with Valtrex and gabapentin 6 days after immunization.
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Began developing redness and pruritis around the area of injection, which then developed into blisters appearing like previous Shingles infection.  Blisters also stung and were painful like a previous shingles infection.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Ear pain, Fatigue, Flushing, Head discomfort
Clinical narrative: Hives, itchy, rash, tongue tingly, ears exploding, headache, head pressure, flushed, nausea, dizzy, tired.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Hives, itchy, rash, tongue tingly, ears exploding, headache, head pressure, flushed, nausea, dizzy, tired.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives, itchy, rash, tongue tingly, ears exploding, headache, head pressure, flushed, nausea, dizzy, tired.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Anger, Cold sweat, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Syncopal episode with LOC for approx. 10 seconds, diaphoretic, pale, with HR at 92 BP 140/80, pt. was on table and placed in lying position, no injury sustained during fainting spell. Kept supine for 20 min, gradually placed in upright position but then felt dizzy,placed back into reclining position for another 10-15 min, VS stable, oriented X3, skin color returned to normal after about 30 min with no more clamminess of skin, tearful and upset, Vs rechecked at 110/70 HR 66, Resp.14, denied SOB or signs of allergic reaction, area of injection appears without signs of reaction. Pt. was able to stand and was taken out of clinic with assistance to family car. Appeared stable upon getting into car.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Tearfulness
Clinical narrative: Syncopal episode with LOC for approx. 10 seconds, diaphoretic, pale, with HR at 92 BP 140/80, pt. was on table and placed in lying position, no injury sustained during fainting spell. Kept supine for 20 min, gradually placed in upright position but then felt dizzy,placed back into reclining position for another 10-15 min, VS stable, oriented X3, skin color returned to normal after about 30 min with no more clamminess of skin, tearful and upset, Vs rechecked at 110/70 HR 66, Resp.14, denied SOB or signs of allergic reaction, area of injection appears without signs of reaction. Pt. was able to stand and was taken out of clinic with assistance to family car. Appeared stable upon getting into car.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt states he began to feel dizzy, light headed, and began sweating.  He checked his blood pressure and got a normal result.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: At 10:OO PM the arm started hurting and started turning red and swelling. The next  day the arm was swollen and red from above the injection site to just below the elbow.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discolouration, Injection site hypersensitivity, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Has developed a local skin allergy around injection site, no constitutional symptoms no fever pain level zero local redness. Patient is a 11 Yrs 4 Mos male with no sig PMH who presents with blister/rash from vaccination. Was vaccinated Monday w/ TDaP and HPV vaccines in L arm. Monday evening developed hyper pigmented rash, with burning sensation Returned to PMD who prescribed oral steroids and topical antibiotic cream Rash improved. However yesterday, developed blistering, which has progressed. Concerned about the blister. No pain, no pruritis. Only located at site of vaccine injection. Otherwise healthy. No fever/chills. No other skin involvement. No hives, no itching. Normal behavior.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted redness around injection sites. It was swollen - hot for a few days. Seems to be improving now, 2 days after administration. Noticed it at both sites.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Balance disorder, Dizziness
Clinical narrative: Patient states that he started having adverse event symptoms about over a week after the shingles shot. Pt. states he is experiencing dizziness all day with difficulty in balancing. He feels that ZOSTAVAX may have neomycin some which in the past other he used similar drugs that he experienced the same symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Erythema
Clinical narrative: Presented with a large erythematous reaction today which does not seem to cause him any discomfort--Size to Left Leg is measured 120x190mm--appears no evidence of itching or pain and his mobility has not been affected--Mother to apply ice no more that 10 minutes and to elevate the leg as much as possible--To return to see MD again tomorrow 04/23/2017.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Throbbing/Pulsating pain around area of injection site has increased over time since (guess at) date of adverse event onset.  No special reaction at time of injection.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Bloody diarrhea and vomiting.
Age: 0.25
Sex: M
Vaccine: PNC
Symptoms: Crying, Diet refusal, Hypersomnia
Clinical narrative: Inconsolable crying, excessive sleeping and refusing to breastfeed for 48 hours.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain
Clinical narrative: PATIENT PRESENTED TO PHARMACY WITH COMPLAINT OF SORE LUMP IN THE BACK OF HER ARM WHERE SHE RECIEVED A TETNUS SHOT A COUPLE OF WEEKS AGO.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain upper, Auditory disorder, Back pain, Blood test, Condition aggravated
Clinical narrative: Stomach Pain, Migraines, Seizure like spells that he had never had before, Inflammation on the brain (encephalitis), Neurological issues-Auditory disturbances. Insomnia, severe neck and back pain.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Electroencephalogram, Insomnia, Migraine, Neck pain, Nervous system disorder
Clinical narrative: Stomach Pain, Migraines, Seizure like spells that he had never had before, Inflammation on the brain (encephalitis), Neurological issues-Auditory disturbances. Insomnia, severe neck and back pain.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Noninfective encephalitis, Nuclear magnetic resonance imaging, Seizure like phenomena, Specialist consultation
Clinical narrative: Stomach Pain, Migraines, Seizure like spells that he had never had before, Inflammation on the brain (encephalitis), Neurological issues-Auditory disturbances. Insomnia, severe neck and back pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt reported itchy rash "all around back, belly, and legs".
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Dehydration, Diet refusal, Irritability, Pyrexia
Clinical narrative: After the administration of the Rotavirus Vaccine patient became very fussy and lost her appetite. She refused to take her bottle or binky.  Our daughter developed a mid grade fever that evening, running 99.6 we administered the proper dose of Infant TYLENOL. She then developed a fever again around 4:30 AM of 100.3, every time we would try to feed her she would immediately throwing-up all that was consumed. Patient has been seen for possible GI issues with digesting her food and has already had an issue with throwing up vigorously, the handout given to my wife and I stated that if the infant had moderately or severe throwing up then this vaccine shouldn't be administered at this given point and time. We've went back to the physicians office several times, they advised us to go to the hospital because she was becoming dehydrated. The only thing she can consume at this point is Pedialyte mixed with water. This is going on the 4th day without being able to hold down anything besides water/Pedialyte.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: After the administration of the Rotavirus Vaccine patient became very fussy and lost her appetite. She refused to take her bottle or binky.  Our daughter developed a mid grade fever that evening, running 99.6 we administered the proper dose of Infant TYLENOL. She then developed a fever again around 4:30 AM of 100.3, every time we would try to feed her she would immediately throwing-up all that was consumed. Patient has been seen for possible GI issues with digesting her food and has already had an issue with throwing up vigorously, the handout given to my wife and I stated that if the infant had moderately or severe throwing up then this vaccine shouldn't be administered at this given point and time. We've went back to the physicians office several times, they advised us to go to the hospital because she was becoming dehydrated. The only thing she can consume at this point is Pedialyte mixed with water. This is going on the 4th day without being able to hold down anything besides water/Pedialyte.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Deafness unilateral, Swelling face, Tenderness
Clinical narrative: Had administered TDaP at approx. 2:00 PM. Noted left side face and jawline swelling. Left side hearing loss. Iced area all night and taking naproxen. Swelling subsided. Jaw tenderness.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Skin reaction, Vaccination complication
Clinical narrative: Information has been received from a pharmacist via Pfizer (mfr # 2017116407) referring to a patient of unknown age and gender. Information about concomitant therapy, concurrent condition and medical history was unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced skin reaction after the vaccination. It was also reported that the patient experienced allergic reaction to PNEUMOVAX 23. The pharmacist was asking if there have warning or precautions regarding administration of PREVENAR 13 in patient with previous reactions to PNEUMOVAX 23. The outcome of the events was unknown. The causality assessment regarding the event "skin reaction" was unknown. The reporter considered the event "allergic reaction" to be related to PNEUMOVAX 23. The pharmacist did not provide additional information. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse prescriber concerning  to a male patient of unknown age. The patient's had not concurrent conditions, medical history nor drug allergies/reactions. Concomitant therapies included AMBIEN and PRINIVIL. On 23-NOV-2016, the patient was vaccinated with the first dose ZOSTAVAX for prophylaxis (the lot #, expiration date, route, and dose were not provided). On approximately 25-NOV-2016, reported as around 2 days after the administration of the vaccine, the patient got a rash on his forehead. The patient was treated with VALTREX. On an unspecified date, the rash was resolved. The causal relationship between the event and the vaccine was unknown. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013216.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15-year-old female patient. The patient's pertinent medical history included scoliosis. It was also reported that she had no drug reactions or allergies. On 01-MAR-2017, the patient received GARDASIL 9, in right arm (lot# M043731, expiration date: 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis (reported as "routine vaccine"). Concomitant medications included etonogestrel implant (NEXPLANON) inserted subdermally in her left arm on an unspecified date, by an unspecified provider at an unspecified location (lot# and expiration date were unknown). The patient's mother informed the medical assistant via voice mail message (dated 04-APR-2017) that the patient experienced a "knot-like swelling" at the injection site since receiving GARDASIL 9, on unspecified date in approximately March 2017 (reported as since receiving GARDASIL 9 and also reported as beginning on an unspecified date). It was reported that the adverse event had not resolved. No treatment was provided for the adverse event. No lab diagnostic studies were performed. The patient did not seek medical attention. No Product Quality Complaint (PQC) was involved. The relatedness between the adverse event and the suspect therapy was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning to a 27 year old female patient. The patient's current conditions included heterozygous for factor 5. The patient was allergic to nitrofurantoin (captured in MARRS# 1704USA009571). Concomitant therapies included vitamin B complex, omega-3 marine triglycerides, and magnesium (unspecified). On 14-FEB-2017, was the patient's last menstrual period. On 06-MAR-2017, the patient had a urine pregnancy screen which resulted as negative. On 10-MAR-2017, the patient was inadvertently vaccinated with a dose of VARIVAX lot # M040139 with expiration date of 28-SEP-2018 for prophylaxis (the dose, strength, and route were not provided) while she was unknowingly pregnant. On 15-MAR-2017, the patient had a new urine pregnancy screen which result was positive. The estimated date of birth was reported for 21-NOV-2017. The initial exposure to VARIVAX was at week 3 of gestation. The pregnancy outcome was pending. Additional information has been requested. Sender's Comments: US-009507513-1704USA009571.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a physician via a field representative, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date, the patient received ZOSTAVAX (lot #, expiration date, strength, dose, route of administration and anatomical location were unknown by the reporter), for prophylaxis. It was reported that the vaccine was administered in two separate visits, which was not indicated on the Prescribing Information for it. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender . No information regarding patients' concurrent conditions, medical history and concomitant therapies was reported. Since 09-DEC-2016, those patients received improperly stored doses of VARIVAX (dose and route of administration were not provided) lot # M009765, expiration date 23-FEB-2018 and lot#M038224, expiration date: 07-SEP-2018. Sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) was used to reconstitute the vaccine. No adverse effects were reported. Time frames for the temperature excursions were as listed (recorded by a "data logger"): - 6 degrees Fahrenheit (F) to 14 degrees F for 1,203 hours, - 15 to 46 degrees F for 5 hours. There was no previous temperature excursions. Additional information has been requested.; Sender's Comments: US-009507513-1704USA007551:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender.. No information regarding patients' concurrent conditions, medical history and concomitant therapies was reported. Since 09-DEC-2016, those patients received improperly stored doses of PROQUAD (rHA) (dose and route of administration were not provided) lot#M029595, expiration date: 10-DEC-2018. Sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) was used to reconstitute the vaccine. No adverse effects were reported. Time frames for the temperature excursions were as listed: - 6 degrees Fahrenheit (F) to 14 degrees F for 1,203 hours, - 15 to 46 degrees F for 5 hours. There was no previous temperature excursions. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006388:
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, Product packaging issue, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist regarding 8 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates, patients missed a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) subcutaneous injection (lot number: M040146; expiration date: 26-DEC-2017) for prophylaxis, as a package of ZOSTAVAX were defective. A product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 06-JAN-2016 by a physician at a military medical care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported that the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-MAY-2016, the patient was treated by a physician (of a medical group)(not the same physician who administered the vaccine to him) for a painful rash that was diagnosed as shingles. On or about 13-MAY-2016 the patient was treated at the same facility for another incident of shingles. Herpes zoster, also called "shingles," is an incurable viral condition, but the patient has been prescribed Acyclovir and NORCO to manage his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested. Sender's Comments:  US-009507513-1704USA009733.