chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Donor reported pain in her right arm related to her 2nd Rabies immunization given on 02/16/19.  Pain began off-site about 4 hours post vaccination at the injection site and slowly radiated up and down the right arm and into the right side of the donor's neck. Donor took a one-time dose of 800 mg Ibuprofen.  Donor reported that 3-4 hours later the pain had decreased.  As of 2/25/19, donor had mild tenderness in the upper right arm upon palpation.
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Flublok intended for 18+ years instead of age appropriate flu vaccination.  No adverse reaction or side effect.  The manufacturer was contacted and it was recommended the patient be revaccinated with the correct vaccine - but that the patient should experience no harm.  During follow up visit on 10/14 for recommended flu vaccine, mother stated the patient had no reaction from the first vaccine.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis
Clinical narrative: PER PATIENT SHE REPORTS SHE HAS BURSITIS ON RIGHT ARM AS ARESULT OF THE FLU SHOT. SHE SAW DR (HER PCP) ON 11/11/2019 AND ACCORDING TO PATIENT THAT WAS THE DR'S DIAGNOSIS.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Rather intense headache still active after 24hrs. I do not normally get headaches. Sore arm - getting better after 24hrs
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Per mother report, it was first puffy and then spread down his arm and became "hard" and "hot".  Mother reports giving him tylenol and benadryl without relief.  Mother took client in to the clinic and they treated him "like it was a reaction" and prescribed famotidine and cetirizine.  Per mothers report, arm is looking "so much better" after a few doses of these medications.
Age: 66.0
Sex: U
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient was given the flu shot at the beginning of the appointment, then seen later by his NP. Patient was sitting down, seemingly normal, then asked for the trash can and had acute onset severe vomiting approximately 30 minutes after the administration of the vaccination lasting for about 5 minutes.  Patient was given promethazine 25 mg/mL 1 mL once . There was no evidence of rash around the injection site or anywhere else.  Patient's vomiting stopped and he was wheeled out of the doctor's office in a wheel chair feeling nauseated.  Patient returned home after appointment.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Client was current on Depo Provera Contraceptive and due her next injection.  Previous injection was given on 6/5/19.  As was due, Depo Provera was given on  9/4/19, as well as an MMR. A pregnancy test was done on 9/4/19 with a negative result.   Client presented on 10/18/19 with a positive pregnancy test.  Per ultrasound, client conceived 9/4/19 and has an EDC of 5/30/2020.  She is now G3P2.  This report is being filed due to a Depo Provera Contraceptive Failure which led to an MMR being inadvertently given to a client who is now pregnant.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: patient reports normal pain no different from any other immunization, however the pain never subsided, even after several days. It has now been almost a full 30 days, and patient states "dull pain when using arm, hurts to pick anything up, hurts to lift arm high."
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MA gave patient extra dose of the flu vaccine by mistake; instead of the HPV vaccine. MA advised patient grandma, Dr., and supervisors. Also MA talked to MA at agency to ask about any adverse reactions patient might have. MA advised that it will just be an invalid dose for the patient since he had already received  his flu vaccine for the season. MA then gave patient the correct immunization the same day.  MA advised grandma that it would just be an invalid dose that it would count against him.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: 815 - flu shot administered, 8:20 throat + chest tightness began. 50mg Benadryl taken at 845, 945 symptoms increased throat swelling. Chest pain and tightness increased heart rate dizziness, short of breath. Sent to ER. IV Benadryl, steroids and anti nausea meds (when vomiting began in ER) given all with good effect. Home w/3 day course of prednisone + orders for Benadryl Q4-6 hours 50 mg
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Vomiting
Clinical narrative: 815 - flu shot administered, 8:20 throat + chest tightness began. 50mg Benadryl taken at 845, 945 symptoms increased throat swelling. Chest pain and tightness increased heart rate dizziness, short of breath. Sent to ER. IV Benadryl, steroids and anti nausea meds (when vomiting began in ER) given all with good effect. Home w/3 day course of prednisone + orders for Benadryl Q4-6 hours 50 mg
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm had significant soreness and limited movement still 1.5 weeks after injection.  After reading a couple articles online, determined it could be caused by an incorrect injection into shoulder tendon instead of deltoid muscle, causing inflammation of the tendon.  Took Aleve and it felt significantly better.  Still a little soreness almost 3 weeks later without Aleve.  Went to see worksite nurse practitioner yesterday.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypoaesthesia, Muscle tightness, Neck pain
Clinical narrative: Numbness in arm, tension and pain in neck, headaches and dizziness.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Pt developed a mobilliform rash and fever to 101, 10 days after the vaccine
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, X-ray
Clinical narrative: subdeltoid bursitis
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Laboratory test normal, Loss of consciousness, Road traffic accident, White blood cell count increased
Clinical narrative: This was her 2nd dose, first dose went fine. On day 2 after vaccine, felt flu like symptoms and ended up passing out in vehicle, hitting another car. Was taken to hospital by ambulance. Tests were negative, only showing elevated white blood cell count. Hospitalist is attributing this to body's reaction to vaccine.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Tetanus vaccine given 11/7/19 at 4:00pm right deltoid. Per patient day after (11/8/19) approximately around 12pm right deltoid became very red and swollen. Swelling and redness continued to get worse. 11/11/19 Patient called to be seen in office for redness and swelling at injections site. Denied fever, SOB, difficulty breathing/swallowing, difficulty w/right arm mobility, chest pain, or palpitations. Patient was treated in office
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hot flush, Neck pain, Pain in extremity
Clinical narrative: Pain in vaccinated arm, all the way to palm, Neck pain & headache since vaccine received, Hot flashes (many per day).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: large red warm patch at site of injection ( about 4 inches in diameter)
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Feeling abnormal, Headache, Mobility decreased, Neck pain
Clinical narrative: got very achey all over - joints ached so bad, the patient reported they could hardly move. had to miss work was so sick. headache/neck-ache. just "did not feel good at all"
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: got very achey all over - joints ached so bad, the patient reported they could hardly move. had to miss work was so sick. headache/neck-ache. just "did not feel good at all"
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Influenza like illness, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: patient stated that right arm near injection site increased in swelling over a couple of hours. became somewhat painful overnight in order to have a hard time sleeping. After waking up, the swelling decreased significantly. had flu-like symptoms overnight as well which has resolved.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling
Clinical narrative: Itching, swelling, large round area 2 inch diameter.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscle spasms, Myalgia, Pain
Clinical narrative: Muscle aches all over, muscle cramps in left leg, left arm still having difficulty in lifting. can more in daytime, pain all over at nite. Has been almost a month. taking hot baths helps. also Advil. mostly now, left arm issues, and pain all over in evenings.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling & itching at injection site times 4 days. No treatment required.
Age: 14.0
Sex: M
Vaccine: HEPA, IPV, MNQ
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Pallor
Clinical narrative: Child was standing with stepmother at the front counter of the health department. They were paying for the vaccines and it had only been a few minutes since he had received the 3 injections. Child lost consciousness and hit head against wall. For about 5 seconds he appeared to have seizure like activity and was posturing. He was very pale. Cold cloth placed on his face. Child took deep breaths and slowly sat up after about 5 minutes of laying on the ground and deep breathing. Color slowly came back to his face and he drank some water. 911 had been called and EMTs came shortly after the event. Child said his head hurt from the fall but was getting better. EMTs took him to Hospital for further evaluation. Step mother followed behind ambulance in private vehicle.
Age: 14.0
Sex: M
Vaccine: HEPA, IPV, MNQ
Symptoms: Posture abnormal, Seizure like phenomena
Clinical narrative: Child was standing with stepmother at the front counter of the health department. They were paying for the vaccines and it had only been a few minutes since he had received the 3 injections. Child lost consciousness and hit head against wall. For about 5 seconds he appeared to have seizure like activity and was posturing. He was very pale. Cold cloth placed on his face. Child took deep breaths and slowly sat up after about 5 minutes of laying on the ground and deep breathing. Color slowly came back to his face and he drank some water. 911 had been called and EMTs came shortly after the event. Child said his head hurt from the fall but was getting better. EMTs took him to Hospital for further evaluation. Step mother followed behind ambulance in private vehicle.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Computerised tomogram, Ovarian cyst torsion, Surgery, Ultrasound scan
Clinical narrative: After 2nd shot in 3-shot series, she developed an ovarian cyst larger than an orange. Ovarian cyst with torsion.  It twisted and she had to have emergency surgery.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: rash; This spontaneous report was received from a pharmacist and refers to a 66-year-old male patient. The patient pertinent medical history included encephalitis (reported as developed encephalitis on an unknown date in the past), chronic obstructive pulmonary disease (COPD) and diabetes. The patient had no allergies or drug reactions.  On 11-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S018140, expiration date 02-MAR-2021, intramuscular (dose, site of administration were not provided) for prophylaxis. On 11-OCT-2019 (reported as later that day), the patient experienced a rash on his arm away from the injection site. The patient contacted the pharmacist, who recommended diphenhydramine (BENADRYL) for the rash. The outcome of the event was reported as not recovered. The causality assessment was not provided.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 13-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 13-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Were real sick for a while; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for her friends. The age at vaccination was not reported. The patients received Shingrix and sick for a while. This case linked with US2019AMR200928 and US2019200243, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Headache, Pyrexia
Clinical narrative: Fever; Headaches; side effects; This case was reported by a physician via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, headache and adverse event. On an unknown date, the outcome of the fever, headache and adverse event were unknown.   It was unknown if the reporter considered the fever, headache and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and had side effects potentially fever and headache. The reporter consent to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Rotator cuff syndrome; Weeks later still has arm pain; This case was reported by a physician via sales rep and described the occurrence of rotator cuff syndrome in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, several weeks after receiving Bexsero, the patient experienced rotator cuff syndrome and pain in arm. On an unknown date, the outcome of the rotator cuff syndrome and pain in arm were unknown.   It was unknown if the reporter considered the rotator cuff syndrome and pain in arm to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and weeks later still has arm pain. The patient was getting physical therapy for rotator cuff now.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased
Clinical narrative: dizziness; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included rituximab (Rituxan Infusion).   On 18th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, couple of days after receiving Shingrix, the patient experienced dizziness and heart rate increased. On an unknown date, the outcome of the dizziness and heart rate increased were recovering/resolving.   It was unknown if the reporter considered the dizziness and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of patient. The patient gets Rituxan twice year for rheumatoid arthritis, and had last dose in June 2019 and had steroid injection into wrist for arthritis on 15th October 2019. Few days after the Shingrix dose, the patient experienced extreme dizziness and elevated heart rate.  The reporter took the patient to emergency room to be evaluated and that patient was sent home without being admitted.   The issues were getting better but had not completely resolved yet. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain at the time of injection; Induration of 1.5 cm in size approximately 4 or 5 cm lower than actual injection site; Area below the injection site is red; Area below the injection site is tender; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site induration, injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site pain, injection site induration, injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site pain, injection site induration, injection site erythema and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the family nurse practitioner for her husband. The patient experienced pain at the time of injection, and is experiencing induration of 1.5 cm in size approximately 4 or 5 cm lower than actual injection site. The area was tender and red.  The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Hypotension
Clinical narrative: Next morning her blood pressure was low, at 100/52; Blood pressure was high, at 169/92; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 1 days after receiving Shingrix, the patient experienced blood pressure high. On 28th September 2019, the patient experienced low blood pressure. On an unknown date, the outcome of the blood pressure high and low blood pressure were recovered/resolved.   It was unknown if the reporter considered the blood pressure high and low blood pressure to be related to Shingrix.  Additional details were provided as follows: The patient was fine for a day or so, but then she took her blood pressure and it was high, at 169/92 mmHg. The patient went to bed. In the morning, 2 days after receiving Shingrix, the patient's blood pressure was low, at 100/52 mmHg. Later her blood pressure went back to normal.  The patient's blood pressure usually runs around 120/78 mmHg. The reporter consented to follow up. This case was related to patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Nerve tingling in the same area where she originally had shingles.  It is also into her ear lobe and the roof of her mouth.; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in 2013).   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th October 2019, less than a day after receiving Shingrix, the patient experienced pain. On 18th October 2019, the patient experienced tingling. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tingling was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix. It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient had no issue with shingles since 2013. 10 days to 2 weeks after receiving Shingrix, the patient experienced nerve tingling in the same area where she originally had shingles. It was also into her ear lobe and the roof of her mouth.  The reporter did not consent to follow-up. The patient wished to remain anonymous.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after receiving two doses of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd September 2019, the patient received the 2nd dose of Shingrix. On 17th September 2019, 14 days after receiving Shingrix and 81 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient developed Shingles two weeks after receiving Shingrix. The reporter did not have lot numbers or expiration dates of Shingrix at time of call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had sore arm. No other details were available since this was a friend of reporter's patient. For tolerances of 2nd dose, refer case US2019AMR201660, reported by same reporter for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (in April 2018) and nerve pain (from shingles outbreak in April 2018).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient's arm was sore the next day, but it resolved and he had no other adverse event. For tolerances of 2nd dose of Shingrix, refer linked case US2019AMR201604.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on both of legs; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 30th September 2021) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix .5 ml. On 2nd November 2019, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received the first dose of Shingrix on Friday. The patient developed a rash on both of his legs since receiving that. The reporter consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling cold, Headache, Injection site pain
Clinical narrative: soreness at injection site; feels cold; chills; muscle pain; joint pain; headache; feels like skin is burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin. On an unknown date, the outcome of the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and had injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Skin burning sensation
Clinical narrative: soreness at injection site; feels cold; chills; muscle pain; joint pain; headache; feels like skin is burning; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin. On an unknown date, the outcome of the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and had injection site pain, feeling cold, chills, muscle pain, joint pain, headache and burning sensation. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Oedema, Pain
Clinical narrative: pain; flu-like symptoms; fluid filled puff; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, influenza-like symptoms and edema. On an unknown date, the outcome of the pain, influenza-like symptoms and edema were unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms and edema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix 2 months before the date of reporting in arm and experienced pain, flu-like symptoms and a fluid filled puff on the same arm as the injection, but below the injection site. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash running down from her arm to her abdomen; This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The GlaxoSmithKline sales representative stating at the time of reporting had adverse event about a patient.  The additional information not provided.  The patient had rash running down from her arm to her abdomen. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak of herpes zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The health care professional stated that the patient got an outbreak of herpes zoster shortly after getting vaccinated with Shingrix. The reporter did not consent to follow up.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Hypotension, Loss of consciousness
Clinical narrative: Patient blood pressure was severely low at time of Awakening 24-hours after vaccine. Patient blacked out after rising from bed and taking a few steps. Mother found her after hearing her fall to the floor. Patient's blood pressure was 64 / 42. Patient came to a few seconds after blacking out.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eschar, Injection site reaction, Skin necrosis
Clinical narrative: skin necrosis and eschar at the injection site
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right dorsal hand swelling and pain, extending proximally on volar right forearm
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgraphia, Grip strength decreased, Peripheral swelling
Clinical narrative: Right dorsal hand swelling and pain, extending proximally on volar right forearm
Age: 26.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given proquad and had no reaction or adverse events. She was not immune to MMR and needed a dose. Was given Proquad to save a stick. Proquad is not indicated for over 6 years of age.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects; the patient received an improperly store dose ofVARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.    On 10-OCT-2019, the patient was vaccinated with a dose of improperly store varicella virus vaccine live (oka/merck) (VARIVAX) lot # S005078, expiration date 19-FEB-2021 (exact dose, frequency, route of administration and anatomical location were not reported) reconstituted in sterile diluent (lot # and expiration date were not reported). It was not provided whether the diluent was properly stored. Administered dose of vaccine experienced the temperature excursion between minus 14 degrees Celsius to minus 10 degrees Celsius for 45 minutes and minus 9 degrees Celsius to 8 (minus 5) degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to an adolescent patient of unknown exact age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden
Clinical narrative: Bedridden; This case was reported by a consumer via call center representative and described the occurrence of bedridden in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced bedridden. On an unknown date, the outcome of the bedridden was unknown.   It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The caller reported that, her pharmacist told her that some peoples were bedridden for a couple days after having the vaccine. This case linked with US2019AMR200940 and US2019200243, reported by same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: increased heart rate; This case was reported by a physician via call center representative and described the occurrence of heart rate increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingrix. On 4th November 2019, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The day before the reporting date, the patient received Shingrix. On the reporting date, the patient's heart rate was high at 92 beats per minute. The healthcare professional did not had the lot number and expiry date. The reporter consented to follow up. There was discrepancy in the reported event outcome in file and in database, however it is captured as per database.
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Supposed to receive the 23 and instead received another dose of Prevnar 13; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) in 2018 for immunization. On an unspecified date, the patient was supposed to receive "the 23", and instead had received another dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13).  Information on the batch/lot number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Discomfort
Clinical narrative: reaction was very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose and an unspecified shingles vaccine at the same time, both for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated that he had a reaction when he got the shingles vaccine and another vaccine at the same time roughly a year ago. The patient could not remember if the other vaccine was for the flu or for pneumonia. He did not know the type of pneumonia vaccine that he had received. He said the reaction was very uncomfortable and lasted for roughly 10 hours. Outcome of the event was recovered.  Information on the batch number has been requested.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Pyrexia
Clinical narrative: Developed a fever of 101 degrees 24 hours later. Fever subsided later that day.; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (reported as on or around 21Oct2019) at a single dose for immunization; and influenza vaccine (flu shot), via an unspecified route of administration on an unspecified date (reported as on or around 21Oct2019) at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed a fever of 101 degrees 24 hours later. The event took place after use of the product. The fever subsided later that day. Outcome of the event was recovering.  Information regarding the lot number has been requested.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: some soreness at the right deltoid injection sight; 15 year patient was given Flublok vaccine in error; Initial information received on 07-Oct-2019 and follow-up information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old patient who experienced some soreness at the right deltoid injection sight (Vaccination site pain) while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Prefilled syringe (lot number: QSAA1921 and Exp date: 30-Jun-2020) via intramuscular route in the right deltoid.  On an unknown date, patient developed a non-serious soreness at the right deltoid injection sight (vaccination site pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The nurse states that, the soreness is not abnormal.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  (Other relevant tests included No lab data.)  Final diagnosis was vaccination site pain.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for vaccination site pain.  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
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Dose of the Ipol was given to a patient after having an excursion at 60 F for 65 hours, No AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who was vaccinated with IPV (VERO) [IPOL] after having an excursion at 60 f for 65 hour.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Daptacel (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID) and Fluzone preservative-free 0.25 mL (influenza vaccine)  On 07-Oct-2019 around 9:30AM, the patient received a fifth dose of suspect IPV (VERO) (0.5 ml) (lot number: P1A25 and expiry date: 02-May-2019) via intramuscular route in the left thigh after having an excursion at 60 f for 65 hour.  It was an actual medication error due to product storage error.  At the time of report no adverse event was reported.  It was actual medication error due to incorrect product storage. 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.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: itchiness at injection site; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 86 years old female patient who experienced itchiness at injection site (vaccination site pruritus), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the right deltoid.  On an unknown date, the patient developed a non-serious itchiness at injection site (vaccination site pruritus) (since last week) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was itchiness at injection site.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from itchiness at injection site.  Information on batch number is requested.
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 years old patient received Flublok Quadrivalent on 18Oct2019 during a Vaccine Visit only no side effects; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1939, expiry date: 30-Jun-2020 via intramuscular route in the left  deltoid, on 18-OCT-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  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.