chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Tremor, Vision blurred, Vomiting
Clinical narrative: TONGUE SWELLING, DIFFICULTY SWALLOWING, METALLIC TASTE IN MOUTH, FEVER, HEADACHE, NAUSEA, MUSCLE ACHE, TIRED, LEGS SHAKY, DIARRHEA, THEN SEVERE DIARRHEA AND VOMITING, EYES BRIGHT RED AND PAINFUL, VISION BLURRED, HOT AND COLD FLASHES IN BODY. WENT TO ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed erythema/swelling of the R arm area surrounding the injection site. No systemic symptoms reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bedridden, Consciousness fluctuating, Pain, Pain in extremity
Clinical narrative: Shocking pain in arm. Drifted in and out on consciousness. Unable to summon help. Bedridden for 3 days. Saw MD on 10/18/2013. Severe pain for further 7 day. Saw regular MD on 10/25/2013 he RX'd Prednisone. Currently pain when moving arm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Small intestinal obstruction, Vomiting, X-ray abnormal
Clinical narrative: Persistent vomiting and bloody stool. Referred to ER and diagnosed with small bowel obstruction, unspecified. Admitted for observation and further management. Resolved spontaneously.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Migraine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Full blown flu complete with sore throat, respiratory congestion (nasal and bronchial) three-plus degree fever, aches, chills, vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Full blown flu complete with sore throat, respiratory congestion (nasal and bronchial) three-plus degree fever, aches, chills, vomiting.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on upper arm and chest left side (vaccination site left arm).
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Blood culture, Blood test, Chills, Headache, Hyperhidrosis
Clinical narrative: Chills, sweats, neck ache and head ache.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain
Clinical narrative: Chills, sweats, neck ache and head ache.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Arm very sore, red, swollen, hot, low grade temperature.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain at injection site that got progressively worse x 4 days and resolved with warm compresses.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient experiences rash all over the body and itching, no other symptoms.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysphonia, Dyspnoea, Feeling hot, Injection site erythema
Clinical narrative: Itching all over, baseball size redness, with warmth and itching at injection side, onset of difficulty in breathing, face, tongue, mouth throat tingling, hives, feeling dizzy, feeling warm, voice changes, felt like throat closing up.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site warmth, Paraesthesia, Paraesthesia oral, Pruritus generalised
Clinical narrative: Itching all over, baseball size redness, with warmth and itching at injection side, onset of difficulty in breathing, face, tongue, mouth throat tingling, hives, feeling dizzy, feeling warm, voice changes, felt like throat closing up.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Urticaria
Clinical narrative: Itching all over, baseball size redness, with warmth and itching at injection side, onset of difficulty in breathing, face, tongue, mouth throat tingling, hives, feeling dizzy, feeling warm, voice changes, felt like throat closing up.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, nausea, stomach pain, vomiting, fever.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe headaches. I occasionally get headaches but they are easily treated by taking Advil once. At the time I am filing this, I still have a headache after taking Tylenol at lunch time, Advil at 4 pm and Hydrocodone at 10pm.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: General malaise, then sudden swelling and pain of left supraclavicular lymph node (Virchow's node).  By 10/25/2013 condition worsened to include joint pain. As of today 10/28/2013 I'm feeling better, however Virchow's node is still swollen, though without pain.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Dyspnoea, Injection site erythema, Injection site pain, Nausea
Clinical narrative: 24 hrs post vaccination developed temp 101 degrees F, nausea, vomiting, wheezing, dyspnea, pruritus (generalized), localized redness/tenderness at injection site.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus generalised, Vomiting, Wheezing
Clinical narrative: 24 hrs post vaccination developed temp 101 degrees F, nausea, vomiting, wheezing, dyspnea, pruritus (generalized), localized redness/tenderness at injection site.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Pt received FLUZONE vaccine at approximately 2 pm and called us at 4:45 pm. Rash, swelling, itching developed at around 4:00 pm (10/23/13).
Age: 92.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an 80 year old female patient. The reporter stated that after administered a dose of ZOSTAVAX (lot# unspecified) (dose, route and location unspecified) and an unspecified flu vaccine (manufacturer unknown) concomitantly on an unspecified date, the patient developed a high fever and had to be hospitalized overnight. The reporter reported that the patient responded well to the unspecified treatments given at the unspecified hospital and went home on an unspecified date the next day. The outcome was unspecified by reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Pt was feeling itchiness near site of injection. Pt was given BENADRYL and water. Paramedics were called and they checked the pt and she had no sign of adverse effects.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Heart rate irregular, Insomnia, Nodule
Clinical narrative: Gave PT FLUARIX PF vaccines - PT reported a red/swollen knot 2 days later. Also reported the feeling of irregular heart beat soon after the vaccine. PT also reported insomnia the night of the vaccine.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Swelling
Clinical narrative: Pt called pharmacy on 10-27-13 to ask if using an ice pack on the swollen rash from her vaccines. The rash started on the evening of 10-25-13. The patient used ibuprofen and an ice pack. By 10-28-13 the rash was much better. MD not called. She was OK with the improvement.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in the injected arm, lasting for more than 3 weeks, having trouble to move arm.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Had red area near site of injection. It had a hard knot. I iced it all day on 10/17. On 10/18 my doctor told me to go to ER.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Pt reported feeling achy and feverish 3-4 hours after vaccination and had a low grade fever that continued for approximately 24 hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Hypersensitivity, Pruritus, Skin warm
Clinical narrative: Severe headache started the morning of 10/16/13. Allergic reaction on arm of injection site - red, hot, swollen and itchy. Saw my physician on 10/17/13. Was given prescription VALTREX 500mg 2 tabs now and 2 table 12 hrs. Start ADVIL 200mg 1 tab.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Severe headache started the morning of 10/16/13. Allergic reaction on arm of injection site - red, hot, swollen and itchy. Saw my physician on 10/17/13. Was given prescription VALTREX 500mg 2 tabs now and 2 table 12 hrs. Start ADVIL 200mg 1 tab.
Age: 9.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: Patient in lab for immunizations in accordance to transplant team request from hospital. Patient given Flu, Hep B, and PPSV23 at visit.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Fatigue, Feeling cold
Clinical narrative: Had shot at noon on 10/16/13. About 5:30 she got really cold and started shaking. BP 150/125 - it's usually very low (120/70). Went to ER at 8:30 PM. Temperature was 102.5. Started fluids and did tests - bloodwork, urine, chest xray. Arm never red or sore. Came home after 4 hrs. Ran slight fever for another 24 hrs. Very tired for 4 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Urine analysis
Clinical narrative: Had shot at noon on 10/16/13. About 5:30 she got really cold and started shaking. BP 150/125 - it's usually very low (120/70). Went to ER at 8:30 PM. Temperature was 102.5. Started fluids and did tests - bloodwork, urine, chest xray. Arm never red or sore. Came home after 4 hrs. Ran slight fever for another 24 hrs. Very tired for 4 days.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: 10pm at night very painful, Wed went to doctor, no swelling, pain radiates to thumb.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Eyelid oedema, Pruritus, Swelling face, Urticaria
Clinical narrative: Received flu vaccien at flu clinic - 10-26-13 developed face swelling, esp eyelid swelling, some SOB, itchiness, noted hives on chin - approx 8 hours after vaccine - took BENADRYL 50mg at 21:00, woke up on Sunday 10-27-13 still had swelling took another 50mg BENADRYL -Monday 10-25-13 symp resolved.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Swelling face, Urticaria
Clinical narrative: Urticaria, facial swelling w/ in 12 hrs. Lasted 3 days, no h/o egg or other allergy.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Right arm hurting for two weeks since getting vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Fatigue, Pruritus
Clinical narrative: Patient called to complain of: itching, tiredness. Redness on her chest. Being out of breath while performing normal daily activities.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site vesicles
Clinical narrative: Patient presented the day following the vaccination with an inflamed and blistered administration site. Patient then received LEVAQUIN therapy from another pharmacy.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Sore arm weeks after vaccine. Pt states they can not move their arm and is experiencing pain from collarbone to elbow.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching of left arm approx an inch and one-half above elbow. Patient to take BENADRYL and ibuprofen to see if improves pt will let us know if no improvement.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Came to pharmacy 10/26/13 at 10am. Patient presented with red, splotchy, "area about 2" below injection site. Patient stated it was painful but not itchy. She had no problems breathing. She had been applying heat. Advised her to see a doctor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediately after administration, patient experienced a local minor itchiness. Patient continues to having minor itchiness and blister locally for three weeks post injection.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Pruritus
Clinical narrative: Immediately after administration, patient experienced a localized and minor itchiness. Patient continues to having minor itchiness and blisters locally for three weeks post injection.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: One day after PNEUMOVAX 23 administered (R) upper arm red, swollen, warm to touch. Two days later still swollen and warm. Recommended ice/ibuprofen for one more day (was not iced at all previously).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pain, Herpes ophthalmic, Lacrimation increased, Pain
Clinical narrative: Oct 22 PM - Chills, watery eyes, body aches. Oct 24 - Eyes started to bother, throbbing eye pain. Oct 25 - Went to optometrist - who said flu shot triggered herpes of the eye. Rx Atropine, Prednisolone, GENTAK.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Painful at site, also swollen, itching, hot, and red. Swollen to "size of orange" per patient. 10/26 - felling much better and no longer swollen.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Pt took a nap when he got home and when he woke up about an hour later he had swelling and a knot at injection site. He applied ice and it has gone down considerably today.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swollen, red, and painful. On 10/26 still a little red and swollen but much better. Took 1 BENADRYL at onset.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a consumer's friend refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 21-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot, dose and route not reported). Concomitant medication was not reported. On 21-OCT-2013, the reporter stated that the patient received an overdosage of PNEUMOVAX 23 (also reported as received the large dose). The reporter also stated that she was unsure if the patient had experienced any adverse effects at this time. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Lip swelling, Paraesthesia oral
Clinical narrative: Red, swollen lip, tingly tongue.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On 29-AUG-2013 the patient was vaccinated with ZOSTAVAX (0.6t5 ml, once, subcutaneous, lot # J002692 EXP 30-APR-2014). Concomitant therapies included PREMARIN, potassium chloride (manufacturer unknown), LEXAPRO, amlodipine, furosemide (manufacturer unknown), metoprolol, alendronate, losartan (manufacturer unknown), MOBIC, SINGULAIR, COMBIVENT and ADVAIR. The pharmacist reported that the patient developed "red spots" at the injection site after receiving a dose of ZOSTAVAX. The red spots are not painful and not itchy. The patient sought for medical attention but received no treatment. No lab diagnostic studies were performed. The outcome of the "red spots" at the injection site was reported as not recovered at the time of the report. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after influenza vaccine administered. Her head hit table and then she "woke up".
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to her sister of unknown age. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # batch # unspecified) route, dose and location unspecified. On an unspecified date the patient "didn't feel well" for a few days after the ZOSTAVAX injection. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 64 year old male patient with pertinent medial history of hernia surgery. Patient's drug reactions and allergies included: patient had received an unspecified Flu vaccine: influenza virus vaccine (manufacturer unknown) in 1993 and 2 days after receiving this unspecified flue vaccine he then developed the flu (MARRS#1310USA012808); patient received an unspecified pneumonia shot: pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as well as an unspecified tetanus shot: Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown) on 03-SEP-2013 and then developed pain which he recovered from 2 days later (MARRS#1310USA012809); Patient had liquid MORPHINE (unspecified manufacturer/dose/frequency) and made his "arm completely red" and raised his blood pressure (date unspecified). On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, "one-shot", route as "under the skin", lot #,  strength, formulation were unknown). After receiving ZOSTAVAX, on 18-OCT-2013, patient developed an injection site reaction which included redness, swelling, itching, warmth, pain, and the reaction site is the size of a silver dollar that was red and raised. The patient had sought medical attention via speaking to the pharmacist. No lab diagnostics studies were performed. Treatment of BENADRYL (unspecified manufacturer) was given for the event. The outcome was reported as not recovered. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a 64 year old male patient with pertinent medial history of hernia surgery. Patient's drug reactions and allergies included: patient had received an unspecified Flu vaccine: influenza virus vaccine (manufacturer unknown) in 1993 and 2 days after receiving this unspecified flue vaccine he then developed the flu (MARRS#1310USA012808); patient received an unspecified pneumonia shot: pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as well as an unspecified tetanus shot: Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown) on 03-SEP-2013 and then developed pain which he recovered from 2 days later (MARRS#1310USA012809); Patient had liquid MORPHINE (unspecified manufacturer/dose/frequency) and made his "arm completely red" and raised his blood pressure (date unspecified). On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, "one-shot", route as "under the skin", lot #,  strength, formulation were unknown). After receiving ZOSTAVAX, on 18-OCT-2013, patient developed an injection site reaction which included redness, swelling, itching, warmth, pain, and the reaction site is the size of a silver dollar that was red and raised. The patient had sought medical attention via speaking to the pharmacist. No lab diagnostics studies were performed. Treatment of BENADRYL (unspecified manufacturer) was given for the event. The outcome was reported as not recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from an approximately 60 year old female patient regarding herself. Current conditions included allergic reactions to amoxicillin (unspecified dose, frequencies and manufacturer) and many unspecified medications (unspecified names, dose, frequencies and manufacturer) make her sick to her stomach. There was no pertinent medical history. On 10-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J004599 and 18-JUL-2014 respectively), subcutaneously. There were no concomitant medications. On 10-OCT-2013, after the vaccination, the patient experienced redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The patient sought medical attention with her gynecologist on an unspecified date because her primary care doctor was not available. The Gynecologist prescribed prednisone (unspecified dose, frequency and manufacturer). No lab tests were performed. The patient was not recovered from redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This spontaneous report was received from an approximately 60 year old female patient regarding herself. Current conditions included allergic reactions to amoxicillin (unspecified dose, frequencies and manufacturer) and many unspecified medications (unspecified names, dose, frequencies and manufacturer) make her sick to her stomach. There was no pertinent medical history. On 10-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J004599 and 18-JUL-2014 respectively), subcutaneously. There were no concomitant medications. On 10-OCT-2013, after the vaccination, the patient experienced redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The patient sought medical attention with her gynecologist on an unspecified date because her primary care doctor was not available. The Gynecologist prescribed prednisone (unspecified dose, frequency and manufacturer). No lab tests were performed. The patient was not recovered from redness, swelling and a hard itchy lump at the injection site and itchy hives all over her body. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age who was familiar with the administration practices of the vaccine regarding herself via a company representative. It was reported that approximately on an unknown date in June 2013 (reported as 4 months ago), the patient felt that she may have been vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), intramuscularly instead of subcutaneously due to the placement in the arm. No concomitant therapy was reported. Approximately on an unknown date in June 2013 (reported as 4 months ago), the patient experienced soreness and redness after receiving the vaccine at the injection site. The patient did not seek any medical attention. It was unspecified if any treatment was given or if any lab tests were performed. Approximately on an unknown date in 2013, the patient recovered from soreness and redness. The relatedness for soreness and redness was unknown for ZOSTAVAX. Additional information has been requested
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Borrelia test, Hypoaesthesia, Injection site erythema, Local swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old male consumer refers to himself with high blood pressure and high cholesterol. There were no drug reactions/allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported), 1 injection in the left arm. Concomitant medication included lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 27-AUG-2013, right after the "got the shot", the patient's arm swelled up like crazy and turned red around the injection area. Approximately on 10-SEP-2013 (reported as 2-3 weeks later), he started experiencing tingling and numbness in various parts of the body. This had not yet gone away. None treatment was given for adverse events. Blood test for lymes and thyroid were performed. The patient sought unspecified medical attention. The outcome of "arm swelled up like crazy" and "turned red around the injection area" was unknown. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Thyroid function test
Clinical narrative: This spontaneous report as received from a 60 year old male consumer refers to himself with high blood pressure and high cholesterol. There were no drug reactions/allergies. On 27-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported), 1 injection in the left arm. Concomitant medication included lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 27-AUG-2013, right after the "got the shot", the patient's arm swelled up like crazy and turned red around the injection area. Approximately on 10-SEP-2013 (reported as 2-3 weeks later), he started experiencing tingling and numbness in various parts of the body. This had not yet gone away. None treatment was given for adverse events. Blood test for lymes and thyroid were performed. The patient sought unspecified medical attention. The outcome of "arm swelled up like crazy" and "turned red around the injection area" was unknown. Additional information is not expected.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male adult patient of unknown age. The patient was administered a dose of TWINRIX (lot# unspecified) (dose, route and location unspecified) on 30-AUG-2011, a second dose of TWINRIX (lot# unspecified) (dose, route and location unspecified) on an unspecified date after 04-OCT-2011. No adverse event was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HEPAB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female adult patient of unknown age. The patient was administered a dose of TWINRIX (lot# unspecified) (dose, route and location unspecified) on 30-AUG-2011, a second dose of TWINRIX (lot# unspecified) (dose, route and location unspecified) on 04-OCT-2011, a dose of RECOMBIVAX HB (lot# unspecified) (dose, route and location unspecified) on an unspecified date after 04-OCT-2011. No adverse event was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old patient of unknown gender with coronary artery disease and no drug reactions and allergies. On 07-SEP-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intravenous (lot#, expiration date and frequency unknown). On 07-SEP-2013, a new nurse on orientation administered PNEUMOVAX23 intravenously. The patient was being treated for coronary artery disease. The nurse pulled up PNEUMOVAX23 and morphine in separate syringes, did not label, and gave PNEUMOVAX23 through the hep-lock. On 07-SEP-2013 the patient experienced flushing to his face, which resolved. No lab diagnostics and studies were performed. The patient didn't sought medical attention and was not given treatment for the event. Therapy with PNEUMOVAX23 was continued. Vital signs were done, within normal limits. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood pressure increased, Erythema, Hernia repair, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 64 year old male patient. Patient's drug reactions and allergies including: patient had received an unspecified FLU vaccine: influenza virus vaccine (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) in 1993, and 2 days after receiving this unspecified flu vaccine he then developed the flu (MARRS# 1310USA012808); On 03-SEP-2013, patient received an unspecified pneumonia shot: pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) as well as an unspecified tetanus shot: Tetanus and Diptheria Toxoids, Adsorbed (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) and then developed pain (unspecified date in 2013) which he recovered from 2 days later. The action taken was unknown. Patient had liquid MORPHINIE (unspecified manufacturer/dose/frequency) and made his "arm completely red" and raised his blood pressure (date unspecified). On unspecified date, patient had a hernia surgery. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, "one shot", route as "under the skin", lot #, strength, formulation were unknown) for prevention of shingles. After receiving ZOSTAVAX, on 18-OCT-2013, patient developed an injection site reaction which included redness, swelling, itching, warmth, pain, and the reaction site is the size of a silver dollar that was red and raised (MARRS# 1310USA011487). Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a 64 year old male patient. Patient's drug reactions and allergies including: patient had received an unspecified FLU vaccine: influenza virus vaccine (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) in 1993, and 2 days after receiving this unspecified flu vaccine he then developed the flu (MARRS# 1310USA012808); On 03-SEP-2013, patient received an unspecified pneumonia shot: pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) as well as an unspecified tetanus shot: Tetanus and Diptheria Toxoids, Adsorbed (manufacturer unknown) (strength, formulation, lot #, dose, route and duration were unspecified) and then developed pain (unspecified date in 2013) which he recovered from 2 days later. The action taken was unknown. Patient had liquid MORPHINIE (unspecified manufacturer/dose/frequency) and made his "arm completely red" and raised his blood pressure (date unspecified). On unspecified date, patient had a hernia surgery. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, "one shot", route as "under the skin", lot #, strength, formulation were unknown) for prevention of shingles. After receiving ZOSTAVAX, on 18-OCT-2013, patient developed an injection site reaction which included redness, swelling, itching, warmth, pain, and the reaction site is the size of a silver dollar that was red and raised (MARRS# 1310USA011487). Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Foetal disorder, Foetal exposure during pregnancy
Clinical narrative: information has been received from a female patient of unknown age, for GARDASIL (lot # was unknown), a Pregnancy Registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The patient was intramuscularly vaccinated with 0.5ml GARDASIL on 21-AUG-2012 when she was approximately one week pregnant. No concomitant medications were reported. The LMP was 14-AUG-2012 and EDD is 21-MAY-2013. Initial exposure to GARDASIL was at 1 week(s). The patient was exposed to GARDASIL during trimester 1. No adverse event involved. No treatment information was reported. The outcome of the exposure was unknown at the time of report. Follow up information has been received from a nurse who reported that the patient was last seen in the office in July 2013 for a work physical. She was able to find a obstetrician (OB) note in the chart which indicated there were no problems with the delivery or the baby. In regarding the note she reported that baby seemed normal and healthy and no congenital anomalies were noted. No further information is available.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: information has been received from a female patient of unknown age, for GARDASIL (lot # was unknown), a Pregnancy Registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The patient was intramuscularly vaccinated with 0.5ml GARDASIL on 21-AUG-2012 when she was approximately one week pregnant. No concomitant medications were reported. The LMP was 14-AUG-2012 and EDD is 21-MAY-2013. Initial exposure to GARDASIL was at 1 week(s). The patient was exposed to GARDASIL during trimester 1. No adverse event involved. No treatment information was reported. The outcome of the exposure was unknown at the time of report. Follow up information has been received from a nurse who reported that the patient was last seen in the office in July 2013 for a work physical. She was able to find a obstetrician (OB) note in the chart which indicated there were no problems with the delivery or the baby. In regarding the note she reported that baby seemed normal and healthy and no congenital anomalies were noted. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood iron, Exposure during pregnancy, Full blood count, Laboratory test, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, for VARIVAX (Merck) a Pregnancy Registry product, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On an unknown date the patient became pregnant with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 01-NOV-1996, patient was vaccinated with first dose of VARIVAX (Merck) (Lot #, exp date, dose, route were unspecified). On 25-FEB-2013 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) while pregnant. Concomitant vaccination given the same day included Tdap, hepatitis A virus vaccine, and MENACTRA while pregnant. All administered while pregnant (all at the same visit, separate sites). The pregnancy outcome was pending with a due date in 10-SEP-2013. No adverse event reported. No treatment was given to the patient. The patient sought unspecified medical attention at the doctor's office. Laboratory test were performed as follow: Full blood count (CBC), Iron Level, Sexually Transmitted Diseases (STD) test, Unspecified Pregnancy test in January of 2013. The outcome of pregnancy is unknown. This case is one of several reports from the same patient. Information about GARDASIL was collected in MARRS: 1303USA006654. Follow-up information has been received from licensed practical nurse and refers to a 17 years old female student (patient's weight reported as 111.0) who was vaccinated on 25-FEB-2013 (also reported as 01-NOV-1996) with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) in the left arm while pregnant. The patient was not tested for varicella antibodies before vaccination. The patient delivered baby on an unknown date in 2013 (liveborn infant). The patient's gravida was 3 and para was 2. The patient had no pre-term deliveries. No birth defects occurred in any previous pregnancy. Stillbirth or miscarriage did not occur in any previous pregnancy. There was no local reaction at vaccination site, no varicella (chickenpox) and herpes zoster (shingles) symptoms post vaccination (reported also as none adverse event). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood iron, Delivery, Exposure during pregnancy, Full blood count, Laboratory test
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, for VARIVAX (Merck) a Pregnancy Registry product, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On an unknown date the patient became pregnant with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 01-NOV-1996, patient was vaccinated with first dose of VARIVAX (Merck) (Lot #, exp date, dose, route were unspecified). On 25-FEB-2013 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) while pregnant. Concomitant vaccination given the same day included Tdap, hepatitis A virus vaccine, and MENACTRA while pregnant. All administered while pregnant (all at the same visit, separate sites). The pregnancy outcome was pending with a due date in 10-SEP-2013. No adverse event reported. No treatment was given to the patient. The patient sought unspecified medical attention at the doctor's office. Laboratory test were performed as follow: Full blood count (CBC), Iron Level, Sexually Transmitted Diseases (STD) test, Unspecified Pregnancy test in January of 2013. The outcome of pregnancy is unknown. This case is one of several reports from the same patient. Information about GARDASIL was collected in MARRS: 1303USA006654. Follow-up information has been received from licensed practical nurse and refers to a 17 years old female student (patient's weight reported as 111.0) who was vaccinated on 25-FEB-2013 (also reported as 01-NOV-1996) with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) in the left arm while pregnant. The patient was not tested for varicella antibodies before vaccination. The patient delivered baby on an unknown date in 2013 (liveborn infant). The patient's gravida was 3 and para was 2. The patient had no pre-term deliveries. No birth defects occurred in any previous pregnancy. Stillbirth or miscarriage did not occur in any previous pregnancy. There was no local reaction at vaccination site, no varicella (chickenpox) and herpes zoster (shingles) symptoms post vaccination (reported also as none adverse event). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, for VARIVAX (Merck) a Pregnancy Registry product, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On an unknown date the patient became pregnant with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 01-NOV-1996, patient was vaccinated with first dose of VARIVAX (Merck) (Lot #, exp date, dose, route were unspecified). On 25-FEB-2013 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) while pregnant. Concomitant vaccination given the same day included Tdap, hepatitis A virus vaccine, and MENACTRA while pregnant. All administered while pregnant (all at the same visit, separate sites). The pregnancy outcome was pending with a due date in 10-SEP-2013. No adverse event reported. No treatment was given to the patient. The patient sought unspecified medical attention at the doctor's office. Laboratory test were performed as follow: Full blood count (CBC), Iron Level, Sexually Transmitted Diseases (STD) test, Unspecified Pregnancy test in January of 2013. The outcome of pregnancy is unknown. This case is one of several reports from the same patient. Information about GARDASIL was collected in MARRS: 1303USA006654. Follow-up information has been received from licensed practical nurse and refers to a 17 years old female student (patient's weight reported as 111.0) who was vaccinated on 25-FEB-2013 (also reported as 01-NOV-1996) with the second dose of VARIVAX (Merck) (lot number H006538, route, dose not provided) in the left arm while pregnant. The patient was not tested for varicella antibodies before vaccination. The patient delivered baby on an unknown date in 2013 (liveborn infant). The patient's gravida was 3 and para was 2. The patient had no pre-term deliveries. No birth defects occurred in any previous pregnancy. Stillbirth or miscarriage did not occur in any previous pregnancy. There was no local reaction at vaccination site, no varicella (chickenpox) and herpes zoster (shingles) symptoms post vaccination (reported also as none adverse event). Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Dizziness, Electromyogram, Muscle contractions involuntary, Muscle spasms
Clinical narrative: Tingling in legs, dizziness and nausea.  Dizziness and nausea resolved on its own after 3 days.  Tingling has progressed to cramps, muscle contractions and fasciculations.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Neurological examination, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Tingling in legs, dizziness and nausea.  Dizziness and nausea resolved on its own after 3 days.  Tingling has progressed to cramps, muscle contractions and fasciculations.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Injection site reaction, Pruritus, Swelling
Clinical narrative: Injection site reaction.  Itchy and inflamed size of half a chicken egg.  Swelling slowly increasing. Not on any current medicines, did not take any treatment medicines.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Nausea, Pain
Clinical narrative: Vomiting, diarrhea, soreness, stomach cramps, nausea, dizziness.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, soreness, stomach cramps, nausea, dizziness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Redness, heat, and swelling the size of a chicken egg at injection site.  Very mild pain associated with raising arm in muscle that received injection.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Pain
Clinical narrative: I received my flu vaccine shot from a pharmacist on 10/17/2013 at pharmacy.  She gave the shot in my left arm and I looked away.  She put the bandaid up over the shoulder joint.  Two hours later I started experiencing intense pain and inability to move my left arm.  It is now 10/29/2013 and I only have partial use of my left arm and I still am experiencing this pain.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site joint movement impairment, Injection site pain, Musculoskeletal disorder
Clinical narrative: I received my flu vaccine shot from a pharmacist on 10/17/2013 at pharmacy.  She gave the shot in my left arm and I looked away.  She put the bandaid up over the shoulder joint.  Two hours later I started experiencing intense pain and inability to move my left arm.  It is now 10/29/2013 and I only have partial use of my left arm and I still am experiencing this pain.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Mental status changes, Pyrexia
Clinical narrative: Fever of 103.1F so far for an hour not reducing after Ibprofen. Shivering and chills.  Random talking about fears and just nonsense.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Mumps antibody test negative, Respiratory tract congestion, Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to a 1 year old male patient (presently 9 years of age). Patient has no drug reactions or allergies. On an unknown date approximately 8 years ago in October 2005, the patient was vaccinated with a dose of M-M-R II (lot #, expiry not reported). On an unknown date, the patient developed anaphylaxis, urticaria and chest congestion. The patient was found to be negative for mumps antibodies when a titer was performed on an unspecified date. The outcome of negative for mumps antibodies when a titer was performed was unknown. The patient recovered from anaphylaxis, urticaria and chest congestion on an unknown date. The reporter considered the events anaphylaxis, urticaria, chest congestion and negative for mumps antibodies when a titer was performed as life threatening. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Administered HIGH DOSE FLUZONE to patient at around 6:30 PM on 10/17/2013. After 1 to 2 minutes after administration; pt complained of leg pain in the site. Contacted ambulance. Pt refused to go to hospital at the time.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender. The patient had a question about the GARDASIL vaccination. If the patient had received the first dose back on an unknown date in 2009, then the patient recently got the second dose of GARDASIL on an unknown date in May 2013 and my last one coming up on 16-OCT-2013. Patient asked is there any chance it could still work the same even though the dates are spread apart? Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Musculoskeletal chest pain
Clinical narrative: This spontaneous report was received from a 62 year old female patient with high blood pressure and high cholesterol regarding herself. Patient had no drug allergies or reactions. On 03-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J007856, expiry: 28-SEP-2014), subcutaneously for prevention of shingles. Concomitant therapies included Crestor, Zebeta, Benicar and Aspirin. On 05-OCT-2013, the patient reported that she received the ZOSTAVAX injection and had "water blisters break out on her chest. These blisters had gone away after about 48 hours. She continued to feel a dull burning and aching under her left breast and around her rib cage. The patient was in the doctor's office at the time of the call. The patient handed the phone to the doctor who requested information on treating the symptoms. No treatment was given for the events. No laboratory diagnostic studies were performed. The outcome of water blisters break out on her chest was reported as recovered approximately on 07-OCT-2013. The outcome of dull burning and aching under her left breast and around her rib cage was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program conducted by Evolution Marketing Research, refers to her daughter's friend of unknown gender and age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose and lot# not reported). It was reported that the patient "stayed puffy for a couple months" after 2nd shot and finished off the series. This is one of several reports received from the same source. Additional information is not expected.