chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a adult female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Concomitant products included FLUARIX QUADRIVALENT. On 26th September 2016, the patient received BOOSTRIX .5 ml. On 30th September 2016, 4 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site warmth, injection site rash and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site rash and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site rash and injection site itching to be related to BOOSTRIX. Additional details were provided as follows: The pharmacists stated that this case was already reported on FDA VAERS website. The age at vaccination was not reported. The patient received BOOSTRIX in her right deltoid along with FLUARIX QUADRIVALENT in her left deltoid. The patient experienced skin hot to touch with itching and rash at injection site and surrounding area on her right arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Pain in right arm and difficulty moving arm after PNEUMOVAX.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Ultrasound scan normal
Clinical narrative: Pain in right arm and difficulty moving arm after PNEUMOVAX.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in right arm and difficulty moving arm after PNEUMOVAX.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Inflammation, Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Pain, discomfort in the shoulder accompanied by limited range of motion and weakness to the point of needing pain meds. The pain feels like a rotator cuff injury. The pain has been present since the injection 16 days ago. The injection was administered at the top of the shoulder, instead of the muscle.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Pain, discomfort in the shoulder accompanied by limited range of motion and weakness to the point of needing pain meds. The pain feels like a rotator cuff injury. The pain has been present since the injection 16 days ago. The injection was administered at the top of the shoulder, instead of the muscle.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Pain, discomfort in the shoulder accompanied by limited range of motion and weakness to the point of needing pain meds. The pain feels like a rotator cuff injury. The pain has been present since the injection 16 days ago. The injection was administered at the top of the shoulder, instead of the muscle.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Myalgia, Pain
Clinical narrative: One hour after the vaccine was given, my left arm was very painful, not tenderness "pain", could not lift or raise the arm, which did not improve at all. My arm was completely impaired, could not shave my right armpit.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: One hour after the vaccine was given, my left arm was very painful, not tenderness "pain", could not lift or raise the arm, which did not improve at all. My arm was completely impaired, could not shave my right armpit.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 3 days after vaccine, I started having pain down the entire length of my arm. Limited range of motion, difficulty dressing and driving. Taking OTC pain relievers. Has persisted for over two weeks now.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: 3 days after vaccine, I started having pain down the entire length of my arm. Limited range of motion, difficulty dressing and driving. Taking OTC pain relievers. Has persisted for over two weeks now.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: 4 hrs after injection, my left shoulder became sore. Soreness and pain got worse thru the evening. Sharp pains woke me up in the nights. Next day-limited mobility, pain w/ any movement. Difficulty driving, dressing, showering, working. Hurt to move my elbow away from the side of my body. Has lasted over 2 weeks now.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: 4 hrs after injection, my left shoulder became sore. Soreness and pain got worse thru the evening. Sharp pains woke me up in the nights. Next day-limited mobility, pain w/ any movement. Difficulty driving, dressing, showering, working. Hurt to move my elbow away from the side of my body. Has lasted over 2 weeks now.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: 4 hrs after injection, my left shoulder became sore. Soreness and pain got worse thru the evening. Sharp pains woke me up in the nights. Next day-limited mobility, pain w/ any movement. Difficulty driving, dressing, showering, working. Hurt to move my elbow away from the side of my body. Has lasted over 2 weeks now.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Pain in extremity
Clinical narrative: Soreness in arm, shoulder. Unable to to move in pivotal motion. Can't fasten bra, reach in washer or dryer or mailbox. Sends shooting pain down my arm. Can't paint. Hard to drive my car. Wakes me up in my sleep.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Impaired work ability, Middle insomnia, Musculoskeletal pain
Clinical narrative: Soreness in arm, shoulder. Unable to to move in pivotal motion. Can't fasten bra, reach in washer or dryer or mailbox. Sends shooting pain down my arm. Can't paint. Hard to drive my car. Wakes me up in my sleep.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm, shoulder. Unable to to move in pivotal motion. Can't fasten bra, reach in washer or dryer or mailbox. Sends shooting pain down my arm. Can't paint. Hard to drive my car. Wakes me up in my sleep.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. While no medical history was reported, her concurrent conditions included a chronic lung disease. Notably, she had no drug reactions/allergies. On 03-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (which had a lot # of M006141 with an expiration date of 17-MAY-2018), intramuscularly, in the right arm, (the dose and dosage number were unknown). On the same day, she had also been vaccinated with influenza virus vaccine (unspecified) (which had a lot number of UI703AA with an expiration date of 08-MAY-2017; the dose, dosage number, route of administration and anatomical location were unknown). Additionally, her concomitant therapies included prednisone (Manufacturer unknown). Subsequently, on 04-OCT-2016, the patient developed a fever of 104 F, which lasted for three days. She did seek medical attention by going to a primary physician. Then, on 10-OCT-2016, she was admitted to an unspecified hospital. An unspecified treatment was given for the adverse event but it was unknown whether any laboratory diagnostic studies had been performed. Additionally, no product quality complaint was involved. At the time of reporting, the event was resolving itself. The patient considered the event and the subsequent hospitalization to be related to the PNEUMOVAX 23. No causal assessment with the influenza virus vaccine (unspecified) was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. While no medical history was reported, her concurrent conditions included a chronic lung disease. Notably, she had no drug reactions/allergies. On 03-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (which had a lot # of M006141 with an expiration date of 17-MAY-2018), intramuscularly, in the right arm, (the dose and dosage number were unknown). On the same day, she had also been vaccinated with influenza virus vaccine (unspecified) (which had a lot number of UI703AA with an expiration date of 08-MAY-2017; the dose, dosage number, route of administration and anatomical location were unknown). Additionally, her concomitant therapies included prednisone (Manufacturer unknown). Subsequently, on 04-OCT-2016, the patient developed a fever of 104 F, which lasted for three days. She did seek medical attention by going to a primary physician. Then, on 10-OCT-2016, she was admitted to an unspecified hospital. An unspecified treatment was given for the adverse event but it was unknown whether any laboratory diagnostic studies had been performed. Additionally, no product quality complaint was involved. At the time of reporting, the event was resolving itself. The patient considered the event and the subsequent hospitalization to be related to the PNEUMOVAX 23. No causal assessment with the influenza virus vaccine (unspecified) was reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pt. received vaccine on 8/25/16. Pt. comes in 9/23/16 complaining of (L) upper arm pain. Not painful to touch just when moving or laying on it. No redness. She stated pain has worsened. Complaining in joint pain in shoulder.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Back pain, Chills, Cough, Dizziness
Clinical narrative: Dizziness, chills, fever (103 F), neck stiffness, back pain, epigastric pain, mild tachycardia (110), severe headache with photophobia. HA was unresponsive to 100mg of sumatriptan. Back and neck pain worsening over 24 hours, fever slowly decreasing to 101F over 24 hours. Severe head pain with coughing.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Photophobia, Pyrexia
Clinical narrative: Dizziness, chills, fever (103 F), neck stiffness, back pain, epigastric pain, mild tachycardia (110), severe headache with photophobia. HA was unresponsive to 100mg of sumatriptan. Back and neck pain worsening over 24 hours, fever slowly decreasing to 101F over 24 hours. Severe head pain with coughing.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Tachycardia
Clinical narrative: Dizziness, chills, fever (103 F), neck stiffness, back pain, epigastric pain, mild tachycardia (110), severe headache with photophobia. HA was unresponsive to 100mg of sumatriptan. Back and neck pain worsening over 24 hours, fever slowly decreasing to 101F over 24 hours. Severe head pain with coughing.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large (4 in. diameter), raised, erythematous area below injection site. Painful to the touch. Border irregular and not well demarcated. Resolved after 2 days.
Age: 11.0
Sex: M
Vaccine: FLU4, HPVX
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, warmth & swelling at injection site. All still present 48 hours post injection.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Lacrimation increased, Pruritus, Rash erythematous, Rash macular
Clinical narrative: Red splotchy swollen rash - no treatment, 4 days later dizziness, itchy hands/feet and watery eyes - no treatment.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: Red splotchy swollen rash - no treatment, 4 days later dizziness, itchy hands/feet and watery eyes - no treatment.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Influenza A virus test negative, Influenza B virus test, Influenza like illness
Clinical narrative: Flu-like symptoms. Chills, vomiting, headache, muscle pain. Was seen at Urgent Care on 10/10/16. Diagnosed with intractable headache. Coarse of sickness lasted until 10/12/2016.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Myalgia, Vomiting
Clinical narrative: Flu-like symptoms. Chills, vomiting, headache, muscle pain. Was seen at Urgent Care on 10/10/16. Diagnosed with intractable headache. Coarse of sickness lasted until 10/12/2016.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from nurse on 03 October 2016. This case involves patient (age and gender not reported) who was vaccinated with a single dose of Fluzone Quadrivalent Syringes (Batch number: U1683AA, expiration date, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medication were not reported. On unspecified date, about three hours following vaccination patient experienced loss of consciousness (suspected severe reaction to vaccine). On an unspecified date patient was hospitalized. Lab data and corrective treatment were not reported. Outcome of event was not reported. On an unspecified date, the patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Patient had loss of consciousness following FLUZONE QUADRIVALENT. This is a poorly documented case as time to onset is unknown and additionally information regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assess.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 04 Oct 2016. This case involves a 73-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI636AA, expiry date: 27 Mar 2017, dose, dose in series, were not reported) intramuscularly in left deltoid on 24 Sep 2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to Penicillin, Ampicillin, FLAGYL. Concomitant medications were not reported. On 24 Sep 2016, same day following the vaccination, the patient developed redness at injection site and arm soreness. On an unknown date, following the vaccination the patient had difficulty in moving her arm. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the events (On 04 Oct 2016, still the patient has arm soreness and also has difficulty moving her arm.). List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Cough, Hypersensitivity, Pharyngeal oedema, Swelling face
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 05-Oct-2016. This case involves a three-months-old male patient who was vaccinated with a dose of Acthib (batch number: UI265AA, expiry date: 17 May 2016), DAPTACEL (batch number C4754AA, expiry date: 23-Jun-2017), MMR (manufacturer: other, batch number K011317) (dose, site and route of administration: not reported for all vaccines) on 15-Aug-2014. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included egg, dairy allergy. On 15-Aug-2014, 10 to 30 minutes after vaccination, patient experienced coughing, facial swelling and throat swelling shut. The patient was transported to the hospital ER and on an unspecified date, was then admitted to the hospital. Relevant diagnostic tests were not reported. Patient was treated with Benadryl and "epi" on advice from doctor's office. On an unspecified date, patient recovered from the events. Documents held by sender: none. Sender's Comments: This case concern 3 month old male patient who received HIB (PRP/T) VACCINE simultaneously with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and MEASLES, MUMPS AND RUBELLA VACCINE . After 10 to 30 minutes patients experienced coughing, facial swelling, throat swelling shut and treated with benadryl and epinephrine. Time to onset is compatible. Events are consistent with hypersensitivity reaction. Based on available information role of vaccines cannot be excluded. Role of a particular vaccine cannot be assessed since multiple vaccines were administered simultaneously.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Deafness bilateral, Tinnitus
Clinical narrative: Initial unsolicited report received from a registered nurse on 07 Oct 2016. This case involves a 19 years old male patient who was vaccinated with a second dose of MENACTRA (Batch number- U5260AA, expiration date: 16 May 2017, route of administration was not reported) intramuscularly on right deltoid on 22 Aug 2016. Illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies (NKA). Concomitant medications were not reported. On 01 Sep 2016, 10 days of following the vaccination, the patient had Ringing in ears and hearing loss in both ears. Patient required emergency visit. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of the events were not recovered. Upon internal review, the company decided to consider the case serious because of important medical event hearing loss in both ears. List of documents held by sender: none. Sender's Comments: Patient had Tinnitus and hearing loss in both ears following MENACTRA vaccine. Time to onset is compatible, but additional information regarding patient medical history, any ear disorder or trauma, past vaccination history and its tolerance are needed to further assess the case.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient. Symptoms include: rash, unilateral, painful.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 104-105 temporal x 1 with vomiting x3. Fever reduced with Ibuprofen. Afebrile since then, vomiting stopped.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Severe pain at injection site 1-2 hours after injection. Within 4 hours decreased mobility of arm where shot was given (can barely lift arm). Within that same 4 hours, shoulder/arm swelling at injection site. Following morning injection site looks like a big red welt, worsening during the day and into the following morning. Day following injection, felt ill and whole body was aching.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain
Clinical narrative: Severe pain at injection site 1-2 hours after injection. Within 4 hours decreased mobility of arm where shot was given (can barely lift arm). Within that same 4 hours, shoulder/arm swelling at injection site. Following morning injection site looks like a big red welt, worsening during the day and into the following morning. Day following injection, felt ill and whole body was aching.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient. Symptoms include: rash, unilateral, painful.
Age: 43.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Severe pain, redness & swelling in the left arm. Arm visibly red and hot to the touch.  Unable to move or lift arm.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Erythema, Injection site erythema, Local swelling
Clinical narrative: Localized swelling, tenderness, erythema at the injection site the day following the injection. Redness/swelling roughly the size and shape of a small egg. Also experienced severe thoracic back pain, likely a muscle spasm--although it is questionable this is a reaction to the vaccine.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Tenderness
Clinical narrative: Localized swelling, tenderness, erythema at the injection site the day following the injection. Redness/swelling roughly the size and shape of a small egg. Also experienced severe thoracic back pain, likely a muscle spasm--although it is questionable this is a reaction to the vaccine.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eye swelling, Headache, Nausea, Skin warm
Clinical narrative: Headache. Eyes felt like they were swollen. Tongue felt a little swollen.  Ears felt hot on the inside. Dizziness/Light headed. Nauseous.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Headache. Eyes felt like they were swollen. Tongue felt a little swollen.  Ears felt hot on the inside. Dizziness/Light headed. Nauseous.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills initially, fever, treated with Tylenol and blankets and rest. 2nd dose of Tylenol 650 given 4hrs after onset.
Age: 32.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: 3" DIA red, warm.
Age: 32.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3" DIA red, warm.
Age: 34.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Red and swollen site to left upper arm area warm to touch.
Age: 34.0
Sex: F
Vaccine: TTOX, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red and swollen site to left upper arm area warm to touch.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling at and around injection site. Diagnosed as cellulitis.
Age: 11.0
Sex: M
Vaccine: FLUX, MEN, TD
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Large red swollen area on right upper arm after receiving two shots (I believe it was either a meningitis booster or MMR booster and flu shot); warm to the touch; measured 7.5cm in diameter.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dysgeusia, Glassy eyes, Hypotension, Pallor
Clinical narrative: Instantly had a metal taste in my mouth, became very dizzy/lightheaded, skin paled, nurses observed "glassy" eyes, low blood pressure. Sores developed on side of tongue later at night, took Benadryl.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Tongue ulceration
Clinical narrative: Instantly had a metal taste in my mouth, became very dizzy/lightheaded, skin paled, nurses observed "glassy" eyes, low blood pressure. Sores developed on side of tongue later at night, took Benadryl.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Local redness swelling and faint trunkal rash, fever. Treatment- Tylenol, Benadryl, Cool Compress.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Herpes zoster, Irritability, Polymerase chain reaction positive, Rash
Clinical narrative: Herpes zoster diagnosis in one-dose varicella vaccine recipient. Symptoms: painful unilateral rash, cough, runny nose, cranky.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in one-dose varicella vaccine recipient. Symptoms: painful unilateral rash, cough, runny nose, cranky.
Sex: U
Vaccine: VARZOS
Symptoms: Necrotising fasciitis
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, the patient developed necrotizing fasciitis. The infection did not develop at the injection site. The patient sought medical attention and visited the physician's office on an unspecified date. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and ZOSTAVAX. Upon internal review, the event of necrotizing fasciitis was determined to be medically significant. Additional information is not expected as there was no consent for further contact.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Ataxia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Ataxia, numbness lower extremities and hands, visual changes of both eyes (ex. increased time focusing).
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Ataxia, numbness lower extremities and hands, visual changes of both eyes (ex. increased time focusing).
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Laboratory test, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in one-dose varicella vaccine recipient. Symptoms: unilateral rash (not painful). Treatment given, Valtrex.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest discomfort, Dizziness, Vision blurred
Clinical narrative: Patient received the flu vaccine at the hospital. Patient is an employee of the hospital. Patient had no allergies and receives the flu vaccine yearly. Five minutes after receiving the flu vaccine, patient started experiencing symptoms: Dizziness, lightheadedness, clouding of vision and mild chest discomfort. He was initially given epinephrine 0.3ml IM within minutes of symptoms and was taken to the emergency department around 11:25 AM. The patient within minutes of receiving the epinephrine, symptoms began to resolve. He was later given one prednisone 20mg tablet by mouth, diphenhydramine 25mg tablet by mouth once, methylprednisolone succinate IV push once and famotidine 20mg IV once. The patient improved and was discharged from the emergency department at 4:52 PM.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diabetes mellitus, Nausea, Tremor, Vomiting
Clinical narrative: Pt was seen in office at 10:30AM for a diabetic follow up and given flu shot. Her Levemir was also increased. She then left office and ate breakfast (bacon, egg and cheese). She noted some nausea and vomited once at 3pm. She also reported shaking chills at that time as well. Felt better after vomiting.
Age: 64.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Dysarthria, Eye irritation, Swelling face, Throat irritation
Clinical narrative: Right side facial swelling, eyes burning, slurred speech, throat itching.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Pt reports feeling very nauseated after her flu shot on 09/30/16 but did not vomit.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity, Paraesthesia, Skin discolouration, Swelling
Clinical narrative: Immediate swelling, quarter sized blueish area.  1 hour post inject patient reports tingly feeling and an arm that "hurts like hell."
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Sinus congestion, Sinus operation, Wheezing
Clinical narrative: Wheezing, tightness in chest, sinus congestion and drainage, slight difficult breathing.  Symptoms subsided by 2:30 am, 10/13/2016 and had more or less disappeared by 7:00 am, 10/13/2016.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, significant swelling at injection site on left arm. All adverse events got worse and patient was advised by nurse to visit ER. (Time of onset is approximated).
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: On 10/05/2016 I got a flu shot. 12 hours later my left side of my face went numb & I became concerned that I may of had stroke so went to the urgent care. I was informed that I have Bell's Palsy. I was given Prednisone to treat it for 5 days. On 10/11/2016 I went to my doctor because it has not gone away & have been given more Prednisone & Valacyclovir to treat it. I was informed by my doctor to file a report since it happened 12 hours after my flu shot. I'm still waiting for pharmacy to respond since I notified them on 10/11/2016. They informed me that they didn't now how to handle the report? My condition has not changed with the current treatment.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large swollen, red, warm area measuring 3 inches x 4 inches and an inch raised at area of injection. Pain and itching at site. Pain in axillary and "armpit" area.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Large swollen, red, warm area measuring 3 inches x 4 inches and an inch raised at area of injection. Pain and itching at site. Pain in axillary and "armpit" area.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Half-dollar size redness around injection site.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis
Clinical narrative: Patient's HR director called 10/13/2016 and reported to me that the patient had gone to a physician and diagnosed with bursitis. The HR was wanting to know the length of needle used on the patient in order to report back to the physician. HR director states that treatment will be for 3 month.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 30-year-old female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 15 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 15 years before the reporting date, the patient had received Hepatitis B vaccination series. The patient was a healthcare professional (HCP) traveling to high risk area. At the time of reporting, the hepatitis B surface antibody (anti-HBs) titre was negative. Thus, leading the patient to be a therapy non-responder. The reporter asked whether the patient need to restart the series or did she need a booster dose.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L024993 with expiration date 17-OCT-2017; lot # M018810 with expiration date 28-MAY-2018; dose and route were not reported). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificate medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX (dose and route of administration were nor provided; lot number M018645 expiration date 31-MAY-2018). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15 degrees C for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0 degrees C for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Crying, Diet refusal
Clinical narrative: After falling deeply asleep for about 3 hours, child woke up crying inconsolably. We have never heard him cry that loud before, and he refused to nurse which he never does. He wouldn't eat for hours and wouldn't stop crying no matter what we tried, which is very unlike him. There didn't seem to be soreness to his legs specifically either, which causes us to believe it may have been cry-encephalitis. After trying everything else, we gave in and gave him baby TYLENOL because we didn't want him to be in pain any longer. We continued TYLENOL for the night and the next day, and he seemed to be better after the TYLENOL.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Asthma, Dyspnoea, Fatigue, Palpitations
Clinical narrative: I started feeling extremely weak and tired, which never happens to me. Then I noticed that it was hard to breathe and felt as if my asthma was kicking in. I also noticed that my heart rate was racing and felt as if my whole body was shaking. Per my heart rate monitor, my HR was at 97 sitting, when normally this is around 68. Luckily I went home and was able to use my inhaler to help my breathing. The next day, I feel better, but definitely not 100%.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: I started feeling extremely weak and tired, which never happens to me. Then I noticed that it was hard to breathe and felt as if my asthma was kicking in. I also noticed that my heart rate was racing and felt as if my whole body was shaking. Per my heart rate monitor, my HR was at 97 sitting, when normally this is around 68. Luckily I went home and was able to use my inhaler to help my breathing. The next day, I feel better, but definitely not 100%.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain, Joint range of motion decreased, Sleep disorder
Clinical narrative: The injection caused bleeding and significant pain which has grown worse over the past thirteen days. Constant aching that impedes sleep, diminished range of motion, large bruise at the site of the injection high on the arm. Apparent punctured bursa. No treatment other than cold compresses yet, but the pain worsens and the range of motion diminishes daily.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test negative
Clinical narrative: Herpes zoster diagnosis in one-dose varicella vaccine recipient. Symptoms: unilateral rash (pain unknown. Treatment given: acyclovir).
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pt received vaccine on 9/24/16 and developed persistent soreness in deltoid area of arm, especially when lifting arm. Her arm is still sore at time of reporting 19 days after administration.
Age: 4.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Herpes Zoster diagnosis in one-dose varicella vaccine recipient. Symptoms include: unilateral painful rash, itchy. Treatment given: acyclovir
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain, Pain, Rash
Clinical narrative: Rash and right intercostal burning pain I got shingles after getting shingles shot terrible pain not a mild case!
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: No treatment necessary.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient reported developing a fever of 101 late during the night/early morning hours of 10/13/16. She complained of sore arms that were not red or swollen. I informed the patient to inform her PCP and that I would call them as well as the protocol doctor to inform them of the reaction. I told the patient to use an icepack, benadryl, apap/ibuprofen for any injection site reaction symptoms. I also told her to inform her PCP about the fever she developed and that they may want to follow up with her.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site vesicles
Clinical narrative: Time and date above are when it was first noticed. Unsure of exact onset. Fluid filled blister at injection site is what was noted.
Age: 11.0
Sex: F
Vaccine: HIBV, IPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling and redness around vaccination site, > 5 cm in diamter, painful to touch.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Rash, Varicella virus test positive, Vomiting
Clinical narrative: Herpes Zoster diagnosis in one-dose varicella vaccine recipient. Symptoms include: unilateral painless rash, vomiting. Treatment not given.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm where vaccine give was very swollen to just above elbow, warm, erythematous, painful.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Decreased appetite, Feeling of body temperature change, Nausea, Vomiting
Clinical narrative: "Yesterday morning around 11 am I had my first High Dose Flu Vac.  I felt ok & the sun came out so I decided to drive to Cemetery where my husband is buried. I got there about 1:30 pm & just drove in & my stomach started to feel uncomfortable & soon I was very nauseated.  I had a tough time making it the 13 miles back home, luckily having a plastic glass in the car!  After home there was more vomiting & I finally made it to bed where I remained the rest of the day & night.  I would be cool at times & too warm at times. Today my stomach is sore & I don't feel like eating anything. I know this is not the "normal" reaction to a flu vac but I don't believe it is just coincidence.  This is just FYI as the injection nurse said patients are all reporting no problem. I felt I should report it."
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Ocular hyperaemia, Rash erythematous, Rash generalised
Clinical narrative: Small red bumps/rash all over body as well as itchy red eyes.  Took non-drowsy clariton to try to ease rash.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increasing redness, pain and swelling at injection site. Was seen in Urgent care and treated with doxycycline which did not help. Returned to clinic and was treated with BACTRIM and cephalexin with resolution of symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Patient said she did not lie down for several hours after receiving shot. When she did and got back up to watch TV, her vision was blurry and unable to focus. Her vision returned to normal shortly. (As told by patient to Pharm.D. on 10/13/16).
Age: 11.0
Sex: M
Vaccine: FLUX, HEPA, HPVX
Symptoms: Asthenia, Cold sweat, Dizziness, Syncope, Tremor
Clinical narrative: Patient was given the Hep A vaccine, then the flu vaccine, and last the HPV vaccine (1st dose).  Within minutes of the HPV vaccine, patient stated he was dizzy.  Before he could be moved from sitting in a chair to lying on the exam table, patient fainted.  He was caught by the nurse and did not fall.  There seemed to be some mild shaking/jerking as well. He came to and was then picked up by the nurse and laid on the exam table.  He requested something to drink and was given some Sprite and a cool rag for his forehead.  Patient's skin was clammy and he was weak.  After a few minutes he was able to sit up and drink the Sprite.  He sat in the exam room for approximately 30 minutes until he felt strong enough to walk.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Cardiac disorder, Malaise
Clinical narrative: Not feeling well, something wrong with heart.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Given flu vaccine at 1530 at 1730.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Anti-NMDA antibody positive, Encephalitis autoimmune, Partial seizures
Clinical narrative: Focal seizures began 9/4, prolonged w/u at hospital, diagnosed with encephalitis thought to be autoimmune. Still hospitalized. NMDA Encephalitis.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Pt. stated had blurry vision about 1/2 hr after vaccine. It has not returned to normal. She does state she does get an injection in the eye but hasn't had it since August. Was consulted to contact her eye doctor.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Dry mouth, Dysgeusia, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017). On 3rd October 2016 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016 10:00, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue and taste metallic to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient did not mention the severity of the side effects he experienced. The reporter did no have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patients. This is one of the 4 cases reported by the same reporter.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017). On 3rd October 2016 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016 10:00, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue and taste metallic to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient did not mention the severity of the side effects he experienced. The reporter did no have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patients. This is one of the 4 cases reported by the same reporter.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dry mouth, Dysgeusia, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 21-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 20th June 2017). On 3rd October 2016 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016 10:00, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue and taste metallic to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient concerned in this case received FLUARIX QUADRIVALENT in his right deltoid. The patient did not mention the severity of the side effects he experienced. The reporter did no have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patients. This is one of the 4 cases reported by the same reporter.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 21-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 20th June 2017). On 3rd October 2016 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016 10:00, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue and taste metallic to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient concerned in this case received FLUARIX QUADRIVALENT in his right deltoid. The patient did not mention the severity of the side effects he experienced. The reporter did no have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patients. This is one of the 4 cases reported by the same reporter.