chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: manufacturercity: manufacturerstate: manufacturercountry:; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:  manufacturercity:; manufacturerstate: ; manufacturercountry:; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Swelling
Clinical narrative: Allergic reaction; swelling in his trunk; web-like rash; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergic reaction, swelling and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the swelling and rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix. The reporter considered the swelling and rash to be related to Shingrix.  Additional details were provided as follows: The patient had 1st dose of Shingrix 0.5 ml (intramuscular) in unknown deltoid. After receiving 1st dose of Shingrix, the patient experienced web-like rash and swelling on his trunk. The reporter was a pharmacist at a pharmacy. The reporter said the patient was advised to take oral Benadryl. On 12th October 2020, patient woke up and still has the same problem and he dose not want to keep taking Benadryl. He states he was calling to report an allergic reaction. The patient indicated that he was going to see his doctor and that he was not going to receive the 2nd dose of the series. The patient indicated that if he had known this was going to happen he would not have gotten the first dose and that he wants compensation because this has been going on now for more than one month. The reporter said he did not ask the pharmacist for the patient's MD contact information. The reporter consent to follow up.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Deafness unilateral, Ear discomfort
Clinical narrative: Hearing loss in her left ear and felt it was plugged up/Having problems hearing on the telephone and would have to switch to the right ear to hear a conversation; Hearing loss in her left ear and felt it was plugged up; This spontaneous case  was received on 07-Oct-2020 from other non-health professional (consumer)  and concerned a 62-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years.  On an unspecified date in 2020 (reported as 04-Sep-2020 and 04-Oct-2020), the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 276578, expiry date: 30-Jun-2021.     On 06-Oct-2020 about 5 p.m., the patient experienced hearing loss in her left ear and felt it was plugged up. The patient was having problems hearing on the telephone and would have to switch to the right ear to hear a conversation. On the same date, before bed, the patient took a decongestant and was able to hear some better in the morning.   At the time of initial reporting on 07-Oct-2020, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The event of 'hearing loss unilateral' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: On an unspecified date in 2020, a patient was vaccinated with Flucelvax QIV vaccine. On 06-Oct-2020, the patient experienced deafness unilateral and ear discomfort. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years. Due to lack of information regarding temporal relationship, diagnostic findings, causality is unassessable.; Sender's Comments: On an unspecified date in 2020, a patient was vaccinated with Flucelvax QIV vaccine. On 06-Oct-2020, the patient experienced deafness unilateral and ear discomfort. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. The patient reported never having any hearing problems and has not had a flu shot in over 20 years. Due to lack of information regarding temporal relationship, diagnostic findings, causality is unassessable.
Age: 88.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Delirium, Fall, Nausea, Pyrexia
Clinical narrative: Fever, Nausea Vomiting & Chills, Falls, Delirium
Age: 88.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Vomiting
Clinical narrative: Fever, Nausea Vomiting & Chills, Falls, Delirium
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient arrived for flu shot. Last year she received Afluria flu vaccine and had blisters on the posterior palms bilateral to fingertips. Notified and stated okay to give vaccine. Plan discussed with the patient if reaction occurs to take Benadryl ASAP and call the clinic At, 3:30pm the patient presented to clinic. She has started developing hives that were on the bilateral palms to fingertips, left more than right. She denied any chest pain. Shortness of breath, angioedema itching. She had taken a Benadryl immediately after receiving vaccine. Dr. evaluated the patient, he stated that she should continue taking Benadryl until the hives resolves, Take as directed on the packaging. She was advised to never received the vaccine again in her lifetime.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: & URTICARIA
Age: 54.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Myalgia
Clinical narrative: Continued muscle soreness
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Condition aggravated, Eye swelling, Headache, Lacrimation increased
Clinical narrative: 09/29/2020:  HA, Eye swelling, weeping eyes stared 03:00, chills, sinus drainage  09:00. Increased sinus symptoms since vaccination. Sudafed 10:30, Seasonal allergy drops 10:45, Benadryl  and Ventolin 10:55.  Throat started constricting after drops taken.  did not need to use epipen.  Intermittently clear from one or both throughout the day and Left facial swelling. Stopped allergy drops that day.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Paranasal sinus hypersecretion, Sinus disorder, Swelling face, Throat tightness
Clinical narrative: 09/29/2020:  HA, Eye swelling, weeping eyes stared 03:00, chills, sinus drainage  09:00. Increased sinus symptoms since vaccination. Sudafed 10:30, Seasonal allergy drops 10:45, Benadryl  and Ventolin 10:55.  Throat started constricting after drops taken.  did not need to use epipen.  Intermittently clear from one or both throughout the day and Left facial swelling. Stopped allergy drops that day.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: acute onset sore throat, chills and achiness and light headache 4 hours after injection. S/xs abated after 12 hours except for slight residual achiness
Age: 9.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Skin warm
Clinical narrative: redness and warm to touch
Age: 41.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram abnormal, Hypersensitivity
Clinical narrative: I started having tightness in my chest within an hour after the vaccine. Then I had tingling down my right arm. It worsened to the point where I felt like I could not take a deep breath
Age: 41.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia, Sinus tachycardia
Clinical narrative: I started having tightness in my chest within an hour after the vaccine. Then I had tingling down my right arm. It worsened to the point where I felt like I could not take a deep breath
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: redness, warmth, swelling
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Extreme body aches, fatigue, chills
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Localized hives near injection site
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cold sweat, Headache, Hyperhidrosis
Clinical narrative: had chills, fell asleep, woke up in a sweat, headache, next day headache continued, feeling clammy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: headache, chills, fever got as high as 100.5, body aches, nausea - this all occurred the day after vaccine.  Now 48 hours have gone by...  headache is still there but not as intense,  body temp down to 99.5., nausea gone, muscle pain not as severe.  Arm still hurts and now there is swelling and redness at site of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: headache, chills, fever got as high as 100.5, body aches, nausea - this all occurred the day after vaccine.  Now 48 hours have gone by...  headache is still there but not as intense,  body temp down to 99.5., nausea gone, muscle pain not as severe.  Arm still hurts and now there is swelling and redness at site of injection.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Patient got a rash on her shoulders, neck and back approximately 1 hour after receiving vaccine. Patient said she was able to tolerate it while applying calamine lotion. Patient did not require further hospitalization.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Left arm swelling, extending from site to shoulder and elbows 24 hours after vaccination. Hives within 48 hours after
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm and painful, body aches and pains and slight fever
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site swelling, Pain in extremity
Clinical narrative: large amount of swelling at injection site lasting 1 day. persistent "achey" pain from elbow to wrist on arm of injection continuing through last 2 days to now.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives in the neck and back
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: After 5 days of administration of vaccine, patient noticed  bluish black bruise in his upper arm, arm was swollen and painful.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Axillary pain, Breast pain, Chest pain, Chills, Injected limb mobility decreased
Clinical narrative: Pt presented to our clinic on 10/14/2020 for possible reaction to vaccine/s listed in Item 17 that were administered on 10/08/2020. Pt reports she developed redness and pain in her left upper extremity about 8 hours after receiving these vaccines. Pt reports her pain intensified and spread to her left chest/breast and axilla. She reports she also developed chills and nausea. She reports her pain persists but not as severe. She presently has redness, swelling, and knot over injection site that is warm to the touch. She reports it is also painful to the touch. She has limited mobility in her left arm due to the pain she experiences with movement including lifting her arm. She was diagnosed with cellulitis of left upper limb and was prescribed: Keflex 500 mg TID for 7 days and cetirizine 10 mg once daily. She is to follow up at our clinic in 1 week.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pt presented to our clinic on 10/14/2020 for possible reaction to vaccine/s listed in Item 17 that were administered on 10/08/2020. Pt reports she developed redness and pain in her left upper extremity about 8 hours after receiving these vaccines. Pt reports her pain intensified and spread to her left chest/breast and axilla. She reports she also developed chills and nausea. She reports her pain persists but not as severe. She presently has redness, swelling, and knot over injection site that is warm to the touch. She reports it is also painful to the touch. She has limited mobility in her left arm due to the pain she experiences with movement including lifting her arm. She was diagnosed with cellulitis of left upper limb and was prescribed: Keflex 500 mg TID for 7 days and cetirizine 10 mg once daily. She is to follow up at our clinic in 1 week.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site warmth, Nausea, Pain
Clinical narrative: Pt presented to our clinic on 10/14/2020 for possible reaction to vaccine/s listed in Item 17 that were administered on 10/08/2020. Pt reports she developed redness and pain in her left upper extremity about 8 hours after receiving these vaccines. Pt reports her pain intensified and spread to her left chest/breast and axilla. She reports she also developed chills and nausea. She reports her pain persists but not as severe. She presently has redness, swelling, and knot over injection site that is warm to the touch. She reports it is also painful to the touch. She has limited mobility in her left arm due to the pain she experiences with movement including lifting her arm. She was diagnosed with cellulitis of left upper limb and was prescribed: Keflex 500 mg TID for 7 days and cetirizine 10 mg once daily. She is to follow up at our clinic in 1 week.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed swelling at the site the following day that kept increasing in size and became hot to the touch.  On 10/11 patient f/u at urgent care and was started on Cephalexin 500mg 1 tid x 7 days for cellulitis. On 10/16 patient's arm looks remarkably better, little to no redness and just a little "tight" at the site or a "tough spot".  Definitely improving.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Barium enema, Diarrhoea, Haematochezia, Intussusception, Laparoscopic surgery
Clinical narrative: PT PRESENTED TO ED WITH VOMITING AND DIARRHEA AND BLOOD IN STOOL  PT DEVELOPED INTUSSUSCEPTION ON  10/10/2020, HAD REDUCTION WITH BARIUM ENEMA, RETURNED TO HOSPITAL ON 10/14/2020 ATTEMPTED REDUCTION TO RELIEVE AGAIN, FAILED HAD SURGICAL INTERVENTION ON 10/15/2020.  PLANNED DISCHARGE ON 10/16
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Procedural failure, Small intestinal intussusception reduction, Small intestinal obstruction, Surgery, Vomiting
Clinical narrative: PT PRESENTED TO ED WITH VOMITING AND DIARRHEA AND BLOOD IN STOOL  PT DEVELOPED INTUSSUSCEPTION ON  10/10/2020, HAD REDUCTION WITH BARIUM ENEMA, RETURNED TO HOSPITAL ON 10/14/2020 ATTEMPTED REDUCTION TO RELIEVE AGAIN, FAILED HAD SURGICAL INTERVENTION ON 10/15/2020.  PLANNED DISCHARGE ON 10/16
Age: 60.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Arthralgia, Pain in extremity, Painful respiration
Clinical narrative: Pain in left arm spreading to left side scapula now causing pain when she inhales. She is taking ibuprofen already at this point.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: Vasovagal-light headedness, dizziness, weakness, nausea, fatigue
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient stiffened and was unresponsive and vomited x 1 approximately 5 minutes post vaccination.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Pain
Clinical narrative: Right shoulder weakness and pain.  Joint pain shooting all the way to my elbow.  Trouble rotating arm without pain.  Not getting better
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Induration, Swelling
Clinical narrative: Pt presented to pharmacy for influenza and shingrix (dose #2) vaccinations. Patient reported severe pain for 2 months after shingrix dose #1 (administered 11/25/19 per WIR). Pharmacy intern administered influenza vaccine to R Deltoid first, without complication. Pharmacy intern then administered shingrix vaccine to L Deltoid, and upon placing bandage noted swelling and induration. Pharmacy intern advised patient of concern for reaction and called for supervising pharmacist. The patient was observed for 20 minutes after reaction and denied any symptoms of anaphylaxis. After 15 minutes of observation, the patient opted to self-administer a dose of Benadryl and Tylenol from her own personal supply. She was educated on the signs and symptoms of infection and instructed to follow-up as needed. Pharmacy intern and pharmacist will followed up with patient 24 hours after the event. Patient reported that the swelling resolved overnight but that the pain persists. Denied any signs or symptoms of infection.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Musculoskeletal stiffness, Pyrexia
Clinical narrative: after receiving this vaccine she had redness, slight fever, and a stiffness in the arm that radiated to her neck as well. she has had flu shots before, but never has she experienced this. this started day of administration and lasted for 3 days.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Woke up Thursday morning 10/15/2020 with severe right calf pain, that hurts to touch and does not get better with rest , tylenol ice or heat. Having trouble putting full weight on right leg. Left calf is starting to feel achy as of Friday 10/16/2020. Will continue to monitor
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Lethargy, Local reaction
Clinical narrative: 1. Local reaction on injection site 2. Facial redness 3. Lethargy
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site cellulitis, Peripheral swelling
Clinical narrative: Patient's arm swelled up  and turned red sometime,  after injection at patient's  home.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: PT PRESENTED TO PHARMACY 48 HOURS AFTER VACCINATION WITH A CLEARLY DEFINED RED, SWOLLEN AND HOT AREA SURROUNDING THE VACCINATION SITE. ADVISED PT TO MONITOR FOR PROGRESSION (BETTER OR WORSE, CONTACT PHYSICIAN, AND TO USE OTC PAIN RELEIVER (IBU OR APAP), AND TO APPLY ICE.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT HAS A WELT AND IT ITCHES
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site irritation, Pain, Pruritus
Clinical narrative: Patient returned to pharmacy about a week after vaccine administration with complaint of visible irritation/discoloration at injection site and minimal pain and itching for a few days after vaccination.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a reaction to vaccine. His arm near injection was swollen and red.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Hep A was given to a 2 month  old child instead of a Hep B. Mom was informed of this error. Mom chose to receive Hep B dose when they come back for their next well child exam in Nov.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face, Swelling of eyelid
Clinical narrative: Reports woke up with rash 10-09-2020 10-10-2020 Woke up with swelling to her face and reports her left eye was swollen shut. Sought medical treatment, was given steroids. States she is fine today. 10-16-2020
Age: 90.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Peripheral swelling
Clinical narrative: swelling of arm one day after injectiuon
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain in left arm that became almost unbearable throughout 24 hr after injection (much more intense than any vaccination I have ever had).   This pain was not at the injection site, but throughout the arm.  Arm pain has continued until today (14 days later) albeit much less intense.  Pain increases upon some arm movements. Treated with Advil.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Asphyxia, Cardio-respiratory arrest, Cyanosis, Death
Clinical narrative: Per ER record- 2 month old male presented to ER per EMS in cardiopulmonary arrest at 0837 on 10/10/2020, According to ER report from Medical Center, EMS reported call came in approx 30 min prior to arrival  after mother awoke on the couch where she was sleeping with her older daughter and the patient. The patient was found apneic and without spontaneous pulse. He was unresponsive and cyanotic. Last known well time was reported around 0200 after breastfeeding. On arrival to ER pt is described as cyanotic, cold and rigid, no palpable pulse, no heart rate, no pulse, no respirations. Pulse oximetry is 0. Pupils were documented as fixed and dilated. There is a notation regarding "dried blood noted to both nostrils and dried blood surrounding his mouth" reported by EMS. Patient was pronounced deceased at 0842. Clinical impression documented-primary impression cardiopulmonary arrest in newborn, asphyxia in infant
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Epistaxis, Mouth haemorrhage, Muscle rigidity, Peripheral coldness, Pulse absent
Clinical narrative: Per ER record- 2 month old male presented to ER per EMS in cardiopulmonary arrest at 0837 on 10/10/2020, According to ER report from Medical Center, EMS reported call came in approx 30 min prior to arrival  after mother awoke on the couch where she was sleeping with her older daughter and the patient. The patient was found apneic and without spontaneous pulse. He was unresponsive and cyanotic. Last known well time was reported around 0200 after breastfeeding. On arrival to ER pt is described as cyanotic, cold and rigid, no palpable pulse, no heart rate, no pulse, no respirations. Pulse oximetry is 0. Pupils were documented as fixed and dilated. There is a notation regarding "dried blood noted to both nostrils and dried blood surrounding his mouth" reported by EMS. Patient was pronounced deceased at 0842. Clinical impression documented-primary impression cardiopulmonary arrest in newborn, asphyxia in infant
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pupil fixed, Respiratory failure, Unresponsive to stimuli
Clinical narrative: Per ER record- 2 month old male presented to ER per EMS in cardiopulmonary arrest at 0837 on 10/10/2020, According to ER report from Medical Center, EMS reported call came in approx 30 min prior to arrival  after mother awoke on the couch where she was sleeping with her older daughter and the patient. The patient was found apneic and without spontaneous pulse. He was unresponsive and cyanotic. Last known well time was reported around 0200 after breastfeeding. On arrival to ER pt is described as cyanotic, cold and rigid, no palpable pulse, no heart rate, no pulse, no respirations. Pulse oximetry is 0. Pupils were documented as fixed and dilated. There is a notation regarding "dried blood noted to both nostrils and dried blood surrounding his mouth" reported by EMS. Patient was pronounced deceased at 0842. Clinical impression documented-primary impression cardiopulmonary arrest in newborn, asphyxia in infant
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient stated that the right arm where the Pneumovax-23 was injected is red and hot and was diagnosed by her PCP as Cellulitis. MD prescribed antibiotics to treat it per patient.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: At 1305, 49-year old female received her first flu vaccine and was directed to the fifteen minute observation area to sit. Approximately ten minutes after the flu shot, patient reported feeling "whoozy". Patient's legs were elevated and vital signs were taken. BP 210/112 (RA) 192/98 (LA), HR 88, Respiration 16. Patient was negative on the Cincinnati Stroke Scale. Patient was also negative for the following: chest pain, dyspnea, urticarial, dizziness. Patient's skin pink, dry, warm, normal. Pupils PERRLA. Patient's vitals were re-assessed at 1317. BP 174/80 (LA) 170/84 (RA). At 1324, patient's BP 162/82 (LA) 166/84 (RA). Patient's primary care MD was contacted with the patient's consent, and patient was able to make an appointment for the afternoon.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Feeling cold
Clinical narrative: PT HUSBAND SAID SHE IS COLD AND SHIVERING. PT GETS FLU VACCINE EVERY YEAR ACCORDING TO HUSBAND
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, MENB
Symptoms: Loss of consciousness, Syncope, Tension, Tremor
Clinical narrative: Patient stated that she has previously gotten faint and passed out after getting immunizations. Patient was given crackers and juice before the injection.  Patient was alert and oriented until after the last injection (Men B) at which point she stated "I'm going to faint". This RN assisted the patient to a lying position on the couch where she was seated.  Patient lost consciousness for approximately 10 seconds, during which she became tense and slightly shaky.  The patient then regained consciousness and quickly sat upright, stating "I'm OK. Wow, that was a weird dream."  This RN was with the patient the entire time and remained with patient for 15 minutes after the event.  An M.D. was called to the room to assess the patient, vital signs were obtained, and patient was given more juice and crackers.  The patient remained at the facility for 15 more minutes and was determined to be safe to leave.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dreamy state, Gaze palsy, Loss of consciousness, Paranasal sinus hypersecretion
Clinical narrative: Less than 10 min after the shot I passed out in the car. I felt like I was dreaming almost immediately after the shot and everything was surreal. My wife was with me and she drove me home and pulled over several times. I threw up in the car and could not hear her asking me if I was OK. We almost went to the emergency room but I felt better after an hour.  Almost two hours later I feel somewhat better and I have a headache but my sinuses are irritated and I keep blowing my nose.  Feel a bit weak.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Sinus disorder, Vomiting
Clinical narrative: Less than 10 min after the shot I passed out in the car. I felt like I was dreaming almost immediately after the shot and everything was surreal. My wife was with me and she drove me home and pulled over several times. I threw up in the car and could not hear her asking me if I was OK. We almost went to the emergency room but I felt better after an hour.  Almost two hours later I feel somewhat better and I have a headache but my sinuses are irritated and I keep blowing my nose.  Feel a bit weak.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Patient returned to the pharmacy about 15-20 minutes after receiving vaccination. She described she was feeling like she was experiencing dizziness, light headedness, nausea. After about 45 minutes, patient still felt weak, but she had no trouble swallowing or breathing. Patient also stated that she had recently cut back on carbs and sugars over the last few days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: pt called pharmacy 4 days after treatment to report redness that was warm to the touch , and a hard nodule under the skin at the injection site.
Age: 79.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Disturbance in attention, Dizziness, Gait disturbance
Clinical narrative: Patient is complaining of losing train of thought, stumbling around, and dizziness
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Muscular weakness
Clinical narrative: Site injection pain within couple of hours,  pain in arms- hands - feet - legs within 6-7 hours, fever/chills-headache-tiredness within 8 hours ,muscle weakness 24+ hours
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Site injection pain within couple of hours,  pain in arms- hands - feet - legs within 6-7 hours, fever/chills-headache-tiredness within 8 hours ,muscle weakness 24+ hours
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Red hot warm to touch. Hard lump under skin. 4 x 2 inches swollen area
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Peripheral swelling, Pruritus
Clinical narrative: Mother states noticed patients right arm was very hard and swollen after picking him up from school today.  Arm swollen to about the size of a "tennis ball" according to mother.  Mother states child is not experiencing any pain and is not have any other signs/symptoms other than itching to the site. Instructed mother to first measure the reaction, then to apply cool compresses for 15minutes on and 15minutes off, and to administer 2.5mL of Benadryl by mouth, every 4-6 hours.   Instructed mother if any worsening signs/symptoms or no resolution is observed after treatments, follow up with urgent care clinic immediately.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching to bilateral arms and upper back - took Benadryl which helped with itching Hives
Age: 65.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Abdominal pain upper, Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: Low grade fever that began the night of vaccine. Never past 100.4.  Pt taking acetaminophen for fever. Stomach ache, not diarrhea Nausea dizziness Radiating pain in both arms
Age: 65.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Pyrexia
Clinical narrative: Low grade fever that began the night of vaccine. Never past 100.4.  Pt taking acetaminophen for fever. Stomach ache, not diarrhea Nausea dizziness Radiating pain in both arms
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Nausea
Clinical narrative: injection site pain and redness, fever, joint pain, fatigue, nausea, vomiting.  Meclizine for nausea and when tolerated 500mg acetaminophen for fever and pain.  Severe symptoms resolved within 24 hours; all symptoms resolved within 48 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: injection site pain and redness, fever, joint pain, fatigue, nausea, vomiting.  Meclizine for nausea and when tolerated 500mg acetaminophen for fever and pain.  Severe symptoms resolved within 24 hours; all symptoms resolved within 48 hours.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt received flublok on 10/15 at store and called pharmacy today (10/16) saying her arm is pretty tender and there?s a huge red spot where she got the shot and was concerned enough to call. I told her injection site reaction and tenderness is normal and to wait a few days to see if the redness and tenderness goes away. If it gets worse, contact doctor.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Date of injection 9-22-20 Left shoulder pain began on 9-24-20. Decreased shoulder ROM, pain with lifting noted on 10-2-20 Evaluated at Employee Health on 10-6-20. Referred for physical therapy, given Naproxen, home exercises also given, assigned light duty. Follow-up appointment on 10-14-20: improved ROM.  PT approved, first appointment pending. Continue med, home exercises, LD. Next follow-up scheduled for 10-28-20.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: About 30 hours after immunized, patient began a rash around site of left arm where shingrx was administered on 10/15/20, the rash progressed to cover her entire body including both arms, stomach, back, and legs. The patient claims it is slightly itchy, but tolerable. She took Benadryl at the onset of the rash. Patient does not want to contact her doctor at this point. Rash is red and inflammed and was further irritated after she showered.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphonia, Headache, Lacrimation increased, Ocular hyperaemia
Clinical narrative: -Received vaccination at 17:30 -20:30-Dry cough; swelling in throat; hoarse and "cracky" voice; sinus congestion; Headache -23:00- Heart Palpitation; red and watery eyes. pt took Benadryl and started to feel better
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Pharyngeal swelling, Sinus congestion
Clinical narrative: -Received vaccination at 17:30 -20:30-Dry cough; swelling in throat; hoarse and "cracky" voice; sinus congestion; Headache -23:00- Heart Palpitation; red and watery eyes. pt took Benadryl and started to feel better
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache
Clinical narrative: extreme redness radiating down arm almost to her wrist along with headaches
Age: 41.0
Sex: M
Vaccine: FLUC4, MMR, TDAP
Symptoms: Blood test normal, Chills, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Swollen glands around both ears, neck and Left cheek. Swollen on both sides but predominantly on left side. It has been hurting. Feels warm in the left cheek like when you have an allergic reaction. 3rd day now
Age: 41.0
Sex: M
Vaccine: FLUC4, MMR, TDAP
Symptoms: Skin warm, White blood cell count normal
Clinical narrative: Swollen glands around both ears, neck and Left cheek. Swollen on both sides but predominantly on left side. It has been hurting. Feels warm in the left cheek like when you have an allergic reaction. 3rd day now
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Lip swelling, Paraesthesia, Peripheral swelling
Clinical narrative: Woke up 10/4 with lip swelling and tingling of my face. Went to emergency room at hospital. Was started on pred ison , pepcid and benadryl .  On Saturday 10/3 did complain to my husband my arm was swollen and just felt run down
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: 24h post injection pt had a nodule distal to the injection site (rt injection arm) it was larger than a quarter, warm to touch and painful, pt stated that it started as some bruising the evening of the injecton and that formed the following day. i discussed with the pt and aske if they had a temp, pt denied. I told the pt to follow-up with primary care dr. recommended, pt said they will
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Palpitations
Clinical narrative: Nightly Palpitations while at rest, lasting a few hours for 1 week
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Injection site haemorrhage
Clinical narrative: Around 4 pm, I administered vaccine to patient's left arm  in presence of mother. Patient bleed a little and I compressed until bleeding stopped and bandaged site. Patient was sent out of vaccination room while I provided vaccination to brother. After brother left room, was informed that patient felt dizzy and hot. Had patient sit down and attempted to assess for EPIPEN necessity. Mother and Father refused EPIPEN and asked for liquid Benadryl instead. Assessed patient for anaphylaxis and patient was still only dizzy and hot. Offered EPIPEN again but was refused. Gave patient liquid Benadryl and had patient wait in room for 15 min after.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in the middle, ring, and small fingers of the right hand.  First seen Saturday morning after vaccine administered.  No pain reported.  Has not changed.  Reported to the pharmacy 10/14/20 (Wednesday)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 2 inch rash under arm on side
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discharge
Clinical narrative: Patient reports experiencing having a clear, oily discharge on the arm of vaccine administration about 2 hours after administration (patient states that vaccine seemed routine, and she did not notice any discharge, moisture, spillage immediately during or after immunization administration); Patient's primary concern is that she received sufficient amount of dose of flu vaccine and does not need to be re-vaccinated. The patient received her flu shot on 8/18/2020, but did not report this to the pharmacy until 10/16/2020. We did not recommend re-vaccination. We also reached out to Sanofi Pasteur for additional information from their medical team to see if they had any recommendations. They also said they could not recommend anything with certainty given the discharge occurred so long after the vaccine was administered, and that the patient took almost 2 months to report this to the pharmacy. The pharmacy has recommended the patient follow up with her physician if she has any additional concerns.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Patient reported feeling tingling on the lip, nose,  cheeks and both arms especially when she went outdoor, about 1 to 2 hours after receiving the flu shot. No redness or swelling on the injected site. I advice patient to go see doctor as soon as possible and to report back to me if the symptoms become worse.
Age: 50.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave patient Fluad Quad instead of Flucelvax Quad. No symptoms reported by patient
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: reaction to MENINGOCOCCAL MCV4P  - influenza vaccine placed on other arm and no swelling noted                   - soft ball size swelling  - wide as his arm  - 3 inches diameter  - swelling is not sticking out but arm is hot  - feels hot to the touch
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: The patient reports feeling achy all over, having arm pain, and having chills that started about 12 hours after vaccine administration. She reported no fever during that time, and did not take any supportive medications to help deal with symptoms. The patient's condition seemed to continue until she spoke with the pharmacy about 24 hours later. The patient was counseled that she could take supportive medication for aches and pains if necessary. The patient was also told to report back to us or her physician if her condition worsened or did not improve.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Patient received vaccine on 10/4/20. On 10/5/20, patient reports a fever of 101.5, chills, and body aches. Symptoms lasted for two days, then fever broke on 10/9/20. When fever broke, she broke out in mild shingles rash on her back and neck. This prompted her to seek medical attention at Urgent Care on 10/9/20. She was prescribed Valacyclovir there from Dr. She is still currently taking the medication as of 10/15/20.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Erythema at the injection site. No heat or fever within the skin.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased
Clinical narrative: PATIENT UNABLE TO RAISE ARM MORE THAN ABOUT 60 DEGREES OUT FROM HER SIDE.  THIS IS STILL AN ONGOING ISSUE
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: PATIENT SAID SHE HAD HER LEFT SIDE OF FACE SWOLLEN ON 10/13/20  AT 12 PM, THEN SHE HAD HIVES ON HER BODY ON 10/14/20 AT 7 AM , THEN HER LIPS WERE SWOLLEN ON 10/15/20 AT 6 PM
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: At first arm was sore, then entire upper arm became red, swollen and hot to the touch.  Then I developed hives, headache, nausea and fatigue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Urticaria
Clinical narrative: At first arm was sore, then entire upper arm became red, swollen and hot to the touch.  Then I developed hives, headache, nausea and fatigue.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Nausea
Clinical narrative: Patient began to feel weak and nauseous. I had patient lay down while I measured blood pressure and heart rate and 911 was called. Patients feet were elevated to increase blood pressure after no improvement in blood pressure and heartrate 62/38, 48bpm, patient was administered  epinephrine 0.3mg dose in the thigh. Patient was monitored until emergency services arrived and took over.
Age: 12.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Pyrexia
Clinical narrative: High fever of 103 and severe body aches
Age: 81.0
Sex: M
Vaccine: FLUR4
Symptoms: Cerebrovascular accident, Confusional state, Device power source issue, Disorientation, Laboratory test
Clinical narrative: Patient left the pharmacy pushing shopping cart after I administered flublok in left arm. He returned to the pharmacy 10 minutes later and sat down. When I went to talk to him he was slightly disoriented and confused and said he was unable to lift his right arm to pick something up while he was shopping and thought he should come sit down at the pharmacy. No swelling or redness on the immunization arm, blood pressure and pulse were normal for patient. He wouldn't let me call 911 but he did let me call his son. His son picked him up and took him to the ER and he was later diagnosed with mild stroke and issues related to the battery on his pacemaker not working.  It is unknown if the flu shot had anything to do with the stroke or if it was just coincidence.
Age: 81.0
Sex: M
Vaccine: FLUR4
Symptoms: Mobility decreased
Clinical narrative: Patient left the pharmacy pushing shopping cart after I administered flublok in left arm. He returned to the pharmacy 10 minutes later and sat down. When I went to talk to him he was slightly disoriented and confused and said he was unable to lift his right arm to pick something up while he was shopping and thought he should come sit down at the pharmacy. No swelling or redness on the immunization arm, blood pressure and pulse were normal for patient. He wouldn't let me call 911 but he did let me call his son. His son picked him up and took him to the ER and he was later diagnosed with mild stroke and issues related to the battery on his pacemaker not working.  It is unknown if the flu shot had anything to do with the stroke or if it was just coincidence.