chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site induration, Injection site mass, Mass, Mobility decreased
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 02-May-2018. This case involves a female patient (age was not reported), who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 28-Mar-2018 at physician's office. Patient's medical history and concomitant medications were not reported. On an unknown date, three days following the vaccination the patient had a large, hard lump at injection site of right arm, extending to the shoulder and to neck area, painful and could not move her right arm without difficulty. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 02-May-2018. This case involves a female patient (age was not reported), who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 28-Mar-2018 at physician's office. Patient's medical history and concomitant medications were not reported. On an unknown date, three days following the vaccination the patient had a large, hard lump at injection site of right arm, extending to the shoulder and to neck area, painful and could not move her right arm without difficulty. Laboratory investigations and corrective treatment was not reported. The patient was not yet recovered/resolved from all the events. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Limb mass, Pruritus, Rash
Clinical narrative: Lump in thigh about three inches in size with a visible rash and itchiness. Diarrhea. Rash and itchiness still prevalent today (two days after vaccine).
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: SEVERE MUSCLE AND JOINT ACHES, MALAISE.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Rash
Clinical narrative: The patient presents for Rash. This episode began 1 day ago. The symptom(s) are described as moderate and improving. Affected area(s) include left arm. The patient describes the affected area(s) as burning, itchy, red and pain. Denies aggravating factors. Denies relieving factors. Associated symptoms include erythema (skin) and pruritus. Pertinent negatives include bleeding and scaling. Additional information: She had a pneumovax-23 vaccine yesterday and got a rash and had pain in the area the evening after the rash and pain started. The pain is starting to subside a bit. She took TYLENOL and aspirin to help. She definitely has a rash after the pneumonia-23 vaccine. I will have our team report it to VAERS. I am concerned with the warmth that there could be some cellulitis. I will start her on a short course of KEFLEX to treat this. TYLENOL PRN pain. Do supportive care to the arm with ice packs 2-3 times a day as needed. You can use the arm as much as your pain will allow. TYLENOL as needed for pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Neck pain, Pain
Clinical narrative: Shooting pain up into her neck as well as tenderness, erythema, and induration of the site and below the injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Mild fever, body ache, malaise, possible palpitations; lasting 1 day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting, dizziness, mental fog. Dizziness and mental fog lasted 3 days. Severe pain in arm for about 3 hours, a few hours after the shot.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Erythema, Immediate post-injection reaction, Neck pain
Clinical narrative: Pain shot up her neck while receiving the vaccine. Her arm became red and sore, the redness has spread down her arm 3 days later. Patient will go see her physician.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Bronchitis, Cellulitis, Oral discomfort, Paraesthesia
Clinical narrative: This spontaneous report was received from a healthcare professional and consumer via Pfizer concerning a female patient of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015, the patient started therapy with pregabalin (LYRICA), 225 mg daily for an unknown indication (route, lot# and expiry date unknown). On an unspecified date in the end of December 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose number, dose, unit, route, anatomical location, lot# and expiry date not reported). On the same day after vaccination, the patient had a reaction. The following day, the patient went to the emergency room (ER) for having hives (urticaria). She was advised that she had cellulitis and acquired bronchitis. On an unknown date, the patient experienced burning mouth sensation (oral discomfort) due to which the physician added 100 mg of pregabalin (LYRICA) making it to a total dose of 325 mg and that 100 mg was making her drowsy in the morning (somnolence). On 16-APR-2018 (reported as "this morning"), the patient woke up with half of her body feeling more tingly than normal (paraesthesia). Action taken with pregabalin (LYRICA) for the event "burning mouth sensation" was dose increased and for all other events it was unknown. Outcome of all the events was unknown. The reporter's causality assessment was not provided. Upon internal review, the event "cellulitis" was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Somnolence, Urticaria
Clinical narrative: This spontaneous report was received from a healthcare professional and consumer via Pfizer concerning a female patient of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015, the patient started therapy with pregabalin (LYRICA), 225 mg daily for an unknown indication (route, lot# and expiry date unknown). On an unspecified date in the end of December 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose number, dose, unit, route, anatomical location, lot# and expiry date not reported). On the same day after vaccination, the patient had a reaction. The following day, the patient went to the emergency room (ER) for having hives (urticaria). She was advised that she had cellulitis and acquired bronchitis. On an unknown date, the patient experienced burning mouth sensation (oral discomfort) due to which the physician added 100 mg of pregabalin (LYRICA) making it to a total dose of 325 mg and that 100 mg was making her drowsy in the morning (somnolence). On 16-APR-2018 (reported as "this morning"), the patient woke up with half of her body feeling more tingly than normal (paraesthesia). Action taken with pregabalin (LYRICA) for the event "burning mouth sensation" was dose increased and for all other events it was unknown. Outcome of all the events was unknown. The reporter's causality assessment was not provided. Upon internal review, the event "cellulitis" was determined to be medically significant.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Haemorrhage subcutaneous, Injection site haematoma, Vaccination site bruising
Clinical narrative: Patient returned to the pharmacy three days after receiving vaccine to show a large hematoma that had formed as a result. After initial vaccination on 5/8 pharmacist noted signs of bleeding under the skin, although not seemingly severe yet, and asked patient if she was on blood thinners, to which she responded she was taking EFFIENT 10mg daily. Also noted multiple bruises along arms that she stated were due to the blood thinner. Pharmacist asked patient to follow up if it worsened, which led her to return on 5/11 to show the large area of bruising (around 3-4inches).  She is going to see her doctor regarding the reaction and will ask about switching or re-evaluating blood thinner.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hearing loss in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown. It was unknown if the reporter considered the hearing loss to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The reporter had limited information and would call back to provide additional details. There was no other details were available at the time of reporting.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe injection site reaction including pain, swelling, redness, and warmth approximately 8 hours after administration.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Dysstasia, Injection site erythema
Clinical narrative: Very sore at injection site and right shoulder joint, red rash, swelled up about the size of an egg, hot at injection site, extreme dizziness about 30 hours later - after exercising (could barely stand up, when turning head or looking up or down it would come on, only staying really still would stop it, had to move very slowly to get around), weakness, nausea - took BENADRYL which helped to mitigate the symptoms, still taking ALLEGRA after a week because the site keeps getting red and sore again, along with upset stomach and more dizziness if I stop taking it. The doses are not large, using children's liquid versions and taking the young child dose because I respond strongly to it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site joint pain, Injection site pain, Injection site warmth, Nausea, Rash erythematous
Clinical narrative: Very sore at injection site and right shoulder joint, red rash, swelled up about the size of an egg, hot at injection site, extreme dizziness about 30 hours later - after exercising (could barely stand up, when turning head or looking up or down it would come on, only staying really still would stop it, had to move very slowly to get around), weakness, nausea - took BENADRYL which helped to mitigate the symptoms, still taking ALLEGRA after a week because the site keeps getting red and sore again, along with upset stomach and more dizziness if I stop taking it. The doses are not large, using children's liquid versions and taking the young child dose because I respond strongly to it.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Raised red area at injection site which is tender to the touch. Chills and malaise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Arthralgia, Blood test, C-reactive protein, Cytomegalovirus test
Clinical narrative: Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count, Epstein-Barr virus test, Fatigue, Full blood count, Liver function test
Clinical narrative: Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Neuritis, Ophthalmic herpes zoster, Papule
Clinical narrative: Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash, Red blood cell sedimentation rate, Rotator cuff syndrome
Clinical narrative: Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenosynovitis, Varicella virus test
Clinical narrative: Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash vesicular
Clinical narrative: Red shingles looking rash around injection site on upper arm with a 3 inch radius.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Myalgia, Oedema peripheral
Clinical narrative: Left arm with peripheral edema, cellulitis measured 4 x 4 inches to upper left arm, mild myalgia which went away. Seen in our office on 5/11/18 at 8:15 AM.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Vaccination error
Clinical narrative: Client presented with mother for child vaccines. Administered the above four vaccines without incident. Both exited the clinic. Administered several vaccines to another child also one year old. Noted empty vials did not match vaccines listed on child medical record. I realized I pulled an MMRV & a VzV from the freezer for the first child. I notified the ARNP in clinic; the Assistant Director of the agency; called 800# CDC.gov; called 800# VAERS in this order. I called client's mother phone number which had outgoing message 'not accepting incoming calls'. I notified the Asst. Dir. of this update. She indicated it would be necessary to send a letter to the mother. I sent an email to my immediate supervisor.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Computerised tomogram normal, Hyperaesthesia, Injection site pain
Clinical narrative: Day of the vaccine, she started feeling pain in the injection site and legs within 2-3 hrs when she got home. Sensitive to touch, soreness etc.. The pain got worse as days passed, the pain got stronger on left leg, abdomen, on 3rd day, she started seeing red dots. and a big blister on left side of the abdomen. The pain increased daily, as did the red rashes, all around the left side of the  abdomen, keeping her up at night due to sharp shooting pain on her sides. Daly 11, the pain is felt all the way up to her upper chest area including breast and neck, again keeping her up all night with pain. Today is day 22. The pain is at worst to date.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash erythematous
Clinical narrative: Day of the vaccine, she started feeling pain in the injection site and legs within 2-3 hrs when she got home. Sensitive to touch, soreness etc.. The pain got worse as days passed, the pain got stronger on left leg, abdomen, on 3rd day, she started seeing red dots. and a big blister on left side of the abdomen. The pain increased daily, as did the red rashes, all around the left side of the  abdomen, keeping her up at night due to sharp shooting pain on her sides. Daly 11, the pain is felt all the way up to her upper chest area including breast and neck, again keeping her up all night with pain. Today is day 22. The pain is at worst to date.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eyelid oedema, Wheezing
Clinical narrative: Per Mother, about 8 hrs. after injections pt's eyes swelled shut and started to wheeze. Denied difficulty swallowing. Mom called on call. Advised BENADRYL and VENTOLIN inhaler-ER if worsening. Mom continued treatment for 48 hrs and symptoms resolved.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever after administration in the pharmacy on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about the batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at injection site, low grade fever to 99.4, chills, muscle and joint pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea and fatigue for a few hours after injection. No treatment taken. Still feeling nauseated now, so I do not yet know the eventual outcome.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Initially a low-grade headache within 4 hours. Later that evening muscle aches and pains in thighs and knees similar to flu-like symptoms. Taking TYLENOL the following morning around 7:00 am in an attempt to arrest the headache. These symptoms lasted approximately 72 hours and TYLENOL was taken during the course of the symptoms. On this day, flu-like symptoms have subsided but continue with a low-grade headache. Injection site remains tender but no redness or swelling.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity
Clinical narrative: Initially a low-grade headache within 4 hours. Later that evening muscle aches and pains in thighs and knees similar to flu-like symptoms. Taking TYLENOL the following morning around 7:00 am in an attempt to arrest the headache. These symptoms lasted approximately 72 hours and TYLENOL was taken during the course of the symptoms. On this day, flu-like symptoms have subsided but continue with a low-grade headache. Injection site remains tender but no redness or swelling.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Urticaria
Clinical narrative: Muscle pain then on day four urticarial deltoid and axilla.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastrooesophageal reflux disease, Infantile spasms, Myoclonus, Sandifer's syndrome
Clinical narrative: Increase in myoclonic like activity. Child has having episodes before the vaccines but had a noticeable increase. Differential diagnosis per Hospital include Sandifer Syndrome, reflux, myoclonic jerk, infantile spasm. Patient is responsive during episodes and no postictal phase per the hospitalist. Referred to neurology for further evaluation and advised to go to the ER if anything changes.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: Rash from injection site at right deltoid to right antecubital area. Slight dyspnea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: First three knuckles on hands swelled and burned. Started mid to late afternoon and has lasted for four days. Today is fourth day and very little pain is left now as it has gradually disappeared. What is left is in first knuckle on left hand. Same side as injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Swelling
Clinical narrative: 1 yr vaccines given May 2015 followed 8 hours later total body rash and swelling, relieved by epinephrine, BENADRYL and steroids, received MMR varicella, HepA, and PEC 13 at time. Has had DTaP Hep A and flu vaccines since then without problems.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo, Visual impairment
Clinical narrative: Patient states he was fine for a few days following the vaccine, then on the Tuesday following the vaccine administration he started having "vision problems." He states he "does not feel dizzy but it appears everything is spinning." He said the first morning it happened he almost fell off the bed and has had persistent vision problems since Tuesday.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cold sweat, Malaise, Skin warm
Clinical narrative: After immunizations. Pt was in check out with her mother. Told her mother she felt sick and then laid down. Did not hit head. Staff who were present did not think child lost consciousness. Was able to talk and communicate. BP 90/58, Pulse 100, skin warm mildly clammy, BS 97. Declined drink. Was able to get up within a few minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: MD states, patient started with redness, warmth, and swelling to Left arm that night. Patient was seen by MD 5/11/2018 in clinic.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Rash, Streptococcus test
Clinical narrative: 5/9/18, fine macular rash developed bilaterally on arms bilaterally; biceps down to dorsum nd palmar surface of hands. Left occipital node enlargement since 5/2/18.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by non-health professional via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extremities hot feeling of, swelling arm, induration and erythema of extremities. On 20th April 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, extremities hot feeling of, swelling arm, induration and erythema of extremities were not recovered/not resolved. It was unknown if reporter considered the pain in arm, extremities hot feeling of, swelling arm, induration and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the deltoid muscle of left arm. The patient stated that the arm was hot swollen hard and painful. She had experienced pain upon injection but called office 5 days later on 25th April 2018 to say her arm was still red swollen and painful. The doctor suggested to take whatever she normally took for pain (i.e. NSAID). The patient replied that she did not take anything for pain. The patient did not seek medical attention just called office to alert them that what they told her might happen did but she did make a point to emphasize the pain. The patient's arm pain had not gotten any better since date of injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by non-health professional via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extremities hot feeling of, swelling arm, induration and erythema of extremities. On 20th April 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, extremities hot feeling of, swelling arm, induration and erythema of extremities were not recovered/not resolved. It was unknown if reporter considered the pain in arm, extremities hot feeling of, swelling arm, induration and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the deltoid muscle of left arm. The patient stated that the arm was hot swollen hard and painful. She had experienced pain upon injection but called office 5 days later on 25th April 2018 to say her arm was still red swollen and painful. The doctor suggested to take whatever she normally took for pain (i.e. NSAID). The patient replied that she did not take anything for pain. The patient did not seek medical attention just called office to alert them that what they told her might happen did but she did make a point to emphasize the pain. The patient's arm pain had not gotten any better since date of injection.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Contusion, Drug administered to patient of inappropriate age, Injection site bruising
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to a 28 year old female patient. The patient had drug reactions or allergies to penicillin, cephalexin (KEFLEX) and to sulfanilamide (SULFA). On 19-APR-2018, the patient was vaccinated with GARDASIL 9 injection, expiration date in 29-APR-2020 (strength, dose, frequency, administration route and lot number were not reported), for prophylaxis (reported as "vaccination"). Concomitant therapies included an unspecified birth control pill. On 07-MAY-2018, the patient reported to the nurse practitioner, having bruising at the injection site and all over her body (injection site bruising and contusion), which started on an unspecified date in 2018. The patient reported the bruising as significant disability. Lab diagnostics or studies were not performed and treatment was not given. The outcome of contusion and injection site bruising was reported as not resolved. The causality assessment between GARDASIL 9 and the aforementioned events was not provided. The patient considered contusion and injection site bruising to be serious due to significant disability.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 02-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020353 with expiration date on 18-APR-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion, at or above, the range between 32°F to 35°F for 3 hours and 15 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Malaise, Syncope
Clinical narrative: Pt received Hep A vaccine (HAVRIX) and stated feeling lightheaded after a few min. Shortly after saying not feeling well she fainted, started talking after 15-30 seconds. EMS was called.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager refers to a 9 year old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 04-OCT-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, units, route and frequency not reported) (lot # N013276 and expiration date: not reported) at a temperature of 29 Fahrenheit for 2 hours. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cold sweat, Crying, Fall, Flushing, Immediate post-injection reaction
Clinical narrative: Approximately 1-2 minutes after injections patient became pale and fell to the ground. She cried immediately. Was clammy and flushed for 5-10 minutes after near syncopal collapse. Baseline after 30 minutes.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Presyncope
Clinical narrative: Approximately 1-2 minutes after injections patient became pale and fell to the ground. She cried immediately. Was clammy and flushed for 5-10 minutes after near syncopal collapse. Baseline after 30 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 2 days after injections swelling, redness and warm to touch on right thigh. 5/10/2018 Patient is a 4 y.o. 1 m.o. male who presents in office today for evaluation of injection site reaction on right thigh. Dtap/IPV given 5/7/18. Swelling, redness and warm to touch noticed yesterday. Pain to touch this morning. Appetite and activity levels are normal. Sleep is normal. No ill contact. No other contributing factors.
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation reaction, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of myalgia in a 58-year-old female a patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia, fever, injection site erythema and immunization reaction. On an unknown date, the outcome of the myalgia, fever, injection site erythema and immunization reaction were unknown. It was unknown if the reporter considered the myalgia, fever, injection site erythema and immunization reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a large immune reaction complete with myalgia low grade fevers and an 8 cm erythematous area over the injection site. The nurse was agreeing to follow up from safety department.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: Per mother-"He woke up the next morning complaining of his heart "racing". I used an app on my phone and he had a fast heart rate with irregular rhythm. He rested and he was O.K."
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Lymphadenopathy, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced fever (serious criteria disability and other: as per reporter), diarrhea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), muscle pain (serious criteria disability and other: as per reporter) and joint pain (serious criteria disability and other: as per reporter). On 4th May 2018, the patient experienced enlargement of lymph nodes (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fever, diarrhea, headache, muscle pain and joint pain were recovering/resolving and the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the fever, diarrhea, headache and joint pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. It was not reported if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX at 13:30 in the left deltoid. The patient experienced fever, severe diarrhea, severe muscle and joint pain and severe headache. On the reporting date, 3 days after receiving SHINGRIX, the patient developed lymph nodes under her arms and down to her breasts. The pharmacist was not sure if this was on both sides, or just the side where she received the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced fever (serious criteria disability and other: as per reporter), diarrhea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), muscle pain (serious criteria disability and other: as per reporter) and joint pain (serious criteria disability and other: as per reporter). On 4th May 2018, the patient experienced enlargement of lymph nodes (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fever, diarrhea, headache, muscle pain and joint pain were recovering/resolving and the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the fever, diarrhea, headache and joint pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. It was not reported if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX at 13:30 in the left deltoid. The patient experienced fever, severe diarrhea, severe muscle and joint pain and severe headache. On the reporting date, 3 days after receiving SHINGRIX, the patient developed lymph nodes under her arms and down to her breasts. The pharmacist was not sure if this was on both sides, or just the side where she received the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Patient had severe chill, fever, body ache and pain, also rash. Pt. took one dose of ADVIL 500 g and symptoms went away. Pt. has same symptoms after 1st dose, but only mild.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pharyngeal oedema, Throat irritation
Clinical narrative: Prickly sensation in throat prior to swelling of throat. Slight dizziness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, bruising and itching at injection site Right arm.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported that after receiving the injection he developed a non itchy rash to right deltoid, that was localized to the deltoid area. Resolved after a few days.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Red spotty rash on neck, trunk and thighs.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain, Pyrexia, Vomiting
Clinical narrative: Patient reported that after receiving the second dose of SHINGRIX he experienced vomiting, body aches and pains, and fever. These symptoms prevented him from attending work for two days. His condition is improving at this time but he does not feel back to his usual self.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling, severe pain in arm. Talked to MD and she suggested to try ice, TYLENOL, and BENADRYL for reaction (according to patient at time of report- reaction was not better, but not worse)
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pruritus, Skin warm
Clinical narrative: 2" diameter site reaction with pain, itching, heat shortly after vaccination; per patient worsened on 5/10/18 overnight and patient seen in office today. Advised BENADRYL and cold compress and continue to monitor.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Erythema, warmth, raised to left arm around vaccine site and shooting pains down left arm and leg.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 16-APR-2018, the patient may have been vaccinated with an improperly stored dose of PEDVAXHIB (lot # M046133, expiry date: 26-SEP-2019; lot # M034410, expiry date: 01-FEB-2020 or lot # M031493, expiry date: 03-OCT-2019) intramuscularly for prophylaxis. The reporter was unsure which lot the patient received. The temperature excursion occurred on an unknown date between 9 degrees Celsius (°C) to 25°C for a time frame of 12 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-FEB-2007, 20-FEB-2010 and 02-MAY-2018, the patient was vaccinated with doses of M-M-R II, subcutaneously (dose, anatomical place of vaccination, lot# and expiration date were not provided), for prophylaxis. No known adverse effects.
Age: 0.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 1 day old male baby. Pertinent medical history, concurrent conditions, concomitant medications and allergies  regarding the baby were not provided. In APR-2018, the patient was inadvertently vaccinated with M-M-R II for prophylaxis (strength, dose, route, dosage schedule, anatomical location, lot # and expiry date were not provided) instead of hepatitis B vaccine (manufacturer unknown) (strength, dose, frequency, route, lot #, and expiration date were not provided) for prophylaxis (wrong drug administered; drug administered to patient of inappropriate age). The physician reported that after the hospital realized the baby got the wrong vaccine they decided to keep the baby in the hospital for a longer time as a precautionary measure to monitor the patient. Also, as precaution, the hospital arranged for the baby's parents to consult with staff neurologist and infectious disease specialist before they let the baby to leave the hospital and go home with his parents. It was mentioned that, at the day of reporting, the baby had a follow up visit with the reporting physician. The hospital duration was unspecified. No adverse reaction reported. Upon internal review, the wrong drug administered and drug administered to patient of inappropriate age were considered to be serious due to hospitalization.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab
Clinical narrative: PATIENT SAYS THE VACCINATION GAVE HIM SHINGLES. IT LOOKED LIKE A SCAB A WEEK AFTER THE SHOT. HE SAYS IT WAS NOT ITCHY OR PAINFUL. IT WAS ON THE PATIENT'S FOREARM.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea and stomach ache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Complication associated with device, Limb discomfort, Pain
Clinical narrative: Excruciating pain, could not turn, move arm or touch shoulder. Pain radiated down to elbow. Could not lift arm for several days. As of 4/30/18, still does not have full range of motion.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin discolouration, Wound secretion
Clinical narrative: Patient reporting whole body fatigue and raised bump on right hand that is reddish/slight purple hint in color which was oozing in the morning.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discharge, Fatigue, Purpura
Clinical narrative: Patient reporting whole body fatigue and raised bump on right hand that is reddish/slight purple hint in color which was oozing in the morning.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Bone marrow failure, Immunodeficiency, Infection, Rash, Varicella virus test positive
Clinical narrative: In the setting of profound immunocompromise, he has reactivated his VZV Oka strain (confirmed by sequencing). He has a rash and possible intestinal manifestations.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella zoster virus infection
Clinical narrative: In the setting of profound immunocompromise, he has reactivated his VZV Oka strain (confirmed by sequencing). He has a rash and possible intestinal manifestations.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling spreading down arm to elbow, redness, hot to touch. Painful.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: Extreme fatigue to the point that I could not go to work the next day. Extreme muscle and joint pain, felt paralyzed with pain whenever I moved. Chills, then overheating, nausea, (did not vomit) diarrhea, redness and heat at the injection site. Took two days to feel normal again.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site warmth, Myalgia, Nausea
Clinical narrative: Extreme fatigue to the point that I could not go to work the next day. Extreme muscle and joint pain, felt paralyzed with pain whenever I moved. Chills, then overheating, nausea, (did not vomit) diarrhea, redness and heat at the injection site. Took two days to feel normal again.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain
Clinical narrative: Extreme fatigue to the point that I could not go to work the next day. Extreme muscle and joint pain, felt paralyzed with pain whenever I moved. Chills, then overheating, nausea, (did not vomit) diarrhea, redness and heat at the injection site. Took two days to feel normal again.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: Baseball size swelling on arm around injection site.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Within 24 hours of the vaccine, patient reports that shingles-like rash developed on her left buttock and extended down the back of her left leg toward her knee. At urgent care, it was confirmed to be shingles, and she was immediately started on antiviral treatment.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Eye movement disorder, Fall, Head injury
Clinical narrative: Checking out at front desk, while standing up, passed out, fell and hit back of head on floor. Observed by mother. Had several seconds of seizure like activity, flexed one arm, extended other arm, eyes rolled back. Unresponsive for approx. 30 seconds. Staring and slow to respond with glazed look. No loss of continence. No change in respirations; no tachycardia. Pale. 911 called and transported to ER.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hyporesponsive to stimuli, Laboratory test normal, Loss of consciousness, Pallor, Seizure like phenomena
Clinical narrative: Checking out at front desk, while standing up, passed out, fell and hit back of head on floor. Observed by mother. Had several seconds of seizure like activity, flexed one arm, extended other arm, eyes rolled back. Unresponsive for approx. 30 seconds. Staring and slow to respond with glazed look. No loss of continence. No change in respirations; no tachycardia. Pale. 911 called and transported to ER.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Staring, Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: Checking out at front desk, while standing up, passed out, fell and hit back of head on floor. Observed by mother. Had several seconds of seizure like activity, flexed one arm, extended other arm, eyes rolled back. Unresponsive for approx. 30 seconds. Staring and slow to respond with glazed look. No loss of continence. No change in respirations; no tachycardia. Pale. 911 called and transported to ER.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site streaking, Injection site warmth, Pain in extremity
Clinical narrative: Patient said he felt fine following injection but woke up in the middle of the night with severe pain radiating up his arm, with a hard lump at the injection site. He stated the area was warm to the touch and had red streaking. He said the pain persisted the next day and then resolved. I looked at the site on 5/10/18 and the area was not red or swollen.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has injection site reaction. She said she has had it since Wednesday when the vaccine was given and today is Friday. She said there is redness, pain and swelling at the site. She said it is getting better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu-like symptoms: Low grade fever, aches, chills, nausea. Treated with acetaminophen ongoing..
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives around eyes daily since vaccine administration.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, CSF protein increased, Computerised tomogram, Disturbance in attention, Guillain-Barre syndrome
Clinical narrative: Weakness in lower extremities, changes in concentration level, auditory hallucinations, admitted to the hospital and diagnosed with Guillan-Barre syndrome after lumbar puncture and clinical examination.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, auditory, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Weakness in lower extremities, changes in concentration level, auditory hallucinations, admitted to the hospital and diagnosed with Guillan-Barre syndrome after lumbar puncture and clinical examination.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, CSF protein increased, Delusion, Guillain-Barre syndrome, Insomnia
Clinical narrative: Weakness in lower extremities, changes in concentration level, auditory hallucinations, admitted to the hospital and diagnosed with Guillan-Barre syndrome after lumbar puncture and clinical examination.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Weakness in lower extremities, changes in concentration level, auditory hallucinations, admitted to the hospital and diagnosed with Guillan-Barre syndrome after lumbar puncture and clinical examination.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Mid/high fever for two/three days.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site induration, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever(101.1 degrees) even while on ALEVE, Pain in the left arm, Feels hard at the injection site started on 2nd day. Severe pain in the right arm, slightly swollen, feels hard at the site and unable to move the arm started on day-2. Lying down all day on day-5(5/11/18). Continuing to suffer from fever on Day-4.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: Flu like symptoms for 3 days...body pain all over not just at the injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Patient complained of disrupted sleep for 2 nights following the immunization. Patient claims that after the 2 nights, his sleep resumed back to his normal schedule.