chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There is no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 2014, the patient was treated by a physician at a family practice center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On 18th October 2018, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: At 14:00, the patient received SHINGRIX. The patient said that 3 to 4 hours after receiving SHINGRIX, his injection site was a little bit sore. During the conversation the patient said that he had the flu injection recently and experienced event (refer case US2018GSK206938). This case has been linked with US2018190930 (patient's wife) by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL Tetra (2018-2019 season) for prophylaxis. On an unknown date, the patient received FLULAVAL Tetra 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL Tetra 2018-2019 season, the patient experienced influenza-like symptoms and injection site stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site stinging to be related to FLULAVAL Tetra 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced stinging at the time of injection and had flu like symptoms which lasted for 2 to 3 days. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received flu injection recently from the time of reporting. He did not know the brand of the vaccine, but the site of injection after that flu vaccine is also sore. For tolerance to SHINGRIX, refer case US2018190928. This case is also linked to case US2018190930 (wife's case), reported by same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chest X-ray normal, Electrocardiogram normal, Injection site paraesthesia, Photosensitivity reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of photosensitive rash in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included AUGMENTIN with an associated reaction of nonspecific reaction (received year before the time of reporting). Concomitant products included SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced photosensitive rash, erythromacular rash and injection site tingling. On an unknown date, the outcome of the photosensitive rash, erythromacular rash and injection site tingling were unknown. It was unknown if the reporter considered the photosensitive rash, erythromacular rash and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received their 1st dose of SHINGRIX in May 2018, and their second injection in late August 2018. About 3 weeks before the time of reporting, the patient began to experience a sunburn like rash on the side of the torso. The patient also experienced tingling at the site. The day before reporting, the patient reported seeing small rash at the torso site of the sunburn described as dot like in appearance. The patient was seen by their physician who did an EKG, chest X-ray, and blood work which was unremarkable. The reporter given consent to follow up. This case has been identified as duplicate of case US2018199619 which is going to be deleted from Agency core and this case would remain as case of record.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of photosensitive rash in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included AUGMENTIN with an associated reaction of nonspecific reaction (received year before the time of reporting). Concomitant products included SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced photosensitive rash, erythromacular rash and injection site tingling. On an unknown date, the outcome of the photosensitive rash, erythromacular rash and injection site tingling were unknown. It was unknown if the reporter considered the photosensitive rash, erythromacular rash and injection site tingling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received their 1st dose of SHINGRIX in May 2018, and their second injection in late August 2018. About 3 weeks before the time of reporting, the patient began to experience a sunburn like rash on the side of the torso. The patient also experienced tingling at the site. The day before reporting, the patient reported seeing small rash at the torso site of the sunburn described as dot like in appearance. The patient was seen by their physician who did an EKG, chest X-ray, and blood work which was unremarkable. The reporter given consent to follow up. This case has been identified as duplicate of case US2018199619 which is going to be deleted from Agency core and this case would remain as case of record.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced diarrhea and malaise. On an unknown date, the outcome of the diarrhea and malaise were recovered/resolved. It was unknown if the reporter considered the diarrhea and malaise to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The caller reported that 1 to 2 days after receiving SHINGRIX, the patient experienced diarrhea and malaise that resolved 5 to 6 days later.
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling on arm after receiving TRUMENBA. He did not require further treatment. The outcome of the event was unknown.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA313488 (same patient and same reporter). This case involves a 9 years old male patient who was vaccinated with TENIVAC instead of ADACEL (lot number: U5882AA, expiry date: 08 March 2020) in the left arm on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at this visit. It was also a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. 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.
Age: 3.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old male patient who was vaccinated with a 0.5 ml dose of vaccine FLUBLOK QIV (lot QFAA1807 and Exp. Date 29-JUL-2019) via intramuscular route in the right deltoid on 26-Sep-2018. The patient's past medical history was not reported. No other meds or immunizations were given. At the time of the event, the patient had ongoing Food allergy (he is allergic to egg white). It was an actual medication error due to inappropriate age at vaccine administration. It was reported that, he was given this vaccine because he is allergic to egg white. No information reported whether patient had any adverse event. 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: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 32 years old female patient who was exposed to vaccine FLUBLOK QIV while she was pregnant. Data regarding this pregnancy was received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, concomitant medication and family history were not provided. Information about the patient's previous pregnancy/ies was not reported. Notes- the patient has a sensitivity to Neomycin. On 09-Nov-2018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1827, expiry date 30-jun-2019 via unknown route in unknown administration site. On 09-Nov-2018, the patient received a FLUBLOK QUADRIVALENT shot while she was pregnant, the consumer was pregnant before taking the flu shot. Lab data was not provided. Final diagnosis gave a FLUBLOK QUADRIVALENT shot to a pregnant lady, the consumer was pregnant before taking the flu shot. It was unknown whether patient experienced any adverse reaction after the injection. The pregnancy outcome was not reported. List of documents held by sender- none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302269, 2018SA313505 and 2018SA302120. This case involves a child patient who was vaccinated with 0.5 ml IPOL (batch number P1A251M, expiration date 02-May-2020) via intramuscular route in left thigh on 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was an actual medication error due to incorrect product storage. It was reported that an open IPOL was administered following 2 excursions. The patient had no 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 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: 0.5
Sex: M
Vaccine: HEP, IPV, PNC13, RVX
Symptoms: Product storage error
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302269, 2018SA313496 and 2018SA302120. This case involves child patient who was vaccinated with 0.5 ml IPOL (batch number, expiration date was not reported) via intramuscular route in right thigh on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PREVNAR 13 and HEPATITIS B VACCINE for Immunisation. It was an actual medication error due to incorrect product storage. It was reported that an open IPOL was administered following 2 excursions. It was unknown whether the patient had any 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 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: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient of unknown age who received 5th dose of PENTACEL (lot C5437AA) via unknown route in the left thigh on 18-Jul-2018. On the same day, the patient also received a dose of vaccine HEPATITIS A not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in the right thigh. It was reported that the patient had received her 4th dose of PENTACEL on 17-Jan-2018 at the same practice. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if patients had any adverse event. 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: F
Vaccine: TD, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves approximately 35 years old female patient for whom receive ADACEL after receiving TENIVAC inadvertently was reported, while she received vaccines ADACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant meidctaion and family history were not provided. On 08-Nov-2018, the patient received a 0.5 ml dose  of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via intramuscular route in the right arm. On 08-Nov-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. The patient receive ADACEL after receiving TENIVAC inadvertently (extra dose administered) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Final diagnosis was receive ADACEL after receiving TENIVAC inadvertently. It was an actual medication error due to extra dose administered. It was not reported that if any adverse event occurred or not. Outcome of event was not applicable. 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.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Per pt's 11/15/18 follow-up e-mail: 10/05/2018 @ 2pm the pt states her left arm hurt & worsened into the evening. By 11/09/2018 discomfort limited ROM & she began icing left deltoid area & taking 800mg ibuprofen every 4 hours which reduced the pain so that she could manage her office setting work obligations. The brief exam performed 11/13/18 outside of clinic (while pt remained at her work station where we unexpectedly met) exhibited no palpable left deltoid abscess nor change in color of injection site or surrounding area. Lymph: LUE lymph neg. by palpation & inspection. MSK: AROM LUE possible but performed with statement of discomfort & admits that she could not perform left shoulder motion without ibuprofen 800mg on-board. PV: Neg LUE peripheral edema. Integumentary: warm, dry with tanning bed color variations but without local redness nor swelling at site or near site. Neuro: Denies LUE sx of neuropathy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: The location of her arm is felt warm and also red and swollen. Pt has been advised to take some ibuprofen in order to keep the swelling goes down.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain to L arm/shoulder since receiving flu vaccine on 10.23.18. Per pt, she was told by PCP she may have nerve damage.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphonia, Dyspnoea, Oral pain
Clinical narrative: At first my throat began to feel like it was getting a very sore throat and I became hoarse and was coughing, I was having a slight problem breathing well. I could breathe but it was uncomfortable. I then began to run a fever and decided just to go to bed with chills and fever this was around 7:45 pm. Around midnight I woke up and realized my tongue was swollen. Never having experienced this before I got up and looked in mirror and took a couple pictures. I considered going to emergency but I could breathe so I opted not to go to emergency. When I woke in the morning my tongue was still slightly swollen and the underside of my tongue was tender and swollen. Eventually this went away - mouth remained sore for several days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Swollen tongue
Clinical narrative: At first my throat began to feel like it was getting a very sore throat and I became hoarse and was coughing, I was having a slight problem breathing well. I could breathe but it was uncomfortable. I then began to run a fever and decided just to go to bed with chills and fever this was around 7:45 pm. Around midnight I woke up and realized my tongue was swollen. Never having experienced this before I got up and looked in mirror and took a couple pictures. I considered going to emergency but I could breathe so I opted not to go to emergency. When I woke in the morning my tongue was still slightly swollen and the underside of my tongue was tender and swollen. Eventually this went away - mouth remained sore for several days.
Age: 0.17
Sex: M
Vaccine: HIBV, IPV
Symptoms: Rash erythematous, Rash generalised, Rash papular
Clinical narrative: Very fine dense pink pinpoint papular rash scattered over most of the body.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 3cm x 4.5cm erythematous irregularly shaped area on the left lateral humerus and a smaller circular area noted proximally, both areas firm; no fluctuance or warmth.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Confusional state, Immediate post-injection reaction, Loss of consciousness, Seizure, Syncope
Clinical narrative: Pt. was receiving multiple vaccines at the time of administration. Had not eaten breakfast. Immediately after receiving 2nd vaccination patient had an episode of syncope with loss of consciousness followed by convulsions that lasted approximately 30 seconds and followed by short term confusion. Reported feeling like she was in a cartoon. Pt. stayed in clinic for additional 15 minutes given apple juice, crackers, and chocolate afterwards and VS were stable before leaving clinic. LPN
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate pain upon injection. Continued pain for 3 weeks. Some improvement but pain upon movement. Severe pain with specific movements. Cannot do normal activities without pain. Having pain when lifting arm above head, swimming and lifting weights.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal pain, Neck pain, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, arm/neck/shoulder pain, injection site feels hot to the touch, and fever (currently 100.3).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient had redness and soreness in arm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Pt has fever and body aches took a BENADRYL slept that night felt better next day still had headache, body ache and tired.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Dyskinesia, Fall, Musculoskeletal stiffness, Seizure like phenomena, Syncope
Clinical narrative: Just minutes after receiving the vaccine the patient fainted, fell to the floor, and had very slight seizing like symptoms with arms stiff and jolting. He was able to respond when his mother called his name, but once he came to he had no recollection of that time.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Just minutes after receiving the vaccine the patient fainted, fell to the floor, and had very slight seizing like symptoms with arms stiff and jolting. He was able to respond when his mother called his name, but once he came to he had no recollection of that time.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: Second Shingles Shot--night of shot, could not sleep on that side, next day felt very achy all over, did not want to move. Felt like I was in slow motion, arm has large red circle at injection site. Very itchy. No extra treatment other than TYLENOL. Today--still red, swollen, sore, itchy.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: Second Shingles Shot--night of shot, could not sleep on that side, next day felt very achy all over, did not want to move. Felt like I was in slow motion, arm has large red circle at injection site. Very itchy. No extra treatment other than TYLENOL. Today--still red, swollen, sore, itchy.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Employee received the flu vaccine on 10/08/2018. On 10/10/2018, employee noticed an itching rash to right upper arm where injection was given. Employee stated rash was from the top of his arm down to his elbow. He was seen in Employee Health on 10/17/2018 and at that time there was a reddened raised area, approximately one inch in diameter, noted to the right upper arm. Employee complained of itching and stated he had not had any pain or fever. He was sent to Dr. and he advised employee to take ZYRTEC OTC.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Headache within 30 minutes after vaccine that has persisted for almost 24 hours. Headaches are usually associated with the intranasal vaccine not the shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient is having tingling in her face.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh localized redness, with slight swelling, right thigh slight redness no swelling. Patient seen and evaluated by Dr. Diphenhydramine 12.5/5ml given for treatment.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Headache, Tunnel vision
Clinical narrative: Employee received the flu vaccine on 10/19/2018 and the next day had a headache to the back of head. Employee was seen in Employee Health on 10/30/2018 where she complained that she had a headache every day since receiving the vaccine, the pain was dull and located to the back of head, and complained of a pulling sensation to her eyes. She stated the headache was so bad on 10/29/2018 that it caused tunnel vision when turning her head to the left. She was seen by Dr. and he ordered FLEXERIL 10mg PO at bedtime PRN. On 11/13/2018, employee returned to Dr. complaining that she continued to have headaches every day since receiving the vaccine. Dr. ordered ROBAXIN 750mg PO Q6H PRN and a MEDROL Dose Pack taper.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pruritus, Rash vesicular
Clinical narrative: Initially itching of arms and scalp then later cold sores on or about 10-15-2018. Then long resolution of some sores but then new ones appeared (vesicular). MD contacted 11/15/2018. A prescription on Acyclovir was started on 11/15/18.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Two months after receiving the first dose of SHINGRIX, I broke out with Shingles. Couldn't get in that day to see my doctor, so I went to a local quick care to have the rash diagnosed and to get a prescription for Acyclovir. The anti virus medication seems to be working and the rash is clearing . In the eight weeks between the vaccine and the outbreak, I had a Flu shot and a tetanus shot. I had a fairly severe case of Shingles in 1965 when I was 15 years old. I also had the ZOSTAVAX shot in 2016.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Influenza like illness, Vision blurred
Clinical narrative: DIZZINES AND FLU LIKE SYMPTOMS THAT SUBSIDED AFTER 24 HOURS. BUT BLURRED VISION WAS SEVERE AND WAS STILL A PROBLEM 3 DAYS AFTER VACCINATION.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Swelling face, Urticaria
Clinical narrative: Swelling of face, hives, start of anaphylactic reaction started 2 hours later. Taken to urgent care and treated patient issues were resolved and sent home with rescue EPIPEN for future.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Vomiting
Clinical narrative: Vomiting starting 6:30 AM morning after immunization and fatigue.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Erythema, warmth, mild edema, pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient last seen 10/30 for WCC, was given KINRIX in left deltoid region, MMRV was given in the right deltoid. As per mom after 24-48 hours she noticed the arm start to swell and feel warm, she also noticed blister like lesions last night. Deny: fevers, vomiting, pruritus, discharge. Patient states her arm hurts when it is touched. Tolerating PO with normal UOP. Diagnosed with Cellulitis of arm (disorder) - Given swelling and heat will treat with course of abx for presumed cellulitis. Rx KEFLEX 50mg/kg Q6 hours x 10 days. ER precautions discussed in detail. RTC prn or for f/u in 2 week.
Age: 74.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Stabbing pain in arm, not able to lift or move arm well for over 3 days symptoms started night of injection. On day three started treating symptoms with ice pack and TYLENOL. Patient after a few hours had minor relief from pain but is planning to contact primary care provider within 24 hours (day 4) if symptoms do not rapidly improve.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The injection site was red, swollen, and painful to the touch. An MD gave a prescription antibiotic in case it was cellulitis.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Influenza like illness, Pericardial effusion
Clinical narrative: PATIENT CLAIMS 2 DAYS AFTER RECIEVING THE VACCINE SHE HAD FLU LIKE SYMPTOMS WHICH GOT WORSE OVER THE NEXT 24 HOURS. SHE SAYS SHE ENDED IN THE HOSPITAL WITH CHEST PAIN AND WAS EVENTUALLY DIAGNOSED WITH A PERICARDIAL EFFUSION WHICH HER MEDICAL PROVIDERS THINK/WERE CONVINCED WAS QUITE SUDDEN AND SUSPECT WAS DUE TO THE SHINGRIX VACCINE ADMINISTERED TO HER.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Flu & Pneumoccacol vacines lt arm. Pain developed in arm during day Flu like symptoms that night for two days. Today (11/15/2018) arm remains sore, headache. Reported to the RN that he felt better today and did go to work.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Muscular weakness, Pain, Pain in extremity
Clinical narrative: As soon as I looked down at my left arm after the nurse had injected the flu shot I notice the injection site was low. The injection site was in the middle of my arm rather than closer to my shoulder like it had been in years past. My left arm felt more sore instantly after the flu injection and to this day it continues to be in pain. I have weakness in my left arm that limits my day to day activities. I experience weakness and throbbing pain in my left arm all through the day and night.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: As soon as I looked down at my left arm after the nurse had injected the flu shot I notice the injection site was low. The injection site was in the middle of my arm rather than closer to my shoulder like it had been in years past. My left arm felt more sore instantly after the flu injection and to this day it continues to be in pain. I have weakness in my left arm that limits my day to day activities. I experience weakness and throbbing pain in my left arm all through the day and night.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site warmth, Similar reaction on previous exposure to drug, Skin mass
Clinical narrative: On 10/19 he got immunization on left leg (PCV, DTAP, HIB) and per mom it was red and warm the next day. It cleared up over time, Never had fever, However there is a small hard lump under the skin, No other concern, Per mom he had a similar reaction on another pervious and had gone to ER. This time no clinical visit was done.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: Arm redness-giant circle on arm. Numbness, tingling difficulty breathing, muscle weakness, difficulty walking: 2 days after shot. Lasted for 24 hours. 3 days later had laryngitis for 5 days. Fatigue continues.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Gait disturbance, Hypoaesthesia, Laryngitis, Muscular weakness
Clinical narrative: Arm redness-giant circle on arm. Numbness, tingling difficulty breathing, muscle weakness, difficulty walking: 2 days after shot. Lasted for 24 hours. 3 days later had laryngitis for 5 days. Fatigue continues.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Arm redness-giant circle on arm. Numbness, tingling difficulty breathing, muscle weakness, difficulty walking: 2 days after shot. Lasted for 24 hours. 3 days later had laryngitis for 5 days. Fatigue continues.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Local reaction, Rash generalised, Vaccination complication, Viral rash
Clinical narrative: Complication of immunization (disorder). I think two problems: Localized reaction to Hep A. Generalized rash; looks like a viral exanthema. It's possible that it was after MMRV. She does not looks 'sick' or 'septic. --AUGMENTIN po; -- if any concern or not getting better then go to ER ASAP; F/U in 3 days.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Noticed rash left upper arm (deltoid) within 4 hours after injection. By 11 PM rash had extended to both arms, chest and abdomen. And legs. I have seen 3 providers, been on 3 prednisone tapers, CLARITIN and PEPCID. Rash waxes and wanes but gets worse if not on antihistamines.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: Pateint said he has developed a bump on the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Patient reports extreme redness, soreness, and fever starting the day after the vaccine that led her to the MD's office to start an antibiotic (KEFLEX) 3 days later.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient came into pharmacy on 11/15/18 to tell us about the pain in his arm that he has had for the past month where he got the high dose flu vaccine. He said he has gone to doctor's office and they informed him to ice it. He has also been taking TYLENOL or ibuprofen and still has pain at injection site and he said he is bruised at injection site area.
Age: 2.0
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Sibling 2 mo had his WCC 11/04/2018-ROTARIX was given. Patient started with vomiting and diarrhea 5 days post administration of sibling's ROTARIX vaccine.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Amnesia, Dyspnoea, Headache, Tension headache
Clinical narrative: Head felt tight on Right side of head, difficulty remembering, shortness of breath, memory loss, headache.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Left deltoid area with mild edema and severe tenderness, no erythema.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Differential white blood cell count abnormal, Full blood count normal, Macule, Peripheral swelling, Rash
Clinical narrative: Rash is spotted, flat macules to BLE w/swelling. He was treated w/doxycycline 100 mg BID in ER on 11-13-18 w/no relief. Treated w/DECADRON 4 mg IM on 11-15-2018 and given Rx for methylprednisolone dose pack on 11-15-18. Has F/U 2 weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left thigh with 16 cm circular erythema, warm to touch and tender. BENADRYL 12.5 mg/ 5 ml - gave 5 ml PO in office and cool pack 15 minutes every 6 hrs. Cephalexin 250 mg/5 ml - 9 ml PO 7 d.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Hypoaesthesia oral, Paraesthesia oral, Rash
Clinical narrative: Rash on arms after contact with the skin. Tingling/numbing sensation on the tip of the tongue. Reaction during vaccine administration/preparing not receiving.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dizziness, Migraine, Nausea, Tremor
Clinical narrative: Patient called in and reported that experienced symptoms about 10-12 hours after dose. She reported Temp=102 degree F, nausea, dizziness, migraine, and shaking.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Mother reports entire upper arm swollen and red with itching. On PE: Red swollen area to lateral deltoid with warmth and mildly tender from x 4.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Diabetic neuropathy, Pain
Clinical narrative: Patient experienced worsening of diabetic neuropathy symptoms after receiving the vaccine. The patient reached out to the pharmacy 11/12/18 because the stinging sensation had spread to her trunk. On 11/1418 the patient was given a rx for NORCO 5/325 mg to help with these sensations and the husband reported the patient was feeling somewhat better.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Rhinorrhoea
Clinical narrative: Patient's mother stated that patient is fine only has a runny nose and a small bruise at injection site (normal reaction). Appointment for re-vaccination is on Friday December 14th, 2018.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Axillary pain
Clinical narrative: (L) arm pit pain. No swelling. No lymphadenopathy.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Patient is stating it is tender in that area and it started about 4 days after. He still states it is a little tender still.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Scab, Vaccination complication
Clinical narrative: Patient came to pharmacy stating she got a reaction to the shingles vaccine - the blister/scab was on mid arm-tricep area - RPh stated she did not inject there.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Inability to crawl, Posture abnormal, Somnolence
Clinical narrative: The day following receiving vaccines is refusing to crawl, cannot sit up and is napping frequently.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction/gave too low of dose.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction/pt. was given too low a dose.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction/pt. received too low of dose.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient got the FLUZONE HD on 10-10-2018 and patient is still experiencing pain in shoulder.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction/pt. given too low of dose.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest X-ray, Chills, Electrocardiogram, Hyperhidrosis
Clinical narrative: Repeat symptoms of 1st shot. Severe nausea, dry heaves with little emesis. Chills,sweating,rigors,weakness..unable to pick headercause of nausea. Tachycardia.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Nausea, Retching, Tachycardia, Urine analysis
Clinical narrative: Repeat symptoms of 1st shot. Severe nausea, dry heaves with little emesis. Chills,sweating,rigors,weakness..unable to pick headercause of nausea. Tachycardia.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Repeat symptoms of 1st shot. Severe nausea, dry heaves with little emesis. Chills,sweating,rigors,weakness..unable to pick headercause of nausea. Tachycardia.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness/fatigue. Lasted several days. Went to doctor. Never had problem with flu shot before. Is high dose right for people nearing 80 yrs?
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction/gave too low of dose.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction/pt. given too low of dose.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received first dose of PREVNAR 13, via an unspecified route of administration in the right arm on 13May2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she can get a second dose a year after developing cellulitis with the first dose. The patient clarified that on 19May2018, her right arm was swollen and red. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received first dose of PREVNAR 13, via an unspecified route of administration in the right arm on 13May2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she can get a second dose a year after developing cellulitis with the first dose. The patient clarified that on 19May2018, her right arm was swollen and red. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Rashes and lumpes in the back of my head, the doctor said it looks like shingles, and I went back to the pharmacist and he looked at the red rashes on the left side of my arm that I had the shot and he said it looks like shingles.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Herpes zoster, Mass, Rash, Rash erythematous
Clinical narrative: Rashes and lumpes in the back of my head, the doctor said it looks like shingles, and I went back to the pharmacist and he looked at the red rashes on the left side of my arm that I had the shot and he said it looks like shingles.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament disorder, Pain, Pain in extremity, Tendon disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included nerve pain (experience 15 years ago in his right arm that was caused by neck issues.) and neck discomfort (neck issue). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018196933). On 9th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd August 2018, the patient experienced ligament pain and tendon pain. On an unknown date, the patient experienced nerve pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was resolved with sequelae and the outcome of the ligament pain, tendon pain and nerve pain were recovering/resolving. The reporter considered the pain in arm, ligament pain and tendon pain to be related to SHINGRIX. The reporter considered the nerve pain to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid and experienced arm pain. Fourteen days after receiving SHINGRIX, the patient experienced additional ligament or tendon pain the radiates from where the vaccine was administered in the shoulder to the elbow. Less than a year after receiving SHINGRIX, the patient had nerve pain in his left arm and he did not feel that it was related to the SHINGRIX vaccination.