chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-APR-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-DEC-2017 and 11-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N004815 and expiration date 07-OCT-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-JAN-2018 and 23-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N004815 and expiration date 07-OCT-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-JAN-2018, 09-APR-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018) orally for prophylaxis (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 29-MAY-2018 and 30-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N028258 and expiration date 30-MAY-2019; lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None, this was second vaccine by mistake in same season.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Localised infection
Clinical narrative: Infection of arm injected.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient's injection site and surrounding area are inflamed, reddened, hot, and painful. She experienced lethargy, chills, and a general unwell feeling. Was concerned because of the duration of the adverse reaction, the lack of resolution, and was wondering if there was possibly a secondary bacterial infection. Advised the patient to continue to observe the injection site and seek medical attention if the situation got worse.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Lethargy, Malaise
Clinical narrative: Patient's injection site and surrounding area are inflamed, reddened, hot, and painful. She experienced lethargy, chills, and a general unwell feeling. Was concerned because of the duration of the adverse reaction, the lack of resolution, and was wondering if there was possibly a secondary bacterial infection. Advised the patient to continue to observe the injection site and seek medical attention if the situation got worse.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and increased pain at site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Rash
Clinical narrative: Patient broke out in a rash and had increased pain.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Pyrexia, Rash, Urticaria
Clinical narrative: The evening of the vaccinations, the patient ran a 101.7 fever with chills. Upon vaccination, I recommended that the patient take Ibuprofen or Acetaminophen to prevent symptoms especially from the SHINGRIX. She did not take either since she took Tramadol, and therefore she thought it would be unnecessary. Early two days later(on 10/18/18) she broke out in rashy hives on her neck, chest, below her bra line, and on her upper abdomen. There are no signs of rash at either injection site. The fever and chills had subsided on 10/17/18.
Age: 8.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Antibody test positive, Blood immunoglobulin M increased, Malaise, Oropharyngeal pain, Rash
Clinical narrative: Pt given vaccinations on documented day to catch up on vaccinations. On day 10 pt began with maculopapular rash over torso and legs, and severe sore throat, general malaise, no fever. Seen by PCP on day 13, rapid strep negative, IgM drawn. Day 17 IgM positive at 3.5. Pt remains fever free, rash never became weepy, did spread to face and arms and was itching, pt never experienced a fever.
Age: 8.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Rash maculo-papular, Rash pruritic, Streptococcus test negative
Clinical narrative: Pt given vaccinations on documented day to catch up on vaccinations. On day 10 pt began with maculopapular rash over torso and legs, and severe sore throat, general malaise, no fever. Seen by PCP on day 13, rapid strep negative, IgM drawn. Day 17 IgM positive at 3.5. Pt remains fever free, rash never became weepy, did spread to face and arms and was itching, pt never experienced a fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, chills, muscle ache.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Injection site warmth
Clinical narrative: Patient came in and reported that starting two inches under the injection site her left arm was red and hot. Redness stopped at her elbow. She reported feeling lightheaded as well. She was contacted again at 5:15pm on 10/18/18 and she stated that there was no change and not sore.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Loss of consciousness
Clinical narrative: Pt received both FLUAD and PREVNAR 13 on 10/17/2018. Husband reported pt passed out in the morning of 10/18/2018. Pt recovered with no injuries and did not seek medical attention.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness; swelling; hot to the touch; little itchy.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Injection site swelling, Irritability
Clinical narrative: She received her shot around noon and by dinnertime, her leg was swollen, her fever was 103, she wouldn't eat, very fussy. This is common so it was upsetting but not worrisome. I treated her with cold compresses and children's MOTRIN. However, that evening she awoke after going to bed and cried a piercing, screaming cry for six straight hours. I emailed her doctor who said he was sleep to hear it and brushed off my concerns, saying the vaccines do more good than harm. MOTRIN did nothing. Her crying continued off and on for two weeks. She woke crying frequently at night. Her fever lasted five days. She did not want to eat or play. She was withdrawn and definitely not herself for at least two weeks and my husband and I were very concerned. She honestly seemed like a different child. It was incredibly upsetting and worrisome and I hated that the doctors office was more concerned with making sure I brought her back for more shots than making sure she was actually okay. I have not done any vaccines since.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Middle insomnia, Pyrexia, Social avoidant behaviour
Clinical narrative: She received her shot around noon and by dinnertime, her leg was swollen, her fever was 103, she wouldn't eat, very fussy. This is common so it was upsetting but not worrisome. I treated her with cold compresses and children's MOTRIN. However, that evening she awoke after going to bed and cried a piercing, screaming cry for six straight hours. I emailed her doctor who said he was sleep to hear it and brushed off my concerns, saying the vaccines do more good than harm. MOTRIN did nothing. Her crying continued off and on for two weeks. She woke crying frequently at night. Her fever lasted five days. She did not want to eat or play. She was withdrawn and definitely not herself for at least two weeks and my husband and I were very concerned. She honestly seemed like a different child. It was incredibly upsetting and worrisome and I hated that the doctors office was more concerned with making sure I brought her back for more shots than making sure she was actually okay. I have not done any vaccines since.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Pain at injection site when raising arm above shoulder and bruising from injection site to below the elbow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: 2 AM nausea; 4 AM chills, intense frontal headache, nausea, body aches started and progressed through mid-day; 8:00 AM TYLENOL 1 gm and sips ginger ale; 11 AM T-100.7, nausea decreased, headache increased; 2PM T-101.6 and TYLENOL 1 gm; 4 PM temp 99.8; 6 PM TYLENOL 1 gm; In bed all day. 9 PM T-98.7; intense frontal headache continued through 10/17 not relieved with TYLENOL. 10/18 no fever, mild headache, relieved with TYLENOL.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Abdominal pain, Feeling jittery, Flatulence, Injection site erythema
Clinical narrative: Round hot red circle around injection site developed within 18 hours of shot surrounding injection area; upset digestive system, abdominal pain and gassiness, nausea, feeling jittery. Persists at time of filing report at same intensity (48 hours later).
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Nausea
Clinical narrative: Round hot red circle around injection site developed within 18 hours of shot surrounding injection area; upset digestive system, abdominal pain and gassiness, nausea, feeling jittery. Persists at time of filing report at same intensity (48 hours later).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Rash
Clinical narrative: On 10/15/18 (almost 3 weeks after vaccine) the patient started to present with a progressively worsening rash on her forehead and scalp, which also affected spots on her nose, face, and lips. She came into our pharmacy today on 10/18/18 to notify us about possible vaccine reaction, and I counseled her on otc and non pharmacologic care for the rash.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Insomnia, Pruritus, Pyrexia, Skin discomfort
Clinical narrative: Two days after getting the vaccine I woke up with a fever and allergy hives on my upper forehead, scalp"inside head" neck and all of my back. I could not sleep with all the hives and felt so itchy. It has been a very horrible experience with not being able to sleep properly and feel the discomfort on my skin due to the vaccine. I went to pharmacy and told the pharmacist what had happened and she told me to take BENADRYL allergy pills. I did that but it did not work, I still had the allergy hives. I then called my doctor and told me to come in to see me for an appointment. I explained to my doctor my symptoms and my doctor concluded that I had a very severe allergy reaction to the vaccine.Then My doctor prescribed me two medications first one was Methylprednisolone 4mg dose and second was SARNA anti -itch lotion. The hives went away very slowly, I am still currently dealing with a mild itch on my skin and have no choice but to try and deal with it an still use the anti lotion.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Two days after getting the vaccine I woke up with a fever and allergy hives on my upper forehead, scalp"inside head" neck and all of my back. I could not sleep with all the hives and felt so itchy. It has been a very horrible experience with not being able to sleep properly and feel the discomfort on my skin due to the vaccine. I went to pharmacy and told the pharmacist what had happened and she told me to take BENADRYL allergy pills. I did that but it did not work, I still had the allergy hives. I then called my doctor and told me to come in to see me for an appointment. I explained to my doctor my symptoms and my doctor concluded that I had a very severe allergy reaction to the vaccine.Then My doctor prescribed me two medications first one was Methylprednisolone 4mg dose and second was SARNA anti -itch lotion. The hives went away very slowly, I am still currently dealing with a mild itch on my skin and have no choice but to try and deal with it an still use the anti lotion.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity, Palpitations, Tachycardia
Clinical narrative: Pt. got vaccine SHINGRIX and Flu at local grocery store on date listed, later that PM reported heart palpitations, tachycardia, weakness/fatigue, arm pain lasting 4 days, improved after taking DAYQUIL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Woke up with a 101.5 fever and really bad headache on 9/19/18 (the day after the shot). Had chills and fever all day. Fever that night still 100.5. Was fine on the Thursday 9/20/18 like as if nothing happened.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, Asthenia, Back pain, Full blood count normal
Clinical narrative: Patient began experiencing intense joint, back, and leg pain and weakness, beginning two days after SHINGRIX vaccine (7/4/18). She reported these symptoms to the pharmacy when the pharmacist called to schedule her second SHINGRIX vaccine the middle of September 2018. The pharmacist advised her to contact her physician immediately. She saw Dr on 10/02/18 and was prescribed prednisone 20mg twice daily for 4 days, then once daily for 4 days. She states that her pain has improved as of 10/16/18.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Urine ketone body present
Clinical narrative: Patient began experiencing intense joint, back, and leg pain and weakness, beginning two days after SHINGRIX vaccine (7/4/18). She reported these symptoms to the pharmacy when the pharmacist called to schedule her second SHINGRIX vaccine the middle of September 2018. The pharmacist advised her to contact her physician immediately. She saw Dr on 10/02/18 and was prescribed prednisone 20mg twice daily for 4 days, then once daily for 4 days. She states that her pain has improved as of 10/16/18.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Monoplegia
Clinical narrative: Pt experienced weakness progressing almost to the point of paralysis in vaccination arm. Pt is also taking chemotherapy (IMFINZI) and had an infusion about 1 week prior to vaccination in the same arm. Patient is somewhat better today.
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Pt started having severe upper arm pain with large area of redness that is warm and tender to the touch. Symptoms started early am following the vaccine administration and gradually worsened. Diagnosed with cellulitis of arm and given Clindamycin 300mg four times daily for ten days.
Age: 73.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Pt started having severe upper arm pain with large area of redness that is warm and tender to the touch. Symptoms started early am following the vaccine administration and gradually worsened. Diagnosed with cellulitis of arm and given Clindamycin 300mg four times daily for ten days.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received FLUZONE HIGHDOSE 9/18 and came back today intending to get SHINGRIX, but we misunderstood and billed FLUAD and administered that instead. She hasn't had any reactions but it still was an error that a second shot was given this season.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Myalgia, Pain
Clinical narrative: Muscle ache particularly when raising arm began immediately and has continued to date. Worse now that second shot was given at same sight. Did not have 2nd shot in other arm as flu shot had been given there 2 days before. Second dose at same pharmacy at same site on 10/05/2018 NDC:58160-0819-12 resulted in increased arm ache plus 2 weeks of tiredness, headaches, and general body ache. Senior flu shot in right arm by same pharmacy 2 days before.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Hospice care, Pyrexia
Clinical narrative: Staff from a senior living facility called me stating the patient was actively dying and presented with high fever unsure of specific symptoms. I told staff if the patient is dying taking him to urgent care, and she said that he is in hospice.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Headache, Injection site pain, Paraesthesia oral
Clinical narrative: Burning with injection; tingling of lips within five minutes. Given 50 mg liquid diphenhydramine. Developed chest heaviness within several hours - called advice nurse/physician, was told to go to ED if symptoms worsened; symptoms abated, but woke next morning with headache.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient developed high fever the next day and is actively dying per the coordinator at site. I asked her to take him to the ER if dying, but she replied he is in the hospice. Reaction may not be due to vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic fatigue syndrome, Condition aggravated, Immune system disorder, Impaired work ability, Myocardial infarction
Clinical narrative: Started having symptoms of CFIDS again within a few weeks of the vaccine leading to having to quit my job. Then had a heart attack a month and a half later.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site streaking, Injection site swelling
Clinical narrative: Patient complained of pain, swelling, stiffness, a bruise at injection site and a red streak on the underside of arm. She contacted the pharmacy 2 days after injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient complained of pain, swelling, stiffness, a bruise at injection site and a red streak on the underside of arm. She contacted the pharmacy 2 days after injection.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient reports itchy sensation over the entire body that lasted for about 3 days.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dyspnoea, Pruritus, Wheezing
Clinical narrative: Patient reported about 5 minutes after the shot that she was feeling itchy over her entire body and was having some trouble breathing. She was wheezing, but reported she also has asthma. We administered 35 mg of diphenhydramine intramuscularly and asked her to use her emergency inhaler (albuterol). She reported after about 10 minutes that she felt completely normal, and her symptoms remained resolved thereafter.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Acidosis, Dehydration, Diarrhoea, Fatigue, Malaise
Clinical narrative: I spent over one week in the hospital with Acidosis, nausea, vomiting, diarrhea, dehydration and severe fatigue. Prior to this I spent one week on my couch with the same symptoms. I was sicker than I had ever been.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: I spent over one week in the hospital with Acidosis, nausea, vomiting, diarrhea, dehydration and severe fatigue. Prior to this I spent one week on my couch with the same symptoms. I was sicker than I had ever been.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Full blood count, Immunoglobulin therapy, Platelet count decreased, Platelet transfusion
Clinical narrative: I started getting bruising throughout my body and when have a CBC blood count platlets had dropped to 2,000. I had seen my primary care before the flu shot and my platlet count was normal.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: 48 to 72 hours of flu-like symptoms: muscle aches, joint pain, weariness, high temperature, headache.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 48 to 72 hours of flu-like symptoms: muscle aches, joint pain, weariness, high temperature, headache.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site mass
Clinical narrative: Patient immediately formed a grape-sized lump at the injection site. Some bleeding was present, but not profuse, less than 1ml.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm, Urticaria
Clinical narrative: This was patient's first time receiving the flu vaccine. Pharmacist asked patient to stay for 15 after shot to make sure patient did not have an allergic reaction. Patient states several hours after getting the flu shot she experienced hives all over body and face was warm to touch. Patient was told to take BENADRYL which help alleviate symptoms but not completely. The following patient still had hives and was told to take ZYTREC. Patient stated did not have any trouble breathing.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PT REPORTED REDNESS AND SWELLING IN HER ARM. WENT TO URGENT CARE, AND THEY PRESCRIBED BACTRIM IN CASE OF CELLULITIS. TOLD PT TO FOLLOW UP WITH PCP.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Diarrhoea, Dizziness, Fatigue, Impaired work ability
Clinical narrative: For about one month after I had the vaccine, I experienced weekly episodes of sudden onset severe diarrhea with nausea and dizziness to the point of almost passing out. The dates of these events (which mostly occurred in the middle of the night and caused me to stay home from work the following day) were: June 6, June 13, June 22, July 3. On June 22 I had 6 episodes of diarrhea throughout the night, with nausea and dizziness. One July 3, I had 5 episodes of diarrhea from 5:30-7:30 a.m., also including nausea and dizziness. Also during that month I suffered from severe muscle pain, fatigue and general feeling of malaise.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: For about one month after I had the vaccine, I experienced weekly episodes of sudden onset severe diarrhea with nausea and dizziness to the point of almost passing out. The dates of these events (which mostly occurred in the middle of the night and caused me to stay home from work the following day) were: June 6, June 13, June 22, July 3. On June 22 I had 6 episodes of diarrhea throughout the night, with nausea and dizziness. One July 3, I had 5 episodes of diarrhea from 5:30-7:30 a.m., also including nausea and dizziness. Also during that month I suffered from severe muscle pain, fatigue and general feeling of malaise.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Gaze palsy, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient suffered brief LOC within minutes of receiving the flu vaccine, lasting approx 30 seconds. Patient was diaphoretic and pale with eyes rolled back. 10:40 BP 98/60. Placed in prone position with legs elevated and ice pack to back of neck. Mom was present. 10:56 BP 110/80 L arm. Patient stated hadn't eaten today, she was seated up and given water and snack. Color improved and she left with mom at 11:15am.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Rash not at site but on other parts of his body.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: Fever of 99.9, Chills, upset stomach a little.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Her arm has been sore since she received the shot. It hasn't gotten worse, and hasn't gotten better. No swelling or redness at site of injection.
Age: 1.75
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Rash, Rash erythematous
Clinical narrative: My son has developed a rash of tiny red bumps on his lower back and stomach. This is the first I have noticed it. He is also rather cranky and has loss of appetite.
Age: 49.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injected limb mobility decreased, Ligament rupture, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: PAIN CAN ONLY LEFT ARM HALF WAY, CAN NOT LAY ON MY LEFT SIDE.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness transient, C-reactive protein increased, Computerised tomogram, Echocardiogram, Nuclear magnetic resonance imaging
Clinical narrative: Pain above right eye with double vision. Several episodes lasting about 1 minute for several days. Visited family doctor, suspected sinus problem and treated for same. Also gave senior flu shot at time of visit. Next day started having temporary blindness in left eye lasting 1 or 2 minutes. Repeated episodes for about 4 days. Went to emergency room on Sunday, admitted for testing.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, Scan with contrast
Clinical narrative: Pain above right eye with double vision. Several episodes lasting about 1 minute for several days. Visited family doctor, suspected sinus problem and treated for same. Also gave senior flu shot at time of visit. Next day started having temporary blindness in left eye lasting 1 or 2 minutes. Repeated episodes for about 4 days. Went to emergency room on Sunday, admitted for testing.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Received recommended shingles vaccine. Have been in pain with limited mobility of left arm ever since.
Age: 65.0
Sex: U
Vaccine: FLUA3
Symptoms: Arthralgia, Myalgia, Pain, Swelling
Clinical narrative: I had the flu shot (for over 65) on Tuesday around noon. Only some localized swelling that afternoon and evening. However, I woke up Wednesday feeling major (!) body-wide pain. All day long every muscle and every joint screamed at me. I was barely able to function. On the Mankowski pain scale of 1-10, I would rate the pain at 7-8, needing oxycodone 10 mg to temporarily relieve the pain. The pain started to subside around 6 pm, and I slept well that evening. On the sheet that was given to me at the time of the injection it listed "muscle or joint pain" as a possible side effect. I would interpret that as possibly being up to a 5 on the pain scale. In my case I would have preferred to have known that SEVERE BODY-WIDE PAIN could be a possible side effect! Luckily I am retired now, because that kind of pain would have precluded being able to function in a job setting.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Influenza virus test negative, Lethargy, Pyrexia
Clinical narrative: Patient received a FLUZONE High Dose (NDC 49281-403-65, lot UJ000AA exp 03/28/19) on 09/05/2018. His wife reports that he began a fever that resulted in an emergency room visit. At its peak the fever was 102 degrees F. In addition, he was lethargic and had no appetite. The fever was controlled with Acetaminophen; however, persisted for 9 days. During the ER visit, he was swabbed and it came back negative for the flu.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Fatigue, Productive cough
Clinical narrative: I was given a FLUZONE HIGH-DOSE influenza vaccine. Since then I have been consistently more fatigued and my asthma is worse, coughing phlegm up more.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Asthenia, Fatigue, Headache, Hypersomnia
Clinical narrative: The morning after receiving the flu shot I woke up with a tension headache. I was able to make some breakfast then I laid back down in the bed. The headache slowly became worse to unbearable. It was a migraine and I never experienced that before. A few hours into the migraine I experienced strong heart palpitations. They came in waves over the course of about 30 minutes. I was very weak and spent the rest of the day in bed. I slept a lot. Today (the day after) I am feeling better but still have a slight headache and am very tired. I've had slight angioedema for the last 24 to 48 hours.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Palpitations, Tension headache
Clinical narrative: The morning after receiving the flu shot I woke up with a tension headache. I was able to make some breakfast then I laid back down in the bed. The headache slowly became worse to unbearable. It was a migraine and I never experienced that before. A few hours into the migraine I experienced strong heart palpitations. They came in waves over the course of about 30 minutes. I was very weak and spent the rest of the day in bed. I slept a lot. Today (the day after) I am feeling better but still have a slight headache and am very tired. I've had slight angioedema for the last 24 to 48 hours.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site joint swelling, Injection site swelling, Pyrexia
Clinical narrative: Patient was given PREVNAR 23 vaccine on 10/17/18. Today - 10/18/18 patient reported to primary care office with very swollen right shoulder joint, unable to complete full ROM, low grade fever, swelling/redness at injection site on right deltoid.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Blood test, Condition aggravated, Electrocardiogram ambulatory
Clinical narrative: PROLIA injection was given on Sept. 24, 2018 as well as a flu vaccine. By October 12, patient experienced atrial fibrillation. Although patient has a history of atrial fibrillation, the condition was surgically corrected years ago and has generally been in a normal rhythm for years. Patient has had previous doses of PROLIA with no adverse effects.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After receiving October 2, 2018 the first SHINGRIX vaccine injection at Pharmacy, I had an outbreak of shingles on forehead starting on October 12, 2018. I went to my pharmacy care physician on October 16, 2018 who prescribed valacyclovir HCL 1 gram tablet to treat side effects of the shingles outbreak.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: I called store asking the pharmacist if they have flu shot in vial not the prefilled syringe. The pharmacist assured me that the prefilled flu vaccines they have are latex free. So I went to get the vaccine because it is required by my job. The pharmacist gave me the vaccine. In less than 3 hours later my arm starts swollen and becomes painful. My neck starts hurting too.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Two red spots on both upper thighs, blanching. Reaction to PEDIATRIX - left thigh. Flu - right thigh. Patient presents with rash since yesterday. Child received vaccines 2 days ago - 6 month plus flu shot. No other symptoms, no fever. Patient accompanied by mother.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Pyrexia
Clinical narrative: I am 66, received the PNEUMOVAX 23 vaccine on 10-10-2018 and have been in bed with a fever, weakness, fatigue and extreme redness with a radius of 4" at injection site since receiving this terrible vaccine. My symptoms do not seem to be dissipating.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Blood test, Burning sensation, Dyspnoea, Erythema
Clinical narrative: Received tdap vaccine on 6/26. On 6/30 I started with severe pain at the injection site. Next day the pain and swelling was from elbow to shoulder. By 7/2 the SJS symptoms started and progressed everyday. Rash, itching all over blisters in throat, hands and feet red and burning, tongue swollen, trouble breathing, fever (low grade) no temp control of my body. Went to dermatologist on 7/6 received cortisone shot. Returned 7/9 was put on steroids and ZYRTEC. Symptoms did not go away, so went to immunology and was put on stronger steroids finished on 8/13. Am still dealing with symptoms although not as severe. Currently waiting for blood test results and an appointment with ENT.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Oropharyngeal blistering, Pruritus generalised, Pyrexia
Clinical narrative: Received tdap vaccine on 6/26. On 6/30 I started with severe pain at the injection site. Next day the pain and swelling was from elbow to shoulder. By 7/2 the SJS symptoms started and progressed everyday. Rash, itching all over blisters in throat, hands and feet red and burning, tongue swollen, trouble breathing, fever (low grade) no temp control of my body. Went to dermatologist on 7/6 received cortisone shot. Returned 7/9 was put on steroids and ZYRTEC. Symptoms did not go away, so went to immunology and was put on stronger steroids finished on 8/13. Am still dealing with symptoms although not as severe. Currently waiting for blood test results and an appointment with ENT.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swollen tongue, Temperature regulation disorder
Clinical narrative: Received tdap vaccine on 6/26. On 6/30 I started with severe pain at the injection site. Next day the pain and swelling was from elbow to shoulder. By 7/2 the SJS symptoms started and progressed everyday. Rash, itching all over blisters in throat, hands and feet red and burning, tongue swollen, trouble breathing, fever (low grade) no temp control of my body. Went to dermatologist on 7/6 received cortisone shot. Returned 7/9 was put on steroids and ZYRTEC. Symptoms did not go away, so went to immunology and was put on stronger steroids finished on 8/13. Am still dealing with symptoms although not as severe. Currently waiting for blood test results and an appointment with ENT.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has extreme arm pain two weeks after FLUZONE QUADRIVALENT injection.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Anal incontinence, Asthenia, Balance disorder, Blood test, Chest X-ray
Clinical narrative: I received the SHINGRIX and flu vaccine Sept. 10, 2018. My pharmacist said I may experience some flu like symptoms and headache, which I did. On 9-11-2018 I didn't feel well. On 9-12-2018 I felt better. Then at 9 pm, while sitting on the sofa, I got sudden severe nausea. I had immediate severe projective vomiting for over an hour. It was continuous. I also was, embarrassingly, incontinent of stool at the same time. I told my husband I had to go to the hospital. I was so weak and dizzy he had to hold me up. I felt like a rag doll with no strength. As we made turns or went over bumps I had severe vertigo and nausea. I went to the emergency room about 11 pm. After IVs, an EKG, CT scan and chest x-ray and I believe anti-nausea medicine I was transferred to another hospital via ambulance to their stroke center. Eventual ruling was that I did not have a stroke. After about two days at hospital I realized I could not hear anything in my right ear. Up to this time I had perfect hearing. During my stay in both hospitals I was nauseous, vomited during a CT scan and very imbalanced where I needed a walker or help to get up or walk around. I had numerous tests, inner ear crystal treatment, IVs, meds (specifically meclizine, prednisone) diabetic check and insulin and the regular meds I'm on. I was discharged with vertigo, absolutely no hearing and imbalance. I fell 3 times since I've been home. I started physical therapy yesterday on 10-10-2018. Total time in both hospitals was 9-12-2018 about 11 pm to 9-17-2018 early afternoon.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Computerised tomogram, Deafness unilateral, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: I received the SHINGRIX and flu vaccine Sept. 10, 2018. My pharmacist said I may experience some flu like symptoms and headache, which I did. On 9-11-2018 I didn't feel well. On 9-12-2018 I felt better. Then at 9 pm, while sitting on the sofa, I got sudden severe nausea. I had immediate severe projective vomiting for over an hour. It was continuous. I also was, embarrassingly, incontinent of stool at the same time. I told my husband I had to go to the hospital. I was so weak and dizzy he had to hold me up. I felt like a rag doll with no strength. As we made turns or went over bumps I had severe vertigo and nausea. I went to the emergency room about 11 pm. After IVs, an EKG, CT scan and chest x-ray and I believe anti-nausea medicine I was transferred to another hospital via ambulance to their stroke center. Eventual ruling was that I did not have a stroke. After about two days at hospital I realized I could not hear anything in my right ear. Up to this time I had perfect hearing. During my stay in both hospitals I was nauseous, vomited during a CT scan and very imbalanced where I needed a walker or help to get up or walk around. I had numerous tests, inner ear crystal treatment, IVs, meds (specifically meclizine, prednisone) diabetic check and insulin and the regular meds I'm on. I was discharged with vertigo, absolutely no hearing and imbalance. I fell 3 times since I've been home. I started physical therapy yesterday on 10-10-2018. Total time in both hospitals was 9-12-2018 about 11 pm to 9-17-2018 early afternoon.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Fall, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: I received the SHINGRIX and flu vaccine Sept. 10, 2018. My pharmacist said I may experience some flu like symptoms and headache, which I did. On 9-11-2018 I didn't feel well. On 9-12-2018 I felt better. Then at 9 pm, while sitting on the sofa, I got sudden severe nausea. I had immediate severe projective vomiting for over an hour. It was continuous. I also was, embarrassingly, incontinent of stool at the same time. I told my husband I had to go to the hospital. I was so weak and dizzy he had to hold me up. I felt like a rag doll with no strength. As we made turns or went over bumps I had severe vertigo and nausea. I went to the emergency room about 11 pm. After IVs, an EKG, CT scan and chest x-ray and I believe anti-nausea medicine I was transferred to another hospital via ambulance to their stroke center. Eventual ruling was that I did not have a stroke. After about two days at hospital I realized I could not hear anything in my right ear. Up to this time I had perfect hearing. During my stay in both hospitals I was nauseous, vomited during a CT scan and very imbalanced where I needed a walker or help to get up or walk around. I had numerous tests, inner ear crystal treatment, IVs, meds (specifically meclizine, prednisone) diabetic check and insulin and the regular meds I'm on. I was discharged with vertigo, absolutely no hearing and imbalance. I fell 3 times since I've been home. I started physical therapy yesterday on 10-10-2018. Total time in both hospitals was 9-12-2018 about 11 pm to 9-17-2018 early afternoon.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Scan, Ultrasound Doppler, Vertigo, Vomiting
Clinical narrative: I received the SHINGRIX and flu vaccine Sept. 10, 2018. My pharmacist said I may experience some flu like symptoms and headache, which I did. On 9-11-2018 I didn't feel well. On 9-12-2018 I felt better. Then at 9 pm, while sitting on the sofa, I got sudden severe nausea. I had immediate severe projective vomiting for over an hour. It was continuous. I also was, embarrassingly, incontinent of stool at the same time. I told my husband I had to go to the hospital. I was so weak and dizzy he had to hold me up. I felt like a rag doll with no strength. As we made turns or went over bumps I had severe vertigo and nausea. I went to the emergency room about 11 pm. After IVs, an EKG, CT scan and chest x-ray and I believe anti-nausea medicine I was transferred to another hospital via ambulance to their stroke center. Eventual ruling was that I did not have a stroke. After about two days at hospital I realized I could not hear anything in my right ear. Up to this time I had perfect hearing. During my stay in both hospitals I was nauseous, vomited during a CT scan and very imbalanced where I needed a walker or help to get up or walk around. I had numerous tests, inner ear crystal treatment, IVs, meds (specifically meclizine, prednisone) diabetic check and insulin and the regular meds I'm on. I was discharged with vertigo, absolutely no hearing and imbalance. I fell 3 times since I've been home. I started physical therapy yesterday on 10-10-2018. Total time in both hospitals was 9-12-2018 about 11 pm to 9-17-2018 early afternoon.