chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Rash, Swelling, Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient had a reaction to PNEUMOVAX 23. The patient had rash and swelling. The doctor suggested to try PREVENAR 13. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of M-M-R II (lot # K024824 with expired date 02-DEC-2016) which were exposed to temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient unknown age and gender. On 06-OCT-2015, the patient was inadvertently vaccinated with VARIVAX (Merck) (lot# L013066 and expiry date: 14-APR-2017) and PROQUAD (Merck) (Lot# L016393 and expiry date: 08-NOV-2016). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP, HIBV, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unspecified date in August 2015, the patient was vaccinated with improperly stored doses of ROTATEQ, RECOMBIVAX HB, PEDVAXHIB and PNEUMOVAX 23. No adverse effects were reported. Additional information is not expected as the reporter contact details were not reported.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-OCT-2015, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and lot# were not reported) intramuscularly. It was reported that the patient will receive another dose of RECOMBIVAX HB on 02-OCT-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the unspecified patients were vaccinated with 6 doses of improperly stored ZOSTAVAX (lot # L000448 and expiry date: 08-MAR-2016, lot# L002422 and expiry date: 23-APR-2016). 0.65 ml subcutaneously. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with unspecified doses of GARDASIL series on 23-JUN-2011, 23-AUG-2011 and 23-DEC-2011. On 29-AUG-2015, the patient received an unspecified dose of GARDASIL 9 (lot# L007560 and 15-JUN-2017). No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and a medical assistant referring to a 20 year old female patient. No pertinent or historical conditions were reported. On 01-OCT-2015 the patient was in with her father and inadvertently vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left arm (Lot number L0216808 was an invalid lot number for ZOSTAVAX, expiration date 10-SEP-2016) instead of the flu vaccine by mistake. This was reported as staff error only. No adverse effects were reported at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker professional concerning a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On multiple unspecified dates, ranging from August 2015 up to an including October 2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD, lot # reported as: 1002421, expiration date: 23-JUL-2016, lot#: 1009290, expiration date: 17-SEP-2016 (route, anatomical location and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. Lot numbers: 1002421 and 1009290 are invalid lot numbers for (Merck) PROQUAD. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker concerning a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On multiple unspecified dates, ranging from August 2015 up to and including October 2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), lot # reported as: 1011083, expiration date: 01-APR-2017, lot#: 1017145, expiration date: 13-MAY-2017 (route, anatomical location and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. Lot numbers: 1011083 and 1017145 are invalid lot numbers for M-M-R II. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored RECOMBIVAX HB (lot# K021444, expiration date 17-SEP-2016, lot# L004754, expiration date 10-NOV-2016, lot# was reported as L016427, expiration date 13-APR-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored VAQTA (lot# L002717, expiration date 02-JUN-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored ROTATEQ orally (lot# K011948, expiration date 07-JUN-2016, lot# K024700, expiration date 30-JUL-2016, lot# was reported as L001316, expiration date 11-OCT-2016, strength and dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, strength dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with doses of improperly stored GARDASIL (lot# K016966, expiration date 10-MAY-2017, strength, dose and route unknown). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of he several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 50 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 26-SEP-2015, the patient was vaccinated with improperly stored ZOSTAVAX lot # L021612, expiration date- 10-SEP-2016, 0.65 ml, subcutaneous in the back side of right arm. No concomitant medication was reported. Patient experienced no adverse event. The outcome of the event was unknown. Additional information is not expected because reporter does not want to get contacted.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: Patient received PREVNAR 13 vaccine in left arm on 09/17/2015. She now complains that she is having pain from this arm. When vaccine serum was injected she immediately felt tingling down her arm. This numbness/tingling (down to pinky finger) would come and go for 3 days, then stopped. She now experiences extreme pain with movement of the arm. She went to the doctor whom did an x-ray which did not lead to a diagnosis. Doctor prescribed her clindamycin for 10 days thinking she might have an abscess. She also wore a sling for a couple days to limit movement of the arm. Pain is still not resolved. Patient stated that while in doctor's office she had to take left across body to touch right shoulder and the pain was so bad she was about to cry. Patient does not feel this was a reaction to the vaccine. She previously received Flu and ZOSTAVAX on 08/27/2015 with no complaints. Patient is a nurse and feels the PREVNAR 13 vaccine was given too high in the arm. She states vaccine was given within 1 inch of top of shoulder and thinks a nerve was hit. I am going to fill our a VAERS form concerning the incident. She does not require a follow-up call. She requested that administering pharmacist was made aware of incident and that he re-evaluated technique so this does not happen again.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperaesthesia, Pain
Clinical narrative: Pain with lifting and moving left arm, not alleviated with TYLENOL. Pain radiates to chest and neck. Pain is described as a burning feeling and unbearable. And skin is sensitive to touch.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, sweating, slight dizziness.  At first, attributed it to climbing ladder and moving head to look up and then down at tools.  Had to quit working outside and go inside to sit in front of fan.  Pretty much had to do that all day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Fall, Feeling cold, Hyperhidrosis
Clinical narrative: World closing in on me; freezing cold; sweating; fell off the toilet seat; peed on the floor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: Swollen area 4 inches x 12 inches down the back of the arm. Red, Swollen, inflamed and pruritic.
Age: 34.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Laboratory test normal, Pallor, Presyncope, Syncope
Clinical narrative: Syncope and paleness within 5 minutes of receiving the vaccines.  Patient had what seemed like 2 short (10-20 second) seizures.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: Pt developed rash, pain at site of injection; area is hot to touch, throbbing.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, chills, nausea, vomiting.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: EMPLOYEE STATED FEELING LIGHT HEADED, DIZZY, HEADACHE, AND NAUSEA ABOUT 5 MIN AFTER VACCINATION. EMPLOYEE CONTINUES TO HAVE "WAVES OF DIZZINESS, LIGHT HEADED AND NAUSEA. TEMP AT TIME OF SYMPTOMS 98.1, BP132/84, P82.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Muscle and joint pain in all 4 extremities, slight paralysis of hands, headache that lasted 3 days. Redness and itching at site of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Paralysis
Clinical narrative: Muscle and joint pain in all 4 extremities, slight paralysis of hands, headache that lasted 3 days. Redness and itching at site of injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTIONS SITE CONTINUING FOR 2 WEEKS POST IMMUNIZATION.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Almost immediate pain in arm of injection down arm to fingers.  Headache throughout evening.  Redness, hardness, itching and pain at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Almost immediate pain in arm of injection down arm to fingers.  Headache throughout evening.  Redness, hardness, itching and pain at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site radiating down to hand lasting at least 7 days.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, swollen, itchiness, throbbing pain. All occurred where vaccine was injected (upper arm) and spread to under the armpit.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Redness, swollen, itchiness, throbbing pain. All occurred where vaccine was injected (upper arm) and spread to under the armpit.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient describes terrible pain in her right arm. Patient had 2 vaccines administered that day, Fluzone HD and Prevnar 13.  Her right arm with the pain was the arm the Prevnar was administered.  The arm was slightly swollen and very red.  Hot to the touch.  Patient came to the health care clinic where it was administered, and was given a course of antibiotics 10/10 for a possible cellulitis.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: LEFT ARM, REDNESS AROUND VACCINATED AREA. NO REPORTED ITCHING, ONLY "DULL PAIN" (PAIN SCALE RATING 4 OUT OF 10). NO FAINTING. ADMINISTERED 50MG ORAL DOSE DIPHENHYDRAMINE. HER SPOUSE RECEIVED SAME VACCINATION, SAME VACCINE LOT# ON SAME DAY. NO REPORTED REACTION.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood urine present, Dysuria, Micturition urgency, Urinary tract infection, Urine abnormality
Clinical narrative: Urgent need to urinate, painful urination, difficulty passing urine. Same symptoms about 30 minutes later. Later that evening, about 6:30 PM, I also noticed cloudy urine and blood spotting on toilet tissue. Contacted the doctor's office and was connected to the doctor on call as it was after business hours. I was assured this reaction had nothing to do with either the Prevnar 13 vaccine, or the Flu vaccine, which had both been administered at around 11:00 AM. I was told it was nmost likely a urinary tract infection and I would be prescribed an antibiotic. I began taking the medication (Cipro) on Wednesday, Sept. 23 at about 7:30 PM. after leaving a urine sample with the nurse at the doctor's office.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urine analysis normal
Clinical narrative: Urgent need to urinate, painful urination, difficulty passing urine. Same symptoms about 30 minutes later. Later that evening, about 6:30 PM, I also noticed cloudy urine and blood spotting on toilet tissue. Contacted the doctor's office and was connected to the doctor on call as it was after business hours. I was assured this reaction had nothing to do with either the Prevnar 13 vaccine, or the Flu vaccine, which had both been administered at around 11:00 AM. I was told it was nmost likely a urinary tract infection and I would be prescribed an antibiotic. I began taking the medication (Cipro) on Wednesday, Sept. 23 at about 7:30 PM. after leaving a urine sample with the nurse at the doctor's office.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot
Clinical narrative: Pt reports redness, warmth, and chills. Onset about 48 hours after administration.  The red area is rather large (about 5"x3")  no fever.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Constant sneezing, sore throat, developing over next 48hrs to cough, congestion and fever to 101.4.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site nodule, Myalgia, Pain, Peripheral swelling
Clinical narrative: Pain, soreness, muscle aches, raised bump/knot on arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: Generalized tonic-clonic seizure while sleeping.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Flu shot was given to the patient. Patient was sitting down when the shot was given. While the patient was waiting in line to checkout, he fainted and fell to the floor. There was loss of consciousness. Patient regained consciousness quickly. 911 was called. Patient stated that he had not had anything to eat since 0600 that day.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Cough, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Coughing, flu like symptoms, stomach cramps, Headache, arm swelling and pain - AM 10/7/15.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Coughing, flu like symptoms, stomach cramps, Headache, arm swelling and pain - AM 10/7/15.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Injection site reaction-inflammation and pain.
Age: 1.08
Sex: F
Vaccine: DTAP, HBPV, HEPA, MMRV, PNC13
Symptoms: Herpes zoster
Clinical narrative: Shingles rash on back/chest, doesn't seem to be painful.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Body temperature increased, Dysphagia, Feeling hot, Flushing
Clinical narrative: She began to have an itchy throat and realized that she was having difficulty swallowing. She felt flushed and a bit warm. She went to an urgent care/emergency facility. Upon arrival, her temperature and blood pressure were slightly elevated. Provider gave Solu-Medrol, famotidine and diphenhydramine IV. She was released at 7:15pm feeling much better. She was given 3 rxs which were filled on 10/9/2015 for Medrol dosepak, famotidine and diphenhydramine.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Throat irritation
Clinical narrative: She began to have an itchy throat and realized that she was having difficulty swallowing. She felt flushed and a bit warm. She went to an urgent care/emergency facility. Upon arrival, her temperature and blood pressure were slightly elevated. Provider gave Solu-Medrol, famotidine and diphenhydramine IV. She was released at 7:15pm feeling much better. She was given 3 rxs which were filled on 10/9/2015 for Medrol dosepak, famotidine and diphenhydramine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling abnormal, Heart rate increased, Rash
Clinical narrative: After shot gradual onset of weakness, dizziness (patient reports feeling "off") continued to get worse. In the evening patient's reported her neck and chest became red with a rash and her pulse was very high (124bpm & 221bpm reported by patient). Patient went to the Emergency Room to be seen and treated.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: After shot gradual onset of weakness, dizziness (patient reports feeling "off") continued to get worse. In the evening patient's reported her neck and chest became red with a rash and her pulse was very high (124bpm & 221bpm reported by patient). Patient went to the Emergency Room to be seen and treated.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Body temperature increased, Chills, Ear pain, Eye discharge
Clinical narrative: Tight, sore throat, complete loss of voice, nasal congestion, very painful left ear, bloodshot/runny eyes all within 1/2 hr of 6:00 PM. Later in evening intense shivering, 101 temp, body aches. All symptoms gone by 10/03/2015.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pain, Throat tightness
Clinical narrative: Tight, sore throat, complete loss of voice, nasal congestion, very painful left ear, bloodshot/runny eyes all within 1/2 hr of 6:00 PM. Later in evening intense shivering, 101 temp, body aches. All symptoms gone by 10/03/2015.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Needle issue, No adverse event
Clinical narrative: Patient received Afluria with a 25 G, 5/8 inch needle instead of a 25 G 1 inch needle on 10/8/2015. Patient came to the pharmacy today (10/11/15) to pick up her prescription and was notified today (10/11/15) about the needle length. Patient is very petitite and thin with minimal subcutaneous tissue; therefore it is likely that the flu shot was administered into the muscle. Patient stated she feels fine and feels that the flu shot went into her muscle. Patient is happy with no complaints at this time.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Ear disorder, Fatigue, Injection site erythema
Clinical narrative: Patient noticed the injection site was red and hot the morning of 10/11/15 but no other symptoms reported. Advised patient to apply cold compress & take a dose of Benadryl. Patient returned to the pharmacy around 3 PM on 10/11/15 stating that she felt "clammy, tired, dizzy, & her ears stopped up." Reiterated the earlier instructions & advised her to lay down and rest (as she was at work) and to let use know of any further issues.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Patient noticed the injection site was red and hot the morning of 10/11/15 but no other symptoms reported. Advised patient to apply cold compress & take a dose of Benadryl. Patient returned to the pharmacy around 3 PM on 10/11/15 stating that she felt "clammy, tired, dizzy, & her ears stopped up." Reiterated the earlier instructions & advised her to lay down and rest (as she was at work) and to let use know of any further issues.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient stated that her arm has swelling surrounding the injection site approximately 4 inches in diameter.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eye movement disorder, Fall, Headache, Loss of consciousness
Clinical narrative: Patient was sitting at the time of vaccination. Patient then stood waiting against the wall for less than 5 minutes after administration before her eyes had rolled back, she lost consciousness and fell to the floor. Patient's mother immediately picked her up into her lap and patient regained consciousness after a minute. She was able to speak and tell us her name, location, and describe any pain. Patient reported having a slight pain in the center of her forehead, some dizziness, but no other weaknesses. Paramedics were called and after examining and measure patient's vitals, they determined she was stable. Patient's mom refused any hospital visit or further treatment.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Developed a 3" diameter swollen, red. warm, area with orange peel appearance at injection site.  Mild pain and itching to site. It is 2 days later and symptoms have not changed much.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest pain, Chills, Epistaxis
Clinical narrative: Patient complained of chest pain in the middle of the night the night after vaccination, daily nosebleeds, stomach pain, and chills.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Eyelid oedema, Lip swelling, Pruritus, Swelling
Clinical narrative: Swollen eye lids, swollen lips, red itchy hives on neck, face, lips, arms, butt, vaginal area. Treated with Benadryl 50 mg every 8 hours, did not get better, more swelling and hives persisted, forced to seek help 10/11/2015 at urgent care center, received a cortisone shot and week worth of steroids. Continue with Benadryl 50mg every 8 hours.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Swollen eye lids, swollen lips, red itchy hives on neck, face, lips, arms, butt, vaginal area. Treated with Benadryl 50 mg every 8 hours, did not get better, more swelling and hives persisted, forced to seek help 10/11/2015 at urgent care center, received a cortisone shot and week worth of steroids. Continue with Benadryl 50mg every 8 hours.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Cellulitis, Chills, Dizziness, Fatigue
Clinical narrative: Pain at injection site and swollen glands. Next day: a lot more pain in upper arm region, swollen, red, hard lump on upper arm, very tender, painful with any movement of arm. Throughout the night: high fever, chills, stiff and aching joints, vomiting, dizziness malaise and fatigue.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site and swollen glands. Next day: a lot more pain in upper arm region, swollen, red, hard lump on upper arm, very tender, painful with any movement of arm. Throughout the night: high fever, chills, stiff and aching joints, vomiting, dizziness malaise and fatigue.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Joint stiffness, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Pain at injection site and swollen glands. Next day: a lot more pain in upper arm region, swollen, red, hard lump on upper arm, very tender, painful with any movement of arm. Throughout the night: high fever, chills, stiff and aching joints, vomiting, dizziness malaise and fatigue.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Pain at injection site and swollen glands. Next day: a lot more pain in upper arm region, swollen, red, hard lump on upper arm, very tender, painful with any movement of arm. Throughout the night: high fever, chills, stiff and aching joints, vomiting, dizziness malaise and fatigue.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Dizziness, Nausea
Clinical narrative: Patient was taken by ambulance to hospital with severe dizziness and nausea. Patient was found to be dehydrated at hospital.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Influenza
Clinical narrative: Patient said she had every symptom of the flu within 2 hours of receiving FLUZONE HD and PREVNAR 13.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Acute shoulder/arm pain radiating through elbow and down in fingers. Unable to hold the arm in any position for over 30 secs without pain kicking in. Pain persisting for more than 7 days. No visible wounds. Pain killer meds haven't helped.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient said about 1 1/2 hrs after her vaccine, her arm broke out in a rash which spread to both arms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came in and showed a red round area around the injection site that was warm to the touch.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Talked to patient on 10/10/15 (1 day after receiving flu shot). Pt's health condition is the same, no serious reaction after receiving 2nd dose of the shot (didn't know pt had a flu shot previously in Aug 2015.)
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pt. says arm is painful. It is bruised from elbow almost to shoulder.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Insomnia, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Arm hurt - could only sleep 3 hours for 3 nights. Shot right arm. Cannot sleep on right arm (side). Cannot lift arm.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Crying, Insomnia, Mobility decreased, Musculoskeletal pain, Paralysis
Clinical narrative: Arm hurt - could only sleep 3 hours for 3 nights. Shot right arm. Cannot sleep on right arm (side). Cannot lift arm.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU4, FLU3
Symptoms: Cancer surgery, Insomnia, Pain, Renal failure, Vaccination error
Clinical narrative: Arm hurt - could only sleep 3 hours for 3 nights. Shot right arm. Cannot sleep on right arm (side). Cannot lift arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash all over her trunk and under armpits. The rash was getting worse and patient had to go to clinic to get steroid shot by MD.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: A few days after shot, patient complains of tingling from shoulder down to fingers and any pressure on his hand makes it worse. This is the same arm the shot was given in (left arm only).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: At 6:01 pm om 9/30/2015, patient contacted vaccine provider telling him that he was experiencing extreme shoulder pain at the injection site. Both his shoulder and arm hurt. He contacted his doctor. His doctor told him to take OTC pain reliever BENADRYLL and apply ice.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received vaccine then fainted while sittting in the chair. Regained consciousness after a few seconds.
Age: 74.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in (L) arm that began 1 day after vaccination. Advised pt to consult physician, he said he would 1stt see how it progressed. Spoke to pt on 10/11/15 a.m - said he has much improved and would monitor. He had not seen a doctor.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 110, 111 and 112). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. On course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5./0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to 63 year old male patient. There was no pertinent medical history, drug reactions or concomitant medications reported. On 02-OCT-2015 the unspecified male patient was vaccinated with an expired dose of ZOSTAVAX (lot # K007987; expired date reported as 23-SEP-2015) (dose and route were not reported). No adverse effects reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a 73 years old female patient referring to herself. Pertinent medical history and drug reactions/allergies were not reported. On 23-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) in the left arm. Concomitant therapies included losartan for high blood pressure and omeprazole (manufacturer unknown). On 25-SEP-2015, the patient noticed a little pink area underneath her bra area with little bumps. There was no itching or pain. The patient sought unspecified medical attention on an unknown date. Outcome of the events and the causality were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, drug reactions or concomitant medications reported. On 01-OCT-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number K004483; expired date 16-AUG-2015, 0.5 ml, subcutaneous). No adverse effect reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, drug allergies or concomitant medications reported. On 03-OCT-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J013138; expired date 17-JAN-2015) (dose and route were not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 103 and 104). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 96 and 97). Background: Since June 2915, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 14-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 107, 108 and 109). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 18-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 12-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 92, 93, 94 and 95). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7 F. On 04-JUL-2015, there was a low temperature of 30.2F. On 13-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 17-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 14-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborns (numbered 23). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 12-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 11-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 18-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.