chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M022400 with expiration date of 01-NOV-2017; lot # reported as M036294 with expiration date of 13-FEB-2018; doses and routes of administration were not provided). No adverse symptoms were reported. Administered doses of vaccines experienced temperature excursions of: > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 10 hours and 15 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 2 hours; > 5 degrees Fahrenheit but < 14 degrees Fahrenheit for 1 hour; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 1 hour and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 3 hours and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 6 hours and 15 minutes. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact physician. Sender's Comments: US-009507513-1701USA011718.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored VARIVAX, subcutaneously, lot # M023382, expiry date 11-MAY-2018 (dose and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered vaccine underwent temperature excursion between 6 and 14 degrees Fahrenheit for 2.5 hours and between 15 and 46 degrees Fahrenheit for 12 hours. Previous temperature excursion was reported as between 6 and 14 degrees Fahrenheit for 2 hours and between 15 and 46 degrees Fahrenheit for 15 minutes. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Oral administration complication, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy was not provided. On 05-JAN-2017, the patient was vaccinated ROTATEQ oral liquid (orally, lot # M016919, expiration date 17-FEB-2018) for prophylaxis (strength and dose was unknown). During administration, the patient spit some of the vaccine into the medical assistant's eye. The nurse reported that the patient received a less than recommended dose of ROTATEQ due to the incident. The nurse could not verify  if the patient still received a full dose. No adverse effects were reported. This is one of two reports from the same source. MARRS: 1701USA003097 Additional information has been requested.; Sender's Comments: US-009507513-1701USA003097:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 23-JAN-2017, the patient was vaccinated with expired dose of ZOSTAVAX vial 19400 Plaque forming units (PFU), lot # L040443, expiry date 15-JAN-2017 (route of administration, dose and anatomical location were not reported). No adverse effects reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from an approximately 84 year old female consumer referring to herself. Concurrent conditions included heart problems. She refused to provide concomitant medications. On an unspecified date, the patient received ZOSTAVAX subcutaneously to prevent shingles (lot number not provided). On an unspecified date, the patient experienced bumps on her head. She spent time at a hospital for an unspecified amount of time. No labs or diagnostics were performed. The patient stated that she might be allergic to unspecified ingredients in ZOSTAVAX. The patient's status was not recovered. The patient stated she "wanted her name to be put down for a class action suit". Additional information is not expected. The patient did not provide contact information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M025864 with expiration date of 24-MAY-2018; lot # M033904 with expiration date of 20-JUL-2018; lot # M035142 with expiration date of 30-AUG-2018; doses and routes of administration were not provided). No adverse symptoms were reported. Administered doses of vaccines experienced temperature excursions of: > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 10 hours and 15 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 2 hours; > 5 degrees Fahrenheit but < 14 degrees Fahrenheit for 1 hour; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 1 hour and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 3 hours and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 6 hours and 15 minutes. Digital Data Logger was involved. This is one of two reports received from the same reporter.  Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1701USA005281:
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Pain in extremity, X-ray limb
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A 72-year-old female patient received the 2nd dose of PREVNAR 13, via an unspecified route of administration in the right arm, on 29Nov2016, at 0.5 ml single, for immunisation and FLU VACCINE VII injection, via an unspecified route of administration in the left arm, on 28Nov2016, at single dose, for immunisation. PREVNAR 13 was given at the pharmacy. Relevant medical history included ongoing bipolar disorder since about 25 years, ongoing high cholesterol started 2 or 3 years before, water retention, supplementation therapy and heart disorder. Previously the patient received 1st dose of PREVNAR 13, in 2015, for immunisation, with no adverse effect and a total of 8 doses of Influenza vaccine in the past, for immunisation with no adverse effect. Concomitant medications included oxybutynin hydrochloride, from an unspecified date (two or three years before) and ongoing, for unspecified indication; simvastatin (unspecified trade name), from an unspecified date (two or three years before) and ongoing, for high cholesterol; risperidone (unspecified trade name), from an unspecified date (six or seven years before) and ongoing, for bipolar disorder; hydrochlorothiazide (HCTZ), from an unspecified date (four or five years before) and ongoing, for water retention; carvedilol (unspecified trade name), from an unspecified date (three or four years before) and ongoing, for cardiac disorder; acetylsalicylic acid, from an unspecified date (three or four years before) and ongoing, for unspecified indication; calcium (unspecified trade name), from an unspecified date (three or four years before) and ongoing, for supplementation therapy; fish oil (unspecified trade name), from an unspecified date (four or five years before) and ongoing, for supplementation therapy and multivitamins (unspecified trade name), from an unspecified date (eight or ten years before) and ongoing, for unspecified indication. The patient experienced pain in her right arm on 29Nov2016 with outcome of not recovered. Early in the morning her right arm became sore. The event was evaluated at physician office. The reporter stated that about the next day after she received the injection, her right arm was sore. It had progressively gotten worse. The patient was given an antiinflammatory when she was seen at an urgent care facility, after she saw NP because her right arm hurt so bad. Patient saw her primary care nurse practitioner first, and was given combination pain pill/antiinflammatory Diclofenac Potassium 50 mg tablet, at 1 tablet by mouth twice a day. These products helped some. The patient saw an orthopedic doctor on 11Jan2017 and he prescribed Celecoxib 200 mg, at 1 capsule by mouth a day. The patient underwent lab tests and procedures which included: x-ray of right arm (Dec2016), x-ray of right arm (11Jan2017).
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. An around 65 year old male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient previously received with pneumococcal vaccine PPSV23 for immunisation. The patient experienced severe swelling all over upper arms for the 3 days following administration of PREVNAR 13 vaccine on an unspecified date with outcome of unknown.   Pharmacist wondering if connection between 1 year interval of the 2 pneumonia vaccines and an increased reaction.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) through a Pfizer sales representative. A 76 year old female patient of an unspecified race received, on 20Oct2016, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain, redness, swelling and joint pain. No treatment was received. The patient recovered from the adverse events on an unknown date.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative. A female patient of an unspecified age and race received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced upper respiratory cold symptoms. She had no local reaction, no pain neither swelling. Clinical outcome of the adverse event was unknown at time of this report.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-09-21.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Adverse event
Clinical narrative: Adverse effect of other bacterial vaccines, subs encntr on 2016-10-19. Adverse effect of vaccines and biological substances, init on 2016-11-14.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2016-12-13.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Neuralgia
Clinical narrative: Muscle soreness at injection site progressed to joint pain and decreased range of motion. There was also some nerve pain around 11PM. Pain was a 4 without movement and a 7 with.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, UNK, VARCEL
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2017-01-05.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-08-26.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site discomfort, Injection site inflammation, Injection site pain
Clinical narrative: Flu vaccine administered at pharmacy high on left arm  -  patient had intense pain for a few days then became chronic with moderate to severe pain worsened with motion, better with rest, aching, burning. Seen by dr in orthopedics: likely inflammation from injection into joint capsule. MRI done, MEDROL DOSEPAK prescribed; patient continues to have discomfort in her shoulder 1/25/17.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging abnormal, Oedema, Pain, Synovitis
Clinical narrative: Flu vaccine administered at pharmacy high on left arm  -  patient had intense pain for a few days then became chronic with moderate to severe pain worsened with motion, better with rest, aching, burning. Seen by dr in orthopedics: likely inflammation from injection into joint capsule. MRI done, MEDROL DOSEPAK prescribed; patient continues to have discomfort in her shoulder 1/25/17.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: Flu vaccine administered at pharmacy high on left arm  -  patient had intense pain for a few days then became chronic with moderate to severe pain worsened with motion, better with rest, aching, burning. Seen by dr in orthopedics: likely inflammation from injection into joint capsule. MRI done, MEDROL DOSEPAK prescribed; patient continues to have discomfort in her shoulder 1/25/17.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Child contracted Pertussis despite having been vaccinated against it. Diagnosis was confirmed by respiratory swab.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2016-10-05.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, UNK, VARCEL
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-11-01.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, subs on 2016-11-25.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, init on 2016-09-29.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-11-02.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Swelling, Tenderness
Clinical narrative: Raised, red tender rash.
Age: 50.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, subs on 2016-11-25.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-01-05.
Age: 18.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, init on 2017-01-09.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2016-10-04.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017, the patient was inadvertently administered improperly stored GARDASIL 9 injection, lot # M009378, expiration date 23-APR-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 9.5 degrees Celsius  (C) for 8 hours and 33 minutes, which was detected by a digital data logger. There was previous temperature excursion of 1.2 degrees  Celsius  (C) for 30 minutes. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received 1st dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date 1 week after vaccination. Outcome of the event was unknown.
Age: 16.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-10-06.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Post vaccination fever on 2016-09-19.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, init on 2016-10-19.
Age: 60.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-12-15.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-12-26.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-07-29.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, UNK, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-11-17.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autism, Constipation, Crying, Eczema, Erythema
Clinical narrative: Fever, crying, swelling, red mark. Later on constipation, eczema, and autism.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, crying, swelling, red mark. Later on constipation, eczema, and autism.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Localized erythema/swelling with itching.  Advised benadryl and cool compresses for tx.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abnormal behaviour, Asthenia, Decreased appetite, Fluid intake reduced, Headache
Clinical narrative: Fever over 102 - 2:30PM. Weakness - 6:00PM. Behavior changes - fussiness - 5:30PM. Vomitting - 11:45PM. Paleness - two days after symptoms began. Loss of appetite and didn't want to drink fluids - 6:00PM. Fast Heartbeat - 7:30PM. Headache - on and off days one and two after symptoms began. Drowsiness - all three days following when symptoms began. Inflamed throat tissue - 8:00PM.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Heart rate increased, Irritability, Pallor, Pharyngeal inflammation, Pyrexia
Clinical narrative: Fever over 102 - 2:30PM. Weakness - 6:00PM. Behavior changes - fussiness - 5:30PM. Vomitting - 11:45PM. Paleness - two days after symptoms began. Loss of appetite and didn't want to drink fluids - 6:00PM. Fast Heartbeat - 7:30PM. Headache - on and off days one and two after symptoms began. Drowsiness - all three days following when symptoms began. Inflamed throat tissue - 8:00PM.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Somnolence, Vomiting
Clinical narrative: Fever over 102 - 2:30PM. Weakness - 6:00PM. Behavior changes - fussiness - 5:30PM. Vomitting - 11:45PM. Paleness - two days after symptoms began. Loss of appetite and didn't want to drink fluids - 6:00PM. Fast Heartbeat - 7:30PM. Headache - on and off days one and two after symptoms began. Drowsiness - all three days following when symptoms began. Inflamed throat tissue - 8:00PM.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Somnolence
Clinical narrative: Fever over 102 - 2:30PM. Weakness - 6:00PM. Behavior changes - fussiness - 5:30PM. Vomitting - 11:45PM. Paleness - two days after symptoms began. Loss of appetite and didn't want to drink fluids - 6:00PM. Fast Heartbeat - 7:30PM. Headache - on and off days one and two after symptoms began. Drowsiness - all three days following when symptoms began. Inflamed throat tissue - 8:00PM.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MEN, TDAP, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This is a new problem. Episode onset: 3 days ago, day after vaccine. The problem is unchanged. The rash is diffuse. The rash is characterized by itchiness (vesicular). Associated with: varicella vaccine 1/19/2017. Past treatments include nothing. Varicella without mention of complication.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with VAQTA, (strength, route of administration, frequency, and dose were not provided),  lot # M017982 and expiration date 13-SEP-2017 for prophylaxis. The nurse stated that the vaccine was stored in a syringe for 26 hours in the refrigerator between 36F to 46F, she also reported that the vaccine did not have any previous temperature excursions. No adverse symptoms were reported nor product quality complaint was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Eye pain, Eye swelling, Headache, Influenza like illness, Injection site erythema
Clinical narrative: A 69 year old female received an intramuscular injection of MassBiologics Td (lot A083A) in the deltoid on April 18, 2016 for wound prophylaxis after injuring her thumb. No other immunizations were reported at that time. The patient has a past medical history of hypothyroidism, anxiety disorder, and acid reflux and reported taking her routine medications SYNTHROID, sertraline, and ranitidine that day. Approximately 3 days post-Td administration (4/21/16), she developed erythema and induration at the injection site. These symptoms subsequently worsened and she additionally developed soreness and swelling around her eyes and forehead, and flu-like symptoms. These symptoms were similar to a previous adverse reaction the patient had experienced following lidocaine administration. The patient contacted the ENT physician who had treated her for the lidocaine adverse reaction and was instructed via phone to restart the same allergy medications she had taken for the lidocaine reaction: fluticasone nasal spray, cetirizine oral tablets, and PROAIR HFA inhaled aerosol. She did not require an office visit. At the time of the report (approximately 3 weeks post-Td administration), the patient had ongoing symptoms of slight erythema around the injection site and swelling around her eyes. Sender's Comments: The adverse events reported by the primary source were assessed as non-serious and contain both labeled reactions and unexpected events. Injection site reactions, such as the local erythema and induration, as well as flu-like symptoms like malaise are listed in the package insert for Td. The soreness and swelling around the eyes and forehead were assessed as unexpected. It is possible that the soreness and swelling of the eyes/forehead were secondary to angioedema, though allergic angioedema typically has an onset over a period of minutes to hours following exposure to the allergen and also resolves over a period of days. At the time of the initial report, the patient had not fully recovered. MassBiologics (Sender) performed a follow up with the patient (primary source reporter) on two occasions as summarized below: Follow up on May 31, 2016: The patient was unavailable to answer the telephone call and a voicemail was left requesting call back. Follow up on June 06, 2016:  The reporter informed MassBiologics over the telephone that she had recovered.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Swelling face
Clinical narrative: A 69 year old female received an intramuscular injection of MassBiologics Td (lot A083A) in the deltoid on April 18, 2016 for wound prophylaxis after injuring her thumb. No other immunizations were reported at that time. The patient has a past medical history of hypothyroidism, anxiety disorder, and acid reflux and reported taking her routine medications SYNTHROID, sertraline, and ranitidine that day. Approximately 3 days post-Td administration (4/21/16), she developed erythema and induration at the injection site. These symptoms subsequently worsened and she additionally developed soreness and swelling around her eyes and forehead, and flu-like symptoms. These symptoms were similar to a previous adverse reaction the patient had experienced following lidocaine administration. The patient contacted the ENT physician who had treated her for the lidocaine adverse reaction and was instructed via phone to restart the same allergy medications she had taken for the lidocaine reaction: fluticasone nasal spray, cetirizine oral tablets, and PROAIR HFA inhaled aerosol. She did not require an office visit. At the time of the report (approximately 3 weeks post-Td administration), the patient had ongoing symptoms of slight erythema around the injection site and swelling around her eyes. Sender's Comments: The adverse events reported by the primary source were assessed as non-serious and contain both labeled reactions and unexpected events. Injection site reactions, such as the local erythema and induration, as well as flu-like symptoms like malaise are listed in the package insert for Td. The soreness and swelling around the eyes and forehead were assessed as unexpected. It is possible that the soreness and swelling of the eyes/forehead were secondary to angioedema, though allergic angioedema typically has an onset over a period of minutes to hours following exposure to the allergen and also resolves over a period of days. At the time of the initial report, the patient had not fully recovered. MassBiologics (Sender) performed a follow up with the patient (primary source reporter) on two occasions as summarized below: Follow up on May 31, 2016: The patient was unavailable to answer the telephone call and a voicemail was left requesting call back. Follow up on June 06, 2016:  The reporter informed MassBiologics over the telephone that she had recovered.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Peripheral swelling, Rash
Clinical narrative: A 65 year old woman received an intramuscular injection of Td (Lot #A084A) in her right arm as a routine booster at a Pharmacy on June 20, 2016. She received no other vaccinations that day or within the preceding 4 weeks. She was taking her routine medications at the time of the immunization: Lisinopril (40 mg/day), Atorvastatin (20 mg/day), Amlodipine (5 mg/day), and Levothyroxine (100 micrograms/day). On June 21, 2016 (1 day post-immunization) she developed numbness in her right arm extending to her finger tips, swelling of her right 2nd and 3rd fingers, stiffness of her right hand, and a rash on the inside of her right wrist. The patient did not seek immediate medical advice for her symptoms but reported them to her physician after taking Ciprofloxacin on June 23, 2016 to determine relatedness of the event. The patient later contacted the pharmacy where she received the Td vaccine and the pharmacist reported the adverse event to MassBiologics. Reporter's Comments: The primary reporter mentioned that the patient is allergic to Penicillin. Sender's Comments: All of the adverse events presented in this case were assessed as non-serious. Musculoskeletal stiffness and rash are labeled reactions described in the package insert. Swelling is also a labeled reaction that can occur at the injection site; while the reported swelling is distal to the injection site, it did occur in the limb injected and may have been most noticeable in dependent areas, particularly at the fingers. The development of numbness is unexpected, as it is not described in the package insert. It is possible that the patient's symptoms of numbness, swelling, and stiffness are all related to a local inflammatory response to the vaccine administration as they are localized in the injected arm. All of the patient's symptoms fully resolved after 1 week, before the AE was reported. Therefore, no patient follow-up by MassBiologics was performed or is planned.
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Erythema, Headache, Injection site swelling, Muscle spasms
Clinical narrative: A woman (age is unknown) received an immunization with MassBiologics' Td (Lot# A079B) on September 1, 2016 in the upper arm (route of administration is unknown). On the same day, she experienced muscle pain and spasms, joint pain, headache, nausea, tingling sensations, itching, and swollen hands; along with upper arm redness, swelling and pain. The symptoms were initially reported as mild but worsened the next day and the patient developed a bump at the injection site.  No information is available on whether the patient sought medical care or took any medication for these symptoms. At the time of the report, the patient's symptoms had not recovered/resolved. Reporter's Comments: The patient reported this event to the vaccine distributor (Akorn) who then reported the event to MassBiologics. The Akorn report indicated that the patient thought she had received the Tdap vaccine, however, Akorn was able to confirm that the lot number provided was a MassBiologics Td lot and alerted the patient that she had received the Td vaccine. Sender's Comments: Based on information provided to MassBiologics, all of the adverse events described in this case were assessed as non-serious. Muscle pain (myalgia), joint pain (arthralgia), headache, nausea, swollen hands (peripheral edema), and the local redness (erythema), swelling, and pain along with the nodule (induration) at the injection site are labeled reactions described in the product insert. The itching (pruritis) may also be associated with injection site reaction as described in the label, but it is unclear from the report if this pruritis was generalized or localized. Muscle spasm is unexpected as it is not a labeled reaction, though a sensation of spasm could occur in association with muscle pains. The development of tingling sensations/paresthesia is unexpected, as it is not described in the package insert. MassBiologics (Sender) attempted to follow up with the patient (primary source reporter) on two occassions as summarized below: Follow up on October 4, 2016: MassBiologics called the patient and left a voicemail requesting a call back to obtain additional and follow-up information for this event and to check on the current status of her symptoms. Follow up on October 10, 2016: The patient answered the phone but told MassBiologics that she was not feeling well and was unable to speak at that time. She acknowledged that she received the voicemail left by MassBiologics on October 4, 2016 with MassBiologics' contact information and said she would be in-touch at a later date to discuss the event. The patient did not follow up with MassBiologics after the October 10, 2016 phone call and no further attempts were made to contact the patient.
Sex: F
Vaccine: TD
Symptoms: Myalgia, Nausea, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: A woman (age is unknown) received an immunization with MassBiologics' Td (Lot# A079B) on September 1, 2016 in the upper arm (route of administration is unknown). On the same day, she experienced muscle pain and spasms, joint pain, headache, nausea, tingling sensations, itching, and swollen hands; along with upper arm redness, swelling and pain. The symptoms were initially reported as mild but worsened the next day and the patient developed a bump at the injection site.  No information is available on whether the patient sought medical care or took any medication for these symptoms. At the time of the report, the patient's symptoms had not recovered/resolved. Reporter's Comments: The patient reported this event to the vaccine distributor (Akorn) who then reported the event to MassBiologics. The Akorn report indicated that the patient thought she had received the Tdap vaccine, however, Akorn was able to confirm that the lot number provided was a MassBiologics Td lot and alerted the patient that she had received the Td vaccine. Sender's Comments: Based on information provided to MassBiologics, all of the adverse events described in this case were assessed as non-serious. Muscle pain (myalgia), joint pain (arthralgia), headache, nausea, swollen hands (peripheral edema), and the local redness (erythema), swelling, and pain along with the nodule (induration) at the injection site are labeled reactions described in the product insert. The itching (pruritis) may also be associated with injection site reaction as described in the label, but it is unclear from the report if this pruritis was generalized or localized. Muscle spasm is unexpected as it is not a labeled reaction, though a sensation of spasm could occur in association with muscle pains. The development of tingling sensations/paresthesia is unexpected, as it is not described in the package insert. MassBiologics (Sender) attempted to follow up with the patient (primary source reporter) on two occassions as summarized below: Follow up on October 4, 2016: MassBiologics called the patient and left a voicemail requesting a call back to obtain additional and follow-up information for this event and to check on the current status of her symptoms. Follow up on October 10, 2016: The patient answered the phone but told MassBiologics that she was not feeling well and was unable to speak at that time. She acknowledged that she received the voicemail left by MassBiologics on October 4, 2016 with MassBiologics' contact information and said she would be in-touch at a later date to discuss the event. The patient did not follow up with MassBiologics after the October 10, 2016 phone call and no further attempts were made to contact the patient.
Sex: F
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: A woman (age is unknown) received an immunization with MassBiologics' Td (Lot# A079B) on September 1, 2016 in the upper arm (route of administration is unknown). On the same day, she experienced muscle pain and spasms, joint pain, headache, nausea, tingling sensations, itching, and swollen hands; along with upper arm redness, swelling and pain. The symptoms were initially reported as mild but worsened the next day and the patient developed a bump at the injection site.  No information is available on whether the patient sought medical care or took any medication for these symptoms. At the time of the report, the patient's symptoms had not recovered/resolved. Reporter's Comments: The patient reported this event to the vaccine distributor (Akorn) who then reported the event to MassBiologics. The Akorn report indicated that the patient thought she had received the Tdap vaccine, however, Akorn was able to confirm that the lot number provided was a MassBiologics Td lot and alerted the patient that she had received the Td vaccine. Sender's Comments: Based on information provided to MassBiologics, all of the adverse events described in this case were assessed as non-serious. Muscle pain (myalgia), joint pain (arthralgia), headache, nausea, swollen hands (peripheral edema), and the local redness (erythema), swelling, and pain along with the nodule (induration) at the injection site are labeled reactions described in the product insert. The itching (pruritis) may also be associated with injection site reaction as described in the label, but it is unclear from the report if this pruritis was generalized or localized. Muscle spasm is unexpected as it is not a labeled reaction, though a sensation of spasm could occur in association with muscle pains. The development of tingling sensations/paresthesia is unexpected, as it is not described in the package insert. MassBiologics (Sender) attempted to follow up with the patient (primary source reporter) on two occassions as summarized below: Follow up on October 4, 2016: MassBiologics called the patient and left a voicemail requesting a call back to obtain additional and follow-up information for this event and to check on the current status of her symptoms. Follow up on October 10, 2016: The patient answered the phone but told MassBiologics that she was not feeling well and was unable to speak at that time. She acknowledged that she received the voicemail left by MassBiologics on October 4, 2016 with MassBiologics' contact information and said she would be in-touch at a later date to discuss the event. The patient did not follow up with MassBiologics after the October 10, 2016 phone call and no further attempts were made to contact the patient.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Wrong drug administered
Clinical narrative: A 42 year old woman, who is a nurse at the health care provider, received an injection of MassBiologics' Td vaccine (Lot #A090A) on October 25, 2016 intradermally in her left forearm instead of administering PPD. The patient experienced same day onset of injection site pain, erythema, and induration. At the time of the report, one day after administration, the patient had not recovered.  Treatment of the event was not reported. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled, consistent with local injection site reactions causing tenderness, erythema, and induration described in the Td vaccine package insert.  The Td vaccine was administered incorrectly. MassBiologics performed a follow up with the primary source reporter in order to receive an update on the patient's recovery status. Details of the follow up are provided below: Follow up on November 28, 2016: The primary source reporter informed MassBiologics that her reactions had resolved completely. She also added that an administration error had occured because she had failed to read the product label completely and mistaken it for PPD. She clarified that she administered the dose for PPD and not the Td dose. Please note that report 'US-MassBiologics-AE1608' has been linked to this report. The events were similar events and were reported to MassBiologics at the same time by the same primary source reporter for the same Td lot. In the linked reports, both patients worked at the provider's office as nurses and were also the individuals that administered the doses to each other.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Product label confusion, Wrong drug administered
Clinical narrative: A 27 year old woman, who is a nurse at the health care provider, received an injection of MassBiologics' Td vaccine (Lot #A090A) on October 25, 2016 intradermally in her left forearm instead of being administered PPD. The patient experienced same day onset of injection site pain, erythema, and induration. At the time of the report, one day post-administration, the patient had not recovered. Treatment of the event was not reported.; Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled, consistent with local injection site reactions causing tenderness, erythema, and induration described in the Td vaccine package insert.  The Td vaccine was administered incorrectly. MassBiologics (Sender) performed a follow up with the primary source reporter on one occasion as summarized below: Follow up on November 28, 2016: The reporter informed MassBiologics over the telephone that the patient's reactions had resolved completely. When queried about the dose, the reporter (and person who administered the vaccine) indicated that the administration error occurred because she did not read the product label completely and confused it with PPD. The reporter clarified that she administered the dose for PPD and not the full Td dose. Please note that report 'US-MassBiologics-AE1607' has been linked to this report. The events were similar events and were reported to MassBiologics at the same time by the same primary source reporter for the same Td lot. In the linked reports, both patients worked at the provider's office as nurses and were also the individuals that administered the doses to each other.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Blood glucose increased, Hypotension
Clinical narrative: Patients states that his normally steady blood pressure and blood glucose have had higher than normal fluctuations with blood pressure being very low and blood glucose being very high. He said this seemed to occur at around time of vaccination and continues to date of this report.
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Bursitis, Inflammation, Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Severe shoulder pain, pain with abduction and extension and weakness in rotator cuff muscles. stable and persistent over the next 6 weeks. (SIRVA).
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: 1210 Patient arrived after vaccinations administered with hives on face and chest, no respiratory distress. Was examined by Dr. 1215 7ml BENADRYL given PO. 1232 HR 116 Pulse Ox 99%. 1238 ZYRTEC 2.5 mg tablet dissolved in water given PO. Observed in office 55 minutes. Pt. symptoms improved, rash and hives were improved, no respiratory distress noted.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS, SWELLING.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain, Poor quality sleep
Clinical narrative: The patient came in today around 4:45pm (1/25/17) stating that she has been in pain (shoulder pain) for 2 weeks after receiving a flu shot at our pharmacy. She also states that she hasn't been sleeping well and that her range of motion is now limited. She had a physical done at her MD's on 1/18/17, states the RN looked at her shoulder and told her the injection was "placed too high", as in too close to the joint of the shoulder instead of her deltoid muscle. The patient was seen again today by her doctor and he said that the injection was placed in the joint, and that she should contact us to file an incident report. MD also suggested Ibuprofen or naproxen to her by mouth, also use heat and cold on the injection site. The patient says there is no swelling in her arm or rash. MD also suggested that she go to physical therapy to help with range of motion, which has become limited after the shot. The patient states that she cannot commit to physical therapy right now due to cost, and doesn't want any medical bills.
Age: 35.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: PATIENT WAS GIVEN ZOSTAVAX INSTEAD OF VARIVAX.  PATIENT REPORTED MILD PAIN AT THE INJECTION SITE BUT DENIES OTHER SYMPTOMS.
Age: 35.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS GIVEN ZOSTAVAX INSTEAD OF VARIVAX.  PATIENT REPORTED MILD PAIN AT THE INJECTION SITE BUT DENIES OTHER SYMPTOMS.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: Severe, copious, frequent diarrhea with vomiting and fussiness.  Diarrhea was up to 20 times a day until 1/25/17 at which time it decreased to 3 times and was not entirely liquid.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest X-ray, Injection site pain, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in right arm and then shoulder. Progressed to back muscles ending with 3 days in hospital.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray limb
Clinical narrative: Pain in right arm and then shoulder. Progressed to back muscles ending with 3 days in hospital.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: REDNESS AND MUSCLE PAIN IN THE RIGHT ARM (ADMINISTRATION SITE), FLU-LIKE SYMPTOMS, BODYACHE.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Began with tiredness, long nap, followed by fever and headache. The fever, bad headache, and eye ache continued until 1/24/2017, when she broke out in a rash starting on her face. The rash eventually spread to her neck, truck, arms, and legs on 1/25/2017.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Information given over the phone from provider to PHN - PA. Fever of 101.9 and 97.6 with tonic-clonic seizing - seizures occurred 16-18 hours after vaccination. VALIUM was given - Medivaced to Hospital for evaluation. Monitored for 2 days. Doing well - No known sequela.
Sex: U
Vaccine: MNQ
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included GSK medically significant. The outcome of idiopathic thrombocytopenic purpura was unknown. It was unknown if the investigator considered the idiopathic thrombocytopenic purpura to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura (ITP) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled post licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the risk window. [In this study, the risk window was 1-42 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination)]. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 1 and 42 days post index vaccination, the patient developed ITP. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of ITP and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.