chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Buring at injection site.  Significant pain at injection site / shoulder post injection.  Patient pain did lessen but did not resolve upon waiting over 1/2 hour.  Improvement did occur but not completely resolve.
Age: 0.27
Sex: F
Vaccine: 6VAX-F, MMR, PPV
Symptoms: Induration, Pain, Pyrexia
Clinical narrative: Slight fever & pain at area, hardness at area about 1 inch in diameter. Hardness persisted at 1 inch diameter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, sore, itching at injection site and getting worse as the days progress.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthma, Chills, Condition aggravated, Injection site erythema, Malaise
Clinical narrative: Patient with history of asthma and recurrent respiratory infections requested a Fluvirin and Pneumovax immunization. Patient had no known allergies and no prior pneumococcal immunization. Patient was vaccinated by standing order and SOP in opposing arms.  A 0.5ml dose of Pneumovax was given SC in the right lateral arm. Patient 48 hours later developed a large erythematous patch around the Pneumovax injection site along with myaglia, chills, malaise, low grade fever and asthma exacerbation. Patient went to her physicians assistant and was given a Medrol dose pack for the allergic reaction and albuterol inhaler for her asthma symptoms.  Currently taking Medrol dose pack.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient with history of asthma and recurrent respiratory infections requested a Fluvirin and Pneumovax immunization. Patient had no known allergies and no prior pneumococcal immunization. Patient was vaccinated by standing order and SOP in opposing arms.  A 0.5ml dose of Pneumovax was given SC in the right lateral arm. Patient 48 hours later developed a large erythematous patch around the Pneumovax injection site along with myaglia, chills, malaise, low grade fever and asthma exacerbation. Patient went to her physicians assistant and was given a Medrol dose pack for the allergic reaction and albuterol inhaler for her asthma symptoms.  Currently taking Medrol dose pack.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Blood test normal, Computerised tomogram normal, Dysarthria, Fatigue
Clinical narrative: Felt off balance, extreme lethargy, muscle aches above knee, slight slur of speech. On Wednesday October 29th, went to doctor, all blood tests came back normal. On October 30th next day, went to emergency room, Cat scan showed no signs of stroke. Symptoms are worse, twitching in legs, complete exhaustion.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Lethargy, Muscle twitching, Myalgia
Clinical narrative: Felt off balance, extreme lethargy, muscle aches above knee, slight slur of speech. On Wednesday October 29th, went to doctor, all blood tests came back normal. On October 30th next day, went to emergency room, Cat scan showed no signs of stroke. Symptoms are worse, twitching in legs, complete exhaustion.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Pharyngeal oedema, Pruritus, Swollen tongue
Clinical narrative: Itching, chest tightness, swelling of throat and tongue, and cough.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site swelling, Pruritus, Rash
Clinical narrative: When I awoke that morning, the injection site was very swollen, the area being about 5 inches in diameter. Under the exact point of needle-entrance, there was a large-marble-sized hard lump. My entire arm itched, with intense itching around a five-inch area of the injection site. The next day, both arms were itching with a mild rash. About three days later, both legs began to itch intensely, with a rash on the fronts of both legs. The itching on my legs was SO intense that I could hardly stand it. I finally had to purchase medication designed for extreme itching. It helped somewhat, but until yesterday, the itching was HORRIBLE!!! I have cream that was prescribed to me by my physician. It is Desoximetasone (sp?). I mixed it with the anti-itch medication. The itch has gradually subsided... THANKFULLY!!! I'm not so sure I wouldn't rather have Shingles!!!
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Injection site of left arm hurt immediately after administration of Pneumovax 23 vaccine.  The arm was sore while making dinner.  At 6 PM ice was placed and took Advil.  Any movement of arm was painful. Site was red and hot.  Took Bnadryl at 9 PM and second dose of Advil.  Ice relieved some of the pain.  Went to bed and woke up in morning with plaque welt size of 2 fists. Marked outside outline of welt with permanent marker per Pharmacist recommendation. No other physical symptoms besides arm pain.  Pharmacist instructed her to go to ER/Urgent care if redness extended outside marker outline or worsening of symptoms.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Skin plaque, Urticaria
Clinical narrative: Injection site of left arm hurt immediately after administration of Pneumovax 23 vaccine.  The arm was sore while making dinner.  At 6 PM ice was placed and took Advil.  Any movement of arm was painful. Site was red and hot.  Took Bnadryl at 9 PM and second dose of Advil.  Ice relieved some of the pain.  Went to bed and woke up in morning with plaque welt size of 2 fists. Marked outside outline of welt with permanent marker per Pharmacist recommendation. No other physical symptoms besides arm pain.  Pharmacist instructed her to go to ER/Urgent care if redness extended outside marker outline or worsening of symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site nodule, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: BURNING UPON INJECTION, KNOT AT INJECTION SITE, SWELLING 2IN BLUISH/PURPLISH RASH, AND ITCHING.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: BURNING UPON INJECTION, KNOT AT INJECTION SITE, SWELLING 2IN BLUISH/PURPLISH RASH, AND ITCHING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Itchy, red rash on abdomen and back. Injection site red, swollen and feverish.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy, red rash on abdomen and back. Injection site red, swollen and feverish.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: FEVER, SWELLING AND REDNESS AT INJECTION SITE (LEFT ARM), BASEBALL SIZE LUMP AT INJECTION SITE. STILL RECOVERING.
Age: 24.0
Sex: M
Vaccine: FLUC3
Symptoms: Anxiety, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Injection was given at 8:15 am.  Patient returned thirty minutes later complaining of difficulty breathing, throat tightness, anxiety, uticaria on right flank.
Age: 28.0
Sex: M
Vaccine: FLUC3
Symptoms: Angioedema
Clinical narrative: Minimal angioedema of left upper lip without respiratory symptoms.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Patient presented to clinic around 1 pm on 11/02/2013 c/o redness, discomfort and warmth of the back of her right upper arm. Patient stated that the symptoms began within 24 hours of receiving vaccines at clinic on 10/30/2013. Patient was checked in and vital signs were taken. Tmax-98.0 BP- 122/84 p-94 O2-98% R-12. Pt in NAD, A & O x3. Exam revealed an induration of the posterior right upper arm (deltoid area) with an 11 cm x 12 cm area of erythema with a wavy irregular border and mild edema, with a central indurated area measuring 6 cm x 6 cm. + TTP. + warmth to touch. Skin intact. No pustule. No discharge. With patients permission, PA-C used a pen to outline erythematous area. Patient was treated with Bactrim DS po BID x7 days. Patient was instructed to monitor her arm for spreading of rash outside the pen line, if spreading occurs or redness does not improve within 12-24 hours, pt instructed to seek urgent/emergent care ASAP. ER Precautions given repeatedly (Fever, BA, chills, N/V, spreading of redness/swelling, etc). Pt with verbal understanding.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Pain
Clinical narrative: Diarrhea, aches.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Swollen and red, area was about 3 inches circle. Hard lump where shot was given. Progressively worsened. Started taking Benadryl. 10/18: Patient saw doctor and received a Medrol dose pack and continued to take Benadryl.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Member presented to medical for bandage change and noted a few inadvertent inoculations on left deltoid. Member re-educated on proper site care and bandage change and instructed to return if symptoms worsen.
Age: 1.06
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ear swelling, Eye swelling, Swelling face, Wheezing
Clinical narrative: Swelling of ears eyes and face, wheezing, treated with Benadryl. Identical symptoms of peanut allergy from 1 month prior.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: No symptoms immediately after immunization. After a few hours called in reporting redness size of a tennis ball. Took BENADRYL. Stopped in store later. Whole of deltoid region red. Went to ER, got a dose pak.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Sore shoulder where vaccine was given. Moved down arm all the way to elbow within 3 days with redness and swelling along the way. Fever, as much as 102 degrees.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Pt got PNEUMOVAX and FLUVIRIN shots on same arm (L) given 1 1/2 inches part (pt did not want on different arms). Pt got swelling but had gone down after 1 days. Asked pt to call MD if condition got worse. Pt is taking ibuprofen for pain and swelling.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient reports extreme pain in shoulder radiating to neck, started the day after the shot and continues without relief through 11/2/13 (still ongoing). Patient has not examined injection site for signs of swelling, but will be seeing her physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 10/30/13 two days after administration patient presented with large, red, warm circle at site of injection. Advised ice, Ibuprofen and BENADRYL and follow up.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Patient was vomiting. Patient was given (2) ondansetron orally disintegrating tablets, USP 4mg.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash on her upper arm, it was a big rash and had to take BENADRYL for several days. The rash is completely cured and gone now.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called pharmacy 2 days after receiving PNEUMOVAX vaccine and noticed still redness and swollen area around injection site.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient stated he felt hot and dizzy. Gave patient cool compresses to hold on his head. Patient felt fine and was able to go home.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot, Pallor, Vomiting
Clinical narrative: Patient stated he felt hot and dizzy. Gave patient cool compresses to hold on his head and an ice pack. Patient has clammy skin, was pale and cold to the touch with vomiting. Patient waited in office for 30 minutes before he was able to go home.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Skin exfoliation, Urticaria
Clinical narrative: Hives began 2 hrs > shot. Covered most of body. Hands and feet peeled - prednisone Rx. Splotches. Unresponsive to BENADRYL.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Constipation, Respiratory rate increased
Clinical narrative: Bloating - full stomach - Declined but still present for 48 hrs. Constipation - for two days. Panting rapid breathing - symptom declined overnight.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient without any medical history and with allergic to fluoxetine, bupropion and azithromycin. On 25-SEP-2013 the patient was vaccinated with subcutaneous with a dose of 0.65 ml ZOSTAVAX (lot# reported as J003305, expired date 03-JUL-2014). Concomitant therapies included VALTREX, lorazepam and omeprazole. On 27-SEP-2013, the patient experienced a red rash on the inside of the left ankle that is the size of 2 inches x 4 inches that looks like "pinpoint subdermal hemorrhage". No treatment was given for the event. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the event was not recovered. The patient sought medical attention by visiting to the pharmacist. The lot# J003305 was an invalid lot for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient without any medical history and with allergic to fluoxetine, bupropion and azithromycin. On 25-SEP-2013 the patient was vaccinated with subcutaneous with a dose of 0.65 ml ZOSTAVAX (lot# reported as J003305, expired date 03-JUL-2014). Concomitant therapies included VALTREX, lorazepam and omeprazole. On 27-SEP-2013, the patient experienced a red rash on the inside of the left ankle that is the size of 2 inches x 4 inches that looks like "pinpoint subdermal hemorrhage". No treatment was given for the event. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the event was not recovered. The patient sought medical attention by visiting to the pharmacist. The lot# J003305 was an invalid lot for ZOSTAVAX. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Anxiety, Blindness, Chest pain
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Constipation, Convulsion, Dehydration, Dizziness
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspareunia, Dyspepsia, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Gastric emptying study, Headache, Hemiparesis, Hemiplegia, Hemiplegic migraine
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperacusis, Hypoaesthesia, Impaired gastric emptying, Influenza like illness, Menorrhagia
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Milk allergy, Nasal congestion, Nausea, Neuropathy peripheral
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pelvic floor muscle weakness, Pelvic pain, Photophobia, Stomatitis
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Temperature intolerance, Tremor, Vitamin D deficiency
Clinical narrative: Constant nausea, fatigue, heavy periods, abdominal pain, pelvic pain, left side weakness, numbness, flu-like symptoms, sore throat, nasal congestion, anxiety, heartburn, chest pain, bloating, mouth sores, constipation, seizures, brain fog, dyspareunia, vision loss, left side paralysis, hemiplegic migraines, neuropathy, pressure in head, gait disturbances, light and sound sensitivity, dizziness, tremors, temp intolerance.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Abdominal pain, Arthralgia, Blood prolactin increased, Blood testosterone decreased, Borrelia test positive
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Brucella test positive, Cardiac disorder, Chest pain, Chronic sinusitis, Confusional state
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Convulsion, Dizziness, Eosinophil count decreased, Eosinophilia, Epstein-Barr virus antibody positive
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Erythema, Fatigue, Fibromyalgia, Hypogonadism, Influenza like illness
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Intervertebral disc protrusion, Joint range of motion decreased, Narcolepsy, Nausea, Neck pain
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Nerve conduction studies abnormal, Neutropenia, Neutrophil count decreased, Pain, Parvovirus B19 test positive
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP, TYP
Symptoms: Respiratory tract congestion, Vitamin D decreased
Clinical narrative: Was given three IM vaccinations in right shoulder with no option of refusal - Influenza, Tdap, Typhoid.  Area became red and painful.  Joint became difficult to move.  Within 1-3 hours had severe nausea, fatigue, congestion and neck pain.  The following day, became physically ill with flu-like symptoms and severe joint, neck, and abdominal pain.  Was seen by GP and prescribed oral Augmentin to no effect, then Levaquin with increased pain, dizziness, confusion, chest pain, cardiac abnormalities and was hospitalized.  Continued to be chronically ill with frequent hospitalizations.  Diagnosed with chronic sinusitis, acquired immune deficiency (neutropenia, eosinophilia), thoracic disc herniations, seizure, fibromyalgia, narcolepsy, Lyme Disease, EBV, Parvo virus infections.  Presently being treated through central line therapy with remission of some symptoms.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: VOMITING; HIGH FEVER; RIGORS; MUSCLE ACHES AND PAINS; UNUSUAL PAIN AT INJECTION SITE; HEADACHE; WEAKNESS; DIZZINESS.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: VOMITING; HIGH FEVER; RIGORS; MUSCLE ACHES AND PAINS; UNUSUAL PAIN AT INJECTION SITE; HEADACHE; WEAKNESS; DIZZINESS.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Depression, Influenza like illness, Lymphadenopathy, Nausea
Clinical narrative: Flu-like symptoms, low-grade depression, joint pain, nausea, swollen lymph nodes.  Condition persisted for several weeks.  Lymph nodes still swollen after several months.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Ear disorder, Fatigue, Histamine intolerance, Migraine
Clinical narrative: Migraine, extreme histamine reaction in head producing ear symptoms and stiff neck, swallowing difficulties, fever, extreme fatigue...unable to get out of bed...24 hrs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Migraine, extreme histamine reaction in head producing ear symptoms and stiff neck, swallowing difficulties, fever, extreme fatigue...unable to get out of bed...24 hrs.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Dizziness postural, Fatigue, Headache
Clinical narrative: Began with a sore arm in the evening of the day of the flu shot. The next day by 10:00 AM I was light headed with a mild headache. If I put my head down for any reason I felt dizzy and like I would throw up. I have not thrown up but I have been light headed up to today. Unable to put my head below my heart without feeling dizzy.  Also dizzy when getting up from lying down. Situation improving but not over. On the day after the flu shot (10/31/2013) I had fatigue, runny nose, fever/chills and headache, along with the dizzy sensation.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Began with a sore arm in the evening of the day of the flu shot. The next day by 10:00 AM I was light headed with a mild headache. If I put my head down for any reason I felt dizzy and like I would throw up. I have not thrown up but I have been light headed up to today. Unable to put my head below my heart without feeling dizzy.  Also dizzy when getting up from lying down. Situation improving but not over. On the day after the flu shot (10/31/2013) I had fatigue, runny nose, fever/chills and headache, along with the dizzy sensation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: Systemic hives lasting 6 weeks, including swollen eyes, lips, face. Used Claritin and Benadryl to offset side effects throughout 6 weeks.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Hives, dizzines, tightness in chest, problem breathing.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, X-ray
Clinical narrative: Hives, dizzines, tightness in chest, problem breathing.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Impaired driving ability, Loss of consciousness, Nausea, Vertigo
Clinical narrative: Still lying in bed (had worked until 5 AM, work nights a lot) started noticing dizziness when turning on my side. When I got out of bed almost fell down because I blacked out, had extreme dizziness, vertigo, nausea that lasted about 5 days, gradually getting better as time went by. Had a total of about 5 micro blackouts (one while driving, pulled over to let my wife drive it was so frightening).
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm and a month later intermittant throbbing pain daily and nightly.  Still continuing to this date of 11/03/2013.  Have tried heat as well as Aleve and Advil to no relief as well as heat.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: Back pain followed by full Shingles.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Decreased appetite, Faeces discoloured, Full blood count
Clinical narrative: CHILD BROUGHT IN FOR EVALUATION DUE TO POOR FEEDING X PREVIOUS 24 HRS, "LETHARGY" PER MOTHERS DESCRIPTION. DARK STOOL X 1 ( NOT SEEN IN OFFICE ) UA AND EXAM NOT REVEALING. SENT TO ER FOR PERSISTENT SYMPTOMS CHEM WNL, US AND AXR POSTIVE FOR INTUSSUSCEPTION. REDUCED BY BARIUM ENEMA ON 11/03/2013.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Laboratory test normal, Lethargy, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: CHILD BROUGHT IN FOR EVALUATION DUE TO POOR FEEDING X PREVIOUS 24 HRS, "LETHARGY" PER MOTHERS DESCRIPTION. DARK STOOL X 1 ( NOT SEEN IN OFFICE ) UA AND EXAM NOT REVEALING. SENT TO ER FOR PERSISTENT SYMPTOMS CHEM WNL, US AND AXR POSTIVE FOR INTUSSUSCEPTION. REDUCED BY BARIUM ENEMA ON 11/03/2013.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: CHILD BROUGHT IN FOR EVALUATION DUE TO POOR FEEDING X PREVIOUS 24 HRS, "LETHARGY" PER MOTHERS DESCRIPTION. DARK STOOL X 1 ( NOT SEEN IN OFFICE ) UA AND EXAM NOT REVEALING. SENT TO ER FOR PERSISTENT SYMPTOMS CHEM WNL, US AND AXR POSTIVE FOR INTUSSUSCEPTION. REDUCED BY BARIUM ENEMA ON 11/03/2013.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Injection site allergic reaction.  Red, swollen, hot area 4 inches in circumference.  Resolved without medication after 1 week.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Lethargy, Nausea
Clinical narrative: 10/21/2013 Nausea and headache 7:00 PM - 12 MN. 11/01/2013 Fever, chills, dizziness, headache and nausea 12MN - 6 AM. Dizziness, headache 6:00 AM - 8:00 AM. Lethargy, headache 8:00 AM - 4:00 PM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 10/21/2013 Nausea and headache 7:00 PM - 12 MN. 11/01/2013 Fever, chills, dizziness, headache and nausea 12MN - 6 AM. Dizziness, headache 6:00 AM - 8:00 AM. Lethargy, headache 8:00 AM - 4:00 PM.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and headache... ibuprofen as needed.
Age: 29.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Member had reddened pruitic area to R upper arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chills, Headache, Nausea
Clinical narrative: Fever of 103.3, strong chills, headache, weakness. Fever reduced over 7 hours with ibuprofen & acetaminophen. Second day (11/3/13) I had nausea and vomiting, weakness, headache. I have spent two days in bed with this reaction to the vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever of 103.3, strong chills, headache, weakness. Fever reduced over 7 hours with ibuprofen & acetaminophen. Second day (11/3/13) I had nausea and vomiting, weakness, headache. I have spent two days in bed with this reaction to the vaccination.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: Developed flu-like symptoms-headache and body ache.  Symptoms lasted 3 days.  I was sick for my 2 days off from work and had to call in sick the 3rd day of illness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle swelling, Myalgia
Clinical narrative: Patient reported severe swelling and soreness of deltoid muscle. Swelling had subsided by the time she came to pharmacy to report event (11/1/2013) but still sufferes from soreness and light swelling. She took Aleve to help with the pain.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme arm pain that has continued for the last four weeks.  Difficulty moving and lifting objects with that arm.  Limited mobility.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Fatigue, Head injury, Vertigo
Clinical narrative: Vertigo and fatigue resulting in fall, head injury and hospitalization.  As a health care provider, I and many others will no longer recommend flu shots to our patients.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Chest pain, Cough, Dysphagia, Dyspnoea
Clinical narrative: Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fear, Feeling abnormal, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Panic reaction, Tachycardia, Urticaria, Wheezing
Clinical narrative: Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Laboratory test, Pruritus
Clinical narrative: Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Felt tachy, had a "funny feeling", injection site in left arm sore, itching and large welt forming.  "Panic" feeling increasing.  Coughing, wheezing increased. Then audible wheezing, tried to take 50mg of Benadryl orally and hard to swallow. Was double swallowing. Increasing feeling of "something bad was going to happen".  Chest pain, couldn't breathe, hard to swallow and arm now had softball size welt. Was overwhelmed with "fear" and barely could dial 911..then ambulance came. Had just ended shift at work and was in car when it hit. Ambulance took me and went to ER. Was a bit delayed reaction and then blew up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Pt called back Sunday Nov 3, reporting rash, bump around her waistline, sound like an event of shingles. Itching and a little swelling at the injection sites. So I advised pt to use Benadryl for tonight to relieve rash and call MD asap tommorow. I will call her back her on Wed to follow up.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Infection, Pain, Swelling
Clinical narrative: Redness, swelling, warmth, soreness. Physician's assistant saw patient and diagnosed infection, prescribed antibiotic.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Concussion, Contusion, Face injury, Fall, Laceration
Clinical narrative: My 15 yr old daughter fainted within minutes after receiving the HPV vaccination. no warning was given to us that she may faint. The nurse left the room immediately after shot, and my daughter fell off the dr table face first onto the tile floor and was unconscious. They called 911, and took her to clinic. She had 15 stitches in her forehead, her nose has a deviated septum and teeth were loose and sore. Concussion and bruising from fall on knees and shoulder.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loose tooth, Loss of consciousness, Nasal septum deviation, Suture insertion, Syncope
Clinical narrative: My 15 yr old daughter fainted within minutes after receiving the HPV vaccination. no warning was given to us that she may faint. The nurse left the room immediately after shot, and my daughter fell off the dr table face first onto the tile floor and was unconscious. They called 911, and took her to clinic. She had 15 stitches in her forehead, her nose has a deviated septum and teeth were loose and sore. Concussion and bruising from fall on knees and shoulder.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Toothache
Clinical narrative: My 15 yr old daughter fainted within minutes after receiving the HPV vaccination. no warning was given to us that she may faint. The nurse left the room immediately after shot, and my daughter fell off the dr table face first onto the tile floor and was unconscious. They called 911, and took her to clinic. She had 15 stitches in her forehead, her nose has a deviated septum and teeth were loose and sore. Concussion and bruising from fall on knees and shoulder.
Age: 62.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Ear pain, Eye pain, Eyelid function disorder, Facial paresis, VIIth nerve paralysis
Clinical narrative: Droopy smile, could not spit out of mouth, could not close right eye, pain in right eye, right ear, and behind right ear. Was dx'd with Bell's Palsy.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: Sore arthritic feeling in knuckles on both hands, right ankle and both right and left wrists.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood urine present, Dizziness, Pain, Pyrexia, Vomiting
Clinical narrative: High fever, dizziness, vomited, peeing blood, aches all over the body.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Arm where vaccine was given developed large bump, was hot, itchy and sore to touch. Prior to this date, I did not experince more than a little soreness at the vaccine site.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain starting upper left arm around shoulder to left wrist that lasted about 1 week.  Next 3 weeks range of motion was limited and pain with movement of left arm. Though slowing recovering.  First appointment with an orthopedic was 9/20, MRI was done 9/25, and I was diagnosed with subacromial bursitis in left shoulder.  No previous pain in the area prior to this incident.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Pain starting upper left arm around shoulder to left wrist that lasted about 1 week.  Next 3 weeks range of motion was limited and pain with movement of left arm. Though slowing recovering.  First appointment with an orthopedic was 9/20, MRI was done 9/25, and I was diagnosed with subacromial bursitis in left shoulder.  No previous pain in the area prior to this incident.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Injection site pain, Vomiting
Clinical narrative: Vomiting at 11:00PM then again after taking a sip of water at 1:00AM on 10/30/2013. Complained her "tummy hurt." Also complaining of leg pain where injection was given and refused to move her leg.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Neck pain
Clinical narrative: Neck ache progressing to severe/debilitating neck pain over the next 3 days. Ibuprofen does not help. Hard to lie down and bend/turn head.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Pain in arm that injection was administered from neck to the wrist; warm at injection site and slightly swollen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm that injection was administered from neck to the wrist; warm at injection site and slightly swollen.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Erythema, Local swelling
Clinical narrative: Red swollen arm. Dry mouth.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Injection site bruising, Injection site haemorrhage
Clinical narrative: Bleeding/bruising within 5 minutes of injection. Later that night/next morning: headache, neck and back pain, chills, sore throat. Advised to take TYLENOL/ADVIL and ice arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: Bleeding/bruising within 5 minutes of injection. Later that night/next morning: headache, neck and back pain, chills, sore throat. Advised to take TYLENOL/ADVIL and ice arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Influenza, Pyrexia, Skin warm
Clinical narrative: Redness, hot - softball size. On 2nd day, mild flu symptoms, fever, chills.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Local swelling
Clinical narrative: Patient called complaining of localized swelling the size of a silver dollar and pain around injection site. Recommended anti-inflammatory and BENADRYL. Patient does not want to take any medications due to ongoing Heart Disease and Diabetes. Patient is icing arm and calling MD.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out and possibly had a seizure following flu shot vaccination.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A), concerning a 22 years old female patient. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (Lot # and expiration date were not reported) as part of the pregnancy registry program. Then, on 09-JUL-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (Lot # and expiration date were not reported). Subsequently, on an unspecified date, the patient became pregnant, and because of this, she did not receive the third dose of GARDASIL that was due in September 2012. The patient's last menstrual period (LMP) and estimated delivery date (EDD) were not known. The patient's history of previous pregnancies and live births was not known. There were no adverse effects. No treatment was given for the event. Patient called office for medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the medical assistant. It was reported that she could not find anyone with the patient's name in their system. She also looked under the reported date of birth and there was no patient with that date of birth/name combination either. She apologized but said she had no additional information to provide. This patient was lost to follow up. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received form a physician via company representative refers to an about 20 year old female patient. On 11-DEC-2012 the patient received a 0.5 ml dose of GARDASIL (lot# unspecified) subcutaneous injection (location unspecified) by mistake. No concomitant therapies. The patient was found to be pregnant with LMP (Last Menstrual Period) of 24-JUL-2012 (20 weeks as reported) while received a 0.5 ml dose of GARDASIL and EDD (estimated due date) of 30-APR-2013. Trimester(s) of exposure was the second. The patient was not supposed to receive the vaccine, she was at the healthcare center for an unspecified reason, presumably a check-up. There was another patient in the waiting room with the same name, she was the one who was supposed to receive GARDASIL. The patient in this event received the GARDASIL instead. No adverse effect was reported. No treatment was given for the event. Follow up information as received from the physician's nurse who reported that the baby boy was born full term on 26-APR-2013 with no complications. Baby was normal and healthy and there were not congenital anomalies. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 36 year old female patient. On 25-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml (route, lot# and expiration date unknown) instead of VARIVAX (Merck). The patient didn't seek medical attention. No adverse effect was reported. Additional information has been requested.