chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site rash, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at the pharmacy. The patient had rash at injection site which did not itch but it hurts upon touch and it's warm. The patient was not sure if it's common side effect. The patient denied to share information regarding provider.
Sex: F
Vaccine: MEN
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his daughter had a bad reaction and was in the hospital. The reporter also stated that as he wrote this so people should think twice before getting a vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient experienced fever (body temperature: 103 F). It was unknown if the reporter agreed to be followed up. Medical Science Liaison (MSL) would follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Erythema, Fatigue
Clinical narrative: (L) arm pain, swelling, erythema, headache, joint pain all over body, fatigue, generalized weakness, decreased appetite.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm pain, swelling, erythema, headache, joint pain all over body, fatigue, generalized weakness, decreased appetite.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Exposure during pregnancy, Vomiting
Clinical narrative: 19 weeks, 2 days gestation awakening this morning with vomiting and extreme dizziness, unable to retain fluids. Instructed to go to the ER for evaluation of her symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chemotherapy, Herpes zoster, Pain, Pruritus
Clinical narrative: Patient had vaccine 7/27/18 and had KEYTRUDA chemo administered on 8/13/18; Pt developed rash on lower back on 8/16/18; Pt went to see FNP 8/20/18 and reported the rash; Per pt rash was a different location and different symptoms as the usual rash that develops after KEYTRUDA; FNP examined pt and DX was shingles; rash described as blistering per pictures taken by FNP, itchy/painful as described by pt; Pt given valacyclovir RX and picked up 8/21/18 by pt.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had vaccine 7/27/18 and had KEYTRUDA chemo administered on 8/13/18; Pt developed rash on lower back on 8/16/18; Pt went to see FNP 8/20/18 and reported the rash; Per pt rash was a different location and different symptoms as the usual rash that develops after KEYTRUDA; FNP examined pt and DX was shingles; rash described as blistering per pictures taken by FNP, itchy/painful as described by pt; Pt given valacyclovir RX and picked up 8/21/18 by pt.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: About an hour after receiving the vaccine patient's arm became itchy, red, and swollen. Overnight the swelling and pain worsened so the patient went to the pediatrician on 9/10 who diagnosed her with cellulitis. The cellulitis appeared to spread in the evening on 9/10 so the patient with to the ER.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: About an hour after receiving the vaccine patient's arm became itchy, red, and swollen. Overnight the swelling and pain worsened so the patient went to the pediatrician on 9/10 who diagnosed her with cellulitis. The cellulitis appeared to spread in the evening on 9/10 so the patient with to the ER.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Rash papular
Clinical narrative: Patient presents today fussy with red papules all over the body, 1/2 mm to 3 mm in size no pustules and vesicles. Not concentrated on hands and feet.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Cold sweat, Erythema, Feeling cold
Clinical narrative: Shot given. Arm redness and sore. Ice applied. That evening chills started with teeth chattering. Unable to feel warn until overwhelming heat flashes overtaking body. Clammy all over. Then back to chills. Pain all over body as if I had the flu. Unable to sleep deeply with weird dreams. Day 2 thru 6 not as intense but chills and clammy overall off and on for the 5 days. No doctor call but TYLENOL taken to alleviate head ache and soreness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hot flush, Insomnia, Pain, Pain in extremity
Clinical narrative: Shot given. Arm redness and sore. Ice applied. That evening chills started with teeth chattering. Unable to feel warn until overwhelming heat flashes overtaking body. Clammy all over. Then back to chills. Pain all over body as if I had the flu. Unable to sleep deeply with weird dreams. Day 2 thru 6 not as intense but chills and clammy overall off and on for the 5 days. No doctor call but TYLENOL taken to alleviate head ache and soreness.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: 9-10-18 Patient says shoulder pain since shot and "can barely take shirt off. I feel like I got SIRVA from what I read on the internet".
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Peripheral swelling, X-ray limb
Clinical narrative: Chills, arm pain, on 07/25/2018 left hand and fingers started to swell. Between 07/26/2018 -> 07/29/18 swelling and pain in hand.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Pt developed an urticarial rash that developed on the leg in which the PENTACEL was administered. Then the rash appeared within 5-10 minutes and resolved in 5-10 minutes. Subsequently the legs became very red which was likely possible pt was getting a blood draw for unrelated matter. Then the patients redness resolved but had few remaining red spots.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given DTaP instead of Tdap. He had left the office before this was discovered. Message left for parents to call our office. Parent called back same day and reports no adverse event yet.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient experienced redness and swelling at the injection site that spread throughout the entire upper arm. Area was red, swollen and hot to the touch. Slight fever was noted 99.2 and patient experienced chills. Patient saw his PCP and they felt it was infected. Patient was prescribed an antibiotic and steroid to help with the reaction.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Rash, Rash pruritic
Clinical narrative: Fine rash on torso (posterior/anterior) itching. Treatment provided. BENADRYL ELIXIR as directed.
Age: 1.92
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Rash started on thigh within hours of receiving vaccine. Progressed rapidly to torso and face. No resp. sxs. Rash was urticarial.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis, Rash
Clinical narrative: Pt noticed mottled rash on torso. Then spread to face, neck, buttocks and thighs. No itching, no anaphylactic symptoms. 11 days after it started, it is still resolving. Pt took BENADRYL 50mg per the ER, but didn't notice a difference. He didn't try anything else to resolve it.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis, Pallor, Rash erythematous, Rash generalised
Clinical narrative: Pt noticed mottled rash on torso. Then spread to face, neck, buttocks and thighs. No itching, no anaphylactic symptoms. 11 days after it started, it is still resolving. Pt took BENADRYL 50mg per the ER, but didn't notice a difference. He didn't try anything else to resolve it.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: Uncontrollable shivering began at 4:00 a.m. Patient also could not get warm. This continued for 6 hours. After shivering stopped, patient had extreme headache (which required a trip to express care clinic), joint pain, rubbery legs, fatigue, dizziness. Also, the injection site was very swollen and red. 3 days later, he is still unable to work due to fatigue and dizziness (requiring another trip to the physician).
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Headache, Impaired work ability, Injection site erythema, Injection site swelling, Muscular weakness
Clinical narrative: Uncontrollable shivering began at 4:00 a.m. Patient also could not get warm. This continued for 6 hours. After shivering stopped, patient had extreme headache (which required a trip to express care clinic), joint pain, rubbery legs, fatigue, dizziness. Also, the injection site was very swollen and red. 3 days later, he is still unable to work due to fatigue and dizziness (requiring another trip to the physician).
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Spoke with patient. He states he does have significant loss of movement and ROM. Pain has always been there since receiving vaccination however it is progressively worsening. Yesterday he noticed that he was having issues with moving arm and today it is even worse. He is applying heat and taking ibuprofen PRN but that is not doing much.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Pyoderma gangrenosum
Clinical narrative: Developed pyoderma gangrenosum (by biopsy) on the anterior abdomen and posterior back.
Age: 22.0
Sex: M
Vaccine: MENB, MMRV, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 22 year old male was given PROQUAD for second MMR dose and first varicella dose.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Patient experienced shaking and shivering of the entire body as well as extreme achy and tiredness that last about 2 weeks. Several days after the injection she developed a raised, red rash at the injection site. At this time she has recovered fully.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Patient experienced shaking and shivering of the entire body as well as extreme achy and tiredness that last about 2 weeks. Several days after the injection she developed a raised, red rash at the injection site. At this time she has recovered fully.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient care giver complained about severe pain and swelling of whole arm.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: At time of second vaccination, client reported that for several months following vaccination (initial start of symtoms unknown), reported intermittent red and itchy bumps, approximately 5mm in diameter, down same limb as vaccine and then on various spots across body. Client indicated this lasted up until 3 weeks before receiving second vaccine on 9/10/18.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling face
Clinical narrative: Soreness and fever on next day (8/30/2018) followed by swelling on face day after (8/31/18).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 11 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-OCT-2017, the patient received the first GARDASIL 9 lot #N019923, expiry date on 28-APR-2020, for prophylaxis (strength, dose and route of administration were not reported). Then, the patient continued with the GARDASIL 9 series, but it was outside the recommended dosing schedule according with the prescribing information as the second dose was administered on 25-MAY-2018 (lot #N026814, expiry date on 15-JUL-2020, for prophylaxis; strength, dose and route of administration were not reported). On 21-JUN-2018, the patient received the third GARDASIL 9 lot #N026814, expiry date on 15-JUL-2020, for prophylaxis (strength, dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23, lot number: N024717 (expiration date: 06-APR-2019) for prophylaxis (strength, route and dosage schedule were not provided). There was digital data logger involved. The storage characteristics were the following:  Temperature: 9 degrees C to 25 degrees C (9.7C) for 2 hours.  Previous temperature excursion: No. No adverse effects were reported.
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 19-years-old male patient received TRUMENBA, via an unspecified route of administration on 04Sep2018 for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age and gender receive PREVNAR 13, (Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for for pneumonia vaccine. The patient's medical history and concomitant medications were not reported. The patient experienced bad swelling on arm which lasted for a week. It was reported that event took place after use of product. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician (reporting for his wife) via a sales representative. A female patient of an unspecified age received pneumococcal PREVNAR 13, via an unspecified route of administration on an unspecified date, single dose for immunization. The patient medical history was not reported. The patient's concomitant medication includes an unspecified steroid. On an unspecified date, the patient was feeling very sick, fever and chills. The physician said that his wife has been "sick" for a few months and may have also been on steroids during the time she received the vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 (lot number: S74424, expiration date: Dec2019), via an unspecified route of administration on arm on an unspecified date at a single dose for immunization at a pharmacy. The patient's medical history and concomitant medications were not reported. A pharmacist gave a patient pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and patient experienced red swelling on her arm. Outcome of the events vaccination site erythema and vaccination site swelling was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, MNQ, PNC13, RV5
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: Initial solicited report received on 10 August 2018 from an investigator participating in the study. This case involves an 11-week-old male subject who developed congestion and breathing problem during the study participation. The subject's medical history was not reported. The subject's concomitant therapies were not reported. On 23 July 2018, seven days after receiving an intramuscular dose of blinded therapy in the upper right thigh (dose number: 1367126), the subject developed congestion and breathing problem. The subject also received non-investigational products i.e. an intramuscular dose of PENTACEL in the upper left thigh (batch number: C5461AA), an intramuscular dose of PREVNAR 13 in the lower left thigh (batch number: T88778), an oral dose of ROTATEQ vaccine (batch number: N021101) and an intramuscular dose of ENGERIX B in the lower right thigh (batch number: 52X7T) on 16 July 2018. The event appeared after visit 1. On an unspecified date the subject was hospitalized. The event was MAAE. The lab data was not reported. The subject had no corrective treatment. The event congestion and breathing problem was resolved on 09 August 2018. According to the investigator, the event was not related to the study vaccine or trial procedures. Relationship to non-investigational products according to investigator: not reported. Relationship to investigational product according to company: not reportable. Relationship to non-investigational products according to company: not reportable. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Sender's Comments: Follow-up information received on 08 September 2018: A 11-week-old male subject who developed congestion, seven days after receiving a dose of study product. Based on the available information, the sponsor assesses the event as not related to study product or trial procedure, in agreement with the investigator.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (lot no UI998AD and Expiry date not reported) via unknown route in unknown administration site instead of FLUZONE HIGH DOSE on 30-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No AEs have been reported by the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number: UJ00AB and expiry date not reported) instead of FLUZONE QUADRIVALENT on an unknown date. The patient's medical history, previous medications and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No AEs have been reported by the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA251618. This case involves a three-years old patient who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves Adult male patient who received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IMOVAX RABIES lot number not reported. 3 other doses were administered on unknown dates for suspect IMOVAX RABIES. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was reported that patient received doses on day 0, 3, and 7, and is now 1 day late for his day 14 dose. It was unknown whether patient had adverse event. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who experienced patient received vaccine QUADRACEL by SQ route. The patients past medical history included a bleeding disorder. Concomitant medications included MMR on 05-Sep-2018. On 05-Sep-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number, expiry date not reported via subcutaneous route in the posterior arm. It was an actual medication error due to inappropriate route of vaccination. It was reported that patient received QUADRACEL vaccine by SQ route. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reports that within hours of the injection the site became red and painful for multiple days. The site redness then spread down to the elbow and appeared on the right arm as well. He describes it as red and bumpy. He has a prescription for triamcinolone topical that he states he has used along with CALMOSEPTINE topical ointment. Using these products has helped minimally per the patient. At this time he has not shown a pharmacist at pharmacy, but has spoken on the phone with us.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chest discomfort, Decreased appetite, Headache, Injection site pain
Clinical narrative: Recipient of vaccine states approximately 4 hours after vaccine administration she began to have pain at the injection site, could hardly lift arm, began to experience muscle pain throughout entire body along with severe headache. Also states her skin was tender to touch, she had no appetite, and felt a heaviness in her chest having to use her inhaler 3 times in one day. States that prior to this she has only used her inhaler one time in the past year. States she was "pretty much bed ridden" for 24 hours before beginning to feel better.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain of skin
Clinical narrative: Recipient of vaccine states approximately 4 hours after vaccine administration she began to have pain at the injection site, could hardly lift arm, began to experience muscle pain throughout entire body along with severe headache. Also states her skin was tender to touch, she had no appetite, and felt a heaviness in her chest having to use her inhaler 3 times in one day. States that prior to this she has only used her inhaler one time in the past year. States she was "pretty much bed ridden" for 24 hours before beginning to feel better.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dry skin, Skin warm, Swelling face
Clinical narrative: On Friday I received the current flu vaccine. Later in the day my face was hot and over the weekend the skin on my face was very dry and my face had some mild puffiness. Nothing serious, in fact I am not completely sure the puffiness is from the vaccine. But I thought I would report it as that is the only cause of the facial dryness and puffiness that I can think of as a cause.
Age: 85.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient reported to feeling weak and ill two days following vaccinations. She said she had a headache and couldn't get out of bed. Also she said that she got red, patchy areas on her arm below the site of administration and reported some swelling as well. This is patient's second shot and she said that during her first shot she didn't experience any of these side effects.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient experienced widespread redness of the skin from the injection site extending down toward the elbow region. Denies any fever. Area is not warm to the touch. Area of redness is not painful. These symptoms appeared approximately 24 to 48 hours following vaccination .
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Exhaustion, chills, body aches, headache - no stomach issues. Lasted all day, the day after the vaccine. Symptoms gone the following day, except for some tiredness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Swelling, warmth, erythema to left thigh at vaccination site starting 2 days after vaccination. She also developed a "slapped cheek" type rash to her face.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Feeling abnormal
Clinical narrative: I had my second vaccination yesterday of SHINGRIX. Both times I had flu like symptoms. The first time they lasted about 2 days. Chills. Possibly a fever as I sure felt like I did. Weak and tired, no energy. Headache. A little of upset stomach, not bad. I had the shot about 30 hours ago and I started feeling better at about the 24 hour mark. I still feel a bit off, weak and tired, but I am at work at my desk job. I took this morning off.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: I had my second vaccination yesterday of SHINGRIX. Both times I had flu like symptoms. The first time they lasted about 2 days. Chills. Possibly a fever as I sure felt like I did. Weak and tired, no energy. Headache. A little of upset stomach, not bad. I had the shot about 30 hours ago and I started feeling better at about the 24 hour mark. I still feel a bit off, weak and tired, but I am at work at my desk job. I took this morning off.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Erythema, Headache, Malaise, Swelling
Clinical narrative: Patient reported feeling weak and unwell. She said she said was in bed all day and experienced headaches. She got red patches on her left arm below the site of administration of her SHINGRIX vaccine and also reported some swelling.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Insomnia, Middle insomnia
Clinical narrative: Had trouble sleeping due to pain at injection site. Could not roll onto arm without waking up (this happened repeatedly). Woke up with a slight fever, body aches, extreme fatigue. Headache started around 10 AM. Continued all day. Temp is 99.6 at 3:30 PM.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Had trouble sleeping due to pain at injection site. Could not roll onto arm without waking up (this happened repeatedly). Woke up with a slight fever, body aches, extreme fatigue. Headache started around 10 AM. Continued all day. Temp is 99.6 at 3:30 PM.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient states she noticed the next day left arm large swelling, warm to touch.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: At the injection site it is red and bruised which looks like a normal injection site reaction. But about 4-5 inches below the injection site on the left arm is a red thick band of skin (almost a rash) that is red and warm to the touch.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Impaired work ability, Influenza like illness, Injection site pain
Clinical narrative: Significant and pronounced flu-like symptoms, fever (100.9), weakness, aches/pains in joints and muscles throughout body (in addition to injection site). Could not continue work after 1/2 day and went home sick.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Significant and pronounced flu-like symptoms, fever (100.9), weakness, aches/pains in joints and muscles throughout body (in addition to injection site). Could not continue work after 1/2 day and went home sick.
Sex: F
Vaccine: HPV9
Symptoms: Hypotension, Nausea, Pallor
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 13-year-old female patient. The patient's concurrent condition included unspecified allergies (hypersensitivity). On 25-AUG-2018, the patient was vaccinated with her second dose of GARDASIL 9 (Lot # and expiry date was not reported) for prophylaxis. The patient's concomitant therapies included BENADRYL. On 25-AUG-2018, the patient became pale, had lower blood pressure and felt like she was going to throw up. The patient received treatment with oxygen for the events and was transported to an unspecified hospital. The outcome of pallor, hypotension and nausea were unknown. The medical assistant also reported that the patient did not pass out or throw up and according to the patient's mother the patient had not eaten anything that day and took an unspecified dose of BENADRYL for unspecified allergies that morning. The reporting medical assistant did not provide the causality assessment for the events. There was no product quality complaint involved. Upon internal review, the events pallor, hypotension and nausea was determined to be medically significant due to oxygen therapy.
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to an unspecified 18 year old patient. The patient's medical history included vaccination with the first and second doses of GARDASIL 9 on 05-JUN-2018 and 17-JUL-218, respectively. No other information was provided regarding the patient's concurrent conditions, drug reaction/allergies or concomitant medications. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The Nurse reported that there might had been an administration error with RECOMBIVAX HB. No adverse effects were reported.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Culture negative, Eyelid pain, Hyperhidrosis, Injection site irritation
Clinical narrative: This spontaneous report was received from an employee on 22JUN2018, 25JUN2018, 26JUN2018 and 27JUN2018. On 21JUN2018 the Environmental Health and Safety manager at a manufacturing plant reported an incident regarding a 41-year-old male who was immunized with ACAM2000 and experienced satellite lesions with cellulitis and eyelid soreness and swelling following ACAM2000 vaccination. On 11JUN2018, the male received vaccination with ACAM2000 at an occupational health clinic. On 16JUN2018 (day 5) the male spent the day fishing. He noted that the vaccination site bandage was filled with sweat; he removed the bandage and the 'pock ripped'. On 18JUN2018 (day 7) he returned for a post vaccination appointment with the physician. No issues were noted with the vaccination site. There was notable irritation of the skin where the bandage adhesive was in contact with the skin. On 19JUN2018 (day 8), the male noted small bumps around the vaccination site. On 20JUN2018 (day 9), the small bumps had escalated to small pocks. At that time he experienced discomfort of the lymph nodes under his arm. He reported the symptoms to his employer, and was told to follow up with the Occupational health clinic who had administered the vaccine. The patient did not follow up with health care at that time despite recommendations. On 21JUN2018 (day 10), he reported the issue to his employer's safety office. He was immediately sent to the Occupational health clinic for re-evaluation. At that time the area was re-dressed with teflex tape and he was prescribed KEFLEX and NAPROSYN. On 22JUN2018 (day 11), he consulted with the manufacturing facility safety officer. At that time, he was noted to have swollen and sore eyelids. The male reported that the bandage of the vaccination site had become loose. He also reported that he had been residing at a motel, and the bedding had been exposed to leaking bandage. He was sent back to the administering physician who sent him for follow up with an ear and eye specialist. At the ear and eye specialist, an eye culture was performed; the result was subsequently negative. He was prescribed antiviral drops as a precautionary measure. That evening he reported that he felt better and his eyes were fine. The administering physician reported the events to the local health department and CDC. Additional information received on 03JUL2018. The patient returned to work without further issues; all symptoms had resolved. Further information is not anticipated.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Lymph node pain, Rash pustular, Swelling of eyelid, Vaccination complication, Vaccination site rash
Clinical narrative: This spontaneous report was received from an employee on 22JUN2018, 25JUN2018, 26JUN2018 and 27JUN2018. On 21JUN2018 the Environmental Health and Safety manager at a manufacturing plant reported an incident regarding a 41-year-old male who was immunized with ACAM2000 and experienced satellite lesions with cellulitis and eyelid soreness and swelling following ACAM2000 vaccination. On 11JUN2018, the male received vaccination with ACAM2000 at an occupational health clinic. On 16JUN2018 (day 5) the male spent the day fishing. He noted that the vaccination site bandage was filled with sweat; he removed the bandage and the 'pock ripped'. On 18JUN2018 (day 7) he returned for a post vaccination appointment with the physician. No issues were noted with the vaccination site. There was notable irritation of the skin where the bandage adhesive was in contact with the skin. On 19JUN2018 (day 8), the male noted small bumps around the vaccination site. On 20JUN2018 (day 9), the small bumps had escalated to small pocks. At that time he experienced discomfort of the lymph nodes under his arm. He reported the symptoms to his employer, and was told to follow up with the Occupational health clinic who had administered the vaccine. The patient did not follow up with health care at that time despite recommendations. On 21JUN2018 (day 10), he reported the issue to his employer's safety office. He was immediately sent to the Occupational health clinic for re-evaluation. At that time the area was re-dressed with teflex tape and he was prescribed KEFLEX and NAPROSYN. On 22JUN2018 (day 11), he consulted with the manufacturing facility safety officer. At that time, he was noted to have swollen and sore eyelids. The male reported that the bandage of the vaccination site had become loose. He also reported that he had been residing at a motel, and the bedding had been exposed to leaking bandage. He was sent back to the administering physician who sent him for follow up with an ear and eye specialist. At the ear and eye specialist, an eye culture was performed; the result was subsequently negative. He was prescribed antiviral drops as a precautionary measure. That evening he reported that he felt better and his eyes were fine. The administering physician reported the events to the local health department and CDC. Additional information received on 03JUL2018. The patient returned to work without further issues; all symptoms had resolved. Further information is not anticipated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Head banging, Immediate post-injection reaction, Neurological examination normal
Clinical narrative: Dizziness and headache immediately following the vaccine administration, and persistent dizziness the next day. Seen back, and PE was normal. Normal neurologic exam.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: Patient reports sudden onset sore throat/ itchiness that occurred several hours after he received the vaccine and around the same time his wife had same symptom and she had received vaccine as well. He didn't take anything to alleviate symptoms and they went away on their own a few mins to hour later.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Started Left upper arm cellulitis = started on KEFLEX on 09/07. Now has cellulitis on left lower arm = antibiotic changed to BACTRIM 09/11 to cover possible MRSA. The reaction could possibly be due to a bug bite (incidental).
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Oropharyngeal pain, Pruritus
Clinical narrative: Patient reports sudden onset sore throat/ itching a few hours after receiving vaccine. She took an allergy medicine (name not given) and symptoms went away in a few mins-hour. Husband also had similar symptoms around the same time and he had received same vaccine as well.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Headache, Neck pain, Pain in extremity, Swelling face
Clinical narrative: Headache, fatigue, pain in right arm extending into neck, mild right-sided facial swelling. Treated with TYLENOL/ibuprofen and BENADRYL.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Insomnia, Pain, Pain in extremity
Clinical narrative: I started experiencing immense pain throughout my entire body. I had difficulty walking because I  was in so much pain. I could not sleep during most of the night because I was in so much pain.  This morning by about 10:00 am the pain had subsided quite a bit and I was able to get up and eat a slice of toast but immediately fell back to sleep. About 2:00 pm I was able to take a shower and my right arm is still a little sore but I feel like I am getting back to normal. My brain seemed foggy to me last night and this morning but I am back to normal now.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling cold, Muscular weakness, Myalgia
Clinical narrative: Patient experienced a lot of chills, muscle pain, and weakness overnight after the vaccination. Was very tired the next day and was still experiencing a lot of muscle weakness throughout the day.  Patient did not report fever and is slowly feeling better as the day progressed (9/11/18).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Pt was given TRUMENBA instead of BEXSERO.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cough, Dizziness, Immediate post-injection reaction, Nausea, Pain
Clinical narrative: Patient immediately felt pain, nausea, dizziness, coughing and fast breathing. Skin color turned pale.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pallor, Respiratory rate increased
Clinical narrative: Patient immediately felt pain, nausea, dizziness, coughing and fast breathing. Skin color turned pale.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pharyngeal oedema, Weight decreased
Clinical narrative: Coughing, beginning next day. Partial throat swelling - only able to eat soup. Weight loss to date - 19 lbs.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Tongue pruritus, Urticaria
Clinical narrative: Hives. Rash from head to toe. Itchy Tongue. BENADRYL 50mg PO. Pt sent to ED for further evaluation.
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction noted.
Age: 65.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site pain, Rash macular, Skin reaction, Urticaria
Clinical narrative: Pt experienced a patch of raised, blotchy, red welts, extreme soreness and extreme tenderness to the touch on the right deltoid region of administration. This started the evening of the shot and continued until at least 2 days post-administration when patient reported it to me. Pt also experienced severe side effects similar to this but worse after 1st dose was given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Fatigue, Feeling hot, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Symptoms started around 10pm the day patient received the shot. Started off with an overall feeling of being over heated and clammy skin. Patient reports redness and swelling at the injection site that continued to spread over the next 3 days. (Patient has picture of this on her phone as well). Also had a home thermometer that showed a fever greater than 100 degrees for 2 days.  Patient said she felt really ill and tired, barely got out of bed all weekend. Additionally reports trouble moving arm and numbness in her hand of the arm that received the shot. All symtoms listed in the VIS patient says she experienced besides the swelling of the throat and the nausea.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Mobility decreased, Pyrexia
Clinical narrative: Symptoms started around 10pm the day patient received the shot. Started off with an overall feeling of being over heated and clammy skin. Patient reports redness and swelling at the injection site that continued to spread over the next 3 days. (Patient has picture of this on her phone as well). Also had a home thermometer that showed a fever greater than 100 degrees for 2 days.  Patient said she felt really ill and tired, barely got out of bed all weekend. Additionally reports trouble moving arm and numbness in her hand of the arm that received the shot. All symtoms listed in the VIS patient says she experienced besides the swelling of the throat and the nausea.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Dizziness, fever (100 degrees), malaise, stiff back and arm, headache especially through the eyes, lack of appetite.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Dizziness, fever (100 degrees), malaise, stiff back and arm, headache especially through the eyes, lack of appetite.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Mobility decreased, Neck pain, Pain, Product administered at inappropriate site
Clinical narrative: Pt complained of immediate pain following the im injection. Pain got worse during the night (9/10 pain scale) and was spreading to the neck. Pain was 6/10 after APAP treatment but stated shoulder is "immobilized". Patient mentioned that the injection site was "surprisingly high" and wanted to go to the ER for pain management and imaging. Injection site was inspected by pharmacist and found that it was given high on the shoulder- about 1.5cm from the pivot point and off center towards the back of the arm. Pt went to the urgent care the following day (9/8/18) and received a prednisone prescription.  On 9/10/18, I called to follow up with patient and she stated that the pain was getting somewhat better with the prednisone, but that her pain is still very significant and her mobility is restricted. She is icing the area and resting. Pt will follow up with her primary care physician after the completion of prednisone or if her condition worsens.