chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Abdominal pain, Chest pain, Dizziness, Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16 year-old female patient of an unspecified race and ethnicity received for immunisation on an unspecified date a single dose of TRUMENBA and a dose of MENVEO in the left arm and a dose of influenza vaccine. The patient medical history and concomitant medications were not reported. On an unspecified date, 3-4 hours post the vaccinations, the patient experienced pain in arm and she felt dizzy almost like she was going to faint. By the next day she had intense pain in entire arm, neck, chest down her abdomen and down her leg. This was only on left side where meningococcal vaccines were given together. Outcome was unknown.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age, race and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced first dose of TRUMENBA reoccurring after the second or third dose of TRUMENBA, specifically regarding pain in the general area of the injection on an unspecified date with outcome of unknown.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Lot # N16562, Expiry Date Oct 2017, NDC # 00005-1971-02, UPC # 13: 30005-1971-02) intramuscular at 0.5 ml, single, FLUZONE High-Dose via an unspecified route of administration at an unspecified dose, both  on 02Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced reaction under chin (not on the injection site) and it itches on 07Nov2016 with outcome of unknown. The patient did not even want to go but she wanted the pharmacist to diagnose the reaction under the chin over the phone. Pharmacist actually didn't know that reaction was from Prevnar or not because on same day she had a flu shot but she wanted to make sure is there anything that listed for the product. Pharmacist wanted to double check to make sure that might be something that was not in insert.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Dysgraphia, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: Pt reports worsening bilat extremity "muscle soreness" over past 3 days.  Started out as muscle soreness in bilat quadriceps, then hamstrings and calves (all bilat and symmetrical presentation.) Throughout the weekend, has ascended up his body.  Bilat arm and leg muscle soreness is chief complaint, he states, "My arms and leg muscles feel sore and muscles feel tired like I worked out really hard.  But I have not worked out."  For the past 2 days he also noticed bilat hand fine motor weakness.  He was having trouble shaving with either hand; struggled with zippers/ putting in contact lenses; and holding a pen in either hand takes some effort.  States, "my writing looks like a 5 year olds."  Denies feeling of illness, fatigue, fevers, headaches, neck pain, current visual disturbances, confusion, nausea, chest pain or shortness of breath.  Denies difficulty walking, balance issues, impaired speech, bowel/bladder disturbance.  Under significant stress r/t currently simultaneously buying a house and selling a house; and has 2 young children.  Received flu vaccine 10/6/16. Exam demonstrated bilat hand grasp weakness- no other neuro deficits. Pt was referred from employee clinic to ER for further eval per above to rule out neuro deficits. Upon next day phone follow-up, pt reports full hospital workup was conducted at Hospital. CT, labs, lumbar puncture all WNL per pt.  Pt is admitted and being treated for Guillain-Barre syndrome.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test normal, Lumbar puncture normal, Muscular weakness, Myalgia, Stress
Clinical narrative: Pt reports worsening bilat extremity "muscle soreness" over past 3 days.  Started out as muscle soreness in bilat quadriceps, then hamstrings and calves (all bilat and symmetrical presentation.) Throughout the weekend, has ascended up his body.  Bilat arm and leg muscle soreness is chief complaint, he states, "My arms and leg muscles feel sore and muscles feel tired like I worked out really hard.  But I have not worked out."  For the past 2 days he also noticed bilat hand fine motor weakness.  He was having trouble shaving with either hand; struggled with zippers/ putting in contact lenses; and holding a pen in either hand takes some effort.  States, "my writing looks like a 5 year olds."  Denies feeling of illness, fatigue, fevers, headaches, neck pain, current visual disturbances, confusion, nausea, chest pain or shortness of breath.  Denies difficulty walking, balance issues, impaired speech, bowel/bladder disturbance.  Under significant stress r/t currently simultaneously buying a house and selling a house; and has 2 young children.  Received flu vaccine 10/6/16. Exam demonstrated bilat hand grasp weakness- no other neuro deficits. Pt was referred from employee clinic to ER for further eval per above to rule out neuro deficits. Upon next day phone follow-up, pt reports full hospital workup was conducted at Hospital. CT, labs, lumbar puncture all WNL per pt.  Pt is admitted and being treated for Guillain-Barre syndrome.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Local reaction
Clinical narrative: Flu-like symptoms.  What was most concerning to pt was local reaction which was noted 2 days after immunization.  Pink hue, 1inx2in between where shot was given and right axillae.  No LAD noted but was tender.  No anaphylaxis symptoms.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Subdermal raised red irritation at injection site 4 inches in diameter.
Age: 19.0
Sex: F
Vaccine: HEPA, HPVX, MEN
Symptoms: Urticaria
Clinical narrative: Patient developed hives after receiving the immunization.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Skin rash on upper left extremity.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Rash, fever, itching, pain.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling, Ultrasound Doppler
Clinical narrative: Pain redness and swelling.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient states that he had severe pain on left arm on the same day where PPSV 23 was administered. Patient states pain traveled down his arm to his fingertips. Patient also describes area as red and swollen. Patient put ice at injection site. Patient states that today, 11/3/16, his symptoms almost completely resolved. Patient declined to be seen by provider in clinic today stating he is fine now.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient states that her left arm has been sore since they received the shots.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt developed local site reaction (swelling, warmth, itchiness, erythema) and itchiness and faint rash that appeared off and on on face and chest. Has history of getting rash when stressed, but usually only on chest. Rash is not vesicular in nature.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Pt developed local site reaction (swelling, warmth, itchiness, erythema) and itchiness and faint rash that appeared off and on on face and chest. Has history of getting rash when stressed, but usually only on chest. Rash is not vesicular in nature.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, heat and pain on arm from shoulder to elbow. Dr recommended to use BENADRYL, ibuprofen and application of ice to affected area.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injury, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Within 3 hours after receiving the flu vaccine I had pain in upper shoulder with decreased movement and inability to raise my arm. The symptoms worsened and two days later (on 10/22) I was unable to lift my arm. I was treated at local emergency department for traumatic bursitis.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: Within 3 hours after receiving the flu vaccine I had pain in upper shoulder with decreased movement and inability to raise my arm. The symptoms worsened and two days later (on 10/22) I was unable to lift my arm. I was treated at local emergency department for traumatic bursitis.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Dysphonia, Pharyngeal oedema
Clinical narrative: Very raspy voice, swelling of the throat, approximately 3 hours after injection lasted several hours, management had me go to the E.R., MD gave me ATARAX within 20 minutes swelling of throat and raspy voice went away.
Age: 54.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Developed a pink rash that covers my arms, upper back and chest, as well as my thighs. Visited dr and she said it was not scabies or shingles. She said there is no drainage, no fluid. Itches. Taking BENADRYL & oatmeal soaks. Prescribed steroid and ointment to manage symptoms. Rash is not showing improvement.
Age: 56.0
Sex: F
Vaccine: FLUR3
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Rash, malaise, fever.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site movement impairment, Injection site urticaria, Lethargy, Pain
Clinical narrative: Patient began exhibiting symptoms the morning of the 8th, but did not notify me until around 1230pm. He had a fever of 100.6 (oral). He said he could not move his right shoulder at all. There is a large (3 x 2 in) welt at the injection site. I made him Echinacea and Elderberry tea, and gave him both a bottle of water and a bottle of Gatorade. He refused anything to eat. We began alternating cold and warm packs on the injection site. Cold when he was hot, and hot when he was cold to try and disperse the vaccine and keep him comfortable at the same time. I gave him 500 mgs of TYLENOL and called the drs office. Drs office called back and suggested switching to ibuprofen and adding 25 mgs of BENADRYL. All Tuesday evening and so far all day today, his fever ranges between 99.8 and 101.2. The fever does break and I do not give fever reducer unless it is above 101. He is lethargic, sleepy, complains of "everything in his body hurting to include his hair". He has only had 2 bowls of chicken soup Tuesday morning. We are still actively treating similar to the flu, and as of 630pm this evening, he still has a fever of 99.9, and a headache that will not go away. If his fever is not gone tomorrow morning, I will be taking him to the local emergency room.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Somnolence
Clinical narrative: Patient began exhibiting symptoms the morning of the 8th, but did not notify me until around 1230pm. He had a fever of 100.6 (oral). He said he could not move his right shoulder at all. There is a large (3 x 2 in) welt at the injection site. I made him Echinacea and Elderberry tea, and gave him both a bottle of water and a bottle of Gatorade. He refused anything to eat. We began alternating cold and warm packs on the injection site. Cold when he was hot, and hot when he was cold to try and disperse the vaccine and keep him comfortable at the same time. I gave him 500 mgs of TYLENOL and called the drs office. Drs office called back and suggested switching to ibuprofen and adding 25 mgs of BENADRYL. All Tuesday evening and so far all day today, his fever ranges between 99.8 and 101.2. The fever does break and I do not give fever reducer unless it is above 101. He is lethargic, sleepy, complains of "everything in his body hurting to include his hair". He has only had 2 bowls of chicken soup Tuesday morning. We are still actively treating similar to the flu, and as of 630pm this evening, he still has a fever of 99.9, and a headache that will not go away. If his fever is not gone tomorrow morning, I will be taking him to the local emergency room.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Red itchy splotchy rash area on left upper arm, encompassing approximately 3.5 inches x 3.0 inches of non-connective tissue. Used Benadryl for itchiness.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Seizure lasting 3 minutes, no treatment required.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm naturally a bit sore at time of shot; however, still sore some three weeks later. Rcvd influenza vaccine dosage for seniors.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Crying, Cytogenetic analysis normal, Electroencephalogram abnormal, Infantile spasms
Clinical narrative: High pitched cry, sometime after that he began having infantile spasms.  He was diagnosed with the spasms specifically on 8/25/2016 and hospitalized.  After two courses of treatment, he is now recovering as of 11/09/2016.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging normal, Urine analysis normal
Clinical narrative: High pitched cry, sometime after that he began having infantile spasms.  He was diagnosed with the spasms specifically on 8/25/2016 and hospitalized.  After two courses of treatment, he is now recovering as of 11/09/2016.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient said she is unable to raise her arm after immunization. Onset unknown but reported the symptoms on 11/8/2016.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Day after the immunization patient woke up with swollen arm and knee (the knee in which he had replaced) went to dr..dr said could not rule out infection.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Extreme Vertigo.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was swollen and red and extremely sore for several days. Since I have had the flu shot I still get pain in the shot area and it hurts when I move my arm certain ways like to sleep on it, to put my coat on or do a jumping jack. It also is weaker.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Patient described arm tenderness, swelling, and pain.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of arthralgia in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92D9J, expiry date unknown). On 4th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovering/resolving. The reporter considered the arthralgia to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Concurrent medical conditions included media allergy (details not provided). The patient received FLUARIX QUADRIVALENT in her left deltoid. On the same day of vaccination, in the night, after receiving the vaccine the patient developed severe arthralgia all over.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site urticaria
Clinical narrative: 1-2 hours after injection pt had redness and hives around injection site. As the day progressed, she was at work, she became more SOB she also felt her heart was beating fast. She went to ER around 8:30pm and was seen. She was treated with Albuterol 2.5mg/0.5ml neb, 80mg Dexamethasone IV, BENADRYL 50mg IM, Ipratropium 0.5mg/2.5 ml neb.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Patient received several vaccines from prefilled syringes and vials on 10/31/16. On 11/02/16, we received call from school nurse at 9am that patient presented with redness and swelling on left arm. Patient was seem in our office same day with irregular shaped erythema over right deltoid, warm but not tender 7x4 cm. Diagnosed with cellulitis and treated with ZITHROMAX Z-pak 250mg, 2 tabs on 1st day, then 1 tab daily for 4 days.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza virus test negative, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 52-year-old female patient who received FLUARIX QUADRIVALENT  (batch number 579KX, expiry date 30th June 2017). Concomitant products included Ropinirole, CELEXA and ELIQUIS. On 26th October 2016 the patient received FLUARIX QUADRIVALENT. In October 2016, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced fever, vomiting and chills. On an unknown date, the outcome of the fever, vomiting and chills were not recovered/not resolved. The reporter considered the fever and vomiting to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. In the morning of reporting date, the patient woke up with the symptoms. The patient's body temperature was 102 degrees F. The patient was seen by the physician and a flu test was performed, but she did no have the flu. The call was transferred from vaccine service center.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received FLUARIX 10/23/16. Mother reported on 10/26/16 that he had fever the next day after receiving vaccine and now has swelling, warmth, and redness of site. Patient seen in our office 10/26/16, no fever, irregular shaped erythema, warm but not tender on left arm measuring 5 x 3 cm on left arm. Diagnosed with cellulitis and started on cephalexin 250 mg/5 ml, 11 mL TID for 10 days.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cold sweat, Feeling cold, Headache, Malaise
Clinical narrative: Patient received vaccine early afternoon. After dinner patient told mom he wasn't feeling well. Complained of severe headache and body ache. Mom observed patient had chills and felt clammy to the touch. Patient work up complaining of headache, tingling fingers, feeling nauseous and weak. Pharmacist recommended acetaminophen 500 to 1000mg every six hours and to keep patient very hydrated. Also advised that if symptoms persist or worsen to take patient to emergency room.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: Patient received vaccine early afternoon. After dinner patient told mom he wasn't feeling well. Complained of severe headache and body ache. Mom observed patient had chills and felt clammy to the touch. Patient work up complaining of headache, tingling fingers, feeling nauseous and weak. Pharmacist recommended acetaminophen 500 to 1000mg every six hours and to keep patient very hydrated. Also advised that if symptoms persist or worsen to take patient to emergency room.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on Legs - got similar reaction last year. Taking BENADRYL and will monitor if it gets better or worse.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warm and dry, erythema, swelling and mild tenderness on right deltoid. Given BENADRYL and Ibuprofen.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin warm
Clinical narrative: 1 day later, patient developed a rash that is approximately 3 inches in diameter. Warm to touch. Patient used hydrocortisone cream and is slowly experiencing relief. Will take BENADRYL at night.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Administration site turned red, swollen the size of a baseball, and hot to touch. Recommended to patient to visit urgent care. Urgent care gave her a prescription for Doxycycline.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported continued soreness in Left arm after receiving a flu shot. Pain was still persisting over a month after receiving the shot. Patient states the pharmacist injection technique not the vaccine itself gave him the pain in his arm.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient called clinic to report subjective fever, chills, shakiness, and emesis x2. RN recommended evaluation in urgent care clinic.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Syncope
Clinical narrative: Syncope less than 2 minutes after vaccine injection.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates. the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017) (dose and unit unknown). The vaccine was exposed to 47.8F for 1.5 hours. No previous temperature excursion. Data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information was not reported. On an unknown date the patient was vaccinated with improperly stored M-M-R II lot #: M008589 with expiration date: 16-FEB-2018 and lot # reporter as: M022408 with expiration date: 02-MAY-2018 (dose and route were not provided). The reporter stated that the M-M-R II vaccine was exposed to 11.6 C for 42 hours 55 minutes. No adverse event was reported. There was no product quality complaint (PQC) involved. 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: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043214 with expiry date on 30-AUG-2017; dose, route of administration and anatomical location were not reported). Administered doses of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger was involved. No adverse effects were 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: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (lot # M019708 with expiry date on 25-OCT-2017; dose was not reported. Administered doses of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Information was received 13-OCT-2016 via a telephone call from a nurse regarding a 65 year old male patient. The patient was presently undergoing chemotherapy for an unspecified type of cancer when on 13-OCT-2016 he was administered a dose of ZOSTAVAX (lot # and expiration date unspecified). No adverse events were reported. No further information available The nurse was to call back with more information. Additional information was requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office administrator referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of VARIVAX (lot # M003439, expiration date 19-JAN-2018, dose and route not provided) on unspecified dates. No adverse effects had been reported. There was no product quality issue (PQC) involved. Temperature and Time frame: 9.7F for 1 hour and 18 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No. Was call because of a "data logger"? Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a 23 year old patient. No medical history and concurrent conditions were reported. On 13-OCT-2016 the adult patient was vaccinated with a 1 pediatric dose of 0.5 ml dose VAQTA (drug administered to patient of inappropriate age) (incorrect dose administered) (lot number M007124, expiry date 20-OCT-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1611USA002885 via same reporter link. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site numbness in a 61-year-old female patient who received BOOSTRIX (batch number 7C73A, expiry date 25th August 2017). On 11th June 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) 0.5 ml. On 11th June 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site numbness and injection site tingling. On an unknown date, the outcome of the injection site numbness and injection site tingling were not recovered/not resolved. It was unknown if the reporter considered the injection site numbness and injection site tingling to be related to BOOSTRIX. Additional details were provided as follows: This case was not previously reported to anyone. At 9:30 am, the patient received BOOSTRIX in the left deltoid and experienced numbness and tingling at the injection site, which was radiating down her arm. The patient required emergency room visit. On 13th September 2016, the patient was last seen at the office to evaluate the left arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, drug reactions/allergies, concomitant therapy and concurrent conditions were not reported. On unspecified dates in August 2016 (also reported as from 26-AUG-2016 until 30-AUG-2016), the patients were vaccinated with improperly stored doses of ROTATEQ orally (Lot number, expiration date, concentration, dose and frequency were not provided), which were exposed at a temperature excursion of 35 Fahrenheit degrees during a time frame of 32 hours on 22-AUG-2016; at 35 Fahrenheit for 56 hours on 26-AUG-2016 and at 34 Fahrenheit 56 hours on 30-AUG-2016. No previous temperature excursions were reported. The temperature excursions were detected by a digital data logger. No adverse effects were reported. A product quality complaint was not involved. 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: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M017982 with expiry date on 13-SEP-2017; dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of -0.24 degree Celsius for 285.5 total cumulative hours. Data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office administrator referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M015926, expiration date 28-JUN-2017, dose and route not provided) on unspecified dates. No adverse effects had been reported. Temperature and Time frame: 9.7F for 1 hour and 18 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No. Was call because of a "data logger"? Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, concomitant medications, concurrent conditions, drug reactions, or allergies was provided. On 28-OCT-2016, the patient was vaccinate with expired dose of ROTATEQ, oral liquid (dose was not provided; lot # K019372, expiration date: 16-JUL-2016). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a 21 year old patient. No medical history and concurrent conditions were reported. On 12-OCT-2016 the adult patient was vaccinated with a 1 pediatric dose of 0.5 ml dose VAQTA (lot number M007124, expiry date 20-OCT-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1611USA003754 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M011117, expiration date: 07-DEC-2017 (route and dose were not reported). The reporter stated that the vaccine temperature excursions were of 35F for 30 minutes and 34.2F for 2 hours. No adverse event was reported in any patient. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patient received improperly stored PNEUMOVAX 23 (lot # L024129, expiry date: 21-JAN-2017; lot # M00386, expiry date: 17-AUG-2017; lot # M005287, expiry date: 08-OCT-2017 and lot # M020521, expiry date: 17-NOV-2017). She mentioned that it could not be ruled out that the vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the 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: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (incorrect product storage) (lot # L038503, expiry date: 18-DEC-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered vaccine underwent a temperature excursion at 1.3 degrees (C) for a time frame of 12 minutes. Previous temperature excursions reported occurred on 06-JUL-2016 at a temperature of 2.2 C (low), 10.7 (high) for a time frame of 3 hours and 9 minutes and on 15-AUG-2016 at a temperature of 1.2 C for a time frame of 48 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lip swelling, Oral mucosal erythema
Clinical narrative: Information has been received on 12-OCT-2016 and from a certified medical assistant referring to 2 patients of unknown age and gender. The patients' medical history and concomitant therapy were not reported. On 12-OCT-2016, two patients were vaccinated with ROTATEQ lot # M019707, expiration 25-OCT-2016, (dose and route not reported). The patients experienced lip swelling with redness around the mouth on 12-OCT-2016 immediately following the administration of ROTATEQ. The primary reporter stated that the two patients were also administered other vaccines during the vaccination session on 12-OCT_2016, however, the reaction occurred following the ROTATEQ and not following the administration of PEDVAX HIB, PREVNAR 13 and PEDIARIX on 12-OCT-2016, The primary reporter stated that the two patients were then observed in the office for 15 to 20 minutes and the symptoms that consisted of lip swelling with redness around the mouth resolved without treatment on 12-OCT-2016. No further information was provided. Additional information has been received on 18-OCT-2016 from a nurse. The primary reporter is requesting a lot check concerning ROTATEQ lot # M019707, expiration 25-OCT-2016. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This solicited report was received from a pharmacist via a company representative referring to a patient of unknown age and gender enrolled in an unspecified patient support program. The patient's medical history and concurrent conditions were not reported. The pharmacist reported that the patient was vaccinated with ZOSTAVAX 19400 PFU, on unspecified dates, reported as "3 times in the last 3 years" (strength, route of administration, dose, lot number and expiration date were not reported). The patient's concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 12-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ lot # L000568, expiration date: 10-JUL-2016, (Strength and dose were not reported), orally. No adverse effect was reported. When a callback was made to the facility attempting to obtain additional information, the staff member who answered stated that the reporting medical assistant no longer worked at the facility. A product quality complaint was not involved. Additional information is not expected because no additional information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-NOV-2016, an expired dose of ZOSTAVAX (lot number: L028285; expiry date: 28-OCT-2016) was administered to the patient. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB injection (dose, route of administration, lot # and expiry date were not reported. On 26-OCT-2016, less than four months following the second dose, the patient was vaccinated with the third dose of RECOMBIVAX HB injection (lot#, expiration date, dose and route of administration were not reported) (no information regarding the first dose of the vaccine was provided). No adverse effect was reported. There was no product quality complaint involved. Additional information is not expected because there was no consent for follow-up.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date in 2014, the patient was vaccinated with unidentified Merck HPV vaccine (dose and route unknown, therapy type: unidentified Merck HPV vaccine). In September 2016 (reported as last month, prior to 11-OCT-2016), the patient received the second dose of unidentified Merck HPV vaccine (dose and route unknown, therapy type: unidentified Merck HPV vaccine) (Inappropriate schedule of vaccine administered). No adverse effect was reported. The nurse inquired whether the patient could be administered the third dose of unidentified Merck HPV vaccine on 11-OCT-2016. It also could not be determined whether the third dose was actually administered on 11-OCT-2016. Additional information is not expected as the reporter was unable to be reached for follow up information.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a consumer referring to her 12 month old grandson. There were no pertinent medical history or drug reactions/allergies. On 03-NOV-2016, the patient was vaccinated with PROQUAD (dose, lot number, route not provided) and VARIVAX (dose, lot number, route not provided). The patient did not seek medical attention and there was no treatment given for the event. The outcome of the event was unknown. There was no product quality issue (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot No. not provided) and a dose of PNEUMOVAX 23 (Lot No. M018766; expiration date: unspecified) in separate arms (Start date, and dose were not provided). The pharmacist reported that on an unknown date after the patient received both vaccines developed injection site swelling at the ZOSTAVAX injection site. At the time of reporting, the outcome of injection site swelling was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (route, dose, lot # and expiration date were not reported). The pharmacist confirmed that the ZOSTAVAX went through defrost cycling (temperature, time frame and amount of cycles unspecified). No adverse event was reported. There was any product quality complaint (PQC) involved. 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 multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple dates, the patients received improperly stored VAQTA (lot # M012261, expiry date: 01-MAR-2018; lot # M031806, expiry date: 30-MAR-2018; lot # M011116, expiry date: 17-JUN-2017; lot # M002268, expiry date: 20-SEP-2017 and lot # M022924, expiry date: 24-JUN-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the 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: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, which had a lot # of M031802 and a lot # reported as "M007301", with expirations dates of 09-NOV-2017 and 19-NOV-2017 respectively. Nevertheless, no adverse effects and product quality complaint were reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Vaccine administered 11/7/16 in (Lt) Deltoid. Pt returned 11/8/16 for adjunct flu. Nurse (vaccine provider) noted swelling in the area of injection site from 11/7/16. Pt checked in and immediately eval by provider.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling, Rash macular
Clinical narrative: Information has been received from a 70 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 28-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # was reported as M036826, expiration date 05-MAY-2016; 1 shot, route not reported). On the day of injection (28-OCT-2016), the patient experienced injection-site pain. The following day (29-OCT-2016) her arm had red blotches covering most of her arm and her arm doubled in size due to swelling. The patient didn't sought medical attention. Treatment was given for the events. The patient stated that she took BENADRYL and the swelling decreased a little. The patient also stated it was getting better by the reporting day. At the reporting time, the patient had not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M010485 with expiry date on 01-MAR-2018; dose, route of administration and anatomical location were not reported). Administered doses of vaccines experienced the temperature excursion of -0.29 degree Fahrenheit for 231.5 total cumulative hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site pain, Nausea, Pyrexia, Sensory loss
Clinical narrative: Shaking/shivering, fever, nausea, loss of feeling in arms and legs, extreme pain at injection site.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: Shaking/shivering, fever, nausea, loss of feeling in arms and legs, extreme pain at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Peripheral swelling, Rash, Urticaria
Clinical narrative: Patient said her arm became swollen and she developed a rash along her entire arm where vaccine was administered. Developed hives on arm too. Put ice packs and took ibuprofen. (Lasted 3 days).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration
Clinical narrative: Skin reaction of localized redness 2 inch by 2 inch and induration at injection site.