chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm and intramuscular formulation administered by other route. The patient was treated with BENADRYL and Ice Pack (Nos). On an unknown date, the outcome of the swelling arm and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were reported as follows: The reporter was a pharmacist calling on behalf of the patient. The reporter stated that the patient received SHINGRIX subcutaneously on left arm, which led to incorrect route of administration. The reporter also reported that the patient had a swollen arm after the SHINGRIX dose. The patient used BENADRYL and ice on the swollen arm. The reporter stated that she would also be filling out a VAERS report for this event.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 16th July 2018, the patient received SHINGRIX (intramuscular). On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills and tremor. On an unknown date, the outcome of the injection site pain, fever, chills and tremor were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills and tremor to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported the patient had a fever of 103 degree F with shakes and chills for a day after getting SHINGRIX. Less than a day after vaccination, the patient also had pain in her arm at the injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 74-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th June 2020) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 18th July 2018, the patient experienced injection site lump, headache, injection site pain, chills, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site lump, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the headache, chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site lump, headache, injection site pain, chills, injection site warmth, injection site erythema and fever to be related to SHINGRIX. Additional information reported as follows: In the evening, 1 day after vaccination the patient had a knot about 4 inches in diameter on her arm at the injection site, which was red, hot to touch and painful. The day of reporting, the fever and chills had resolved, but the knot was still present and was still red, hot to touch and painful.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 74-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th June 2020) for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 18th July 2018, the patient experienced injection site lump, headache, injection site pain, chills, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site lump, injection site pain, injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the headache, chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site lump, headache, injection site pain, chills, injection site warmth, injection site erythema and fever to be related to SHINGRIX. Additional information reported as follows: In the evening, 1 day after vaccination the patient had a knot about 4 inches in diameter on her arm at the injection site, which was red, hot to touch and painful. The day of reporting, the fever and chills had resolved, but the knot was still present and was still red, hot to touch and painful.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Intensive care, Type 1 diabetes mellitus
Clinical narrative: 1 month after receiving the vaccine, patient was admitted critically ill to ICU for the onset diabetes Type 1. Was seen 1 month prior for WCC and was asymptomatic. Date of vaccine 06/27/2018. Date of hospital admission 07/28/2018.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Wife states that the patient woke up this morning around 3:30, extremely dizzy and nauseous. She noted that he has been running a fever, but did not have a reading. He has vomited and has not been able to keep down solid food. He has also experienced diarrhea.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: SHINGRIX vaccine caused a flu like illness, a red injection site so painful I could not raise my arm. I had a fever 101 on second day. I was ill for 7 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Gait disturbance
Clinical narrative: Pain, Redness and swelling of arm. Had 6" X 6" hardness and swollen arm, shivering, fatigue, mild fever, severe muscle and joint paint. Almost unable to walk for 2 days. I was unable to do regular activities for 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Loss of personal independence in daily activities, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, Redness and swelling of arm. Had 6" X 6" hardness and swollen arm, shivering, fatigue, mild fever, severe muscle and joint paint. Almost unable to walk for 2 days. I was unable to do regular activities for 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain, Redness and swelling of arm. Had 6" X 6" hardness and swollen arm, shivering, fatigue, mild fever, severe muscle and joint paint. Almost unable to walk for 2 days. I was unable to do regular activities for 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: The arm pain, achiness and chills, started right away. About 8 pm at night, I started feeling waves of nausea, dizziness and started vomiting. I broke out into a sweat that drenched my hair and body. Also, stomach cramping and non stop runny nose. This lasted a full 5 hours, until 1 a.m. this morning (7-30-18) Still have some mild nausea and stomach pain, but am better today. This is worse than dose number 1. I had nausea with that, but never vomiting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Vomiting
Clinical narrative: The arm pain, achiness and chills, started right away. About 8 pm at night, I started feeling waves of nausea, dizziness and started vomiting. I broke out into a sweat that drenched my hair and body. Also, stomach cramping and non stop runny nose. This lasted a full 5 hours, until 1 a.m. this morning (7-30-18) Still have some mild nausea and stomach pain, but am better today. This is worse than dose number 1. I had nausea with that, but never vomiting.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: Patient was talking and laughiong throughout administration. Told parent that she needed to wait 15-20 mins after vaccines to make sure she feels OK. About 5 mins after vaccines given, patient was being moved to an outside hall bench (within the practice) she took a few steps and stated her eyes felt "funny" and she became pale and slightly sweaty. Moved to a lying position with feet elevated above heart. Given water. Patient felt "back to normal" about 10 mins later. Kept an additional 15 mins for observation.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Arthralgia, Burning sensation, Epstein-Barr virus test positive, Hypoaesthesia
Clinical narrative: A few weeks after SHINGRIX admin pt. started experiencing knee pain and then other joint pain. Pain was described as numbing, burning and tingling of booths hands and feet. blood work done by Dr. indicates elevated alt and reactivated Epstein barr. pt. had chicken pox 8 yrs. ago and has done nothing medically before the shot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: A few weeks after SHINGRIX admin pt. started experiencing knee pain and then other joint pain. Pain was described as numbing, burning and tingling of booths hands and feet. blood work done by Dr. indicates elevated alt and reactivated Epstein barr. pt. had chicken pox 8 yrs. ago and has done nothing medically before the shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Shivering, headache, muscle aches, nausea.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site inflammation, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: SIGHT INFLAMMATION, SWELLING AND PAIN, PATIENT EXPERIENCED NECK PAIN, FEVER AND CHILLS.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: SIGHT INFLAMMATION, SWELLING AND PAIN, PATIENT EXPERIENCED NECK PAIN, FEVER AND CHILLS.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Gastrooesophageal reflux disease, Influenza like illness, Muscle tightness
Clinical narrative: EXPERIENCED FLU-LIKE SYMPTOMS EARLY AFTERNOON FRIDAY, JULY 27, 2018 THEN ON SATURDAY EXPERIENCED A TIGHT FEELING IN CHEST AND ONE SIDE OF THE NECK THAT FELT LIKE AIR PRESSURE, LIKE HE NEEDED TO BURP. THAT FEELING DIDN'T SUBSIDE BY SUNDAY SO HE WENT TO THE EMERGENCY ROOM AND THEY RULES OUT HEART AND TREATED HIM FOR GERD. MD STATED THIS COULD BE RELATED OR JUST A COINCIDENCE UPON RECEIVING THE SHINGRIX VACCINE.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Influenza like illness, Injection site pain, Middle insomnia
Clinical narrative: Pain at injection site more than a tetanus. Woke up overnight with aches in body similar to a flu symptom, tired and achy and sweating.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain at injection site more than a tetanus. Woke up overnight with aches in body similar to a flu symptom, tired and achy and sweating.
Age: 19.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Dyspnoea, Hypersensitivity, Rash, Throat tightness, Vomiting
Clinical narrative: Rash over neck/face, chest. SOB. vomiting and throat tightness. 19 yo female presents by private vehicle for evaluation of allergic reaction. Pt reports 1hr of progressively increasing: (+) rash over neck/face chest (-) facial swelling (-) tongue swelling (-) dysphonia (-) difficulty swallowing (+) SOB (-) wheezing (+) vomiting x 1 (+) throat tightness. She received her Tdap and meningitis vaccine today and symptoms started within 1-2 hours of receiving these. The patient reports no prior hx of similar problem. No other new foods, medications or exposures. EPIPEN IM given. BENADRYL 50 mg IM, ZANTAC 300 mg by mouth and prednisone 60 mg by mouth given. She is observed in the emergency department for approximately two hours, resolution of symptoms noted and she feels ready to go home. They verbalize understanding of discharge instructions as well as return precautions.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed red, goose egg at injection site. Itching at site. Pt did have pain when injection occurred. On 7/27/18 redness measured 11x12cm.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Rash 5 inches length of Deltoid, swelling, hot to touch and pain. Treatment per MD Ice for 15 min 3 times a day, BENADRYL every 6 hours for swelling and itching. Patient will use 911, ER or Urgent Care if symptoms worsen.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Antinuclear antibody negative, Borrelia test negative, C-reactive protein normal, Dysarthria, Electroencephalogram normal
Clinical narrative: Pt received her Tdap, MENACTRA and HPV vaccines on 7/2/18, her parents noticed some slurred speech intermittently within a few days and saw me in the office on 7/9/18. Multiple lab tests were normal, brain MRI/MRA and EEG. Her exam was also normal both by me and Neuro. Seems to have resolved after 2-3 weeks.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Full blood count normal, Metabolic function test normal, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal
Clinical narrative: Pt received her Tdap, MENACTRA and HPV vaccines on 7/2/18, her parents noticed some slurred speech intermittently within a few days and saw me in the office on 7/9/18. Multiple lab tests were normal, brain MRI/MRA and EEG. Her exam was also normal both by me and Neuro. Seems to have resolved after 2-3 weeks.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Serum ferritin normal
Clinical narrative: Pt received her Tdap, MENACTRA and HPV vaccines on 7/2/18, her parents noticed some slurred speech intermittently within a few days and saw me in the office on 7/9/18. Multiple lab tests were normal, brain MRI/MRA and EEG. Her exam was also normal both by me and Neuro. Seems to have resolved after 2-3 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Within an 1 1/2 I had a quick fever, sweating and chills. It subsided quickly. The red now at the injection side the next morning was hard red and about 2" in diameter. It increased in size over several days to over 3". It did not go away for a week. A strawberry birth mark on my left hand became itchy and scratchy (unusual) four days after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Within an 1 1/2 I had a quick fever, sweating and chills. It subsided quickly. The red now at the injection side the next morning was hard red and about 2" in diameter. It increased in size over several days to over 3". It did not go away for a week. A strawberry birth mark on my left hand became itchy and scratchy (unusual) four days after injection.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Myalgia
Clinical narrative: Muscle pain at various location of body. Redness at location of shot. On Friday felt like I would before getting fever/sick. Still having pain on Monday morning, 7/30/2018, 11 AM.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: She said within hour inside of her arm (opposite side from injection in deltoid) became swollen, red, painful, and warm to touch from slightly above elbow to mid forearm. Progressively improved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Night sweats, Pyrexia
Clinical narrative: First 48 hours unremarkable. After this period, episodes of fever, shivers, muscle ache, joint pain, night sweats.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: Approximately 24 hours after receiving his first SHINGRIX dose, the patient had extreme pain in his left arm. He had trouble moving his left arm. He had overall malaise and what he described as a Rheumatoid Arthritis flare up. This lasted for approximately four days and left the patient extremely debilitated.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: Approximately 24 hours after receiving his first SHINGRIX dose, the patient had extreme pain in his left arm. He had trouble moving his left arm. He had overall malaise and what he described as a Rheumatoid Arthritis flare up. This lasted for approximately four days and left the patient extremely debilitated.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, Vomiting, Raised erythematous area on the left deltoid where he received his injection, Left arm pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Swelling left underarm, collar bone area, and base of neck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Rash, Rash erythematous
Clinical narrative: Given. 10 minutes after the shots grandmother noticed red rash. 4yr old with a red rash on both cheeks, uppers arms, and upper chest and ears. Throat without redness, lungs without wheezing. Denies itching. BENADRYL 20 mg orally given and monitoring. Instructed to go to the ER if the rash gets worse, SOB and difficulty breathing. Grandmother verbalized good understanding. Dismissed home alert OX3 and ambulating with grandmother and mother. No SOB, Respiratory distress, rash cleared, lungs without wheezing and clear in all lobes, throat without redness or swelling. Followed-up with mother on 07/30/18 at 0930 and per mother "she is fine" she did not need any other medical attention. Reinstructed to follow up with her PCP within 2 weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 5 days post vaccine she had bumbs rash on both arms.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 15 March 2016. This case involves a 27-year-old female patients who were vaccinated with first dose of ADACEL (batch number: U5298AA, expiry date, dose, dose in series, site of administration was not reported) intramuscularly on 11-Mar-2016 (reported as last week). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. The patient was not vaccinated with any other vaccinations 4 weeks prior to the event onset. On an unknown date (reported as last week) following the vaccination, the patient's had developed redness and swelling at the injection site and had fever. The patients required doctor visit. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. Follow-up report received from a non- healthcare professional on 21-Jul-2018. The patient's age was reported and number of patient was updated from two to one as (based upon the updated narrative). The patient's vaccination history was reported. The patient's details about concomitant history was reported. The event outcome was updated. It was reported that patient only had a doctor visit despite of emergency room visit. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a two months old male patient who experienced expired PENTACEL was administered, while he received vaccine PENTACEL. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jul-2018, the patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5385AA via unknown route in left leg. On an unknown date, (Unknown latency period), of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE the patient had expired pentacel was administered. Final diagnosis was expired pentacel was administered. It was not reported if the patient received a corrective treatment. The patient outcome reported as Not Applicable. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: RAB
Symptoms: Abnormal dreams, Decreased appetite, Headache, Injection site swelling, Nightmare
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer or other non healthcare professional. This case was cross-referenced with the case 2018SA206137 (same reporter). This case involves a 75 years old female patient who experienced the site looked lumpy (injection site), she states the pain went away after 3 days, swole up, she started getting a weird tingling sensation toward her hips and buttocks, decrease in appetitie, headache, she is having weird crazy dreams ("nightmares"),while she received vaccine IMOVAX RABIES. Patient's medical history included had a scratch wound from raccoon about 3 years ago on an unknown date. On 03-Jul-2018, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported in the right thigh. On 05-Jul-2018 she also received a dose  dose of the same vaccine  with an unknown batch number in the left thigh. On an unknown date, the patient developed a non-serious the site looked lumpy (injection site) (injection site mass)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she states the pain went away after 3 days (pain)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious swole up (swelling) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she started getting a weird tingling sensation toward her hips and buttocks (paraesthesia) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious decrease in appetitie (decreased appetite) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious headache following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she is having weird crazy dreams ("nightmares") (nightmare)  following the administration of RABIES (HDC) VACCINE. Patient required emergency department or doctor visit. (Other relevant tests included No lab data was reported..) Final diagnosis was she was having weird crazy dreams ("nightmares"), headache, decrease in appetitie, she started getting a weird tingling sensation toward her hips and buttocks, swole up, she states the pain went away after 3 days and the site looked lumpy (injection site). Bandaid was covered with so much blood where usually there would be just a couple of dots. The patient outcome is reported as Unknown for the site looked lumpy (injection site), as Unknown for she states the pain went away after 3 days, as Unknown for swole up, as Unknown for she started getting a weird tingling sensation toward her hips and buttocks, as Unknown for decrease in appetitie, as Unknown for headache, as Unknown for she is having weird crazy dreams ("nightmares"). List of documents held by the sender: None.
Age: 75.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Paraesthesia
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer or other non healthcare professional. This case was cross-referenced with the case 2018SA206137 (same reporter). This case involves a 75 years old female patient who experienced the site looked lumpy (injection site), she states the pain went away after 3 days, swole up, she started getting a weird tingling sensation toward her hips and buttocks, decrease in appetitie, headache, she is having weird crazy dreams ("nightmares"),while she received vaccine IMOVAX RABIES. Patient's medical history included had a scratch wound from raccoon about 3 years ago on an unknown date. On 03-Jul-2018, the patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported in the right thigh. On 05-Jul-2018 she also received a dose  dose of the same vaccine  with an unknown batch number in the left thigh. On an unknown date, the patient developed a non-serious the site looked lumpy (injection site) (injection site mass)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she states the pain went away after 3 days (pain)  following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious swole up (swelling) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she started getting a weird tingling sensation toward her hips and buttocks (paraesthesia) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious decrease in appetitie (decreased appetite) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious headache following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious she is having weird crazy dreams ("nightmares") (nightmare)  following the administration of RABIES (HDC) VACCINE. Patient required emergency department or doctor visit. (Other relevant tests included No lab data was reported..) Final diagnosis was she was having weird crazy dreams ("nightmares"), headache, decrease in appetitie, she started getting a weird tingling sensation toward her hips and buttocks, swole up, she states the pain went away after 3 days and the site looked lumpy (injection site). Bandaid was covered with so much blood where usually there would be just a couple of dots. The patient outcome is reported as Unknown for the site looked lumpy (injection site), as Unknown for she states the pain went away after 3 days, as Unknown for swole up, as Unknown for she started getting a weird tingling sensation toward her hips and buttocks, as Unknown for decrease in appetitie, as Unknown for headache, as Unknown for she is having weird crazy dreams ("nightmares"). List of documents held by the sender: None.
Sex: U
Vaccine: TTOX
Symptoms: Pain in extremity
Clinical narrative: 2018SA202309 Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves patient (age and gender not reported) who experienced reaction with a sore arm, while received vaccine Tetanus Toxoid. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date, dosing details not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious reaction with a sore arm (pain in extremity) (unknown latency) following the administration of TETANUS TOXOID. Reaction description: A nurse was calling on behalf of an another nurse to find out if the ADACEL contains horse serum. She reported that a patient was refusing this injection because of this concern. She also reported that the nurse caring for the patient told her that in the past, this patient reported a reaction with a sore arm from a past Tentanus shot but the caller was not sure if this true or if this was for a product we make as Sanofi. She was not sure if this reaction was from a past Tdap or not. She did not know the patient information, date of reported past event, or any details for the template regarding this. The information was asked and the caller did not have this information to provide. Other relevant tests included no lab data. Final diagnosis was reaction with a sore arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for reaction with a sore arm.
Age: 68.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from consumer. This case involves a 68 years old male patient who was administered of DAPTACEL instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jul-2018, the patient received 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in deltoid instead of ADACEL. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from nurse on 23-Jul-2018. This case involves six-month-old patient (gender not reported) who was vaccinated with expired dose 0.5 ml of PENTACEL (Batch number: C5390AA, expiration date: 17 Jul 2018, dose, route and site of administration was not reported) intramuscular route in right thigh on 23 Jul 2018. The patients medical history was not reported. Concomitant medications include HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PREVENAR 13. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in DirectivE and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who was vaccinated with a 0.5 ml dose of MENACTRA (batch number: U5984AC, expiration date: 14-Aug-2019, dose in series were not reported) via intramuscular route in the left deltoid instead of KINRIX.) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included PROQUAD for Immunisation. It was a case of an actual medication error due to wrong vaccine administered. It was unknown if patient experienced any adverse events post vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old female patient (also reported as 15 months old) who received an expired 0.5 mL dose of PENTACEL (fourth dose, lot C5384AA, expiry date: 30-Jul-2018) via intramuscular route in the right thigh on 23-Jul-2018. The patient's past medical history, medical treatment, vaccination and family history were not provided. No other vaccines were given with the PENTACEL. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 4 years old male patient who was vaccinated with an expired vaccine, PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included Prevenar 13 in left thigh. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C4976AA (expiry date: 4Jun2018) in the right thigh. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect route of drug administration
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical assistant). This case involves a 16 years old female patient who received on 17-Apr-2018, injection dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. On 24-Apr-2013 she also received injection of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 24-Jul-2018 she also received injection of the same vaccine lot U6002AA, expiry date 11 Sep 2019 via subcutaneous route in the left arm due to blood disorder. The patients past history was not reported. The patient did not received any concomitant medication. It was an actual medication error due to extra dose administered and inappropriate route of vaccination. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Diarrhoea, Dysstasia, Malaise, Nausea
Clinical narrative: Was fine until May 7 - got so nauseated, violently throwing up - emptied stomach - could not talk, stand up - called ambulance and went to ER. I am totally convinced that if I had heart trouble or high BP - or was in delicate health - this could have killed me. My husband was scared to death; I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Speech disorder, Vomiting
Clinical narrative: Was fine until May 7 - got so nauseated, violently throwing up - emptied stomach - could not talk, stand up - called ambulance and went to ER. I am totally convinced that if I had heart trouble or high BP - or was in delicate health - this could have killed me. My husband was scared to death; I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Erythematous, warm, and indurated at site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Mobility decreased, Pain in extremity
Clinical narrative: Patient woke up around 2 am the morning following the vaccine (approx. 12 hours after vaccination) with fever, chills, and sweating. Patient also states his arm is excessively sore and he cannot raise his arm. Patient feels awful, and says this reaction is much worse than after his first vaccination with SHINGRIX. Patient is feeling slightly better on the second day following vaccination, but still not feeling great. Patient is aware these are possible side effects to vaccination, but feels it is more excessive than usual.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient woke up around 2 am the morning following the vaccine (approx. 12 hours after vaccination) with fever, chills, and sweating. Patient also states his arm is excessively sore and he cannot raise his arm. Patient feels awful, and says this reaction is much worse than after his first vaccination with SHINGRIX. Patient is feeling slightly better on the second day following vaccination, but still not feeling great. Patient is aware these are possible side effects to vaccination, but feels it is more excessive than usual.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain lower, Anaemia, Menorrhagia, Ultrasound pelvis normal
Clinical narrative: Persistent abdominal pain in lower right quadrant, followed by abnormally heavy menstrual bleeding in the next week or two. Patient was bleeding through a tampon and large pad every 30-45 minutes for two weeks and became anemic. A pelvic ultrasound was ordered. No cysts or other abnormality was found. Uterus lining was noted as being very thin. Gynecologist prescribed one type of "birth control" pill which helped slow bleeding a little. Another type of pill was prescribed and was able to stop the bleeding.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Erythema, swelling, heat left arm, and soreness beginning evening following vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Rash erythematous, Rash pruritic
Clinical narrative: I did have the body aches, headache, tired symptoms the day right after the shot but the adverse reaction started a week later. I have very itchy red bumps in my scalp, on my back, stomach, neck, legs, arms and groin area. In some areas I may just have one or two and others more but they are very itchy like a bug bite. I have let my Doctor know but am just treating it with anti-itch cream, if it gets worse I will call my doctor for an appointment.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Acute kidney injury, Blood culture, Computerised tomogram, Injection site cellulitis, Injection site erythema
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Sepsis
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Dysstasia, Functional gastrointestinal disorder, Hypokinesia, Malaise
Clinical narrative: Was fine for 2 days-then deathly ill-violently projectile vomit-empty bowels-could not talk, move, stand-took nausea pill from previous incident 2 mos before-then hit me it had to be vaccine. Almost called ambulance again. I am totally convinced that if I had heart trouble or high BP-or was in delicate health-this could have killed me. My husband was scared to death. I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting projectile
Clinical narrative: Was fine for 2 days-then deathly ill-violently projectile vomit-empty bowels-could not talk, move, stand-took nausea pill from previous incident 2 mos before-then hit me it had to be vaccine. Almost called ambulance again. I am totally convinced that if I had heart trouble or high BP-or was in delicate health-this could have killed me. My husband was scared to death. I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Dehydration, Nervousness, Pain in extremity
Clinical narrative: Anxious, nervous, dehydrated, a lot of pain in left arm lasted for about 5 days. I called clinic but was told to wait and to contact VAERS.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Myalgia, Pain, Photophobia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Bexsero for prophylaxis. On 22nd June 2018, the patient received the 1st dose of Bexsero. In June 2018, less than a week after receiving Bexsero, the patient experienced back pain, photophobia, headache and muscle pain. On 22nd June 2018, the patient experienced fever. On 24th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the back pain, photophobia, headache and muscle pain were unknown. It was unknown if the reporter considered the fever, back pain, photophobia, headache and muscle pain to be related to Bexsero. Additional details were provided as follows: The patient was 17.5 years old at the time of the event onset. The patient had a PPD skin test on 22nd June 2018. Latency of fever was less than a day. On 22nd, 23rd and 24th June 2018, the patient experienced fever that finally resolved on 24th June 2018. The patient also complained about throbbing on the front of her head, back pain, pain when moving her head and photophobia. The patient visited her physician on 29th June 2018 for the headache, photophobia, back muscle pain and tenderness on her back. The sales representative did not have any details on whether events were still continuing or resolved. It was reported that, sales representative was having an MSL following up with the physician.