chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Cellulitis with redness, swelling and pain to touch; induration of 1 cm at injection site SC left upper outer arm; redness, swelling and pain started left upper arm. Cellulitis migrated to left elbow and left forearm, with pain by 2/6/16, with resolution of left upper arm redness and swelling. By 2/8/16 still with redness, slight swelling and pain left elbow and left forearm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Sleep disorder
Clinical narrative: Received flu shot high dose and 4 days later started itching under arms, chest, back, neck, abdomen, groins and upper thighs severely. Itching so bad had trouble sleeping for 2 nights. After 2 nights of not hardly sleeping, bought anti-itch lotion, stopped itchy 2 days later.
Age: 1.17
Sex: M
Vaccine: PNC13
Symptoms: Crying, Gait disturbance, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: On left leg: Three inch diameter, red, hot and hard lump. My child had difficulty walking with his left leg and appeared to drag leg on 2/6 & 2/7. Hard 3 inch lump is still present and discolored. He was also in pain and crying most of the weekend. I contacted the doctors office and they asked me to bring my child in. He will be evaluated this afternoon.
Age: 1.17
Sex: M
Vaccine: PNC13
Symptoms: Injection site mass, Injection site warmth, Pain
Clinical narrative: On left leg: Three inch diameter, red, hot and hard lump. My child had difficulty walking with his left leg and appeared to drag leg on 2/6 & 2/7. Hard 3 inch lump is still present and discolored. He was also in pain and crying most of the weekend. I contacted the doctors office and they asked me to bring my child in. He will be evaluated this afternoon.
Age: 16.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Induration, Inflammation, Skin warm
Clinical narrative: Deltoid warm, inflamed, indurated.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Client called 2/3/15 c/o of lt deltoid where flu shot was given is red with a lg red circle and a rash and bruise noted. Advised client to apply ice pack, and take ibuprofen every 4-6 hrs for pain. States applied pain analgesic spray to area.
Age: 79.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 18 January 2016. This case involves a male patient (age not reported) who was vaccinated with a 5 ml dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date, immediately (few seconds following the vaccination) the patient's arm burned at the shot spot and turned red and began to swell. About an hour later patient felt like an elephant was sitting on his chest and his breathing became labored. Lab data was not reported. Patient corrective treatment included Benadryl. It was reported that after taking Benadryl, the pressure eased. On 13 January 2016, the patient recovered from the event of breathing and outcome of the event of arm turned red and began to swell was unknown. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 18 January 2016. This case involves a male patient (age not reported) who was vaccinated with a 5 ml dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date, immediately (few seconds following the vaccination) the patient's arm burned at the shot spot and turned red and began to swell. About an hour later patient felt like an elephant was sitting on his chest and his breathing became labored. Lab data was not reported. Patient corrective treatment included Benadryl. It was reported that after taking Benadryl, the pressure eased. On 13 January 2016, the patient recovered from the event of breathing and outcome of the event of arm turned red and began to swell was unknown. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest discomfort, Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 18 January 2016. This case involves a male patient (age not reported) who was vaccinated with a 5 ml dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On an unspecified date, immediately (few seconds following the vaccination) the patient's arm burned at the shot spot and turned red and began to swell. About an hour later patient felt like an elephant was sitting on his chest and his breathing became labored. Lab data was not reported. Patient corrective treatment included Benadryl. It was reported that after taking Benadryl, the pressure eased. On 13 January 2016, the patient recovered from the event of breathing and outcome of the event of arm turned red and began to swell was unknown. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: OBJECTIVE Physical Exam EXTREMITIES: R arm: large red indurated area over mid upper arm over tricep muscle.  Gardasil injection site was cephaled to the affected area. Duration 72 hours. Treatment: Ice to affected area and Ibuprofen 400 mg every 4-6 hours as needed for discomfort.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Musculoskeletal pain, Pain
Clinical narrative: Patient experienced warmth at injection site as well as pain in left and right shoulder. Pain in hand of vaccinated arm as well as a "saucer sized" welt at injection site. Symptoms have persisted for over a week...Other symptoms reported were body aches and pains, but no reported fever.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Patient experienced warmth at injection site as well as pain in left and right shoulder. Pain in hand of vaccinated arm as well as a "saucer sized" welt at injection site. Symptoms have persisted for over a week...Other symptoms reported were body aches and pains, but no reported fever.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Metabolic function test normal, Myocardial necrosis marker normal
Clinical narrative: Patient started having chest pain which increased over two days. Patient was seen in ER on 02/08/2016 at 12:00 Noon and diagnosed with mild case myocarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myocarditis
Clinical narrative: Patient started having chest pain which increased over two days. Patient was seen in ER on 02/08/2016 at 12:00 Noon and diagnosed with mild case myocarditis.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Electrocardiogram, Pericarditis
Clinical narrative: Patient started having chest pain which increased over two days. Patient was seen in ER on 02/08/2016 at 12:00 Noon and diagnosed with mild case myocarditis.
Age: 40.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Chills, Contusion, Erythema, Nausea, Pain in extremity
Clinical narrative: Arm swelled up, was red and bruised, and sore. She had fevers and chills, and nausea. She had to go to urgent care.
Age: 40.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm swelled up, was red and bruised, and sore. She had fevers and chills, and nausea. She had to go to urgent care.
Age: 55.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1-08-2016 PATIENT PRESENTED TO CLINIC C/O PAIN REDNESS, HOT AREA AT SITE OF INJECTION WITH Tdap. WORSENING DAILY.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site of injection, hot, red, itching. Felt tired, run down, checked blood pressure and it was around 186/97 and remained elevated for about 2 weeks. Pt. normally had good BP.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Foreign body sensation in eyes, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe sore throat...high fever...chills..red eyes that felt like sand was in them.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Low grade fever on 2/05 and 2/06. Right upper arm (where vaccine was administered) swelled (from just above elbow to below shoulder) from 2/05-today (2/08), with the swelling reducing incrementally day by day. It is still slightly swollen today.
Age: 73.0
Sex: M
Vaccine: TYP
Symptoms: Anaphylactic reaction, Chills, Diarrhoea, Dizziness, Erythema
Clinical narrative: Pt started the Vivotif 1 capsule po every other day x 4 doses regimen on 2/1/2016.  On 2/4/2016 he noticed that he had a headache, at that time he did not attribute it to the Vivotif.  The following day, on 2/5/2016 he took the third dose.  On 2/6/2016 he noticed a rash on hands and feet with pruritis.  Rash spread centrifigully but only with itching on palms and soles of feet.  Also had an episode of diarrhea overnight with brown stool and became lightheaded.  Endorses some neck stiffness which began 2 days on 2/4/2016, in addition to the headache as previously mentioned.  Endorses chills without fever.  He has hx of urinary urgency over last 3-4 months, but 24 hours prior to admission became more urgent.  Upon presentation to the emergency room patient was hypotensive 77/54 mmHg, HR 74, RR 16, Temp 36.4C. SpO2 98% on room air.  Rash described by MD as involving his hands and feet, both palms and soles, face, trunk and extremities, erythematous, not urticarial and does blanch.  Anaphylaxis vs septic shock.  Given IV fluid bolus 30 ml/kg and blood pressure improved.  Given methylprednisolone as pt complained of throat tightening. Also give IM epinephrine which helped with throat tightening. Rash defervesced.
Age: 73.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Hypotension, Musculoskeletal stiffness, Pruritus, Rash
Clinical narrative: Pt started the Vivotif 1 capsule po every other day x 4 doses regimen on 2/1/2016.  On 2/4/2016 he noticed that he had a headache, at that time he did not attribute it to the Vivotif.  The following day, on 2/5/2016 he took the third dose.  On 2/6/2016 he noticed a rash on hands and feet with pruritis.  Rash spread centrifigully but only with itching on palms and soles of feet.  Also had an episode of diarrhea overnight with brown stool and became lightheaded.  Endorses some neck stiffness which began 2 days on 2/4/2016, in addition to the headache as previously mentioned.  Endorses chills without fever.  He has hx of urinary urgency over last 3-4 months, but 24 hours prior to admission became more urgent.  Upon presentation to the emergency room patient was hypotensive 77/54 mmHg, HR 74, RR 16, Temp 36.4C. SpO2 98% on room air.  Rash described by MD as involving his hands and feet, both palms and soles, face, trunk and extremities, erythematous, not urticarial and does blanch.  Anaphylaxis vs septic shock.  Given IV fluid bolus 30 ml/kg and blood pressure improved.  Given methylprednisolone as pt complained of throat tightening. Also give IM epinephrine which helped with throat tightening. Rash defervesced.
Age: 73.0
Sex: M
Vaccine: TYP
Symptoms: Septic shock, Throat tightness, White blood cell count increased
Clinical narrative: Pt started the Vivotif 1 capsule po every other day x 4 doses regimen on 2/1/2016.  On 2/4/2016 he noticed that he had a headache, at that time he did not attribute it to the Vivotif.  The following day, on 2/5/2016 he took the third dose.  On 2/6/2016 he noticed a rash on hands and feet with pruritis.  Rash spread centrifigully but only with itching on palms and soles of feet.  Also had an episode of diarrhea overnight with brown stool and became lightheaded.  Endorses some neck stiffness which began 2 days on 2/4/2016, in addition to the headache as previously mentioned.  Endorses chills without fever.  He has hx of urinary urgency over last 3-4 months, but 24 hours prior to admission became more urgent.  Upon presentation to the emergency room patient was hypotensive 77/54 mmHg, HR 74, RR 16, Temp 36.4C. SpO2 98% on room air.  Rash described by MD as involving his hands and feet, both palms and soles, face, trunk and extremities, erythematous, not urticarial and does blanch.  Anaphylaxis vs septic shock.  Given IV fluid bolus 30 ml/kg and blood pressure improved.  Given methylprednisolone as pt complained of throat tightening. Also give IM epinephrine which helped with throat tightening. Rash defervesced.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Developed urticarial rash to bilateral wrists and sacrum/coccyx. Was treated with Benadryl, Zantac, Zyrtec, and 5 days of Prednisone. Rash went away. At the end of the Prednisone course rash returned. No new products the only thing identified was the Anthrax Vaccine given the day before rash. Was seen in ER given Dexamethasone. Rash improved but didn't resolve. Was given 3 week Prednisone taper. Rash resolved. Still currently taking this tx. Has referral to allergy specialist.
Age: 47.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: 4-inch painful welt on L arm at site of administration, lasted 20 days.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Left arm was sore for a couple weeks.  After that I have muscle ache in my left shoulder and if I have blood pressure taken in that arm much muscle pain for days afterward.  This was still happening over a month after the shot! Pain is severe enough that I've taken OTC pain meds for it.
Age: 26.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt states that 24 hours after being administered MMR, redness, itchy, warm to touch.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. states the injection site became red, swollen and warm to touch. She also verbalized she had flu like symtoms.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine that was given to patient was expired on 1/10/2016. The date was not checked prior to giving vaccine. Manufacturer was called and recommended that patient be revaccinated. Patient was called. No adverse reactions noted. Patient will return to clinic today for revaccination.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: REDNESS, INFLAMMATION, SWELLING AT SITE OF INJECTION AND UPPER ARM AREA.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Seizure
Clinical narrative: Per Hospital MD client had seizures and was released home.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Noticed skin around belly was red and itchy. Then gradually the skin on the back was itchy. Rash between thighs developed a day later, following with inner areas of both arms a day later. Same itchy red rashes developed on both feet another day later. Burned like being bitten by ants. Took OTC Benadryl the first four days before seeking a MD who prescribed prednisone. Directions to take 2 10mg tablets every day, quantity 10 tablets. Also I took one OTC Zyrtec a day.
Age: 39.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Amino acid level, Antinuclear antibody, Back pain, Blood homocysteine, Borrelia test
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Computerised tomogram head, Dizziness, Electrocardiogram, Electromyogram, Electrophoresis protein
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Full blood count, Glycosylated haemoglobin, HIV test, Headache, Hepatitis viral test
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Lipids, Metabolic function test, Pain in extremity, Paraesthesia, Protein total
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Red blood cell sedimentation rate, Treponema test, Troponin I, Urine analysis, Vitamin B12
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 57.0
Sex: M
Vaccine: FLUC3
Symptoms: Vitamin D
Clinical narrative: Severe right sided back pain with pain radiating down right leg. Treated 11/10/2015 with Toradol and Kenalog. Symptoms did iimprove slightly. December 24, 2015 started with tingling in feet and legs. Continued to progress to upper extremities. Had periods of dizziness and headaches. Was seen 1/05/2016 in the Emergency Department. Followed up with Dr 1/7/2016 and was referred to a Neurologist. Evaluated by Neurologist 1/ 22/2016. EMG study on lower extremities 2/04/2016. 2/08/2016 Symptoms continue.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Aspartate aminotransferase increased, Blood thyroid stimulating hormone, Discomfort, Fatigue, Full blood count
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse (L.P.N) concerning a 37 year old female patient with asthma, migraines and hypothyroidism. The patient's medical history included vomiting, as a reaction to PERCOCET, and back pain. On 25-JAN-2016, the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX 23, (Lot # reported as L036437) intramuscularly. Concomitant therapies included SYNTHROID, FIORICET, EVOCLIN, DILAUDID, DEPO-PROVERA and PROVENTIL HFA. On 25-JAN-2016, the nurse reported that the patient experienced pain at the left deltoid injection site, initially, and the pain at the injection site had increased to a pain level 6; and when the injection site was touched the pain increased to a pain level of 8 (on a pain scale of 1-10). On 25-JAN-2016, the annual blood tests of CBC, CMP, THS and lipid panel were performed (results not provided). On the same date, the result for the aspartate aminotransferase (AST) was slightly elevated. On 28-JAN-2016, the patient experienced injection site erythema, swollen, hot to touch, and half the size of baseball. On an unspecified day, in January 2016, the nurse also mentioned the patient she feels very fatigued, and the swelling and discomfort were radiating to her armpit. The patient sought medical attention by calling the office and there was no treatment given for the events. The patient would be seen in the office on 28-JAN-2016. The outcome of swelling, AST slightly elevated, discomfort, fatigue, injection site mass, injection site warmth, injection site swelling, injection site erythema and injection site pain was unknown at the time of the report. Follow up information was received on 01-FEB-2016, indicating that the Lot # L036437 is valid for PNEUMOVAX 23. There was no PQC involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse (L.P.N) concerning a 37 year old female patient with asthma, migraines and hypothyroidism. The patient's medical history included vomiting, as a reaction to PERCOCET, and back pain. On 25-JAN-2016, the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX 23, (Lot # reported as L036437) intramuscularly. Concomitant therapies included SYNTHROID, FIORICET, EVOCLIN, DILAUDID, DEPO-PROVERA and PROVENTIL HFA. On 25-JAN-2016, the nurse reported that the patient experienced pain at the left deltoid injection site, initially, and the pain at the injection site had increased to a pain level 6; and when the injection site was touched the pain increased to a pain level of 8 (on a pain scale of 1-10). On 25-JAN-2016, the annual blood tests of CBC, CMP, THS and lipid panel were performed (results not provided). On the same date, the result for the aspartate aminotransferase (AST) was slightly elevated. On 28-JAN-2016, the patient experienced injection site erythema, swollen, hot to touch, and half the size of baseball. On an unspecified day, in January 2016, the nurse also mentioned the patient she feels very fatigued, and the swelling and discomfort were radiating to her armpit. The patient sought medical attention by calling the office and there was no treatment given for the events. The patient would be seen in the office on 28-JAN-2016. The outcome of swelling, AST slightly elevated, discomfort, fatigue, injection site mass, injection site warmth, injection site swelling, injection site erythema and injection site pain was unknown at the time of the report. Follow up information was received on 01-FEB-2016, indicating that the Lot # L036437 is valid for PNEUMOVAX 23. There was no PQC involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Lipids, Metabolic function test, Swelling
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse (L.P.N) concerning a 37 year old female patient with asthma, migraines and hypothyroidism. The patient's medical history included vomiting, as a reaction to PERCOCET, and back pain. On 25-JAN-2016, the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX 23, (Lot # reported as L036437) intramuscularly. Concomitant therapies included SYNTHROID, FIORICET, EVOCLIN, DILAUDID, DEPO-PROVERA and PROVENTIL HFA. On 25-JAN-2016, the nurse reported that the patient experienced pain at the left deltoid injection site, initially, and the pain at the injection site had increased to a pain level 6; and when the injection site was touched the pain increased to a pain level of 8 (on a pain scale of 1-10). On 25-JAN-2016, the annual blood tests of CBC, CMP, THS and lipid panel were performed (results not provided). On the same date, the result for the aspartate aminotransferase (AST) was slightly elevated. On 28-JAN-2016, the patient experienced injection site erythema, swollen, hot to touch, and half the size of baseball. On an unspecified day, in January 2016, the nurse also mentioned the patient she feels very fatigued, and the swelling and discomfort were radiating to her armpit. The patient sought medical attention by calling the office and there was no treatment given for the events. The patient would be seen in the office on 28-JAN-2016. The outcome of swelling, AST slightly elevated, discomfort, fatigue, injection site mass, injection site warmth, injection site swelling, injection site erythema and injection site pain was unknown at the time of the report. Follow up information was received on 01-FEB-2016, indicating that the Lot # L036437 is valid for PNEUMOVAX 23. There was no PQC involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Pain in extremity, Tenderness
Clinical narrative: Patient received vaccine Friday afternoon and noticed she had a sore arm Sunday morning. Has a red, swollen and tender to touch area on back of left arm. Area is about 2 1/2 inches in size and also hard to the touch. Today (Monday) she feels it is the same but will monitor it.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5x5 cm red, swollen, warm to touch, and painful area at left deltoid area.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Pyrexia, Rash vesicular
Clinical narrative: Fever of 104 degrees F and rash at injection site that looked like chicken pox.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Screaming since she got immunes.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt. received HPV9 on 2-4-16 at approx 10:15AM, at 12:11 PM, foster home staff called and reported pt.  was lethargic, non responsive to staff questions, vomited x2. Advised to call 911.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with improperly stored PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-NOV-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with improperly (Oka-Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding to unspecified number of patients. Patient demographics, concurrent conditions,  medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD lot # L033698, expiry date 28-FEB-2017 (dose number, dose and units were not specified). Concomitant medications were not reported. No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-FEB-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II (rHA) (lot # K000738; 16-JAN-2016; route and dose were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 20-MAY-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H020692, expiration date 15-AUG-2015, dose, anatomical loction and route of administration were not reported). On 28-JUN-2013, the patient was vaccinated with the second dose of GARDASIL (lot # J004770, expiration date 27-NOV-2015, dose, anatomical location and route of administration were not reported). On 27-NOV-2013, the patient was vaccinated with the third dose of GARDASIL (lot # J009993, expiration date 04-DEC-2015), dose, anatomical location and route of administration were not reported). On 29-JAN-2015, the patient received the fourth dose of GARDASIL 9) (lot # L019297, expiration date 08-AUG-2017), dose, anatomical location and route of administration were not reported). No adverse events 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored (temp 12 degree Celsius, time 6 hours) RECOMBIVAX HB (lot # L025738, exp. 14-AUG-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issued was involved. This is one of the several reports from th same reporter link. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a physician on behalf of another physician refers to an unidentified patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose and route of administration was not reported). No concomitant therapy was reported. On an unknown date the patient experienced injection site reaction at unspecified location. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Viral titre
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 32 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 28-DEC-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # L026405, expiry date 15-JUL-2017 (route and site of administration were not reported). No concomitant medications were reported. The patient became aware of the pregnancy on 30-DEC-2015. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy was pending. The patient reported she would be seen by her physician on an unspecified date. On an unknown date, chickenpox titer test was performed with unknown result. There was no treatment given for the patient. The patient did not seek medical attention.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a 60 year old male patient regarding himself. No concomitant conditions was reported. The patient's medical history included genital herpes. On 22-JAN-2016 the patient was vaccinated with ZOSTAVAX, (dose, lot #, strength expiry date were not reported) one shot/once subcutaneously. Concomitant therapies included VALTREX. Patient will remain off the VALTREX for 14 days per his physician's instructions. On an unknown date in January 2016 the patient experienced an injection site reaction consisting of a "red small firm lump about 2 inches in diameter". The lump was "tender". The patient sought medical attention which included an office visit. No lab diagnostics studies were performed. The patient did not receive any treatment. The outcome of the event was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved.  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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 7 year old patient of unknown gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. On 16-APR-2012 the patient was vaccinated with dose 1 of GARDASIL. On 19-JUN-2012, dose 2 of GARDASIL 1 dosage was given. The reporter stated that the patient was "seven years of age" when the first dose and second dose of GARDASIL was administered (inappropriate schedule of drug administration). The third dose in the series of GARDASIL was not administered. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Company (PQC) involved. 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On23-SEP -2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored (temp 12 degree Celsius, time 6 hours) VAQTA (lot # L015460, exp 20-JUL-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding to unspecified number of patients. Patient demographics, concurrent conditions, medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L017142, expiry date: 13-MAY-2017 and lot # L026407, expiry date: 15-JUL-2017 (dose number, route, anatomical location, dose and units were not specified). Concomitant medication were not reported. No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Temperature at which the vaccines were stored was: -8.9C, for a total time of 41 hours. There was no previous temperature excursion done. This case is linked to case # 1602USA003059 via same reporter link. 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 medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 21 year old student. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. Reporting physician stated that the patient received the first dose in the HPV vaccine series of GARDASIL (lot #/expiry date unspecified) on 19-JAN-2015 and the second dose on 17-NOV-2015. The patient received their third dose in the HPV series with GARDASIL 9 (lot # L024993, expiry date: 17-OCT-2017) on 02-FEB-2016. Physician reported that the second and third doses were given outside the recommended dosing schedule. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored (temp. 12 degree Celsius, time 6 hours) GARDASIL 9 (lot # L020015, exp. 16-AUG-2-17, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality was involved. This is one of the several reports from the same reporter link. Additional information is not expected since the reporter did not wish further contact.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy diagnosed 01-26-2016.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) shoulder induration and erythema approximately 7 cm diameter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.