chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Headache, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 70-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR and SINGULAIR. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 7 days after receiving SHINGRIX and an unknown time after starting Doxycycline Hydrochloride, the patient experienced cellulitis (serious criteria GSK medically significant), chills, skin warm, swelling arm and headache. The patient was treated with Doxycycline Hydrochloride. On an unknown date, the outcome of the cellulitis, feeling hot and swelling arm were recovering/resolving and the outcome of the chills was recovered/resolved and the outcome of the headache was unknown. The reporter considered the cellulitis, chills, feeling hot, swelling arm and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine. The patient went to sleep about 4 to 5 hours after having the vaccine. Several hours after receiving the vaccination, the patient woke up with terrible chills. She put another cover up at night but was still experiencing chills. The patient also woke up the next day with a very annoying headache on the top of the headache, she stayed home the next day. A few days later (several days) after receiving vaccination, her arm where she received the vaccine started to swell and it got really hot to the touch. Then the next day, the patient did not have it and then it came back in full force. A week after receiving the vaccine, one of her coworkers said that she had cellulitis on her arm. She visited her physician and was prescribed doxycycline for one week to treat cellulitis. The patient required Emergency visit. The patient wanted to know should she take another dose.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Gait disturbance, Gait inability, Pain in extremity, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local swelling in a 4-year-old male patient who received ENGERIX B (batch number 34PK5, expiry date 27th July 2020). Concomitant products included XYZAL. On 13th April 2018, the patient received the 1st dose of ENGERIX B .5 ml. On 14th April 2018, 1 days after receiving ENGERIX B, the patient experienced local swelling, localized feeling of warmth, walking difficulty and leg pain. On an unknown date, the outcome of the local swelling, localized feeling of warmth, walking difficulty and leg pain were not recovered/not resolved. The reporter considered the local swelling, localized feeling of warmth, walking difficulty and leg pain to be related to ENGERIX B. Additional details were provided as follows: The mother left an afterhours voicemail message for her son. The concomitant products included muiti vitamins. The patient received the vaccine at approximately 9:45 AM. The patient had a very swollen ring about 2 to 3 inches in diameter that was got to the touch and he had complained of his leg hurting badly and he could not walk. The patient had no fever. The voicemail message was left on the 14th April 2018 and the mother indicated that the symptoms were worsening in her message. The health care professional had another patient to report an adverse event for the ENGERIX vaccine but she had to disconnect the call immediately and would call us back later today. No additional  details were available.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Pain and swelling injection site (L) upper arm within hours. 2-3 days later swelling of (L) forearm and rash. 2 weeks after injection swelling pain and swelling of (L) 1st MCP joint and PIP (L) index finger.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Pain and swelling injection site (L) upper arm within hours. 2-3 days later swelling of (L) forearm and rash. 2 weeks after injection swelling pain and swelling of (L) 1st MCP joint and PIP (L) index finger.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Injection site erythema, Injection site pain
Clinical narrative: Severe shoulder pain where I received the injection on 4-30-18 and still sore, but improving as of 5-2-18. Muscle and joint pain for 2 days, but now improving, shivering for a day, weakness for 2 days, on 5-1-18 bicep in the arm I received the vaccination started getting very sore and turned red and warm to the touch and is still this way today 5-2-18.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Severe shoulder pain where I received the injection on 4-30-18 and still sore, but improving as of 5-2-18. Muscle and joint pain for 2 days, but now improving, shivering for a day, weakness for 2 days, on 5-1-18 bicep in the arm I received the vaccination started getting very sore and turned red and warm to the touch and is still this way today 5-2-18.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Tremor
Clinical narrative: Shaking, fever of 102.9, body aches, pain in right shoulder later the day of receiving the vaccine, no improvement in symptoms the day after, 2 days after symptoms improved, 3 days after patient was feeling back to normal.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Night sweats, Pyrexia
Clinical narrative: High fever, night sweats, myalgias, nausea, and headache.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient received immunizations and was discharged home, as she walked down the hall with her parents, per father he stated she leaned on the wall and slid to the floor. Dad picked her up and nurse assisted her to a bench were she showed signs of vasovagal syncope, nurse and NP used alcohol wipe to awaken patient. She did not completely lose consciousness. It took a few minutes before we were able to obtain a blood pressure which was 100/54 Patient observed for 30 to 40 minutes, when she left she was stable, walking down the hall unassisted and playing on her phone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Initially red, very sore, progressed to itching and now a rash has developed below the shot site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site rash, Injection site vesicles, Rash
Clinical narrative: Blisters and rash on injection arm, a little at injection site, more between elbow and wrist. Pharmacist thought it was probably related to the injection.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Broke out in a rash. Had one small bump prior to shots. In the evening broke out in a rash that progressed to hives by the next morning. Had tactile temp this morning as well.
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness & swelling.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Vaccination site warmth
Clinical narrative: Pt called on 5-2-18 complaining of fever and her arm being red which feels hot at the site of vaccine. Pt was seen by Dr she was DX with cellulitis of right upper extremity. Antibx sent in for pt. Pt scheduled for a follow up with Dr on 5-6-18. Dr's encounter not closed yet at the time of reporting VAERS.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Fairly substantial body aches and slight fever. I had a similar reaction with the first shot, only worse. It started about 24 hours after the shot and I thought it was a virus. It was so strong that I went to the doctor thinking I had the flu. 101F fever and major body aches. Same thing this time though and to a lesser degree, so now I think the first incident was due to the vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient reports that she developed red itchy rash on 4/10/18, first on back of neck and progressing down trunk, arms, and legs over course of one week. As of today 5/2/18, rash has subsided but itching remains on arms. Denies other signs of allergic reaction when questioned. Patient does have Hx of eczema.  Patient advised to contact primary physician to report incident. 2nd Shingles vaccination will be postponed by this clinic until physician determines reason for rash and clears patient to receive.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 71 year old female patient. The patient's medical history included breast cancer in 2009, now in remission. Concomitant therapies included budesonide, SYMBICORT, VENTOLIN, magnesium (manufacturer unknown), ALEVE and DIFLUCAN. Drug reactions/allergies occurred with prednisone (manufacturer unknown). On 10-APR-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # N030111, expiration date: 21-APR-2019) (strength, dose, unit and frequency not specified) intramuscularly for the prevention of pneumonia. On 11-APR-2018, 2 days after onset of therapy the patient experienced urticaria, rash, and hotness in the arm the vaccine was administered in. The patient called Physician office and patient was instructed to take oral BENADRYL and use a cold compress on the affected area. The patient was treated for the adverse events. Lab diagnostics/studies were not performed. There was no intervention to prevent serious criteria. The events did not cause a significant disability or incapacity and hospitalization to the patient. The events were not life threatening. The outcome of the events urticaria, feeling hot and rash were reported as recovered/resolved. The reporter did not assess the causality of the event with suspect therapy. Product quality complaint was not involved.
Age: 23.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a 23 year old patient of unknown gender. The patient has been taking aspirin 81mg (Manufacturer unknown) daily, since 08-JUL-2014 for an unknown indication. No information was provided regarding the patient's concurrent conditions and medical history. On 19-APR-2018, the patient was vaccinated with VARIVAX lot # N014371, subcutaneous for prophylaxis (dose not reported). No adverse effect reported. I was not reported if the patient continued the therapy with aspirin.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from the referral coordinator of the physician's office and refers to a male 13 month patient. The patient has had an unknown reaction to MOTRIN. No other information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 10-FEB-2017, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # M011666, expiration date 08-MAR-2018, intramuscular for prevention of measles, mumps and rubella  (dose and anatomical location were not reported). On an unknown date, after the administration the patient was diagnosed with Autism spectrum disorder. The outcome of the event autism spectrum disorder and the causal relationship between the event autism spectrum disorder and therapy with M-M-R II (wistar ra 27-3) were not reported. Upon internal review the event autism spectrum disorder was considered to be medically significant.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning a 6 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "several months ago"), the patient was inadvertently administered GARDASIL 9 for prophylaxis, by mistake (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse events were reported for the patient and no product quality complaints were involved.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Malaise, Pruritus
Clinical narrative: This case involves a 57-year old female patient who was vaccinated once with a 0.5 ml dose of FLUZONE HIGH-DOSE (batch number, expiry date, dose in series and site of administration was not reported) via intramuscular route on 17-Jan-2018. The patient's concurrent condition includes penicillin allergy and hypertension. The patient's concomitant medications were not reported. On 17-Jan-2018, same day (in the evening) following the vaccination, the patient's neck, back and arms were feeling hot, headache, itchy and was feeling unwell. No rash was reported. It was also a case of an actual medication error due to overdose and inappropriate age at vaccine administration. The patient's laboratory investigations and corrective treatment was not reported. The patient was recovering from the event. 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. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 45-year-old female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine (intramuscular). On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown. It was unknown if the reporter considered the fever and muscle pain to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that her mother had a Tdap (unknown date, unknown manufacturer) and experienced the side effects.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Mom noted on 4/20/18 that injection area starting to get red and area is hardened, mom thought it was a normal reaction. Around 4/24/18, area is more red and a bump was noted and is getting more hard. Also, pt is seemingly in pain when mom is touching the area. The pt cries and doesn't want mom to touch it.
Age: 58.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Dysphonia, Hypersensitivity, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: STIFF LEFT ARM, HOARSENESS, GENERAL BODY PAIN AND SORE THROAT. PATIENT WAS ADVISED TO TAKE BENADRYL TO HELP WITH ALLERGIC REACTION AND TYLENOL TO HELP WITH PAIN AND WAS ADVISED TO GET MEDICAL ATTENTION IF THEY HAVE ANY TROUBLE BREATHING.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Rash morbilliform
Clinical narrative: Patient developed Morbilliform rashes 1-2 days following vaccination.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patients arm got extremely sore and she was unable to even use her arm for 1 day. She went to the Dr. the morning she woke up and was unable to use arm because she was sure she would have to see a neurologist and would have long lasting problems. The Dr. just told her that it was not unusual to have that reaction and just give it a few days. She actually regained use within 12 hours and her arm was back to normal in 2 days.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Monoplegia, Pain in extremity, Sensory disturbance
Clinical narrative: Patients arm got extremely sore and she was unable to even use her arm for 1 day. She went to the Dr. the morning she woke up and was unable to use arm because she was sure she would have to see a neurologist and would have long lasting problems. The Dr. just told her that it was not unusual to have that reaction and just give it a few days. She actually regained use within 12 hours and her arm was back to normal in 2 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Reaction to previous exposure to any vaccine, Vaccination site warmth
Clinical narrative: Patient was in on Friday, 4/27/18 for routine 11 year old vaccines. Received HPV in right arm and Tdap and MENACTRA in Left arm. On Saturday late morning, noticed his left arm had a dime sized red, warm to touch, circle where the vaccines were given. By Saturday night, it was quarter sized. Sunday it was about a 2 1/2" diameter circle and it is still that size on Monday. Mom noted that he has had a sensitivity and reaction to the flu vaccine in the past. She has given him TYLENOL, MOTRIN, 3 doses of BENADRYL, and pt has been icing the arm. Denies fever, trouble breathing, headache, etc.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Middle insomnia, Musculoskeletal pain, Night sweats
Clinical narrative: SHOULDER SORENESS PRESENTING IN THE EVENING OF THE VACCINATION. DURING SAME NIGHT PATIENT AWOKE WITH FLU-LIKE SYMPTOMS RESULTING IN BODY ACHES AND LOW ENERGY THE FOLLOWING DAY. THE FOLLOWING NIGHT PATIENT REPORTED NIGHT SWEATS WHICH LASTED UNTIL FOLLOWING MORNING. THAT MORNING ALL SYMPTOMS  RESOLVED.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: SHOULDER SORENESS PRESENTING IN THE EVENING OF THE VACCINATION. DURING SAME NIGHT PATIENT AWOKE WITH FLU-LIKE SYMPTOMS RESULTING IN BODY ACHES AND LOW ENERGY THE FOLLOWING DAY. THE FOLLOWING NIGHT PATIENT REPORTED NIGHT SWEATS WHICH LASTED UNTIL FOLLOWING MORNING. THAT MORNING ALL SYMPTOMS  RESOLVED.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face
Clinical narrative: The employee returned to work the day after her vaccination with facial swelling. She stated that she woke up around 7am and noticed the swelling. The employee arrived at work at 11am today. The employee was given 25mg BENADRYL by medical staff at 1105.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling at injection site 3" in diameter. Slight Pain (scale of 1-10) 3 No treatment.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Left arm-there are two erythematous area at the deltoid muscle-each approximately 2cm diameter. There is clearing in the middle area between the two erythematous areas.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, erythromacular rash, fever and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, erythromacular rash, fever and chills were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, erythromacular rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist. The age at vaccination was not reported. The health care professional reported that the patient experienced a red rash at the injection site, described as red spots. The health care professional declined to provide any additional information. This is 1 of the 4 cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Tongue dry
Clinical narrative: After 5 minutes of receiving vaccine patient stated that her lips were feeling numb, after another minute she stated her tongue was going numb, we called 911. I observed patient she stated her tongue felt dry and she was a little sweaty. The ambulance showed up and took her vitals, she appeared at that time to have no numbness and just a dry mouth. She did not leave by ambulance.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swelling (induration measuring 4x4 inches) with warmth and tenderness.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: The adverse event effected mother only and had no effect on baby. The site where the shot was administered was not the right location and hit my rotator cuff. I had to attend 6 weeks of physical therapy to gain back mobility in my arm and it took well over a year for my arm to feel back to normal.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Face oedema, Pharyngeal oedema
Clinical narrative: Patient was seen at her PCP and treated with the Hep A vaccine. She presented to our facility (hospital) with throat swelling, mild facial edema, and difficulty breathing. In the emergency department she was treated with BENADRYL 25mg IV, famotidine 20mg IV, and SOLU-MEDROL 125mg IV.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chest pain, Pain, Pain in extremity, Painful respiration
Clinical narrative: Patient developed left arm pain with radiation to midsternal area. Also, she had pain on deep inspiration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rigors in a 62-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020. Previously administered products included SHINGRIX with an associated reaction of chills (For tolerance to the 1st dose received on 9th February 2018, refer case US2018GSK069429). Concomitant products included Venlafaxine, Aspirin, WELLBURTIN XL, Atorvastatin, BRILINTA, Metoprolol Succin and (NOS) Omega Fatty Acid. On 10th April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced rigors. The patient was treated with TYLENOL and (NOS) BENADRYL. Rechallenge with SHINGRIX was positive. In April 2018, the outcome of the rigors was recovered/resolved. The reporter considered the rigors to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced severe rigors with 2nd dose of SHINGRIX. The reaction lasted for about 12 hours approximately. Before the second dose was administered patient was pre medicated with TYLENOL and BENADRYL.
Sex: M
Vaccine: VARZOS
Symptoms: Necrotising retinitis
Clinical narrative: This spontaneous report was received from a physician refers to a male patient whose age was "over sixties". The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were reported as unknown. On an unknown date in 2015, the patient was vaccinated with ZOSTAVAX (dose, units, frequency, lot number and expiry date unknown) for prophylaxis reported as "shingles." On an unknown date in 2017 (also reported as two years later) the patient developed acute retinal necrosis. Medical attention was sought. It was unknown if any lab diagnostics or studies performed. It was reported that the patient was treated with unknown medications and was now stable. The outcome of the event necrotizing retinitis was reported as recovered. The casual relationship between event necrotizing retinitis and ZOSTAVAX was not provided by the reporter. No product quality complaint (PQC) was reported. Upon internal review, the event necrotizing retinitis was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Physician Assistant referring to a 1 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 04-APR-2018, the patient was inadvertently vaccinated with a dose of GARDASIL 9 0.5 ml, intramuscularly, for prophylaxis (strength, lot # and expiration date were not reported), instead of the intended ACTHIB for prophylaxis (strength, dose, route, lot # and expiration date were not reported). The Physician assistant reported that this was a product confusion because the Medical Assistant, who administered the GARDASIL 9, thought the letters "HPV" and "HIB" looked similar on both of the vials. The Physician Assistant reported that the ACTHIB was in a vial with a green cap and was an unknown strength and size. Additionally, the GARDASIL 9 was a 0.5 ml vial with a brown cap. It was unknown if the patient received the dose of ACTHIB. No adverse effects were reported and a Product Quality Complaint was filed. At the reporting time, the outcome of product quality issue was unknown and the causality assessment between product quality issue and GARDASIL 9 and ACTHIB was not provided.
Age: 1.17
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a register nurse, and refers to a 14 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unspecified date, the patient received a dose of PROQUAD through the oral route for prophylaxis (strength, dose number, lot number and expiration date were not reported). There were no adverse effects or product quality complaint involved.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Necrotising retinitis
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In or around February 2007, the patient was vaccinated with ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose, the prevention of shingles. Shortly after, the patient suffered vision loss and within one month vision was completely lost in his left eye. In or around May 2007, the patient presented to his physician for this injury and was diagnosed with retinal necrosis. The patient's physician diagnosed the patient's vision loss as being related to receiving the ZOSTAVAX vaccine. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations, and experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. The patient suffered serious, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX vaccine. Upon internal review, vision loss, complete vision loss left eye and retinal necrosis were determined significant medical event. Vision loss, complete vision loss left eye and retinal necrosis were considered disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-MAY-2018, the patient inadvertently received an expired dose of GARDASIL 9, intramuscular injection, lot # M009378 and expiration date on 23-APR-2018, for prophylaxis. There were no adverse effects reported.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 75-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Concomitant products included Atorvastatin, lorazepam, Losartan, Demeclocycline, vitamin D, fish oil, LEXAPRO, and SYNTHROID. On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and rigors. In April 2018, the outcome of the extensive swelling of vaccinated limb, injection site erythema and rigors were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and rigors to be related to SHINGRIX. Additional details were provided as follow: The patient received SHINGRIX in the right deltoid. The patient experienced sever rigors after receiving SHINGRIX which lasted for about 24 hours approximately. The reporter stated the patient developed swelling and redness at the injection site from arm to all the way down to the elbow area which has lasted almost more than 72 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Listless, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, general body pain, headache, listless, influenza like illness and feeling unwell. On an unknown date, the outcome of the chills, general body pain, headache, listless, influenza like illness and feeling unwell were recovering/resolving. It was unknown if the reporter considered the chills, general body pain, headaches, listless, influenza like illness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Several weeks before the date of reporting, the patient received shingles vaccine and by that evening, she experienced chills, body aches, a headache and felt listless and flu like. The next day of vaccination, the patient was unable to go to work and felt sick all day. By the day after, the patient felt somewhat better. The patient stated that she understood these symptoms were side effects of the vaccine, but she was wondering that in 6 months she was supposed to get the second part of the vaccine. The patient was asking if she should get the second shot if she had this reaction. The patient was also asking if she do get the second vaccine, would she have a stronger or more serious reaction or a lesser reaction. The patient stated her internist was unable to answer these questions.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, general body pain, headache, listless, influenza like illness and feeling unwell. On an unknown date, the outcome of the chills, general body pain, headache, listless, influenza like illness and feeling unwell were recovering/resolving. It was unknown if the reporter considered the chills, general body pain, headaches, listless, influenza like illness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Several weeks before the date of reporting, the patient received shingles vaccine and by that evening, she experienced chills, body aches, a headache and felt listless and flu like. The next day of vaccination, the patient was unable to go to work and felt sick all day. By the day after, the patient felt somewhat better. The patient stated that she understood these symptoms were side effects of the vaccine, but she was wondering that in 6 months she was supposed to get the second part of the vaccine. The patient was asking if she should get the second shot if she had this reaction. The patient was also asking if she do get the second vaccine, would she have a stronger or more serious reaction or a lesser reaction. The patient stated her internist was unable to answer these questions.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased
Clinical narrative: 103.3 on second day after vaccine.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: After both vaccine doses, patient had a seizure. Seizures are occurring exactly around a month time.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2018-04-27.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site swelling
Clinical narrative: Within 6 hours After vaccine employee has red raised area3 inches by 1 inch on left dorsal site. Burning sensation described. Reported to Occ health within 24 hours.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-04-25.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Groin pain, Headache, Lymphadenopathy, Nausea
Clinical narrative: Severe rigors, painful groin node swelling, headache, and nausea.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Disturbance in attention, Feeling abnormal, Nausea, Pain
Clinical narrative: 1 to hours started feeling spacey/weird. Then starting hurting all over, stomach pain, slight nausea, could not focus and not get much done. Bed for 12 plus hours; Symptoms dissipated after 2 PM the next day or at 24 hrs after shot. Was most unpleasant.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Pallor, Rotavirus test positive, Ultrasound abdomen, Vomiting
Clinical narrative: Vaccines given on 4/30 at pediatric clinic. Following day, mother of child reported feeding her a rice cake and patient had clear-colored vomiting and turned very pale. Continued vomiting episodes became bilious. Presented to the emergency department on 5/1 and was given intravenous sodium chloride fluid. Had imaging studies done including ultrasound and xray of abdomen and upper GI study with barium. Patient recovered soon after the intravenous fluids and did not have any more episodes of vomiting. Mother of child reported stool was suspicious for rotavirus. Siblings may have also had recent rotavirus exposure or similar reactions when they received their vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Vaccines given on 4/30 at pediatric clinic. Following day, mother of child reported feeding her a rice cake and patient had clear-colored vomiting and turned very pale. Continued vomiting episodes became bilious. Presented to the emergency department on 5/1 and was given intravenous sodium chloride fluid. Had imaging studies done including ultrasound and xray of abdomen and upper GI study with barium. Patient recovered soon after the intravenous fluids and did not have any more episodes of vomiting. Mother of child reported stool was suspicious for rotavirus. Siblings may have also had recent rotavirus exposure or similar reactions when they received their vaccines.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Urticaria
Clinical narrative: Injection site reaction local redness and swelling. Hives on arms and torso, intermittent headache, body aches. Treated with oral prednisone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site nodule, Injection site urticaria, Injection site warmth
Clinical narrative: Pt received vaccines on 4/30/18. On 5/2/18, mom reported that pt began to have a welt to his right leg, estimated at 3-4 inches, with a large knot palpated at injection site as well. Mom also reports some tactile warmth at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Patient developed chills, headache, body aches that started the day of vaccination and lasted about 48 hours.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong patient received medication
Clinical narrative: The child was given the PREVNAR 13 dose meant for her younger sibling in error.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: PT COMPLAINED OF HIGH FEVER (103 DEG), PAIN IN ARM, NECK, UPPER BACK, ARM STIFFNESS and TIGHTNESS, SWELLING, ARM WAS WARM TO THE TOUCH. ALSO, SOME RED AREAS ON UPPER ARM BUT NOT AN ACTUAL RASH (ALMOST LOOKED LIKE CELLULITIS OF UPPER ARM).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin tightness, Skin warm, Swelling
Clinical narrative: PT COMPLAINED OF HIGH FEVER (103 DEG), PAIN IN ARM, NECK, UPPER BACK, ARM STIFFNESS and TIGHTNESS, SWELLING, ARM WAS WARM TO THE TOUCH. ALSO, SOME RED AREAS ON UPPER ARM BUT NOT AN ACTUAL RASH (ALMOST LOOKED LIKE CELLULITIS OF UPPER ARM).
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Feeling abnormal, Skin warm, Urticaria
Clinical narrative: Pt. stated that she was dizzy after vaccine was given. She had a 30 min drive home in that time she noticed her chest was hot, patient states that her son noticed this also. Patient stated that she broke out in hives on her chest, and that her lips felt "funny", denies any swelling to her lips. Pt. took a 3 hour nap when she woke up she felt better, so did not see anyone for it.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Blood culture negative, CSF test normal, Computerised tomogram head normal, Culture urine negative, Fontanelle bulging
Clinical narrative: 4/23/18 patient presented to ED with increased fussiness and bulging fontanelle. Head CT done was WNL and d/c to home. Patient returned to the ED on 4/24/18 with continued fussiness, bulging fontanelle and new onset fever.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: 4/23/18 patient presented to ED with increased fussiness and bulging fontanelle. Head CT done was WNL and d/c to home. Patient returned to the ED on 4/24/18 with continued fussiness, bulging fontanelle and new onset fever.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Local reaction
Clinical narrative: Patient states headache immediately after vaccine 2 days ago. Still headache and local reaction with redness to upper Left arm where vaccine injected. No cellulitis noted today area is 2" x 2 ".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received her first dose of the SHINGRIX vaccination on 4-10-18 and she stated that when she woke up on 4-11-18 her arm was stinging and burning around the injection site. She stated that it continued to get worse and it started stinging under her arm as well. She did end up going to the doctor because she states that she can not move her arm anymore. Patient is currently going to physical therapy for her arm.
Age: 1.92
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Abnormal behaviour, Aggression, Aphasia, Pyrexia, Screaming
Clinical narrative: My son started having a fever next day after the shot, but I thought it would go away. It stayed for a while and my son was very down, meaning he was not playful like his usual self. He started not saying much and then completely stopped saying any words and having tantrums and screaming all the time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a rash around injection site, red, raised and warm.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2005, when the patient was 12 years old, was vaccinated with first dose of GARDASIL (strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in 2017, reported as "last year", when the patient was 24 years old, was vaccinated with first dose of GARDASIL 9, as second dose of dose in the HPV vaccination series (strength, route of administration, anatomical location, lot number and expiration date were not reported).
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Patient's caretaker called and complained about severe dizziness along with severe pain in arms and legs. Pt is not able to describe the pain. Pt had already called her physician because she was concerned. Her doctor referred her to call the pharmacy that administered the shot.
Age: 1.75
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: Pt was given MMR II one day after expiration date of 05/01/2018. Manufacturer was contacted and stated dose was still viable and patient can continue on second dose when the time comes. Incident report was documented. No treatment or repeat dose necessary. Good outcome. No further action necessary.
Age: 1.75
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given MMR II one day after expiration date of 05/01/2018. Manufacturer was contacted and stated dose was still viable and patient can continue on second dose when the time comes. Incident report was documented. No treatment or repeat dose necessary. Good outcome. No further action necessary.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Fever, nausea, malaise throughout the weekend.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Vaccination site rash
Clinical narrative: Approximately 1 week post vaccination the patient experienced a wide spread rash up and down the arm where the vaccine was administered and on his hand on the opposite arm. The rash does not have much pain associated with it but is very itchy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: After 7 days, redness at injection site, possible cellulitis (not confirmed), warm to touch, itchy, rash on body and pimples on face, sleepy, fatigue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Somnolence
Clinical narrative: After 7 days, redness at injection site, possible cellulitis (not confirmed), warm to touch, itchy, rash on body and pimples on face, sleepy, fatigue.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Rash erythematous
Clinical narrative: Patient developed a red, burning rash on his hip two weeks after receiving the SHINGRIX vaccine. Patient's doctor stated that the rash appeared to be mild shingles.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Flu like symptoms (fever, chills, headache, fatigue, extreme body aches, loss of appetite), extreme pain in arm injection was given- can hardly lift arm. End of day 2- still experiencing the above symptoms. Day 2- raised red spot approximately the size of a plum, hard and very hot, with a smaller red raised mark diagonally below it. Very tender.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Influenza like illness, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Flu like symptoms (fever, chills, headache, fatigue, extreme body aches, loss of appetite), extreme pain in arm injection was given- can hardly lift arm. End of day 2- still experiencing the above symptoms. Day 2- raised red spot approximately the size of a plum, hard and very hot, with a smaller red raised mark diagonally below it. Very tender.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Skin warm, Swelling, Tenderness
Clinical narrative: Flu like symptoms (fever, chills, headache, fatigue, extreme body aches, loss of appetite), extreme pain in arm injection was given- can hardly lift arm. End of day 2- still experiencing the above symptoms. Day 2- raised red spot approximately the size of a plum, hard and very hot, with a smaller red raised mark diagonally below it. Very tender.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Injection site pain, swelling, local rash, fatigue, myalgia, headache, mild fever to 100.4F, dizziness, confusion starting 2 days after vaccination, peak symptoms 3-4 days after vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Injection site pain, swelling, local rash, fatigue, myalgia, headache, mild fever to 100.4F, dizziness, confusion starting 2 days after vaccination, peak symptoms 3-4 days after vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Pt had pain in arm went to ER dx cellulitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site. Fatigue. Headache. Chills. Body aches.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swelling and redness at injection site. Fatigue. Headache. Chills. Body aches.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Injection site erythema, Injection site haemorrhage, Injection site inflammation
Clinical narrative: 1-2 days post vaccinations patient experienced what appears to be an injection site reaction. The site is hot to touch, red, and inflamed. He is experiencing some discomfort with pain and itching. Last evening (5/1/18) he had a low grade fever and experienced some body aches and fatigue that kept him up most of the night. He also had some mild bleeding days later from the injection site.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Pain, Pruritus, Pyrexia
Clinical narrative: 1-2 days post vaccinations patient experienced what appears to be an injection site reaction. The site is hot to touch, red, and inflamed. He is experiencing some discomfort with pain and itching. Last evening (5/1/18) he had a low grade fever and experienced some body aches and fatigue that kept him up most of the night. He also had some mild bleeding days later from the injection site.