chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia
Clinical narrative: Tingling to Right arm, and back. Epigastric distress, Nausea, Weakness, body aches, diarrhea, abdominal pain.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Mild headache lasting approximately three days, sought no treatment.
Age: 18.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local injection site erythema and 2 mm induration right arm.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Orthostatic hypotension, Vertigo
Clinical narrative: Headache, vertigo, weakness, postural hypotension. Lasted 7 days so far. Today almost better; still vertigo with turning head fast or standing fast.
Age: 10.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Acne, Rash
Clinical narrative: Rash across bilateral shoulder blades that looked like acne, spread through her entire back and up through her waist by the morning, a few spots on her face and on her chest into Monday.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Numbness and tingling in left foot, full body rash, itching, fatigue, sore joints, fever. Given prednisone.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Numbness and tingling in left foot, full body rash, itching, fatigue, sore joints, fever. Given prednisone.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient given Fluarix instead of Tdap vaccine.  Patient had received Fluvirin on 9/19/14.  Dr. notified of event.  No treatment necessary.  Patient called and informed of above.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, left arm pain. Fever and body aches resolved but had lingering left arm pain. Arm pain treated with Diclofenac Gel.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-VGKC antibody positive, Back pain, Electromyogram abnormal, Hyperreflexia, Immediate post-injection reaction
Clinical narrative: Received IM FLUZONE vaccine by pharmacist. Vaccine on 12/13/2012. Immediately noticed pain radiating down arm and in lower back. Noted fasciculations Feb 10 2013. Seen by MD Feb 11 2013 for this symptom. Seen Feb 18 2013 by neurology for EMG for fasciculations. Insomnia began in Feb 2013. Seen May at clinic for EMG- fasciculations. Found to have positive voltage gated potassium channel antibodies. Sleep study clinic Oct 2014- no stage 3 or 4 sleep, severe insomnia. MRI sleep/ neurology 11/14 shows FLAIR white scatter spots. Neurologist states condition is likely immune response.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Muscle contractions involuntary, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity, Sleep study abnormal
Clinical narrative: Received IM FLUZONE vaccine by pharmacist. Vaccine on 12/13/2012. Immediately noticed pain radiating down arm and in lower back. Noted fasciculations Feb 10 2013. Seen by MD Feb 11 2013 for this symptom. Seen Feb 18 2013 by neurology for EMG for fasciculations. Insomnia began in Feb 2013. Seen May at clinic for EMG- fasciculations. Found to have positive voltage gated potassium channel antibodies. Sleep study clinic Oct 2014- no stage 3 or 4 sleep, severe insomnia. MRI sleep/ neurology 11/14 shows FLAIR white scatter spots. Neurologist states condition is likely immune response.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Blood creatinine normal, Blood electrolytes normal, Diarrhoea, Dizziness
Clinical narrative: Fever, myalgias, arthralgia, nausea, diarrhea, fatigue, frontal headache, dizziness, insomina. Symptoms lasted for 6 weeks. Treated symptomatically. Unable to return to work.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Full blood count normal, Headache, Impaired work ability, Insomnia
Clinical narrative: Fever, myalgias, arthralgia, nausea, diarrhea, fatigue, frontal headache, dizziness, insomina. Symptoms lasted for 6 weeks. Treated symptomatically. Unable to return to work.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Nausea, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Fever, myalgias, arthralgia, nausea, diarrhea, fatigue, frontal headache, dizziness, insomina. Symptoms lasted for 6 weeks. Treated symptomatically. Unable to return to work.
Age: 0.2
Sex: F
Vaccine: DTP
Symptoms: Nuchal rigidity, Pyrexia
Clinical narrative: Initial unsolicited case received from a physician on 08 January 2015. A 2-month-old female patient received DTP (manufacturer and lot number not reported) approximately 25 years ago. Medical history and illness at time of vaccination was unknown. An unspecified amount of time following vaccination, the patient developed fever and nuchal rigidity. She subsequently recovered. No additional information was reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria no wheezing. No angioedema.
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Hearing impaired, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: After receiving Havrix and Boostrix immunizations patient started immediately experiencing nausea, light headed, sweating, tunnel vision, and voice sounding like in a tunnel (she experience this for about 20 minutes after the shot and then she felt okay).
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Tunnel vision
Clinical narrative: After receiving Havrix and Boostrix immunizations patient started immediately experiencing nausea, light headed, sweating, tunnel vision, and voice sounding like in a tunnel (she experience this for about 20 minutes after the shot and then she felt okay).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Axillary pain, Chills, Fatigue, Full blood count normal
Clinical narrative: Lymph node swelling, axillary that was painful; fatigue, chills at night, low energy; Treated with course of Bactrim DS BID for 10 days; sxs recurred and sonogram was performed. It confirmed the swelling was lymph nodes but did not appear pathologic. May have mammogram and sonogram pending but now suspicious this may be reaction to vaccine. Labs for mono and her CBC were normal.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Ultrasound scan abnormal
Clinical narrative: Lymph node swelling, axillary that was painful; fatigue, chills at night, low energy; Treated with course of Bactrim DS BID for 10 days; sxs recurred and sonogram was performed. It confirmed the swelling was lymph nodes but did not appear pathologic. May have mammogram and sonogram pending but now suspicious this may be reaction to vaccine. Labs for mono and her CBC were normal.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: Lymph node swelling, axillary that was painful; fatigue, chills at night, low energy; Treated with course of Bactrim DS BID for 10 days; sxs recurred and sonogram was performed. It confirmed the swelling was lymph nodes but did not appear pathologic. May have mammogram and sonogram pending but now suspicious this may be reaction to vaccine. Labs for mono and her CBC were normal.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Flu shot 10/30/14 - instant pain wtih injection - got worse over time. Pain became severe and has lasted weeks.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyskinesia, Feeling abnormal, Gait disturbance, Movement disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis in an adult female patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). The patient's past medical history included vasculitis and cellulitis (in left arm). Concurrent medical conditions included lymphatic disorder (in left arm) and esophageal disorder. In 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In 2014, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced vasculitis, movements involuntary of limbs (serious criteria disability), unstable feeling (serious criteria disability), movement disorder (serious criteria disability), gait shuffling (serious criteria disability), dizziness (serious criteria disability), swelling arm and erythematous rash. On an unknown date, the patient experienced fever. The patient was treated with medication unknown (Unknown). On an unknown date, the outcome of the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever were recovered/resolved. The reporter considered the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever to be related to FLUARIX QUADRIVALENT. Additional details provided: The pharmacist reported to field representative that about 4 hours after she received a FLUARIX QUADRIVALENT vaccine as required by her hospital she started having involuntary movement in her right hand. She felt unstable and had difficulty moving her legs such that she was shuffling her feet, and she was dizzy. She went home because of the symptoms, so the representative thought they were disabling for her. When she got home she had a fever, which she treated with medication. She fell asleep for several hours. When she woke up she was feeling less unstable but not 100%. 1 day after receiving the vaccination and a couple hours after waking up her left arm was swollen with red rash all down. She received the vaccine in her right arm, but she has a history of cellulitis and impaired lymphatic system in her left arm. She saw her HCP who stated that it looked like vasculitis. The symptoms all resolved after a couple days. The pharmacist was concerned about Guillain-Barre, but it was never mentioned as an actual diagnosis. The pharmacist could not remember when the vaccination happened, but it might have been in Nov or Dec 2014. The rep believes the pharmacist is currently 59 years old, and that she administered the vaccine to herself, but is not certain.
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Rash erythematous, Vasculitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vasculitis in an adult female patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). The patient's past medical history included vasculitis and cellulitis (in left arm). Concurrent medical conditions included lymphatic disorder (in left arm) and esophageal disorder. In 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In 2014, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced vasculitis, movements involuntary of limbs (serious criteria disability), unstable feeling (serious criteria disability), movement disorder (serious criteria disability), gait shuffling (serious criteria disability), dizziness (serious criteria disability), swelling arm and erythematous rash. On an unknown date, the patient experienced fever. The patient was treated with medication unknown (Unknown). On an unknown date, the outcome of the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever were recovered/resolved. The reporter considered the vasculitis, movements involuntary of limbs, unstable feeling, movement disorder, gait shuffling, dizziness, swelling arm, erythematous rash and fever to be related to FLUARIX QUADRIVALENT. Additional details provided: The pharmacist reported to field representative that about 4 hours after she received a FLUARIX QUADRIVALENT vaccine as required by her hospital she started having involuntary movement in her right hand. She felt unstable and had difficulty moving her legs such that she was shuffling her feet, and she was dizzy. She went home because of the symptoms, so the representative thought they were disabling for her. When she got home she had a fever, which she treated with medication. She fell asleep for several hours. When she woke up she was feeling less unstable but not 100%. 1 day after receiving the vaccination and a couple hours after waking up her left arm was swollen with red rash all down. She received the vaccine in her right arm, but she has a history of cellulitis and impaired lymphatic system in her left arm. She saw her HCP who stated that it looked like vasculitis. The symptoms all resolved after a couple days. The pharmacist was concerned about Guillain-Barre, but it was never mentioned as an actual diagnosis. The pharmacist could not remember when the vaccination happened, but it might have been in Nov or Dec 2014. The rep believes the pharmacist is currently 59 years old, and that she administered the vaccine to herself, but is not certain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Infant became very "fussy", developed a fever and diarrhea.  Resolved itself with administration of Tylenol for fever reduction.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Headache, Influenza virus test, Nasal congestion, Pyrexia
Clinical narrative: Nasal Congestion for 2 weeks post 1st Hep B vaccine. Then....Fever, Cough, Nasal Congestion, Headache after 2nd injection of Hep B. No redness, irritation or swelling at injection site. Patient told to take Tylenol for fever and call or return if symptoms worsen or does not improve in 2 days.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling redness at site of Hep A and fever (100F). On exam she has a 12 x & cm induration on her left arm.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Lymphadenopathy
Clinical narrative: Client returned to clinic on 01/09/15 to report that she was having swelling of her right arm at site of injection and nurse informed me via note, that client's lymph nodes were swollen as well and client was unable to lift her right arm. Client was sent to be seen by pcp, who referred client directly to ER for further eval and treat.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Dysphonia, Vaccine positive rechallenge
Clinical narrative: Infant had hoarseness of voice today after immunizations given 24 hours prior. No breathing problemsor fever, no color changes. Had same reaction 24 hours after 4 month immunizations.
Age: 0.56
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Had shots yesteday, both in left leg, HIB and pneumococcal.  Last night noted area of redness and swelling, increased today.  Remains active, playful, no pain or restriction of movement.  Eating well.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, PNC13, TDAP
Symptoms: Headache
Clinical narrative: Headache about 10-15 min after administration, self-resolved. Vital signs stable.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema peripheral, Pain, Pruritus, Rash, Swelling
Clinical narrative: Given Prevnar13.  5 days later had rash and edema involving 2/3 of upper arm, itching, pain.  This has lasted for two days now but is improving.  Treated with oral generic acetaminophen and diphenhydramine x 2 on 1/11 and x 2 on 1/12 and once so far on 1/13.  Also applied cold compresses several times to the swollen area.  No wheezing (I'm asthmatic) or fever.  Never went to doctor but consulted with telephone nurse.  I had Pneumovax in 2001 and 2011.  Had flu shot in OCT 2014.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore Arm onset is unknown time course. Problem unknown until 01/07/15 (3 months).
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Depression, Dizziness, Electromyogram, Headache
Clinical narrative: Please see physician records; acute onset of headache, dizziness, general malaise followed by acute bilateral upper extremity paresthesias (numbness and tingling, mild component of weakness).  Symptoms listed first were gone within 48 hours of the vaccine administration time.  However, upper extremity paresthesias persisted- very intense for about 1-2 weeks with a gradual decrease in symptoms at 2-3 weeks and minimal symptoms after 3-4 weeks and nearly complete resolution of symptoms about 5-6 weeks later. Also caused anxiety and depression, secondary to symptoms.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Malaise, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Please see physician records; acute onset of headache, dizziness, general malaise followed by acute bilateral upper extremity paresthesias (numbness and tingling, mild component of weakness).  Symptoms listed first were gone within 48 hours of the vaccine administration time.  However, upper extremity paresthesias persisted- very intense for about 1-2 weeks with a gradual decrease in symptoms at 2-3 weeks and minimal symptoms after 3-4 weeks and nearly complete resolution of symptoms about 5-6 weeks later. Also caused anxiety and depression, secondary to symptoms.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Please see physician records; acute onset of headache, dizziness, general malaise followed by acute bilateral upper extremity paresthesias (numbness and tingling, mild component of weakness).  Symptoms listed first were gone within 48 hours of the vaccine administration time.  However, upper extremity paresthesias persisted- very intense for about 1-2 weeks with a gradual decrease in symptoms at 2-3 weeks and minimal symptoms after 3-4 weeks and nearly complete resolution of symptoms about 5-6 weeks later. Also caused anxiety and depression, secondary to symptoms.
Age: 1.07
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Mom reported red itchy rash all over arms, chest and legs within 1-2 hours after 12mo vaccines and flu vaccine.  Pt still has rash 1 wk later; responding to topical hydrocortisone.  Denies any resp, CV, GI, nasal, ocular sx concerning for anaphylaxis.  Pt has h/o atopic dermatitis.  Egg allergy consists of positive skin prick testing, with h/o vomiting and hives with scrambled eggs and hives with skin contact only of cake baked with eggs.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore Arm and shoulder and has continued to be sore with pain.
Age: 1.04
Sex: F
Vaccine: DTAPH, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever of 100 degrees; Injection site very painful, red and swollen; Site is now 4 days past injection and site is still very swollen and red.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLUX, PPV, RVX
Symptoms: Body temperature increased, Discomfort, Rhinorrhoea
Clinical narrative: Baby was uncomfortable. Took temp to find that it was 103.0  Even with Tylenol, it has been hard to bring down. Her nose also began running today.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Mass
Clinical narrative: FLUVIRIN administered on 10/31/14 at 10:30. Administered in left deltoid muscle IM. The following morning patient experienced a bruise on left upper chest/shoulder area. Bruise is about 2 inches round and lump the size of a pen. F/U with pt with pt 2 weeks later, bruise has gone but lump remains.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Muscle spasms, Muscular weakness
Clinical narrative: Started coughing that night. Turned into muscle weakness that is constant - not getting better. Occasionally has muscle spasms.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: Patient states they developed tendonitis as a result of the vaccine. They have been prescribed antiinflammatory medication as a result.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Red, painful rash on upper left arm. Fever up to 102.0 for 2 days. Reports arm as "sore". Advised cool compress to area. No other treatment needed. Symptoms resolved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity, Tendonitis
Clinical narrative: Pain in shoulder, limited mobility, throbbing pain through neck and arm. Sought medical attention after 2 weeks. Also saw an orthopedic who diagnosed pt w/ tendonitis.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Pain in shoulder, limited mobility, throbbing pain through neck and arm. Sought medical attention after 2 weeks. Also saw an orthopedic who diagnosed pt w/ tendonitis.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red and swollen at the injection site. MOTRIN and ice packs used to resolve.
Age: 20.0
Sex: U
Vaccine: FLUN4, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pain from injection site on rt. arm to elbow area hard at site of inject several days after inject. Today tender to touch, warm to touch.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site nodule, Injection site pain, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: 12/31/14 pt. came to HD and reported to secretary that she had knots and pain in her (L) arm where she rec'd vaccines the previous week.
Sex: F
Vaccine: RV1
Symptoms: Product quality issue, Wound
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of puncture wound in a adult female patient who received ROTARIX. On 17th November 2014 10:30, the patient received ROTARIX. On 17th November 2014 10:30, during the preparation of the vaccine of ROTARIX, the patient experienced puncture wound. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the puncture wound and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the puncture wound to be related to ROTARIX. Additional information received on 17 November 2014: When the patient was opening the bag of transfer adapters, she was pierced by one of the adapters (puncture of hand by transfer adapter of ROTARIX). This case was associated to a product complaint.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in an unknown number of female subjects were vaccinated with FLULAVAL, (GlaxoSmithKline) during pregnancy. On an unknown date, the subjects received a dose of FLULAVAL (unknown details) and experienced vaccine exposure during an unknown trimester of pregnancy. The gestational age, date of last menstrual period, and the estimated date of delivery were not reported. The reporter stated that they had been administered FLULAVAL in pregnant patients. At the time of reporting, the reporter was not aware of any adverse events. At the time of reporting, the pregnancy was ongoing. Follow-up received on 5 January 2015 by a healthcare professional. This is a prospective pregnancy case. This female subject was enrolled in an open label study. The subject received FLUARIX on an unknown date. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up. Additional information: On 12 October 2014, this case was considered as lost to follow-up.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV on 16th October 2014. The subject's estimated date of delivery was 10th November 2014. The subject received Flu Seasonal QIV at week 35 of the pregnancy and during the third trimester of pregnancy. On 16th October 2014, an unknown time after receiving Flu Seasonal QIV the subject developed drug exposure during pregnancy (Non-serious). The outcome of the drug exposure during pregnancy was unknown. The pregnancy outcome was unknown. It was unknown if the investigator considered the drug exposure during pregnancy to be related to Flu Seasonal QIV. Investigator comments received: Received flu vaccine while pregnant. No other AEs reported. Gestational age when received vaccine: 35 weeks. Due date: 11/10/2014.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain
Clinical narrative: Case number PHHY2014US049408 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518195) website on 14 Apr 2014. This report refers to a 64-year-old male patient. His medical history included sulfa antibiotic allergies but never had had a bad reaction to triple antibiotic ointment. His current condition included diabetes and hypertension. He was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, after vaccination she experienced flu like symptoms with general achiness. The outcome, seriousness and causality of the events were not reported.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever of 103.0 - treated w/ ADVIL and TYLENOL. Redness at injection site - size of a dime.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine (PREVNAR 13) administered 12/31/14 and she developed rash, itching 1/1/15. She took medication (BENADRYL) for symptom relief. Called the clinic on 1/9/15. Visit with doctor on 1/12/15. Provider encourage BENADRYL.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Injection stung. following day pt c/o normal soreness. The next day c/o swelling, redness, intense sorenes. Treated ith cold packs, NSAIDS, BACITRACIN ointment. Lasted 5 weeks.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a health professional and described the occurrence of incorrect storage of drug in an 37-year-old female patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patient got ENGERIX B which was not stable. No AE reported.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Blood pressure decreased, Dyskinesia, Pallor, Seizure like phenomena
Clinical narrative: Pt. was given HPV vaccine and pt. had reaction - fainted and had a very brief seizure like jerking movements for about 10 seconds. Pts. face was pale and BP decreased after episode. Glucose was checked and ok at 89. Pt was given water put in Trendelenburg posit. till he was stabilized.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt. was given HPV vaccine and pt. had reaction - fainted and had a very brief seizure like jerking movements for about 10 seconds. Pts. face was pale and BP decreased after episode. Glucose was checked and ok at 89. Pt was given water put in Trendelenburg posit. till he was stabilized.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: 2 days after administration, patient noticed a 4 inch red circular rash around site of injection. It was slightly warm and itched a little.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received ENGERIX B (batch number995J5, expiry date 6th February 2017). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patient got ENGERIX B which was not stable. No AE reported.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This is a spontaneous report received from a field representative who was told by the physician that an unspecified male patient who received ZOSTAVAX two years ago now has shingles. It was told to the representative that this patient had herpes at the time of vaccination. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a female patient of unknown age, who received a dose of ZOSTAVAX 0.65 ml, once, subcutaneously in December 2013. On 02-DEC-2014, the patient received a second dose of ZOSTAVAX. No adverse events were reported. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Myalgia, Vertigo
Clinical narrative: Vertigo and generalized feeling of weakness developed within hours of vaccine. Normal exam. No redness or swelling at injection site. Some tenderness of muscles in axilla on side of the injection.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient (age and gender not provided). On an unspecified date the patient was vaccinated with GARDASIL. The medical assistant reported that GARDASIL had not been stored properly. No adverse effects were reported. Additional information is expected.
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a male patient of unknown age. On an unknown date the patient was vaccinated with MMR II, subcutaneous. The medical assistant reported that the MMR II was administered to the patient post supported excursion. No adverse effects were reported. Additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Left thigh moderate erythema 4x3" firm with edema, not painful with palpation. Instructed antihistamines use as directed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles (APR2014) and herpes zoster over 20 years ago that resulted in left side facial paralysis. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX lot # K007989, expiration SEP-2015 subcutaneous. On 17-NOV-2014, the patient presented with complaints of symptomatic tingly feeling of shingles (onset 16-NOV-2014). It was reported that the patient had a blister on her left elbow. The outcome of tingly feeling of the shingles and left elbow blister was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unkonwn age and gender. On an unknown date those patients were vaccinated with 10 doses of PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported) which had been improperly stored. No adverse effects reported. Follow up information was received from the medical assistant which reported that the PEDVAXHIB (Batch No. K002818, exp. 10-DEC-2016) affected by temperature excursion were been administered to a pediatric population of 4 month old patients. The reporter stated that approximately 15 doses (previously reported as "10 doses") of PEDVAXHIB were administered. This is one of several reports form the same source. Additional information has been reported.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse, via field representative, refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route, lot number and expiration date were not reported) (specified dose in series unspecified). Concomitant medication was not provided. After receiving the vaccine the patient fainted. The patient sought medical attention, visited the office on an unspecified date. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with 10 doses of LIQUID PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported) which had been improperly stored. No adverse effects reported. Follow up information was received from the medical assistant which reported that the LIQUID PEDVAXHIB (Batch No. K002818,. exp. 10-DEC-2016) affected by temperature excursion were been administered to a pediatric population of 2 month old patients. The reporter stated that approximately 15 doses (previously reported as "10 doses") of LIQUID PEDVAXHIB were administered. This is one of several report from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient with none drug reactions/allergies. On 14-DEC-2014, the patient was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number reported as: K011002 and expiration date: 07-NOV-2015). Concomitant medication included simvastatin (manufacturer unknown) 40 mg daily. On 14-DEC-2014, the patient experienced a 4 to 5 inch round, red, painful, raised area at the injection site after receiving ZOSTAVAX. It was reported that patient sought medical attention during unspecified doctor visit. No laboratory tests were performed. The outcome of 4 to 5 inch round, red, painful, raised area at the injection site was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and current conditions were not reported. On 16-DEC-2014, the patient w as vaccinated with a dose of ZOSTAVAX lot # K012924, expiration date: 29-NOV-2015 int he right arm. Concomitant medication was not reported. 15 minutes after vaccination the patient developed a small red area at the injection site. On 18-DEC-2014 after two days from vaccination, the patient returned and reported that the adverse event had progressed, it was inflamed and swollen down to her elbow, also reported as a hard, dark and irregular area the size of a silver dollar around the injection site. Patient did not seek medical attention. Patient used ice to treat the events. The outcome of events was reported as not recovered. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Varicella virus test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 year old female patient. The patient's current conditions included hypercholesterolaemia, B12 deficiency, vitamin D deficiency, mitral valve insufficiency, leiomyoma of the uterus, endometriosis, drug allergy to penicillin and vertigo. The patient's medical history included Methicillin-resistant Staphylococcus aureus infection (MRSA), rash and edema. Historical drug included unspecified penicillin. On 09-MAY-2014, the patient was subcutaneously vaccinated with VARIVAX (Merck) (dose and anatomical location were not provided) lot # H009634, expiration date 09-MAY-2014. Concomitant therapies included calcium carbonate, cholecalciferol, mupirocin, cyanocobalamin, vitamin D (unspecified) and vitamins (unspecified). On 01-NOV-2014, the patient had varicella titers drawn which were 135 (units not provided) and should have been more than 165 (units not provided). Nurse also noted that the patient had allergy to penicillin which manifested as a rash and edema. The patient was not given any treatment for adverse event. The outcome of event was unknown. The causality between the event and the therapy with VARIVAX (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (route, dose and lot # not reported). The temperature excursion was found to be supported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 month old patient of unknown gender. On 11-NOV-2014, the patient was vaccinated with a dose of VAQTA, 0.5 ml, intramuscular (lot # and expiration date were not provided). On 11-NOV-2014, the patient received VAQTA at the age of two months. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unkown. Additional information is not expected. There was no authorization to contact physician.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 9 month old patient of an unknown gender. On 03-DEC-2014 the patient was vaccinated with a dose of VAQTA, dose of 0.5 ml (route, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (route, dose and lot # not reported). The temperature excursion was found to be unsupported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patient of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of VARIVAX (Merck), (exact dose, anatomical location, lot # and expiration date were not reported) which underwent supported temperature excursion, have been subcutaneously administered to an unknown number of patients. No adverse effects reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant who reported that an unspecified number of patients received doses of PROQUAD (Merck) and VARIVAX (Merck) that underwent a supported temperature excursion. The patients received these doses on unspecified dates. No adverse experiences were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In approximately January 2015, reported as since the first stability assessment on 07-JAN-2015, the patients were vaccinated with doses of VARIVAX (Merck) (dose, lot numbers, expiration dates were not reported) that were exposed to a maximum -11.3 Celsius degree for a total time of 2.5 hours, due to defrost cycles. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number patient of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of PROQUAD (Merck), (exact dose, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursion, have been subcutaneously administered to an unknown number of patients. No adverse effects reported. This is the of several reports from the same reporter source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from Pfizer and was assigned manufacturer report number 2014360492 for PREVNAR 13. This was initially reported by a consumer and refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date the patient went to the pharmacy and asked for PREVNAR 13, since they did not have it, the patient was PNEUMOVAX 23 (wrong vaccine administered). There were no concomitant medications reported. The patient queried if the vaccines were the same. Thereafter patient was informed that PNEUMOVAX 23 was a different product and worked to stimulate the immune system differently. The outcome of wrong vaccine administered was unknown. It was referred to a physician to discuss if the patient had already received the vaccine. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from employee (unspecified) refers to a 66 year old male patient. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Other co-suspects and concomitant medication was not reported. On an unkonwn date the patient experienced shingles, rash and pain in his left leg after receiving ZOSTAVAX. It was reported that the patient received treatment with Gabapentin (unspecified dose/frequency and manufacturer). Cancer and overdose was not reported. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse concerning her male cousin. The patient's pertinent medical history, drug reactions/allergies were not provided. In October 1966, the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were not provided). (To note that M-M-R II was not approved until 22-APR-1971). It was reported patient developed a fever after getting a dose of M-M-R II in October 1966. The patient recovered from fever on unkonwn date. The relatedness between the event and suspect therapy was not provided. Additional information is not expected since no follow up information can be obtained.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red and raised, 2" x 4", itchy, and warm to the touch.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Master of Science in Nursing) refers to his 17 year old son who is the patient. Reporter stated that the patient got 2 doses of GARDASIL (dates were not reported), dose, route of administration, lot numbers and expiration dates were not provided. Reporter stated that pharmacist told them the series needed to be restarted, since the third dose would be late. The patient has restarted the series, and now (dates unspecified) has received 2 additional doses of GARDASIL, dose, route of administration, lot numbers and expiration dates were not provided. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Master of Science in Nursing) refers to his 14 year old female daughter who is the patient. Reported stated that the patient got 2 doses of GARDASIL (dates were not reported), dose, route of administration, lot numbers and expiration dates were not provided. Reporter stated that pharmacist told them the series needed to be restarted, since the third dose would be late. The patient has restarted the series, and now (exact dates were not reported) have received 2 additional doses of GARDASIL, dose, route of administration, lot numbers and expiration dates were not provided. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 0.12
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 week old female infant. No pertinent medical history or drug reaction/allergies. On 09-JAN-2015 the patient was vaccinated with the first 2 ml dose in a series of three doses of ROTATEQ, (lot # was reported as K008140, expiration date 30-MAR-2016), oral. No concomitant therapy included. On 09-JAN-2015, the patient experienced vomited immediately after vaccination. The event outcome was reported as recovered on 09-JAN-2015. No lab diagnostics studies performed. The patient sought medical attention via saw nurse. No treatment was given. Additional information has been requested.