chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 4 months after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The age at vaccination was not reported but could be 62 or 63 years. The patient experienced flu like symptoms after vaccination. No additional detail were provided on flu like symptoms. The reporter consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: fatigue; sleppness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cold agglutinins and hepatitis c.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue and sleepiness. On an unknown date, the outcome of the fatigue and sleepiness were recovered/resolved.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient receives Vitamins concomitantly. The patient had the vaccine 2 months ago and experienced severe fatigue for several days following the vaccination. The patient felt very tired, like she was coming down with something and slept for 5-6 days. The follow up consent was not granted. This case has been linked with case US2019232407 and US2019232409, reported by same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Contusion, Fatigue, Feeling abnormal, Headache
Clinical narrative: Muscle Pain; Fatigue; Ringing in Ears; Headache; Stomach Ache; Nausea; Soreness at Injection Site; Redness at Injection Site; Bruising; Being down; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal. On an unknown date, the outcome of the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix 1 week ago and being down for 2 to 3 days and experienced muscle pain, fatigue, ringing in ears, headache, stomach ache, nausea,soreness and redness at the injection site, and bruising. The reporter declined to provide more information for safety report partly due to consumer reporting it to her doctor's office with the belief that the doctor's office reported her reactions.  The caller inquires if patient receive 2nd dose or not or partial dose. This case has been linked with case US2019AMR233004 , US2019AMR233005, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Nausea, Tinnitus
Clinical narrative: Muscle Pain; Fatigue; Ringing in Ears; Headache; Stomach Ache; Nausea; Soreness at Injection Site; Redness at Injection Site; Bruising; Being down; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal. On an unknown date, the outcome of the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix 1 week ago and being down for 2 to 3 days and experienced muscle pain, fatigue, ringing in ears, headache, stomach ache, nausea,soreness and redness at the injection site, and bruising. The reporter declined to provide more information for safety report partly due to consumer reporting it to her doctor's office with the belief that the doctor's office reported her reactions.  The caller inquires if patient receive 2nd dose or not or partial dose. This case has been linked with case US2019AMR233004 , US2019AMR233005, reported by same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS LASTED 3 HOURS FEVER MUSCLE ACHE HEADACHE PATIENT TOOK ALEVE
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as adult as per the vaccine indication. The patient had pain at the injection site that began with the injection and lasted 3 days. On 22nd November 2019, the patient received 2nd dose of Shingrix, had no pain with the injection and arm was not at all sore. The patient was concerned that there may had been a medication error and that may had received a flu vaccine by mistake. The reporter wanted to know  were there any cases of patients having no reaction at all after having a reaction to the first shot. The patient did not want to be partially protected from shingles. This case was linked to the case US2019AMR232140.
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonitis, Pulmonary fibrosis
Clinical narrative: I received the Shingrix vaccine September 3, 2019 / been diagnosed with Pulmonary Fibrosis; Lung Inflammation; This case was reported by a consumer and described the occurrence of pulmonary fibrosis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix 50 ug. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pulmonary fibrosis (serious criteria GSK medically significant) and lung inflammation. The patient was treated with mycophenolic acid (Mycophenolate). On an unknown date, the outcome of the pulmonary fibrosis and lung inflammation were unknown.   It was unknown if the reporter considered the pulmonary fibrosis and lung inflammation to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but it was selected as adult as per vaccine indication. The patient was taking 1500 mg Mycophenolate daily. The patient delayed starting the Mycophenolate until he or she could receive both the Shingrix and flu vaccines and allow 2 weeks for them to take effect. Now, the vaccinator advised the patient that they have the 2nd Shingrix available. The patient's doctor did not want the patient to discontinue the Mycophenolate to receive the 2nd vaccine. The doctor said that the patient could receive the 2nd dose while continuing the Mycophenolate. The patient asked an opinion on same. The patient further reported the purpose of this medication was to tone down the immune response to reduce inflammation in the lungs. It was working. The patient asked about the efficacy of Shingrix while on the Mycophenolat and asked if there were any other problems that the patient should be aware of.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had vomiting. Limited information was provided by the reporter because the patient did not received the first injection at their pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Mobility decreased, Urinary incontinence
Clinical narrative: Difficulty moving extremities; loss of bladder control; tired; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included injection site pain (had injection site pain). Previously administered products included Shingrix (1st dose received on 25th September 2019,refer case US2019AMR230369).   On 14th December 2019, the patient received the 2nd dose of Shingrix. On 14th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th December 2019, the patient experienced mobility decreased, urinary incontinence and tiredness. On 15th December 2019, the outcome of the mobility decreased and urinary incontinence were recovered/resolved. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased, urinary incontinence, tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with Shingrix, the patient experienced difficulty moving extremities, loss of bladder control, tired and injection site pain. The reporter consented to follow up with physician.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: tenderness at injection site; Redness; Swelling; Flu symptoms; This case was reported by a pharmacist and described the occurrence of injection site tenderness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site tenderness, injection site erythema, injection site swelling and flu symptoms. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling and flu symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness, swelling, tenderness at injection site and flu symptoms. The reporter stated the patient had scheduled to receive her 2nd Shingrix shot but postponed it because she described her reaction after the first shot. She claimed the effects lasted over 7 days. She did not describe anaphylaxis.The reporter asked should she receive a 2nd dose. Did not consent to follow up. The Health care professional disconnected the chat before the reporter was able to probe further for details.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Headache, Insomnia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: cough; feels like he is getting a cold.; sore throat; severe headache; sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (4 to 5 years ago).   On 17th December 2019, the patient received the 1st dose of Shingrix. On 17th December 2019, less than a day after receiving Shingrix, the patient experienced headache and sleeplessness. On 18th December 2019, the patient experienced sore throat. On 19th December 2019, the patient experienced cough and cold. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the sore throat was recovering/resolving and the outcome of the cough was not recovered/not resolved and the outcome of the cold and sleeplessness were unknown.   It was unknown if the reporter considered the headache, sore throat, cough, cold and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had a dose of shingrix and experienced a very sever headache that kept him awake all night and most of the day yesterday. The bad headache all over but especially painful at the back on his head. The patient developed a severe sore throat and it was better but he developed a cough and feels like he was getting a cold. The follow up consent was not granted. This case has been linked with case US2019232406, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Incisional drainage, Injection site abscess, Injection site mass
Clinical narrative: patient states she got a lump at injection site after vaccine was given. She checked with her doctor and they said it was ok, just to  watch it. Then she stated around Thanksgiving she developed an abscess below injection/back of her arm.  Then she just had to get it lanced before Christmas. She is till being treated
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Pain in extremity, Tremor
Clinical narrative: Shivers and tremors started that evening, then sharp burning feeling in hands that lasted for hours.  600 mg of Advil did not receive the pain. On 12/24 took one Tramidol, which relieved the hand pain.  The pain did not come back,  but occasionally, hand pain  does present and appeared to be triggered by the Shingrix vaccine, according to the patient.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No adverse effect; inadvertent administration of MMR II reconstituted with expired merck diluent; inadvertent administration of MMR II reconstituted with expired merck diluent; This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 23-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (lot number S015284 and expiration date: 19-MAY-2021) reconstituted with expired diluent MRK (STERILE DILUENT) (lot number M009800 and expiration date: 12-SEP-2018) (strength, dose, route of administration and anatomical location were not reported) as prophylaxis (expired product administered and product preparation error). No additional adverse events were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: No adverse event; Expired product administered; Product preparation error; This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 02-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number S018593 and expiration date: 17-JUN-2021) reconstituted with expired Diluent MRK (STERILE DILUENT) (lot number M009800 and expiration date: 12-SEP-2018) (strength, dose, route of administration and anatomical location were not reported) as prophylaxis (expired product administered and product preparation error). No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: 12 month old patient was administered both VARIVAX and PROQUAD; No adverse event; This spontaneous report was received from a physician referring to a 12 month old patient. Information about patient's medical history, concurrent condition, concomitant medication, drug allergy/reaction was not reported.   On the same unspecified date, the patient was vaccinated with both varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, dose number, route, lot/batch #, expiration date was not reported for both the vaccines) for prophylaxis ( inappropriate schedule of product administration). No adverse events were reported. No product quality complaint was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; who received the GARDASIL 9, May 29, 2019 first dose and then October 9, 2019 second dose beyond the two month recommended schedule; This spontaneous report as received from a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.    On 29-MAY-2019, the patient was vaccinated with first dhpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (lot# expiry date, strength, route of administration and anatomical locations were unknown) for prophylaxis On 09-OCT-2019, the patient was vaccinated with first dhpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2 for prophylaxis. The second dose was received more than the two month recommended schedule (inappropriate schedule of product administration). No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I just get shingles again today/Several years ago I got shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Zoster vaccine at an unknown dose. On an unknown date, less than 3 months after receiving Zoster vaccine and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Zoster vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Several years before the reporting date, the patient got shingles for the first time regardless of already having Zoster shot in earlier two months. On the day of reporting, the patient again had shingles and was puzzled. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. The patient got prescription of Valacyclovir medicine but the patient asked if this medicine was a right kind that help to fight off shingles and was really a good medicine. The patient also asked about the ineffectiveness of Zoster vaccination.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: could not sleep; achy; she ached like she had the flu; fever; shivering; TIRED; sick to her stomach/stomach that felt like a pulled muscle.; nauseated; PAIN; Pain at injection site; cold sores; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had a bad chickenpox as a child in her ears, vagina and toenails).   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix and an unknown time after starting Aspirin and Abreva, the patient experienced cold sores. On 18th November 2019, the patient experienced pain in arm and injection site pain. On 19th November 2019, the patient experienced stomach pain and nausea. On 21st November 2019, the patient experienced tiredness. On 23rd November 2019, the patient experienced flu-like aching, fever, shivering and pain. On an unknown date, the patient experienced insomnia. The patient was treated with acetylsalicylic acid (Aspirin) and docosanol (Abreva). On 22nd November 2019, the outcome of the fever and shivering were recovered/resolved. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved and the outcome of the stomach pain, nausea, flu-like aching, cold sores, injection site pain and insomnia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tiredness, stomach pain, nausea, flu-like aching, fever, shivering, cold sores, injection site pain, insomnia and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported severe pain at the injection site during administration. The pain traveled down her arm and into her fingers. The pain down her arm and into her fingers resolved in a short time but the pain in her arm at the injection site is still present. She could not sleep on that side due to the pain. She has been treating it with aspirin. She also said she was tired after the injection and slept for 2 hours. Her arm from her deltoid to her fingers and lasted about 24 hours.  The patient was sick to her stomach, nauseated and tired. The patient ached like she had the flu but the fever and shivering were gone by the next day. She also had pain across her stomach that felt like a pulled muscle. She contracted cold sores from her husband and gets outbreaks on her nose. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: could not sleep; achy; she ached like she had the flu; fever; shivering; TIRED; sick to her stomach/stomach that felt like a pulled muscle.; nauseated; PAIN; Pain at injection site; cold sores; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had a bad chickenpox as a child in her ears, vagina and toenails).   On 18th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix and an unknown time after starting Aspirin and Abreva, the patient experienced cold sores. On 18th November 2019, the patient experienced pain in arm and injection site pain. On 19th November 2019, the patient experienced stomach pain and nausea. On 21st November 2019, the patient experienced tiredness. On 23rd November 2019, the patient experienced flu-like aching, fever, shivering and pain. On an unknown date, the patient experienced insomnia. The patient was treated with acetylsalicylic acid (Aspirin) and docosanol (Abreva). On 22nd November 2019, the outcome of the fever and shivering were recovered/resolved. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved and the outcome of the stomach pain, nausea, flu-like aching, cold sores, injection site pain and insomnia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tiredness, stomach pain, nausea, flu-like aching, fever, shivering, cold sores, injection site pain, insomnia and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported severe pain at the injection site during administration. The pain traveled down her arm and into her fingers. The pain down her arm and into her fingers resolved in a short time but the pain in her arm at the injection site is still present. She could not sleep on that side due to the pain. She has been treating it with aspirin. She also said she was tired after the injection and slept for 2 hours. Her arm from her deltoid to her fingers and lasted about 24 hours.  The patient was sick to her stomach, nauseated and tired. The patient ached like she had the flu but the fever and shivering were gone by the next day. She also had pain across her stomach that felt like a pulled muscle. She contracted cold sores from her husband and gets outbreaks on her nose. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Urticaria
Clinical narrative: urticaria; flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number JCU55-2273 ?, expiry date unknown) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 6th December 2019, the patient experienced urticaria. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the urticaria was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and urticaria to be related to Shingrix.  Additional details were provided as follows: The doctor reported that a patient developed flu like symptoms and urticaria after administration of Shingrix. The caller had no expiration date and he was not sure this was the lot  but it was the only number he could find at the time of the call.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: flu-like symptoms; felt bad; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (Received 10 years go).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. On 12th August 2019, the patient had receive the 1st dose of Shingrix vaccine arin the evening and the next day when he woke up, he felt bad with flu like symptoms that lasted about 24 hours. The reporter asked if the injection was given intramuscularly and she said she assumes so. She did not have the lot number or the expiry date for the injection. The reporter consented to follow up. This case has been linked with case US2019232375 and case US2019232371, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Tremor
Clinical narrative: Severe Shivering; Sweating Profusely; patient woke up in the middle of the night with severe shaking; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On 12th December 2019, less than a day after receiving Shingrix, the patient experienced shivering, excess sweating and tremor. On 13th December 2019, the outcome of the shivering and excess sweating were recovered/resolved and the outcome of the tremor was recovering/resolving.   It was unknown if the reporter considered the shivering, excess sweating and tremor to be related to Shingrix.  Additional information was provided as follows: The patient after receiving 1st dose, woke up in the middle of the night, experienced severe shaking, severe shivering and sweating profusely. The patient was so incapacitated that she couldn't reach the phone. On 13th December, the patient was fine. The reporter wanted to knowhow to proceed with 2nd dsoe of Shingrix. The reporter did not consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced extreme flu-like symptoms. Additional information was unknown at the time of reporting.  Due to this adverse event the patient was not given the 2nd dose.  The site and route of injection were unknown.  No additional information available at this point. The reporter did not consent to follow up.
Age: 7.0
Sex: F
Vaccine: RAB
Symptoms: Diabetes mellitus
Clinical narrative: diabetes; This case was reported by a nurse via call center representative and described the occurrence of diabetes in a 8-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   In October 2018, the patient received RabAvert. On 24th November 2019, less than 2 years after receiving RabAvert, the patient experienced diabetes (serious criteria GSK medically significant). On an unknown date, the outcome of the diabetes was unknown.   It was unknown if the reporter considered the diabetes to be related to RabAvert.  Additional details were provided as follows: It was unknown if the patient received Rabavert vaccine for pre or post exposure prophylaxis.  The patient was diagnosed with diabetes on 24th November 2019. The reporter was questioning whether the company had seen any correlation between diabetes and Rabavert. The case has been linked to the case US2019234437, reported by same reporter.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Diabetes mellitus
Clinical narrative: diabetes; This case was reported by a nurse via call center representative and described the occurrence of diabetes in a 7-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   In October 2018, the patient received RabAvert. On 27th November 2019, less than 2 years after receiving RabAvert, the patient experienced diabetes (serious criteria GSK medically significant). On an unknown date, the outcome of the diabetes was unknown.   It was unknown if the reporter considered the diabetes to be related to RabAvert.  Additional details were provided as follows: It was unknown if the patient received Rabavert vaccine for pre or post exposure prophylaxis.  The patient was diagnosed with diabetes on 27th November 2019. The reporter was questioning whether the company had seen any correlation between diabetes and Rabavert. The case has been linked to the case US2019234432, reported by same reporter.
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache, Influenza A virus test positive, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: not able to move her head; achiness throughout her body; headache; myalgia; Initial information received on 12-Dec-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 77 years old female patient who experienced serious headache (headache), achiness throughout her body (pain), myalgia (myalgia ) and not able to move her head (musculoskeletal stiffness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HIGH DOSE and was tested positive for A influenza one month after the vaccine. Family history were not provided. At the time of the event, the patient had ongoing Hypothyroidism and Type IIa hyperlipidaemia.  On an unknown date (about 2 weeks ago), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious headache, achiness throughout her body (pain), same day post vaccination. On an unspecified date, patient developed a serious myalgia and not able to move her head (musculoskeletal stiffness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  The headache continued to progress in severity, rating it an 11 on a 0-10 scale.  Relevant laboratory test results included: Computerised tomogram - On an unknown date:  [negative for aneurysm or stroke]  Final diagnosis was not able to move her head, myalgia, achiness throughout her body and headache.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for headache and General body pain,  Patient was not yet recovered from myalgia and outcome was not reported for Stiff neck.; Sender's Comments: This case involves a 77 years old female patient who experienced serious headache, General body pain, myalgia and stiff neck ,while she received vaccine FLUZONE HIGH DOSE. Time to onset is unknown. Moreover, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: not able to move her head; achiness throughout her body; headache; myalgia; Initial information received on 12-Dec-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 77 years old female patient who experienced serious headache (headache), achiness throughout her body (pain), myalgia (myalgia ) and not able to move her head (musculoskeletal stiffness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HIGH DOSE and was tested positive for A influenza one month after the vaccine. Family history were not provided. At the time of the event, the patient had ongoing Hypothyroidism and Type IIa hyperlipidaemia.  On an unknown date (about 2 weeks ago), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious headache, achiness throughout her body (pain), same day post vaccination. On an unspecified date, patient developed a serious myalgia and not able to move her head (musculoskeletal stiffness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  The headache continued to progress in severity, rating it an 11 on a 0-10 scale.  Relevant laboratory test results included: Computerised tomogram - On an unknown date:  [negative for aneurysm or stroke]  Final diagnosis was not able to move her head, myalgia, achiness throughout her body and headache.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for headache and General body pain,  Patient was not yet recovered from myalgia and outcome was not reported for Stiff neck.; Sender's Comments: This case involves a 77 years old female patient who experienced serious headache, General body pain, myalgia and stiff neck ,while she received vaccine FLUZONE HIGH DOSE. Time to onset is unknown. Moreover, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Hyperacusis, Tinnitus
Clinical narrative: Developed severe headache, then oversensitivity to sound and tinnitus--worse on the same side as vaccine injection.   While the symptoms have diminished somewhat, they persist
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Muscle tightness, Myalgia, Pain in extremity
Clinical narrative: upper arm pain one day, next day, left lower thumb/palm muscle tight/painful. Lump has formed in past three weeks. Still tight/painful.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Pt here for f/u on her pneumococcal vaccination. On 12/1619 pt received prevnar 13 in the R deltoid. Since then she has experienced swelling, pain, and redness at the site of the injection. Pt notes that she had a swollen lymph node on the R side of her neck a few days ago which has since gone away. She has been taking tylenol for pain which has helped but has been taking up to 2000mg at a time. Pt is still taking doxycycline for sinusitis as of last week. Did have a low grade fever after vaccination Will do ibuprofen for pain and swelling and advised pt to ice regularly. She will contact us with an update in approximately 7 days. Advised to notify us sooner if worsening.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Mobility decreased, Musculoskeletal pain, Pain in extremity, Somnolence
Clinical narrative: extreme pain in right arm down to fingertips, could not get out of bed Friday am so I slid to the floor and could not get up,  had to call my apt facility to get help, Friday afternoon fell asleep on couch and slid to floor while sleeping and had to get hep again to get me up, could not stay awake all day or night for about 48 hours, my daughter had to help dressing me, could not walk without a walker, loss of appetite, pain subsided in arm but still severe pain in shoulder
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: extreme pain in right arm down to fingertips, could not get out of bed Friday am so I slid to the floor and could not get up,  had to call my apt facility to get help, Friday afternoon fell asleep on couch and slid to floor while sleeping and had to get hep again to get me up, could not stay awake all day or night for about 48 hours, my daughter had to help dressing me, could not walk without a walker, loss of appetite, pain subsided in arm but still severe pain in shoulder
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm redness, warmth, swelling and tenderness starting within 12 hours of vaccination. Ice and ibuprofen used. Redness and swelling spread to elbow. Started to improve after 48 hours and was seen for follow up visit.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: I became sick with nausea, dizziness, a "floating" sensation, PVCs (weird heartbeats which I have never had before) , tachycardia, sudden "cold" symptoms with trouble breathing and speaking which usually resolve in an hour or so, greatly heightened sensivity to head and cold (particularly cold), and extreme fatigue.  I have to take Metoprolol ER 50 mg a day now to control these PVCs and tachycardia recommended by Dr. and Dr. confirmed this is the best course of action at this time.  These acute symptoms lasted about a week and I slowly began feeling better but I still have the problems now, and a feeling that something is basically wrong and it probably won't change.  I think this is permanent since it has been over 3.5 months.  I had Roux-en-Y surgery on 8/1/2018 which weakened my immune system and Dr. and my cardiologist Dr. both suspect this may have had something to do with my severe reactions.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myocardial necrosis marker normal, Nasopharyngitis, Nausea, Speech disorder, Tachycardia
Clinical narrative: I became sick with nausea, dizziness, a "floating" sensation, PVCs (weird heartbeats which I have never had before) , tachycardia, sudden "cold" symptoms with trouble breathing and speaking which usually resolve in an hour or so, greatly heightened sensivity to head and cold (particularly cold), and extreme fatigue.  I have to take Metoprolol ER 50 mg a day now to control these PVCs and tachycardia recommended by Dr. and Dr. confirmed this is the best course of action at this time.  These acute symptoms lasted about a week and I slowly began feeling better but I still have the problems now, and a feeling that something is basically wrong and it probably won't change.  I think this is permanent since it has been over 3.5 months.  I had Roux-en-Y surgery on 8/1/2018 which weakened my immune system and Dr. and my cardiologist Dr. both suspect this may have had something to do with my severe reactions.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Temperature intolerance, Ventricular extrasystoles
Clinical narrative: I became sick with nausea, dizziness, a "floating" sensation, PVCs (weird heartbeats which I have never had before) , tachycardia, sudden "cold" symptoms with trouble breathing and speaking which usually resolve in an hour or so, greatly heightened sensivity to head and cold (particularly cold), and extreme fatigue.  I have to take Metoprolol ER 50 mg a day now to control these PVCs and tachycardia recommended by Dr. and Dr. confirmed this is the best course of action at this time.  These acute symptoms lasted about a week and I slowly began feeling better but I still have the problems now, and a feeling that something is basically wrong and it probably won't change.  I think this is permanent since it has been over 3.5 months.  I had Roux-en-Y surgery on 8/1/2018 which weakened my immune system and Dr. and my cardiologist Dr. both suspect this may have had something to do with my severe reactions.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from contactable pharmacist. This pharmacist reported same events for three patients. This is 1st of three reports.   A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness of the arm after getting administered the suspected vaccine on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548927 same reporter/drug/event, different patient;US-PFIZER INC-2019548928 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from contactable pharmacist. This pharmacist reported same events for three patients. This is 2nd of three reports.   A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness of the arm after getting administered the suspected vaccine on an unspecified date. The outcome of the event was unknown.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548921 same reporter/drug/event, different patient;US-PFIZER INC-2019548928 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: patient experienced soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for three patients. This is the third of three reports.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness of the arm after getting administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Outcome of the event was unknown.  No follow-up attempts are possible. Information regarding the batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548927 same drug, reporter, and event; different patient;US-PFIZER INC-2019548921 same drug, reporter, and event; different patient
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Allergy: Pneumococcal Vaccine; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergy: pneumococcal vaccine. Outcome of the event was unknown.  The following information on the batch number has been requested.