chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: PATIENT DID NOT HAVE AN ADVERSE EVENT, BUT SHE HAD ALREADY RECEIVED ONE DOSE OF PREVNAR 13 ON 4/25/2015.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Severe itching around trunk and other areas. It gets worse at night and is ongoing.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Another MA-C, drew up 6 vaccinations for patient. I helped administer these vaccines, but I did not double check what vaccines I was giving the patient. When I was entering the vaccines into the patient's chart, I realized that I gave the patient a DTAP (for ages 6 wks-6 yrs) instead of giving a TDAP (meant for 8yrs of age and older). Pt was still in the clinic waiting for his imms records. I called the CDC to find out what needed to be done to correct giving the pt the wrong dosage/immunization. The CDC representative stated that since the pt has already had one TDAP in 2017, and has not received any DTAPs in childhood, the pt will need one more TD shot in 6 months from today to be fully vaccinated. No adverse effect to patient since pt received a lower dose of the vaccine than is expected for his age.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Am swelling, redness, and tenderness.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Injection site rash
Clinical narrative: Rash at injection sit, 25 mg PO Benadryl given. Rash began resolving.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling hot, Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: Patient exhibited initial signs of presyncope immediately following immunization administration. Symptoms were characterized by feeling faint, warm and nauseous. Patient remained seated for approximately 15 minutes, was given a glass of water and an ice pack. After initial episode patient felt better and was able to walk out of pharmacy without incident.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Approximately 10 min after immunizations were given, patient became light headed, diaphoretic, pallor. Patient was given oxygen via mask at 6lpm for approx. 5 minutes. Patient responded well. Patient did not lose consciousness at any time. Provider evaluated patient, vital signs were stable during the event. Patient left clinic after being observed for 30 minutes, in stable condition.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large area of redness from top of shoulder down to the mid humerus. Site was itchy and slightly raised with well demarcated borders.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Severe muscle ache, fatigue, weakness, swelling and redness at injection site about the size of an orange. Patient took ibuprofen to help with pain. Swelling at injection site lessened over the course of a week, but not completely dissipated.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore after 3 weeks. Patient to contact MD.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hot flush, Mobility decreased, Nausea, Pain
Clinical narrative: Woke up in the morning with pain. Couldn't lift my arm up, had fever 101-102 for 4 days, headaches, hot flushes, nausea, vomited once and my whole body was sore. Have a rash on my arm.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Woke up in the morning with pain. Couldn't lift my arm up, had fever 101-102 for 4 days, headaches, hot flushes, nausea, vomited once and my whole body was sore. Have a rash on my arm.
Age: 94.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Chills, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: Patient stated the one I had on the right (Oct.18 first injections),was very painful. I got home and I was chilling and had a fever. I felt so bad, I called my son to go to the hospital. I took a TYLENOL before he got here and it eased up so I didn't go. My right 'shoulder' hurt all night. I don't want the other shots.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash to the thighs and groin. Could be explained by contact with diaper, but mom says he gets it after all his vaccines (not previously mentioned). He is being referred to allergist for multiple food allergy history.
Sex: U
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Hypersensitivity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a patient who received BOOSTRIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX and not applicable after receiving BOOSTRIX, the patient experienced allergic reaction, extra dose administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction, extra dose administered and circumstance of information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional stated that the patient with an allergy to horse serum had an allergic reaction, extra dose administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the allergic reaction, extra dose administered and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional stated that the patient with an allergy to horse serum had an allergic reaction to BOOSTRIX several years ago. The age at vaccination was not reported. The patient would like to receive BOOSTRIX but was concerned about horse serum content, this was the circumstance of information capable of leading to medication error of extra dose administered. No patient data or vaccine information was available. No specific details about the allergy were given.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, fever and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site erythema, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, fever and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. Less than 24 hours later, the patient called to report redness at the injection site, fever and chills. The batch number reported for SHINGRIX (3V4KL), did not exist and was updated to 3Z4KL, as per sales database. The reporter was unable to provide much details.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number DK74P, expiry date unknown) and (batch number 75A37 ?, expiry date unknown). Concomitant products included FLUZONE Quadrivalent. On 25th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient had SHINGRIX (subunit vial lot number DK74P, adjuvant vial lot number 75A37) in the left deltoid. She also simultaneously received Quadrivalent FLUZONE intramuscularly in the right deltoid. The patient presented to the pharmacy on 29 January 2018, after having seen her physician who advised her not to get a second shot, complaining significant pain to the light touch over a 3 by 3 area in the vicinity of where she received the SHINGRIX shot. The pharmacist described the area as red. She did not press on the area but only gave a light touch and the patient complained of significant pain. She did not think the area was indurated. The patient was able to perform normal range of motion. The patient did not have any significant local reaction at the injection site of FLUZONE QIV. There were no other complaints reported. No further information was provided regarding the event. The reported adjuvant batch number (75A37) did not exist in the sales database and was updated to 75A37 ?.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 75-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th February 2018, 6 hrs. after receiving SHINGRIX, the patient experienced weakness, injection site pain, injection site lump and tiredness. On an unknown date, the outcome of the weakness, injection site pain, injection site lump and tiredness were recovering/resolving. The reporter considered the weakness, injection site pain, injection site lump and tiredness to be related to SHINGRIX. Additional information was received as follows: This case was reported by patient's husband. The patient had an unknown medication as a concomitant product. At noon on 19th February 2018, the patient received SHINGRIX on left arm. The patient developed tremendous weakness and tiredness. She was never checked for a fever and did not have any shivering. This case has been linked to the case US2018029337, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Mom reports redness to right deltoid area and red round area to right upper lateral side of arm. Mom states via interpreter she noticed areas on 2/20/18 the day after pt. received shots.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Anion gap increased, Asthenia, Balance disorder, Biopsy skin abnormal, Blister
Clinical narrative: This serious spontaneous case, initially received on 14-Feb-2018, from physician, concerns a 77-year-old, elderly male patient. The patient's historical condition included pancreatitis (on an unspecified date, it had occurred twice and last was 20 years ago). The patient's historical drugs included prednisone (had been off prednisone x 2 days before getting influenza vaccine) and bronchial thermoplasty (new asthma treatment) procedure performed on unspecified dates in Sep and Oct-2017. The patient underwent cardioversion for atrial flutter and right heart catheterization for ablation of abhorrent pathways. The patient's current conditions included asthma (for 40 years), normo pressure hydrocephalus (NPH) (since 6 years) and had shunt for it, diabetes and bilateral cataract induced by prednisone, supraventricular tachycardia (SVT) due to overload of beta agonist (since an unspecified dates). The patient's concomitant medications included prednisone, NOVOLOG and sliding scale, LANTUS, ADVAIR and ELIQUIS all for an unknown indications. On unspecified date in November, the insulin dose was adjusted. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On the same day, within 12 hrs the patient developed painful rash on legs (entire area around ankles) which spread to chest and arms. It was difficult to walk because of the blisters on legs and ankles (look like haemorrhagic blisters). On an unspecified date, biopsy (unspecified) showed immunoglobulin A (IGA) vasculitis (Henoch-Schonlein purpura). Other lab data included elevated blood urea nitrogen (BUN) and creatinine (CR) and ion gap (results not provided). On an unknown date, the abnormal values were normalised by the time then patient visited the convenient care (CC). At the time of this report, the rash was disappeared (which took more than a month). At an undetermined time, the patient had an exercise intolerance, weakness, balance problems, strength and stamina problems. It was stated that, prior to FLUAD administration, the patient was able to walk without any problems and he did not experience any of those symptoms. At present, the symptoms were not getting better. The patient went to CC next week for examination and it was stated that, his physician did not know what to do with him. It was reported that, patient was able to walk short distances and was not able to walk long distances, he needs a wheelchair to manage. The outcome of the events (IGA vasculitis, exercise intolerance, balance disorder, strength and stamina problems) was not recovered.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood creatinine increased, Blood urea increased, Exercise tolerance decreased, Gait disturbance, Henoch-Schonlein purpura
Clinical narrative: This serious spontaneous case, initially received on 14-Feb-2018, from physician, concerns a 77-year-old, elderly male patient. The patient's historical condition included pancreatitis (on an unspecified date, it had occurred twice and last was 20 years ago). The patient's historical drugs included prednisone (had been off prednisone x 2 days before getting influenza vaccine) and bronchial thermoplasty (new asthma treatment) procedure performed on unspecified dates in Sep and Oct-2017. The patient underwent cardioversion for atrial flutter and right heart catheterization for ablation of abhorrent pathways. The patient's current conditions included asthma (for 40 years), normo pressure hydrocephalus (NPH) (since 6 years) and had shunt for it, diabetes and bilateral cataract induced by prednisone, supraventricular tachycardia (SVT) due to overload of beta agonist (since an unspecified dates). The patient's concomitant medications included prednisone, NOVOLOG and sliding scale, LANTUS, ADVAIR and ELIQUIS all for an unknown indications. On unspecified date in November, the insulin dose was adjusted. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On the same day, within 12 hrs the patient developed painful rash on legs (entire area around ankles) which spread to chest and arms. It was difficult to walk because of the blisters on legs and ankles (look like haemorrhagic blisters). On an unspecified date, biopsy (unspecified) showed immunoglobulin A (IGA) vasculitis (Henoch-Schonlein purpura). Other lab data included elevated blood urea nitrogen (BUN) and creatinine (CR) and ion gap (results not provided). On an unknown date, the abnormal values were normalised by the time then patient visited the convenient care (CC). At the time of this report, the rash was disappeared (which took more than a month). At an undetermined time, the patient had an exercise intolerance, weakness, balance problems, strength and stamina problems. It was stated that, prior to FLUAD administration, the patient was able to walk without any problems and he did not experience any of those symptoms. At present, the symptoms were not getting better. The patient went to CC next week for examination and it was stated that, his physician did not know what to do with him. It was reported that, patient was able to walk short distances and was not able to walk long distances, he needs a wheelchair to manage. The outcome of the events (IGA vasculitis, exercise intolerance, balance disorder, strength and stamina problems) was not recovered.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash, Wheelchair user
Clinical narrative: This serious spontaneous case, initially received on 14-Feb-2018, from physician, concerns a 77-year-old, elderly male patient. The patient's historical condition included pancreatitis (on an unspecified date, it had occurred twice and last was 20 years ago). The patient's historical drugs included prednisone (had been off prednisone x 2 days before getting influenza vaccine) and bronchial thermoplasty (new asthma treatment) procedure performed on unspecified dates in Sep and Oct-2017. The patient underwent cardioversion for atrial flutter and right heart catheterization for ablation of abhorrent pathways. The patient's current conditions included asthma (for 40 years), normo pressure hydrocephalus (NPH) (since 6 years) and had shunt for it, diabetes and bilateral cataract induced by prednisone, supraventricular tachycardia (SVT) due to overload of beta agonist (since an unspecified dates). The patient's concomitant medications included prednisone, NOVOLOG and sliding scale, LANTUS, ADVAIR and ELIQUIS all for an unknown indications. On unspecified date in November, the insulin dose was adjusted. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On the same day, within 12 hrs the patient developed painful rash on legs (entire area around ankles) which spread to chest and arms. It was difficult to walk because of the blisters on legs and ankles (look like haemorrhagic blisters). On an unspecified date, biopsy (unspecified) showed immunoglobulin A (IGA) vasculitis (Henoch-Schonlein purpura). Other lab data included elevated blood urea nitrogen (BUN) and creatinine (CR) and ion gap (results not provided). On an unknown date, the abnormal values were normalised by the time then patient visited the convenient care (CC). At the time of this report, the rash was disappeared (which took more than a month). At an undetermined time, the patient had an exercise intolerance, weakness, balance problems, strength and stamina problems. It was stated that, prior to FLUAD administration, the patient was able to walk without any problems and he did not experience any of those symptoms. At present, the symptoms were not getting better. The patient went to CC next week for examination and it was stated that, his physician did not know what to do with him. It was reported that, patient was able to walk short distances and was not able to walk long distances, he needs a wheelchair to manage. The outcome of the events (IGA vasculitis, exercise intolerance, balance disorder, strength and stamina problems) was not recovered.
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional on 14-Feb-2018, concerning a male patient of an unspecified age. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: left deltoid muscle, batch number and expiry date: not reported). On 13-Feb-2018 (reported as yesterday), the patient developed unspecified symptoms (reported that, the patient was exposed to a sick family member in the past weekend). On 14-Feb-2018, after 4 months 19 days of vaccination, the patient was diagnosed with influenza type A virus infection. It was not clear, whether the patient received antiviral treatment. At the time of this report, the outcome of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 14-Feb-2018, was reported by a physician and concerns an adult male patient of unspecified age. The patient's current conditions included asthma (since an unspecified date). On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date (reported as once in past 40 years), the patient had flu after flu vaccination. The outcome of the event was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck mass, Pain, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 60-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced nausea, pain, neck mass and vomiting. On an unknown date, the outcome of the nausea, pain, neck mass and vomiting were not recovered/not resolved. The reporter considered the nausea, pain, neck mass and vomiting to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy student. On 15th February 2018 at 9:21, the patient received SHINGRIX on left arm. The patient experienced a lump around the thyroid area of their neck. The reporter was unable to provide additional information. The reporter's call was transferred to Medical Information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number S45FC ?, expiry date 30th January 2020). On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 3 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were unknown. The reporter considered the injection site erythema, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The patient reported to the pharmacist that after the initial dose, there was a large red area at the injection site. It was hard and hot to the touch. The reporter said it did not itch and it seems to be getting better but she was concerned about proceeding with the 2nd dose. The reporter's call was transferred to medical information for further assistance. The batch number of SHINGRIX (S45FC) did not exist as per sales database and was updated to S45FC ? Clarification has been requested for the same.
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This serious spontaneous case, initially received on 14-Feb-2018, from the other health professional (pharmacist), concerns a patient of unspecified age and unspecified gender. On an unspecified date, the patient was administered with INN (dose, route of administration, anatomical location, manufacturer, trade, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient had an anaphylactic reaction. The reporter stated that, it was unclear whether the reaction was due to egg or egg-based unspecified influenza vaccine which was administered to the patient. The outcome of the event-anaphylactic reaction was not reported.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Eye swelling, Heart rate increased, Lip swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 23-year-old female patient who received ENGERIX B (batch number 9X4E7, expiry date 26th May 2019). Concomitant products included CLARITIN, ZYRTEC and ALLEGRA. On 15th February 2018 11:30, the patient received ENGERIX B. On 15th February 2018 15:00, 3 hrs 30 min after receiving ENGERIX B, the patient experienced hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever. In February 2018, the outcome of the hives, weakness, heart rate increased, tremor, lip swelling and fever were recovered/resolved. On an unknown date, the outcome of the facial swelling and eye swelling were recovering/resolving. The reporter considered the hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever to be related to ENGERIX B. Additional details were provided as follows: At 11:30 am, the patient received ENGERIX B on the left arm. The symptoms started to present at 3:00 PM. The patient went to the emergency room at 3:30 PM. Her face, lips and eyes were swollen and she had hives on her face and neck. The fever was 101 to 102 degrees F and she described her heart rate as a high heart rate. Her eye and face were still a little swollen at the reporting time.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face, Tremor, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 23-year-old female patient who received ENGERIX B (batch number 9X4E7, expiry date 26th May 2019). Concomitant products included CLARITIN, ZYRTEC and ALLEGRA. On 15th February 2018 11:30, the patient received ENGERIX B. On 15th February 2018 15:00, 3 hrs 30 min after receiving ENGERIX B, the patient experienced hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever. In February 2018, the outcome of the hives, weakness, heart rate increased, tremor, lip swelling and fever were recovered/resolved. On an unknown date, the outcome of the facial swelling and eye swelling were recovering/resolving. The reporter considered the hives, weakness, heart rate increased, tremor, facial swelling, eye swelling, lip swelling and fever to be related to ENGERIX B. Additional details were provided as follows: At 11:30 am, the patient received ENGERIX B on the left arm. The symptoms started to present at 3:00 PM. The patient went to the emergency room at 3:30 PM. Her face, lips and eyes were swollen and she had hives on her face and neck. The fever was 101 to 102 degrees F and she described her heart rate as a high heart rate. Her eye and face were still a little swollen at the reporting time.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Cough, Irritability, Pyrexia, Screaming
Clinical narrative: Fever, fussy, coughing, and screeching.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Redness, swelling, itchiness, fever, burning sensation Lt arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: At first I thought I was overreacting. The site swelled to about the width of a tennis ball - red and hot. Throbbing w/pain I googled - used warm heat packs, took some aspirin. After Sunday - friend saw it - has a medical family background took me ASAP to ER - confirmed cellulitis. ER PA prescribed KEFLEX and to follow up in 72 hrs. w/my MD. I called today, left VM requesting to be seen in the next 48 hrs. Other adverse symptoms: terrible rock hard and inflammed vaccine site and large red circumference area surrounding site approx. 3 to 5 inches out. Fever, chills, muscle aches, terrible itching on and around site. All symptoms began early Sat. AM approx. 1-2 AM except, itching. Itching began approx. Sat. 11:00 AM - 12 PM. I thought it was a normal reaction until friend(s) looked at site. Fever 99 degrees approx. 10:00 AM 2/24/2018, 100 degrees approx. 1:00 PM 2/24/2018, 99 degress approx. 4:00 PM 2/24/2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia, Vaccination site induration
Clinical narrative: At first I thought I was overreacting. The site swelled to about the width of a tennis ball - red and hot. Throbbing w/pain I googled - used warm heat packs, took some aspirin. After Sunday - friend saw it - has a medical family background took me ASAP to ER - confirmed cellulitis. ER PA prescribed KEFLEX and to follow up in 72 hrs. w/my MD. I called today, left VM requesting to be seen in the next 48 hrs. Other adverse symptoms: terrible rock hard and inflammed vaccine site and large red circumference area surrounding site approx. 3 to 5 inches out. Fever, chills, muscle aches, terrible itching on and around site. All symptoms began early Sat. AM approx. 1-2 AM except, itching. Itching began approx. Sat. 11:00 AM - 12 PM. I thought it was a normal reaction until friend(s) looked at site. Fever 99 degrees approx. 10:00 AM 2/24/2018, 100 degrees approx. 1:00 PM 2/24/2018, 99 degress approx. 4:00 PM 2/24/2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site inflammation
Clinical narrative: At first I thought I was overreacting. The site swelled to about the width of a tennis ball - red and hot. Throbbing w/pain I googled - used warm heat packs, took some aspirin. After Sunday - friend saw it - has a medical family background took me ASAP to ER - confirmed cellulitis. ER PA prescribed KEFLEX and to follow up in 72 hrs. w/my MD. I called today, left VM requesting to be seen in the next 48 hrs. Other adverse symptoms: terrible rock hard and inflammed vaccine site and large red circumference area surrounding site approx. 3 to 5 inches out. Fever, chills, muscle aches, terrible itching on and around site. All symptoms began early Sat. AM approx. 1-2 AM except, itching. Itching began approx. Sat. 11:00 AM - 12 PM. I thought it was a normal reaction until friend(s) looked at site. Fever 99 degrees approx. 10:00 AM 2/24/2018, 100 degrees approx. 1:00 PM 2/24/2018, 99 degress approx. 4:00 PM 2/24/2018.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness and a lot of swelling at the injection site. Area was also hot to the touch. Patient went to urgent care where they diagnosed him with and infection and prescribed him a steroid and antibiotic.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pruritus, Rash erythematous, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-year-old female patient who received SHINGRIX (batch number P539L, expiry date unknown) and (batch number 545FC, expiry date 30th January 2020). On 10th February 2018 15:14, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In February 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced rash symptoms of redness, itching and swelling from her shoulder down to elbow after receiving the SHINGRIX vaccine. The patient stated the issues had progressively gotten worse. The pharmacist denied any patient allergies to any of the components of the vaccine. The reporter's call was transferred to medical information system for discussion on how to proceed with 2nd dose.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-year-old female patient who received SHINGRIX (batch number P539L, expiry date unknown) and (batch number 545FC, expiry date 30th January 2020). On 10th February 2018 15:14, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In February 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site rash, injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced rash symptoms of redness, itching and swelling from her shoulder down to elbow after receiving the SHINGRIX vaccine. The patient stated the issues had progressively gotten worse. The pharmacist denied any patient allergies to any of the components of the vaccine. The reporter's call was transferred to medical information system for discussion on how to proceed with 2nd dose.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Pruritus generalised
Clinical narrative: Persistent red itchy swollen rash in two patches on upper right arm, each about 2 inches by 2 inches. General feeling of itchiness all over body.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N025718, expiry date 17-MAR-2019 (exact dose and route of administration were not reported) for prophylaxis. The sterile diluent (manufacturer unknown) with lot# N016189, expiry date 13-AUG-2019 used was stored properly. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: HEP
Symptoms: Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a male patient of unknown age. No medical history, concurrent condition and concomitant medications were reported. On an unknown date in February-2018 the patient was vaccinated with RECOMBIVAX HB, dose/frequency: vaccine dose, intramuscularly for prevention of Hepatitis B. On an unknown date in February-2018, approximately 5 days after receiving the vaccine injection, the patient experienced fatigue. The patient did not sought medical attention and no treatment was given for the adverse event. The outcome of fatigue was reported as not recovered/not resolved. Causality assessment was not provided. No product quality complaint was present.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 21-Oct-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 27-JUL-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 17-AUG-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 11-OCT-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 04-OCT-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 31-DEC-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 09-DEC-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 07-NOV-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a physician via Pfizer (manufacturer report # 2016260779) regarding a female of currently 82 years old. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # were not reported) for prophylaxis. Other suspect include unspecified nonsteroidal anti-inflammatory drug administered on an unknown date for unspecified indication. On an unknown date the patient experienced drug allergies to ZOSTAVAX and nonsteroidal anti-inflammatory drug. Outcome of the event was not reported. Causality of the event with ZOSTAVAX and nonsteroidal anti-inflammatory drug was considered to be related.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Strabismus
Clinical narrative: Baby began crossing eyes and going into confusion state. This lasted for a couple weeks.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Pain at right arm biceps and shoulder starting 2 days after the vaccination. Treated with RICE and Naproxen Sodium 550 mg one tab orally every 12 hours as needed.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red spots appeared on entire body including the face. No treatment. Spots do not seem to bother baby.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness
Clinical narrative: Dizziness, back pain, light headed.
Age: 22.0
Sex: F
Vaccine: HPVX
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician regarding a currently 25 year old non-pregnant female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date at the age of 22 years, the patient was vaccinated with first dose of GARDASIL 9 or GARDASIL unidentified Merck HPV vaccine administered (name and lot number not provided) (dose, route of administration, and expiry date were not reported) as vaccine. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 or GARDASIL unidentified Merck HPV vaccine administered (name and lot number not provided) (dose, route of administration, and expiry date were not reported) as vaccine. On an unknown date (reported as recently), the patient was seen in the physician's office seeking medical attention. The patient had an abnormal Papanicolaou (PAP) test and was known to have human papilloma viral infection (HPV infection). The outcome of papilloma viral infection and smear cervix abnormal was not recovered/not resolved. The relationship between human papilloma viral infection and smear cervix abnormal with GARDASIL 9 or GARDASIL was not provided. There was no product quality complaint (PQC) reported.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site rash, Pain in extremity, Paraesthesia
Clinical narrative: Patient experiencing pain, rash, and general soreness in location of the shot. The pain and tingling sensation radiates to the rest of the arm as well. Patient also reports knee pain (where he had the knee implant surgery). This pain started several hours after getting the shot. Also, for the first shot in the series, patient reported similar side effects. The side effects resolved in a few days, but the rash lasted about 3 weeks before resolution.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, MEN, TDAP
Symptoms: Lip swelling
Clinical narrative: PATIENT RECEIVED THE ABOVE VACCINATIONS, AS WELL AS A BICILLIN INJECTION. WITHIN 10 MINUTES THE LAST INJECTION (BICILLIN), THE PATIENT'S LOWER LIP BEGAN TO SWELL.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Syncope
Clinical narrative: Student received vaccination in school-based vaccination clinic setting. Upon returning to classroom, student had syncopal episode, was excused from class, and presented to school R.N. for evaluation. Vital signs reported as stable by school R.N., student noted to be slightly pale. Student was provided water and laid down in treatment room for 10 minutes. After rest period, color improved and student reported feeling less faint. Parent notified and advised regarding post vaccination monitoring. Student was dismissed to home.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Seizure, Syncope
Clinical narrative: 4 hrs after taking the vaccine she fainted in home while taking a shower. Mom thinks she had a brief seizure. She was taken to the local emergency room. She was discharged. Continues with headache and pain at the site of injection.