chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Incorrect route of drug administration, Injection site pain
Clinical narrative: Initial unsolicited report received from a physician on 11-Jan-2018. This case involves a 4-year-old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (Batch no: C5248AA) via subcutaneous route at right thigh and also with 0.5ml dose of PROQUAD via intramuscular route (Batch number: N020619) at left thigh (expiry date and dose in series were not reported for both the vaccines) on 10-Jan-2018. Patient's medical history and concomitant medications were not reported. Pt did not have any chronic illness, no known drug allergy. It was also reported that this was a well visit for vaccination. On an unknown day following the vaccination, patient's right thigh had local tenderness to the injection site and was limping and dragging the right foot. No other symptoms were reported. It was also a case of actual medication error due to inappropriate route of vaccination as patient received QUADRACEL subcutaneously instead of intramuscularly. Laboratory investigations and corrective treatment were not reported. The outcome of the events limping and vaccination site tenderness were not recovered at time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from an other non-health professional on 11 Jan 2018. This case was linked with 2018SA014660. This case involves a patient of unknown age and gender, who was vaccinated with 0.5 ml dose of ADACEL once via intramuscular route (Batch number: U5879AB, expiration date: 13-Mar-2020, dose in series and site of administration were not reported) on an unknown date (reported as 12/17). Patient's medical history and concomitant medications were not reported. On an unknown day (reported as 1/17), following the vaccination, the patient had flu like symptoms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from an other non-health professional on 11- Jan-2018. This case was linked with 2018SA012740. This case involves a patient of unknown age and gender, who was vaccinated with 0.5 ml dose of ADACEL once via intramuscular route (Batch number: U5879AB, expiration date: 13-Mar-2020, dose in series and site of administration were not reported) on an unknown date (reported as 01/17). Patient's medical history and concomitant medications were not reported. On an unknown day (reported as 1/17), following the vaccination, the patient had flu like symptoms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Influenza vaccine Quadrivalent. Additional information was provided as follows: The age at vaccination was not reported. The patient received a Flu vaccine (manufacturer unknown) several years ago. The patient experienced arm redness and arm soreness after injection. The events lasted for about one day. The patient declined to proceed with safety report.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye swelling, Oropharyngeal pain, Swollen tongue
Clinical narrative: Started with sore throat then eyes started swelling-tongue was swelled started coughing couldn't breathe.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 48-year-old female patient who received SHINGRIX. Concomitant products included PRISTIQ. On 26th December 2017, the patient received the 1st dose of SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site itching, injection site induration, injection sire discoloration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site itching, injection site induration, injection site discoloration, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provide as follows: The patient received the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Almost immediately, the site of injection turned red and the redness was spreading around bigger and bigger. The reporter said that the site of injection itched, hurt and was hard. She said that it even hurt if something touched it. The redness and other symptoms went away after one week and a half. After the redness went away, the patient started having discoloration or brownness at the injection site. The patient said that she had an x-ray that same day before having the injection, and she hoped that would not be a problem.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 48-year-old female patient who received SHINGRIX. Concomitant products included PRISTIQ. On 26th December 2017, the patient received the 1st dose of SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site itching, injection site induration, injection sire discoloration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site itching, injection site induration, injection site discoloration, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provide as follows: The patient received the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Almost immediately, the site of injection turned red and the redness was spreading around bigger and bigger. The reporter said that the site of injection itched, hurt and was hard. She said that it even hurt if something touched it. The redness and other symptoms went away after one week and a half. After the redness went away, the patient started having discoloration or brownness at the injection site. The patient said that she had an x-ray that same day before having the injection, and she hoped that would not be a problem.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Drug administered to patient of inappropriate age, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 48-year-old female patient who received SHINGRIX. Concomitant products included PRISTIQ. On 26th December 2017, the patient received the 1st dose of SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site itching, injection site induration, injection sire discoloration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site itching, injection site induration, injection site discoloration, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provide as follows: The patient received the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Almost immediately, the site of injection turned red and the redness was spreading around bigger and bigger. The reporter said that the site of injection itched, hurt and was hard. She said that it even hurt if something touched it. The redness and other symptoms went away after one week and a half. After the redness went away, the patient started having discoloration or brownness at the injection site. The patient said that she had an x-ray that same day before having the injection, and she hoped that would not be a problem.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Five papular rash on torso.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 11-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, first dose, lot# N020616, expiration date 22-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of -12.1 °C, during 1 hour 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles after getting the SHINGRIX vaccine.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site hypoaesthesia, Sensory loss
Clinical narrative: Patient stated that immediately after the shot was administered he felt numbness in his right arm that was vaccinated from elbow to the shoulder. His sensitivity to touch has been decreased but he feels a burning sensation when touched or moving the arm. He has not tried anything to treat it except moving his arms through exercise and work. It has been 16 days before he mentioned it to me.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Red patch on arm the day after shot.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Right upper arm arthralgia- pain in right shoulder and sometimes in right antecubital area.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Chills, Erythema, Pyrexia, Urticaria
Clinical narrative: Fever and chills, red welt reported by patient to her physician and to the pharmacy.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE EVENT. PEDS DOSE GIVEN TO ADULT PATIENT.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Product administered at inappropriate site, Pruritus
Clinical narrative: Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin discolouration, Skin warm, Swelling, Tenderness, Wound secretion
Clinical narrative: Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Local reaction
Clinical narrative: Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin discolouration, Skin disorder
Clinical narrative: Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Administering nurse purposefully injected the vaccine in the volar aspect of the upper left forearm in an attempt to give it subcutaneously. It is suspected however that the vaccine was administered intradermally. The patient reported that 3 days later she noted redness. The redness measured 2 inches wide by 2 inches long and did not change over the first 3 days after it appeared. Today it measures 7 cm by 7 cm and is bigger than it was yesterday substantially. It was initially more red 3 days ago and then the redness has improved and today it worsened in size swelling pain and tenderness. She has itching and warmth locally. No fevers. The redness has not receded. She has a tiny brown mark in the center that is new as of one day and apparent oozing new today. She had some Ibuprofen and BENADRYL 2-3 days ago. She did not take any medications yesterday or today. She is otherwise healthy. She has never reacted to any immunizations prior.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dyspnoea, Flushing, Heart rate increased, Injection site pain
Clinical narrative: Patient is a 33 year old female is here today with a possible allergic reaction to the flu vax, just received less than 10" ago. She has received flu vaccines in the past without reaction, no history of allergy, including foods. No upper respiratory infection symptoms, felt well today. Received the vaccine in the L deltoid, hurt a bit more than previous. Felt flushed, with rapid heartbeat, mild SOB, no throat tightness, no reaction at the vaccine site, felt anxious, is with her young daughter. No chest pain, no palpitations, no nausea, no vomiting, no neuro symptoms, but is understandingly anxious. No wheezing. O-BP 104/68 | Pulse 75 | Temp (Src) 98 °F (36.7 °C) (Oral) | Resp 16 | SpO2 97% | LMP 11/26/2017 well nourished well developed female in no acute distress but slightly anxious. Lungs-clear. CV-regular rate normal S1S2 without murmur. Eyes-extra ocular motions intact, pupils equal and reactive to light and accommodation. Neck-supple without adenopathy. Throat-airway open and clear, no lip or oral swelling. Skin-flushed at her face, no urticaria, injection site is clear without erythema or swelling,  No dermatographism. Patient is given benadryl 25mg po and prednisone 40mg po and then observed, with no further reaction. A-possible reaction to the flu vaccine, consider also anxiety reaction as well. Discussed at some length. P-reassurance, information given, repeat benadryl at bedtime, if any further symptoms continue benadryl and start prednisone, return to clinic if no improvement.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Discomfort, Dizziness, Epigastric discomfort, Hyperhidrosis
Clinical narrative: Patient is a 36 year old female here to influenza vaccine clinic. About 2 min after receiving injection patient became light headed, developed red rash, felt FB sensation in throat. Diffuse itching. Feels tight in epigastric area. Has had flu shot before, remote Patient Active Problem List: Hyperhidrosis;   Malabsorption Soc Married. Current Medications Current Outpatient Prescriptions Medication fluticasone propionate (FLOVENT HFA) 110mcg Oral Inhaler fluticasone/salmeterol (ADVAIR DISKUS) 250mcg/50mcg Oral Inhaler No current facility-administered medications for this visit.  OBJECTIVE: There were no vitals taken for this visit. Vitals were recorded for visit but are in another encounter Patient uncomfortable and anxious Patient tachycardic, BP wnl, O2 Sat 98 % Conjunctiva without erythema Nose neg rhinorrhea OP mild edema and erythema Lungs CTA BBS Diffuse erythema about neck/chest/trunk/extremities Given possible swelling in throat And FB sensation in throat Given IM epinephrine, IM Benadryl  Rash improved significantly after medications.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema, Pruritus, Rash erythematous, Sensation of foreign body, Tachycardia
Clinical narrative: Patient is a 36 year old female here to influenza vaccine clinic. About 2 min after receiving injection patient became light headed, developed red rash, felt FB sensation in throat. Diffuse itching. Feels tight in epigastric area. Has had flu shot before, remote Patient Active Problem List: Hyperhidrosis;   Malabsorption Soc Married. Current Medications Current Outpatient Prescriptions Medication fluticasone propionate (FLOVENT HFA) 110mcg Oral Inhaler fluticasone/salmeterol (ADVAIR DISKUS) 250mcg/50mcg Oral Inhaler No current facility-administered medications for this visit.  OBJECTIVE: There were no vitals taken for this visit. Vitals were recorded for visit but are in another encounter Patient uncomfortable and anxious Patient tachycardic, BP wnl, O2 Sat 98 % Conjunctiva without erythema Nose neg rhinorrhea OP mild edema and erythema Lungs CTA BBS Diffuse erythema about neck/chest/trunk/extremities Given possible swelling in throat And FB sensation in throat Given IM epinephrine, IM Benadryl  Rash improved significantly after medications.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 32 year old female patient. No information regarding the patient's concomitant therapies was provided. The patient did not have pre-existing physician diagnosed allergies, birth defects or medical conditions. On 01-DEC-2017, the patient was vaccinated with the firs dose of VARIVAX subcutaneous, lot # M038857, lot expiration: 14-SEP-2018 (strength and anatomical location were not provided) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On 06-DEC-2017 (also reported as: "5 days after vaccination"), there was a positive unspecified pregnancy test, however no adverse event was reported.
Sex: U
Vaccine: HEPA, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Information regarding their medical history and concomitant medications was not provided. On an unknown dates from 15-DEC-2017 to 01-JAN-2018, the patients were vaccinated with improperly stored doses of ROTATEQ lot # N005617, expiration date 03-OCT-2018 (strength and dose were not provided), VAQTA lot # M038572, expiration date 11-MAR-2018 (strength, dose and route were not provided) and PNEUMOVAX 23 lot # N025656, expiration date 19-APR-2019 (strength, dose and route were not provided), all for prophylaxis. No adverse effects were reported. There was a data logger involved. Time frame and temperature excursion details were not provided. There was previous unspecified temperature excursion.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Abnormal behaviour, Crying, Culture stool negative, Diarrhoea, Emotional distress
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Faeces pale, Parasite stool test negative, Poor quality sleep, Stool analysis normal, Streptococcus test negative
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Vomiting projectile
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Abnormal behaviour, Asthenia, Crying, Decreased interest, Diarrhoea
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Faeces discoloured, Fatigue, Influenza virus test negative, Injection site erythema, Injection site induration
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Rash, Screaming, Sleep disorder, Stool analysis normal, Streptococcus test negative
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, FLU4, HEPA, MMR, PNC13
Symptoms: Urticaria, Vomiting projectile, Weight decreased
Clinical narrative: "Projectile" vomiting 2-3 times and "white" diarrhea for approximately one week. Mother's primary concern was "behavior changes" which lasted 6 days. Behavior changes included not sleeping well at night and for naps, crying more frequently, inconsolable, and "not acting himself".
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Basophil count decreased, Basophil percentage decreased, C-reactive protein increased, Eosinophil count normal
Clinical narrative: Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eosinophil percentage, Fontanelle bulging, Haematocrit normal, Haemoglobin normal, Lymphocyte count increased
Clinical narrative: Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count increased
Clinical narrative: Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage decreased, Platelet count normal, Red blood cell count normal
Clinical narrative: Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red cell distribution width normal, Ultrasound skull normal, White blood cell count increased
Clinical narrative: Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient received a flu shot in her right arm and the next day she noticed it started to swell and turn red. Three days later she realized that it was getting worse and came to the pharmacy. By then it was 3 inches in diameter.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Feeling of body temperature change
Clinical narrative: Patient unsure if her symptoms are related to this vaccine. Patient reports that she has some diarrhea, hot and cold chills and no other side effects. Patient reports that these symptoms lasted for 24 hours and then went away.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 10th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site induration were unknown and the outcome of the fatigue, myalgia, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a very severe local reaction with pain and tenderness, erythema and induration. The erythema was extended approximately 3 inches in diameter around the injection site. The patient had myalgias and fevers and some intermittent nausea with fatigue. All the symptoms and signs were improving at the time of reporting although the injection site remains erythematous indurated and quite painful. No additional information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 10th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site induration were unknown and the outcome of the fatigue, myalgia, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a very severe local reaction with pain and tenderness, erythema and induration. The erythema was extended approximately 3 inches in diameter around the injection site. The patient had myalgias and fevers and some intermittent nausea with fatigue. All the symptoms and signs were improving at the time of reporting although the injection site remains erythematous indurated and quite painful. No additional information provided.
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Confusional state, Dizziness, Dysphagia, Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of dizziness in a female patient who received BEXSERO. On 10th January 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced dizziness, confusion, tremor, nausea, facial swelling, red face and facial pain. On 11th January 2018, the patient experienced swallowing difficult and hives. In January 2018, the outcome of the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain and swallowing difficult were recovered/resolved. On an unknown date, the outcome of the hives was unknown. The reporter considered the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain, swallowing difficult and hives to be probably related to BEXSERO. Additional details were provided as follows: Medical Science liaison reported on behalf of health care professional. The patient was administered BEXSERO in the morning. Later in day, patient experienced dizziness, confusion, shakiness and nausea, followed by red swollen and painful cheeks. On 11th January 2018 in the morning, one day after receiving vaccination, the patient experienced hives on chest, shoulder and legs appeared along with difficulty swallowing (no respiratory distress). The patient reached out to facility in afternoon. The patient told to be seen immediately. When the patient was seen at 5pm on only remaining event was hives. The Medical Assistant (not reporter) noted hives as itchy and painful on right hand which spread to left shoulder and left side of chest; no mention of hive on legs.
Sex: F
Vaccine: MENB
Symptoms: Facial pain, Musculoskeletal pain, Nausea, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of dizziness in a female patient who received BEXSERO. On 10th January 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced dizziness, confusion, tremor, nausea, facial swelling, red face and facial pain. On 11th January 2018, the patient experienced swallowing difficult and hives. In January 2018, the outcome of the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain and swallowing difficult were recovered/resolved. On an unknown date, the outcome of the hives was unknown. The reporter considered the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain, swallowing difficult and hives to be probably related to BEXSERO. Additional details were provided as follows: Medical Science liaison reported on behalf of health care professional. The patient was administered BEXSERO in the morning. Later in day, patient experienced dizziness, confusion, shakiness and nausea, followed by red swollen and painful cheeks. On 11th January 2018 in the morning, one day after receiving vaccination, the patient experienced hives on chest, shoulder and legs appeared along with difficulty swallowing (no respiratory distress). The patient reached out to facility in afternoon. The patient told to be seen immediately. When the patient was seen at 5pm on only remaining event was hives. The Medical Assistant (not reporter) noted hives as itchy and painful on right hand which spread to left shoulder and left side of chest; no mention of hive on legs.
Sex: F
Vaccine: MENB
Symptoms: Swelling face, Tremor, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of dizziness in a female patient who received BEXSERO. On 10th January 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced dizziness, confusion, tremor, nausea, facial swelling, red face and facial pain. On 11th January 2018, the patient experienced swallowing difficult and hives. In January 2018, the outcome of the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain and swallowing difficult were recovered/resolved. On an unknown date, the outcome of the hives was unknown. The reporter considered the dizziness, confusion, tremor, nausea, facial swelling, red face, facial pain, swallowing difficult and hives to be probably related to BEXSERO. Additional details were provided as follows: Medical Science liaison reported on behalf of health care professional. The patient was administered BEXSERO in the morning. Later in day, patient experienced dizziness, confusion, shakiness and nausea, followed by red swollen and painful cheeks. On 11th January 2018 in the morning, one day after receiving vaccination, the patient experienced hives on chest, shoulder and legs appeared along with difficulty swallowing (no respiratory distress). The patient reached out to facility in afternoon. The patient told to be seen immediately. When the patient was seen at 5pm on only remaining event was hives. The Medical Assistant (not reporter) noted hives as itchy and painful on right hand which spread to left shoulder and left side of chest; no mention of hive on legs.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received PEDIARIX (batch number 7275T, expiry date unknown). On 29th December 2017, the patient received PEDIARIX. On an unknown date, less than a month after receiving PEDIARIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs to be related to PEDIARIX. Additional details were provided as follows: The patient experienced baseball size redness on the thigh. This case has been linked with case US2018005860 and US2018005859 reported by the same reporter.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site.  Warm to the touch.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Aphasia, Guillain-Barre syndrome, Hypoaesthesia, Influenza, Laboratory test
Clinical narrative: Got a cold which turned into flu for several weeks. Thought he was beginning to get better, when feet started feeling numb, etc. Planned to go to doctor on a Monday to get checked out for numb feet and now hands, however, on Sunday could not move or talk. Fire department and paramedics had to break in my apartment to get to me after a friend called and could not reach me. I was diagnosed with Guillain Barre Syndrome (GBS). I am still unable to move. I need get in and out of bed, dressed, everything. I am in a healthcare facility. Once someone puts me in a wheel chair, I can wheel myself around the hospital/care center.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nasopharyngitis, Wheelchair user
Clinical narrative: Got a cold which turned into flu for several weeks. Thought he was beginning to get better, when feet started feeling numb, etc. Planned to go to doctor on a Monday to get checked out for numb feet and now hands, however, on Sunday could not move or talk. Fire department and paramedics had to break in my apartment to get to me after a friend called and could not reach me. I was diagnosed with Guillain Barre Syndrome (GBS). I am still unable to move. I need get in and out of bed, dressed, everything. I am in a healthcare facility. Once someone puts me in a wheel chair, I can wheel myself around the hospital/care center.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and slight swelling at injection site. Warm to the touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Lethargy, Muscular weakness
Clinical narrative: Patient stated she started with soreness at the injection site and then the next day she had headache, joint pain, lethargy and muscle weakness/pain which lasted for 4 days. She would like to know if she should risk getting the second dose. She is worried the symptoms might be worse the next time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient stated she started with soreness at the injection site and then the next day she had headache, joint pain, lethargy and muscle weakness/pain which lasted for 4 days. She would like to know if she should risk getting the second dose. She is worried the symptoms might be worse the next time.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient called pharmacy around 8 pm Mon 1/22. She stated that she received 2 immunizations on Saturday, 1/20, the influenza and pneumonia vaccines. Patient stated that a female pharmacist gave her the immunizations and counseled her that she would not develop any side effects such as feeling "sick" or any soreness/redness at the site of injection. Patient states that all day Sunday she felt very ill and had a fever of 104. She also stated that she could not feel her arm and she had redness and swelling at the site of injection. On Mon 1/22, she states that her fever and symptoms of feeling ill subsided, but her arm was even more red and swollen, and she was experiencing numbness/tingling in her fingertips of the same arm. She then stated that her mom had been drawing circles around the area of redness and the circles had "gotten bigger," and the redness was now spreading up onto her shoulder and chest area. It was at that time she was instructed to go to the emergency room.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Patient called pharmacy around 8 pm Mon 1/22. She stated that she received 2 immunizations on Saturday, 1/20, the influenza and pneumonia vaccines. Patient stated that a female pharmacist gave her the immunizations and counseled her that she would not develop any side effects such as feeling "sick" or any soreness/redness at the site of injection. Patient states that all day Sunday she felt very ill and had a fever of 104. She also stated that she could not feel her arm and she had redness and swelling at the site of injection. On Mon 1/22, she states that her fever and symptoms of feeling ill subsided, but her arm was even more red and swollen, and she was experiencing numbness/tingling in her fingertips of the same arm. She then stated that her mom had been drawing circles around the area of redness and the circles had "gotten bigger," and the redness was now spreading up onto her shoulder and chest area. It was at that time she was instructed to go to the emergency room.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Hypoglycaemia, Influenza like illness, Insomnia
Clinical narrative: Later that night flu like symptoms for 48 hours, pain, SOB, heavy chest, sleeplessness, tachycardia, hypoglycemic event.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tachycardia
Clinical narrative: Later that night flu like symptoms for 48 hours, pain, SOB, heavy chest, sleeplessness, tachycardia, hypoglycemic event.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray, Cough, Inflammation, Lethargy, Pyrexia
Clinical narrative: Day of immunization developed fever of 102.8 taken rectally, a cough, was lethargic, vomiting couple of times. Parents took child to urgent care who thought it might be a bad reaction to vaccine. Symptoms lasted 2 days and then fever broke, slight cough for 1 wk after, did have x-ray of lung - slight inflammation but no treatment, no major irritation at site of infection.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: Day of immunization developed fever of 102.8 taken rectally, a cough, was lethargic, vomiting couple of times. Parents took child to urgent care who thought it might be a bad reaction to vaccine. Symptoms lasted 2 days and then fever broke, slight cough for 1 wk after, did have x-ray of lung - slight inflammation but no treatment, no major irritation at site of infection.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient complained of extreme soreness that had a quick onset. She felt nothing during the injection, nor any soreness for the hours in between. She was not able to lift her arm above the waistline. She took naproxen and used a heating pad. The following day, she kept the arm moving and took more naproxen. She reported soreness, but not near as bad.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Erythema, Inflammation, Skin warm
Clinical narrative: Redness, inflammation, hot to the touch.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red, bumpy rash that began a few days after the vaccine.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Wrist surgery
Clinical narrative: Pt came to clinic on 1/23/18 and reported that she has had pain at injection site since administration on 11/1/17. Pt had had surgeries on wrist on same arm, possible nerve inflammation/irritation triggered higher up in upper arm after flu shot injection. Provider advised pt to schedule an apt for evaluation with her PCP to assess arm.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Patient felt a little nausea, then he appeared to lose consciousness for about 1 to 2 minutes and was slouched over. He recovered, and after a few minutes he felt fine. He left the facility with no other adverse affects.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient called and said she is experiencing a red, swollen, warm, 4 inch around spot under the injection site.