chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm pain at site of vaccination (left deltoid) 20 minutes after injection. Site was hot to touch. Tried ice to site, did not help. Had her see urgent care provider. Given oral Benadryl.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Epistaxis, Headache, Malaise
Clinical narrative: Nosebleed, Headache, Malaise, Temperature of 100.7.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Malaise, Pain in extremity
Clinical narrative: The patient feels very sick. His right arm was in pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received a flu shot on 10/10/15 in left arm, and later that night the injection site became inflamed, approximately the size of a marble, and itched.  She stated scratching it worsened it.  Today there was a knot at the site of injection, it was still inflamed and very itchy and was now also giving off heat.  There was no pain at injection site and she stated it was more annoying than anything.  I recommended Benadryl for the itching and a cold compress to get the swelling down.
Age: 1.05
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Swelling redness welting around site. Ice pack applied and oral Benadryl given.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 10/5/15: per patient, on right arm where Prevnar was administered, a couple of small lesions appeared, and arm became red, swollen, warm to the touch, itchy, and slowly spread down her arm towards her elbow.  She stated that she didn't feel it was, "bad enough to contact her primary care doctor," but she had an appointment on Thursday (10/8/15) and would have them take a look at it at that time; 10/9/15 patient called pharmacy back and stated that it slowly got better and was almost gone at this point; 10/13/15 the patient stopped into the pharmacy and said that it has resolved and she has no further issues.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin lesion
Clinical narrative: 10/5/15: per patient, on right arm where Prevnar was administered, a couple of small lesions appeared, and arm became red, swollen, warm to the touch, itchy, and slowly spread down her arm towards her elbow.  She stated that she didn't feel it was, "bad enough to contact her primary care doctor," but she had an appointment on Thursday (10/8/15) and would have them take a look at it at that time; 10/9/15 patient called pharmacy back and stated that it slowly got better and was almost gone at this point; 10/13/15 the patient stopped into the pharmacy and said that it has resolved and she has no further issues.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Feeling cold, Skin warm, Tremor
Clinical narrative: Patient began trembling all over and complained of feeling cold. Her daughter assisted her but was unable to help her warm up. Later patient felt hot to the touch but temp was not taken. Pt exhibited signs of confusion. The next day patient was still trembling in hand area and was weak and required assistance arising from couch/chair. Pt continued to show signs of confusion.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tenderness
Clinical narrative: MINOR RASH AND TENDERNESS ON FRONT OF UPPER ARM. ASKED THE PATIENT TO TAKE BENADRYL, PATIENT IS FINE.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Entire upper arm turned bright red and very hot to the touch. Itched. Redness continued to spread and grow through Saturday evening. Went to ER Saturday evening and left with a diagnosis of cellulitis of the upper arm with a treatment plan of 10 days of antibiotics.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site warmth, Neck pain, Peripheral swelling
Clinical narrative: Pt mom called on 10/11/2014 to inform that pt had had difficult night complaining of head and neck ache as well as "sensation of something traveling up her neck vessels"; on waking had "half-dollar sized warm red spot at injection site and arm swelling".  Advised to take Benadryl and ibuprofen and check back in 30 minutes.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: Pt mom called on 10/11/2014 to inform that pt had had difficult night complaining of head and neck ache as well as "sensation of something traveling up her neck vessels"; on waking had "half-dollar sized warm red spot at injection site and arm swelling".  Advised to take Benadryl and ibuprofen and check back in 30 minutes.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Peripheral swelling, Syncope
Clinical narrative: Very swollen arm, dizziness, fainted.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, OPV, VARCEL
Symptoms: Cellulitis, Immediate post-injection reaction, Inflammatory marker increased, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from the patient's mother, referring to her son, a 5 year old male patient with asthma but no drug reactions or allergies. On 30-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number and expiration date unspecified, dose and route of administration were not reported, in the leg), a dose of M-M-R II (lot number and expiration date unspecified, dose and route of administration were not reported, in the leg), a dose of DTaP, a dose of IPV (unspecified) and a dose of OPV-MERIEUX. Concomitant therapies included SYMBICORT, NASACORT and SINGULAIR. On 30-JUL-2015, after the vaccines were received (reported as immediately), the patient developed unspecified red, local rashes at the injection sites and red rings that surrounded each injection site. Also, "growing pain" like pains limited to only the injection sites on each leg were the vaccines were given, that accompanied an unspecified low grade fever. Whenever the patient did experience the "growing pain" like pains, the red ring that surrounded the injection sites developed again. The patient visited his primary care physician, but she was unable to make a diagnosis. On an unknown date, the patient was admitted to hospital A (unspecified admission and discharge date) and, therefore on 25-SEP-2015, transferred to hospital B and admitted on the same date. Multiple unspecified blood tests were completed during the hospitalization time, showing inconclusive result, with only "a few", unspecified "inflammation markers" were elevated. The patient was treated with unspecified antibiotics, possibly including ZITHROMAX, since the unspecified physicians at the hospital thought the patient had cellulitis. On 26-SEP-2015, the patient was discharged from hospital B. The outcome and causality cellulitis was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, OPV, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from the patient's mother, referring to her son, a 5 year old male patient with asthma but no drug reactions or allergies. On 30-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number and expiration date unspecified, dose and route of administration were not reported, in the leg), a dose of M-M-R II (lot number and expiration date unspecified, dose and route of administration were not reported, in the leg), a dose of DTaP, a dose of IPV (unspecified) and a dose of OPV-MERIEUX. Concomitant therapies included SYMBICORT, NASACORT and SINGULAIR. On 30-JUL-2015, after the vaccines were received (reported as immediately), the patient developed unspecified red, local rashes at the injection sites and red rings that surrounded each injection site. Also, "growing pain" like pains limited to only the injection sites on each leg were the vaccines were given, that accompanied an unspecified low grade fever. Whenever the patient did experience the "growing pain" like pains, the red ring that surrounded the injection sites developed again. The patient visited his primary care physician, but she was unable to make a diagnosis. On an unknown date, the patient was admitted to hospital A (unspecified admission and discharge date) and, therefore on 25-SEP-2015, transferred to hospital B and admitted on the same date. Multiple unspecified blood tests were completed during the hospitalization time, showing inconclusive result, with only "a few", unspecified "inflammation markers" were elevated. The patient was treated with unspecified antibiotics, possibly including ZITHROMAX, since the unspecified physicians at the hospital thought the patient had cellulitis. On 26-SEP-2015, the patient was discharged from hospital B. The outcome and causality cellulitis was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Eye pruritus, Ocular hyperaemia
Clinical narrative: Chest tightness, shortness of breath, dizziness, sore throat, cough, itchy red eyes.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Chest tightness, shortness of breath, dizziness, sore throat, cough, itchy red eyes.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Pruritus
Clinical narrative: Flushing and itching went to ER. See ER note attached.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Swollen, hot, red left arm 8" x 8" area. Still affected 1 week later. No medical treatment.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphagia, Dyspnoea
Clinical narrative: On 10/9/2015 at 9:15 patient was administered the flu vac-at 09:30 she began to cough, c/o difficulty swallowing and dyspnea. RN escorted patient to immunization room. Patient indicated she had epipens in her purse. Pt. self injected at 9:24. Dr was notified, and EMS was called. Sx: worsened and self inj and epi at 09:27. IV site started. EMS arr.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cold sweat, Dysphonia, Dyspnoea, Hyperhidrosis
Clinical narrative: Approximately 4 hours after receiving vaccine pt had sudden onset diaphoresis, nausea, very sore injection site, shortness of breath and hoarseness. He became achy and broke out in a cold sweat and felt chilled. He woke up in the am 10/9/15 and felt fine - all symptoms gone.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Approximately 4 hours after receiving vaccine pt had sudden onset diaphoresis, nausea, very sore injection site, shortness of breath and hoarseness. He became achy and broke out in a cold sweat and felt chilled. He woke up in the am 10/9/15 and felt fine - all symptoms gone.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Cough, Pyrexia, Vomiting
Clinical narrative: Was administered FLUMIST at office 2 pm and mom stated at 7 pm pt c/o stomach hurting. Developed a "seal" like cough, fever 102 and vomited - liquid. Felt fine in the morning.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Local swelling erythema induration.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, Periarthritis
Clinical narrative: Soreness, swelling, limited range of motion, frozen shoulder, and bursitis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, X-ray
Clinical narrative: Soreness, swelling, limited range of motion, frozen shoulder, and bursitis.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warm, tenderness, swelling to left deltoid/upper arm. 1 Tramadol 50 mh p.o. 1 tablet 3 times daily prn. 2 prednisone 40 mg po x 1.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt had severe pain in his arm for the last 3 weeks.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Dizziness, Feeling abnormal, Nausea
Clinical narrative: 1:10 pm Pt. received influenza vaccine to right deltoid. 1:13 om on her way back to her desk while in elevator pt. felt "dizziness" "nausea" and like her right pinky was "falling asleep". Pt. walked back to clinic and immediately assisted to exam room and to lay down. BP 90/60, HR 63 req. exam unremarkable. Pt monitored closely, given water. Blood glucose 128. S/s resolved except for the sensation of her right pinky "falling asleep." No weakness or skin discoloration. Ne edema or erythema at injection site. Sensation in fact to B/L hands. Pt will monitor s/s and I will f/u tomorrow. BP improved to 100/60, HR 74 bpm reg. D/C at 220 om.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: 1:10 pm Pt. received influenza vaccine to right deltoid. 1:13 om on her way back to her desk while in elevator pt. felt "dizziness" "nausea" and like her right pinky was "falling asleep". Pt. walked back to clinic and immediately assisted to exam room and to lay down. BP 90/60, HR 63 req. exam unremarkable. Pt monitored closely, given water. Blood glucose 128. S/s resolved except for the sensation of her right pinky "falling asleep." No weakness or skin discoloration. Ne edema or erythema at injection site. Sensation in fact to B/L hands. Pt will monitor s/s and I will f/u tomorrow. BP improved to 100/60, HR 74 bpm reg. D/C at 220 om.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received PNEUMOVAX vaccination that had expired the previous month. Administering Rph contacted Merck manf and was informed vaccine was still stable and full immunization effect would be achieved. Called pt. to inform and pt reported no adverse effects.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 24 hours after receiving flu host (2 Oct 2015) I noticed a red area at the injection site of my right arm. Also some pruritis at injection site/right arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Mass
Clinical narrative: Evening of injection noticed large lump under skin. Next morning large red, warm circle around injection site. Later that evening the spot became very itchy.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: No problems until the 29th (Day after shot) got very red and had a fever in arm, got very itchy and sore and was swollen, bumped up.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Arm started tingling and had numbness in arm.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Fear of injection, Loss of consciousness, Syncope
Clinical narrative: The patient lost consciousness about 5 minutes after receiving the vaccine. He immediately regained consciousness and EMS was called. The patient fainted again while EMS was taking vitals. He went to the ER and they found nothing wrong. He admitted to a huge fear of needles.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling, Nerve injury
Clinical narrative: Immediately after administration of HD Flu vaccine pt's injection site swelled to about the size of a golf ball. Pt went to urgent care and was told it was nothing to worry about, a nerve was possibly hit. Swelling decreased and pt was fine.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Pt said that she got cellulitis.
Age: 1.47
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Rash erythematous, Urticaria
Clinical narrative: Dad called 2hr after received FLUZONE .25 ml and stated child had a rash, red, raised and whelpy. Instructed to give BENADRYL 1/2 tsp every 6h. Seen this AM due to rash worse.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle twitching, Muscular weakness, Neck pain
Clinical narrative: Left deltoid pain radiating into shoulder and neck. Arm weakness and muscle twitching. Referral to Occ. Med. thru work comp.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Breast pain, Injection site pain, Oedema peripheral
Clinical narrative: Puncture site pain lasted more than 48 hrs. Within 8 hours of injection began having lateral breast pain that moved in axilla of same side of injection. Swollen axilla and painful at 3-4/10 on pain scale. Treated with ALEVE. Symptoms decreasing in severity but continue at 76 hrs post injection (time of this documentation).
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Cardiac flutter
Clinical narrative: Pt received flu shot on 9/25/15. She stated she went to ER on 9/30/15 with heart flutter and low potassium levels. She was released the same day. She followed up with cardiologist; per pt cardiologist does not think it is related to flu shot but pt thinks it is and wants to be reported.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Administration site warmth, Cellulitis, Injection site erythema
Clinical narrative: At the site of administration, it was red, warm to touch. Patient went to urgent care and they are treating her for cellulitis. They gave her an Rx for CLEOCIN 300mg.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Lt upper arm - red, swollen and painful.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt upper arm where the vaccine was given on 10/5/15 -> extremely swollen and red, no fever.
Age: 65.0
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Localized area of redness and warmth surrounding injection site within 24 hours after injection (8x6 cm size). Possible cellulitis vs allergic reaction. Was treated with antibiotic for staph infection of left axilla following insect bite the week prior. Vaccine given in left arm. Sent to PCP for further eval and treatment.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/o, 3 inch x 5 inch patch of red raised skin on upper arm below point of injection. Husband had same reaction. Gone in 4 days.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/o 3 inch by 5 inch patch of red raised skin on upper arm below point of injection. Wife had same reaction. Gone in 4 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Received FLUZONE HD on Sunday. Arm was sore and red rash developed 2 days later. Also feels warm to touch. Pt states it is getting better.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Feeling hot, Headache, Injection site paraesthesia, Limb discomfort
Clinical narrative: 10/7/2015 at 15:30AM, received FLUCELVAX vaccination after leaving employee health nurses's office noted feeling of weakness tingling sensation traveling in an "L" pattern from left upper arm into neck and head. Took one tablet of MOTRIN about 10-15 minutes after flu vaccination was given. Headache, warm fever sensation and left arm discomfort subsided in 3 hours around 18:30PM. No further symptoms or discomfort noted.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Paraesthesia
Clinical narrative: 10/7/2015 at 15:30AM, received FLUCELVAX vaccination after leaving employee health nurses's office noted feeling of weakness tingling sensation traveling in an "L" pattern from left upper arm into neck and head. Took one tablet of MOTRIN about 10-15 minutes after flu vaccination was given. Headache, warm fever sensation and left arm discomfort subsided in 3 hours around 18:30PM. No further symptoms or discomfort noted.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza, Nasal congestion, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a 60-year-old female patient who received Influenza vaccine. Concurrent medical conditions included systemic lupus erythematosus. Concomitant products included fish oil, PLAQUENIL, Vitamin B12 and Vitamin D. On 4th October 2015, the patient received Influenza vaccine. On 4th October 2015, less than a day after receiving Influenza vaccine, the patient experienced cold and flu symptoms. On 6th October 2015, the patient experienced nasal congestion and feelings of weakness. On an unknown date, the outcome of the cold, flu symptoms, nasal congestion and feelings of weakness were not recovered/not resolved. The reporter considered the cold, flu symptoms, nasal congestion and feelings of weakness to be possibly related to Influenza vaccine. Additional details provided were as follows: This case was not previously reported to anyone. This case was reported by the patient herself. The patient also concomitantly received living green multivitamin. The patient reported that, she received a flu vaccine, of an unknown manufacturer at a health fair this past on 4th October 2015. On that day she started felt like she had the flu or a cold. On 6th October 2015, 2 days after vaccination, the patient felt weak and had congestion in her nose. Till the time of reporting, she has not discussed with her physician, but she was encouraged to do so.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 41-year-old female patient who received FLUARIX quadrivalent (batch number 7994K, expiry date 16th June 2016). On 24th September 2015, the patient received the 1st dose of FLUARIX quadrivalent (intramuscular) .5 ml. On 24th September 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovered/resolved. The reporter considered the local swelling to be possibly related to FLUARIX quadrivalent. Additional details were provided as follows: The patient experienced red bumps (local swelling) on her upper torso following the administration of FLUARIX QIV vaccine. The bumps lasted for 5 or 7 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Erythema, Feeling hot, Flushing, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 63-year-old female patient who received FLUARIX. The patient's past medical history included tinnitus (did not experience for a long time). Concurrent medical conditions included asthma, drug allergy (causes tinnitus) and drug allergy (causes arm to become red and swollen). On 5th October 2015, the patient received FLUARIX (intramuscular) .5 ml. On 5th October 2015, 2 hrs after receiving FLUARIX, the patient experienced tinnitus. On 6th October 2015, the patient experienced feeling hot, rash, erythema and flushing. The patient was treated with prednisone. On an unknown date, the outcome of the tinnitus and feeling hot were not recovered/not resolved and the outcome of the rash was recovering/resolving and the outcome of the erythema and flushing were recovered/resolved. The reporter considered the tinnitus to be probably related to FLUARIX. The reporter considered the feeling hot and rash to be almost certainly related to FLUARIX. It was unknown if the reporter considered the erythema and flushing to be related to FLUARIX. Additional details were received as follows: The reporter stated that, she usually gets the Sanofi flu vaccine, and has noticed that FLUARIX contains gentamicin, while the Sanofi vaccine does not. She is very sensitive to ear side effects, and wonders if the small amount of gentamicin could have led to the tinnitus. While she has had tinnitus in the past, it has not been for a long time. On 6th October 2015, 1 day after vaccination, the patient woke up with redness or flushing on her arms that might be a rash and she was also feeling a bit hot. The flushing had about resolved at the time of reporting (today). The patient was treated with prednisone today and thought that it might have improved the reaction a bit. The patient had denied permission to contact her physician.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 63-year-old female patient who received FLUARIX. The patient's past medical history included tinnitus (did not experience for a long time). Concurrent medical conditions included asthma, drug allergy (causes tinnitus) and drug allergy (causes arm to become red and swollen). On 5th October 2015, the patient received FLUARIX (intramuscular) .5 ml. On 5th October 2015, 2 hrs after receiving FLUARIX, the patient experienced tinnitus. On 6th October 2015, the patient experienced feeling hot, rash, erythema and flushing. The patient was treated with prednisone. On an unknown date, the outcome of the tinnitus and feeling hot were not recovered/not resolved and the outcome of the rash was recovering/resolving and the outcome of the erythema and flushing were recovered/resolved. The reporter considered the tinnitus to be probably related to FLUARIX. The reporter considered the feeling hot and rash to be almost certainly related to FLUARIX. It was unknown if the reporter considered the erythema and flushing to be related to FLUARIX. Additional details were received as follows: The reporter stated that, she usually gets the Sanofi flu vaccine, and has noticed that FLUARIX contains gentamicin, while the Sanofi vaccine does not. She is very sensitive to ear side effects, and wonders if the small amount of gentamicin could have led to the tinnitus. While she has had tinnitus in the past, it has not been for a long time. On 6th October 2015, 1 day after vaccination, the patient woke up with redness or flushing on her arms that might be a rash and she was also feeling a bit hot. The flushing had about resolved at the time of reporting (today). The patient was treated with prednisone today and thought that it might have improved the reaction a bit. The patient had denied permission to contact her physician.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, IPV
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Patient started having sore throat and nasal congestion after leaving the clinic. Pt developed a fever of 101 last night with severe headache and vomited x4.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Raised, inflamed area around injection site. Will see Dr. if not going down today.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Eye pain, Eyelid oedema, Fatigue, Nausea
Clinical narrative: Local redness, pain within 24 hrs. Nausea, fatigue 24 hrs later. Swelling around eyes, pain around eyes - Day 4.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Local redness, pain within 24 hrs. Nausea, fatigue 24 hrs later. Swelling around eyes, pain around eyes - Day 4.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with ROTATEQ (lot # K007247 with expiration date 17-MAR-2016, orally; strength, dose and dose number were not reported), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cough, Injection site erythema, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician referring to a 43 year old male patient. Concurrent conditions and medical history of the patient were not reported. On 02-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose, route unspecified). Other suspect and concomitant therapies were not reported. On 04-OCT-2015 the patient experienced a small reddened area and a skin rash "that looked like cellulitis" localizing at the injection site. On 05-OCT-2015, the patient was seen in an unspecified emergency department where he presented with a larger reddened area at the injection site, a fever, mild cough, malaise, generalized weakness, and a possible urinary tract infection. The primary reporter confirmed that the patient was not admitted to the hospital, and was treated in the emergency department with an unspecified dose, and type of antibiotic. The outcome of the events was not recovered. Additional information is not expected as the physician was not consented to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered, 78, 79, 80 and 81). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 07-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborns(numbered 86). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 11-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 73, 74 and 75). Background: Since June 2015, there had been 1645 times (30 times each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 times each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 05-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to his or her 62 year old mother. The patient had drug reactions to sulfa, cephalosporins and sulfamethoxazole, BACTRIM with skin rash and hives. There was no pertinent medical history. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date and dose unknown) intramuscularly (incorrect route of administration). There was no concomitant medication. After receiving ZOSTAVAX, the patient experienced soreness at the injection site. The patient did not seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. The causality between the injection site soreness and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Informatino has been received from a pharmacist referring to a newborns (numbered 113). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn (numbered 85). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 times each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 10-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn (numbered 84). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 09-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 82 and 83). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 08-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 03-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a female patient of unknown age. There was no medical history or drug allergies/reaction reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expired date were unknown). No concomitant medication was reported. On 08-OCT-2015, the patient went to see the doctor and it was found that she had shingles. The patient considered that the vaccine was useless. The outcome of the events was unknown. Additional information is not expected since there was no contact information available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 71 and 72). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 04-AUG-2015 patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/5.0 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported. There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 06-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Back pain, Musculoskeletal pain, Swelling
Clinical narrative: Information has been received from a female consumer of unknown age via Pfizer Inc. referring to herself. No concurrent conditions or medical histories were mentioned. In back of June 2015 (exact date not available) the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route unspecified). In 2015, the vaccine made her back sore hurt, she had ache in her back and one of her shoulder, her back was bothering and when she looked her back one day before reporting day (exact date not available) it was swelled. There was no product complaint reported. The outcome of events was unknown. Additional information is not expected because the consumer was not willing to share further information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with MMR II (lot # J013316 with expiration date 22-OCT-2015 and K002816 with expiration date 25-FEB-2016; strength, dose and route were not reported), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via field representative referring to a 72 year old male patient. There was no pertinent medical history. On an unknown date ("several years ago"), the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot number not provided). There were no concomitant medications reported. On 04-OCT-2015, the patient developed shingles after receiving ZOSTAVAX. He visited the physician's office and was treated with acyclovir. No lab diagnostics studies were performed. The outcome of  the event was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker via field representative referring to a 18 year and 7 months old male patient. Information about medical history and concurrent conditions were unspecified. On 16-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot number, dose and route were unknown) (drug administered to patient of inappropriate age). No adverse experience has been reported. The reporter declined to provide patient identifiers and discussed Health Insurance Portability and Accountability Act (HIPAA). No PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to 2 patients of unknown age and gender. On 07-OCT-2015 the patients were vaccinated with improperly stored ZOSTAVAX injection (lot # L007222, expiration date 03-JUN-2016) (dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. The nurse reported that an expired dose of MMR II (route of administration, dose, lot number and expiration date were not reported) may have been given to an unspecified patient on an unspecified date. No adverse effects were reported. 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 healthcare worker, immunization coordinator refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. Reporter stated that on unspecified dates since 01-JUL-2015, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dosing details were not reported) (lot # K007973 with an expiry date of 03-JUN-2016; K005178 with an expiry date of 10-APR-2016; K026385 with an expiry date of 15-DEC-2016), which have been exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with GARDASIL 9 (lot # L011846 with expiration date 16-JUN-2017; strength, dose, dose number and route were not reported), which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 22-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL lot # K006960, expiry date 19-FEB-2017, 0.5 ml (route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored (Merck) PROQUAD (lot number L008353, expiry date 11-SEP-2016, 0.5 ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. Follow up information has been received on 02-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received from the nurse on 08-OCT-2015. The nurse reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to an 8 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with the dose of improperly stored (Merck) PROQUAD. Temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested. The patient details and narrative was updated.