chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chest discomfort, Cough, Dizziness, Flushing, Paraesthesia
Clinical narrative: Flushing, dizziness, parasthesia of arms/hands, coughing, tightness of chest.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Abasia, Cerebral palsy, Crying, Diplegia, Injection site erythema
Clinical narrative: Site was hard red raised bump and she cried when it was touched even gently. Constant high fevers She is still scarred. Doctor prescribed tylenol.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: Site was hard red raised bump and she cried when it was touched even gently. Constant high fevers She is still scarred. Doctor prescribed tylenol.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Motor dysfunction, Nuclear magnetic resonance imaging brain normal, Pyrexia, Scar
Clinical narrative: Site was hard red raised bump and she cried when it was touched even gently. Constant high fevers She is still scarred. Doctor prescribed tylenol.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count, Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation and redness at injection sight.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Initial unsolicited report received from a pharmacist on 15 September 2016. This case involves a patient (age and gender not reported) who was vaccinated with a 0.5 ml intramuscular dose of Fluzone QIV (batch number UT5629LA and expiration date 30 June 2017), in the arm on 13 September 2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies. On 13 September 2016, same day following the vaccination, the patient developed redness, rash from elbow to shoulder and itching on injection arm. Patient was seen in Emergency Room of a hospital. The patient's Lab data and corrective treatment not reported. The outcome of the event was reported as unknown. List of documents held by sender: None.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 15 Sep 2016. Manufacturer Report Number: 2016423144. This case involves a patient (gender and age was not reported) who was vaccinated with a dose of TETANUS TOXOIDS (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history includes hyperlipidaemia, diabetes mellitus 2, hypertension (it was unknown whether they are ongoing) and Concomitant medications were not reported. It was reported that the patient was allergic to tetanus toxoids. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a consumer on 15 Sep 2016. This case involves a 53-year-old female patient who was vaccinated with FLU VACCINE (manufacturer: unknown, batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were reported as unknown by reporter. On an unknown date, following the vaccination, the patient had allergic reaction. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose, Wrong drug administered
Clinical narrative: Inncorrect vaccination given to patient. Ped/adol Hep A given instead of adult Hep A.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016417468) on 13-Sep-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to tetanus toxoid. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site, warm to touch, reaction spread over next day over both injection sites-was seen at the doctor and told it was cellulitis-treated with Clindamycin.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe Headache -top of head.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pt was sick at her stomach, had a red, swollen, painful arm where vaccine was administered.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cough, Headache, Influenza like illness, Wheezing
Clinical narrative: Patient called approx 2 1/2 - 3 1/2 hours after vaccination reporting: Headache, Temp over 101 degree F, Body aches, wheezing/coughing, "Flu like symptoms". Symptoms improved after pt. took APAP and Diphenhydramine. Symptoms lasted 3-4pm until 10-11 PM. No symptoms next day - completely resolved.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Arthralgia, Chills, Dizziness, Muscular weakness, Nausea
Clinical narrative: Dizziness, nausea, sore throat, fever chills, severe joint pain and muscle weakness. Patient self-treated with ibuprofen and acetaminophen. Reports symptoms ceased 9/22/16 in the afternoon.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Dizziness, nausea, sore throat, fever chills, severe joint pain and muscle weakness. Patient self-treated with ibuprofen and acetaminophen. Reports symptoms ceased 9/22/16 in the afternoon.
Age: 1.33
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area around injection site red and swollen.
Age: 4.0
Sex: M
Vaccine: FLUX, MMRV, TDAPIPV
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever and seizure.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: Rash, severe pain at injection site, Moderate Fever (101.5), Body aches.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Pain, Rash
Clinical narrative: I had no adverse reaction with atorvastatin, calcium or, gabapentin. I have extreme pain and rash from "PREVNAR 13" continuous pain since December 17, 2015.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Asthenia, Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Generalized weakness mainly legs, vertigo 1 day after PREVNAR 13. Unable to walk, hospitalized 9/7-9/13/16, no other etiology found.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging spinal, Spinal X-ray, Ultrasound Doppler, Vertigo
Clinical narrative: Generalized weakness mainly legs, vertigo 1 day after PREVNAR 13. Unable to walk, hospitalized 9/7-9/13/16, no other etiology found.
Age: 12.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in an unspecified number of patients who received MENVEO. Co-suspect products included BEXSERO. On an unknown date, the patients received MENVEO and BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO and BEXSERO, the patients experienced extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth to be related to MENVEO and BEXSERO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. the physician had prescribed oral antibiotics for most of these patients. the reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc), but none had proved effective in reducing reaction rates. the reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their parents. This case has been linked to 5 other cases (MENVEO vaccine), reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Musculoskeletal stiffness, Rash erythematous, Skin warm
Clinical narrative: FLUZONE HD administered approximately 3:30P 9-22. Patient reported stiffness, general tiredness, some mild dizziness and came in 9-23 approximately 5pm with red warm rash on vaccinated arm extending about 5" down from vaccine site. Advised cold compress and BENAFRYL and seek medical care if not better, it worse or more generalized sx.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Conjunctival haemorrhage, Extra dose administered, Oedema peripheral, Purpura
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of subconjunctival hemorrhage in a 77-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date unknown). Previously administered products included BOOSTRIX (on 28th February 2013). On 19th August 2016, the patient received BOOSTRIX .5 ml. On 19th August 2016, less than a month after receiving BOOSTRIX, the patient experienced extra dose administered. On an unknown date, the patient experienced subconjunctival hemorrhage (serious criteria GSK medically significant), purpura and edema of lower extremities. On an unknown date, the outcome of the subconjunctival hemorrhage and purpura were not recovered/not resolved and the outcome of the edema of lower extremities and extra dose administered were unknown. It was unknown if the reporter considered the subconjunctival hemorrhage, purpura and edema of lower extremities to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient received BOOSTRIX vaccine on right deltoid. The physician reported that the patient experienced unilateral oedema in right lower extremities, bilateral eye sub-conjunctival haemorrhage and purpura in upper extremities. The right sub-conjunctival haemorrhage was resolved and left sub-conjunctival haemorrhage was not resolved. The physician reported that, the patient previously received BOOSTRIX on 28th February 2013, but again on 19th August 2016, the patient received BOOSTRIX, which led to the extra dose administered.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of knee pain in a 64-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. On an unknown date, the patient received the 1st dose of ENGERIX B adult 1 ml and the 2nd dose of ENGERIX B adult. In July 2016, less than a year after receiving ENGERIX B adult and not applicable after receiving ENGERIX B adult, the patient experienced knee pain and leg pain. On an unknown date, the patient experienced arthralgia aggravated. On an  unknown date, the outcome of the knee pain, leg pain and arthralgia aggravated were not recovered/not resolved. It was unknown if the reporter considered the knee pain and leg pain to be related to ENGERIX B adult. It was unknown if the reporter considered the arthralgia aggravated to be related to ENGERIX B adult. Additional details were provided as follows: The health care professional reported that the patient experienced knee arthralgia, aching legs, knees, with the right knee worse than the left knee. In 2016, less than a year after the patient received their 2nd dose of ENGERIX B adult, the arthralgia worsened. The patient did not receive their 1st and 2nd ENGERIX B doses at this reporting physician office, but the patient was ready for their 6 month and final shot in the series. The reporter inquired whether to administer the third dose in series and if arthralgia was a common side effect of ENGERIX B. No product lot or expiration dates of the vaccine were available.
Age: 83.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Back pain, Pain in extremity
Clinical narrative: Injection-No symptoms for two (2) minutes, then-severe lower back pain and minor pain to left leg, for 10 minutes. Pain:-numerous needles to back: then pain subsided.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Welt at site of injection the day after vaccine was administered.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ, orally which had a lot # of M007124, with an expiration date of 05-OCT-2017 and lot # of M014753 and an expiration date of 11-OCT-2017 (concentration, dose number, dose and anatomical place of vaccination were not provided). Which were reported because of a data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 8 months old male patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 02-AUG-2016 at 09:30, the patient was vaccinated with an improperly stored third dose of ROTATEQ lot # L039141 and expiration date 16-AUG-2017, (Strength and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medications was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: (R) leg 1" red area posterior thigh bruise at site. (L) leg 1" red area site with bruise.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Injection site reaction. Was running 104 degree fever seen Dr.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Bone pain, Fatigue, Feeding disorder, Haematochezia
Clinical narrative: Very severe pain: head, liver, muscular, skeleton; strong nausea, unable to eat or drink, extreme tiredness. Impossibility to do any routine activity. In bed for two plus (2+) days.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hepatic pain, Myalgia, Nausea
Clinical narrative: Very severe pain: head, liver, muscular, skeleton; strong nausea, unable to eat or drink, extreme tiredness. Impossibility to do any routine activity. In bed for two plus (2+) days.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 76 years female received her PNEUMOVAX 23 vaccine at pharmacy in her left deltoid. Patient comes today (09-17-2016) complaining of pain and discomfort at the injection site in the left shoulder. She also reports having a low fever at 100. On physical exam the area of injection is warm, tender, hard, swollen, and red. The swelling extend down to the level of elbow. Patient is able to move her arm. Patient advised to go to emergency and refused to call 911 for her.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: 76 years female received her PNEUMOVAX 23 vaccine at pharmacy in her left deltoid. Patient comes today (09-17-2016) complaining of pain and discomfort at the injection site in the left shoulder. She also reports having a low fever at 100. On physical exam the area of injection is warm, tender, hard, swollen, and red. The swelling extend down to the level of elbow. Patient is able to move her arm. Patient advised to go to emergency and refused to call 911 for her.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia
Clinical narrative: Employee c/o double vision in (R) eye, he had surgery on (R) eye back in the summer and he feels it could be reaction to the flu shot.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: (9/21)12:15: left arm numbness. (9/21)14:15: face numbness. 09/22/2016: diagnosed with Bell's Palsy at doctor's office, prescribed acyclovir, methylprednisolone. 09/23/2016 self reported improvement.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dry skin, Erythema, Pruritus, Urticaria
Clinical narrative: Patient stated she had Hives on her face from just below her eyes to her neck. They were around her mouth. Patient took a Benadryl. The next day her symptoms had improved but her skin is really dry now and her chest was red and itchy.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Blood electrolytes normal, Electrocardiogram abnormal, Supraventricular tachycardia, Thyroid function test normal, Troponin normal
Clinical narrative: Developed Supraventricular Tachycardia with a Heart Rate into the 200's.  Documented at a local hospital.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Blood test, Electromyogram, Muscular weakness, Myelitis transverse
Clinical narrative: Initial symptoms woke up lost his balance and lower extremity weakness, and hospitalized for 4 weeks, and eventually diagnosed with Idiopathic transverse myelitis on 3/2015 after what pt feels is related to the Pneumovax immunization.  He has a ngeative MRI and negative inflammatory last test.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial symptoms woke up lost his balance and lower extremity weakness, and hospitalized for 4 weeks, and eventually diagnosed with Idiopathic transverse myelitis on 3/2015 after what pt feels is related to the Pneumovax immunization.  He has a ngeative MRI and negative inflammatory last test.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Severe headache, emesis the same day once, then fever 102 for 2 days.  Headache lasted for 5 days, less severe after the 1st day.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAR-2016, the patient was vaccinated with the first dose of the vaccination series, GARDASIL (route of administration, lot number and expiry date were not reported). On 28-JUL-2016, the patient received the second dose of the vaccination series, GARDASIL 9 (intramuscularly, dose: 0.5 ml, lot# L048459, expiry date: 22-FEB-2018). No concomitant therapy was reported. No adverse effect was reported. The patient's outcome was not reported. Relatedness between the adverse event and vaccination with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70-year-old female patient with Crohn's disease. The patient's medical history included palpitations after SUDAFED. Concomitant therapies included PENTASA. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX. On 03-SEP-2016, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneously (dose and lot number not reported). On 03-SEP-2016, the patient had itching and warmth to the are of injection. No rash was present. There were no lab diagnostics studies performed. The patient sought unspecified medical attention and was given treatment for the adverse events. The outcome of itching and warmth to the area of injection was unknown. The relationship between vaccination with ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in September 2013 the patient was vaccinated with GARDASIL (lot # J0006850, expiry date: 31-MAR-2016). On an unknown date in August 2016, the patient received the next dose of GARDASIL 9 (also reported as "Unknown if GARDASIL HPV4 or GARDASIL 9") (Lot # M0003659, expiry date: 20-SEP-2017). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates or on 01-AUG-2016, some patients among these multiple unspecified patients were vaccinated with improperly stored ROTATEQ (lot # M019690, expiration date 02-NOV-2017, oral, dose not reported). On 21-JUN-2016 or 14-JUL-2016 or 03-AUG-2016 or 09-AUG-2016, another some unspecified patients were vaccinated with the same improperly stored vaccine (lot # L033543, expiration date 30-MAY-2017, oral, dose not reported). On 14-JUL-2016, another some unspecified patients were vaccinated with the same improperly stored vaccine (lot # K022995, expiration date 22-JUL-2016, oral, dose not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L013190, expiration date: 16-NOV-2016, (Strength and dose were unknown by the reporter), orally. Patients' concomitant medication was not reported. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: FLU4, HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Medication error-FLUZONE over 3 yrs old was given to a less than 3 patient.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling, extreme redness from above elbow to shoulder. This was 4 days after injection.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received FLUZONE vaccine intended for 3 years of age or older.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Dad reported swelling. Warmth and redness to left deltoid 1 day after immunization. Area of swelling 7x7 cm. Given BENADRYL and are iced. Resolved on 9/10/16.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Pain, Skin warm, Somnolence
Clinical narrative: Mom stated 1 hr after shot, area began to swell with redness, warmth and pain. Swelled to baseball size 9-16. 9-17 had a temp of 102.6 and was sleepy. Treated with ibuprofen, BENADRYL and ice packs to area. Swelling receded and back to normal by 9/17/16.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Mom stated 1 hr after shot, area began to swell with redness, warmth and pain. Swelled to baseball size 9-16. 9-17 had a temp of 102.6 and was sleepy. Treated with ibuprofen, BENADRYL and ice packs to area. Swelling receded and back to normal by 9/17/16.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Awoke 9-23-16 with fever, chills, (L) deltoid hot to touch, redness, swollen. Given TDaP 9-21-16. TX with KEFLEX one tab QID x 7 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid where DTaP given slight swollen with pinkness. Warm to touch.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, can't raise.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Incoherent, Loss of consciousness, Pain, Pallor
Clinical narrative: EMS called. No treatment. Pale, lost color in face, passed out, incoherent. After 10 min color came back. Pain upon moving.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Headache, Hypersensitivity, Musculoskeletal pain
Clinical narrative: Pt called 09/21/16 and spoke with triage R.N. Pt states she had an allergic reaction to pneumonia vaccine, given 09/19/16. Pt reported redness, warm to touch, pain, shoulder pain, and stiffness in right arm. Pt reported having sx of chills and headache (09/19/16). Time of call 9/21/16 at 2:22 pm. PCP notified. PCP returned phone call to patient at 4:06 pm 9/21/16.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain, Skin warm
Clinical narrative: Pt called 09/21/16 and spoke with triage R.N. Pt states she had an allergic reaction to pneumonia vaccine, given 09/19/16. Pt reported redness, warm to touch, pain, shoulder pain, and stiffness in right arm. Pt reported having sx of chills and headache (09/19/16). Time of call 9/21/16 at 2:22 pm. PCP notified. PCP returned phone call to patient at 4:06 pm 9/21/16.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, itching, swelling to insertion site 9/21. Area of redness has gotten larger and more tender since then. Area is warm to touch. Patient prescribed a round of steroids and will return for re-check.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered MenCYW-135 liquid conjugate without reconstituting with MenA Lyophilized conjugate.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination site mass
Clinical narrative: On Tuesday patient reports a lump at vaccination site accompanied by redness, warmth & itching. She called me at the pharmacy on Wednesday (9/21) to report this. I recommended she take diphenhydramine 25mg, ibuprofen 600mg and use ice as needed for the warmth and itching. Also she was going to take a CLARITIN 10mg the next morning. I followed up with her Thursday (9/22) afternoon. She reported the warmth and itching had subsided but the lump was still present. She was going to call her primary care physician today (9/23) to let him know and to ask if she should be seen or wait thru the weekend.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever of 101, severe chills, muscle aches, lethargy. Lasted from about 8PM the day of the vaccine until the next morning.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Lethargy, Mobility decreased, Nausea, Paraesthesia
Clinical narrative: Patient at first felt an electric shock 15 min after she received the vaccine. Then when she arrived home felt very lethargic and took a nap. When she awoke, she felt feverish, couldn't move and very nauseated. She called 911 and went to the hospital where they gave her IV fluids and Zofran.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient at first felt an electric shock 15 min after she received the vaccine. Then when she arrived home felt very lethargic and took a nap. When she awoke, she felt feverish, couldn't move and very nauseated. She called 911 and went to the hospital where they gave her IV fluids and Zofran.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient claims that arm is still sore, swollen and warm to the touch. The soreness and swollen is below the injection site.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Peripheral swelling
Clinical narrative: Arm swelled, difficult to raise/grab/lift anything, same side knee swelled and painful.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RV5
Symptoms: Fatigue, Noninfective encephalitis, Pyrexia, Weight bearing difficulty
Clinical narrative: Soft spot bulging out/ brain inflammation. Fever. Tired wouldn't wake up. Has milestone delays. Couldn't bear weight on his legs for months, he was doing it before vaccines.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient's arm is red and warm at injection site and she feels like she has a fever "feels terrible".
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: Patient has reported a fever with night sweats and chills.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Herpes zoster, Pruritus, Urticaria
Clinical narrative: On the evening of 9/16/16, patient presented with itchy, red, raised/welted areas about the size of a 50 cent piece on the upper right portion of his trunk and right arm. He also went to the doctor who diagnosed him with shingles.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Gluten sensitivity, Injection site pain, Lethargy
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (the patient's mother) and then from a contactable nurse on behalf of a physician. A 16-year-old female patient received the first single dose of TRUMENBA, (lot M37315) intramuscular in the right deltoid, on 04May2016 at 04:30 pm, for immunisation. Relevant medical history included acne, seasonal allergies and abdominal pain. Concomitant medications included oral doxycycline (unknown manufacturer, tablet) at 100 mg daily from unknown date (about 1 1/2 years before this report) for abdominal pain and acne, IMODIUM for abdominal pain, ongoing norgestimate and ethinyl estradiol (unknown manufacturer) oral at 1 DF daily from Jan2016 for acne. On the same date of meningococcal group b rlp2086 the patient also received the second single dose of MENACTRA, (Sanofi Pasteur, lot U5185BA) given intramuscular in the left deltoid (the patient had received for immunisation on an unspecified date the first dose of this meningococcal vaccine without any adverse event). The patient was vaccinated to the physician office. On 04May2016 the patient experienced soreness at injection site about an hour or two after she went home, and on the night she was extremely lethargic. She was wiped out for 2-3 days. The patient experienced gluten sensitivity in Jul2016. Due to the reported events the patient was visited, but no specific tests and/or treatment were required. The events did not require an emergency room or physician visit.  The outcome of gluten sensitivity was unknown while the patient recovered from the soreness at injection site on 07May2016 from and wiped out on 04May2016 and from the lethargy on 08May2016. The reporting nurse considered that meningococcal group b rlp2086 had a causal effect to the adverse event wiped out. Follow-up (15Aug2016): New information reported from a contactable nurse on behalf of a physician includes: suspect vaccine details (lot, route, anatomical location and time of administration), concomitant medications (meningococcal vaccine and loperamide hydrochloride were added), reaction data (new event wiped out was added), details on visit, treatment and tests, causality assessment. Follow-up (13Sep2016): New information reported from a contactable nurse includes outcome of the event. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): 2016364316 Legacy paper report number.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Irritability, Pharyngitis streptococcal, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician (Pediatrician) through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 1st of 3 patients. A 18-year-old female patient of an unspecified race received two doses of TRUMENBA intramuscular at 0.5 ml single, the first on 08Feb2016 and the second dose on 08Aug2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headaches, chills, irritability and fever for both injections, started within a day of both injections and lasted about 2 days after on an unspecified date in 2016 with outcome of unknown. The patient also experienced wound up having strep throat on an unknown date with outcome of unknown. Follow-up (12Sep2016): New information received from a contactable Other HCP includes: New reporter details. Follow-up (13Sep2016): New information received from the contactable physician includes wound up having strep throat added as adverse event. Sender's Comments: Linked Report(s): US-PFIZER INC-2016402459 same reporter, same drug, same AE, different pt. US-PFIZER INC-2016402890 same reporter/drug/event, different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The solicited report was received from a physician referring to a 62 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2015, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in March 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a physician referring to a 65 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2010, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in May 2016, the patient went down with "mild case" of shingles that last approximately 3 days after receiving ZOSTAVAX . The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date and site were not reported), subcutaneously. It was provided that the dose of vaccine had been reconstituted with more than the recommended 0.5 ml. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Papule, Skin discolouration
Clinical narrative: Mom noted skin colored papules day after vaccines along both thighs. On 09/19 scabbing near some papules along right thigh. Rash worse this time than previously seen/reported with last vaccine administrations. No evidence of allergic reaction. No evidence of other systemic reactions at this time.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Neoplasm malignant, Psoriasis
Clinical narrative: Information has been received from a 94 years old female patient referring to herself. The patient had cancer in spleen. She had no drug reaction or allergies. Concomitant therapy included levothyroxine sodium (manufacturer unknown). On an unspecified date in approximately September 2012 (about 4 or 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (strength and dose unknown, route reported as vaccine). Some years later, on an unknown date, the patient got cancer and then since she had a weak "immune system", she believed this triggered her body to get shingles. She stated she had the shingles for a year since 18-SEP-2015. She went to a clinic and they gave her some strong pills that she believed contain opium. After that she still had the shingles, so someone prescribed her the gabapentin, but then she broke out with psoriasis. Now she took TYLENOL maybe once a week. She woke up with the shingles in the morning and went to sleep with it. She was able to sleep even though she has the shingles. No lab was performed. The outcome of the events were unknown. The causal relationship between the events and ZOSTAVAX was unknown. Upon internal review, cancer was considered to be medically significant. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a "couple of patients" of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-SEP-2016, the patient's were vaccinated with improperly stored ZOSTAVAX 19400 Plaque Forming Unit (dose and route not reported) from lot # L046900 with expiry date of 23-FEB-2017, lot # L039095 with expiry date of 15-JAN-2017. The vaccines were exposed to a temperature of 11.87 Fahrenheit for a time frame of 1 to 5 minutes. Digital data logger was involved. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients' were vaccinated with improperly stored ROTATEQ (lot # L033693 expiry date 31-MAY-2017, lot# M012495 expiry date 09-OCT-2017, lot# M025568 expiry date 07-NOV-2017). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report was received from a physician referring to an 89 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2008, the patient was vaccinated with his first dose of ZOSTAVAX, one time injection (route of administration, lot # and expiry date were not reported). On an unknown date in July 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted in waiting room after checking out.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017) 0.65 ml. Excursion temperature was possibly 9F for 288 hours. No adverse effects reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Bone pain, Injection site pain
Clinical narrative: In for Hep A vaccine today and reports that left deltoid muscle still sore and tender after BEXSERO given 9-9-16. ROMWNL. No redness or firmness notes to sites. Patient states (L) deltoid muscle became sore 2-3 hours after vaccine given 9-9-16. States that she had "bone" pain up to (L) side of neck and down (L) back, along with (L) deltoid sore. States "bone" pain lasted up to 2-3 days ago. From shoulder to neck. Denies further "bone" pain.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Feeling abnormal, Pyrexia, Throat irritation
Clinical narrative: Scratchy throat, dizzy, fever for 2 days.  Generally felt out of sorts.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Altered state of consciousness, Blood glucose normal, Flushing, Foaming at mouth, Hyporesponsive to stimuli
Clinical narrative: Around 12:54 pm, the father frantically carried him into the clinic.  Father passed the patient to me and I carried him into room 2 onto the table. He was slightly responsive but had foaming saliva around the mouth, and when his mother asked him to repeat his sister's name he repeated it. He was not in an respiratory distress. His father denied any seizures, but said he was almost passing out. Blood glucose was checked and it was 118 by MA. The patient responded to the fingerprick and cried normally. Pulse ox with portable finger oximetry was at 65-70% but that was rechecked with a child pulse oximetry which confirmed the low oxygen level. MA, brought the oxygen. Oxygen 10 L face mask was given. Because the patient did not like the face mask, we sat him up in his father's lap. We removed the oxygen and his oxygen level was more than 95%. However, then he lost consciousness for less than 10 seconds. No seizure activity. Once we moved him back to the table and put on oxygen he woke up again. That is when we noticed the hive over 5-7 cm oval next to the left leg injection site. Because he had a change in mental status, I decided to give epinephrine 0.15 mg SQ. The injection was given by RN at 1:03 pm.  911 was called by MA. After the injection, the patient's mental status returned to normal and he started talking. He face and body became flushed and there was mild swelling in the extremities.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site urticaria, Loss of consciousness, Mental status changes, Oxygen saturation decreased, Peripheral swelling
Clinical narrative: Around 12:54 pm, the father frantically carried him into the clinic.  Father passed the patient to me and I carried him into room 2 onto the table. He was slightly responsive but had foaming saliva around the mouth, and when his mother asked him to repeat his sister's name he repeated it. He was not in an respiratory distress. His father denied any seizures, but said he was almost passing out. Blood glucose was checked and it was 118 by MA. The patient responded to the fingerprick and cried normally. Pulse ox with portable finger oximetry was at 65-70% but that was rechecked with a child pulse oximetry which confirmed the low oxygen level. MA, brought the oxygen. Oxygen 10 L face mask was given. Because the patient did not like the face mask, we sat him up in his father's lap. We removed the oxygen and his oxygen level was more than 95%. However, then he lost consciousness for less than 10 seconds. No seizure activity. Once we moved him back to the table and put on oxygen he woke up again. That is when we noticed the hive over 5-7 cm oval next to the left leg injection site. Because he had a change in mental status, I decided to give epinephrine 0.15 mg SQ. The injection was given by RN at 1:03 pm.  911 was called by MA. After the injection, the patient's mental status returned to normal and he started talking. He face and body became flushed and there was mild swelling in the extremities.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness, redness, and swelling to injection site of right upper arm and left upper arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Apnoea, Chills, Decreased appetite, Dizziness
Clinical narrative: Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Epistaxis, Haemorrhage, Head injury, Headache, Hot flush
Clinical narrative: Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.