chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Administration site swelling, Hypoaesthesia, Injection site erythema, Lethargy, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a healthcare professional on 23-Oct-2017. This case involves a 42-year-old female patient who was vaccinated with a dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (Batch number: C5036A), IPV (VERO) (POLIO VACCINE) (Batch number: N1F931M) in left deltoid, MEASLES, MUMPS AND RUBELLA VACCINE (M-M-R) (Batch number: M029229) in hip (Expiration date: not reported) (dose, dose in series and route of administration, site of administration were not reported for all) and suspension of injection of DIPHTHERIA/TETANUS ADSORBED TOXOIDS (TETANUS AND DIPHTHERIA TOXOIDS ADSORBED) (Batch number: A098A1, Expiration date: not reported) with 0.5 ml intradermal in right deltoid on 03-May-2017 at 2:00 PM. The patient's medical history were not reported and had taken Synthroid (thyroid medication) as routine medication on 03-May-2017. On 06-May-2017, three days post-vaccination, the patient experienced redness that got increasingly bigger and swelling around the site of administration (right deltoid), shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness, and she felt both sore and lethargic. The patient visited the doctor's office 1-month post-administration. Laboratory data were not reported and no treatment was reported. It was reported that patient's recovery status is unknown. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 23-Oct-2017. This case involves a 42-year-old female patient who was vaccinated with a dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (Batch number: C5036A), IPV (VERO) (POLIO VACCINE) (Batch number: N1F931M) in left deltoid, MEASLES, MUMPS AND RUBELLA VACCINE (M-M-R) (Batch number: M029229) in hip (Expiration date: not reported) (dose, dose in series and route of administration, site of administration were not reported for all) and suspension of injection of DIPHTHERIA/TETANUS ADSORBED TOXOIDS (TETANUS AND DIPHTHERIA TOXOIDS ADSORBED) (Batch number: A098A1, Expiration date: not reported) with 0.5 ml intradermal in right deltoid on 03-May-2017 at 2:00 PM. The patient's medical history were not reported and had taken Synthroid (thyroid medication) as routine medication on 03-May-2017. On 06-May-2017, three days post-vaccination, the patient experienced redness that got increasingly bigger and swelling around the site of administration (right deltoid), shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness, and she felt both sore and lethargic. The patient visited the doctor's office 1-month post-administration. Laboratory data were not reported and no treatment was reported. It was reported that patient's recovery status is unknown. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Back pain, Injection site discolouration, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 28 years old female patient. The patient did not have any concomitant medication, pertinent medical history, drug reactions or allergies. On 22-NOV-2017, the patient was vaccinated with VARIVAX lot # N012618; expiry date 21-APR-2019 (dose and route of administration were not reported). On an unknown date in November 2017 (reported as unspecified time between 22-NOV-2017 and 24-NOV-2017), the patient returned to the pharmacy and the pharmacist noted that, the patient developed a palm sized nodule at the injection site which was purple. The patient felt pain throughout her arm, from her back into her pinky finger. The pharmacist referred the patient to an unspecified clinic and the patient was treated with MOTRIN and hydroxyzine. The outcome of the event was recovering (reported as "The injection site was still swollen and irritated"). The causality assessment was not provided.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site irritation, Injection site nodule, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 28 years old female patient. The patient did not have any concomitant medication, pertinent medical history, drug reactions or allergies. On 22-NOV-2017, the patient was vaccinated with VARIVAX lot # N012618; expiry date 21-APR-2019 (dose and route of administration were not reported). On an unknown date in November 2017 (reported as unspecified time between 22-NOV-2017 and 24-NOV-2017), the patient returned to the pharmacy and the pharmacist noted that, the patient developed a palm sized nodule at the injection site which was purple. The patient felt pain throughout her arm, from her back into her pinky finger. The pharmacist referred the patient to an unspecified clinic and the patient was treated with MOTRIN and hydroxyzine. The outcome of the event was recovering (reported as "The injection site was still swollen and irritated"). The causality assessment was not provided.
Age: 18.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Laboratory test, Urticaria
Clinical narrative: Two days after shot-developed hives-HIVES extensive over next several days-Took BENADRYL. Spoke to teledoc Developed Heartburn-face and lip swelling-Headache-urgent care physician-Took ZYRTEC/PEPSCID.
Age: 18.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Dyspepsia, Headache, Lip swelling, Swelling face, Urticaria
Clinical narrative: Two days after shot-developed hives-HIVES extensive over next several days-Took BENADRYL. Spoke to teledoc Developed Heartburn-face and lip swelling-Headache-urgent care physician-Took ZYRTEC/PEPSCID.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Local hypersensitivity reaction to right upper arm: edema and rubor.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Very painful arm right after vaccine given, and by the end of the day there was already a limited range of motion. Still painful at injection site almost 3 months later, still limited range of motion, hard to raise arm above shoulder height, much weaker in arm (especially when raised up) - very hard to take shirts off over my head now, especially if I need to try to use any strength to pull it off if it's not loose enough and then followed by pain after I finally can exert enough strength to finally get the shirt off. Painful to lay in bed or change sleep positions if needing to use left arm at all.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm redness and swelling.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M048201 with expiry date 05-JUN-2018 or lot # N008826 with expiry date 12-SEP-2018 (dose, vaccination site and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009218: US-009507513-1711USA009219:
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain, Diarrhoea, Hepatitis A, Hepatitis A antibody positive
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 24-year-old female patient.  The patient had none pertinent medical history, none drug reactions or allergies. The patient's concomitant therapies included levothyroxine sodium(manufacturer unknown). On 28-AUG-2017, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml strength, intramuscularly, lot number N005796 with expiration date 26-MAY-2018, (dose and anatomical location were not reported) for Hepatits A Vaccination. On the same date, the patient was vaccinated with a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine, intramuscularly, lot number U5110AA (dose, anatomical location and expiration date were not reported) for prophylaxis. The illness at the time of the vaccination was reported as flu and unspecified thyroid disorder. On 28-SEP-2017 (also reported as October 2017), the patient experienced abdominal pain and loose stools for 3 weeks (diarrhoea).  The patient was seen by the doctor and was diagnosed with Hepatitis A on unspecified date in 2017. Health department traced exposure to hepatitis A at the end of August 2017. On 07-NOV-2017, an Hepatitis A antibody  IgM was performed which result was positive (hepatitis a antibody positive). No treatment was given for the events. At the time of the report, the patient was recovering from the abdominal pain and diarrhea. The outcome of the hepatitis a antibody positive and hepatitis a was unknown. The relatedness between the events and therapy with VAQTA  and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine was not reported.
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site reaction, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse via company representative concerning to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-OCT-2008, the patient was vaccinated with PNEUMOVAX 23 to prevent pneumonia (route, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced fever of 104 °F, severe pain in an unspecified area on her body, injection site swelling and the area was sensitive to touch. On an unspecified date in November 2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular to prevent pneumonia (dose, lot number and expiration date were not reported). Subsequently in 2017, the patient experienced again severe pain in an unspecified area on her body, injection site swelling and the area was sensitive to touch. It was also reported that the patient was seen at the health office for a follow-up appointment. The treatment as well the outcome of the events injection site hypersensitivity, pain, pyrexia and injection site swelling was unknown. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Feeling hot, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from a 57-year-old female patient regarding herself. The patient had none pertinent medical history and none drug reactions or allergies. The patient's concomitant therapies included tizanidine and gabapentin. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The patient did not experience any adverse effects except for a minor temporary soreness at the injection site which was recovered on an unspecified date. Then, on 13-OCT-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23, one shot, injected, (anatomical location, lot number and expiration date were not reported) for prevention of pneumonia. Since 13-OCT-2017, the patient had been experiencing severe pain, swelling, heat, and weakness in her arm. After received the vaccination, the patient went to Emergency Room; she was not admitted to the hospital but she received treatment with MICARDIS, unspecified antibiotics and unspecified steroid. No laboratory diagnostics were performed. At the time of the report, the patient did not recover from the severe pain, furthermore, it was causing her on unspecified date to cry frequently and often prevented her from sleeping at night. Additionally, in 2017 the patient could not raise her arm because of how badly her arm hurt. The outcome of the muscular weakness, injected limb mobility decreased, peripheral swelling, feeling hot, insomnia and crying was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 57-year-old female patient regarding herself. The patient had none pertinent medical history and none drug reactions or allergies. The patient's concomitant therapies included tizanidine and gabapentin. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The patient did not experience any adverse effects except for a minor temporary soreness at the injection site which was recovered on an unspecified date. Then, on 13-OCT-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23, one shot, injected, (anatomical location, lot number and expiration date were not reported) for prevention of pneumonia. Since 13-OCT-2017, the patient had been experiencing severe pain, swelling, heat, and weakness in her arm. After received the vaccination, the patient went to Emergency Room; she was not admitted to the hospital but she received treatment with MICARDIS, unspecified antibiotics and unspecified steroid. No laboratory diagnostics were performed. At the time of the report, the patient did not recover from the severe pain, furthermore, it was causing her on unspecified date to cry frequently and often prevented her from sleeping at night. Additionally, in 2017 the patient could not raise her arm because of how badly her arm hurt. The outcome of the muscular weakness, injected limb mobility decreased, peripheral swelling, feeling hot, insomnia and crying was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M048201, expiration date 05-JUN-2018 or lot # N008826, expiration date 12-SEP-2018 (dose, vaccination site and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1711USA005336: US-009507513-1711USA009219:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001527, expiration date 13-JAN-2019 (dose, vaccination site and route of administration were not reported) which was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported) for prophylaxis. No adverse effect were reported. Administered dose of vaccine underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1711USA009218: US-009507513-1711USA005336:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with PROQUAD injection, lot # M042500 with expiration date: 17-APR-2018, therapy type: recombinant human albumin (rHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 9 to 8 degrees Celsius for 7 hours. There was no previous temperature excursion. Digital data logger was used. Product quality complaint was not involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-JAN-2014, 06-MAR-2014 and 07-JUL-2014, the patient received the first, second and third doses of GARDASIL for prophylaxis (strength, dose, route, lot # and expiration date were not reported), respectively. Then, on 24-NOV-2017, the patient received an extra dose of GARDASIL 9 for prophylaxis, lot #N021571, expiration date on 29-APR-2020 (strength, dose and route were not reported). No symptoms were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, reported as "during his childhood" the patient was vaccinated with two doses of VARIVAX injection, subcutaneous (strength, dose, lot # and expiration date were not provided) to prevent chickenpox. On an unknown date in approximately 2017, (reported as over 5 weeks ago) the patient had a blood titer performed, which was negative for varicella antibodies. No treatment was given for the event. After that, on an unknown date in approximately 2017, the patient received a third dose of VARIVAX injection, subcutaneous (strength, dose, lot # and expiration date were not provided). The outcome of the event and the relatedness between the event and VARIVAX were not reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD subcutaneously in the abdomen (dose, frequency, lot# and expiration date were not reported). No adverse effects were reported. No causality assessment was reported.
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 25 year old female patient. Concurrent conditions, medical history and concomitant medications were not reported. On 09-SEP-2017, the patient was vaccinated with GARDASIL 9, for prevention of HPV; dose number, frequency, route of administration, lot # and expiration date were unknown. It was reported that on 12-SEP-2017, the patient experienced grand mal seizure which caused hospitalization (on an unspecified date in 2017). The patient received treatment with oxcarbazapine. It was unknown if laboratory tests were performed. The outcome for the event grand mal seizures as well as the causality were unknown by the reporter. Upon internal review the event grand mal seizures was considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy breast abnormal, Chemotherapy, Incomplete course of vaccination, Invasive lobular breast carcinoma, Lobular breast carcinoma in situ
Clinical narrative: This spontaneous report was received from a physician referring to a 34 year old female patient with no pertinent medical history or drug allergies/drug reactions. Information regarding concomitant medications was not provided. On an unspecified date in 2007 (reported as ten years ago) the patient was vaccinated with two doses of GARDASIL (frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. However, the physician reported that the patent's third dose was missed. Physician reported the patient was diagnosed with invasive lobular carcinoma of the breast stage 1b by mammogram, MRI (magnetic resonance imaging) of the breast, and breast biopsy in January 2016. It was also reported that the patient received unspecified chemotherapy. The outcome of invasive lobular breast carcinoma was unknown. The reporter did not assess the causal relationship between therapy with GARDASIL and invasive lobular breast carcinoma. Upon internal review, invasive lobular breast carcinoma was considered to be a medically significant event.
Sex: F
Vaccine: HPV4
Symptoms: Mammogram abnormal, Nuclear magnetic resonance imaging breast abnormal
Clinical narrative: This spontaneous report was received from a physician referring to a 34 year old female patient with no pertinent medical history or drug allergies/drug reactions. Information regarding concomitant medications was not provided. On an unspecified date in 2007 (reported as ten years ago) the patient was vaccinated with two doses of GARDASIL (frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. However, the physician reported that the patent's third dose was missed. Physician reported the patient was diagnosed with invasive lobular carcinoma of the breast stage 1b by mammogram, MRI (magnetic resonance imaging) of the breast, and breast biopsy in January 2016. It was also reported that the patient received unspecified chemotherapy. The outcome of invasive lobular breast carcinoma was unknown. The reporter did not assess the causal relationship between therapy with GARDASIL and invasive lobular breast carcinoma. Upon internal review, invasive lobular breast carcinoma was considered to be a medically significant event.
Age: 4.0
Sex: M
Vaccine: FLUX, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 102.9 for 3 days, not linked to illness.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Per patient red blotches appeared on 12/08/2017, no itchiness, no burning. Patient start taking Benadryl, blotches starting to fade out.
Age: 14.0
Sex: F
Vaccine: FLUC4, HPV9, PPV
Symptoms: Erythema, Local reaction, Pain in extremity
Clinical narrative: Localized reaction to PPV 23 with large area erythema and pain to arm. Taken to ER by mother.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Swelling face
Clinical narrative: Patient reports that their face swelled on same side as injection site from ear to lower jaw. Lasted only 2-3 hours.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Contusion, Pain, Rash, Skin discolouration
Clinical narrative: Pain, swelling, chills, rash, discoloration/bruising of the skin below the injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Pain, swelling, chills, rash, discoloration/bruising of the skin below the injection site.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: Fever, chills, shortness of breath, headache, weakness.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Cardiac monitoring, Chest X-ray, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Approximately 15 minutes after administration, pt c/o headache. Within 45 min to 1 hour after administration, pt c/o dizziness, chest pain/pressure, and shortness of breath. Pt was seen in emergency department. Pt was given NS 0.9% via IV; SOLU-MEDROL 125 mg IV; PEPCID 20mg IV; Diphenhydramine 25mg IV; Ketorolac 30 mg IV; Albuterol 2.5mg Inhalation. Pt was released home after treatment.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dyspnoea, Electrocardiogram, Headache, Laboratory test
Clinical narrative: Approximately 15 minutes after administration, pt c/o headache. Within 45 min to 1 hour after administration, pt c/o dizziness, chest pain/pressure, and shortness of breath. Pt was seen in emergency department. Pt was given NS 0.9% via IV; SOLU-MEDROL 125 mg IV; PEPCID 20mg IV; Diphenhydramine 25mg IV; Ketorolac 30 mg IV; Albuterol 2.5mg Inhalation. Pt was released home after treatment.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red, warm and itchy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Influenza virus test, Pyrexia, Seizure, Tremor, Urine analysis
Clinical narrative: Patient received above vaccines in office at approximately 11:20 am on 11/30/17. Started to get fever 102 at 6:30 pm that same evening, 11/30/17. Patient then had seizure with w to 3 minutes of whole body shaking, fever had increased to 104. Patient went to ER where treated with IV fluids, tylenol and ibuprofen. No further seizure activity.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haematoma, Injection site haemorrhage, Injection site pain
Clinical narrative: When needle was removed after injection, blood came out more forceful than usual. Injection site seemed little bruised or have slight hematoma. Dr was notifed. She advised Wellness nurse what to advise patient. Patient was notified and given Dr's advice. Follow up on 12/11/17 - Client reports arm was only slightly sore when pushed on injection site.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received was received from a healthcare worker from the physician's office and refers to a 26 years old female patient. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On an unknown date, the 26 years old patient was vaccinated with GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Age: 37.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a currently 43 years old male patient who was referring to himself. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis, in 0, 2 and 6 months schedule (route of administration, lot number and expiration date was not provided). The patient was 37 years old at the time of the vaccination. No adverse effect was reported.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer (who was enrolled in the market research program) regarding a female patient of unknown age. Information regarding concomitant therapies, concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot # and expiration date unknown) for prevention of human papillomavirus. It was reported that, the consumer watched a program on 20/20, where a family believed that, their daughter experienced serious side effects from GARDASIL. The outcome of the event was unknown. The reporter considered the event to be related to suspect therapy. The reporter considered the event to be serious (medically significant).
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error, Rash, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from an other health professional (Office manager) via Poison & Drug Center (PDC) refers to a currently 6 years old male patient. The patient's concurrent condition included allergy to amoxicillin. On 15-FEB-2013, the patient was vaccinated with first dose of VARIVAX 0.5 ml (Lot # N022983, Expiry date: 23-AUG-2018) (route of administration was not reported) for prophylaxis. On 05-DEC-2017 the patient was vaccinated with second dose of VARIVAX (Lot # and expiry date was not reported) that had undergone an excursion for prophylaxis. The patient had no relevant concomitant medications. The office manager reported that over the years the patient had been seen for upper respiratory infections. On an unknown date in 2017 (reported as for about a month), the patient had a rash on and off around the gluteal area. The physician ordered triamcinolone ointment for the rash. It was unknown if there was relevant lab work performed. It was reported that as of 05-DEC-2017, it was unknown if the patient will receive further doses of VARIVAX. The outcome of the events was unknown. The reporting office manager did not provide the causality assessment for the events.
Sex: M
Vaccine: FLUX
Symptoms: Fear, Injection site pain, Injection site swelling
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a patient, Male consumer, Height: 71.0 Inches; Weight: 215.0 Pounds, who had been receiving Nasal FLUMIST QUADRIVALENT unknown dose, yearly for FLU PREVENTION. The patient's medical history included ALLERGIC REACTIONS TO INJECT-ABLE FLU VACCINE. The patient received FLUMIST QUADRIVALENT on an unknown date for FLU PREVENTION. The patient experienced ARM PAIN AT THE INJECTION SITE, ARM SWELLING AT THE INJECTION SITE and SCARED. The patient recovered from the event of ARM PAIN AT THE INJECTION SITE and ARM SWELLING AT THE INJECTION SITE on an unspecified date and At the time of reporting, the event of SCARED was ongoing. The report was considered to be non-serious by company physician.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Limb mass, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar reports for 2 patients. This is the second of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, (batch number requested) via an unspecified route of administration in the arm on an unspecified date at single dose for routine vaccination and influenza vaccine via an unspecified route of administration on the arm on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with flu vaccine with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the same arm with an inch apart. Then the patient called back and stated that it hurts. The patient also stated that the arms were swollen and got a lump in 2017 (the reporter thought these events happened between Sep2017 and Nov2017). The patient recovered from the events on 2017. The following information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017527179 same reporter drug event different patients.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Limb mass, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 at a single dose and influenza vaccine at unknown dose and frequency, both via an unspecified route of administration in the arm on an unspecified date for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that during the flu season, for the first four patients, the pharmacist co-administered the flu vaccine with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the same arm with an inch apart. The patient called back and stated that it hurt. The patient reported that the arms were swollen and got a lump. The pharmacist thought that the events happened between Sep2017 and Nov2017 and she believed that the patient had recovered completely on an unspecified date in 2017. The pharmacist stated he changed his vaccinating procedures to one vaccine in each arm and hasn't had any problems since. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017527178 same reporter, drug and event/ different patients.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date about a year ago at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient reported major swelling, lot of pain, redness and cellulitis. The symptoms lasted for 2-3 weeks. The patient was put on antibiotic and recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in Dec2017 at single dose as pneumococcal vaccine administered in physician office. Medical history included: the patient is a cancer patient and she had non-Hodgkin's follicular lymphoma. She was also highly allergic to a lot of medications. The patient's concomitant medications were not reported. In Dec2017, the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine, the same afternoon she broke out with red welts all across her body. She clarified that she broke out between her breasts, under her arm, and around her back to the mid part of her back. The patient went back to doctor and she was told to take BENADRYL and TYLENOL and she stated that it seems like it might be going away. The outcome of the event was recovering. The information on the batch number has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 19-year-old male patient received the first dose of TRUMENBA (lot number and expiration date requested), via an unspecified route of administration on the left arm on 09Aug2017 09:30  at a single dose for Meningitis b Prophylaxis at the physician's office. The patient had no medical conditions, concomitant medications or relevant tests. The reporter stated that her son was in college he sleeps at the dorm. She said that before he went to college she took him to see his physician and the physician recommended that he get the meningococcal group b rlp2086 vaccine. The parent stated that her son received the vaccine on 09Aug2017 and the physician told him to come back to get the second shot in the 3 part series in Dec2017. The parent stated that according to the information she read on the meningococcal group b rlp2086 website, he was supposed to get the second injection in 0-2 month after receiving the first injection which was considered an inappropriate schedule of vaccine administered. It was also mentioned that the patient did feel achy for a couple of days after receiving the injection in Aug2017. The outcome of the event of "feel achy" was recovered in Aug2017. The following information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Bronchitis, Condition aggravated, Malaise
Clinical narrative: This is a spontaneous report from Pfizer sponsored program. A contactable female consumer reported for herself. This female patient of an unspecified age and ethnicity receive PREVNAR 13, via an unspecified route of administration on an unspecified date '5 years before reporting' at single dose for pneumonia immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that had asthma and it turned into bronchitis and got deathly ill after the shot, on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Herpes zoster, Muscular weakness
Clinical narrative: Initial unsolicited report received from a veterinarian on 28-Nov-2017. This case involves a 60-year-old female patient who was vaccinated with a second dose of RABIES VACCINE (lot number and expiry date were unknown, route and site of administration were not reported) in 1980. The patient's medical history and concomitant medications were not reported. On an unspecified date in 1980, post-vaccination, the patient had a reaction because the vaccine had duck embryonic contained in it. The patient described her reaction as severe breathing problems and her left arm had poor muscle control and was weak. Later, she also reported that she had an unknown mild case of shingles on unknown date. No further information was available. It was reported that she had titers checked after the reaction and had no titers. Relevant lab investigations were reported as none. On an unknown date, the patient was given unknown steroids and unknown antihistamines for the reaction and 48 hours later she was recovered from the events (reported as she was back to normal). List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm, enlarging warm area, spreading yesterday, but now less red overnight.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Patient states since the vaccination she has only had tenderness.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Cerebrovascular accident, Confusional state, Medical induction of coma, Visual impairment
Clinical narrative: Spouse called pharmacy later that night to report patient was feeling confused and difficulty in seeing . wanted to know if injection could have been  side effect. I check drug reference and told her i did not believe it was the injection and strongly recommended he go to er. He was admitted with a stroke and has since experienced additional stroke in hospital is currently in induced coma in hospital.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-12-11.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-12-07.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: This literature marketed report was received from the author of a published article and refers to a 2-month-old patient on an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date during an office visit, the patient was vaccinated with a dose of GARDASIL 9 instead of LIQUID PEDVAXHIB (dose, route of administration, lot# and expiration date were not provided for both), due to the vaccines name confusion.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reaction was a few inches below injection site and mother said initially it was the size of a 1/2 dollar but now it's about double that size. It's raised, itchy and hot to the touch. Will treat with 5ml's of ZYRTEC BID for a few days and cool compresses.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Bacterial test positive, Cough, Crepitations, Crying, Diet refusal
Clinical narrative: 2 hours after vaccines, baby had high pitched cry. Sounding like screeching, crying for hours and hours. I called the doctor they kept telling me this is "normal just in pain from the injection swelling. Baby thigh actually wasn't red or swollen so I knew that was not it. Baby would not eat at all, had a blank stare and body jerked a little at times. If baby wasn't sleeping, he was crying. I could not console him. Nothing worked. I called on call doctor again that night still crying, whining all day, won't eat, blank stare. Explained baby just doesn't look like himself. Told me again "normal" just monitor him and if anything changes call us back, still very fussy the next day. Next day severe cough, wheezing, crackling in chest, took him to hospital. Albuterol treatments as needed, sent home for "viral Infection" again took him to hospital 2 days later, ?RSV, Bronchiolitis. No signs of improvement going on 11 -12 days, back to doctors. Performed swab nose, positive for 2 viral infections, 2 bacterial infections, which one was HIB.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dyskinesia, Haemophilus test positive, Irritability, Pain, Staring
Clinical narrative: 2 hours after vaccines, baby had high pitched cry. Sounding like screeching, crying for hours and hours. I called the doctor they kept telling me this is "normal just in pain from the injection swelling. Baby thigh actually wasn't red or swollen so I knew that was not it. Baby would not eat at all, had a blank stare and body jerked a little at times. If baby wasn't sleeping, he was crying. I could not console him. Nothing worked. I called on call doctor again that night still crying, whining all day, won't eat, blank stare. Explained baby just doesn't look like himself. Told me again "normal" just monitor him and if anything changes call us back, still very fussy the next day. Next day severe cough, wheezing, crackling in chest, took him to hospital. Albuterol treatments as needed, sent home for "viral Infection" again took him to hospital 2 days later, ?RSV, Bronchiolitis. No signs of improvement going on 11 -12 days, back to doctors. Performed swab nose, positive for 2 viral infections, 2 bacterial infections, which one was HIB.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Viral test positive, Wheezing, X-ray
Clinical narrative: 2 hours after vaccines, baby had high pitched cry. Sounding like screeching, crying for hours and hours. I called the doctor they kept telling me this is "normal just in pain from the injection swelling. Baby thigh actually wasn't red or swollen so I knew that was not it. Baby would not eat at all, had a blank stare and body jerked a little at times. If baby wasn't sleeping, he was crying. I could not console him. Nothing worked. I called on call doctor again that night still crying, whining all day, won't eat, blank stare. Explained baby just doesn't look like himself. Told me again "normal" just monitor him and if anything changes call us back, still very fussy the next day. Next day severe cough, wheezing, crackling in chest, took him to hospital. Albuterol treatments as needed, sent home for "viral Infection" again took him to hospital 2 days later, ?RSV, Bronchiolitis. No signs of improvement going on 11 -12 days, back to doctors. Performed swab nose, positive for 2 viral infections, 2 bacterial infections, which one was HIB.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus
Clinical narrative: Small rash of hives around the area of injection and some itching "inside" his ears.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fluid intake reduced, Hypophagia, Malaise, Muscle spasms
Clinical narrative: Patient received the vaccine at 10:00 AM on 12/11/17 and started feeling ill (nausea) around 3:00-4:00 PM on 12/11/17. Around 7:00 PM that same day, patient started having diarrhea and vomiting. That same evening he experienced leg cramps throughout the night. He continued to feel ill and have muscle cramps until about 11:00 AM on 12/13/17. The illness subsided on its own - the patient did not seek medical treatment or take any medications for the illness. However, he was unable to eat or drink much during the course of the illness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received the vaccine at 10:00 AM on 12/11/17 and started feeling ill (nausea) around 3:00-4:00 PM on 12/11/17. Around 7:00 PM that same day, patient started having diarrhea and vomiting. That same evening he experienced leg cramps throughout the night. He continued to feel ill and have muscle cramps until about 11:00 AM on 12/13/17. The illness subsided on its own - the patient did not seek medical treatment or take any medications for the illness. However, he was unable to eat or drink much during the course of the illness.
Age: 75.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain, Myalgia, Pain, Sleep disorder
Clinical narrative: Upper frontal shoulder pain including muscles near my neck. Unable to move arm (RT) to reach for an object, unable to move my face/head without pain and unable to sleep on my right side (injection side). Arm has no pain itself. Heat pads and my Dr's  prescribed Med  have not helped at all including daily arm and neck physical exercise plus daily NSAID has not helped at all.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received PNEUMOVAX and FLUZONE HD on 9/14/17. Both were given in left arm for medical reasons. Reports arm is swollen, red, sore, and hot to touch.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe shoulder and arm pain on affected side. Decreased ROM. Tender to palpation. Cannot use arm due to pain.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient got FLUAD shot 12/01/2017 and called in the evening complaining of severe pain in left arm, unable to move arm completely. By todays day, 12-07-17, patient feels much better but still have some pain in left arm.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swollen arm followed by rash.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Client was given MenB, vs recommended Men ACWY for her age. No adverse effects to client, as doctor's office identified discrepancy and notified client's parent.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. From 08-NOV-2017 to 14-NOV-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020, dose, schedule, route of administration were not reported) and PEDVAXHIB (lot # N012120, expiration date:01/30/2020, dose, schedule, route of administration were not reported) both for prophylaxis. Reporter stated that on unknown date, the vaccines were stored between 9 degrees Celsius to 25 degrees Celsius for 5 minutes. There were no previous temperature excursions. The digital data logger was involved. The patients did not experienced any adverse events. Product quality complaint was not involved.