chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient came in today reported extreme pain in left shoulder spanning from shoulder to elbow. In addition she reported muscle spasms and nerve tingling. She saw her primary care doctor and then came in to pharmacy to report.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Site of administration red, swollen, and hot. Pt following up at urgent care. Slightly painful. Swollen arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Throat tightness
Clinical narrative: Pt called saying has sore throat/aches since flu shot. Described feeling of "fullness" in throat, but no difficulty breathing.3  days later SZ resolved.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest pain, Dizziness, Dyspnoea, Influenza like illness
Clinical narrative: Within less than 1 min of vaccine, pt turned pale, felt faint, nauseous, and developed pain in chest w/burning sensation throughout her body, and sharp electric shock-like pain down spine, w/SOB. Almost sent to ER but symptoms subsided over the course of 30 min. Currently, has flu-like illness symptoms the day after the shot.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pallor, Paraesthesia
Clinical narrative: Within less than 1 min of vaccine, pt turned pale, felt faint, nauseous, and developed pain in chest w/burning sensation throughout her body, and sharp electric shock-like pain down spine, w/SOB. Almost sent to ER but symptoms subsided over the course of 30 min. Currently, has flu-like illness symptoms the day after the shot.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Loss of consciousness, Seizure
Clinical narrative: Pt passed out after receiving flu shot. It did bleed a bit. Patient seemed to seize once, but then was layed down. She awoke and was coherent.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: 2nd day after vaccine, felt very tired/sleepy and achy, headache, chills and intense sneezing (sneezed so hard I got a sore throat, and general exhausted - oh, sinus froze-up, couldn't breathe through nose....
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Sinus disorder, Sneezing, Somnolence
Clinical narrative: 2nd day after vaccine, felt very tired/sleepy and achy, headache, chills and intense sneezing (sneezed so hard I got a sore throat, and general exhausted - oh, sinus froze-up, couldn't breathe through nose....
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Oxygen saturation decreased, Syncope, Unresponsive to stimuli
Clinical narrative: Pt received flu vaccine. Pt at baseline for approximately 5 minutes after administration and standing in exam room. Pt had syncopal event and became unresponsive for 1.5 minutes with decreased BP and oxygen saturation. Returned to baseline and transferred to ED for evaluation.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Throat tightness
Clinical narrative: Approximately 2 minutes after administration pt. stated she felt hot , had chest tightness, and it was becoming difficult to breath as if her throat was closing. These symptoms reversed in 1 min with no treatment.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lacrimation increased, Rhinorrhoea, Sinus pain
Clinical narrative: Runny nose, sore sinuses, eyes watering and headache. Taking BENADRYL and switching to ALLEGRA.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Pt present S/P 7 day following flu vaccination to (L) deltoid with healing bruising slightly larger than 1/2 dollar coin. Denies pain.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Abdominal pain began about 5 hours after vaccination. Later had nausea and vomiting 3 times. Pain lasted a day and a half, then disappeared.
Age: 63.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Skin irritation
Clinical narrative: Localize redness and irritation.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Peripheral swelling, Skin reaction
Clinical narrative: Patient's right arm was very red, swollen and uncomfortable for the patient for the last 2 days.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt. w/in 24hrs developed Guillain Barre w/numbness and tingling of extremities; was taken to hospital where he was diagnosed.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red arm at injection site and around 4 in around and radiating heat.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain down elbow and into hand. Treaded with ibuprofen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Red, warm, itchy rash.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient got flu shot on 9/25/16. She came back to the pharmacy on 10-7-16 and states pain/soreness on shoulder of injection site. Claims she has decreased range of motion.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at site of injection. Also itching.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Rash, Skin warm
Clinical narrative: Red, warm to touch, rash in injected arm, pain/soreness.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient has broken out in a rash on the second day after vaccine administration.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Presyncope
Clinical narrative: Patient felt lightheaded and fell (faint) in store's wine aisle. He regain consciousness shortly after. Paramedics believed he was having a vasovagal response.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia, Viral rash
Clinical narrative: Patient has MS and has about 3 viral rashes per year. She experienced chills, fever, headache after vaccine then developed the viral rash.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site joint pain, Injection site pain, Myalgia
Clinical narrative: A couple hrs after injection my shoulder became very sore, achy, weak. Hurt inside the joint. After a few days, muscles felt better but joint still hurts. Had steroid injection so far joint feels better, still sore but not as painful as it was.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient broke into severe rash, starting with upper chest, then lower legs got swollen.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Numb feeling in arm that began to resolve itself within 15 mins. Pt does not wish to be contacted.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Localized quarter-sized hives on the left arm 5 hrs. after getting the Flu vaccine. She applied hydrocortisone cream and took PO BENADRYL. The hives were gone 3-4 hrs after and never came back.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Extreme soreness on the left arm radiate down to patient's elbow. Area is red and hot - 72 hours after vaccinated. Possible cellulitis with treatment of CLEOCIN 300 mg 4 time a day for 10 days with MOTRIN 200 mg every 6 hours.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Approximately 5-7 mins after vaccine administration, pt became pale and slumped back in chair. Pt. was able to open eyes and respond to questions but stated she was dizzy. Breathing and respirations were normal. Episode lasted approximately 30 seconds. Pt. recovered to normal then had a repeat episode with same symptoms x 15-20 seconds. Pt. recovered and stated she felt okay and has had similar reactions with previous vaccines/injections. Pt. walked out of the store with companion with no additional symptoms.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site rash
Clinical narrative: 1" rash at site of injection on left deltoid reported day after administration (10/9/16).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: International normalised ratio increased, Pain in extremity, Subcutaneous haematoma
Clinical narrative: Patient received vaccine, on COUMADIN and days after arm sore to move and hematoma under skin. Pt went to Dr. Pt INR increased. Arm improving per patient.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, hot to touch at injection site.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Hyperhidrosis, Malaise, Mobility decreased
Clinical narrative: Patient left pharmacy and started to feel really hot at the grocery store. She got home and started to sweat a lot and felt really nauseous and sick feeling. She also had a fever and headache so she laid down for a while. Pt also reports she wasn't able to move her arm much on the 11th due to arm pain (Feeling better on 12th).
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient left pharmacy and started to feel really hot at the grocery store. She got home and started to sweat a lot and felt really nauseous and sick feeling. She also had a fever and headache so she laid down for a while. Pt also reports she wasn't able to move her arm much on the 11th due to arm pain (Feeling better on 12th).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt received vaccine on 10/10/16 at approx 4pm. Pt reports waking up at 3:30am 10/11/16 with shortness of breath and difficulty breathing.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Injection site pain, Seizure
Clinical narrative: Pt states vaccine hurt upon administration. Had a what she believes is a seizure about midnight-same night as Admin Date. Body was jerky-lasted 20 minutes-tapered off and stopped. No problems since then.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Diarrhoea, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Headache, fever, sweats, high blood sugar, diarrhea.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Rash
Clinical narrative: Swelling of injection site. Redness and rash on chest  and arm area for a couple of days. Went away on its own.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Very sore arms, fever, headache, lasted 24 hrs. I have had flu shot several for years only second pneumonia shot. Both were given in opposite arms same day.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm was swollen, painful, could not lift. Started approximately 24 hrs after vaccine given, took MOTRIN. Called ER but did not go, right arm was fine no complaints.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt states her arm is still sore to the touch 14 days after vaccine-no redress or fever. I advised her to have her doc take a look at it and assess for infection.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest pain, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Fever, chills, headache, chest pain, nausea, dizzy, diarrhea, in bed 33 hrs slept off and on. 10/2 Still having chest pain and dizziness scheduled for angiogram 10-17-16.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, chest pain, nausea, dizzy, diarrhea, in bed 33 hrs slept off and on. 10/2 Still having chest pain and dizziness scheduled for angiogram 10-17-16.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Musculoskeletal pain, Pain
Clinical narrative: 10-3-16, 10-4-16, Chills, fever, body aches, shoulder sore. 10-5-16- Inj. site red, swollen bicep.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: 10-3-16, 10-4-16, Chills, fever, body aches, shoulder sore. 10-5-16- Inj. site red, swollen bicep.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Haemorrhage subcutaneous, Immediate post-injection reaction, Injection site haemorrhage, Peripheral swelling
Clinical narrative: Upon immunization the pharmacy intern had to have hit a blood vessel as the patient began to bleed more than normal, her arm proceeded to instantly swell with obvious bleeding under the skin. Pharmacist intervened applied gentle pressure x 3 minutes upon which the swelling went down and bleeding stopped.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Received 1st time seasonal flu shot at 1330. Remained in room x 15 minutes and left without any problems. Returned at 1430 with c/o itching on both arms and on neck. No rash/hives. No respiratory problems. Offered epinephrine and/or BENADRYL per anaphylaxis protocol. Pt declined. Returned to work and did not return with further problem.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Gait disturbance, Spinal X-ray normal, Syncope, Walking aid user
Clinical narrative: Vaccine-9AM 6 PM back hurt I am collapse to floor - wheelchair 24 hrs. Walker 6 days - walk with difficulty thru 10-1-16 today 10-7-16 not 100% maybe 75% (chiropractor and family Dr.) (back X-ray) nothing unusual.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Wheelchair user
Clinical narrative: Vaccine-9AM 6 PM back hurt I am collapse to floor - wheelchair 24 hrs. Walker 6 days - walk with difficulty thru 10-1-16 today 10-7-16 not 100% maybe 75% (chiropractor and family Dr.) (back X-ray) nothing unusual.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: She said her left arm was throbbing in pain after the vaccine and her left side up to her neck also in pain. She had severe headache, could not move her body due to the soreness. I did not see any redness or swelling at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Erythema, Mass, Skin discolouration, Subcutaneous haematoma
Clinical narrative: Patient claims vaccine (FLUZONE HIGH DOSE) was given too low and not in the muscle. Her arm is black/blue/red raised and feels like a hematoma/lump below skin.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: 6-13-16 Received Tdap prior to moving. At PE on 9-29-16 got second dose as part of "11 year old" vaccines.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Skeletal injury
Clinical narrative: Time of injection - felt as if bone was hit. Fever, shooting pain, loss of mobility - began 30 min after injection. Patient went to doctor and started PT - Symptoms fully resolved 9/30/16.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: 25 minutes after vaccine given, pt. development hives, whelps, severe itching over entire body.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm around the shot site. Width 7 1/2cm 5 1/2cm of right arm area.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9-29-16-Around 4:00 PM patient developed temperature of 100.3F axillary. 9-30-16-Around 9:00 AM patient developed pain, swelling, redness and warmth at injection site-left deltoid.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise
Clinical narrative: Patient got Flu and PNEUMOVAX at office. She started felling sick and not well Tue. and there was red streaks on her arm. She went to urgent clinic of some sort and they gave her KEFLEX, inj. thinking about may be cellulitis. She still not fee well on Wed. and she got one more KEFLEX shot.
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Fatigue, Hyperhidrosis, Palpitations, Strabismus
Clinical narrative: Palpitations, elevated blood pressure, profuse sweating, extreme fatigue, blurred vision, one eye drifted inwards (like squint).
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Palpitations, elevated blood pressure, profuse sweating, extreme fatigue, blurred vision, one eye drifted inwards (like squint).
Age: 87.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness in large area in (L) arm where both vaccines administered.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blood test, Musculoskeletal pain, Pain in extremity
Clinical narrative: Had soreness and pain in arm and shoulder up to 15 days or more after vaccine. (Believe assistant inexperience, took 4-5 attempts to get blood test).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Extreme dizziness when lying down for 4 nights.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Papule, Rash, Rash pruritic
Clinical narrative: Rec flu vaccine on Sat 10/8/16 next day Sun dev a rash that was initially itchy but after itch stopped rash spread. Did not need to scratch rash-no itching on day of visit which was 10/12/16-rash spread to involve trunk, neck, prox extremities. Small flesh color flat topped papules. (7.5 mm size each) densely distributed but not confluent over trunk, prox extreme, neck-no excoriation (no fever).
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Arthralgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of having fever, achy joints, an upset stomach, a sore arm, and nausea. I recommended TYLENOL for aches/fever. I also told her to contact her physician if she did not feel better.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Cough, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: Patient received immunization on 9/22/16 at approxim. 230pm. On 10/13/16 Patient reported adverse event. Patient stated 2 weeks after immunization she experienced swollen, bruised arm which was warm to the touch. She also experienced flu-like symptoms (coughing,/runny nose/aches/pains).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Skin warm
Clinical narrative: Patient received immunization on 9/22/16 at approxim. 230pm. On 10/13/16 Patient reported adverse event. Patient stated 2 weeks after immunization she experienced swollen, bruised arm which was warm to the touch. She also experienced flu-like symptoms (coughing,/runny nose/aches/pains).
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site hypoaesthesia, Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Patient has a red rash that is itching, painful, causing numbness in the injection site area. It looks and sounds like shingles.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Red inflamed, throbbing, injection site reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Inflammation, Peripheral swelling, Skin warm
Clinical narrative: 10 cm - left arm raised, inflamed, hot to touch. 8 cm - right arm raised, inflamed. Gave patient BENADRYL and MOTRIN.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Paraesthesia oral, Pruritus, Thirst, Tongue disorder
Clinical narrative: 10/4- at 1930 "thick" feeling of tongue and itching, fatigue, excessive thirst 10/5-hives noticed at 0600, thick tongue, itching - took BENADRYL at 0600, 1115, 1630. Approximately 10-15 hives on arms 10/6-hives spread to lower body and scalp.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 10/4- at 1930 "thick" feeling of tongue and itching, fatigue, excessive thirst 10/5-hives noticed at 0600, thick tongue, itching - took BENADRYL at 0600, 1115, 1630. Approximately 10-15 hives on arms 10/6-hives spread to lower body and scalp.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Received FLUZONE HD and PHEUMOVAX 23 in left deltoid on 9/30/16. Reported unresolved red, warm rash 10/2/16 covering majority of bicep. Denies fever.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness of shoulder with pain and limited movement of the arm.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursa disorder, Movement disorder, Pain in extremity
Clinical narrative: Soreness of shoulder with pain and limited movement of the arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash to hands, bilateral.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Broke out with hives all over my body approximately 30 hours after administration. Took 6 BENADRYL 25 mg Liqui-Gels over the next 24 hours.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Dyspnoea, Malaise, Swelling, Syncope
Clinical narrative: 9/21/2016 Patient had a flu shot. (Pseudoephedrine). When he returned to his home by 3:30 pm he fainted and he had a temp of 102 and his head and body severely swollen. Some what better. 09/26/2016 Emergency room had trouble breathing. Patient was sick for 10 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, induration, 16 mm x 16 mm irregularly shaped area (L) arm. At the time of the injection patient's muscle was very tight.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Erythema of eyelid, Eye swelling, Eyelid oedema
Clinical narrative: 4-6 hours after shot developed red swollen eyelids and periocular areas. No airway symptoms. Treated with antihistamines and today given Prednisone (10/13/16). Vaccine given 10/11/16.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Feeling hot, Pruritus, Rash generalised, Urticaria
Clinical narrative: Patient reported to us on 10/12/16 that starting 2 days after she received both FLUVIRIN and BOOSTRIX from us, she experienced hives, itching, burning, warm sensation, rashes all over her body except her face.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm was swollen, warm to touch and red at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient went to bed and woke up with severe swelling in the face. Patient went to urgent care and received steroid treatment - swelling continues 2 days later on 10/13/16.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives and reported to her doctor (PCP).
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left bicep was red, swollen, giving off heat.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in (R) foot about 3:20 pm, received shot about 10:30 am.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Muscular weakness, Tremor
Clinical narrative: Had shot about at noon on 10-3-16, when he went to bed that night e started shaking and got very cold. Put a electric blanket on and was able to go to sleep. Next morning his muscles were very weak. Took 2 days to start feeling better.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus
Clinical narrative: Patient was given FLUARIX QUADRILAVENT vaccine on 9/26/16 and noticed on 9/27/16 her right arm felt very itchy. She also noticed small blisters forming near the injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received the shingles vaccine ZOSTAVAX, on 9-14-16 by RPh. On 9-28-16 patient called saying she now has shingles.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site erythema, Vaccination site warmth
Clinical narrative: Pt said her arm was red and hot to the touch from the shoulder where she received the vaccine down to her elbow. Started to bother her that evening after getting the vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Tendonitis
Clinical narrative: Significant pain in arm where flu shot given DX of tendonitis. Cannot raise arm. RX for ibuprofen and will begin physical therapy. Initial call to pharmacy on 9/18/16, Tendonitis DX 9/23/16.
Age: 16.0
Sex: F
Vaccine: FLU4, HEPA, MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at injection site - (R) deltoid. Afebrile. No problems breathing.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site -3" x 4" area.
Age: 73.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Burning sensation, Pain in extremity, Rash erythematous, Rash macular
Clinical narrative: Both feet both legs and back side. Red dots all over then turned to large red blotches, it burning and both feet and legs ached. I was given Flu shot and PREVNAR 13 same time.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient came to pharmacy 2 days after vaccination with red rash at site of PNEUMOVAX injection. (Right arm). No fever. No pain. She received no treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-OCT-2016, the patient was vaccinated with improperly stored ZOSTAVAX subcutaneously, lot # M030140, expiry date 18-AUG-2017 (dose and site of administration were not reported). No adverse effects were reported. Additional information is not expected, as there was no consent given to contact reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included rheumatoid arthritis. On 07-OCT-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, site of administration, lot # and expiry date were not reported). Concomitant medications included unspecified disease-modifying antirheumatic drugs. In approximately October 2016, reported as within 24 hours, the injection site became red, had swelling and was hot to touch. There was no treatment given for the adverse events. The outcome of the events was reported as not recovered. The patient visited the pharmacy to seek medical attention. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No pertinent concurrent conditions or medical history was reported. On multiple unspecified dates, the patients were vaccinated orally with an unspecified amount of improperly stored doses of ROTATEQ, oral liquid (lot # M004883, with expiration date of 02-OCT-2017; exact dose was not reported). There were no concomitant therapies reported. The doses of the vaccine were exposed to a temperature excursion of -0.3 degrees Celsius for a total time frame of 22 hours on an unspecified date. A Digital Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No pertinent concurrent conditions or medical history was reported. On multiple unspecified dates, the patients were vaccinated with an unspecified amount of improperly stored doses of PEDVAXHIB, intramuscular injection (lot # L042836, with expiration date of 24-AUG-2018; exact dose and route of administration were not reported). There were no concomitant therapies reported. The doses of the vaccine were exposed to a temperature excursion of -0.3 degrees Celsius for a total time frame of 22 hours on an unspecified date. A Digital Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, an improperly stored dose of PEDVAXHIB (intramuscular; dose, lot # and expiration date were unknown) was administered to the patient following a temperature excursion. No adverse effects have been noted. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a receptionist referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unspecified dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route were unknown; lot number was reported as N05077 with expiration date 30-SEP-2017), which were exposed to unspecified temperatures outside of the recommended range. No adverse event was reported. The reporter had not been information of an adverse experience. No product quality complaint was involved in the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with one dose of one of the following lot numbers for VARIVAX; lot# M024683, expiry date: 18-MAY-2018; lot# M025867 expiry date: 24-MAY-2018; lot# L050956, expiry date: 17-DEC-2017; or lot# M024675 expiry date: 18-MAY-2018, via subcutaneous route, following a supported temperature excursion. The nurse confirmed that the lot number involved was unknown. No adverse effects were reported. No product quality complaint involved. No further information available. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a consumer refers to her currently 19 years old daughter with drug allergy to Amoxicillin. None pertinent medical history was reported. In August 2016, the patient was vaccinated with the first dose of unidentified Merck hpv vaccine  which could not be confirmed whether it was GARDASIL or GARDASIL 9 (lot # and dose unknown, intramuscularly. The reporter reported that that patient passed out and became stiff about 15 minutes after receiving the initial dose of the vaccine. She stated that it took her a good 30 minutes to fully recover. No treatment was given to the event. None lab diagnostics studies was performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (strength, dose, frequency and route were unknown; lot number L046900 with expiration date 23-FEB-2017). Temperature for vaccine was 22 F with duration of 8 hours. Tike frame was 8 hours. The call was not because of a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of M-M-R II (dose and route not reported) from lot # L026551 with expiry date of 16-JUL-2017 (also reported as 24-SEP-2017), lot # L036853 with expiry date of 24-SEP-2017 and from lot # M002419 with expiry date of 12-JAN-2018. The vaccines were exposed to temperature of 33 Fahrenheit (F) for 116 hours (8 occurrences of 14.5 hours each) and 47 F for 116 hours (8 occurrences of 14.5 hours each). No adverse effects were reported. Digital data logger was not involved. There was no previous temperature excursion. Product quality complaint was not involved. This is one of the three reports received 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 refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with PROQUAD, L016394, 08-NOV-2016, M011661 08-SEP-2017, M029599 10-DEC-2017. No adverse experience was reported. Temperature was 8.3 Fahrenheit for 2 hours and 14 minutes and it was administered. There was no previous temperature excursion. Data logger was yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046897 and expiration date: 23-FEB-2017. Dose and route were not provided. The vaccine was exposed to 9 Fahrenheit degrees for 4 minutes. A data logger was not used to log temperatures. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown and gender. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with VARIVAX (dose, frequency, route of administration and indication were not reported). Concomitant medications were not reported. On an unknown date, the patient developed a papular rash 3 days after administration of VARIVAX. The physician reported that the rash had no vesicles and the patient experienced no systemic reaction. The outcome of rash papular was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of ROTATEQ (dose and route not reported) from lot # L033543 with expiry date of 30-MAY-2017 and from lot # M025565 with expiry date of 06-NOV-2017. The vaccines were exposed to temperature of 33 degree Fahrenheit (F) for 116 hours (8 occurrences of 14.5 hours each) and 47 F for 116 hours (8 occurrences of 14.5 hours each). No adverse effects were reported. Digital data logger was not involved. There was no previous temperature excursion. Product quality complaint was not involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 86-year-old female patient with antibiotics allergy, hypertension and hyperlipidemia. On 30-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml (lot # and expiration date were not reported). On 02-OCT-2016, the patient experienced pain in the joints. On 04-OCT-2016, the patient began to experienced severe headaches, chills and weakness. The patient did not seek medical attention. No laboratory diagnostics studies were performed and no treatment was given. The outcome of weakness, chills, headache and arthralgia was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number patient of unknown age and gender. No information regarding the patient's pertinent concurrent or historical conditions and concomitant medications were reported. On unspecified dates (from 16-SEP-2016 to 29-SEP-2016), unspecified number of patients might have been vaccinated with unspecified number of doses of ZOSTAVAX subcutaneous injections (lot # L035283, with an expiration date of 15-DEC-2016) that had been improperly stored. Product information was received via product listing. The doses of the vaccine were exposed to a temperature of 44 degrees Fahrenheit for 10 days. There was no previous excursion and no Digital Data Logger was involved. 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 as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored doses of GARDASIL 9 (dose, and route not reported) from lot # L013429 with expiry date of 21-JUL-2017, and from lot # M005714 with expiry date of 03-OCT-2017. The vaccines were exposed to temperature of 33 Fahrenheit (F) for 116 hours (8 occurrences of 14.5 hours each) and 47 F for 116 hours (8 occurrence of 14.5 hours each). No adverse effects were reported. Digital data logger was not involved. There was no previous temperature excursion. Product quality complaint was not involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a consumer, refers to herself, a 79-year-old at the time of the report (also reported as 82-year-old) female patient with unspecified thyroid disorder (reported as "thyroid"). No historical conditions, drug reactions or allergies were reported. The patient was not pregnant. On an unknown date, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23, subcutaneously (lot# reported as M013756, expiration date: October 2017, strength was not reported). Concomitant therapies included unspecified diuretic. As the patient was taking PNEUMOVAX 23, on an unknown date, she experienced a swollen red arm, that was painful for a few days. She sought medication and went the see the pharmacist. No treatment was given for the adverse events. There were no lab diagnostics studies performed. The patient recovered from the events on an unspecified date. No product quality complaint was involved. Causality between swollen red arm, that was painful and PNEUMOVAX 23 was not reported. Lot # M013756 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a physician and refers to a 70 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, site and dose were not reported), subcutaneously. On 27-SEP-2016, the patient noticed rash and lesions on right chest area. On 29-SEP-2016, she experienced pain in the right chest area. The patient sought medical attention, she came to the physician's office but no treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse referring to an adult patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 20-SEP-2016, the adult patient was inadvertently vaccinated with a pediatric dose of VAQTA (dose and expiration date unknown, lot # K000943) intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site reaction, Insomnia, Malaise, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 13-SEP-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 intramuscularly (lot # L014876, expiration date 13-SEP-2016) (it was recommended). Concomitant therapies included lovastatin (manufacturer unknown), metformin, losartan potassium (manufacturer unknown) and omeprazole. On 14-SEP-2016, the patient did not feel well, had general malaise, could not sleep and then developed a red rash at the injection site which was itchy and covered the top half of her arm. The reporter stated, that the patient was self medicated by applying an unspecified antihistamine cream on the rash as treatment (date was unspecified). No lab diagnostic studies were performed. The patient sought medical attention and was seen by pharmacist. The outcome of the events was reported as not recovered. The relationship between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Information has been received from a physician via a company representative referring to a 70 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in 2016, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, lot # reported as M018768, expiration date 15-OCT-2017) subcutaneously. On 21-SEP-2016, after receiving PNEUMOVAX 23, the patient experienced redness and warmth as her arm began to be swollen. The patient sought medical attention, while it was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between PNEUMOVAX 23 and the events was not provided. 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 refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD which had lot # M018638 with expiry: 11-OCT-2017, lot# M021731 with expiry: 17-OCT-2017, and lot # M015695 with expiry: 26-SEP-2017, exposed to temperature of -11.2 degree Celsius for 1 hour 18 minutes. A second freezer containing different lots such as lot # M011663 with expiry: 08-SEP-2017, lot# M015698 with expiry: 26-SEP-2017 and lot # M029595 with expiry: 31-DEC-2017 had a temperature excursion of -12.9 degree Celsius for 48 minutes. Also, one lot of PROQUAD, with lot# M015695 and expiry: 26-SEP-2017, had an additional excursion of -9 C for 2 hours. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse practitioner concerning a 29 year old female patient. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration, dose and route were unknown), at the age of 29 years. After 1 hour of administration, the patient experienced dizziness and fatigue. The outcome of the events was not reported. No product quality complain (PQC) was involved. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had lot # L049316 with expiry: 03-DEC-2017 and lot # M006544 with expiry: 03-FEB-2018 (dosing details not provided). The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes, with an additional excursion of 10 degree Celsius for 2 hours for lot # L049316 with expiry: 03-DEC-2017. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a pharmacist referring to a 60 years old male patient. There was no pertinent medical history or drug reaction/allergies. Concomitant therapies included LIPTIOR, DIOVAN HCT and PREVACID. On 29-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot # M013377, expiration date 25-MAY-2017) subcutaneously. On approximately 30-AUG-2016 (reported as "a day and a half later"), the patient developed redness and itchiness at the injection site which was also swollen, and the reporting pharmacist believed the patient developed blistered at the injection site. It was also reported that the patient went to unspecified urgent care facility on an unspecified day in regarding to the reactions, treatment was given to the event, but there was no lab test performed. As of 15-SEP-2016, the patient was fine. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.