chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TD
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 03 May 2016. Manufacturer report number: 2016230841. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS DIPHTHERIA TOX ADULT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to tetanus and diphtheria (not specified). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Child was vaccinated on 4/18/16 approx. 3:45 PM.  The child went home and took a nap.  At 6:00 PM the child woke up with a 103 degree fever.  The fever continued x 3 days.  The mother contacted the provider on the 3rd day, but was unable to get in to the doctor for a few more days.  The child's fever stopped on the third day and she broke out in a rash all over her body on that same day.  The rash lasted 1 1/2 days.  By the time the child was seen by the provider, she had no symptoms.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Influenza like illness, Influenza virus test negative, Local swelling, Oropharyngeal pain
Clinical narrative: Sore throat; neck swelling;fever to 101.8;chills; "flu like symptoms" swabbed for Strep and Flu and both were negative.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Sore throat; neck swelling;fever to 101.8;chills; "flu like symptoms" swabbed for Strep and Flu and both were negative.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Arm is very sore where shots given. Cannot raise arm. Cannot reach arm around back.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Limb discomfort, Loss of consciousness, Syncope
Clinical narrative: Syncope lasted about 5-10 seconds after HPV9 and varicella vaccination. Patient fainted momentary, I held her up in the chair and kept her head aligned. Patient regained consciousness a few seconds later. She wanted to lay down. I helped her to the floor since the bed was a few feet away and pt wasn't stable on her feet yet. She mentioned "passing out" before during a blood draw and other similar circumstances. She also hadn't had any breakfast I gave her a bar/granola and apple juice. Patient stayed in clinic for 10-15 min and said she was ready to leave and felt much better, she mentioned her arm felt heavy right after HPV9 vaccination. I told the pt she should come back another day for Hep A and Menveo. But after a discussion about vaccination and the A.E she had just experienced, patient decided to go ahead and received the remaining (Hep A and Menveo). Patient stay in bed after receiving those vaccine for another 5-10 min to make sure no A.E would occur. Patient reported feeling good. Patient left at around 1050 am. No other S/S reported by pt or observed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, PNC13, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Mother stated client had a fever 4/28/16. Mother stated she noticed a rash and itching to clients body 5/5/16. Advised Parents to take client to pediatrician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored (temperature/time: to 32F for 60 hours and a previous excursion of 33F for 12 hours) PNEUMOVAX23. The nurse stated that it was unknown at the end and could not be denied or confirmed that doses were administered. No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 46 years old female patient. There was no information about concurrent condition, medical  history or concomitant medication. On 08-SEP-2014 and 07-OCT-2014, the patient was vaccinated with the first and second dose of GARDASIL (lot # J002641, Expiration Date: 12-OCT0-2015) (strength, dose and route unknown) (inappropriate schedule of drug administration). On 11-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K008931, Expiration Date 04-MAR-2017) (strength, dose and route unknown) (inappropriate schedule of drug administration). NO adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product use issue, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative and refers to a patient of an unknown gender and age. The patient's concurrent conditions included shingles. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported) as a treatment for shingles (indication also reported as immunization). It was reported that treatment with ZOSTAVAX "halted" the patient's shingles. Additional information is not expected as there was no consent for further contact.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a 50-year-old female patient who received FLUARIX. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLUARIX.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. information regarding the patient's current condition and medical history was not provided. On 15-APR-2015 the patient was vaccinated with GARDASIL, 120Y). On 03-MAR-2015 the patient was vaccinated with GARDASIL 9) (interchange of vaccine products, product name confusion). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information was provided.  Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, TYP, YF
Symptoms: Headache, Lymphadenopathy, Malaise, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Client stated on 4/11 in the morning, he woke up with a headache and "malaise". He also noticed "tender tissue" under the "crook of right armpit". He denied any discoloration, but reported "severe swelling". Client went to go see primary care provider. Was told there was not lymph node enlargement and was given KEFLEX. Client stated that on 4/12 he felt neck stiffness that was more prominent on the right side. The pain was localized to the "base of the neck." He also stated that on 4/11 he felt "shooting pains" and a "weak sensation" down his right arm but that it had resolved by 4/12. Client stated the headaches he feels are one of the "worst headaches" he has felt before.
Age: 58.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, TYP, YF
Symptoms: Neck pain, Pain in extremity, Swelling, Tenderness
Clinical narrative: Client stated on 4/11 in the morning, he woke up with a headache and "malaise". He also noticed "tender tissue" under the "crook of right armpit". He denied any discoloration, but reported "severe swelling". Client went to go see primary care provider. Was told there was not lymph node enlargement and was given KEFLEX. Client stated that on 4/12 he felt neck stiffness that was more prominent on the right side. The pain was localized to the "base of the neck." He also stated that on 4/11 he felt "shooting pains" and a "weak sensation" down his right arm but that it had resolved by 4/12. Client stated the headaches he feels are one of the "worst headaches" he has felt before.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Red, fluid-filled blisters on foot, and abdomen, about 12-13 total, itchy.
Age: 16.0
Sex: F
Vaccine: FLU3, RAB, TYP, YF
Symptoms: Anxiety, Confusional state, Dizziness, Dyskinesia, Head discomfort
Clinical narrative: Immediately after receiving the 4th vaccine (Typhoid VI, YFV, Rabies & Influenza) pt's face became pale and she closed her eyes.  She was seated. Lowered her to supine.  She became rigid then twitched several times.  Used ammonia inhalant, pt responded by opening her eyes but staring blankly.  She was anxious and started thrashing side to side.  She sat up suddenly and asked what happened.  Initially she didn't understand what was being said to her.  She expressed confusion.  This happened over 3-5 minutes.  Returned her to supine and applied a cool pack.  She was diaphoretic and still pale but spoke coherently.  She sat on and off to drink apple juice.  Each time she stated that her head felt heavy and she was dizzy.  It took about 20 minutes before she felt well enough to sit for about 10 more min. before standing and leaving with her mother.  Her mother and I assisted her down the stairs and into the car.  Called mother's cell phone at 1:45 PM left VM.
Age: 16.0
Sex: F
Vaccine: FLU3, RAB, TYP, YF
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Muscle rigidity, Muscle twitching, Pallor
Clinical narrative: Immediately after receiving the 4th vaccine (Typhoid VI, YFV, Rabies & Influenza) pt's face became pale and she closed her eyes.  She was seated. Lowered her to supine.  She became rigid then twitched several times.  Used ammonia inhalant, pt responded by opening her eyes but staring blankly.  She was anxious and started thrashing side to side.  She sat up suddenly and asked what happened.  Initially she didn't understand what was being said to her.  She expressed confusion.  This happened over 3-5 minutes.  Returned her to supine and applied a cool pack.  She was diaphoretic and still pale but spoke coherently.  She sat on and off to drink apple juice.  Each time she stated that her head felt heavy and she was dizzy.  It took about 20 minutes before she felt well enough to sit for about 10 more min. before standing and leaving with her mother.  Her mother and I assisted her down the stairs and into the car.  Called mother's cell phone at 1:45 PM left VM.
Age: 16.0
Sex: F
Vaccine: FLU3, RAB, TYP, YF
Symptoms: Staring
Clinical narrative: Immediately after receiving the 4th vaccine (Typhoid VI, YFV, Rabies & Influenza) pt's face became pale and she closed her eyes.  She was seated. Lowered her to supine.  She became rigid then twitched several times.  Used ammonia inhalant, pt responded by opening her eyes but staring blankly.  She was anxious and started thrashing side to side.  She sat up suddenly and asked what happened.  Initially she didn't understand what was being said to her.  She expressed confusion.  This happened over 3-5 minutes.  Returned her to supine and applied a cool pack.  She was diaphoretic and still pale but spoke coherently.  She sat on and off to drink apple juice.  Each time she stated that her head felt heavy and she was dizzy.  It took about 20 minutes before she felt well enough to sit for about 10 more min. before standing and leaving with her mother.  Her mother and I assisted her down the stairs and into the car.  Called mother's cell phone at 1:45 PM left VM.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness/swelling at site, pruritus, difficulty breathing, warm to touch, patient "felt hot" all night, sweating.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: Redness/swelling at site, pruritus, difficulty breathing, warm to touch, patient "felt hot" all night, sweating.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: INJECTION SITE IS RED, RAISED, HOT TO THE TOUCH, AND ARM IS SORE AND STIFF.
Age: 24.0
Sex: F
Vaccine: IPV
Symptoms: Asthma, Condition aggravated, Pyrexia, Vomiting
Clinical narrative: Patient experienced vomiting, fever and Asthma exacerbation. Vomiting began approx. 6 hours after vaccination.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Exaggerated startle response, Fontanelle bulging, Hyperreflexia, Pyrexia
Clinical narrative: Large, soft, raised and swollen Fontanelle, 103.2 fever, exagerated Moro reflex two intervals, 5 or 8 startles 20 seconds apart over a four hour period.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 19-year-old female patient who received BEXSERO (batch number 151301C, expiry date 31st December 2016). On 28th April 2016, the patient received BEXSERO. In May 2016, less than a week after receiving BEXSERO, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the right deltoid. On 4th May 2016, the patient was seen by her physician for cellulitis at the injection site, which developed one to two days prior to the visit.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Information has been received from a consumer referring to her child, a 16 year old patient. The patient was a female to male transgender who received testosterone (manufacturer unknown). On unknown dates the patient  was vaccinated with two doses of GARDASIL (dose, route and lot # were unknown). The patient experienced "stomach pain" and "nausea" (date unspecified). The reporter stated that the second shot was "worse" (she did not clarify  how it was worse) than the first. The outcome of the events was unknown. Causality was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body ache, Fever, Nausea, Vomiting, Fatigue.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown ages. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored (temperature/time frame: to 32 F for 60 hours and a previous excursion of 33 F for 12 hours) ROTATEQ (lot number: K020182, expiry date: 25-JUN-2016) at unspecified doses. The nurse stated that it was unknown at the time and could not be denied or confirmed that doses were administered. No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Throat irritation
Clinical narrative: The patient passed out, felt light headed. She said  her throat was scratchy. I gave her BENADRYL. Within 5 mintues she said she was okay and felt better. She later stated she hadn't ate today.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms, muscle aches, fever, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes simplex, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local injection site reaction: redness, swelling, itchiness. Genital HSV outbreak. Patient states HSV had been previously controlled without incident.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Local injection site reaction: redness, swelling, itchiness. Genital HSV outbreak. Patient states HSV had been previously controlled without incident.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: PT SHOWED ME HIS ARM. THERE WAS A CLERA BUBBLE BLISTER AT THE SITE OF INJECTION. HIS FULL TOP PORTION OF HIS ARM WAS RED AND SWOLLEN. PT COMPLAINED OF SORENESS OF HIS FULL UPPER ARM. THE UPPER ARM APPEARED REA AND WITH RAISED RASH LIKE IRRITATION. PT DID NOT COMPLAIN OF PAIN, JUST SORENESS.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: PT SHOWED ME HIS ARM. THERE WAS A CLERA BUBBLE BLISTER AT THE SITE OF INJECTION. HIS FULL TOP PORTION OF HIS ARM WAS RED AND SWOLLEN. PT COMPLAINED OF SORENESS OF HIS FULL UPPER ARM. THE UPPER ARM APPEARED REA AND WITH RAISED RASH LIKE IRRITATION. PT DID NOT COMPLAIN OF PAIN, JUST SORENESS.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal event.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Chronic Guillain-Barre syndrome - unknown diagnosis date. Patient undergoing ongoing treatment.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Alot of hard Swelling, about the size of a large baseball at the injection site and moving upwards towards my left shoulder, alot of soreness at injection site and surrounding swollen area. Heat radiating from skin. Very painful to move my left arm.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient complained of rash on inside of right arm from armpit to elbow. Was red with bumps. Patient tried hydrocortisone cream, to no effect. When patient tried to show us, it had already resolved (4 days after immunization).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid bruising, redness and swelling and warm to touch. Per patient symptoms started next day (5/14/2016). Patient complains of pain starting on 5/14/16 and continues. Seen on 5/16/16.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site abscess, Pruritus, Urticaria
Clinical narrative: Pt had a 2.5 inch in diameter localized area of redness on left deltoid and c/o itching. UrticariaPruritus. Diphenhydramine 25 mg once.
Age: 1.42
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ orally (lot # and expiry date were not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site abscess, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 26 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 24-MAR-2016 (also reported as recently), the patient was vaccinated "in ob office" with the first dose of GARDASIL series, injection (route and site of administration, dose, lot number and expiration date were not reported). Concomitant therapies included ORTHO-CYCLEN and topical tretinoin. On approximately 14-APR-2016 (reported as "on or around 14-APR-2016") a "raised circular area" appeared "near or at" the GARDASIL injection site. On 18-APR-2016, the patient came back to the registered nurse office to report this event. The nurse reported that raised area felt "like a sterile abscess", it was about 2 centimeters wide, "felt like it was filled with water" and was tender. The patient stated that she could "move it", but there was no redness or fever present. The reporting nurse stated that the patient did not recall experiencing any trauma to the site and it did not appear to be an insect bite. Apart from physical examination, no lab diagnostic studies were performed. The patient was advised to administer TYLENOL or ALEVE for treatment of the events and was informed to monitor the site and then call the office back in 2 days. On 21-APR-2016, the patient called back and stated that it was "actually a little bit bigger". On an unknown date in approximately April 2016 (reported as "one month later" in regards to the vaccination), the patient presented to the office complaining of swelling, tenderness at the injection site and reported increased pain (onset date on an unknown date in 2016), no fever and no erythema. The reporter stated that the patient had "palpable mass, tender, mobile, circular in shape that was 1-2 centimeters in diameter" (onset date on an unknown date in 2016). The nurse practitioner, who ordered the vaccination series was questioning if this could be a delayed reaction, asking for advice. The patient sought medical attention as she called and visited the nurse practitioner office. The outcome of raised area, which felt "like a sterile abscess" and was tender was reported as not recovered/not resolved. The outcome of palpable mass, swelling at the injection site and increased pain was not reported. The relatedness between all the events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Broke out around 3:30 PM. Red, raised, spots from waist down on front of body and waist down on back of body. Warm to touch. Mom relates she gave him a luke warm bath. No soap. Only water. Child taken to provider on 05-10-2016 as rash spread to chin. Provider said rash is probably a delayed reaction to Amoxicillin that he is on. Per mom provider said, "if this were my son, I'd keep on it." Follow up with provider on Wednesday, May 18, 2016.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates in May 2016 (reported as "on unspecified dates starting on or after 03-MAY-2016"), the patients were vaccinated with an improperly stored doses of GARDASIL 9 injection, lot # L016429, expiry date 09-AUG-2017 and lot # L048237, expiry date 08-MAY-2017 (dose, route of administration and administration site were not specified). Administered doses of GARDASIL 9 underwent temperature excursion at 31 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fluid intake reduced, Rash, Rhinorrhoea, Skin lesion
Clinical narrative: Twelve days ago infant was seen for 4 mo well check, and immunizations. The next day he developed a rash on his legs. These lesions would come and go. It spread to his trunk and upper extremities and face. He is still having new lesions daily. Mom has not given any medicine for this. He also has a runny nose. No fever. Acting well. Drinking less than normal. ZYRTEC 1 mg/mL 2.5 mL qid x 1 wk, tid x 1 wk, bid x 1 wk then a day for 1 wk (per immunologist). Pt is to RTC in 10-14 days for recheck.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 27-APR-2016, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # L033311, expiration date on 01-DEC-2016; dose was not reported). Concomitant therapies were not provided. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 39 degrees Fahrenheit for 18 hours and 19 minutes. Data logger was not involved. There was a previous temperature excursion of 22 degrees Fahrenheit for 5 hours as well as 23 degrees Fahrenheit for 35 hours. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Rash, Scar
Clinical narrative: By the afternoon, bump started on mid back by shoulder blades - left side. Then pain started for 10 days. Pain originated on back but could feel it on front. Little scar remains now. Did not go to the doctor bcs traveling.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: 5/4/16 came to Dr - itching, swelling, red at site of vaccination.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Peripheral swelling, Pyrexia
Clinical narrative: Patient called pharmacy on 5/6/16 at 11:00 AM reported rash developed on 5/5/16 at injection site and got worse with arm swelling and fever of 101.1 on 5/6/16.
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a localized reaction at the injection site - redness and swelling area has been "hot" to touch and spreading.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: Pt. received ADACEL, MENACTRA, and HPV #1 on 3/8/16. Immed. after became pale and vomited. Received HPV #2 - 5/10/16; again became pale and nauseous.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Pallor, Pharyngeal erythema, Pharyngitis, Rash
Clinical narrative: Rash on stomach - began 5/10/16. Seen in office 5/11/16. Trunk blanching. MP rash on trunk. Dx acute pharyngitis, unspecified (oropharynx erythema left tonsil 3+ size right tonsil 3+ size. Adverse effect of other viral vaccines, initial encounter. Will monitor. RTO if changes or concerns. Cortisone cream.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inflammation, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports pain, swelling and warmth on the right arm. The area is inflamed.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: About 1 hour after receiving injection in (L) arm patient became severely nauseated. 6 hours after injection she developed hives on (R) neck and abdomen. Fever of 99.3.
Age: 1.13
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema
Clinical narrative: Redness 2x2 cm, clinical diagnosis. Cold compresses, improved.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Headache, Lethargy, Malaise, Oropharyngeal pain
Clinical narrative: Temp up to 101 x 3 days following immunizations. Lethargy, headache, body aches, generalized malaise, sore throat.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain
Clinical narrative: Temp up to 101 x 3 days following immunizations. Lethargy, headache, body aches, generalized malaise, sore throat.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant referring to an approximately 44 year old female patient. The patient concurrent condition included high cholesterol, high blood pressure and allergic to LEVAQUIN, CECLOR and penicillin. The patient's medical history included back issues. On 06-OCT-2015, the patient's titers for hepatitis B were drawn and they were non-reactive. On the same date, the patient was vaccinated with her first dose of RECOMBIVAX HB (lot#, dose, and route not reported) and subsequently on 06-NOV-2015 and 16-MAR-2016 (inappropriate schedule of vaccine administration) with the second and third dose of RECOMBIVAX HB (lot#, dose and route not reported) respectively for vaccination. Concomitant therapies include WELLBUTRIN, EFFEXOR, EPIPEN. On 03-MAY-2016, the patient's titers for hepatitis B were drawn again and the results were still non-reactive. At the time of reporting, the outcome of non-reactive hepatitis B titers was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient's medical history and current conditions were not provided. On 28-APR-2016 (reported as "8 days ago"), the patient was vaccinated with ZOSTAVAX (lot number, expiration date and dose were not reported), subcutaneous. Secondary suspects and concomitant therapies were not reported. On 28-APR-2016, immediately after the administration of ZOSTAVAX, the patient experienced redness, itching, swelling, and bruising at the injection site. There was no treatment given for adverse events. The outcome of adverse events was reported as not recovered. The patient sought medical attention via calling the pharmacist. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of M-M-R II (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant via phone call on 26-APR-2016. The patient was vaccinated with improperly stored M-M-R II on 08-MAR-2016. This is one of several reports received from the same reporter. Additional information has been requested. Patient tab, product tab, event tab and narrative updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two unspecified patients of unknown age and gender. On 09-MAY-2016, the two patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017, dose and route not provided) (incorrect product storage). No adverse effects were reported. GARDASIL 9 Lot: L014415 Expiration date: 25-JUL-2017. Sterile water diluent Lot: L051109 Expiration date: 25-JAN-2018. Temperature: 47 F. Time frame: 144 hours. Previous excursion: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of M-M-R II) (rHA) (lot # L026551, expiration date 16-JUL-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. Follow up information has been received from medical assistant via phone call on 26-APR-2016. The patient was vaccinated with improperly stored M-M-R II on 08-MAR-2016. This is one of several reports received from the same reporter. Additional information has been requested. Patient tab, product tab, event tab and narrative updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age and gender. On 09-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534, expiration date 22-MAY-2016, and lot # L028645, expiration date 25-MAY-2017, dose and route not provided) (Incorrect product storage). No adverse effects were reported. ROTATEQ Lot: K023534 Expiration date: 22-MAY-2016; Lot: L028645 Expiration date: 25-MAY-2017. STERILE WATER DILUENT Lot: L051109 Expiration date: 25-JAN-2018. Temperature: 47F. Time frame: 144 hours. Previous excursion: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient was inadvertently administered a dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) (wrong drug administered) (interchange of vaccine products). No adverse effects were reported. The action taken with GARDASIL and GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product confusion reported. There was no product quality complaint reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 78 year old female patient. The patient's medical history included shingles. The patient had unspecified reactions to quinapril and penicillin on unspecified dates. On 18-APR-2016, the patient was vaccinated with ZOSTAVAX 0.65 ml once, subcutaneous, lot # L034727, expiry date: 09-DEC-2016 as a precaution for shingles. On approximately 20-APR-2016 ("with in two days afterwards"), the patient experienced muscle soreness and joint pain. The pharmacist reported that, the patient was currently taking CRESTOR (dose, strength, route, frequency unknown) initiated on an unspecified date for an unspecified indication and "this could be causing muscle soreness". The reporter stated that, the patient sought medical attention by contacting another pharmacist however she did not contact her physician. The patient did not receive any treatment for the events. The outcome of muscle soreness and joint pain was unknown. Causality was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017, dose and route unknown). The vaccine was stored under 1.8 degree Centigrade for 7 hours and 28 minutes. There was no previous temperature excursion. It was called because of a data logger. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 10-OCT-2015 the patient was vaccinated with GARDASIL dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown) of immunization series. No concomitant medications were reported. On 22-NOV-2015 the patient was vaccinated with GARDASIL dose 2 (lot number and expiry date unknown) (dosing regimen and frequency unknown) and on 13-MAY-2016 was receiving third dose with GARDASIL 9 (inappropriate schedule of drug administration) (interchange of vaccine products). No adverse effects were reported. The action taken with GARDASIL and GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis infected, Injection site infection
Clinical narrative: On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, route, lot # and expiration date were not reported). Concomitant drug was not reported. On an unknown date the patient experienced a localized infection at the injection site or an infection rash going up through the arm. The patient sought medical attention with the pharmacist, who then referred her to an unspecified physician. The physicians prescribed unspecified antibiotic therapies. On an unknown date, the patient was recovered after the antibiotic therapies were complete. The causality was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Pt called pharmacy 5/17/16. Reports she is having pain in her arm and shoulder. She felt shot (pain) when she received it. She has been to her doctor but he said there was nothing he could do. She also went to ER on 5/16/16 for shoulder pain. She said ER said they couldn't find anything. Pain, swelling and difficulty moving shoulder.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 01-MAY-2016, the patient was inadvertently vaccinated with a dose of VARIVAX, (dose route of administration, injection site, lot number and expiration date were not reported) in stead of an intended dose of ZOSTAVAX. There were no concomitant medications reported. No adverse effect was reported. 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 physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions 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: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Muscular weakness, Oedema peripheral, Pyrexia
Clinical narrative: Dizzy, weakness and edema in arm from elbow to shoulder. Fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Arthralgia, Borrelia test negative, C-reactive protein increased, Culture throat negative, Differential white blood cell count normal
Clinical narrative: 4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count normal, Gait disturbance, Influenza virus test negative, Injection site erythema, Injection site haemorrhage
Clinical narrative: 4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.