chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site urticaria, Pharyngeal oedema, Pruritus, Swollen tongue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 41 years old female patient with none pertinent medical history. The patient was vaccinated with RECOMBIVAX HB (Intramuscularly in the left arm) (lot #1111AA, exp date 06-JUN-2014) on 03-JUL-2012. No concomitant medications were reported. On 03-JUL-2012 the patient had an allergic reaction to the RECOMBIVAX HB one hour after vaccination. The patient received adult RECOMBIVAX HB on 03-JUL-2012 and about an hour later developed an itchy scalp, hives on the under arm of the injection site arm and hives at the injection site, itchiness and swelling of the throat and some swelling of the tongue, but no problem breathing. The patient reported that a little while later (time frame unspecified) she developed itching in the stomach, ribs and on the other arm (right arm). The patient informed the office that they took BENADRYL (time frame unspecified) and she felt a little bit better. The patient called the office on 05-JUL-2012 and reported itching and some throat swelling, but the hives were gone. The patient was given prednisone and CLARITIN as treatment on 05-JUL-2012. The patient was referred to an allergist. The allergist called the office (date unspecified) and stated that he felt the patient had an allergic reaction to the RECOMBIVAX HB. The office did not plan on completing the vaccination series. The outcome of the adverse event was recovered/resolved. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Throat irritation, Urticaria, Vaccination complication
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 41 years old female patient with none pertinent medical history. The patient was vaccinated with RECOMBIVAX HB (Intramuscularly in the left arm) (lot #1111AA, exp date 06-JUN-2014) on 03-JUL-2012. No concomitant medications were reported. On 03-JUL-2012 the patient had an allergic reaction to the RECOMBIVAX HB one hour after vaccination. The patient received adult RECOMBIVAX HB on 03-JUL-2012 and about an hour later developed an itchy scalp, hives on the under arm of the injection site arm and hives at the injection site, itchiness and swelling of the throat and some swelling of the tongue, but no problem breathing. The patient reported that a little while later (time frame unspecified) she developed itching in the stomach, ribs and on the other arm (right arm). The patient informed the office that they took BENADRYL (time frame unspecified) and she felt a little bit better. The patient called the office on 05-JUL-2012 and reported itching and some throat swelling, but the hives were gone. The patient was given prednisone and CLARITIN as treatment on 05-JUL-2012. The patient was referred to an allergist. The allergist called the office (date unspecified) and stated that he felt the patient had an allergic reaction to the RECOMBIVAX HB. The office did not plan on completing the vaccination series. The outcome of the adverse event was recovered/resolved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Red warm area about 4 x 2.5 cm with sl larger induration plus supraclavicular & lower out cervical nodes mild body aches.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Red warm area about 4 x 2.5 cm with sl larger induration plus supraclavicular & lower out cervical nodes mild body aches.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Tender red warm area approximately 4 x 5 cm (L) deltoid - no systemic symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tender red warm area approximately 4 x 5 cm (L) deltoid - no systemic symptoms.
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Immediately after vaccine pt c/o severe headache, dizziness, tongue tingling. No hives or local reaction. No trouble swallowing. Resolved without rx after about 2 mins.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Pruritus, Skin tightness
Clinical narrative: 1-2 hrs after High Dose flu shot tight hot redness -> proceeded to vesicles around area - decreased symptoms increased itch by 10/2/12.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Fatigue, Pharyngeal oedema
Clinical narrative: Patient received a flu shot on 9/28/12. She called the pharmacy 9/29 around 10 am. She said her throat started swelling 9/28 & her eyes were running green mucous, very tired. She took BENADRYL and is feeling better.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (Completed FLUMADINE 9-19-12). 9-27-12 noticed apx. 2 inch oval below injection site; red & hot to the touch & painful; states had confirmed flu 2 wks prior.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash began approx 2 weeks after vaccines.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Bump on right arm not treatment.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature, Irritability, Rash generalised
Clinical narrative: Mom states temp since the night of vaccines. Four days later started with rash all over her body. Baby seems irritable. Same reaction with 4 mo shots.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Muscular weakness, Nasopharyngitis
Clinical narrative: Patient experienced rubbery legs, chills, cold, upset stomach, diarrhea.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Convulsion, Loss of consciousness, Pruritus, Urticaria
Clinical narrative: Patient reported waking up the day after both vaccinations with hives and itchy hands. Later that day patient passed out and was taken to hospital. Later that evening, patient had a seizure. Pt has past history of hives, but this was first seizure.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/28/12- Received PNEUMOVAX and Flu (TIV) in left deltoid. 8/30/12- Returned with swelling, erythema, and heat over the administration site. Patient received steroid taper to treat.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysgeusia, Immediate post-injection reaction, Pharyngeal oedema, Swelling face
Clinical narrative: Pt. reported a metallic taste in mouth immediately upon receiving vaccines. Patient later reported swelling of face and throat. Was treated with steroids.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: 3 hrs after shot, body aches, nausea, body chills, fever, headache for approximately 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, pain over 2/3 Lt upper arm, some blistering small area.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Joint swelling, Lip swelling, Nausea, Swollen tongue
Clinical narrative: Nauseated shortly after the shot, lips started swelling after about 30 minutes. Tongue swelling on (R) side, went to sleep about 6-7 pm woke up around tongue still swollen, increased swelling of tongue, around inj. site and left wrist. To ED around 11 pm.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Redness, tenderness and swelling around injection site right deltoid. Chills, nausea, low grade fever, near syncope.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Presyncope, Pyrexia
Clinical narrative: Redness, tenderness and swelling around injection site right deltoid. Chills, nausea, low grade fever, near syncope.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Lymphadenopathy
Clinical narrative: Initial report from immunizing pharmacy, referring to prescriber. Patient felt light-headed after vaccine, reports swollen lymph node in neck of left side starting 3 days after vaccine. now has swollen nodes in left axilla and groin.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Friday 9/7/12 pt noted increase in pain & swelling to (L) deltoid. Called hotline Saturday but no answer. Feels swollen under arm & at site warm to touch. Referred to clinic for tx. Pt would like to delay tx. 1 more day. Taking ADVIL & ice pack. 9/11/12 Left msg for f/u. 9/12/12 Left msg for f/u. 9/16/12 Patient had no treatment & symptoms resolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: AE none. Pt was given expired vaccine. Expired 6/12. Pt. reported no adverse events and was revaccinated 9/25/12.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: Pt reports mild soreness in deltoid as usually occurs with flu (IM) vaccine. Expired flu vaccine administered.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: Pt received vaccine on 9/17. On 9/20 pt came to the pharmacy and showed her arm to me which had an area about 5 inches in diameter which was red. Pt stated rash developed on 9/19, was "itchy" but not hot. Informed her to apply hydrocortisone.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Pain, Paraesthesia
Clinical narrative: The day after I received the flu vaccine, I experienced a numbing and tingling feeling in my right deltoid.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: The day after I received the flu vaccine, I experienced a numbing and tingling feeling in my right deltoid.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Pt. states within 24 hours of receiving vaccine pt. had swelling in arm from elbow to underarm. Pt. took Ibuprofen and BENADRYL and swelling is slowly resolving.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Dry mouth, Ear pain, Epistaxis, Full blood count abnormal, Pain
Clinical narrative: Fever, 102.6; earache, dry mouth, body aches, vomiting x 2, bloody nose.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting, White blood cell count decreased
Clinical narrative: Fever, 102.6; earache, dry mouth, body aches, vomiting x 2, bloody nose.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, aching, cough, sore throat, have had numerous flu shots throughout years. Never any problems (last shot 11-11-11 (dr's office).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Hyperhidrosis, Muscle spasms
Clinical narrative: Weak, sweating, cramps, diarrhea.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patients left arm appears swollen, red, and warm to the touch from the injection site (left deltoid) and extending down just before elbow. Patient reports no difficult breathing, chest tightness or swelling of lips, mouth, or tongue.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Hives each day off & on since HPV given.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Woke at 1:30 pm - fussy - said legs red hip to toes per parent. Per ED note - Erythema without induration warm to touch & tender & TYLENOL given.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Pyrexia, Rash generalised
Clinical narrative: 10 days after receiving vaccine developed blotches of rash on left side arms, legs, back, hairline rash turned into blisters, and are itching. Also low grade fever after rash was gone arm hurt for about a week.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: 10 days after receiving vaccine developed blotches of rash on left side arms, legs, back, hairline rash turned into blisters, and are itching. Also low grade fever after rash was gone arm hurt for about a week.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Grip strength decreased, Myalgia
Clinical narrative: Right deltoid pain. Pain causes loose grip of hand. Difficulty doing house chores.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Urticaria
Clinical narrative: Wife said he had hives and was very fatigued.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site urticaria, Pain, Pyrexia, Swelling
Clinical narrative: "Large hives & redness from (R) shoulder to elbow 101.0 F fever; swelling, pain," pt applied "NEOMYCIN & took TYLENOL & applied ice" "called PCP who advised her to do this" this ARNP recommended BENADRYL date occurred 8/30/31 came to clinic in person on 09/01/12.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness approximately 3 cm around injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Patient complained of very sore, painful arm -> swollen and red lower in arm - hurts to touch.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The liquid portion of MENVEO was given only because there was only one bottle in the box. The bin was labeled "it take two" but I thought that was referring to the number of doses a child had to get not the # of bottles used for a single injection. The patient had no reaction.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after vaccine, patient had tenderness (RD), swelling, redness with heat radiating down arm. It went almost from injection site to elbow. Recommended BENADRYL 50mg every 4-6 hours, ice, and TYLENOL. Recovered after 4-5 days. Ran mild temperature. Reaction happened in arm PNEUMOVAX was given.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed swelling in left arm, from joint of shoulder extending to halfway down to elbow. First noticed symptoms in the middle of the night. It wasn't until she woke up in the morning that she realized it was swollen. She said initially there was warmth & itching but that had resolved by the time she called me late morning. She did not feel reaction was severe or required medical attention. I recommended diphenhydramine, ibuprofen and/or ice compress. She said she may apply ice but no medications.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: I broke out in hives 15 mins after my flu shot and started itching all over, I had to take BENADRYL.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Apparent life threatening event, Cyanosis central, Hypotonia, Skin discolouration
Clinical narrative: 1 day following PENTACEL administration, child had 60 sec. ALTE (apnea, color change, loss of tone, central cyanosis). Fully self-recovered within 5 minutes. No fever. Exam normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Paraesthesia, Skin warm, Tenderness
Clinical narrative: Redness (approximately 7in in diameter); Tenderness. Warm to the touch. On & off tingling sensation down the arm. Darker red in center w/ lighter red around surrounding injection site.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Patient reported swollen arm with redness and warm to touch. Patient never had a reaction in the past to flu shots. Pt reported to MD - found to be localized reaction.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Patient complained of swollen, redness, and tenderness on arm. Patient also had chills. Pt. saw MD and was noted to have a possible reaction to the vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient complained of swollen, redness, and tenderness on arm. Patient also had chills. Pt. saw MD and was noted to have a possible reaction to the vaccine.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Activities of daily living impaired, Erythema, Malaise, Nodule, Oedema peripheral
Clinical narrative: Am became swollen, red painful, & nodules developed under arm with a fever & hot feeling well. Patient had to leave work.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Am became swollen, red painful, & nodules developed under arm with a fever & hot feeling well. Patient had to leave work.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, DTAP, PPV, VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Am became swollen, red painful, & nodules developed under arm with a fever & hot feeling well. Patient had to leave work.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Induration, Lymphadenopathy, Nausea
Clinical narrative: 2 x 2 red indurated area to (L) arm, some axillary lymph nodes, lightheaded, dizziness, modest intermittent nausea.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Injection site warmth
Clinical narrative: Very swollen (L) arm x injection site. Warm to the touch & hard to raise. Suggested pt to take acetaminophen or Ibuprofen and place cold compress to injection site, has been going on 7 / day.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Patient reported swollen, red, itchy arm, but stated it was "getting" better on day of report.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site infection, Swelling
Clinical narrative: Patient called pharmacy & reported a red area & swelling. Went to see doctor & he said it was an infection from injection site.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Skin warm
Clinical narrative: (R) injection site on arm swollen. Hard to move arm and warm to the touch. Suggested to pt. to take Ibuprofen or acetaminophen and use a cold compress to injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchy at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Pruritus, Rash
Clinical narrative: 9-27-12 ZOSTAVAX administered left arm sub-Q post instructing client possible side effects/reactions. Client stayed at office 10 min post injection - no problems. 10-1-12 client calls Health Department office & reports on 9-27-12 evening time itchy/rash. Started on (L) thigh, left wrist - behind knee. Tongue tingling sense - continued Friday & into Saturday. Took BENADRYL Sat pm & Sunday & rash/itching clear - tongue no longer tingle, felt she should call us instructed client to call her PCP.
Age: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: Rash on back, chest & neck, macular papular, pruritic and faint in nature. No swelling of lips or eyes. No shortness of breath. Rash developed 2 days after injection of MENACTRA. Given prescription of methylprednisolone med pack.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain left upper arm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypersomnia, Sensation of heaviness, Vomiting
Clinical narrative: Had the booster flu shot 9/6/12. Next day couldn't move legs and arms were very heavy. Went back to bed and slept 24 hrs. Got up and felt lightheaded and started vomiting. Next day started feeling better. Have flu shots many years and never felt sick.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Palpitations
Clinical narrative: (1) Weakness. (2) Diarrhea. (3) Heart racing. (4) Decreased appetite.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Continued, persistent shoulder pain at site of vaccine administration - currently being treated with NSAID's.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site discolouration, Vaccination site haematoma, Vaccination site nodule
Clinical narrative: Within 5 minutes of receiving vaccine, vaccination site was bruised, discolored, & knotted.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Headache, Nausea, Palmar erythema, Pruritus
Clinical narrative: Vaccines were given at 1515 at 1525 when checking out pt. c/o H.A, itchy feet, nausea, palm of hands very red. 1530 - blotchy red rash all over. 1555 BENADRYL 12.5 mg/5 ml - 8 ml given p.o. 1610 - rash & redness decreased. 1645 - Rash increased, face red & swollen with increased itching. 1650 - Epinephrine 0.17 mg given IM. 1655 - Face improved decreased swelling. 1715 Transported to ED.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular, Swelling face
Clinical narrative: Vaccines were given at 1515 at 1525 when checking out pt. c/o H.A, itchy feet, nausea, palm of hands very red. 1530 - blotchy red rash all over. 1555 BENADRYL 12.5 mg/5 ml - 8 ml given p.o. 1610 - rash & redness decreased. 1645 - Rash increased, face red & swollen with increased itching. 1650 - Epinephrine 0.17 mg given IM. 1655 - Face improved decreased swelling. 1715 Transported to ED.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at and around injection site (upper arm) and down to elbow. Accompanied by pain and skin warm to touch. Reaction occurred 2 days post vaccine. Treated with oral BENADRYL. Right side.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on neck and chest.
Age: 1.03
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Patient developed a rash all over body onset 10/1/12.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient described rash & itching on arms and upper torso beginning evening after administration.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Develop severe rash all over the body.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Injection site pain, Injection site swelling
Clinical narrative: Pt. received vaccination of FLUARIX; injection started to swell, asked pt to wait 15 mins; gave pt diphenhydramine 25mg and asked to wait 30 mins. Pain at site and swelling; I then went to Dr. explained what had occurred; schedule pt for a visit and Dr. identified hematoma.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site rash
Clinical narrative: Pt received ZOSTAVAX sub-q. Later redness at site of inj. Gave pt BENADRYL. Pt. called 7pm said she felt ok (9/24). 9/27, pt called 9:10am said area is red and small bump has formed. Asked pt to call primary care physician if not better by 9/28/12.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: 48 hrs after vaccine, mom reported low grade fever, vomiting, (L) arm red, swollen, hard (approximately 5 inches).
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Urticaria
Clinical narrative: Localized erythema, induration within 1 hour started with redness & itching. (L) deltoid 3.5 x 4.0 cm - welt.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Malaise, Pain, Rash, Rash vesicular
Clinical narrative: Patient received both Flu and ZOSTAVAX vaccines on 9/26/12. Few hours later she developed rash and like chicken pox at the chest and upper torso. Feel pain and ache at the T2-L2. She was administered BENADRYL and shot for pain. Later discharged. Still feel sick and had rash one day later.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Rash pruritic
Clinical narrative: Patient received both Flu and ZOSTAVAX vaccines on 9/26/12. Few hours later she developed rash and like chicken pox at the chest and upper torso. Feel pain and ache at the T2-L2. She was administered BENADRYL and shot for pain. Later discharged. Still feel sick and had rash one day later.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Had C7-C8 right shingles starting 2-3 days after vaccine injection. Vesicular rash start soon after pain starting.
Age: 0.23
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: Pt given expired rotavirus. Exp date 9-8-12.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Lymphadenopathy, Mass
Clinical narrative: Lymphadenopathy: left lump on left clavicle area, tender touch at injection site, slight redness for 1 day, still has small hardened area under skin at injection site.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Fever, pain at injection site. Redness and swelling below the injection - 3 days.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edema to (R) thigh. Redness to (R) thigh. Warmth to (R) thigh.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Injection site erythema, Injection site oedema, Irritability
Clinical narrative: Within 1 hour of vaccine became inconsolable, refusing feeds. Take to the ER - no fever but the right thigh had become edematous, 60% of the skin on the right thigh centered at the vaccine site was intensely erythematous. Treated with TYLENOL & BENADRYL. Gradually improved over 24 hours.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Tdap shot ~16 hr. later soreness at site, around 24h. later redness started - no itching - some pain. 14cm x 13cm upper (L) arm area.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: Pt. c/o sore throat cough, starting day after flu shot given. Pt was checked out 9/21 & 9/23, dx with URI, advised supportive tx & to seek further care with any increased problem.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Myalgia, Rash
Clinical narrative: Shot given by pharmacy. The symptoms rash on trunk of body to pubic area & back from neck to buttock fatigue/soreness by injection/site/muscle aches. Rx - MEDROL pack from MD. Shot given 9/12/2012.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose and route not reported) on 13-SEP-2012 and was put on generic cefdinir (manufacturer unknown) on 21-SEP-2012 and experienced a rash (date not reported). The patient was switched to doxycycline (manufacturer unknown) on 24-SEP-2012. On 25-SEP-2012 the patient had a prescription for a steroid pack because the patient had hives all over. It was not reported if the patient sought for medical attention. The patient's status was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: This spontaneous report was received from an 18 year old male patient, as part of a marketing research program (manufacturer number MRK239), concerning himself. The patient was vaccinated with a dose of GARDASIL (lot# not reported) in AUGUST 2012. In AUGUST 2012, the patient experienced dizziness/faintness and pain in arm. The outcome of pain in arm and dizziness/faintness was reported as recovering/resolving. The reporter considered dizziness/faintness and pain in arm was related to GARDASIL. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a currently 10 weeks old female patient who on 10-SEP-2012 was vaccinated orally with a 2 ml expired dose of ROTATEQ, Lot #1527Z, exp date: 29-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported at that time. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Injection site papule, Pruritus generalised, Rash, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old male patient with amoxicillin allergy. The patient's medical history included recent ankle fracture. The patient was vaccinated with dose 1 GARDASIL around 15-JUN-2012. On 29-AUG-2012, the patient received second dose of GARDASIL (left deltoid). Concomitant medications included MINOCIN and LOVENOX. On 29-AUG-2012, the physician reported that his son received dose 2 of GARDASIL and that later that afternoon he developed papules near the site of injection. Later that same day, he developed generalized itching of his trunk with hives but his back and lower extremities were not affected. He had erythema on both arms. There was a maculopapular rash around his umbilicus and pubic area. The GARDASIL was administered by a Doctor who recommended the patient to be treated with BENADRYL and ZANTAC. No laboratory tests were performed. The physician said his son had no symptoms after receiving dose 1 of GARDASIL. The outcome of the events was reported as not recovered. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old male patient with amoxicillin allergy. The patient's medical history included recent ankle fracture. The patient was vaccinated with dose 1 GARDASIL around 15-JUN-2012. On 29-AUG-2012, the patient received second dose of GARDASIL (left deltoid). Concomitant medications included MINOCIN and LOVENOX. On 29-AUG-2012, the physician reported that his son received dose 2 of GARDASIL and that later that afternoon he developed papules near the site of injection. Later that same day, he developed generalized itching of his trunk with hives but his back and lower extremities were not affected. He had erythema on both arms. There was a maculopapular rash around his umbilicus and pubic area. The GARDASIL was administered by a Doctor who recommended the patient to be treated with BENADRYL and ZANTAC. No laboratory tests were performed. The physician said his son had no symptoms after receiving dose 1 of GARDASIL. The outcome of the events was reported as not recovered. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Fatigue, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 63 years old male patient, who in approximately 2010 ("about 2 years ago") was vaccinated with a dose of PNEUMOVAX23 0.5 ml intramuscularly (lot # not reported) and on an unknown date he experienced extreme fatigue and achiness and was in bed about 5 days. No treatment was given. The outcome of extreme fatigue and achiness was reported as recovered (date unspecified). The patient did not seek medical attention. The relatedness for achiness and extreme fatigue was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 70 year old male patient with no medical history and concurrent condition who on 02-JUL-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck), 0.65ml. There was no concomitant medication. The pharmacist mentioned that in June 2012, the patient developed redness and pus at the injection site. The patient contacted pharmacist for seeking medical attention. There was no lab performed. At the time of the report, the patient was not recovered. Follow-up information has been received from the pharmacist concerning a 70 year old male patient, who on 02-JUL-2012 was vaccinated with the first dose of ZOSTAVAX SQ in right arm (lot # 671660/1254AA, Exp: 01-NOV-2012). The pharmacist reported that the patient called and reported that on 03-JUN-2012 the injection site started to get red and sore and slightly swollen. The patient said he would call his doctor and notify him. The patient did not seek medical attention. The pharmacist called the patient back after 3 days and he said it looked better. The patient did not anymore voiced other complaints. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female acquaintance of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that she "heard" that on an unknown date, the female got shingles post vaccination. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient got shingles post vaccination was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On June 2012, the patient was vaccinated subcutaneously (SQ) with, 0.65 ml ZOSTAVAX. The nurse called to report that her husband was administered in the fatty area in the back of his upper arm at a pharmacy about 2 months ago. No adverse effect reported. The outcome of the event was unknown. The event was not related to ZOSTAVAX. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a male patient in his late 60s or early 70s, who on an unknown date, was vaccinated once with a 0.65 ml dose of ZOSTAVAX (route and lot number not reported). No other co-suspects were reported. The physician reported that the patient came to the office on an unknown date and got an unspecified flu vaccine and a few days later he developed shingles on an unspecified date. No treatment information was reported. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for patient developed shingles was unknown for ZOSTAVAX. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Had booster flu shot 9/6/12 on 9/17/12 was dizzy and had a headache for a day and a half.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during breast feeding, Injury associated with device
Clinical narrative: Information has been received from a pharmacist concerning a 30 years old female - another pharmacist, who is currently lactating and was preparing to administer a dose of ZOSTAVAX (lot # not reported) to a patient on 11-SEP-2012 (today), when she accidentally pricked her finger with the administration needle. She immediately washed her finger with the needle puncture would on it. She had not sought medical attention at the moment, because the incident had occurred 20 minutes prior to the time of reporting. The patient for which the dose of ZOSTAVAX was intended did not miss a dose because another dose of ZOSTAVAX was prepared for the patient and administered at that time. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient, who on 11-SEP-2012 was vaccinated with a dose of ZOSTAVAX (also reported PNEUMOVAX), dose and route not reported (lot # 0468AE - in validation, expiration date 04-APR-2013). It was reported that, in September 2012, the patient developed redness and swelling at the injection site as well as a headache. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her 15 years old son who in April 2011, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) and he did not get his second dose of GARDASIL and it had been more than a year. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist refers to her 5 years old female child with no pertinent medical history and no drug reactions or allergies, who on an unknown date was vaccinated with a dose of VARIVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 02-AUG-2012, her child broke out in a rash that looked like chickenpox. Oatmeal bath was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient contacted her mother, the pharmacist. The relatedness for patient broke out in a rash that looked like chicken pox was unknown for VARIVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 65 year old female patient with Hydrocodone Bitartrate and VICODIN and LEVAQUIN allergy. On 22-AUG-2012, the patient was vaccinated subcutaneously with a dose of 0.65 ml of ZOSTAVAX (lot #: 0071AE; Exp date: 03-APR-2013). On approximately 24-AUG-2012 "approximately 2 days later", the patient developed an injection site rash. The patient sought medical attention 29-AUG-2012 by contacting the pharmacist to examine her rash. No treatment was given for the event. Pharmacist reported that the rash extended from the injection site proximally 4 inches and was 1 inch wide. The patient told the pharmacist that "the rash was improving, and that she was keeping it covered to avoid transmitting the zoster virus (VZV) to susceptible contacts". There were no laboratory diagnostic test performed. At the time of the report, the patient's outcome for injection site rash and VZV were reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 08-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (Lot number: 670820/0660AA) that had expired on 04-AUG-2012. No concomitant medications were reported. No adverse event effect reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Doctor of pharmacy (Pharm D.), concerning a 79 year old male patient. The patient had no known drug allergies. On 07-AUG-2012, the patient was vaccinated subcutaneously in the right arm, with a dose of ZOSTAVAX (lot #: 0562AE; expiration date: 20-MAR-2012). The pharmacist reported that in approximately August 2012, the patient developed a red, raised, oblong area on his arm at the injection site after receiving ZOSTAVAX. The patient sought medical attention by calling to the pharmacy. No treatment was given for the events. There was no intervention to prevent serious criteria. The pharmacist stated that "in the past few days", the area seemed to be improving. At the time of the report, the patient was recovering from the events. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 54 year old female patient with a history of chickenpox as a child. The patient's concurrent conditions included hypertension, diabetes (non insulin dependent), hypothyroidism, hypercholesterolemia and smoker "smokes half pack per day". On 28-MAR-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route was not reported) in the right arm(lot #:672557/1601AA; expiration date: 13-JAN-2013). Concomitant medications included verapamil, lisinopril (manufacturer unknown), metformin, ACTOSE, JANUVIA, levothyroxine sodium, and LOVASA. N.P. reported that in "late" MAY 2012 the patient developed a rash on her face. Patient sought medical attention and went to the emergency room (E.R.) Unspecified antibiotics and cream were given as treatment for the event. It was reported that the rash "comes and goes". N.P. stated that she had "given hundreds of ZOSTAVAX doses and had not seen this type rash before". No lab diagnostic studies were performed. At the time of the report, the patient's outcome for rash on her face was unknown. Additional information has been requested.
Age: 46.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 46 years old patient who on 22-AUG-2012, was vaccinated with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1033AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse regarding a 67 year old female who was vaccinated with a dose of GARDASIL. It was reported that the patient erroneously received a dose of ADACEL in the office. No adverse symptoms reported. No further information provided. Additional information requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse referring a patient of unknown age who was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 26-APR-2009 and on 26-JUL-2012 was vaccinated with a second dose of GARDASIL (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 19 years old patient who on 29-AUG-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 55 years old patient who on 22-AUG-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 18 years old patient who on 29-AUG-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 44 years old patient who on 04-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 years old female patient who on 15-SEP-2012 was vaccinated with single 0.65 ml dose of ZOSTAVAX subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included estradiol and timolol (manufacturer unknown). The pharmacist reported that the patient came back into the pharmacy on 18-SEP-2012 with a red area about the size of a quarter with warmth at the immediate injection site and a larger red area about 4 or 5 inches in diameter around the smaller red area. The patient experienced the adverse events several days after the injection. The patient took aspirin and the pharmacist suggested TYLENOL for the treatment of adverse events. The patient's outcome for the adverse event was not reported. The relatedness for the adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 50 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.