chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperaesthesia, Pyrexia, Urticaria
Clinical narrative: My reaction started with itchy eyes.  Then I started experiencing back pain, chills and headache.  On 01/16/2013 I continued to experience chills, fever, headache, fatigue and developed wide spread hives.  On 01/17/2013 I was no longer experiencing chills and fever but the hives and headache continue.  I have extreme sensitivity to touch on my head and abdomen.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Hypertension, Nausea
Clinical narrative: Patient was given influenza and pneumococcal vaccines. Within 10 minutes after administration, patient became severely anxious, holding chest and stating he could not breathe. Oxygen saturation dropped to 84% and patient was placed on oxygen. Patient was severely hypertensive (225/115) and very wheezy and nauseous, beginning to vomit. Patient given 25 mg IV Benadryl; BP, anxiety, and breathing improved afterward.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Oxygen saturation decreased, Vomiting, Wheezing
Clinical narrative: Patient was given influenza and pneumococcal vaccines. Within 10 minutes after administration, patient became severely anxious, holding chest and stating he could not breathe. Oxygen saturation dropped to 84% and patient was placed on oxygen. Patient was severely hypertensive (225/115) and very wheezy and nauseous, beginning to vomit. Patient given 25 mg IV Benadryl; BP, anxiety, and breathing improved afterward.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Herpes zoster, Myalgia
Clinical narrative: Muscle soreness, extreme fatigue, headache for next two weeks. Shingles (mild case) on left leg started one week later (11/25/12).
Age: 1.27
Sex: F
Vaccine: DTAP, FLUX, HIBV
Symptoms: Dyspnoea, Rash, Swelling face
Clinical narrative: Patient received Daptacel, ActHib, and Influenza vaccines at 15 month appointment in the morning. At 1350 the patient developed difficulty breathing, facial swelling, and rash. The patient received Benadryl and Epi-Pen IM. Then presented to the emergency department and also received steroids.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Syncope
Clinical narrative: Fainting and mild seizure.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Alopecia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site, hair loss. Nno treatment needed.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blister, Blood test, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen axillary lymph node. Right side. Fluid filled bumps primarily on hands. Sore left arm (site of injection) - soreness spread to other joints and muscles.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Swollen axillary lymph node. Right side. Fluid filled bumps primarily on hands. Sore left arm (site of injection) - soreness spread to other joints and muscles.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling cold, Vomiting
Clinical narrative: Had two bouts of diarrhea at 2 PM and I threw-up two times at 6:30 PM. Also, my condo was set at 65 degrees at 4 PM and I was bundled up and freezing. I had my last bout of diarrhea after waking up about 6 AM.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site pruritus, Vaccination complication
Clinical narrative: Burning, itching, at injection site and satellite area on lower -mid left side of abdomen. No dyspnea, no wheezing.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Influenza like illness, Palpitations
Clinical narrative: Flu-like chills, fever over 101 F, weakness, cough, racing heart.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Flu-like chills, fever over 101 F, weakness, cough, racing heart.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling abnormal, Headache, Peripheral coldness, Skin discolouration
Clinical narrative: Given Influenza Virus Vaccine Afluria 2012-2013 Formula by pharmacist at approximately 6:30 PM. Within two minutes she started reacting and had to go to the emergency room. Here were the symptoms she experienced: First her vision got blurred She felt like she was not as coherent and was going to faint Turned white as a ghost, hands became extremely cold like they had been in the freezer Started trembling really badly all over Started wheezing Bad headache She was really out of it  We called 911. The paramedics came and said she was just having a panic attack and insinuated we were wasting their resources. They were wrong as my daughter does not react to shots at all nor has she ever had a panic attack. We personally drove her to the emergency room close by, since we didn't want to "tie up resources". Our daughter was diagnosed with having an adverse reaction to an ingredient in the vaccination. After about one hour at the ER (we lost track of time), slowly she started trembling less and the warmth came back into her hands. The color returned in her face. Her vision came back. She was left with a bad headache and fogginess in her head.   The er doctor suggested we go back to Rite Aid and get a list of the ingredients to give to our primary physician. She suggested it could be the preservative in the vaccination. Doctor sent us home after some observation time and when she started to return back to normal. Gave us the option of them hydrating her through I.V. or we hydrate her. Since we have medical insurance with a $10K deductible, we decided on the latter.   Today she just had a slight headache but overall was fine.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Vaccination complication, Vision blurred, Wheezing
Clinical narrative: Given Influenza Virus Vaccine Afluria 2012-2013 Formula by pharmacist at approximately 6:30 PM. Within two minutes she started reacting and had to go to the emergency room. Here were the symptoms she experienced: First her vision got blurred She felt like she was not as coherent and was going to faint Turned white as a ghost, hands became extremely cold like they had been in the freezer Started trembling really badly all over Started wheezing Bad headache She was really out of it  We called 911. The paramedics came and said she was just having a panic attack and insinuated we were wasting their resources. They were wrong as my daughter does not react to shots at all nor has she ever had a panic attack. We personally drove her to the emergency room close by, since we didn't want to "tie up resources". Our daughter was diagnosed with having an adverse reaction to an ingredient in the vaccination. After about one hour at the ER (we lost track of time), slowly she started trembling less and the warmth came back into her hands. The color returned in her face. Her vision came back. She was left with a bad headache and fogginess in her head.   The er doctor suggested we go back to Rite Aid and get a list of the ingredients to give to our primary physician. She suggested it could be the preservative in the vaccination. Doctor sent us home after some observation time and when she started to return back to normal. Gave us the option of them hydrating her through I.V. or we hydrate her. Since we have medical insurance with a $10K deductible, we decided on the latter.   Today she just had a slight headache but overall was fine.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypoaesthesia, Peripheral coldness, Thirst, Tremor
Clinical narrative: Given Influenza Virus Vaccine Afluria 2012-2013 Formula by pharmacist at approximately 6:30 PM. Within two minutes she started reacting and had to go to the emergency room. Here were the symptoms she experienced: First her vision got blurred She felt like she was not as coherent and was going to faint Turned white as a ghost, hands became extremely cold like they had been in the freezer Started trembling really badly all over Started wheezing Bad headache She was really out of it  We called 911. The paramedics came and said she was just having a panic attack and insinuated we were wasting their resources. They were wrong as my daughter does not react to shots at all nor has she ever had a panic attack. We personally drove her to the emergency room close by, since we didn't want to "tie up resources". Our daughter was diagnosed with having an adverse reaction to an ingredient in the vaccination. After about one hour at the ER (we lost track of time), slowly she started trembling less and the warmth came back into her hands. The color returned in her face. Her vision came back. She was left with a bad headache and fogginess in her head.   The er doctor suggested we go back to Rite Aid and get a list of the ingredients to give to our primary physician. She suggested it could be the preservative in the vaccination. Doctor sent us home after some observation time and when she started to return back to normal. Gave us the option of them hydrating her through I.V. or we hydrate her. Since we have medical insurance with a $10K deductible, we decided on the latter.   Today she just had a slight headache but overall was fine.
Age: 16.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred
Clinical narrative: Given Influenza Virus Vaccine Afluria 2012-2013 Formula by pharmacist at approximately 6:30 PM. Within two minutes she started reacting and had to go to the emergency room. Here were the symptoms she experienced: First her vision got blurred She felt like she was not as coherent and was going to faint Turned white as a ghost, hands became extremely cold like they had been in the freezer Started trembling really badly all over Started wheezing Bad headache She was really out of it  We called 911. The paramedics came and said she was just having a panic attack and insinuated we were wasting their resources. They were wrong as my daughter does not react to shots at all nor has she ever had a panic attack. We personally drove her to the emergency room close by, since we didn't want to "tie up resources". Our daughter was diagnosed with having an adverse reaction to an ingredient in the vaccination. After about one hour at the ER (we lost track of time), slowly she started trembling less and the warmth came back into her hands. The color returned in her face. Her vision came back. She was left with a bad headache and fogginess in her head.   The er doctor suggested we go back to Rite Aid and get a list of the ingredients to give to our primary physician. She suggested it could be the preservative in the vaccination. Doctor sent us home after some observation time and when she started to return back to normal. Gave us the option of them hydrating her through I.V. or we hydrate her. Since we have medical insurance with a $10K deductible, we decided on the latter.   Today she just had a slight headache but overall was fine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site infection
Clinical narrative: Develop infection below injection site cellulitis after 3 days.
Age: 1.25
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Rash to face, itchy & painful.
Age: 68.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Activities of daily living impaired, Asthenia, Body temperature increased, Decreased appetite, Headache
Clinical narrative: On 1/7/13 6pm headache, aching - sharp over the body, shaking. 1/8/13 Temp 101 degrees weakness. Missed 2 days work. Rash red over left arm injection site. Took ALEVE Q6 hrs on advise of MD. Diminished appetite, No N&V.
Age: 68.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Injection site reaction, Pain, Rash erythematous, Tremor
Clinical narrative: On 1/7/13 6pm headache, aching - sharp over the body, shaking. 1/8/13 Temp 101 degrees weakness. Missed 2 days work. Rash red over left arm injection site. Took ALEVE Q6 hrs on advise of MD. Diminished appetite, No N&V.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: A few minutes after administration, patient got lightheaded and fell. She immediately stated she'd had no lunch, so I figured low sugar coupled with the shot mad her woozy. Orange juice and peanut butter crackers fixed it quickly and she was fine.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: (L) upper arm with swelling, erythema, c/o pain with difficulty of ROM, warm to touch. Rx with BACTRIM, DS 1 tab BID x 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling / pins & needles lips & tongue - right side. Has progressed "numbness L novocaine shot" (R) side face. No swelling at site no swelling in mouth. Pt noting improvement 11:07 AM. 1:00 No more pins & needles on mouth & tongue...still numbness in parts of right side of face, she feels it is improving.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to a patient of unknown age. The patient was vaccinated with the first time of GARDASIL (Lot # not reported) on 02-AUG-2012, the second dose of GARDASIL (Lot # not reported) on 09-OCT-2012 and the third dose of GARDASIL (Lot # not reported) on 07-JAN-2013. No adverse symptoms were reported. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information has been received from a licensed practical nurse concerning a 59 years old patient with an unspecified gender, pertinent medical history or drug reactions / allergies. On 11-JAN-2013, the patient was vaccinated subcutaneously with 0.5 ml (Merck) PROQUAD (lot # (H015642 exp date 06-JAN-2014) instead of (Merck) ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information has been received from a licensed practical nurse concerns a 61 years old patient with an unspecified gender, pertinent medical history or drug reactions/allergies. On 11-JAN-2013, the patient was vaccinated subcutaneously with 0.5 ml dose of (Merck) PROQUAD (lot# H015642 exp date 06-JAN-2014) instead of (Merck) ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Condition aggravated, Fatigue, Irritability, Medication error, Pyrexia
Clinical narrative: This spontaneous report as received from a patient's mother refers to her 6 months old son with severe ear infection and fever who had no pertinent medical history and no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated mistakenly with a dose of GARDASIL (Lot # not reported) when visiting the doctor's office for an unspecified antibiotic shot. No other co-suspects were reported. Concomitant medications included: amoxicillin. The consumer reported that, the patient had been suffering with a severe ear infection and fever at the time of injection, and after receiving the GARDASIL, the patient's fever had worsened and remained at 102.4. The patient's parents had been giving him TYLENOL and ADVIL to attempt to reduce the fever, unsuccessfully. Also it was reported that the patient had been tired and very cranky since receiving the GARDASIL. The patient sought unspecified medical attention. No lab test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a patient's mother refers to her 6 months old son with severe ear infection and fever who had no pertinent medical history and no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated mistakenly with a dose of GARDASIL (Lot # not reported) when visiting the doctor's office for an unspecified antibiotic shot. No other co-suspects were reported. Concomitant medications included: amoxicillin. The consumer reported that, the patient had been suffering with a severe ear infection and fever at the time of injection, and after receiving the GARDASIL, the patient's fever had worsened and remained at 102.4. The patient's parents had been giving him TYLENOL and ADVIL to attempt to reduce the fever, unsuccessfully. Also it was reported that the patient had been tired and very cranky since receiving the GARDASIL. The patient sought unspecified medical attention. No lab test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Accidental exposure to product, Blood culture, Condition aggravated, Culture urine, Pyrexia
Clinical narrative: This spontaneous report as received from a patient's mother refers to her 6 months old son with severe ear infection and fever who had no pertinent medical history and no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated mistakenly with a dose of GARDASIL (Lot # not reported) when visiting the doctor's office for an unspecified antibiotic shot. No other co-suspects were reported. Concomitant medications included: amoxicillin. The consumer reported that, the patient had been suffering with a severe ear infection and fever at the time of injection, and after receiving the GARDASIL, the patient's fever had worsened and remained at 102.4. The patient's parents had been giving him TYLENOL and ADVIL to attempt to reduce the fever, unsuccessfully. Also it was reported that the patient had been tired and very cranky since receiving the GARDASIL. The patient sought unspecified medical attention. No lab test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a patient's mother refers to her 6 months old son with severe ear infection and fever who had no pertinent medical history and no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated mistakenly with a dose of GARDASIL (Lot # not reported) when visiting the doctor's office for an unspecified antibiotic shot. No other co-suspects were reported. Concomitant medications included: amoxicillin. The consumer reported that, the patient had been suffering with a severe ear infection and fever at the time of injection, and after receiving the GARDASIL, the patient's fever had worsened and remained at 102.4. The patient's parents had been giving him TYLENOL and ADVIL to attempt to reduce the fever, unsuccessfully. Also it was reported that the patient had been tired and very cranky since receiving the GARDASIL. The patient sought unspecified medical attention. No lab test was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site erythema, Injection site rash
Clinical narrative: Patient developed large, raised red area at site of injection. She consulted her physician who placed her on antibiotics for suspicion of infection.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Dyspnoea, Feeling hot, Ocular hyperaemia
Clinical narrative: 2 hours following vaccination - pt had difficulty breathing for 15 mins. For remainder of day, pt had red eyes, runny nose, "felt like steam/heat were coming out of her," felt like she had a fever but she didn't take her temperature. Joint pain and pain throughout body. Tx: took 2 TYLENOLS every time her bone hurt. Client instructed to call 911 next time she has difficulty breathing.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: 2 hours following vaccination - pt had difficulty breathing for 15 mins. For remainder of day, pt had red eyes, runny nose, "felt like steam/heat were coming out of her," felt like she had a fever but she didn't take her temperature. Joint pain and pain throughout body. Tx: took 2 TYLENOLS every time her bone hurt. Client instructed to call 911 next time she has difficulty breathing.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted while sitting in chair immediately after receiving HPV, MCV4, Tdap, Hep A, Hep B, influenza and PPD used an ammonia inhalant to nose received immediately cool compresses to face head & nape of neck BP 90/60 P 60.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was given vaccine on 1-10-13 and the next day developed redness, swelling, and extreme tenderness to the left arm from deltoid to elbow. Symptoms subsided after several days.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Full blood count normal, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Night after vaccines (L) arm, pt had low fever, chills, body aches. Next day aches, fever, vomiting & redness/rash at site. Next 2 days decreased pain but increased redness, heat, pain in arm at site. Today site is flat & less red/sore but area distal is red, raised, hot, very painful to touch.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Vomiting
Clinical narrative: Night after vaccines (L) arm, pt had low fever, chills, body aches. Next day aches, fever, vomiting & redness/rash at site. Next 2 days decreased pain but increased redness, heat, pain in arm at site. Today site is flat & less red/sore but area distal is red, raised, hot, very painful to touch.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) on 09-SEP-2011, second dose of GARDASIL (Lot # not reported) on 14-NOV-2012 and third dose of GARDASIL (Lot # not reported) on 14-JAN-2013. The nurse stated that even though the patient did not adhere to the GARDASIL recommended schedule she had not shown any symptoms of adverse reactions. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 56 years old female patient without any pertinent medical history and with drug reactions/allergic to latex. The patient were vaccinated subcutaneously with a dose of 0.65 ml live ZOSTAVAX (lot# reported as H013944, expired date: 25-OCT-2013) on 05-DEC-2012. There were no concomitant medications. On 06-DEC-2012 the patient developed a rash which was 2 inches wide and 4 inches long around the injection site area. No treatment was given for the AE. The pharmacist noted the patient stated that the rash resolved after a few weeks. There were no lab diagnostics studies performed. The patient did not seek any medical attention. The relatedness between the event and the live ZOSTAVAX was unknown. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dysphagia, Dyspnoea, Eye burns, Eye discharge
Clinical narrative: Initial report was received on 09 January 2013 from a consumer who is also the patient. A 53 year-old female patient with a history of allergies to multiple antibiotics, hypothyroidism and chronic nausea had received on 07 January 2013 an intramuscular dose of FLUZONE SV, lot number UH716AB and three hours post vaccination, experienced bilateral eye and hand swelling, white discharge from eyes, wheezing and difficulty swallowing. Patient was evaluated by her ENT physician and was treated with over the counter (OTC) BENADRYL. According to the patient, the symptoms were "just about all resolved at this time" (also reported as recovered). No further information was available at the time of the report. Documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye irritation, Eyelid oedema, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Initial report was received on 09 January 2013 from a consumer who is also the patient. A 53 year-old female patient with a history of allergies to multiple antibiotics, hypothyroidism and chronic nausea had received on 07 January 2013 an intramuscular dose of FLUZONE SV, lot number UH716AB and three hours post vaccination, experienced bilateral eye and hand swelling, white discharge from eyes, wheezing and difficulty swallowing. Patient was evaluated by her ENT physician and was treated with over the counter (OTC) BENADRYL. According to the patient, the symptoms were "just about all resolved at this time" (also reported as recovered). No further information was available at the time of the report. Documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Sinus headache, Sinusitis, Throat irritation
Clinical narrative: Initial report was received on 09 January 2013 from a consumer who is also the patient. A 53 year-old female patient with a history of allergies to multiple antibiotics, hypothyroidism and chronic nausea had received on 07 January 2013 an intramuscular dose of FLUZONE SV, lot number UH716AB and three hours post vaccination, experienced bilateral eye and hand swelling, white discharge from eyes, wheezing and difficulty swallowing. Patient was evaluated by her ENT physician and was treated with over the counter (OTC) BENADRYL. According to the patient, the symptoms were "just about all resolved at this time" (also reported as recovered). No further information was available at the time of the report. Documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Eye discharge, Eye swelling, Oedema peripheral, Wheezing
Clinical narrative: Initial report was received on 09 January 2013 from a consumer who is also the patient. A 53 year-old female patient with a history of allergies to multiple antibiotics, hypothyroidism and chronic nausea had received on 07 January 2013 an intramuscular dose of FLUZONE SV, lot number UH716AB and three hours post vaccination, experienced bilateral eye and hand swelling, white discharge from eyes, wheezing and difficulty swallowing. Patient was evaluated by her ENT physician and was treated with over the counter (OTC) BENADRYL. According to the patient, the symptoms were "just about all resolved at this time" (also reported as recovered). No further information was available at the time of the report. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Nausea, Pain of skin, Paraesthesia, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to a 52 years old female patient with no drug reactions/allergies. The patient's concurrent condition included low positive for lupus. The patient was vaccinated with a dose of live ZOSTAVAX (lot # not reported) on 21-DEC-2012. No other co-suspects were reported. Concomitant medications included aspirin, omega-3 marine triglycerides, red yeast, CoQ- 10 and adult multi vitamin. On 26-DEC-2012 the patient experienced nausea and that progressed to the serious pain from her belly button around her spine on the left side. The pain varied from a sharp pain to general skin sensitivity. On 31-DEC-2012 the patient experienced a rash on the same area. The rash was described as like "mosquito like eruptions". The treatment included tramadol hydrochloride 50 mg 1 tablet by mouth 3 times a day. The outcome was reported as recovering/resolving. The patient had sought unspecified medical attention. No labs were performed. The relatedness for these adverse events is unknown for live ZOSTAVAX. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 52 years old female patient with no drug reactions/allergies. The patient's concurrent condition included low positive for lupus. The patient was vaccinated with a dose of live ZOSTAVAX (lot # not reported) on 21-DEC-2012. No other co-suspects were reported. Concomitant medications included aspirin, omega-3 marine triglycerides, red yeast, CoQ- 10 and adult multi vitamin. On 26-DEC-2012 the patient experienced nausea and that progressed to the serious pain from her belly button around her spine on the left side. The pain varied from a sharp pain to general skin sensitivity. On 31-DEC-2012 the patient experienced a rash on the same area. The rash was described as like "mosquito like eruptions". The treatment included tramadol hydrochloride 50 mg 1 tablet by mouth 3 times a day. The outcome was reported as recovering/resolving. The patient had sought unspecified medical attention. No labs were performed. The relatedness for these adverse events is unknown for live ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Severe lower back pain.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Ear discomfort, Feeling hot, Pruritus, Urticaria
Clinical narrative: 11:50 Pm felt warm sensation and full feeling up back of neck and in ears. 3 pm- woke up from nap covered in Hives, neck to legs, and extreme itching. Took 50 mg Benadryl, called Dr, was told to take 50 more mg of Benadryl at 4:30 pm then every 4 hours. Took picture of hives on arm and my side.
Age: 13.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Blood test, Bradycardia, Computerised tomogram head, Hypopnoea, Muscle twitching
Clinical narrative: Vaccines given, patient in waiting room shortly afterward, I was called to see her as she was not responding appropriately. When I first saw her she was slumped to her left, sitting in a chair, not responding to me, eyes closed mostly, right arm twitching a bit, bradycardic. I asked her dad to lay her down on the floor. I bent her knees. She continued to be unresponsive. Secretary called 911. Heart rate was 44, BP 68/30s, repeat was about the same. I placed a dissolvable sugar candy in her cheek. Breathing was slow and regular, she was swallowing normally. Capillary refill was brisk. Slight response to painful stimuli. Initial pulse ox 89% but resolved to 99% quickly. Within a minute or two her heart rate and BP slowly started to increase, and at the time of EMS arrival were 60s-70s and 101/60s respectively. She remained unresponsive as she was taken away by EMS.
Age: 13.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Respiratory rate decreased, Slow response to stimuli, Unresponsive to stimuli
Clinical narrative: Vaccines given, patient in waiting room shortly afterward, I was called to see her as she was not responding appropriately. When I first saw her she was slumped to her left, sitting in a chair, not responding to me, eyes closed mostly, right arm twitching a bit, bradycardic. I asked her dad to lay her down on the floor. I bent her knees. She continued to be unresponsive. Secretary called 911. Heart rate was 44, BP 68/30s, repeat was about the same. I placed a dissolvable sugar candy in her cheek. Breathing was slow and regular, she was swallowing normally. Capillary refill was brisk. Slight response to painful stimuli. Initial pulse ox 89% but resolved to 99% quickly. Within a minute or two her heart rate and BP slowly started to increase, and at the time of EMS arrival were 60s-70s and 101/60s respectively. She remained unresponsive as she was taken away by EMS.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Left side of the face feels numb and headache comes and goes.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme fatigue and sleepiness, still occurring.
Age: 5.0
Sex: M
Vaccine: FLUN3, MMRV
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old male patient with no pertinent medical history or drug allergies. The patient was vaccinated with a dose of PROQUAD (merck) (lot number reported as "H015642", exp 06-JAN-2014) on an unspecified date. No other co-suspects were reported. Concomitant medications included: FLUMIST received on the same visit along with PROQUAD (merck). Physician reported that patient passed out after receiving PROQUAD (merck) on an unspecified date. Patient passed out for a few seconds and regained consciousness right away after a few seconds. Patient was observed in the office and sent home. No treatment information was given for the adverse event. At the time of the report, the patient's outcome was unknown. No lab diagnostic studies performed. The relatedness for the adverse event was unknown for PROQUAD (Merck). On internal review, pass out was determined to be an other important medical event. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Blood culture negative, Body temperature increased, Convulsion, Electroencephalogram
Clinical narrative: Temp 101.2 an hour after receiving MMR -V combo. T max 103.9 about 8 hrs after vaccine administration and had 4 seizures in a row. Was hospitalized x 4 days due to increase temp. No other seizures per Mom.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 08-JAN-2013, the patient was vaccinated with expired GARDASIL. Lot number was reported as 0331Z with an expiration date of 20-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of vaccination with GARDASIL that had an expiration date of 20-NOV-2012 is unknown. No further information was available. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Activities of daily living impaired, Computerised tomogram, Convulsion, Migraine
Clinical narrative: This spontaneous report as received from approximately a consumer (patient's mother) regarding an approximately 15-year-old female patient with no pertinent medical history and drug reactions/allergies. Approximately on an unknown date in July 2010, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. The patient's mother reported that after receiving 2 vaccinations of GARDASIL her daughter experienced adverse reactions. On an unknown date in January 2012, the patient developed stomach pains. The doctors had performed the Computed Axial Tomography (CAT) scan and Magnetic Resonance Imaging (MRI) on an unknown date in 2012 to determine the primary issue (the test results were not reported). On an unknown date in May 2012, the patient developed extreme migraine headaches. On an unknown date in August 2012, the patient frequently vomited and suffered from seizures. The patient was a very active person and now after the administration of GARDASIL she was bed ridden, can no longer exercise and go to school. The patient sought medical attention and was treated for the events systematically (details were not provided). The outcome of all the reported events was unknown. Upon internal review, the event suffered from seizures was considered as other medically important event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: This spontaneous report as received from approximately a consumer (patient's mother) regarding an approximately 15-year-old female patient with no pertinent medical history and drug reactions/allergies. Approximately on an unknown date in July 2010, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. The patient's mother reported that after receiving 2 vaccinations of GARDASIL her daughter experienced adverse reactions. On an unknown date in January 2012, the patient developed stomach pains. The doctors had performed the Computed Axial Tomography (CAT) scan and Magnetic Resonance Imaging (MRI) on an unknown date in 2012 to determine the primary issue (the test results were not reported). On an unknown date in May 2012, the patient developed extreme migraine headaches. On an unknown date in August 2012, the patient frequently vomited and suffered from seizures. The patient was a very active person and now after the administration of GARDASIL she was bed ridden, can no longer exercise and go to school. The patient sought medical attention and was treated for the events systematically (details were not provided). The outcome of all the reported events was unknown. Upon internal review, the event suffered from seizures was considered as other medically important event. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received on 08 January 2013 from a non-health care professional. The reporter for this case is the same as for case 2013-00570. A patient (gender, age and date of birth not reported) had received in October 2012 a dose of FLUZONE intradermal, lot number UT4472BA (site of administration not reported) and an unspecified amount of time later in October 2012, experienced redness, swelling, pain, warmth at injection site that resembled cellulitis. Treatment included antibiotics. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest X-ray normal, Pertussis
Clinical narrative: Initial report was received from a consumer on 07 January 2013. A 14-year-old female patient received an injection in the left deltoid of ADACEL vaccine (lot number C2774AA) on 19 February 2009 (route not reported). Three years later, on 15 December 2012 (also reported as future date 15 December 2013), the patient saw a physician and was diagnosed with pertussis. The patient was treated with azithromycin ("zpack") and cough medicine. The patient had blood tests and a chest x-ray (reported as negative) on 15 December 2012. the patient had four DTaP vaccines as an infant/child. The patient had no illness at the time of vaccination, no birth defects, and no allergy. The patient was positive for lactose intolerance. Three other family members had clinical pertussis including mom, dad, and 21-year old sister. Two brother, ages 19 and 16, did not get sick. The patient's outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Malaise
Clinical narrative: High fever (ranging from 102-103.7 for 2.5 days after shot), extreme soreness at area of shot, rash around area of shot.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: High fever (ranging from 102-103.7 for 2.5 days after shot), extreme soreness at area of shot, rash around area of shot.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Allergy test, Chest discomfort, Cough, Headache, Increased upper airway secretion
Clinical narrative: Received call from Mother on 1/14/13 stating childs right arm was itching a couple hrs after the shot, took off bandaid at that time. States she had hives on sides, back, abdomen, arms. Had headache and was light sensitive. Called their PCP since child has food allergies and he advised Zyrtec, Zantac and Benadryl (specific dose schedule). Hives went away 3 hrs after meds. Mother states childs "normal reaction to hives" is cough and phlegm. No tightness in chest, no difficulty breathing, no wheeze, but child stated she felt like a weight was on her chest. Mother states they have a regular scheduled appt. with doctor for further allergy testing the next day. Advised to inform doctor about reaction.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Photophobia, Pruritus, Urticaria
Clinical narrative: Received call from Mother on 1/14/13 stating childs right arm was itching a couple hrs after the shot, took off bandaid at that time. States she had hives on sides, back, abdomen, arms. Had headache and was light sensitive. Called their PCP since child has food allergies and he advised Zyrtec, Zantac and Benadryl (specific dose schedule). Hives went away 3 hrs after meds. Mother states childs "normal reaction to hives" is cough and phlegm. No tightness in chest, no difficulty breathing, no wheeze, but child stated she felt like a weight was on her chest. Mother states they have a regular scheduled appt. with doctor for further allergy testing the next day. Advised to inform doctor about reaction.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Chills, Fall, Fatigue
Clinical narrative: Extreme fatigue and weakness, chills, headache, loss of balance (fell over several times 01/15 through 01/17). Symptoms resolved (except for some lingering weakness) on 01/18/2013 upon waking up at 6:30 AM.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Extreme fatigue and weakness, chills, headache, loss of balance (fell over several times 01/15 through 01/17). Symptoms resolved (except for some lingering weakness) on 01/18/2013 upon waking up at 6:30 AM.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: General malaise, fever, chills, muscle and joint aches.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: RED CIRCULAR MARK AT SIGHT OF INJECTION FROM INTIAL TIME OF INJECTION 10/27/2012 UNTIL PRESENT DATE 01/18/2013.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eye swelling, Lacrimation increased, Pharyngeal oedema
Clinical narrative: Throat swelling with difficulty breathing, swollen and watery eyes.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Chest pain, Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: First day: Swollen painful injection site. Fever, back and sternum pain. Just feeling awful. 2nd day early morning: swollen upper lip back and sternum pain.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Lip swelling, Pyrexia
Clinical narrative: First day: Swollen painful injection site. Fever, back and sternum pain. Just feeling awful. 2nd day early morning: swollen upper lip back and sternum pain.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00527, 2013-00528 and 2013-00529. A three year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 04 October 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 03 December 2012. The patient's outcome was not recovered. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Grip strength decreased, Guillain-Barre syndrome, Muscular weakness, Nasopharyngitis
Clinical narrative: Guillain Barre - Dx approx. 6 weeks after flu vaccine. Patient is a 76 y.o. right handed male who presents for evaluation of weakness and tingling of both hands that started yesterday at 3 pm. He dropped his fork at suppertime yesterday as the fork fell out of his right hand and then he states he was able to use the fork. When shampooing his hair last pm he states his sensation was reduced in both hands as his hair felt different. Today he awakened at his usual time 0400 with his usual chronic back discomfort and stiffness and noted his legs felt weaker today. His wife noted he was a lot weaker. Denies any focal weakness. No vision problems. He has had no urinary or rectal incontinence. He had a busy day yesterday with fall clean up. Denies any back or neck injury or fever or chills, but is recovering from a recent cold with a sore throat and upper congestion. No recent change in medication - has been on ZOCOR 80 mgs for 4 years.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Paraesthesia, Sensory disturbance, Upper respiratory tract congestion
Clinical narrative: Guillain Barre - Dx approx. 6 weeks after flu vaccine. Patient is a 76 y.o. right handed male who presents for evaluation of weakness and tingling of both hands that started yesterday at 3 pm. He dropped his fork at suppertime yesterday as the fork fell out of his right hand and then he states he was able to use the fork. When shampooing his hair last pm he states his sensation was reduced in both hands as his hair felt different. Today he awakened at his usual time 0400 with his usual chronic back discomfort and stiffness and noted his legs felt weaker today. His wife noted he was a lot weaker. Denies any focal weakness. No vision problems. He has had no urinary or rectal incontinence. He had a busy day yesterday with fall clean up. Denies any back or neck injury or fever or chills, but is recovering from a recent cold with a sore throat and upper congestion. No recent change in medication - has been on ZOCOR 80 mgs for 4 years.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Case number PHEH2013US001278 is an initial, spontaneous report combining follow-up information received from a physician on 14 Jan 2013: This report refers to a 67-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to left upper arm on an unknown date in Nov 2011. The reporter stated that 24 hours after vaccination, she experienced a rash that covered most of her upper left arm surrounding the area of injection. The rash was warm, burning and was believed to be cellulitis. It was reported that the patient was now reluctant to receive vaccine again. The outcome of the event was not reported. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Case number PHEH2013US001289 is an initial spontaneous report received from a consumer on 14 Jan 2013: This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of FLUVIRIN (batch number: not reported) on an unknown date. It was reported that on 13 Dec 2012, she experienced seizure like activity and passed out. It was reported that a physician was not consulted. The outcome of the event was not reported. No further information was provided.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Abnormal behaviour, Confusional state, Dizziness, Drug screen negative, Feeling abnormal
Clinical narrative: Within 4 hrs of receiving first HPV vaccine, she became confused, dazed, acting as if intoxicated. This behavior change lasted 48 hrs. She also had headache and dizziness develop immediately after the vaccine, which has persisted. Taken to local ER. No treatment given.