chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Herpes zoster, Malaise, Pain
Clinical narrative: On Monday 10/8/2018 HA and didn't feel well called into work. Tuesday I thought my bra was poking me because the right side kinda hurt. Wed. I thought that maybe I had a heat rash by Thursday I knew I had shingles. Saw a provider and was Dx.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: After 1 hour, student reported mild pain at the injection site. Later that afternoon, he reported to his mother that it hurt more. She examined the site and determined that it was red and slightly swollen. The swelling went down over the course of the school day, but the redness remained and grew in size. It seemed better after 24 hours, but then became more painful.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Mild headache, nausea, low grade fever, and severe injection site swelling and redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Got shot about 6 pm Friday (19 Oct). Arm sore and stiffness started 2 hours later and got worse all evening. I made a point of moving the arm around. Saturday morning (12 hours after injection) woke up with painful arm, fever and lethargy. Took aspirin for the pain, applied a heating pad for the arm, and stayed in bed/on sofa for the lethargy. Injection site was slightly swollen and red, No rash. No nausea, but little appetite. By Saturday evening (24 hours), arm pain was diminishing. Sunday morning, (36 hours), arm was sore, no fever, more energy, underarm was sore. Monday morning (2.5 days) arm still slightly sore, no other symptoms. Resumed normal activities. Injection site continued to be sore until Wednesday (5 days).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Got shot about 6 pm Friday (19 Oct). Arm sore and stiffness started 2 hours later and got worse all evening. I made a point of moving the arm around. Saturday morning (12 hours after injection) woke up with painful arm, fever and lethargy. Took aspirin for the pain, applied a heating pad for the arm, and stayed in bed/on sofa for the lethargy. Injection site was slightly swollen and red, No rash. No nausea, but little appetite. By Saturday evening (24 hours), arm pain was diminishing. Sunday morning, (36 hours), arm was sore, no fever, more energy, underarm was sore. Monday morning (2.5 days) arm still slightly sore, no other symptoms. Resumed normal activities. Injection site continued to be sore until Wednesday (5 days).
Age: 48.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site erythema, Malaise, Pyrexia
Clinical narrative: Right arm redness at injection site, low fever for 48 hours, malaise and fatigue.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient began vomiting almost immediately after receiving the flu shot. Patient was admitted to pediatrics for monitoring.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 54-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number YZ7TR, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). In October 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, pain in arm, swelling arm and fever. On an unknown date, the outcome of the dizziness, pain in arm, swelling arm and fever were recovered/resolved. It was unknown if the reporter considered the dizziness, pain in arm, swelling arm and fever to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The nurse reported that the patient experienced dizziness, slight fever and her arm was very sore and swollen after vaccination. The patient reported these adverse events on 4th October 2018, and since then the symptoms had resolved.
Sex: F
Vaccine: HEPA
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a female patient who received Hepatitis A vaccine for prophylaxis. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the elevated liver enzymes to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was not certain that she received HAVRIX. She only knows that it was a Hepatitis A vaccine. The patient experienced her liver enzymes were elevated. The patient refused to answer any questions. The time frame was unknown. Lab Comments: On an unknown date, the patient's liver enzymes were elevated.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Middle insomnia, Nausea, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 80-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any adverse event). On 4th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 5th October 2018, 1 days after receiving SHINGRIX, the patient experienced itchy rash and erythematous rash. On 6th October 2018, the patient experienced nausea and headache. On an unknown date, the outcome of the itchy rash, headache and erythematous rash were not recovered/not resolved and the outcome of the nausea was recovering/resolving. It was unknown if the reporter considered the itchy rash, nausea, headache and erythematous rash to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left deltoid. Approximately 24 to 48 hours following the dose of SHINGRIX, the patient experienced the red, itchy rash which appeared below the injection site (from deltoid to elbow) and was unresolved, at the time of reporting. The patient also had a complaint of headache and nausea. Both the headache and nausea began 2 days after the vaccine. The headache had been continuous and was unresolved. The nausea had been intermittent, occurring approximately every other night waking the patient up from sleep. The reporter was uncertain if the nausea had resolved as the symptoms had not been continuous. The reporter did not fully certain of timelines above. Lot number and expiry date was seem to be from the pharmacy stock and not from vaccination record, so they might not reflect the actual dose received.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received SHINGRIX (batch number E927Z, expiry date 27th February 2021) for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed arm pain the day after receiving a dose of SHINGRIX.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of numbness of tongue in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included polymyalgia rheumatica. Concomitant products included DTPa (Reduced antigen). On 2nd August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced numbness of tongue, speech disorder and tingling tongue. On an unknown date, the outcome of the numbness of tongue, speech disorder and tingling tongue were unchanged. It was unknown if the reporter considered the numbness of tongue, speech disorder and tingling tongue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. In June 2018, the patient received Tdap vaccine. Around middle of September 2018, the patient experienced tongue numbness, tingling and speech problems. The tongue numbness and tingling only happens in the morning time of the day from 8:30 AM to 9:30 AM, and then it goes away for the rest of the day. The patient reported it was the worse a day before reporting. Due to the numbness and tingling the patient had speech problems and it was hard to pronounce words. The patient required a visit to her vascular surgeon and rheumatologist to follow up in regard to what she was experiencing. The patient was referred to follow up with her primary care physician. The patient denied permission to contact their physician. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Age group was not reported, but was captured as adult as per vaccine indication. The healthcare professional (HCP) stated that the patient developed shingles 2 weeks after a dose of SHINGRIX. The HCP was a retail pharmacist, stated that the had SHINGRIX at another location, and on the day of reporting was presented for dose 2 of SHINGRIX. The HCP did not have vaccine information and declined to provide patient information for this adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. 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 pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were recovering/resolving. It was unknown if the reporter considered the pain and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a patient's mother called in for information regarding whether or not SHINGRIX was a live vaccine. The patient was not feeling well for a day or so after receiving SHINGRIX vaccine. The patient described the feeling as achy. No other information was available through the caller regarding this adverse event. The call center representative failed to obtain the physician's information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site nodule, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 72-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date unknown) for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced injection site bruising. On 19th September 2018, the patient experienced injection site lump, injection site erythema and injection site warmth. On an unknown date, the patient experienced injection site itching. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth and injection site bruising were unknown and the outcome of the injection site itching was recovering/resolving. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site bruising and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. The pharmacist stated 24 hours after receiving the vaccine, the patient developed a knot at the injection site, along with redness and stated that the area was warm to the touch. Three days following the injection, the patient developed bruising at the injection site. In 2018, the patient reported to the pharmacist that the area was itching as it was healing. This was 1 of the 3 cases reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 72-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date unknown) for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced injection site bruising. On 19th September 2018, the patient experienced injection site lump, injection site erythema and injection site warmth. On an unknown date, the patient experienced injection site itching. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site warmth and injection site bruising were unknown and the outcome of the injection site itching was recovering/resolving. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site warmth, injection site bruising and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. The pharmacist stated 24 hours after receiving the vaccine, the patient developed a knot at the injection site, along with redness and stated that the area was warm to the touch. Three days following the injection, the patient developed bruising at the injection site. In 2018, the patient reported to the pharmacist that the area was itching as it was healing. This was 1 of the 3 cases reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, difficulty sleeping and injection site erythema. The patient was treated with Ice Pack (Nos). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, difficulty sleeping and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, difficulty sleeping and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm. The patient's arm was very painful and she could not move it. The patient also had redness at the injection site, but no swelling was reported. The patient put an ice pack on her arm, but it was painful enough to make it difficult to sleep.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been linked with cases US2018GSK192914 and US2018GSK192915 reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Functional gastrointestinal disorder, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th September 2018, 4 days after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant) and intestinal functional disorder. On an unknown date, the outcome of the passed out and intestinal functional disorder were recovered/resolved. It was unknown if the reporter considered the passed out and intestinal functional disorder to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX in the right arm. The patient experienced loss of bowel function. The patient reported that she was seen by urgent care and was sent home. The patient did not want to provide her physician's name and contact information, but was willing to be contacted by safety depertment (GCSP). The patient reported that her husand might have called to report the adverse events listed above, but was unable to locate the patient's husband name in database.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of consciousness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of passed out in a 63-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) and (batch number L349E, expiry date 22nd February 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), injection site pain and injected limb mobility decreased. The patient was treated with Pain Medication. On an unknown date, the outcome of the passed out was unknown and the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the passed out, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: At approximately 2:15 PM, the patient received the SHINGRIX in left arm. The patient claimed that she experienced excruciating pain at the injection site and the patient was still having issues moving her arm on the day of reporting. The patient passed out from the pain and had to go to the emergency room but was not admitted and was provided some medications and they sent her home. The patient claimed that she already had pain medications but she was taking muscle relaxers and something else and the pain issue had not resolved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX. On 10th October 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 10th October 2018, the patient was diagnosed with Shingles.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Eye haemorrhage, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of broken blood vessel in eye in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On 17th October 2018, the patient experienced chills, fever and insomnia. On 19th October 2018, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant). The patient was treated with paracetamol. On 18th October 2018, the outcome of the chills, fever and insomnia were recovered/resolved. On an unknown date, the outcome of the broken blood vessel in eye was unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the broken blood vessel in eye, chills, fever, insomnia and pain in arm to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information received as follows: The patient did like to report possible side effects to the SHINGRIX vaccine. The patient was in good health. The patient received SHINGRIX in the left upper arm muscle and at the same time, she also received a seasonal flu vaccine in the right arm. That same night of vaccination she experienced severe chills, mild fever and insomnia that lasted all night. The next morning to vaccination day, she took some Acetaminophen and felt better by midmorning. On reporting day, she woke up with a burst blood vessel in her left eye with no known trauma to the orbit. There was no pain nor loss of vision, and she felt fine other than some lingering soreness in the left arm where she received the vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been created from case from case US2018188530 and US2018GSK192915 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced full body rash following administration of SHINGRIX. The HCP terminated the call when asked for patient details. No further information was obtained. This case has been created from case US2018188530 and US2018GSK192914, reported by the same reporter.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Extended soreness in arm up till 2+ weeks SO FAR.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Peripheral swelling, Urticaria
Clinical narrative: The patient received a flu shot yesterday morning 10/16/18. The patient called back and said that they had a reaction to the flu shot. They told male that their arm had turned red and swelled and formed a "welp". They also said that they felt "sick". The patient then called back later in the day and said that they were feeling better and that her arm was getting better.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported high fever, headache, malaise and swelling and pain on L deltoid since October 23 PM. Seen at the Center on October 24th. L deltoid: edematous, erythematous and warm 10x10 cm area. Tender.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: Patient reported high fever, headache, malaise and swelling and pain on L deltoid since October 23 PM. Seen at the Center on October 24th. L deltoid: edematous, erythematous and warm 10x10 cm area. Tender.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lymphadenopathy, Pain
Clinical narrative: Employee states that evening, her arm became red, swollen lymph nodes under arm into armpit, with pain radiating to her neck and shoulder. Still sore the following day.
Age: 22.0
Sex: F
Vaccine: FLU4, HPV9, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope -- Pt. was moved to a prone position and feet were elevated. Total time of syncope was approximately 10 seconds. Pt.'s position was maintained for about 5 minutes. Pt. was alert and oriented x 3 within 2-3 seconds after return to consciousness. After 5 minutes pt. was raised to semi-Fowlers position and provided a glass of water. BP was checked: 93/65. Semi-Fowlers position was maintained for another 5 minutes, during which time pt. was provided another glass of water and a small snack. Per pt's report that she felt "fine", she was raised to a sitting position. BP was rechecked: 105/65. Pt. stated that she felt she could stand without difficulty and so was assisted off the exam table. She was escorted to the reception area where she remained under observation for another 10 minutes before she left in stable condition.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Vaccine given on 9/17/2018. Symptoms of numbness, burning, and tingling in bilaterally lower extremities developed on 9/27/18. These symptoms spread to the upper extremities and left side of face. No issues with respiratory complications.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea started 3 hours after. Severe vomiting with fever and headache started 12 hours later and lasted for 5 hours. 24 hours later still had nausea and headache.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient reports developed large area of redness at injection site and experienced low grade fever, has improved since.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: PATIENT REPORTED TO WALK IN CLINIC WITH RED ITCHY ARM. AT THE SITE OF THE FLU SHOT. WALK IN CLINIC CALLED TO REPORT TO US AND PATIENT WAS ADVISED TO TAKE RANITADINE AND LORATADINE.
Age: 5.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Malaise, Swelling face, Urticaria, Vomiting
Clinical narrative: Patient was in the office to receive her 5 year old immunizations. Due to patients history at 15 months, Dr. advised patient stay an extra 20 minutes after injections. Nurse who gave injections came and grabbed RN at her desk to come evaluate. Patient initially did not have any reaction but shortly after the 20 minutes, patient stated she did not feel well. Patients face became puffy and two hives appeared- one on her forehead and one by her right eye. Writer grabbed a co-worker to stay in the room with mom and patient and went to speak to Dr. Dr. came into the room and during his evaluation patient started to vomit. EPI PEN and BENADRYL advised to be given. EPI PEN given to patient with positive results. 15 minutes later, 2mL oral BENADRYL given which patient tolerated as well. Patients vitals remained stable during the entire assessment. Patient remained in room another 30 minutes and was cleared to go by Dr.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Feeling cold, Malaise
Clinical narrative: I got the plus 65 flu shot, after five days I felt very ill. I contracted an upper respiratory infection, very congested, sore throat, and fever with chills. My congestion was so bad that at times I could not stop coughing and had issues breathing. I do get sinus congestion but I have not been sick for years, only seeing my doctor once a year for check-ups. This flu shot knocked me out and I am a  healthy person. I have not had a temperature for at least 15 years. The reason I am concluding that the flu shot made me ill is that my husband got the same 65 plus flu shot and got very sick after five days and our symptoms were similar. My husband had the pneumonia vaccine with no side effects.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Oropharyngeal pain, Pyrexia, Sinus congestion, Streptococcus test negative, Upper respiratory tract congestion
Clinical narrative: I got the plus 65 flu shot, after five days I felt very ill. I contracted an upper respiratory infection, very congested, sore throat, and fever with chills. My congestion was so bad that at times I could not stop coughing and had issues breathing. I do get sinus congestion but I have not been sick for years, only seeing my doctor once a year for check-ups. This flu shot knocked me out and I am a  healthy person. I have not had a temperature for at least 15 years. The reason I am concluding that the flu shot made me ill is that my husband got the same 65 plus flu shot and got very sick after five days and our symptoms were similar. My husband had the pneumonia vaccine with no side effects.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Upper respiratory tract infection
Clinical narrative: I got the plus 65 flu shot, after five days I felt very ill. I contracted an upper respiratory infection, very congested, sore throat, and fever with chills. My congestion was so bad that at times I could not stop coughing and had issues breathing. I do get sinus congestion but I have not been sick for years, only seeing my doctor once a year for check-ups. This flu shot knocked me out and I am a  healthy person. I have not had a temperature for at least 15 years. The reason I am concluding that the flu shot made me ill is that my husband got the same 65 plus flu shot and got very sick after five days and our symptoms were similar. My husband had the pneumonia vaccine with no side effects.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Peripheral swelling, Rash
Clinical narrative: To the best of father's recollection, per telephone conversation with father, today he describes that early AM after the injection the trouble began. Immunization was given on a Wednesday after school, they did not go to Urgent Care until the following Sunday. Father described rash, hives and swelling of the left arm. No treatment at Urgent Care. The troubling part is that today 10/25/18 father is describing swelling yet. Father was asked if they had gone to their primary physician and he thought no.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: To the best of father's recollection, per telephone conversation with father, today he describes that early AM after the injection the trouble began. Immunization was given on a Wednesday after school, they did not go to Urgent Care until the following Sunday. Father described rash, hives and swelling of the left arm. No treatment at Urgent Care. The troubling part is that today 10/25/18 father is describing swelling yet. Father was asked if they had gone to their primary physician and he thought no.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Joint pain, shivering, headache, fever, tired, weak.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Joint pain, shivering, headache, fever, tired, weak.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Feeling cold, Hyperhidrosis, Migraine
Clinical narrative: Patient reports having on and off migraine headaches and freezing chills and sweating since receiving the vaccine. She received the vaccine 6 days ago and I advised her to take TYLENOL for her symptoms and to call her PCP right away. I advised her that I would follow up with her to see how she is feeling.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: On 10/24/2018 around 2:30pm 17yo patient was given Influenza high dose vaccine in the office in error. Mom was notified to watch for local and/or systemic reaction overnight. Advised to follow the VIS sheet patient was given. Also notified by email the Department of Public Health. Called mom on 10/25/2018 @ 10:11am and stated son had no systemic reaction and only c/o his left arm being tender but no redness or swelling she was aware of. He did take ibuprofen for the tenderness but refused to use ice to the site. Staff of the Department of Public Health was recommended us to complete the VAERS report.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Eyelid irritation, Eyelid pain, Foreign body sensation in eyes, Lacrimation increased, Photophobia
Clinical narrative: Around 5am in the morning, Perfuse watery eyes, continuous clear nasal mucus, extreme pain and burning in both upper eyelids, and a "sensation on eyeballs as if there are splinters in it as if there is something in them" and sensitivity to light. Patient then took chlorpheniramine 2mg antihistamine. As per patient, he does not suffer from allergies. "It may have been a virus and has nothing to do with this adverse reaction" As per patient, he also received a influenza vaccination about two weeks before and had flu like symptoms on the night of the flu vaccination.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: Around 5am in the morning, Perfuse watery eyes, continuous clear nasal mucus, extreme pain and burning in both upper eyelids, and a "sensation on eyeballs as if there are splinters in it as if there is something in them" and sensitivity to light. Patient then took chlorpheniramine 2mg antihistamine. As per patient, he does not suffer from allergies. "It may have been a virus and has nothing to do with this adverse reaction" As per patient, he also received a influenza vaccination about two weeks before and had flu like symptoms on the night of the flu vaccination.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Erythema, Extensive swelling of vaccinated limb, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included PNEUMONIA VACCINE. On 10th October 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, nausea, burning sensation, erythema of extremities, tingling of extremity, influenza-like symptoms and headache. In October 2018, the outcome of the fever, nausea, influenza-like symptoms and headache were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, burning sensation, erythema of extremities and tingling of extremity were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, nausea, burning sensation, erythema of extremities, tingling of extremity, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm and Pneumonia vaccine on the left arm both on same day. Around midnight on the day of vaccination, the patient experienced fever, flu like symptoms, nausea and headache. The symptoms got worse on Thursday followed by Friday, and resolved by Saturday. The patient also experienced redness and swelling of the arm, along with tingling and burning sensation on the arm. The redness and swelling went from shoulder down to the elbow. The patient denied permission to contact their physician. No further details were provided.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included PNEUMONIA VACCINE. On 10th October 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, nausea, burning sensation, erythema of extremities, tingling of extremity, influenza-like symptoms and headache. In October 2018, the outcome of the fever, nausea, influenza-like symptoms and headache were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, burning sensation, erythema of extremities and tingling of extremity were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, nausea, burning sensation, erythema of extremities, tingling of extremity, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm and Pneumonia vaccine on the left arm both on same day. Around midnight on the day of vaccination, the patient experienced fever, flu like symptoms, nausea and headache. The symptoms got worse on Thursday followed by Friday, and resolved by Saturday. The patient also experienced redness and swelling of the arm, along with tingling and burning sensation on the arm. The redness and swelling went from shoulder down to the elbow. The patient denied permission to contact their physician. No further details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 3 days after receiving SHINGRIX, the patient experienced muscle pain and swelling. On an unknown date, the patient experienced erythema and pain. On an unknown date, the outcome of the muscle pain, erythema, swelling and pain were unknown. It was unknown if the reporter considered the muscle pain, erythema, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the right deltoid. The healthcare professional reported that the patient experienced muscle pain and swelling. One week after receiving the SHINGRIX, the patient also experienced a circle area that was red and painful (about the size of a golf ball).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: This was reported by Internist. The healthcare professional reported that the patient developed shingles after receiving the SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced a very sore left arm for 10 days. The patient had denied permission to contact their physician and refused to provide date of birth.
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a adult male patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu trivalent vaccine. Additional information received as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced anaphylaxis to an unknown flu vaccine in 2012. The healthcare professional did not have any further information.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who had FLUZONE HD given to 61yo male patient, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AA via intramuscular route in the right arm. It was a case of actual medication error due to Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for fluzone hd given to 61 yo male patient. 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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received only liquid portion of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not received. On 17-Dec-2018, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5288BA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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.
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284734, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 17 years old patient who (gender not reported) was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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..."