chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 62 years old patient received a high dose flu vaccine, no AE; 62 years old patient received a high dose flu vaccine, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 62 years old male patient who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Chronic obstructive pulmonary disease.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB, HEP
Symptoms: Extra dose administered
Clinical narrative: patient received 2 does of DTAP and Polio/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case involves a 5 months old patient of unknown gender who received extra doses comprised with vaccines HEPATITIS B VACCINE (HEPATITIS B VACCINE), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (UI992AAA, left deltoid, 0.5 ml via intramuscular route) on 23-Sep-2019 for all vaccines. The patient received 2 does of DTAP and Polio.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  As concomitant therapy, patient received ROTAVIRUS VACCINE.   It was of actual medication error due to extra dose administered.  It was unknown whether adverse event was experienced or not. .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: large amount of swelling at injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who experienced large amount of swelling at injection site (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had large amount of swelling at injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site swelling.  Recommended ice to site, motrin, and benedryl.  Information on the batch number is requested.  List of document held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Influenza like illness, Malaise, Pyrexia
Clinical narrative: flu like symptoms; sick like a dog; sniffles; headache; feeling like having a fever; feeling like they were dying for a day; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 67 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The concomitant vaccination included prevnar.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On 07-SEP-2019, 1 days post vaccination, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, malaise, rhinorrhoea, headache, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: flu like symptoms; sick like a dog; sniffles; headache; feeling like having a fever; feeling like they were dying for a day; Initial and Additional information received on 23-Sep-2019 and 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacy other/non-hcp.  This case is linked to cases 2019SA267183 and 2019SA267182 (same reporter).  This case involves a 67 years old male patient who experienced flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The concomitant vaccination included prevnar.   On 06-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ232AA and expiry date: 10-Apr-2020) via intramuscular route in the left deltoid.  On 07-SEP-2019, 1 days post vaccination, the patient had flu like symptoms (influenza like illness), sick like a dog (malaise), sniffles (rhinorrhoea), headache (headache), fever (pyrexia) and feeling like they were dying for a day (unevaluable event) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  Final diagnosis was influenza like illness, malaise, rhinorrhoea, headache, pyrexia and unevaluable event.   It was not reported if the patient received a corrective treatment and spent the whole day in bed.  The patient outcome was reported as unknown for all the events.  List of document held by sender:  none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Body temperature increased, Chills, Diarrhoea, Fatigue
Clinical narrative: Received the shingles vaccination (50 Mcg/0.5 ml injection) at 12:00 pm on Tuesday, September 24, 2019. Felt lethargic for the remainder of the day and went to sleep at 10:00 pm. Awoke at 1:00 am Wednesday, September 25, 2019 with extreme shivering and feeling unwell. Took aspirin and went back to bed. Awoke at 5:00 am of the same day and felt extremely hot. Took temperature and it was 100.5 degrees F. Took Tylenol and a Benadryl and lied on the couch watching TV. At 6:30 am I experienced extremely loose bowel movements with abdominal cramping. Ate some breakfast at 7:30 am. Took more Tylenol and Benadryl at 9:00 am and went back to bed. Awoke at 1:00 pm feeling extremely tired--temperature was 98.8 degrees F. Rested the remaining part of the afternoon. At 5:00 pm temperature had returned to 100 degrees F. Took additional Tylenol. Went to bed at 7:30 pm with more Tylenol and Benadryl.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Lethargy, Malaise
Clinical narrative: Received the shingles vaccination (50 Mcg/0.5 ml injection) at 12:00 pm on Tuesday, September 24, 2019. Felt lethargic for the remainder of the day and went to sleep at 10:00 pm. Awoke at 1:00 am Wednesday, September 25, 2019 with extreme shivering and feeling unwell. Took aspirin and went back to bed. Awoke at 5:00 am of the same day and felt extremely hot. Took temperature and it was 100.5 degrees F. Took Tylenol and a Benadryl and lied on the couch watching TV. At 6:30 am I experienced extremely loose bowel movements with abdominal cramping. Ate some breakfast at 7:30 am. Took more Tylenol and Benadryl at 9:00 am and went back to bed. Awoke at 1:00 pm feeling extremely tired--temperature was 98.8 degrees F. Rested the remaining part of the afternoon. At 5:00 pm temperature had returned to 100 degrees F. Took additional Tylenol. Went to bed at 7:30 pm with more Tylenol and Benadryl.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Sensation of foreign body
Clinical narrative: Patient felt like something was in her throat after the vaccine and she was not feeling right.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient had to go to the hospital and reports "cellulitis" caused by the shingles vaccination. Hospital informed her it could have been a contaminated vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Rash papular
Clinical narrative: She notes that she developed a rash about an inch below injection site the day she received, it worked it's way down to elbow crook. Initially raised slightly almost like hives. On Monday 8/12/19 she was going to request and appointment however it had almost completely resolved
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Blister, Chills, Fatigue, Headache
Clinical narrative: First of all, I just went in to get my shingles vaccine at the request of my doctor. The pharmacist asked if I've had my flu vaccine, which I hadn't so I said no. She recommended I get both vaccines at the same time. She said it's better for your immune system if you get them both at once. Within an hour, I had the "common symptoms" from the Shingrix literature...redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. On day three after the injection, I developed a shingles blister on the back of my neck. I called my doctor. She had me come in to verify it was shingles, which it was. Over the next 4 days I developed 8 more shingles blisters and a coldsore on my lip. My Dr. gave me a prescription for Valtrex but said not to take it unless I got significantly worse as it would make the vaccines less effective. At day 7, I started taking 1000 mg Lysine due to the coldsore. The other blisters dried up and scabbed over by day 9.  Today is day 17 and the blisters and coldsore are all gone except the one on the back of my neck. It still has a scab. I've since heard from several nurse friends that the pharmacist shouldn't have recommended I get bot the Shingrix and the Flu vaccines at the same time.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Myalgia, Oral herpes
Clinical narrative: First of all, I just went in to get my shingles vaccine at the request of my doctor. The pharmacist asked if I've had my flu vaccine, which I hadn't so I said no. She recommended I get both vaccines at the same time. She said it's better for your immune system if you get them both at once. Within an hour, I had the "common symptoms" from the Shingrix literature...redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. On day three after the injection, I developed a shingles blister on the back of my neck. I called my doctor. She had me come in to verify it was shingles, which it was. Over the next 4 days I developed 8 more shingles blisters and a coldsore on my lip. My Dr. gave me a prescription for Valtrex but said not to take it unless I got significantly worse as it would make the vaccines less effective. At day 7, I started taking 1000 mg Lysine due to the coldsore. The other blisters dried up and scabbed over by day 9.  Today is day 17 and the blisters and coldsore are all gone except the one on the back of my neck. It still has a scab. I've since heard from several nurse friends that the pharmacist shouldn't have recommended I get bot the Shingrix and the Flu vaccines at the same time.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Scab
Clinical narrative: First of all, I just went in to get my shingles vaccine at the request of my doctor. The pharmacist asked if I've had my flu vaccine, which I hadn't so I said no. She recommended I get both vaccines at the same time. She said it's better for your immune system if you get them both at once. Within an hour, I had the "common symptoms" from the Shingrix literature...redness and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. On day three after the injection, I developed a shingles blister on the back of my neck. I called my doctor. She had me come in to verify it was shingles, which it was. Over the next 4 days I developed 8 more shingles blisters and a coldsore on my lip. My Dr. gave me a prescription for Valtrex but said not to take it unless I got significantly worse as it would make the vaccines less effective. At day 7, I started taking 1000 mg Lysine due to the coldsore. The other blisters dried up and scabbed over by day 9.  Today is day 17 and the blisters and coldsore are all gone except the one on the back of my neck. It still has a scab. I've since heard from several nurse friends that the pharmacist shouldn't have recommended I get bot the Shingrix and the Flu vaccines at the same time.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Electroencephalogram normal, Febrile convulsion, Full blood count normal, Human rhinovirus test positive, Metabolic function test normal
Clinical narrative: Complex febrile seizure with status epilepticus with in 6 -8 hours of vaccination, + fever prior to seizure
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Status epilepticus
Clinical narrative: Complex febrile seizure with status epilepticus with in 6 -8 hours of vaccination, + fever prior to seizure
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Erythema, Headache, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Somnolence, Vomiting
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Cellulitis, Ear pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Lymphadenopathy, Pyrexia, Somnolence, Vomiting
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Fatigue, Headache
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Friday - Pt reports no adverse events Saturday -Arm swelled up wrapping around inside of bicep from underarm (glands swollen) to elbow, glands in neck swollen as well; Headache "like an ice pick in head" went to sleep at 6pm Saturday, "couldn't wake up, kept trying to open eyes but body wasn't listening to brain" didn't wake up until 350P on Sunday Sunday - Arm redness/swelling approx 4 inch x 3 inch area Patient reports fever all weekend (highest temp 102*), generally around 99/100* being treated with otc ibuprofen Patient also reports intermittent vomiting all weekend, last vomiting Sunday but "afraid to eat" today on Monday so uncertain if symptoms resolved Patient reports headache improved on Monday, intermittent sharp pains behind ear, not constant.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Patient reported arm was "very, very sore", red rash across entire width of arm from injection site to elbow, swollen, greatly improving as of today 9/30 Monday (3 days post-injection)
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Gait disturbance, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: On 09/27/19 my son was complaining of his leg hurting, limping and wouldn't really walk much.  Saturday morning (09/28/19) his entire right thigh was swollen from his knee cap to his hip.  He took a nap that afternoon and woke up around 3PM, when he woke up his face was swollen, his hands/feet were swollen, his thigh was still swollen and there were hives on his leg, abdomen and face.  He was complaining about his hands/feet hurting.  He wouldn't walk or put shoes on due to pain.  I gave him 5mls of children's Benadryl and took him to the urgent care clinic.  By the time we got there the redness/swelling of his face had gone down but the hives, swollen thigh and hand/foot pain was still present.  He was evaluated by a physician assistant I believe.  We were instructed to do Benadryl/ranitidine and giving  a dosing schedule.  We were also given the option to try zyrtec during the day rather than Benadryl.  He has been taking the allergy medications since and the hives are gone, he is acting better and walking normal again but his thigh is still swollen at this time.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: On 09/27/19 my son was complaining of his leg hurting, limping and wouldn't really walk much.  Saturday morning (09/28/19) his entire right thigh was swollen from his knee cap to his hip.  He took a nap that afternoon and woke up around 3PM, when he woke up his face was swollen, his hands/feet were swollen, his thigh was still swollen and there were hives on his leg, abdomen and face.  He was complaining about his hands/feet hurting.  He wouldn't walk or put shoes on due to pain.  I gave him 5mls of children's Benadryl and took him to the urgent care clinic.  By the time we got there the redness/swelling of his face had gone down but the hives, swollen thigh and hand/foot pain was still present.  He was evaluated by a physician assistant I believe.  We were instructed to do Benadryl/ranitidine and giving  a dosing schedule.  We were also given the option to try zyrtec during the day rather than Benadryl.  He has been taking the allergy medications since and the hives are gone, he is acting better and walking normal again but his thigh is still swollen at this time.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute myocardial infarction, Death, Laboratory test
Clinical narrative: STEMI (likely unrelated), complex treatment course, died 9/7/19
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: 9/30/19 Based on patient's weight (210 lb), a 22 G 1 & 1/2 inch needle was used to administer the vaccine. The patient jumped during administration & moved arm, but the full dose was given to the patient. Immediately after the vaccine, she said it hurt really bad and she felt tingling in her hand. She was asked to sit for observation. She left while giving a thumbs up to my technician. I called to follow up with her at 5:06 pm. She said the tingling subsided, but her arm is very sore down into her forearm, and she's having a hard time moving it. She said she has some range of motion, but she had a hard time putting her dog's leash on. I told her that a sore arm is typical with the vaccine. She was advised to use a cold compress and oral pain reliever if needed. She said she already took an oral pain reliever. She was advised that if any severe symptoms develop, she should seek emergency medical attention. If symptoms persist, she was advised to follow up w/ her doctor. She received her vaccination today, so I will follow up with patient in a few days to see how she is doing.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia
Clinical narrative: 9/30/19 Based on patient's weight (210 lb), a 22 G 1 & 1/2 inch needle was used to administer the vaccine. The patient jumped during administration & moved arm, but the full dose was given to the patient. Immediately after the vaccine, she said it hurt really bad and she felt tingling in her hand. She was asked to sit for observation. She left while giving a thumbs up to my technician. I called to follow up with her at 5:06 pm. She said the tingling subsided, but her arm is very sore down into her forearm, and she's having a hard time moving it. She said she has some range of motion, but she had a hard time putting her dog's leash on. I told her that a sore arm is typical with the vaccine. She was advised to use a cold compress and oral pain reliever if needed. She said she already took an oral pain reliever. She was advised that if any severe symptoms develop, she should seek emergency medical attention. If symptoms persist, she was advised to follow up w/ her doctor. She received her vaccination today, so I will follow up with patient in a few days to see how she is doing.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states that her RIGHT Arm has been hurting since the administration of the Shingrix vaccine. Pharmacy records indicate that shot was given in left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: red hot area of about 70mm circular from point of injection started in approx. 3-4 hrs after injection and was painful and hot and red all weekend and today (4 days after) remains somewhat red and continues to be slightly warm to touch but appears to be resolving.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Gait disturbance, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen very painful, hot to touch site and entire muscle up into shoulder and neck, fever 99- 101 started 24 hrs after shot, weak legs, body aches, nausea, lack of appetite.  Felt just out of it, staggering  when fever high.   Sxs  began within hours of injection. Sxs  abated 48 hours after injection except for sore site. I took 500 mg of Tylenol several  doses  and ondansetron  2 doses/2 days
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: Swollen very painful, hot to touch site and entire muscle up into shoulder and neck, fever 99- 101 started 24 hrs after shot, weak legs, body aches, nausea, lack of appetite.  Felt just out of it, staggering  when fever high.   Sxs  began within hours of injection. Sxs  abated 48 hours after injection except for sore site. I took 500 mg of Tylenol several  doses  and ondansetron  2 doses/2 days
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site joint pain, Nausea, Pyrexia
Clinical narrative: dizziness, nausea beginning at bedtime, and worsening through the night, chills and fever of 102 degrees next morning. Joint pain in the left shoulder was severe.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Cyanosis, Eye movement disorder, Febrile convulsion, Musculoskeletal stiffness
Clinical narrative: Prior to these vaccines, patient had not been sick once. Patient had unusual cries, she developed a fever and we gave her children's tylenol per doctors instruction. We tried to cool her down the best we could. She suddenly began to stiffen her hand and legs and her eyes rolled back, her lips turned blue and she had a seizure for about 4 minutes. We called 911 and paramedics took us to ER. She was given fever medication at hospital to relieve fever. They ran tests and found nothing wrong and said it was a febrile seizure. I didn't see Hib 4 dose on the list but it is the one administered that resulted in the seizure.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Prior to these vaccines, patient had not been sick once. Patient had unusual cries, she developed a fever and we gave her children's tylenol per doctors instruction. We tried to cool her down the best we could. She suddenly began to stiffen her hand and legs and her eyes rolled back, her lips turned blue and she had a seizure for about 4 minutes. We called 911 and paramedics took us to ER. She was given fever medication at hospital to relieve fever. They ran tests and found nothing wrong and said it was a febrile seizure. I didn't see Hib 4 dose on the list but it is the one administered that resulted in the seizure.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: pt called 9/26/2019 reported left arm was swollen size of baseball, raised and hot.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: At the end of the next day after getting the vaccine, patient reported that she had blisters in her mouth and a rash over the trunk and arms of her body. Patient went to the ER and was given an injection of Kenalog. That did not fully treat all the symptoms, so she went to her family doctor and received prednisone 10mg (9/27/19), triamcinolone 0.1% cream (9/27/19), and azithromycin 250mg dose pack (9/19/19).
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: right deltoid at site of injection redness, swelling 5cm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: localized rash painful
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Decreased appetite, Headache, Inflammation, Injection site pain, Pain
Clinical narrative: Patient received both Fluad and Pneumovax 23 on 9/26/19 in the morning. Both were administered in the left arm (deltoid muscle) at least 1 inch apart. By Thursday evening, patient had massive headaches and soreness at injection site. The next morning,  patient had fever of 101 degrees Fahrenheit and has body aches as well as lack of appetite for 3 days. Patient's left arm is also hot and inflamed with an area of about 4.5 inches by 7.5 inches. Patient went to her primary care physician and was prescribed cephalexin in case of skin infection. Ibuprofen and Benadryl was also ordered as needed for pain and itching. Will follow up with patient in the next couple days to see if low grade fever subsides.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient received both Fluad and Pneumovax 23 on 9/26/19 in the morning. Both were administered in the left arm (deltoid muscle) at least 1 inch apart. By Thursday evening, patient had massive headaches and soreness at injection site. The next morning,  patient had fever of 101 degrees Fahrenheit and has body aches as well as lack of appetite for 3 days. Patient's left arm is also hot and inflamed with an area of about 4.5 inches by 7.5 inches. Patient went to her primary care physician and was prescribed cephalexin in case of skin infection. Ibuprofen and Benadryl was also ordered as needed for pain and itching. Will follow up with patient in the next couple days to see if low grade fever subsides.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Loss of consciousness, Tremor
Clinical narrative: Patient was shopping in the store right after the vaccination and daughter said patient started shaking and that she helped patient to the floor, and shouted for help. Pharmacist responded , patient was unconscious. She regained consciousness within a minute and was disoriented. patient's blood pressure was taken and it was 192/93.  Emergency paramedics were called and they took over care and transported  patient to the ambulance.
Age: 50.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Pain in arm, and redness and swelling where the Shingrix injection was given a few hours of the injection. Flu-like symptoms, (fatigue, chills) within 12 hours lasting 24 hours. After 24 hours, a large area of redness and swelling (more than 4" in diameter) with intense itching developed.
Age: 50.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain in arm, and redness and swelling where the Shingrix injection was given a few hours of the injection. Flu-like symptoms, (fatigue, chills) within 12 hours lasting 24 hours. After 24 hours, a large area of redness and swelling (more than 4" in diameter) with intense itching developed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema
Clinical narrative: Shivering, redness on the site of vacine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: Symptoms:  pounding headache, muscle aches (big time), increased heart rate, chills, lasted about 48 hours.  Swelling  and redness (about the size of a golf ball in circumference) at injection site.  I received NO verbal or written information from the medical office re possible side effects ( my friend who is a nurse told me that these side effects can occur with the vaccine).  I didn't pursue treatment (as I didn't want to move my head to get off the couch) and I didn't think I was going to die...  Anyway, I am reporting this because I told the medical office about 4 times about the reaction I had when they try to reschedule the second vaccine (I can't bring myself to go through that again in order to get the second vaccine).  Thank you.  BTW, I am not the only patient who had an adverse reaction and was not provided with info (verbal or written).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Symptoms:  pounding headache, muscle aches (big time), increased heart rate, chills, lasted about 48 hours.  Swelling  and redness (about the size of a golf ball in circumference) at injection site.  I received NO verbal or written information from the medical office re possible side effects ( my friend who is a nurse told me that these side effects can occur with the vaccine).  I didn't pursue treatment (as I didn't want to move my head to get off the couch) and I didn't think I was going to die...  Anyway, I am reporting this because I told the medical office about 4 times about the reaction I had when they try to reschedule the second vaccine (I can't bring myself to go through that again in order to get the second vaccine).  Thank you.  BTW, I am not the only patient who had an adverse reaction and was not provided with info (verbal or written).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt called and said her arm is red and raised but have no pain in the arm that pt got the shingrix vaccine. rec. pt to ice the area and take ibuprofen and check with pt tomorrow. Checked with pt the day after pt states redness at site is going away, still raised and warm.  advised pt to call dr. Otherwise pt is feeling fine.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Rash, Skin warm, Urticaria
Clinical narrative: Red, raised rash (wheel), warm to touch and measuring 2x2 1/4 inches
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Immediate hive, redness
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient reported soreness in the arm continuing for over 3 weeks after receiving Afluria immunization.  He has noticed significant weakening in the right arm, and pain when lifted laterally.
Age: 11.0
Sex: M
Vaccine: FLU4, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: patient had no adverse events
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: After 1 week, patient reported that she had shingles (confirmed by lab results) and was started on empiric antiviral and antibiotic therapy. She had previously received shingrix and fluad on the same visit.
Age: 58.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider ordered proquad for patient after consult with pharmacy. Patient did not need varicella d/t age per CDC guidelines there for this is a medication error.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and Swelling at the site. 10 cm x 11 cm
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: patient experienced high fever, rash, warm to touch redness and swollen arm patient went to minor emergency and received antibiotics and steriods presented to pharmacy 4 days after showed signs of improvement but still had pain and some redness and swelling
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: patient experienced high fever, rash, warm to touch redness and swollen arm patient went to minor emergency and received antibiotics and steriods presented to pharmacy 4 days after showed signs of improvement but still had pain and some redness and swelling
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient received second dose of shingrix vaccine on 9/13/19.  Patient came to pharmacy on 9/30/19 to report that her arm was still sore.  Stated that there was some redness initially but that had gone away but some pain was still there.  Patient was instructed to contact their physician to discuss the reaction
Age: 53.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Body temperature increased, Cellulitis, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: 9/26 typical local reaction. Quarter sized are, red, pain-full swollen and warm to touch. Body temp 102-102.5 9/27 area of redness increased. Body temp at 08:15 was 103.5. As day progressed area increased by approximately 300%. T-max was 104.  9/28 temp was 103, went to ER area was 10cm x 7-8 cm.  Dx?d as cellulitis. IV  clindamycin given then sent home on oral clindamycin course of treatment. 9/29 no change temp 101.5 9/30 afebrile. Area less red, swollen and painful.
Age: 53.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Local reaction, Pain, Skin warm, Swelling, White blood cell count increased
Clinical narrative: 9/26 typical local reaction. Quarter sized are, red, pain-full swollen and warm to touch. Body temp 102-102.5 9/27 area of redness increased. Body temp at 08:15 was 103.5. As day progressed area increased by approximately 300%. T-max was 104.  9/28 temp was 103, went to ER area was 10cm x 7-8 cm.  Dx?d as cellulitis. IV  clindamycin given then sent home on oral clindamycin course of treatment. 9/29 no change temp 101.5 9/30 afebrile. Area less red, swollen and painful.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Dad describes as a mild itchy rash that began the same night after receiving vaccine. No other new exposures. He was seen in the office today (6 days later) and dad says that the rash has gotten worse. Dad says that the rash is worse with heat.  He took one dose of Benadryl on 9/26/19. He denies fever or any other symptoms. APRN describes the rash as "erythema present to full body, sparing face, palms of hands, and soles of feet - c/w hives to neck and chest,"
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: swelling, soreness, redness, itching
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Pain
Clinical narrative: Significant site pain after nearly 2 weeks (12 days) pt had pain upon  raising arm. no redness, swelling or warm to the touch.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on torso and back
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Eye movement disorder, Febrile convulsion, Foaming at mouth, Musculoskeletal stiffness, Pallor
Clinical narrative: We were driving and patient was in her car seat. She appeared to be falling asleep when suddenly her eyes opened up wide, they rolled up and she appeared frozen. She lost her skin color, was not blinking eye lids, her hands were shaking a bit. She then had clear bubbly liquid coming out of her mouth. She was unresponsive for about 3 minutes as she had the seizure. After that she made slight sounds as if she wanted to speak but could not. The paramedics arrived. We were on the freeway and they took us to the nearest ED. Patient had a fever out of nowhere and they gave her ibuprofen. They did urine test and she had no infections. She slept for an hour and cooled down and they determined she had a febrile seizure. Prior to the seizure patient was not sick nor had a fever.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Staring, Tremor, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: We were driving and patient was in her car seat. She appeared to be falling asleep when suddenly her eyes opened up wide, they rolled up and she appeared frozen. She lost her skin color, was not blinking eye lids, her hands were shaking a bit. She then had clear bubbly liquid coming out of her mouth. She was unresponsive for about 3 minutes as she had the seizure. After that she made slight sounds as if she wanted to speak but could not. The paramedics arrived. We were on the freeway and they took us to the nearest ED. Patient had a fever out of nowhere and they gave her ibuprofen. They did urine test and she had no infections. She slept for an hour and cooled down and they determined she had a febrile seizure. Prior to the seizure patient was not sick nor had a fever.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Hypersensitivity, Photophobia, Pyrexia
Clinical narrative: Headache, chills, fever (unsure of temperature since thermometer did not work, but not super high), increased sensitivity to light and to dust and other trigger allergens, shaking/shivering,
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Tremor
Clinical narrative: Headache, chills, fever (unsure of temperature since thermometer did not work, but not super high), increased sensitivity to light and to dust and other trigger allergens, shaking/shivering,
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Feeling cold, Headache, Pain
Clinical narrative: patient stated about 12 hours after immunization she woke up with a severe headache, itching, weak feeling and pain, thirsty, cold, fever and chills. She stated 12 hours later she was back to normal with only a weak feeling that she has all the time without regard to the immunization.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus, Pyrexia, Thirst
Clinical narrative: patient stated about 12 hours after immunization she woke up with a severe headache, itching, weak feeling and pain, thirsty, cold, fever and chills. She stated 12 hours later she was back to normal with only a weak feeling that she has all the time without regard to the immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, VARCEL
Symptoms: Injection site reaction, Local reaction, Pain
Clinical narrative: Local injection site reaction, first noticed by parent on morning of 9/30/19. Patient complained of pain. No fevers or other signs of infection or illness. Recommended treating with cool compresses and ibuprofen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: 6 Days post immunization pt saw spots appearing on trunk and legs- they then became red and painful where she went to her dr and he diagnosed her with shingles
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Inflammation, Pain, Skin warm, Swelling
Clinical narrative: Patient states swelling/inflammation, redness, soreness, and hotness down to wrist
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient reported immediately feeling numbness/"pins and needles" down her left arm after injection. Monitored for about 25 minutes and no other signs or symptoms of a serious reaction or injection site reaction occurred. When patient left the pharmacy she stated the "tingly feeling" was only in her fingertips.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: dizzy, weak and not breathing well
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Patient felt light headed after second shot, laid head down on table in room.  Complained of feeling "loss of sense of reality".  Respirations normal, blood pressure 112/77, heart rate 83.  Cold, clammy skin.  Asked for water and asked me to call 911.  Patient was able to respond to questions, but did close eyes and seemed to lose full consciousness for a few seconds.  Patient was checked out by EMS and released.
Age: 75.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: REDNESS, SWELLING, PAIN
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: Pt states that 3 hours after leaving pharmacy, she started getting chills, fever of 100, severe headache, weakness, fatigue, chest tightness, trouble breathing, arm pain, and later on large red blotches on her arm, not at the injection site but farther down her arm. Pt went to the ER.  Pt followed up with a dermatologist, dermatologist diagnosed her as having severe adverse reactions to the vaccine, as well as an allergic reaction to the vaccine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypersensitivity, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Pt states that 3 hours after leaving pharmacy, she started getting chills, fever of 100, severe headache, weakness, fatigue, chest tightness, trouble breathing, arm pain, and later on large red blotches on her arm, not at the injection site but farther down her arm. Pt went to the ER.  Pt followed up with a dermatologist, dermatologist diagnosed her as having severe adverse reactions to the vaccine, as well as an allergic reaction to the vaccine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Pt states that 3 hours after leaving pharmacy, she started getting chills, fever of 100, severe headache, weakness, fatigue, chest tightness, trouble breathing, arm pain, and later on large red blotches on her arm, not at the injection site but farther down her arm. Pt went to the ER.  Pt followed up with a dermatologist, dermatologist diagnosed her as having severe adverse reactions to the vaccine, as well as an allergic reaction to the vaccine.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: SWOLLEN ARM AND ITCHING IN HER ARM
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: fever, body ache, headache, diarrhea
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Pyrexia, Throat irritation
Clinical narrative: Vaccine given in AM, patient called in PM complaining of fatigue, fever, swollen eyes, and itchy throat. Patient has never had symptoms with previous flu shots. Patient advised to take Benadryl and attend ER if any anaphylaxis symptoms.