chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Intestinal obstruction
Clinical narrative: blockage in intestine; condition aggrevated; This case was reported by a consumer via call center representative and described the occurrence of intestinal obstruction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colostomy (experienced 5 months before the date of reporting). Concurrent medical conditions included intestinal obstruction and scar.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced intestinal obstruction (serious criteria hospitalization and GSK medically significant) and condition aggravated (serious criteria hospitalization). On an unknown date, the outcome of the intestinal obstruction was recovered/resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the intestinal obstruction and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient could not remember which arm she received either dose of Shingrix. It was reported that, sometimes in between dose 1 and dose 2 of Shingrix, the patient was hospitalized for 4 days due to a blockage in her intestine. It was reported that, the patient gets these blockages from time to time in her intestine due to scar tissue that was there prior to receiving Shingrix.  The reporter did not consent to follow-up. This was 1 of the 2 cases reported by same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Soreness in arm within range of normal. But then I had flu-like symptoms, i.e. body aches, mild headache, tiredness, feeling like I was coming down with flu off and on for the next 3 weeks. The body ache seemed to move around from neck and should areas to feet, etc. I have continued to experience this a 3 more times for 3 -4 days at a time. I'm now worried about going in for the second shot in the series and have been putting off. I've not reported to my healthcare provider at this point because I can't be certain the vaccine is the causative factor and it does go away after 3 - 4 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis without abscess developed in the vaccinated extremity within 2 days after vaccination. Afebrile. He was seen in clinic on the 3rd day after vaccination and prescribed Clindamycin. Anticipate full recovery with no long term sequalae.
Age: 55.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Chest discomfort, Urticaria
Clinical narrative: diffuse hives, with tightness in her chest
Age: 55.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: diffuse hives, with tightness in her chest
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Pt developed hives on face and front of scalp.  No  respiratory difficulty.  No lip /mouth swelling.   Pt given oral diphenhydramine.  Hives beginning to resolve.   Pt discharged home.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site swelling, Nausea, Pain
Clinical narrative: Super swollen knot at the injection spot and ached and nauseous for 2 days. Couldn't use the arm that received the injection
Age: 51.0
Sex: M
Vaccine: UNK, HEPA, PPV, TDAP, VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: Patient was given his Afluria vaccine on our office at Primary Care. He asked for a prescription for a Pneumovax to take to the pharmacy. He took that prescription to Pharmacy. While there the pharmacist working gave him - Pneumovax, Zoster, Tdap and Hep A per staff at the pharmacy. Patient called Primary care Complaining of body aches and pains and shortness of breath. We sent him to the ED Department at Hospital and contacted Pharmacy regarding the reaction. They stated they would follow up on it.
Age: 51.0
Sex: M
Vaccine: UNK, HEPA, PPV, TDAP, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Immune system disorder
Clinical narrative: Patient was given his Afluria vaccine on our office at Primary Care. He asked for a prescription for a Pneumovax to take to the pharmacy. He took that prescription to Pharmacy. While there the pharmacist working gave him - Pneumovax, Zoster, Tdap and Hep A per staff at the pharmacy. Patient called Primary care Complaining of body aches and pains and shortness of breath. We sent him to the ED Department at Hospital and contacted Pharmacy regarding the reaction. They stated they would follow up on it.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Throat irritation
Clinical narrative: Redness, itching at injection site as soon as injected Itching of throat about 3-5 mins after  Redness of cheeks about ( I noticed after I left, my face felt hot on my cheeks)  The clinic watched me for 20mins to watch for anaphylaxis and then released me. I went home and took Benadryl and itching of arm, throat,  and redness went away.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Posture abnormal
Clinical narrative: 6:05PM AFTER THE VACCINE WAS ADMINISTERED HE SPECIFIED THAT HE FELT WEAK AND THREW HIS HEAD BACKWARDS.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had shown me he had sufficient titers for varicella. He was supposed to receive only MMR vaccine, and he was given varicella instead. Error was explained to patient, and was then given the correct vaccine, MMR in the right arm, subcutaneously. Told to follow up with his primary care provider in regards to the error. Patient has not experienced any adverse reaction currently as of 11/14/19.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Fever, Body Ache, Weakness for 4 days.
Age: 23.0
Sex: M
Vaccine: FLUR4
Symptoms: Dizziness, Fall
Clinical narrative: Dizziness/Fall
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient felt light-headed immediately after second vaccination. I made her wait 10 minutes. When I checked on her at 10 minutes she fainted. 911 was called. Her blood pressure was 85/60. She was taken to emergency room via ambulance.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests normal, Computerised tomogram head normal, Dizziness, Headache, Lacrimation increased
Clinical narrative: Two days after the vaccine, my eyes began to water profusely and I began to get dizzy spells, along with headaches. I did not associate this with the vaccine at the time. I had been experiencing a stuffy nose, so I had an appointment with my ENT the following week. He could not pinpoint anything, so he had me get a CT scan and hearing test, which both came out clear. He had no explanation for the sudden dizziness and headaches, and has scheduled me for a VNG in late December. Like I said earlier, I thought this was a sinus issue, but have to look into the possibility of it all being caused by the Shingrix vaccine. I have contacted my GP's office to follow up with them, but was told I should report this to you also.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion
Clinical narrative: Two days after the vaccine, my eyes began to water profusely and I began to get dizzy spells, along with headaches. I did not associate this with the vaccine at the time. I had been experiencing a stuffy nose, so I had an appointment with my ENT the following week. He could not pinpoint anything, so he had me get a CT scan and hearing test, which both came out clear. He had no explanation for the sudden dizziness and headaches, and has scheduled me for a VNG in late December. Like I said earlier, I thought this was a sinus issue, but have to look into the possibility of it all being caused by the Shingrix vaccine. I have contacted my GP's office to follow up with them, but was told I should report this to you also.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itchy face
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patients arm was red and slightly swollen from the injection site to the elbow. She came to the pharmacy the morning of the 14th and stated the conditions had improved from the night before. She went home and took Benadryl and   later in the afternoon on the 14th went to the doctor and got 2 prescriptions
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: 9/13/19 varicella titer result 0.6 (negative)      9/20/19 Varicella #1 administered     11/1/19 Varicella #2 administered (42 days after varicella #1)     11/4/19 Patient noticed arm where varicella was administered was a little red and very itchy.     11/5/19 In the evening the patient noticed a few lesions - stated had about 15 total lesions that she described as red with tiny vesicular spots (clear liquid) in center. They occurred on her abdomen, chest, thighs, and arm (opposite of one where vaccine given).     11/6/19 Employee was sent home from work after seeing nurse practioner. According to the nurse practioner she did not notice any vesicles, just a few red maculopapular lesions. Also on this day her 9 year old son who had previously received 2 doses of varicella vaccine had an outbreak of lesions similar to hers. His lesions totaled approximately 30 and were on his trunk, legs, arms and one lesion was on his face. Employee stayed home until 11/12 after rash resolved/crusted and not having new lesions for 24 hours  Employee does not know if family was exposed to wild-type varicella. Husband and 3 other children did not get rashes.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab, Skin lesion
Clinical narrative: 9/13/19 varicella titer result 0.6 (negative)      9/20/19 Varicella #1 administered     11/1/19 Varicella #2 administered (42 days after varicella #1)     11/4/19 Patient noticed arm where varicella was administered was a little red and very itchy.     11/5/19 In the evening the patient noticed a few lesions - stated had about 15 total lesions that she described as red with tiny vesicular spots (clear liquid) in center. They occurred on her abdomen, chest, thighs, and arm (opposite of one where vaccine given).     11/6/19 Employee was sent home from work after seeing nurse practioner. According to the nurse practioner she did not notice any vesicles, just a few red maculopapular lesions. Also on this day her 9 year old son who had previously received 2 doses of varicella vaccine had an outbreak of lesions similar to hers. His lesions totaled approximately 30 and were on his trunk, legs, arms and one lesion was on his face. Employee stayed home until 11/12 after rash resolved/crusted and not having new lesions for 24 hours  Employee does not know if family was exposed to wild-type varicella. Husband and 3 other children did not get rashes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: Redness, arm swelling, shortness of breath 2 - 3 hours after vaccination
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Gait inability, Muscle spasms
Clinical narrative: Pt reported severe muscle spasms of arms and legs, severe back pain radiating to hips, patient could not walk, touch toes due to leg spasms for 2 days.  Symptoms have subsided now.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Neuritis, Pain, Pain in extremity
Clinical narrative: After Injection, he had a very brisk local site reaction that caused redness and pain.  The redness got better, but the pain progressed and began to radiate down the arm to the  elbow.  The pain is deep and aching.  it has persisted for a month.  It is just now beginning to slowly resolve.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: patient states pain, arm continued to hurt.  unknown how she has treated it  unknown the outcome
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: The patient's arm was sore for 3 days.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: patient states that sometime after vaccine she developed pain in her upper left arm, described as throbbing, sometimes wakes her at night; also has limited range of motion, can not raise left arm above shoulder
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Bone pain, Chills, Ear pain
Clinical narrative: Headache; sore throat; shoulder blade pain, upper arm, armpit, wrist and hand joint pain all on the left side same side as injection; earache; jaw pain; collar bone pain (also same side as injection); nausea; chills; pubic bone painful to walk, low grade fever
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Nausea, Oropharyngeal pain
Clinical narrative: Headache; sore throat; shoulder blade pain, upper arm, armpit, wrist and hand joint pain all on the left side same side as injection; earache; jaw pain; collar bone pain (also same side as injection); nausea; chills; pubic bone painful to walk, low grade fever
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Pubic pain, Pyrexia
Clinical narrative: Headache; sore throat; shoulder blade pain, upper arm, armpit, wrist and hand joint pain all on the left side same side as injection; earache; jaw pain; collar bone pain (also same side as injection); nausea; chills; pubic bone painful to walk, low grade fever
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: significant localized hypersensitivity response with an oval shaped indurated erythematous area 4.5in x 6.5 in surrounding injection site, mild edema and warm to the touch.  no fever, pain, refusal to bear weight on leg.  patient has not been fussy, has been acting normally.  no other rash noted, no hives, no facial or airway edema.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: pt reported to the pharmacy on 11/14 that after the shot he was feeling feverish and had severe arm pain that radiated from the site of the shot up to his neck and didn't seem to be getting better
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: Started with a headache,  from approx. 10pm 11-3  and the whole next day I ran a fever of 101.6 orally- which would come down with Tylenol but then if went up again when the Tylenol was due, I ached all over!! I felt terrible.  I spent the majority of my day on 11-4 in bed and did sleep a lot.. I had a head ache the first evening. This was a nasty nasty  shot!! I was fortunate to have the day off work or I would have missed a day.  I am concerned about the booster shot. My PCP is telling me that he has not heard of this reaction BUT I talked to a employee at work that had a similar experience.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: patient reports arm is still sore from receiving the vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain
Clinical narrative: Patient called complaining of redness and soreness following the dose of shingrix, I asked the patient to come in for me to see it. When the patient arrived I realized I had given the vaccine incorrectly via SQ route instead if IM. After contacting GSK, I was told the dose is still valid but the reaction can last longer.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: Patient called complaining of redness and soreness following the dose of shingrix, I asked the patient to come in for me to see it. When the patient arrived I realized I had given the vaccine incorrectly via SQ route instead if IM. After contacting GSK, I was told the dose is still valid but the reaction can last longer.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Coordination abnormal, Fall, Head injury
Clinical narrative: No problems when vaccine was given, did say she didn't like looking at needles and closed her eyes.  After the injection, she left the consultation room to meet up with her mother.  Witnesses saw her losing her coordination/balance, bump into a display, fall onto her shoulder then bump her head.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy lymph gland normal, Lymphadenopathy, Mammogram abnormal
Clinical narrative: At her annual mammogram, shortly after shot, she had enlarged lymph nodes. Though not certain, believed to have been triggered by the vaccination
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Fatigue, Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever since day of vaccinations (11/07/2019-11-14-2019 and continuing), fatigue, irritable, and red bumps all over body.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness  and swelling at injection site lasting 3 or more days,  Tiredness for one day,
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: He had extensive bruising on his right arm from the shoulder down to the elbow. He went to the hospital and said he could have a possible hematoma and informed him to tell us about the reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Back pain, Blood glucose increased, Dizziness, Dyspnoea
Clinical narrative: Patient came in for their Pneumovax23 immunization. Filled out Questionaire and sat down for their immunization. Immunization was given, pt had no initial reaction. Patient got up and felt fine. Had no issues. Walked away without assistance about 20 steps, Then started feeling dizzy, lightheaded, and warm. Came back to the pharmacy and patient sat down. Upon return, patient was flushed, stated back was hurting. After sitting down, I told the patient to take a deep breathe as I noticed she wasn't taking any conscious breathes. Once she took a deep breathe, the flushing went away and pt stated they started feeling better. Asked patient if she was feeling anything. Stated her back was hurting and was experiencing muscle spasms. She took a few more deep breathes and was feeling better and better with each breathe she took she stated. Pt drank some water and felt better. Talked to the patient and she said she had an intense zumba class this morning and that she hasn't done it in a long time and that it was exhausting. Stated she didn't drink much water today so may have been dehydrated. She asked, what could it be. Told her it didn't seem to be immunization related. I told her, she has been "running around" all day and had a strenuous workout this morning. With her, "resting and sitting down" for the immunization, her body was resting and her getting up, her body possibly just tightened up out of no where. After about 10 minutes, she said she felt fine. Asked her if she wanted us to call 911 to be sure, even though the patient was feeling better. She said, "No, that wouldn't be necessary, she was feeling better." No complications the patient was feeling she stated.. No dizziness or flushing. No warm feelings. Pt stated her back went from a 7 on a pain scale down to a 2, but had no issues or complications after. Talked with the patient some more, she said she felt fine. She stated she felt well enough to leave. Told me if she started to feel anything, she will pull over to the side of the road and call her daughter. She said, "I'm feeling fine". Asked her if she wanted us to call anyone. She said, "No, she was feeling fine." Had no issues she could feel at the moment. Had Pharmacy Technician walk her out to her car to be sure in case anything happened again or if she had any reaction or feeling again. Patient made it out to her car and pharmacy Technician stated pt was doing well. Called patient once she got home safely at 5:56pm and pt stated she felt fine. Stated didn't have a proper lunch today, a big cup of coffee, and a small breakfast. Patient said she was going to take her blood pressure and blood glucose. Those numbers were BS:154, BP: 152/86 Pulse: 65. Says she is feeling anxious. Called back at 6:51pm. Patient stated was feeling a lot better, looked back at her daily food log. Didn't eat lunch. Felt she threw her own body a curveball and didn't adequately hydrate and eat well today. Doing well she said. About to eat her dinner and had no questions.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Flushing, Muscle spasms
Clinical narrative: Patient came in for their Pneumovax23 immunization. Filled out Questionaire and sat down for their immunization. Immunization was given, pt had no initial reaction. Patient got up and felt fine. Had no issues. Walked away without assistance about 20 steps, Then started feeling dizzy, lightheaded, and warm. Came back to the pharmacy and patient sat down. Upon return, patient was flushed, stated back was hurting. After sitting down, I told the patient to take a deep breathe as I noticed she wasn't taking any conscious breathes. Once she took a deep breathe, the flushing went away and pt stated they started feeling better. Asked patient if she was feeling anything. Stated her back was hurting and was experiencing muscle spasms. She took a few more deep breathes and was feeling better and better with each breathe she took she stated. Pt drank some water and felt better. Talked to the patient and she said she had an intense zumba class this morning and that she hasn't done it in a long time and that it was exhausting. Stated she didn't drink much water today so may have been dehydrated. She asked, what could it be. Told her it didn't seem to be immunization related. I told her, she has been "running around" all day and had a strenuous workout this morning. With her, "resting and sitting down" for the immunization, her body was resting and her getting up, her body possibly just tightened up out of no where. After about 10 minutes, she said she felt fine. Asked her if she wanted us to call 911 to be sure, even though the patient was feeling better. She said, "No, that wouldn't be necessary, she was feeling better." No complications the patient was feeling she stated.. No dizziness or flushing. No warm feelings. Pt stated her back went from a 7 on a pain scale down to a 2, but had no issues or complications after. Talked with the patient some more, she said she felt fine. She stated she felt well enough to leave. Told me if she started to feel anything, she will pull over to the side of the road and call her daughter. She said, "I'm feeling fine". Asked her if she wanted us to call anyone. She said, "No, she was feeling fine." Had no issues she could feel at the moment. Had Pharmacy Technician walk her out to her car to be sure in case anything happened again or if she had any reaction or feeling again. Patient made it out to her car and pharmacy Technician stated pt was doing well. Called patient once she got home safely at 5:56pm and pt stated she felt fine. Stated didn't have a proper lunch today, a big cup of coffee, and a small breakfast. Patient said she was going to take her blood pressure and blood glucose. Those numbers were BS:154, BP: 152/86 Pulse: 65. Says she is feeling anxious. Called back at 6:51pm. Patient stated was feeling a lot better, looked back at her daily food log. Didn't eat lunch. Felt she threw her own body a curveball and didn't adequately hydrate and eat well today. Doing well she said. About to eat her dinner and had no questions.
Age: 52.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Laboratory test, Pain in extremity, Paraesthesia
Clinical narrative: Patient states that her arms started hurting the day after the shot but thought it would go away after a few days. However it did not go away and the patient has been complaining about a painful tingling in her left arm since the shot was administered
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting & Diarrhea
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination, Injection site erythema, Injection site swelling, Pharyngeal swelling
Clinical narrative: Itching everywhere, severe swelling and redness at injection site, throat swelling. Symptoms began 15-30 minutes following injection. At 30 minutes, patient took a Diphenhydramine 25mg capsule at home, and symptoms immediately began to subside within another 30 minutes. Patient reported this event on 11/14/19 following a reminder call from our pharmacy for the second dose of Shingrix. Patient refused due to allergic reaction discussed in this report.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching everywhere, severe swelling and redness at injection site, throat swelling. Symptoms began 15-30 minutes following injection. At 30 minutes, patient took a Diphenhydramine 25mg capsule at home, and symptoms immediately began to subside within another 30 minutes. Patient reported this event on 11/14/19 following a reminder call from our pharmacy for the second dose of Shingrix. Patient refused due to allergic reaction discussed in this report.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Feeling hot, Pain in extremity, Rash, Urticaria
Clinical narrative: PT COMPLAINED OF SORE ARM AND A RASH THAT WAS FORMING - HE ALSO STATED HIVES ON LEGS - HE STATED IT STARTED AFTER GIVEN THE VACCINATION - NOT SURE WHICH WAS CAUSING THE ADVERSE EVENT - HE SAID HE WAS FEELING HOT AS WELL
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Immediate post-injection reaction, Injection site erythema, Lethargy, Pyrexia
Clinical narrative: Patient received the newly approved 0.5mL dose. There was redness at the injection site that occurred immediately, fever the next day up to 102 degrees Fahrenheit, lethargy, and anorexia.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Dyspnoea
Clinical narrative: patient presented to clinic on 10/25/2019 c/o shortness of breath since having vaccine. Patient seen by Dr and diagnosed with Acute Bronchitis and give nebulizer & inhaler and advised to return if SOB continues. VS-98.60, 68- 20- 138/62. Stabe at time of departure. Patient did not return to clinic
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Awoke with red itchy rash on anterioposterior torso, upper inner arms, neck groin, all apparent in a.m. given prednisone and medrol dose pak to follow prednisone dosing, zyrtec.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Neuralgia, Pain
Clinical narrative: Immediate severe pain when injected into upper arm muscle. Difficulty using left arm since then with certain movements due to nerve pain. Hasn't improved as of today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 x 4 cm  erythematous, tender region (L) thigh.  Recommended  applying cool compress  to reaction site & giving 5mL Benadryl   PO 3 times daily.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Flushing, Hypersensitivity, Nausea, Tongue disorder
Clinical narrative: ER visit notes from 9/20/2019 -Pt had her shingles vaccine @ 1330 today and has felt relatively well until this evening when she started feeling like her tongue was a little thicker and when she looked in the mirror she couldn't see her uvula as well. She has had some nausea. She denies any significant hives/rash, dysphagia, SOB, stridor, chest pain, abdominal pain. Husband notes that her face appears slightly more flushed" -DX: Angioedema, allergic reaction -Treated: Solu-medrol, Benadryl, Pepcid, Epi pen (discharged)  Prednisone 40mg QD
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: pt said 1st flu shot Friday afternoon. Woke up Saturday morning with rash and welts on buttock area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash vesicular
Clinical narrative: Patient suffered fatigue and possible fever the evening after receiving the vaccine. She then reported a rash (blistery) that occurred a week later.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Immediately after shot she had numbness in her left arm from upper arm down to hand. Then later that night developed a headache, stiffness in her neck down to her left arm & body aches. Persisted for several days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Immediately after shot she had numbness in her left arm from upper arm down to hand. Then later that night developed a headache, stiffness in her neck down to her left arm & body aches. Persisted for several days.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient Recieved Flu shot on 10/16/19 in Left thigh. Patient complained of pain that night, but no redness. Next day left thigh was a little red and daycare circled the spot. The day after the area redness, hotness and grew more painful
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient has developed shingles. She stated that a person who she was in close contact had the shingles already before she received the vaccination.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Swelling (R) arm 8 x 12 cm
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Redness Swelling @ site Temp 100 F in clinic
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling, numbness radiating down left arm-goes into fingers at times,  comes and goes over last 2 weeks-
Age: 0.58
Sex: F
Vaccine: RV5, UNK, UNK
Symptoms: Body temperature increased, Febrile convulsion, PCO2 increased, PO2 increased, Pulmonary oedema
Clinical narrative: Febrile Seizure; respiratory failure; pulmonary edema; shock; Information has been downloaded from Regulatory Authority (US-WYE-H05746008).  This spontaneous report was received from a physician regarding a 7-month-old female patient. The patient's current conditions included mild eczema and nasal congestion for 2 to 3 days prior to immunization. The patient's medical history and concomitant medications was not reported.  On 26-AUG-2008, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) at a dose of 1 dosage form (batch/lot number was reported as 0406X, expiry date was not reported) via oral route, for immunization. On the same day, the patient also vaccinated with pneumococcal conj vaccine (crm197) (reported as 'pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein)') at a dose of 1 dosage form (batch/lot number was reported as C926205B, expiry date was not reported) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid at a dose of 1 dosage form (batch/lot number was reported as C2957AA, expiry date was not reported) both via intramuscular route, for immunization. On 26-AUG-2008, the patient experienced febrile seizure, respiratory failure, pulmonary edema and shock. On an unknown date in August 2008, the patient was hospitalized. On 26-AUG-2008, the patient's body temperature was 36.7, 38.1 and 101.3 (units unspecified); partial arterial pressure of oxygen was 282.6 (units unspecified) and partial arterial pressure of carbon dioxide 74.9 (units unspecified). On the same day, the patient recovered from febrile seizure. On 27-AUG-2008, the patient's partial arterial pressure of oxygen was 225.0 and 198.7 (units unspecified), and partial arterial pressure of carbon dioxide was 33.3 and 33.5 (units unspecified). On 29-AUG-2008, the patient recovered from respiratory failure. On an unknown date, the patient recovered from pulmonary edema and shock. The relatedness between the events and the suspect therapy was not provided.  The Agency considered the events febrile seizure, respiratory failure, pulmonary edema and shock to be life threatening.
Age: 0.58
Sex: F
Vaccine: RV5, UNK, UNK
Symptoms: Respiratory failure, Shock
Clinical narrative: Febrile Seizure; respiratory failure; pulmonary edema; shock; Information has been downloaded from Regulatory Authority (US-WYE-H05746008).  This spontaneous report was received from a physician regarding a 7-month-old female patient. The patient's current conditions included mild eczema and nasal congestion for 2 to 3 days prior to immunization. The patient's medical history and concomitant medications was not reported.  On 26-AUG-2008, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) at a dose of 1 dosage form (batch/lot number was reported as 0406X, expiry date was not reported) via oral route, for immunization. On the same day, the patient also vaccinated with pneumococcal conj vaccine (crm197) (reported as 'pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein)') at a dose of 1 dosage form (batch/lot number was reported as C926205B, expiry date was not reported) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid at a dose of 1 dosage form (batch/lot number was reported as C2957AA, expiry date was not reported) both via intramuscular route, for immunization. On 26-AUG-2008, the patient experienced febrile seizure, respiratory failure, pulmonary edema and shock. On an unknown date in August 2008, the patient was hospitalized. On 26-AUG-2008, the patient's body temperature was 36.7, 38.1 and 101.3 (units unspecified); partial arterial pressure of oxygen was 282.6 (units unspecified) and partial arterial pressure of carbon dioxide 74.9 (units unspecified). On the same day, the patient recovered from febrile seizure. On 27-AUG-2008, the patient's partial arterial pressure of oxygen was 225.0 and 198.7 (units unspecified), and partial arterial pressure of carbon dioxide was 33.3 and 33.5 (units unspecified). On 29-AUG-2008, the patient recovered from respiratory failure. On an unknown date, the patient recovered from pulmonary edema and shock. The relatedness between the events and the suspect therapy was not provided.  The Agency considered the events febrile seizure, respiratory failure, pulmonary edema and shock to be life threatening.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Injection site warmth, Insomnia
Clinical narrative: 3.5 hrs. after the shot, I could not Raise my Left arm It was in severe pain, swollen, and rash develop on the muscle. This process went on from Oct 23, 19 to Oct 28, 2019. I had immediately went back to the Pharmacy & reported the Next morning. Praise Be to God He restored me, after 5 days of trauma.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Skin tightness
Clinical narrative: 3.5 hrs. after the shot, I could not Raise my Left arm It was in severe pain, swollen, and rash develop on the muscle. This process went on from Oct 23, 19 to Oct 28, 2019. I had immediately went back to the Pharmacy & reported the Next morning. Praise Be to God He restored me, after 5 days of trauma.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: 3.5 hrs. after the shot, I could not Raise my Left arm It was in severe pain, swollen, and rash develop on the muscle. This process went on from Oct 23, 19 to Oct 28, 2019. I had immediately went back to the Pharmacy & reported the Next morning. Praise Be to God He restored me, after 5 days of trauma.
Age: 71.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Pain in extremity
Clinical narrative: Bad pain in her arm; nausea; sick to stomach; but it hurts when she moves her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   In August 2019, the patient received DTP vaccine. On an unknown date, 4 days after receiving DTP vaccine, the patient experienced pain in arm, nausea, upset stomach and pain upon movement. On an unknown date, the outcome of the pain in arm, nausea and upset stomach were not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the pain in arm, nausea, upset stomach and pain upon movement to be related to DTP vaccine.  Additional details were provided as follows: The patient reported that she received a tetanus shot at the pharmacy. She called the pharmacy about the side effects and the pharmacy told her that the vaccine was made by GlaxoSmithKline and she should call the company directly. She received the shot in August. About 4 days after the shot she had bad pain in her arm that has only gotten worse. She did not had pain when her arm was resting, but it hurts when she moves her arm. It only on her left arm where she received the shot.  The patient said that she has nausea and was sick to her stomach from bearing the pain in her arm.  The patient visited her physician and physician recommended an MRI.  The patient said she has already spent over $500 in acupuncture to treat the pain in her arm. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Abdominal discomfort, Acupuncture, Nausea, Pain, Pain in extremity
Clinical narrative: Bad pain in her arm; nausea; sick to stomach; but it hurts when she moves her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   In August 2019, the patient received DTP vaccine. On an unknown date, 4 days after receiving DTP vaccine, the patient experienced pain in arm, nausea, upset stomach and pain upon movement. On an unknown date, the outcome of the pain in arm, nausea and upset stomach were not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the pain in arm, nausea, upset stomach and pain upon movement to be related to DTP vaccine.  Additional details were provided as follows: The patient reported that she received a tetanus shot at the pharmacy. She called the pharmacy about the side effects and the pharmacy told her that the vaccine was made by GlaxoSmithKline and she should call the company directly. She received the shot in August. About 4 days after the shot she had bad pain in her arm that has only gotten worse. She did not had pain when her arm was resting, but it hurts when she moves her arm. It only on her left arm where she received the shot.  The patient said that she has nausea and was sick to her stomach from bearing the pain in her arm.  The patient visited her physician and physician recommended an MRI.  The patient said she has already spent over $500 in acupuncture to treat the pain in her arm. The reporter consented to follow up.
Age: 57.0
Sex: U
Vaccine: FLUR4, FLUR4
Symptoms: Pain, Pain in extremity
Clinical narrative: my left arm is still very sore after getting the flu shot. it hurts to move it in any direction,up,down,sideways,and behind my body.it wakes me up at night when I move my arm to roll over. it hurts to lift,push,pull.i have a very hard time brushing my hair,washing using that arm in the shower,getting dressed and un dressed.its been over 4 weeks and not getting any better.it even hurts to put pressure on it.
Age: 57.0
Sex: U
Vaccine: FLUR4, FLUR4
Symptoms: Loss of personal independence in daily activities, Middle insomnia, Pain, Pain in extremity, Tenderness
Clinical narrative: my left arm is still very sore after getting the flu shot. it hurts to move it in any direction,up,down,sideways,and behind my body.it wakes me up at night when I move my arm to roll over. it hurts to lift,push,pull.i have a very hard time brushing my hair,washing using that arm in the shower,getting dressed and un dressed.its been over 4 weeks and not getting any better.it even hurts to put pressure on it.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The same day of receiving both vaccinations, the patient started having symptoms of swelling, redness and tenderness and by bedtime the pain was so severe that she could not lay on her left side.  By the second day the pain was so bad that she could not let arm hang freely.  Most of upper arm was very red and warm.  Patient stated the redness was even worse on the third day.  Most of the tenderness subsided after 1 week but patient states that arm still has redness after almost 3 weeks (although definitely has gotten better).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever & chills, body aches.  Onset 5 hours after injection, Lasted 24 hours.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Chronic arm pain at injection site, and entire arm weakness and soreness extending down to wrist and up to shoulder. This has lasted since the time of receiving vaccine and has not resolved after 7 weeks.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Patient presented 3 weeks after vaccination stating that she had significant pain in her arm for 3 days after vaccination preventing her from sleeping which then progressed to her being unable to abduct or flex shoulder past 90 degrees due to pain
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: I felt pain in my right arm,  after 10 minutes my right arm turned red and edematous, the area also felt hot.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Pyrexia, Skin warm
Clinical narrative: Woke at 2:00 am with headache, body aches and fever.  Fever continued to climb throughout the day topping out at 101, even taking tylenol and ibuprofen.  These symptoms continued through Monday evening.  Also redness and heat on arm - that continued until Wednesday morning.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored rotateq vaccine administered; This spontaneous report was received from a certified medical assistant referred to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 04-NOV-2019 the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial lot # S005876 expiry date 25-NOV-2019, 1 dosage form, via oral route for prophylaxis (product storage error). The vaccine was stored at a temperature of above 47 degree Fahrenheit (F) (46.9 F) for a time frame of 37 minutes. There was no previous temperature excursion. The digital data logger was involved. The patient did not experience any adverse effects.
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; A 15-year-old patient was administered M-M-R II; A 15-year-old patient was administered Proquad; This spontaneous report was received from a nurse concerning a 15-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 29-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported). On 29-JUL-2019, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number R030797 and expiration date 22-APR-2020 (dosage schedule, anatomical location and route of administration were not reported) (product administered to patient of inappropriate age). On 30-AUG-2019, the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported) (product administered to patient of inappropriate age).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered a dose of improperly stored MMRII; The patient was administered a dose of improperly stored MMRII; no adverse event; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.     On an unknown date, the patient was vaccinated with an improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via subcutaneous route, lot # S005249, expiration date on 20-FEB-2021 (formulation, strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported) that reconstitutued with Merck sterile diluent that did not undergo an excursion. No adverse effect reported.      The administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (46.9 degrees Fahrenheit) for 37 minutes. There was no previous temperature excursion reported. Data logger was involved.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effects; A 2 month-old patient was given a dose of VAQTA/The healtcare worker believed it was time for the patient to receive VAQTA, when it was actually time for the patient to be administered with hepatitis B vaccine; The VAQTA was administered instead of a Hepatitis B vaccine; This spontaneous report was received from a nurse, concerning a 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and past drug allergies or reactions were not reported.    On 21-AUG-2019, the patient was vaccinated with a dose (one dosage form) of hepatitis a vaccine, inactivated (VAQTA) 25/0.5, intramuscularly for prophylaxis (anatomical site of injection was not reported), lot number R034340 with expiration date on 23-NOV-2019, instead of hepatitis B vaccine (wrong product administered/ product administered to patient of inappropriate age) that was confirmed it was not Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).  On 07-NOV-2019, the patient received the correspondence dose of hepatitis B vaccine (strength, route of administration, and anatomical site of injection were not reported), lot number KC57F with expiration date on 04-SEP-2021.   The reporter also stated that it was not product confusion as the healthcare worker who administered the vaccine had believed it was time for the patient to be administered hepatitis a vaccine, inactivated (VAQTA). No adverse effects reported nor product quality complain involved.