chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Iodine allergy
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a female patient of an unspecified age started to receive Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) Formulation: Solution for injection in pre-filled syringe and IODINE, both via an unknown route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had drug allergy to Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and Iodine on an unspecified date. The action taken in response to the event for Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and iodine was unknown. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected. Follow-up (23Nov2016): New information received from same contactable physician includes: New suspect drug (Pneumococcal vaccine) was provided. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported Information: Suspect Pneumococcal vaccine was re-coded.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on 18Oct2018 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction, redness, raised area in her arm and difficulty breathing with outcome of unknown. She has been managing this reaction with BENADRYL and has consulted her physician. The information on the lot number has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case is linked to case 2018SA301024 (Same reporter). This case involves a female patient of unknown age who received an expired dose of vaccine FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to expired vaccine used. It was not reported that if the patient experienced any adverse event 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA301010. This case involves a patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used as patient was given a FLUZONE vaccine from a prefilled syringe, that was also expired. It was unknown if any 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 holder 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.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Approx. 5 hrs after vaccine became slightly dizzy, nauseated took a nap approx. 2 hrs, and reported symptoms resolved.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness and swelling and itching.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed severe swelling and redness of left upper arm associated with severe pain. Was seen in the ER and Diagnosed a week ago with cellulitis from ER. Patient received in the ER IV Clindamycin and monitored for several hours then discharged home on oral antibiotics.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient complained of swelling, red, whelped, and tender upper right arm noticed about 20 hours after vaccine was given. Patient was seen by Nurse Practitioner and directed to apply ice and give BENADRYL.
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects. PREVNAR was not supposed to be given. It should have been MENACTRA.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Pt received a flu vaccine (unknown name) high in the left shoulder. She developed severe pain and restriction in ROM of the shoulder a couple of days later. SXs have persisted, causing her to seek medical treatment for the shoulder pain. Denies any injury to the shoulder prior to this.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: On 10/17/18, one day after vaccination, hives were noticed on child's back. Parents contacted child's primary care provider who advised them to give child BENADRYL. They did this and hives improved. Every day since child broke out in hives at different times and on different parts of body. Each time they gave Benadryl and hives improved. On 10/19/18, child was seen at clinic where they did a strep test with negative results. A dose of steroids was given as well as BENADRYL. Hives continued over weekend. Parents continued to treat with BENADRYL, Aveeno baths and cool packs as needed. Parent called here on 10/22 and was advised to contact PCP again.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Diarrhoea
Clinical narrative: Manufacturer: Sanofi-Pasteur - shot received at Pharmacy on 10/17/18. On 10/18/2018 had severe diarrhea, also felt like I was going to pass out. Continued to have diarrhea until 10/29/2018. Attempted to get relief with IMODIUM; KAOPECTATE finally checked the diarrhea. I will not get the shot next year. I feel the dosage was too strong for me and should be evaluated. Just because I am over 65 does not mean I necessarily need same dosage as everyone else that is 65 and over. Please check into this matter, as I felt very close to death. Thank you!
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: On morning after vaccination, patient woke up with deep pain at site of vaccination (left deltoid) and difficulty raising arm. Level of pain worsened over the next 3 days, then plateaued and has continued since then (3 1/2 weeks now). Patient reported that it seemed a little better today, but is still hurting and unable to lift arm. Has been taking ALEVE and TYLENOL alternately. Advised to follow up with primary care provider.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 10/18/18, morning after vaccination, parents noticed redness at vaccination site, but didn't think much of it because child has had pretty strong localized reactions to other vaccines in the past. Child's skin is also very sensitive to other things. Swelling and warmth at site started later that day at school and progressed throughout the day. After school child was seen by primary care provider, who advised that this was likely an inflammatory response and told parents to give child ibuprofen. Parent reports that ibuprofen helped with inflammation. Symptoms started to disappear on Saturday, 10/20 and were completely gone by Wednesday, 10/24.
Age: 41.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large red area surrounding injection site noticed at 8PM 10/31/2018; swelling, pain, redness, hot-to-touch area below injection site above elbow, noticed 7AM 11/1/2018.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site bruising, Injection site erythema, Lethargy
Clinical narrative: 3 hours following vaccines (5PM), began to feel "chilled", achy. (Temperature not evaluated with thermometer).  8PM- Headache becoming severe, mainly in frontal area. 325 mg TYLENOL taken. Headache, and lethargy continue all 10/26/18, and called off work. Fever (? temp) continued until 1a on 10/27/18. Redness beginning 10/27/18 to injection site- approximately 2"x2", with bruising. Not as severe discomfort at site as with dose #1.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 3 hours following vaccines (5PM), began to feel "chilled", achy. (Temperature not evaluated with thermometer).  8PM- Headache becoming severe, mainly in frontal area. 325 mg TYLENOL taken. Headache, and lethargy continue all 10/26/18, and called off work. Fever (? temp) continued until 1a on 10/27/18. Redness beginning 10/27/18 to injection site- approximately 2"x2", with bruising. Not as severe discomfort at site as with dose #1.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site bruising, Injection site swelling, Lethargy
Clinical narrative: Flu Clinic took place at the company building on Tuesday and Thursday. Patient had gotten vaccine on Tuesday, but came back to location of clinic on Thursday saying she had a reaction to the shot and had missed work the day before. Patients arm was slightly bruised and swollen at and around the injection site. Patient was also complaining of headache and lethargy, but said there were no rashes or other swelling that had occurred. Said she had not gotten the shot in about 10+ years before yesterday. She said the pain and headache was reduced with ibuprofen/TYLENOL, but didn't know if she had a fever. She missed work the day after the shot but had shown up on the next day.
Age: 90.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Patient came into the pharmacy on 11/1/18 with a red painful/inflammed arm following vaccination with pneumovax 23 2 days prior. She said she has an appointment next week with her doctor but I was concerned she may have cellulitis so she is going to call her doctor and get in immediately. I will follow back up with her to determine outcome.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed erythema and swelling approx 7 cm X 3.5 cm in diameter on L thigh surrounding injection site.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia, Seizure
Clinical narrative: The day after receiving the vaccine, mom reports patient had a fever and then a seizure Spoke with physician who had seen the child at a well check up the day before states patient had a febrile seizure no adverse affects.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Swelling face, Swollen tongue, Urticaria
Clinical narrative: 2 days after flu vaccine had anaphylaxis- hives all over body, tongue and facial swelling that with treatment continued to return for 24 hours, then discharged from hospital next day as swelling seemed to stop but continued to have hives for 5 more days.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Nasopharyngitis
Clinical narrative: Child had 2 complex febrile seizures on 10/28/18.  She was admitted to the hospital from 10/28/18 to 10/30/18.  She developed mild cold symptoms.  She had a full recovery.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and intense itching beginning 48 hours after injection and ongoing for greater than 10 days.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: 4 hours after the vaccine the patient called and reported that she had shortness of breath and throat swelling which resolved after taking diphenhydramine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fatigue, Feeling hot
Clinical narrative: Pt received first SHINGRIX dose on 4/27, felt a bit fatigued and had mild symptoms. Almost immediately, arm got swollen at site of injection. Area was painful, red, sore and looked like man's muscle. Patient went home, went straight to bed because was fatigued and a terrible headache started. It was a very odd headache. Usually headache, from one brow to the other but this headache was different. There was lot of pressure atop of head and daggers coming out from base of head. Headache lasted to Monday; did not take any meds. Also had upset stomach; threatening to throw up. That day patient could only tolerate water. Next day was able to tolerate some ginger ale and crackers. On the third day, had chicken soup and threw up. During the weekend, maybe had slight fever/felt hot. Also arm was hot to touch and hurt really bad. Rash was directly under the bandage. Patient did not go anywhere for 3 days since felt weak and dizzy. Slowly, patient finally started to feel better by Monday. The redness at site and heat continued. Had follow-up apt to surgeon to remove stich on 10/18. By then swelling was gone but mark at injection site was still thereit was brownish not red; it was still sore. Told pharmacy about symptoms and was told to report it. Patient slowly got back to activities. Today, has recovered completely.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt received first SHINGRIX dose on 4/27, felt a bit fatigued and had mild symptoms. Almost immediately, arm got swollen at site of injection. Area was painful, red, sore and looked like man's muscle. Patient went home, went straight to bed because was fatigued and a terrible headache started. It was a very odd headache. Usually headache, from one brow to the other but this headache was different. There was lot of pressure atop of head and daggers coming out from base of head. Headache lasted to Monday; did not take any meds. Also had upset stomach; threatening to throw up. That day patient could only tolerate water. Next day was able to tolerate some ginger ale and crackers. On the third day, had chicken soup and threw up. During the weekend, maybe had slight fever/felt hot. Also arm was hot to touch and hurt really bad. Rash was directly under the bandage. Patient did not go anywhere for 3 days since felt weak and dizzy. Slowly, patient finally started to feel better by Monday. The redness at site and heat continued. Had follow-up apt to surgeon to remove stich on 10/18. By then swelling was gone but mark at injection site was still thereit was brownish not red; it was still sore. Told pharmacy about symptoms and was told to report it. Patient slowly got back to activities. Today, has recovered completely.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Pt received first SHINGRIX dose on 4/27, felt a bit fatigued and had mild symptoms. Almost immediately, arm got swollen at site of injection. Area was painful, red, sore and looked like man's muscle. Patient went home, went straight to bed because was fatigued and a terrible headache started. It was a very odd headache. Usually headache, from one brow to the other but this headache was different. There was lot of pressure atop of head and daggers coming out from base of head. Headache lasted to Monday; did not take any meds. Also had upset stomach; threatening to throw up. That day patient could only tolerate water. Next day was able to tolerate some ginger ale and crackers. On the third day, had chicken soup and threw up. During the weekend, maybe had slight fever/felt hot. Also arm was hot to touch and hurt really bad. Rash was directly under the bandage. Patient did not go anywhere for 3 days since felt weak and dizzy. Slowly, patient finally started to feel better by Monday. The redness at site and heat continued. Had follow-up apt to surgeon to remove stich on 10/18. By then swelling was gone but mark at injection site was still thereit was brownish not red; it was still sore. Told pharmacy about symptoms and was told to report it. Patient slowly got back to activities. Today, has recovered completely.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Sore pain in left arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt stated that the afternoon of the day she received the vaccine, pt c/o fever, chills. The next day, area was slightly swelled, area  kept increasingly swelled through out the day. Pt came in to office on day 3 of swelling, area was warm to touch, red, and swelled. Pt was given at visit rx for prednisone 10 mg ; 10 mg tablet, 1 tab(s) orally twice for 2 days then once daily for 3 days. Also pt received  rx for triamcinolone topical 0.5% cream, 1 app applied topically 2 times a day. Advised pt to follow up in 2-3 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Decreased appetite, Dyspnoea, Fatigue, Myalgia
Clinical narrative: I have been sick for 2 weeks with muscle aches from head to waist, hard to breath, chronic cough, tired and no appetite.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Non-cardiac chest pain, Pain in extremity
Clinical narrative: Patient experienced sore muscle/arm and chest. Possible tremors late at night that she believes may have been from the shots. All symptoms have subsided. No medical treatment needed.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Per patient, by the time she went to bed on night of immunization, she had fever and chills along with an upset stomach (that she had attributed to wine earlier in the evening). Her left arm was hot and swollen, and by third day, there was a pattern down to almost her elbow that was red and itchy. She has since recovered. Patient does not have primary doctor, and has not seen a doctor, but notified the pharmacy today about the adverse event when stopping in to check on availability of a different immunization.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Per patient, by the time she went to bed on night of immunization, she had fever and chills along with an upset stomach (that she had attributed to wine earlier in the evening). Her left arm was hot and swollen, and by third day, there was a pattern down to almost her elbow that was red and itchy. She has since recovered. Patient does not have primary doctor, and has not seen a doctor, but notified the pharmacy today about the adverse event when stopping in to check on availability of a different immunization.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called a few weeks later reporting lingering pain in arm/shoulder.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Left arm, redness, measured at 13x4 cm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypersomnia, Urine analysis
Clinical narrative: Severe chills, afebrile for approx. 8 hrs. Slept total of 30 hrs after symptoms started. Asymptomatic  and totally normal after 48 hrs.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Inject was given below the deltoid muscle. Patient has a large, red, itchy, painful, warm bump at injection site. Will advise patient on how to keep clean with topical anesthetics and to treat the pain and inflammation with oral ibuprofen. Will advise patient to seek care at urgent care if it worsens tomorrow.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: Inject was given below the deltoid muscle. Patient has a large, red, itchy, painful, warm bump at injection site. Will advise patient on how to keep clean with topical anesthetics and to treat the pain and inflammation with oral ibuprofen. Will advise patient to seek care at urgent care if it worsens tomorrow.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Genital herpes, Paraesthesia
Clinical narrative: Patient states that within 72 hours of receiving FLUARIX QUAD she began having the initial tingling sensation and sensitivity associated with a genital herpes outbreak. Then 10 days after receiving the vaccination she had a genital herpes outbreak/lesion. She believes it to be caused by the influenza vaccination she received. Patient states that she has not had an outbreak since July 2017 and was under no more stress than what is typical and she believes the cause of the outbreak to be the FLUARIX vaccination she received. Patient states that she still currently has 1 lesion from the outbreak.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Injection site pruritus, Paraesthesia
Clinical narrative: Patient's injection site on left arm started itching 5 minutes after the shot. We waited and watched, then her arm experienced tingling and numbness down her left arm and hand within 10 minutes. The right hand also started experiencing numbness. I administered 5 ml of BENADRYL and waited 30 minutes. She did not feel at the time that she needed paramedics or to visit the doctor. I just checked on the patient 7 hours later to see how she was doing and she is reporting numbness and tingling in her legs. I advised that this could be Guillain-Barre syndrome and advised her to go to urgent care and be checked out for that.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt experienced pain in the left shoulder. Sometimes so bad that he dropped items he was picking up or carrying.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: The patient's mother brought him back to our clinic about 1 hour and 30 minutes after receiving the MMRV vaccine complaining of itching to his ears, hands, and feet. Upon inspection by APRN, patient had mild redness and welting to the skin around his ears, his arm pits, 2 areas on his anterior chest measuring approximately 2mm in size, one small area on his back, and at the injection site of the MMRV. He did not have any swelling to his mouth, lips, tongue, or throat. APRN prescribed patient oral benadryl and advised to go to an emergency room with any swelling in his mouth or throat.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Local reaction, Skin tightness
Clinical narrative: Mild/moderate rash on arm around injection site. 5-6 cm diameter. Mild "tight" feeling of skin. Localized. ----note, the immunization data wasn't yet uploaded to pt's chart---call to get info when/if you needed it, I'm not sure exactly which influenza vaccine was given, but it was influenza. Minor local rxn.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at the site of injection and feels a little warm.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Malaise, Rash
Clinical narrative: Lymphadenopathy and mild rash. Patient had also received influenza vaccine on 10/23/18 and had some malaise.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Extremely sore all over my body for 3 days and continuing.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Petechiae
Clinical narrative: Slowly developed petechiae on arms and abdomen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Patient had redness, swelling and a lump around the injection site. She stated that those symptoms resolved after a day or two, but the lump moved down further to be directly above her elbow.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Pain, swelling, difficulty lifting arm since next morning after shot.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Large area of swelling/redness and lump around the injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Breast pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling/Redness and Pain around injection site that also moved around the whole arm, to her back and right breast.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Swelling/Redness and Pain around injection site that also moved around the whole arm, to her back and right breast.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash papular, Rash pruritic, Skin warm
Clinical narrative: On November 1st, patient reported to pharmacy that she had a burning and painful rash begin on her neck around her shirt collar on the night of October 31st. Despite the discomfort, she could not see any marks or redness at the time. On the morning of November 1st, she observed a rash after taking a hot shower. The rash was red with raised bumps that was warm to the touch. The rash was in the original place of discomfort (left side of front neck), as well as on the back of her neck (slightly on the left side). Both rashes were about 3-4 inches long and were burning and itchy. The patient had not done anything to relieve her discomfort at the time of this report. She had a scheduled doctor's visit on November 2nd and was advised to follow-up with her physician. She was advised to take an OTC pain reliever, use calamine lotion, take oatmeal baths, to wear loose clothing, and to use ice to relieve her discomfort in the meantime.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in arm at and around injection site. The redness and swelling wrapped all the way around patients arm. we have had about 3 other patients have similar reactions with this vaccine with the same lot number.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Redness.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Musculoskeletal stiffness, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: About 5 minutes after being administered the flu shot, patient complained of dizziness. Patient was seated at the time and went unresponsive for a few moments. He did not seem to be breathing and a pulse could not be felt since he became so stiff. Before EMS arrived, the patient became responsive and complained of wanting something to drink. EMS arrived and patient claimed that he was okay. He denied any further treatment from EMS and ended up walking out of the pharmacy on his own with his mother and father. No EPIPEN was administered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chest discomfort, Chills, Dyspnoea, Eye swelling
Clinical narrative: Approximately 2-3 hours after injection I developed swelling in my throat difficulty breathing with wheezing and tightness in chest. Swollen and red eyes, chills, headache and rash on my back. Fever of 99 prior to going to the ER. I received a breathing treatment and oral prednisone along with TYLENOL. Started breathing better and sent home with prescription for oral prednisone and a albuterol inhaler.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Ocular hyperaemia, Pharyngeal oedema, Pyrexia, Rash
Clinical narrative: Approximately 2-3 hours after injection I developed swelling in my throat difficulty breathing with wheezing and tightness in chest. Swollen and red eyes, chills, headache and rash on my back. Fever of 99 prior to going to the ER. I received a breathing treatment and oral prednisone along with TYLENOL. Started breathing better and sent home with prescription for oral prednisone and a albuterol inhaler.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Approximately 2-3 hours after injection I developed swelling in my throat difficulty breathing with wheezing and tightness in chest. Swollen and red eyes, chills, headache and rash on my back. Fever of 99 prior to going to the ER. I received a breathing treatment and oral prednisone along with TYLENOL. Started breathing better and sent home with prescription for oral prednisone and a albuterol inhaler.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Ocular hyperaemia, Ophthalmological examination, Uveitis, Vision blurred
Clinical narrative: Started with red eyes then eye pain with focusing and blurring to vision in first 24 hours then started prednisolone drops for 4 times a day for a week, 3 times a day for one week, then 2 times a day for week. Eye issue appeared to resolve a few days ago until today when vision started to blur again today. Client diagnosed with bilateral uveitis most likely caused by flu vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain
Clinical narrative: "I got the flu shot right after our appointment and a couple of hours later I started feeling achy all over. This feeling gradually got worse and now (8 hours post-vaccination) my entire body hurts badly, especially my legs, spine,and jaw, and I have a splitting headache."
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Malaise, Pyrexia, Tremor
Clinical narrative: Received both vaccines and went home. About a hour later started feeling ill and developed a fever with shakes. Fever persisted overnight but started to resolve the next day. The patient still currently feels under the weather but states that they feel much better and that they are getting better.
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Contusion, Lethargy, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: PT CAME INTO PHARMACY TO REPORT FEVER LETHARGIC MUSCLE PAIN. SHE HAD LARGE HOT RED CIRCLE RASH ANS ABOVE BRUISE AREA WHICH WAS ALSO HOT TO THE TOUCH.
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Skin warm
Clinical narrative: PT CAME INTO PHARMACY TO REPORT FEVER LETHARGIC MUSCLE PAIN. SHE HAD LARGE HOT RED CIRCLE RASH ANS ABOVE BRUISE AREA WHICH WAS ALSO HOT TO THE TOUCH.
Age: 1.08
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient spiked a fever 8 days after her injections. She has had the Hib vaccine before but did not react to it. She had a fever on and off the week of 8/13/18 it would break with TYLENOL. Temperature would range from 101.5-104 this lasted 5 days. A week later she spiked a higher fever 103-104.4 on and off for 3 days.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient requested flu vaccine and PNEUMOVAX 23 (Merck lot#N04564) be administered on 10-17. As per patient request both vaccinations were administered on left arm about 2 in. apart. About 2 days after vaccination patient called pharmacy stating  she had developed cellulitis, Upon speaking with primary care Dr. he informed me that patient had a mild cellulitis on left arm below the deltoid on the inward aspect of the arm. He treated with a course of antibiotics and would follow up with patient. Dr did not specify which antibiotics he had prescribed. He stated his expectation the cellulitis would clear up with this course. We spoke with patient about 2 days after she started antibiotics. As of last contact she was improving and would follow up with primary Dr.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Hot flush
Clinical narrative: PT RECEIVED A FLU VACCINE AND WAS ASKED TO REMAIN IN THE WAIT AREA FOR OBSERVATION. SHORTLY AFTER (2-3 MINUTES), HE GOT UP HAVING A SUDDEN HEAT RUSH FLOWING THROUGH HIS BODY AND ASKING FOR A WET TOWEL TO APPLY BEHIND HIS NECK. HE ATTEMPTED GETTING UP AND HE FELT VERY FAINT LIKE SO HE DECIDED TO CRAWL ON THE FLOOR.  HE SAID HE FELT BETTER AFTER 2 TO 3 MINUTES. AT THE SAME TIME, EMT ARRIVED AND CHECKED HIS BLOOD PRESSURE AND PULSE. ACCORDING TO THE EMT STAFF, HIS BLOOD PRESSURE AND PULSE WERE NORMAL. WE CALLED PATIENT ABOUT 5 HOURS AFTER THE VACCINATION TO CHECK UP ON HIM, AND HIS WIFE SAID HIS IS FINE.
Age: 73.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site irritation, Injection site nerve damage, Injection site scab, Pain in extremity
Clinical narrative: Her R arm is swollen, warm, painful, and erythematous. Approximately 6-7 cm in length, warm to touch, erythematous, clear demarcation of swelling. No fevers or chills, has been feeling well.
Age: 73.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Her R arm is swollen, warm, painful, and erythematous. Approximately 6-7 cm in length, warm to touch, erythematous, clear demarcation of swelling. No fevers or chills, has been feeling well.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm (with the flu shot) turned bright red and slightly swollen 2 days after the vaccine, had patient take some Benadryl.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Urticaria
Clinical narrative: Pt developed a welt the size of a golf ball, she went to dr when it became larger and they diagnosed her with cellulitis of the area and prescribed bactrim ds.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Dysstasia, Feeling cold, Flushing, Immediate post-injection reaction
Clinical narrative: Pt received the flu shot HD in right arm with no reaction, followed by the PNEUMOVAX 23 in Left arm where patient reported feeling flushed and feverish within a minute afterwards. Pt was feverish, cold, clammy and unable to stand, but responsive to loud stimuli. Cold packs utilized, no presence of rash on body, no localized swelling or discoloration at injection site. Paramedics were called and she was evaluated and determined due to risk of syncope that she would be transported.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt received the flu shot HD in right arm with no reaction, followed by the PNEUMOVAX 23 in Left arm where patient reported feeling flushed and feverish within a minute afterwards. Pt was feverish, cold, clammy and unable to stand, but responsive to loud stimuli. Cold packs utilized, no presence of rash on body, no localized swelling or discoloration at injection site. Paramedics were called and she was evaluated and determined due to risk of syncope that she would be transported.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient called the next day complaining about redness on arm where she got the PNEUMOVAX injection. She said the redness is from the site of injection to inside of armpit and down to elbow.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Secondary cellulitis.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Biopsy skin, Musculoskeletal pain, Rash generalised, Wheezing
Clinical narrative: Extremely painful shoulder pain started initially, then broke out in a rash over entire body. Wheezing on day 4, given a steroid injection and oral steroids x 5 days with Benadryl and hydroxyzine as well.   To dermatologist today and given triamcinalone ointment and other ointment for face. Rash continues today. Have been to urgent care 3 times and finally was able to see dermatologist.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised
Clinical narrative: Extremely painful shoulder pain started initially, then broke out in a rash over entire body. Wheezing on day 4, given a steroid injection and oral steroids x 5 days with Benadryl and hydroxyzine as well.   To dermatologist today and given triamcinalone ointment and other ointment for face. Rash continues today. Have been to urgent care 3 times and finally was able to see dermatologist.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at site of injection infrequent, light itching, slightly warmer than surrounding area.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus, Rash
Clinical narrative: Patient stated her left arm red with rash and itch, and has a pimple like on her underarm.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient stated she has had a hard lump at the injection site that has not resolved since her vaccination on 10/11/18. The lump is hard and painful and has only slightly resolved. Pt has tried applying heat, applying BIOFREEZE, and massage the lump. There has been only a slight improvement at the injection site.
Age: 35.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Pain in extremity
Clinical narrative: She said her arm is still sore up till today. It comes and goes but has not gone away yet. She said she has not lost range of motion just a sore arm still.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Very red, hard, and inflamed around injection site.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Chromosome analysis normal, Exposure during pregnancy, Gene mutation identification test positive
Clinical narrative: This is an observational study case, initially received on 19-Oct-2018, concerning a 23-year-old, pregnant female, subject of body mass index: 50.1, weight: 285 pounds and height: 63 inches, enrolled in a prospective observational safety study. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject's obstetrical history included one previous pregnancy, with preterm live birth and no birth defects were reported. The subject's last menstrual period date was 04-Jan-2018. The subject's historical conditions included vaginitis (from 01-Mar-2018 to 05-Mar-2018), Candidiasis, gonorrhoea and vulvovaginitis (unspecified date in Mar-2018). The subject's historical drug included METROGEL for vaginitis, DIFLUCAN for candidiasis, Azithromycin for vulvovaginitis and Ceftriaxone sodium for gonorrhoea. The subject's current condition included sickle cell trait (from 22-Feb-2018), nausea (from 22-Feb-2018), pre-eclampsia (from 15-Mar-2018) and cholelithiasis (from 02-Sep-2018). The subject's concomitant medications included Prenatal vitamins for pregnancy and DICLEGIS for nausea. The subject didn't use tobacco, alcohol or illicit drugs during pregnancy. On 22-Feb-2018, the subject underwent prenatal fibrosis mutation analysis test, spinal muscular atrophy screen test and 24 hour urine test; no major congenital malformation noted. On the same day, Hgb (haemoglobin) electrophoresis test performed showed sickle cell trait, which was considered as major structural or chromosomal congenital malformation. On 01-Mar-2018, the subject underwent prenatal test (ultrasound) which showed no major congenital malformation noted. On 09-May-2018, the prenatal advanced trisomy test, ultrasound test and MSAFP (maternal serum alpha-fetoprotein)/ serum markers performed showed no major congenital malformation noted. The prenatal ultrasound tests were repeated on 14-May-2018, 06-Jun-2018, 05-Sep-2018, 19-Sep-2018, the subject underwent prenatal ultrasound tests and no major congenital malformation noted. On 11-Oct-2018, the pregnant subject (38 week and 5 days of gestation period) was administered Flu vaccine cell subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported). On an unspecified date in 2018, the subject had dysmature placenta. 39 week and one day of gestation period the subject gave live birth to a female baby (singleton) with body weight: 2863 grams, head circumference: 33.7 cm and length: 48.9 cm through Caesarean section. The APGAR (appearance, pulse, grimace, activity, and respiration) score at one minute was 8, at five minutes 9 and no data at 10 minutes. The outcome of the event was not reported. The subject's estimated date of delivery was reported as 21-Oct-2018.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Placental disorder, Ultrasound antenatal screen normal, Urine analysis normal
Clinical narrative: This is an observational study case, initially received on 19-Oct-2018, concerning a 23-year-old, pregnant female, subject of body mass index: 50.1, weight: 285 pounds and height: 63 inches, enrolled in a prospective observational safety study. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject's obstetrical history included one previous pregnancy, with preterm live birth and no birth defects were reported. The subject's last menstrual period date was 04-Jan-2018. The subject's historical conditions included vaginitis (from 01-Mar-2018 to 05-Mar-2018), Candidiasis, gonorrhoea and vulvovaginitis (unspecified date in Mar-2018). The subject's historical drug included METROGEL for vaginitis, DIFLUCAN for candidiasis, Azithromycin for vulvovaginitis and Ceftriaxone sodium for gonorrhoea. The subject's current condition included sickle cell trait (from 22-Feb-2018), nausea (from 22-Feb-2018), pre-eclampsia (from 15-Mar-2018) and cholelithiasis (from 02-Sep-2018). The subject's concomitant medications included Prenatal vitamins for pregnancy and DICLEGIS for nausea. The subject didn't use tobacco, alcohol or illicit drugs during pregnancy. On 22-Feb-2018, the subject underwent prenatal fibrosis mutation analysis test, spinal muscular atrophy screen test and 24 hour urine test; no major congenital malformation noted. On the same day, Hgb (haemoglobin) electrophoresis test performed showed sickle cell trait, which was considered as major structural or chromosomal congenital malformation. On 01-Mar-2018, the subject underwent prenatal test (ultrasound) which showed no major congenital malformation noted. On 09-May-2018, the prenatal advanced trisomy test, ultrasound test and MSAFP (maternal serum alpha-fetoprotein)/ serum markers performed showed no major congenital malformation noted. The prenatal ultrasound tests were repeated on 14-May-2018, 06-Jun-2018, 05-Sep-2018, 19-Sep-2018, the subject underwent prenatal ultrasound tests and no major congenital malformation noted. On 11-Oct-2018, the pregnant subject (38 week and 5 days of gestation period) was administered Flu vaccine cell subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported). On an unspecified date in 2018, the subject had dysmature placenta. 39 week and one day of gestation period the subject gave live birth to a female baby (singleton) with body weight: 2863 grams, head circumference: 33.7 cm and length: 48.9 cm through Caesarean section. The APGAR (appearance, pulse, grimace, activity, and respiration) score at one minute was 8, at five minutes 9 and no data at 10 minutes. The outcome of the event was not reported. The subject's estimated date of delivery was reported as 21-Oct-2018.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphemia, Ear pain, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: After I receive my flu shot I noticed that I started stuttering only for a few hours on October 19, October 22, October 26, and out October 28 I was hospitalized thought I was having mini strokes because the stuttering just got worse along with a stiff neck also where they injected the shot on my left arm everything on my left hand side from my left leg my left arm I had a left pain in my neck I only had pain in my left ear my whole left side of my head.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in extremity, Transient ischaemic attack
Clinical narrative: After I receive my flu shot I noticed that I started stuttering only for a few hours on October 19, October 22, October 26, and out October 28 I was hospitalized thought I was having mini strokes because the stuttering just got worse along with a stiff neck also where they injected the shot on my left arm everything on my left hand side from my left leg my left arm I had a left pain in my neck I only had pain in my left ear my whole left side of my head.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: After receiving an influenza vaccination, patient's significant other reported that patient had anaphylaxis reaction hours after the administration. Patient has a history of receiving influenza vaccinations with no reported problems prior to this occasion.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Generalised erythema, Throat tightness
Clinical narrative: I got the PNEUMOVAX 23 vaccine today and about 5 minutes later got really hot, dizzy, redness covering all of my skin, and throat tightening. No difficulty or breathing at that point, but it felt like someone was trying to strangle me from the inside.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Noticed redness (size of tennis ball) and minor swelling. Does not feel ill or anything.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm soreness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Arm had a large rash 4-5 inches in diameter. Red and hot to touch. Arm sore as well. Pharmacist instructed patient to take BENADRYL and watch site to see if rash spreading to then seek medical attention.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives noted morning after vaccine- Generalized - No increased hives or swelling or redness at injection site. No other symptoms of illness. No facial or lip swelling, no respiratory symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Contusion, Erythema, Pruritus, Tenderness
Clinical narrative: Redness, Tender, itchy, some bruising.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Dysgeusia, Headache, Pain in extremity
Clinical narrative: Chills, fever 102.4, metal taste in mouth, horrible headache, joint ache, L arm very sore.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Chills, fever 102.4, metal taste in mouth, horrible headache, joint ache, L arm very sore.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: C/O tingle/itch on the right arm and right neck after getting vaccine. No rash noted. Small amount of swelling at injection site.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Pain in jaw
Clinical narrative: Patient has previously received flu shots. Approx. 20 min after admin of vaccine experienced chest tightness and jaw pain. Stopped and took BENADRYL. Sent to ER. Decided ER wait was too long.