chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child male patient for whom expired dose was administered was reported, while he received vaccine ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and DTAP for Immunisation. On 23-Oct-2018, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI805AA expiry date 23-Sep-2018 via unknown route in unknown administration site. Child was given was given an expired ACTHIB today. No specific AE reported. This case is actual medication error due to Expired vaccine used. Final diagnosis was expired dose was administered. Outcome of the event was not applicable. 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: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL (lot C5515AA and Exp. Date 15-SEP-2019) via unknown route in the right thigh. The patient's medical history was not reported. Concomitant medications included ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE; and HEPATITIS B VACCINE for Immunization. It was reported that, nurse did not see the PENTACEL diluent there and all the vaccines with which she had prior experience were reconstituted with sterile water. She therefore reconstituted the Hib portion of the PENTACEL with sterile water and it was given to the patient. It was an actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves three patients (less than 65 years-old) who received 0.5 mL vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported for both) on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate age at vaccine administration, overdose and wrong vaccine administered. It was reported that FLUZONE HD were not differentiated form the FLUZONE QUADRIVALENT and may have been given to patients under the age of 65 years. No adverse event was reported. 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: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 13 patients who were vaccinated with FLUZONE QUADRIVALENT (lot number not reported) via unknown route in unknown administration site on an unknown date. It was reported that three or possibly four opened multi-dose vials of the vaccine were stored in two separate refrigerators. During a power outage, vaccines were exposed to a maximum temp of 59 degrees for 9 hours in one refrigerator and the second refrigerator reached a maximum temp of 62 degrees for 9 hours. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Accidental exposure to product, Exposure via skin contact, Needle issue, No adverse event, Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a six months old patient (gender not reported) who was vaccinated with 0.5 ml dose of PENTACEL (Batch number: C5591AA, expiration date: 15 Nov 2019) in left thigh on 23 Oct 2018. The patient's medical history was not reported. Concomitant medications includes PREVNAR for Immunisation; FLUZONE for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to underdose as needle was loose and the vaccine came out from around where the needle attaches to the syringe. It was also a case of exposure via skin contact as some of the vaccine ran down onto the infant's leg. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: YF
Symptoms: Overdose, Product preparation error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 29 years old male patient who was vaccinated with YF-VAX via subcutaneous route on 02-Oct-2018 (Batch number, expiry date, dose, dose in series and site of administration were not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. It was a case of actual medication error due to inappropriate reconstitution technique because the vaccine was reconstituted with the wrong diluent (MMRV Sterile Water) and overdose as the patient was administered because approximately twice the normal dose". No known reported symptoms. 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.
Age: 72.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced severe pain- in her left arm and could not lift it, while she received vaccine FLUBLOK TIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 08-Oct-2018, the patient received a dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious severe pain- in her left arm and could not lift it  following the administration of INFLUENZA TRIVALENT RECOMBINANT VACCINE. Lab data was not reported. Final diagnosis was severe pain- in her left arm and could not lift it. It was not reported if the patient received a corrective treatment. The patient was not recovered from event. (The event was ongoing at the time of reporting). Additional information was received on 18-Oct-2018 from a consumer. No new information received. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297471, 2018SA297472, 2018SA297470 (same reporter). This case involves a 5 years old patient (unknown gender) who received single 0.25 ml of vaccine FLUZONE QUADRIVALENT (Suspension for injection) (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the right unspecified site on an unknown date (reporter Sep-25 - Oct-12) for Immunization. Patient's medical history was not reported. No concomitant therapies was received by patient. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Left arm and shoulder pain, weakness, decreased range of motion started evening of vaccination. Tried acetaminophen, ibuprofen, stretches, PT referral placed a little over 1 month after pain started. Symptoms have continued and not resolved.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Asthenia, Burning sensation, Groin pain, Malaise, Pain in extremity
Clinical narrative: 3 days later developed rash on left thigh/leg with burning sensation and pain from groin to foot. Also general weakness and malaise.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash
Clinical narrative: 3 days later developed rash on left thigh/leg with burning sensation and pain from groin to foot. Also general weakness and malaise.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament disorder, Pain, Pain in extremity, Tendon disorder
Clinical narrative: The first of the two vaccines (5/30/18) just caused minor arm soreness for about 48 hours. I don't recall which arm the 1st dose was given. The 2nd dose given on 8/9/18 (in the right arm) caused moderate soreness in the arm, and for about 4-5 days, aproximately. About 10-14 days after the 2nd dose, I began feeling an issue with  what felt like a tendon or ligament problem in the right elbow area, extending UP the arm about 6-8 inches and below the elbow about 3-4 inches. It was most noticeable during a SPECIFIC motion of the right arm. I can only describe the motion as folllows: Grasping even just a full tall glass of water and lifting it towards my mouth. VERY painful. PCP checked out the arm, asking me to do various things with the arm, none of which caused any discomfort. I showed him the motion that was causing the pain, and he was a little baffled. It SEEMED at the time of the visit 10/15 that it felt a little better. But it really isn't. Nothing I did with the arm initiated the problem.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament pain, Neuralgia, Pain in extremity, Tendon pain
Clinical narrative: The first of the two vaccines (5/30/18) just caused minor arm soreness for about 48 hours. I don't recall which arm the 1st dose was given. The 2nd dose given on 8/9/18 (in the right arm) caused moderate soreness in the arm, and for about 4-5 days, aproximately. About 10-14 days after the 2nd dose, I began feeling an issue with  what felt like a tendon or ligament problem in the right elbow area, extending UP the arm about 6-8 inches and below the elbow about 3-4 inches. It was most noticeable during a SPECIFIC motion of the right arm. I can only describe the motion as folllows: Grasping even just a full tall glass of water and lifting it towards my mouth. VERY painful. PCP checked out the arm, asking me to do various things with the arm, none of which caused any discomfort. I showed him the motion that was causing the pain, and he was a little baffled. It SEEMED at the time of the visit 10/15 that it felt a little better. But it really isn't. Nothing I did with the arm initiated the problem.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: The first of the two vaccines (5/30/18) just caused minor arm soreness for about 48 hours. I don't recall which arm the 1st dose was given. The 2nd dose given on 8/9/18 (in the right arm) caused moderate soreness in the arm, and for about 4-5 days, aproximately. About 10-14 days after the 2nd dose, I began feeling an issue with  what felt like a tendon or ligament problem in the right elbow area, extending UP the arm about 6-8 inches and below the elbow about 3-4 inches. It was most noticeable during a SPECIFIC motion of the right arm. I can only describe the motion as folllows: Grasping even just a full tall glass of water and lifting it towards my mouth. VERY painful. PCP checked out the arm, asking me to do various things with the arm, none of which caused any discomfort. I showed him the motion that was causing the pain, and he was a little baffled. It SEEMED at the time of the visit 10/15 that it felt a little better. But it really isn't. Nothing I did with the arm initiated the problem.
Age: 74.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Pt reports tingling, numbness going down her arm and hand. Also, reports of pain if she or someone touches the top of her shoulder.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation
Clinical narrative: Afib for 2 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural
Clinical narrative: Patient reported 10/29 that since receiving the SHINGRIX 10/22/18, she has experiencing dizziness several times a day. She noticed it the day after. It is worse bending over to rising up and getting up from a sit. This to PHN sounded like postural hypertension and inquired if on medications. Patient disclosed she is on hypertension medications. It could be unrelated and due to her hypertension but reporting. She also had influenza vaccine on 10/15/18 at Pharmacy--unsure if this is related. PHN advised patient to call and be seen by primary care provider. PHN reviewed that dizziness can be a rare reaction but usually associated with anaphylaxis and not lingering but acute. Patient stated she would call MD. PHN plans to check back in for status update.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Contusion, Dizziness, Headache
Clinical narrative: 10/26/18   Rec'd 2nd injection of Recombinant Zoster Vaccine. After 1hr: tingling left arm and hand, numb rest of day. Iced several times during day. After 3hrs: dizziness and nausea. Slept 3 hrs, felt better. After 12hrs: at bedtime: chills, head ache, body aches in joints. 10/27/18   Woke with headache, chills. Continued icing arm during day, very sore, red & swollen at injection site. By mid-day injection site very red and hot to the touch. Felt like a severe bruise. Rested during day, felt normal late afternoon. 10/28 and 10/29/18:  Feel normal. Injection site very red, painful like a bruise, very itchy. Still icing periodically.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 10/26/18   Rec'd 2nd injection of Recombinant Zoster Vaccine. After 1hr: tingling left arm and hand, numb rest of day. Iced several times during day. After 3hrs: dizziness and nausea. Slept 3 hrs, felt better. After 12hrs: at bedtime: chills, head ache, body aches in joints. 10/27/18   Woke with headache, chills. Continued icing arm during day, very sore, red & swollen at injection site. By mid-day injection site very red and hot to the touch. Felt like a severe bruise. Rested during day, felt normal late afternoon. 10/28 and 10/29/18:  Feel normal. Injection site very red, painful like a bruise, very itchy. Still icing periodically.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Paraesthesia
Clinical narrative: 10/26/18   Rec'd 2nd injection of Recombinant Zoster Vaccine. After 1hr: tingling left arm and hand, numb rest of day. Iced several times during day. After 3hrs: dizziness and nausea. Slept 3 hrs, felt better. After 12hrs: at bedtime: chills, head ache, body aches in joints. 10/27/18   Woke with headache, chills. Continued icing arm during day, very sore, red & swollen at injection site. By mid-day injection site very red and hot to the touch. Felt like a severe bruise. Rested during day, felt normal late afternoon. 10/28 and 10/29/18:  Feel normal. Injection site very red, painful like a bruise, very itchy. Still icing periodically.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Oropharyngeal pain, Pyrexia
Clinical narrative: Stated he was getting a sore throat and headache shortly after receiving injection. Red at injection site. Fever followed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule
Clinical narrative: Patient experienced some bleeding at the injection site and within a minute after IMZ a moderate size knot developed at injection site along with some bruising. Patient stated no soreness at site or no shortness of breath.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm started to swell soon after the shotm and was described to be hard to the touch. The arm ws painful and hot. The event lasted for 8-9 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: 36 hours of severe chills and muscle soreness (especially in injection site arm; lasted for 5 days).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Cryotherapy, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The injection was given very high in my left arm at a downward angle. Several hours later I had severe pain extending from my left shoulder to my elbow. It continued for 3 weeks during which I iced it and took ADVIL. I went to the doctor at that point and now I am having cryotherapy. I am still having pain in the arm at this time.
Age: 77.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt reports pain on the sides and underside of arm when he lifts his arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Immediately felt different than prior vaccinations. Felt like "hit a nerve". BANDAID placed 1 finger width from top of shoulder. No typical muscle soreness. Muscle stiffness and decreased range of motion within 1-2 days. Pain has persisted, range of motion is slightly improving but not back to baseline. Aches and throbs more at night to the point of awakening pt.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Immediately felt different than prior vaccinations. Felt like "hit a nerve". BANDAID placed 1 finger width from top of shoulder. No typical muscle soreness. Muscle stiffness and decreased range of motion within 1-2 days. Pain has persisted, range of motion is slightly improving but not back to baseline. Aches and throbs more at night to the point of awakening pt.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient describes experiencing pain with the injection followed by a very sore left deltoid for three days. After that it improved and was only painful when she poked at the site. On 10/25/2018 she felt felt severe pain in left deltoid when she reached laterally to pick up papers. The left upper arm has been painful ever since that date.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained of aching pain at the site injection with no radiation pain after 11 days.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: No pain at time of injection. Several hours later the arm became extremely painful with pain radiating through the arm and around the back of the shoulder. Intense pain has resolved, however four weeks later she still has pain when raising her arm and does not have full range of motion.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: She told me that several days after the shot she got a rash that was warm to touch for 1 day but the rash lasted for at least 2 weeks. I didn't see a rash today. She said thinks the rash is gone.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Periarthritis, Rash
Clinical narrative: Left shoulder frozen within hours. Could not lift arm for 3 days. Gradually easing one week later. Still sore spot on shoulder. Within 24 hours of injection developed rash on inner arms (both) and rash above breast to armpit on both arms. One week later not visible.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Inflammation, Injection site cellulitis, Local reaction, Skin warm
Clinical narrative: Assessment: Local reaction to influenza vaccine, initial encounter. Cellulitis of left upper arm, KEFLEX 500 MG capsule. Very large local reaction to influenza vaccine given 2 days ago. Likely an inflammatory reaction, but because of size, and significant warm and inflammation, will treat for cellulitis in case there is a component of bacterial infection. No systemic signs of illness at this point. Plan: Cephalexin as written. Instructed to follow up if this is worsening, for reassessment. Worsened and pt went to ER: mupirocin, no dose recorded, clindamycin HCL 450 mg.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Developed rash and bubbles similar to poison ivy at sites on my body previously stuck by briars or insect bites. No effect at site of injection. Rash was quite itchy and put cortisone cream on. After about a week it seems to have started to dry up. Vaccine was received at a pharmacy, so no doctors visits were involved.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Malaise, Mouth swelling, Ocular hyperaemia, Swollen tongue
Clinical narrative: Coughing, tongue and underneath of tongue swelling, throat scratchy. Took two BENADRYL 25mg each took an hour to become comfortable. Next morning eyes were extremely red with some swelling in mouth area. General feeling of being unwell since.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Coughing, tongue and underneath of tongue swelling, throat scratchy. Took two BENADRYL 25mg each took an hour to become comfortable. Next morning eyes were extremely red with some swelling in mouth area. General feeling of being unwell since.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother states that immediately after injection patient had burning, tingling and itchy. About an hour later the injection site swelled to the size of golf ball, was red and hot to touch, painful and burning.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Paraesthesia, Pruritus
Clinical narrative: Mother states that immediately after injection patient had burning, tingling and itchy. About an hour later the injection site swelled to the size of golf ball, was red and hot to touch, painful and burning.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: The night of the vaccination the patient experienced injection site pain and a fever of 101 F. She also experienced rash on different sites on her body. She was seen at clinic on 10/29/2018 and received a prescription to treat the rash.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing, Hoarseness or wheezing, Swelling around the eyes or lips, Hives, Paleness, Weakness, A fast heartbeat or dizziness.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Lip swelling, Pallor, Swelling of eyelid, Urticaria, Wheezing
Clinical narrative: Difficulty breathing, Hoarseness or wheezing, Swelling around the eyes or lips, Hives, Paleness, Weakness, A fast heartbeat or dizziness.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Injection was given higher than normally received. It was in upper arm/shoulder area. Immediately following vaccination had trouble lifting arm. Still experiencing throbbing pain in shoulder with difficulty moving/lifting.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: PENTACEL dose was given, but not the complete dose. Only Dilunt was given, but it was not reconstituted making it incomplete.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Migraine, Pain
Clinical narrative: Developed migraine headaches two weeks after vaccination. Severe pain and had to see specialist.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site plaque, Injection site warmth
Clinical narrative: There is a 7 x 7 cm erythematous, slightly warm, slightly indurated, and tender plaque on the left deltoid.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Lichen planus, Mastication disorder, Oral pain, Skin tightness, Stomatitis
Clinical narrative: Patient began having symptoms of sore mouth. She said it feels like a sunburn in her mouth, lots of irritation. She is unable to eat normally, and the skin in her mouth feels tight. Was told by Dr. that she had Lichen Planus- is seeing an ENT to have a biopsy to confirm LP. She is concerned as to the possibility of future squamous cell carcinoma secondary to the LP that she believes was the result of the flu vaccine. She reported this to me on 10/29/18.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: She developed fever for 1 day and rash on left deltoid that spread to her left forearm the next day. The rash continued to spread to left arm until 10/27/18. Still with residual rash on left forearm and upper arm on 10/29/18 when I saw her but resolving.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Intussusception, Irritability, Surgery
Clinical narrative: Patient was seen on 9/28/2018 in the ER for increased irritability and fussiness. He then followed up in less than 12 hours with profuse bloody stools and was diagnosed with intussusception on 9/29/2018.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest discomfort, Dysgeusia, Electrocardiogram, Full blood count
Clinical narrative: Nausea, HA, chest tightness, metallic taste in mouth, throat closing.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Laboratory test, Nausea, Throat tightness, Troponin
Clinical narrative: Nausea, HA, chest tightness, metallic taste in mouth, throat closing.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Haematoma
Clinical narrative: Arm was fiery red down entire arm to the elbow-later became a large hematoma. Treated with an antibiotic.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Malaise, Nausea, Peripheral swelling
Clinical narrative: The patient reported feeling very sick to her stomach, nauseous, had burning sensation in the left arm, redness, and swelling in the left arm. She said she took BENADRYL which made her feel better.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine expires 6/30/2019. NDC # 19515-909-41. Produced by ID biomedical corporation Part of GlaxoSmithKline. Patient developed erythema, warmth and tenderness around the injection site the day after administration. Symptoms were rapidly progressive. Similar to the year before. Was treated with antibiotics last year and again for this current reaction that was concerning for cellulitis.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe Pain and lack of motion since injection.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain
Clinical narrative: I am a 76 year old female who got a high dose flu shot on 10/15/18 and on 10/20/18 I got a very painful case of shingles. I believe that the flu shot challenged my immune system so much that it weakened it and allowed the shingles to erupt.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pruritus generalised, Throat irritation, Urticaria
Clinical narrative: Immediately after vaccine injection, staff and supervisor reports: hives on arms, face and chest. Itchiness on body and throat. BENADRYL PO given with improvement 30 min - 1 hour after medication.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Pyrexia
Clinical narrative: Patient experienced hot, feverish and shortness of breath.
Age: 52.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed painful rash on arm around injection site.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site exfoliation, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: PATIENT REPORTS A REDNESS AND SWELLING THAT WAS 4"X2" WITH A HARD LUMP IN THE MIDDLE THAT APPEARED SHORTLY AFTER THE VACCINATION. THIS LASTED FOR APPROXIMATELY ONE MONTH, THEN REDNESS AND SWELLING SLOWLY WENT AWAY AND THE  SKIN PEELED OFF THAT WAS OVER THE SIGHT OF THE INJECTION.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea
Clinical narrative: 1 hour and 50 minutes after immunization, donor called to report chest pain and difficulty breathing. She was advised to seek emergency care immediately and was asked no further questions.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS, ITCHING AND SWELLING AT THE SITE OF INJECTION WHICH RESOLVED AFTER 2-3 DAYS.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Swelling face, Tenderness
Clinical narrative: Left eye swollen under eye - tender sore to touch morning after shot. Following day swelling same plus extended down cheek, 4th day, still slightly swollen under left eye.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Dry skin, Eye pain, Eye swelling
Clinical narrative: Swollen eyes, soreness around eyes, dry skin around eyes. Took antihistamines orally, cold compresses on eyes.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Swelling at Right cubical with redness, rash and itching. No difficulty breathing. Advised to go to nearest ER for evaluation.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Rash, Swelling face, Swelling of eyelid
Clinical narrative: Swelling of face (eyes almost swollen shut,) pain on upper back, rash on chest.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: RASH AT INJECTION SITE. REDNESS, HOT, ITCHING ABOUT 8-9 INCH I HAVE PICTURE PLEASE LET ME KNOW IF YOU WANT ME TO UPLOAD.
Age: 71.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Hepatic pain, Nausea, Palpitations
Clinical narrative: My heart started racing within 2-3 minutes from receiving the vaccine. This lasted about 3 hours. Within 10-15 minutes I felt light headed and then nauseous. Both of these symptoms lasted for several hours. Around 3 PM I felt pain in my liver area. This was intermittent throughout the evening. I rested on my bed for a couple of hours. About 3 PM the first symptoms ceased and only the right side/liver area or pancreas area remained, intermittently as I previously mentioned.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. presented to pharmacy requesting a flu shot for the current year. She stated that she had had pain in her left arm since receiving an immunization on 11/21/2017. She stated that from "what she had read" she believed it was due to the pneumonia shot she received on the same day. We retrieved the paperwork from 11/21/2017 and it showed the immunization given in the left arm was FLUAD. Patient stated that since she received the injection her arm has been sore, even when she lifts her arms to move her hair. She has not seen a doctor about the pain. Patient was advised that she should contact her physician regarding the pain in the left arm and that all further flu shots should be given in her physician's office.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, swollen area around vaccination and spreading down the arm. Hot to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site nodule, Lethargy, Musculoskeletal stiffness
Clinical narrative: The first night after injection I had significant muscle soreness and stiffness, chills, achiness, and severe headache. Symptoms subsided next day w TYLENOL, although felt lethargic. Last night I noticed small bumps along the lymph's of the left arm, which is where I received the injection. I do not feel any swollen in arm pit or neck, just upper arm. I did receive a senior dose of flu vaccine at the same time as the shingles vaccine in the same arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: The first night after injection I had significant muscle soreness and stiffness, chills, achiness, and severe headache. Symptoms subsided next day w TYLENOL, although felt lethargic. Last night I noticed small bumps along the lymph's of the left arm, which is where I received the injection. I do not feel any swollen in arm pit or neck, just upper arm. I did receive a senior dose of flu vaccine at the same time as the shingles vaccine in the same arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Swelling, Urticaria
Clinical narrative: Red wheel with swelling and heat (about 3-4 inch diameter). Soreness.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Flushing, Headache, Nausea, Pruritus
Clinical narrative: Shortly after receiving the flu vaccine, patient presented with nausea, diarrhea, frontal headache. Patient was flushed and C/O itchy skin. 10:20 AM BP=115/70, P=100, R=24, blood sugar was 138. He had taken LEVEMIR 72 mg at 6 AM. Administered 25 mg BENADRYL with good effect. 10:35 AM BP=120/68, P=100, R=24. Released pt to supervisor and he went to primary MD right away. MD said remain on BENADRYL for rest of day until symptoms totally resolve.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Reported a "red wheel" around the injection site. No other action was taken.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Pt received PPV23 and FLULAVAL immunizations in right deltoid on 10/26/2018. Immunizations were administered at patient's place of employment. Within 3 hours of PPV23 immunization, patient's right arm was swollen, red and hot. Motion was painful. These symptoms lasted approximately 48 hours but patient still reports right arm warmth and tenderness today (Monday, 10/29/2018). Within 6 hours of PPV23 immunization, patient had a fever of 100.5F as well as other symptoms mentioned above. Fever was gone when patient woke up Sunday (10/28/2018) morning. Patient reports using ALEVE, DAYQUIL and EXCEDRIN at different times to address symptoms. Pt did not seek medical care for these concerns but reported it to the vaccine coordinator at her place of employment.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Pt received PPV23 and FLULAVAL immunizations in right deltoid on 10/26/2018. Immunizations were administered at patient's place of employment. Within 3 hours of PPV23 immunization, patient's right arm was swollen, red and hot. Motion was painful. These symptoms lasted approximately 48 hours but patient still reports right arm warmth and tenderness today (Monday, 10/29/2018). Within 6 hours of PPV23 immunization, patient had a fever of 100.5F as well as other symptoms mentioned above. Fever was gone when patient woke up Sunday (10/28/2018) morning. Patient reports using ALEVE, DAYQUIL and EXCEDRIN at different times to address symptoms. Pt did not seek medical care for these concerns but reported it to the vaccine coordinator at her place of employment.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Fall, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: A few minutes after receiving the flu vaccine, the patient passed out and fell to the floor hitting her head. Unresponsive for short time, approx 1 minute, skin was cool, clammy and diaphoretic. Mother called 911 and thought patient had lump on back of head. Had patient continue to lie down as we waited for EMT. 6:40 PM BP=101/66, POX 98%. 6:45 PM client is responsive and is being brought to ER. ER evaluated and said her head was fine and didn't find a lump on back of head. No further treatment was necessary.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: A few minutes after receiving the flu vaccine, the patient passed out and fell to the floor hitting her head. Unresponsive for short time, approx 1 minute, skin was cool, clammy and diaphoretic. Mother called 911 and thought patient had lump on back of head. Had patient continue to lie down as we waited for EMT. 6:40 PM BP=101/66, POX 98%. 6:45 PM client is responsive and is being brought to ER. ER evaluated and said her head was fine and didn't find a lump on back of head. No further treatment was necessary.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: REDNESS, WARM TO TOUCH.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Partial seizures
Clinical narrative: Focal complex seizures - eyes deviating to the right.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count, Electrocardiogram, Facial paralysis, Full blood count, Injection site erythema
Clinical narrative: Within the first 24 hours of receiving the vaccine I felt swelling on the left side of my face, and the injection site was red, swollen, and painful. The swelling on my face subsided overnight and in the next 8 hours the right side of my face began to droop significantly. My primary physician's office saw me immediately and told me to immediately go to the ER to be checked for a possible stroke. The ER staff ran multiple tests as well as an MRI and diagnosed me with BELLS PALSY, possibly triggered by the Shingles vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Metabolic function test, Nuclear magnetic resonance imaging brain, Swelling face
Clinical narrative: Within the first 24 hours of receiving the vaccine I felt swelling on the left side of my face, and the injection site was red, swollen, and painful. The swelling on my face subsided overnight and in the next 8 hours the right side of my face began to droop significantly. My primary physician's office saw me immediately and told me to immediately go to the ER to be checked for a possible stroke. The ER staff ran multiple tests as well as an MRI and diagnosed me with BELLS PALSY, possibly triggered by the Shingles vaccine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage, Tenderness
Clinical narrative: Pt reports bleeding for 24 hours starting at time of vaccination. She presents 12 days post vaccination with bruised area on deltoid area; no obvious swelling or redness. She reports still having tenderness in the area. Medical F/U was recommended.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient stated she had sharp pain in her right wrist a few minutes after getting flu vaccine. Patient called later to state she had some joint pain off and on in her ankles, wrists and arms.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Full blood count, Immediate post-injection reaction, Immunology test, Neuralgia, Pain
Clinical narrative: Patient stated she had sharp pain in her right wrist a few minutes after getting flu vaccine. Patient called later to state she had some joint pain off and on in her ankles, wrists and arms.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Injection site erythema, Injection site oedema, Injection site urticaria, Lip disorder
Clinical narrative: 72 YOF pt with C/O erythematous and edematous wheal lesion of left upper arm at injection site after FLUZONE HIGH DOSE and PNEUMOVAX 23 vaccines were given on 10-25-18 at a pharmacy. Pt has had the symptoms x 4 days. Pt also has a C/O erythematous vesicular lesions on lower lip since this morning. No distress observed. PE unremarkable except as noted. Pt treated with valacyclovir for H/O herpes labialis and provided with topical steroid cream to apply on wheal site. I recommended re-assessment by PCP within the next 24 hrs and ER recommendations given. Pt verbalized understanding. Pt declined referral to PCP.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lip erythema
Clinical narrative: 72 YOF pt with C/O erythematous and edematous wheal lesion of left upper arm at injection site after FLUZONE HIGH DOSE and PNEUMOVAX 23 vaccines were given on 10-25-18 at a pharmacy. Pt has had the symptoms x 4 days. Pt also has a C/O erythematous vesicular lesions on lower lip since this morning. No distress observed. PE unremarkable except as noted. Pt treated with valacyclovir for H/O herpes labialis and provided with topical steroid cream to apply on wheal site. I recommended re-assessment by PCP within the next 24 hrs and ER recommendations given. Pt verbalized understanding. Pt declined referral to PCP.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: RED, RAISED, HARD AREA AT SITE OF INJECTION. ADVISED PT ON 10-28-18 TO APPLY COOL COMPRESSES AND CONTACT PCP IF IT GETS WORSE OR DOES NOT IMPROVE. SHE IS ALSO TO ASK PCP IF SECOND VACCINATION IS APPROPRIATE. Nurse also suggested benadryl at night.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Swelling, Vaccine positive rechallenge
Clinical narrative: Patient called stating that the vaccination had caused unusual swelling and worsening of her asthma symptoms. These are the same symptoms that she had experienced with last years high dose vaccine. The issues were resolved using her VENTOLIN HFA inhaler and did not return.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient administered two dosed of Influenza quadrivalent within a 5 day period. Protocol for adults is to administer one influenza vaccine. Patient to return in one week to ensure if adverse reactions are to occur that patient will be assessed.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Swelling
Clinical narrative: Patient had some bleeding and swelling post injection. I gave her an ice pack and suggested to apply pressure to help with the swelling. Patient stayed in waiting area for approximately 10 minutes, after which the swelling had decreased. I tried calling the patient after a couple of hours; I left a message, but have had no callback up to the time of this writing.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Swelling
Clinical narrative: My arm was immediately sore. It felt very thick and I told the nurse. She kept saying 'yes it's cold' but it wasn't cold. It was sore. Over the next two days the soreness continued. It's now been 2 weeks and it's very sore and is sharp pain when I lift or move my arm.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Skin rash on torso and neck.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated the vaccine hurt at the time of administration and was sore from that point on. Pt states she had pain at the site and entire upper arm area that was limiting movement. She went to her Dr. on 10/12 to seek treatment. Patient states she still has some pain in the upper arm today, 10/29.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Diarrhoea, Influenza virus test, Lethargy
Clinical narrative: Fever, diarrhea, lethargic. She was taken by ambulance to Hospital on 10/25/18.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever, diarrhea, lethargic. She was taken by ambulance to Hospital on 10/25/18.