chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017, exact dates and route of administration were not reported). It was reported that the administered doses were exposed to temperatures outside of the recommended range. No adverse experience was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with PEDVAXHIB (lot # L002867, expiration date 11-NOV-2017, exact doses and route of administration were not reported). It was reported that the administered doses were exposed to temperatures outside of the recommended range. No adverse experience was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 73 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. In 2008 (reported as "7 years ago"), the patient was vaccinated subcutaneously with the single 0.65 ml dose of ZOSTAVAX (lot# and expiry date were not reported). Concomitant medications were not reported. In 2008 (reported as "7 years ago"), after being vaccinated, the patient had an adverse experience and was diagnosed with transverse myelitis by the physician. The patient sought medical attention via an unspecified contact and was treated with an unspecified treatment. The outcome of myelitis transverse was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the physician did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot # L006384 Expiration date: 25-FEB-2017) (doses, route and anatomical location of administration were not reported). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (Lot # reported as L030585 Expiration date: 10-FEB-2017) (doses, route and anatomical location of administration were not reported). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. The pharmacist reported that prior to receiving ZOSTAVAX the patient had developed 3 bumps on his back which they thought were bug bites. On 09-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dose and route were not reported). On an unspecified day, in October 2015 the patient developed 3 more bumps on his chest that were red. The pharmacist, at the time of report, thought that the patient might had an active case of shingles prior to getting the ZOSTAVAX. The outcome of the patient's events was not reported. The relatedness between the vaccination with ZOSTAVAX and the patient's events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a license practical nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. Between the dates of 01-SEP-2015 and 07-OCT-2015, the patients were inadvertently vaccinated with unspecified doses of improperly stored GARDAISL (lot# K010574 with expiration date 08-APR-2017, and K009482 with expiration date 06-MAR-2017, dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, lot# and route unknown). Concomitant therapy was not reported. On an unknown date the patient fainted after receiving the GARDASIL. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from an unknown type reporter referring to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route were unknown) (inappropriate schedule of drug administration). The patient's concomitant medication was not reported. No adverse reactions occurred. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of a GARDASIL (dose, route, lot # and expiration date were not reported), and 1 week after, on an unknown date, the patient inadvertently received the second dose of the GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as no consent to contact the reporter was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored ROTATEQ, (dose and route not provided) (lot number # L000569, expiration date: 13-JUL-2016; lot number # reported as L004456, expiration date: 07-AUG-2016; lot number # K022995, expiration date: 22-JUL-2016; lot number # K022992, expiration date: 30-JUN-2016; lot number # L008053, expiration date: 30-NOV-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, lot# and route unknown). Concomitant therapy was not reported. On an unknown date the patient fainted after receiving the  GARDASIL.The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 7-year-old female patient who had received KINRIX (batch number 5TD93, expiry date 10th September 2017). This case was associated with a product complaint.  On 9th October 2015, the patient received KINRIX (intramuscular). On 9th October 2015, less than a day after receiving KINRIX, the patient experienced injection site swelling, injection site redness and inappropriate age at vaccine administration. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site redness, inappropriate age at vaccine administration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to KINRIX. Additional details provided were as follows: The 7 years old patient received a dose of KINRIX, which led to an inappropriate age at vaccination. The patient experienced swelling and redness at an unspecified injection site. This case is linked to 2 other cases US2015144654 and US2015144657 (reported by the same reporter). As a precaution QA report was filed for all cases (see case US2015144654 for more details).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a physician concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot No. reported as L004104 Expiration date: 04-MAR-2017) (dose, route and anatomical location of administration were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site discomfort
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route and anatomical location of administration were not reported). On unknown dates, after vaccination, each of these patients developed "discomfort" at the site of PNEUMOVAX 23 injection (No description about the "discomfort" was specified). No Product Quality Complaint (PQC) was involved. The outcome of injection site discomfort was unknown. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 47-year-old male patient who received BOOSTRIX. The patient's past medical history included myalgia (statins medication). Concurrent medical conditions included diabetes, fibromyalgia, rhabdomyolysis and hypoxia (sore prone on right side, foot). Concomitant products included cod-liver oil, COLACE, influenza vaccine unspecified, HALDOL, Levothyroxine, magnesium, Metformin, MIRALAX, potassium chloride, vitamin B complex, Vitamin C and Vitamin D. On 10th October 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 11th October 2015, 2 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be relate to BOOSTRIX. Additional details were received as follows: This case was not previously reported to anyone. The patient received BOOSTRIX in left shoulder. The patient noted that, he does not usually experiences soreness after vaccinations. The patient stated that, he did not usually get the vaccinations in his right arm, due to the lower oxygen levels on right side. The patient experienced sores on his right foot due to lower oxygen levels. No further information was available.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child unk patient who received KINRIX. This case was associated with a product complaint. On an unknown date, the patient received KINRIX (intramuscular). On an unknown date, an unknown time after receiving KINRIX, the patient experienced injection site reaction (serious criteria hospitalization) and product complaint. On an unknown date, the outcome of the injection site reaction and product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was one of the 3 cases reported by the same reporter. The reporter noted that the friend of patient number 1 had this patient (their child) from a totally different medical practice hospitalized for an injection site reaction to KINRIX. No lot number or other information available at time of report. The reporter considered this an anecdotal report.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received DTPA vaccine. Concomitant products included MOTRIN and LEVSIN. On 9th April 2013, the patient received DTPA vaccine. On 9th April 2013, less than a day after receiving DTPA vaccine, the patient experienced injection site pain, injection site nodule and neck pain. On an unknown date, the outcome of the injection site pain, injection site nodule and neck pain were not recovered/not resolved. The reporter considered the injection site pain and injection site nodule to be related to DTPA vaccine. It was unknown if the reporter considered the neck pain to be related to DTPA vaccine. Additional details provide were as follows: This case was reported by the patient herself. The reporter stated that, she received what she thinks was the BOOSTRIX vaccination in her healthcare professional office over 2 years ago in her right arm. The reporter was only able to provide the components of the vaccine which she received but recalls seeing GlaxoSmithKline on the bottle the nurse was holding (Tetanus, Diphtheria and Whooping Cough or Pertussis). In addition she stated her healthcare professional would not provide her with the name of the vaccine. She has informed her healthcare professional about her right arm. The patient experience soreness, stinging (pain) and a small knot (nodule) at the injection site. She had pain from her right elbow all the way to the back of her neck. Her arms felt like she just got the injection. The reporter also stated that, she thinks the nurse hit a nerve when giving the injection with a very long needle because of her height and weight.
Age: 0.5
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 6 month old patient of unknown gender. Cncurrent conditions, pertinent medical history or concomitant medications were not reported. On 12-OCT-2015, the patient was inadvertently vaccinated with a dose of M-M-R II (lot # K021950, expiration date: 10-NOV-2016 (anatomical location, dose and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer Inc. (Reference # 2015346733) refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that a few years ago, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, expiration date, dose and route were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced pain in extremity and peripheral swelling reported as "sore and swollen arm". The outcome of pain in extremity and peripheral swelling was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to pain in extremity and peripheral swelling. Additional information is not expected because the reporter declined additional information to document adverse event (AE).
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On 15-SEP-2015, 16-SEP-2015, 17-SEP-2015, 18-SEP-2015, 21-SEP-2015, 22-SEP-2015, 23-SEP-2015, 24-SEP-2015, 25-SEP-2015, 28-SEP-2015, 29-SEP-2015, 30-SEP-2015, 01-OCT-2015, 02-OCT-2015, 05-OCT-2015, 06-OCT-2015, 07-OCT-2015, 08-OCT-2015, 09-OCT-2015, 12-OCT-2015, 13-OCT-2015, the patients were vaccinated with improperly stored doses of PEDVAVHIB, (lot # L014426 exp 08-MAR-2018 and lot # L012835 exp. 11-MAR-2018 which was exposed to 0 degrees C for 6 hours), (dose and route were not provided). No adverse effects were 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 medical assistant refers to an unspecified number of patients of unknown age and gender. On 15-SEP-2015, 16-SEP-2015, 17-SEP-2015, 18-SEP-2015, 21-SEP-2015, 22-SEP-2015, 23-SEP-2015, 24-SEP-2015, 25-SEP-2015, 28-SEP-2015, 29-SEP-2015, 30-SEP-2015, 01-OCT-2015, 02-OCT-2015, 05-OCT-2015, 06-OCT-2015, 07-OCT-2015, 08-OCT-2015, 09-OCT-2015, 12-OCT-2015, 13-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L004014 exp. 04-MAR-2017 and lot # L016429 exp. 08-MAR-2018, (dose and route were not provided). The primary reporter could not confirm which vaccines were administered on which dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Dyspepsia, Fatigue, Feeling cold, Headache, Immediate post-injection reaction
Clinical narrative: "I got sick. I became nauseous, achy and very tired".
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: "I got sick. I became nauseous, achy and very tired".
Age: 33.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Fatigue, Malaise, Nausea, Pain
Clinical narrative: "I got sick. I became nauseous, achy and very tired".
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site cellulitis, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 7 October 2015. This case involves a 61-year-old female patient who was vaccinated with a dose of FLUZONE (batch number UI443AD, expiry date 30 June 2016, route of administration not reported) in left arm on 30 September 2015. The medical history of pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as NKA disabled with stroke unaware of other medical history and concomitant medications were reported as none. On 30 September 2015, same day few hours after the vaccination, in the evening the patient's left arm was sore red swollen and was unable to sleep. The patient was seen by the physician next day where the site was examined and then sent to the emergency room. It was reported that the patient had a 4 inch by 5 inch area on the left deltoid. They felt the cellulitis occurred due to an error in administration that the site was too low. It was also a wrong injection technique. The patient required ER/doctor visit. Laboratory investigations were reported as unknown. Corrective treatments included KEFLEX and BACTRIM. The event outcome was not reported for any of the above reported events. Upon internal review the case was assessed as serious due to important medical event cellulitis. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cellulitis, Drug administered at inappropriate site, Erythema, Insomnia, Local reaction
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 7 October 2015. This case involves a 61-year-old female patient who was vaccinated with a dose of FLUZONE (batch number UI443AD, expiry date 30 June 2016, route of administration not reported) in left arm on 30 September 2015. The medical history of pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as NKA disabled with stroke unaware of other medical history and concomitant medications were reported as none. On 30 September 2015, same day few hours after the vaccination, in the evening the patient's left arm was sore red swollen and was unable to sleep. The patient was seen by the physician next day where the site was examined and then sent to the emergency room. It was reported that the patient had a 4 inch by 5 inch area on the left deltoid. They felt the cellulitis occurred due to an error in administration that the site was too low. It was also a wrong injection technique. The patient required ER/doctor visit. Laboratory investigations were reported as unknown. Corrective treatments included KEFLEX and BACTRIM. The event outcome was not reported for any of the above reported events. Upon internal review the case was assessed as serious due to important medical event cellulitis. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 7 October 2015. This case involves a 61-year-old female patient who was vaccinated with a dose of FLUZONE (batch number UI443AD, expiry date 30 June 2016, route of administration not reported) in left arm on 30 September 2015. The medical history of pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as NKA disabled with stroke unaware of other medical history and concomitant medications were reported as none. On 30 September 2015, same day few hours after the vaccination, in the evening the patient's left arm was sore red swollen and was unable to sleep. The patient was seen by the physician next day where the site was examined and then sent to the emergency room. It was reported that the patient had a 4 inch by 5 inch area on the left deltoid. They felt the cellulitis occurred due to an error in administration that the site was too low. It was also a wrong injection technique. The patient required ER/doctor visit. Laboratory investigations were reported as unknown. Corrective treatments included KEFLEX and BACTRIM. The event outcome was not reported for any of the above reported events. Upon internal review the case was assessed as serious due to important medical event cellulitis. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient complained of left uper arm pain and had developed contusions on his arm.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient complained of left uper arm pain and had developed contusions on his arm.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site mass, Injection site pain
Clinical narrative: Patient complained of left uper arm pain and had developed contusions on his arm.
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood potassium decreased, Electrocardiogram ambulatory, Palpitations
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart fluttering in a adult male patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). Concurrent medical conditions included blood pressure high (pre-existing issue). On 25th September 2015 12:00, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 30th September 2015, 5 days after receiving FLUARIX QUADRIVALENT, the patient experienced heart fluttering (serious criteria GSK medically significant) and potassium decreased. On an unknown date, the outcome of the heart fluttering and potassium decreased were unknown. It was unknown if the reporter considered the heart fluttering and potassium decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional reported heart flutter and low potassium following vaccination with FLUARIX QUADRIVALENT. On 30th September 2015, the patient went to emergency room due to events and no overnight hospitalization required. The reporter stated that she preferred not to comment on causality, but the patient thought that the events were due to FLUARIX. This is one of the 3 cases reported by the same reporter (see cases US2015146724 and US2015146723).
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood potassium decreased, Cardiac flutter
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart fluttering in a adult male patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). Concurrent medical conditions included blood pressure high (pre-existing issue). On 25th September 2015 12:00, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 30th September 2015, 5 days after receiving FLUARIX QUADRIVALENT, the patient experienced heart fluttering (serious criteria GSK medically significant) and potassium decreased. On an unknown date, the outcome of the heart fluttering and potassium decreased were unknown. It was unknown if the reporter considered the heart fluttering and potassium decreased to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional reported heart flutter and low potassium following vaccination with FLUARIX QUADRIVALENT. On 30th September 2015, the patient went to emergency room due to events and no overnight hospitalization required. The reporter stated that she preferred not to comment on causality, but the patient thought that the events were due to FLUARIX. This is one of the 3 cases reported by the same reporter (see cases US2015146724 and US2015146723).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .2 ml. On 27th September 2015, 2 days after receiving FLUARIX QUDRIVALENT, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 25th September 2015, at 12:00, the patient received a dose of FLUARIX QUADRIVALENT vaccine in her left deltoid. The patient experienced an unspecified reaction at the injection site. The reporter did not preferred to comment on causality, but the patient thought that the adverse events were due to the vaccine. Reporter declined follow-up and no further information was available. This is one of the 3 cases reported by the same reporter (see cases US2015146723 and US2015146725).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .2 ml. On 27th September 2015, 2 days after receiving FLUARIX QUDRIVALENT, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the injection site to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 25th September 2015, at 12:00, the patient received a dose of FLUARIX QUADRIVALENT vaccine in her left deltoid. The patient experienced an unspecified reaction at the injection site. The reporter did not preferred to comment on causality, but the patient thought that the adverse events were due to the vaccine. Reporter declined follow-up and no further information was available. This is one of the 3 cases reported by the same reporter (see cases US2015146723 and US2015146725).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Induration, Nodule, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received FLUARIX (batch number DF4TX, expiry date 9th June 2016). On 25th September 2015, the patient received FLUARIX (intramuscular) .5 ml. On 27th September 2015, 2 days after receiving FLUARIX, the patient experienced injection site swelling, injection site redness and injection site nodule. On an unknown date, the outcome of the injection site swelling, injection site redness and injection site nodule were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site redness and injection site nodule to be related to FLUARIX. Additional details provided were as follows: On 25th September 2015, at 12:00, the patient received a dose of FLUARIX vaccine in her left deltoid. The patient experienced injection site reaction which was described as a swollen arm the size of a fist. It was also described as red and knotted (nodule). The events took 6 days to resolve. The reporter did not preferred to comment on causality, but the patient thought that the adverse events were due to the vaccine. Reporter declined follow-up and no further information was available. This is one of the 3 cases reported by the same reporter (see cases US2015146724 and US2015146725).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received FLUARIX (batch number DF4TX, expiry date 9th June 2016). On 25th September 2015, the patient received FLUARIX (intramuscular) .5 ml. On 27th September 2015, 2 days after receiving FLUARIX, the patient experienced injection site swelling, injection site redness and injection site nodule. On an unknown date, the outcome of the injection site swelling, injection site redness and injection site nodule were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site redness and injection site nodule to be related to FLUARIX. Additional details provided were as follows: On 25th September 2015, at 12:00, the patient received a dose of FLUARIX vaccine in her left deltoid. The patient experienced injection site reaction which was described as a swollen arm the size of a fist. It was also described as red and knotted (nodule). The events took 6 days to resolve. The reporter did not preferred to comment on causality, but the patient thought that the adverse events were due to the vaccine. Reporter declined follow-up and no further information was available. This is one of the 3 cases reported by the same reporter (see cases US2015146724 and US2015146725).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a child female patient who received FLUARIX QUADRIVALENT (batch number 397A7, expiry date 18th June 2016). In 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient developed hives 12 to 16 hours after receiving FLUARIX QUADRIVALENT.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a child female patient who received FLUARIX QUADRIVALENT (batch number 397A7, expiry date 18th June 2016). In 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The patient developed hives 12 to 16 hours after receiving FLUARIX QUADRIVALENT.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Nasal congestion, Rhinorrhoea
Clinical narrative: Patient developed runny eyes and nose and a congested nose.  No other symptoms reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itching, redness and rashing at injection site and surrounding area.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Heart rate increased
Clinical narrative: Lightheaded, clammy skin, rapid pulse. No nausea, vomiting, rash/pruritis, or difficulty breathing. No treatment at facility, however patient called EMS and was transported. NOTE that actual age/DOB of patient is unknown.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Dysphagia, Oral candidiasis, Oropharyngeal pain
Clinical narrative: Sore throat, difficulty swallowing, cough, oral thrush noted on 10/20/2015 (white patches on tongue and hard palate, inappetance.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Dyspnoea, Oropharyngeal pain, Respiratory rate increased
Clinical narrative: PATIENT WOKE UP COUGHING, WITH AN EXTREMELY HOARSE SORE THROAT, ACCOMPANIED BY RAPID BREATHING THAT WAS LABORED, HE COMPLAINED THAT HIS THROAT HURT.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, body aches, low-grade fever, nausea and vomiting, exhaustion.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Headache, body aches, low-grade fever, nausea and vomiting, exhaustion.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Employee received a mandatory flu shot, 2 days later at the siite she had swelling redness and itching involving the entire upper arm.. She has never had an issue with flu shot before.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Depressed level of consciousness, Erythema, Eye movement disorder, Hypotonia, Opisthotonus
Clinical narrative: Patient arched backward, tensed up, eyes rolled back in head, stopped breathing, face turned red which lasted about 1 minute then she became limp and unarousable. Patient was unable to keep her head up she kept trying to open her eyes and head would nod up and fall. This lasted about 10 minutes. She was very sleepy and after 15 minutes started to act normal again.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Posture abnormal, Respiratory arrest, Somnolence, Tension
Clinical narrative: Patient arched backward, tensed up, eyes rolled back in head, stopped breathing, face turned red which lasted about 1 minute then she became limp and unarousable. Patient was unable to keep her head up she kept trying to open her eyes and head would nod up and fall. This lasted about 10 minutes. She was very sleepy and after 15 minutes started to act normal again.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: Full body hives followed a few hours later by facial/throat swelling.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test positive, Dysphagia, Hypersensitivity, Throat irritation
Clinical narrative: It became difficult for me to swallow; my throat felt like it was burning.  I went directly to ER.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, Cellulitis, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Vaccine given 10/16/15. On 10/17/15, parents report right arm (shoulder to mid-forearm) swelling, pain, redness, and itching that extended to the mid-chest and back. Parents report fever to 105 degrees F. Admitted to hospital on 10/19/15 with significant right arm swelling and suspected cellulitis.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Pruritus, Pyrexia, Swelling
Clinical narrative: Vaccine given 10/16/15. On 10/17/15, parents report right arm (shoulder to mid-forearm) swelling, pain, redness, and itching that extended to the mid-chest and back. Parents report fever to 105 degrees F. Admitted to hospital on 10/19/15 with significant right arm swelling and suspected cellulitis.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Borrelia test negative, Cellulitis, Chlamydia test negative, Erythema
Clinical narrative: Patient given PNEUMOVAX 23 on 9/23/15. Later that day, I developed redness in arm and was sent for admission. Treated as local reaction with cellulitis. On 9/30/15, developed (L) facial droop consistent with Bells Palsy. Treated with steroids and antivirals. Symptoms persist at time of report.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Human rhinovirus test positive, Laboratory test normal, Local reaction, Metabolic function test normal
Clinical narrative: Patient given PNEUMOVAX 23 on 9/23/15. Later that day, I developed redness in arm and was sent for admission. Treated as local reaction with cellulitis. On 9/30/15, developed (L) facial droop consistent with Bells Palsy. Treated with steroids and antivirals. Symptoms persist at time of report.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Polymerase chain reaction positive, Streptococcus test negative, VIIth nerve paralysis
Clinical narrative: Patient given PNEUMOVAX 23 on 9/23/15. Later that day, I developed redness in arm and was sent for admission. Treated as local reaction with cellulitis. On 9/30/15, developed (L) facial droop consistent with Bells Palsy. Treated with steroids and antivirals. Symptoms persist at time of report.
Sex: F
Vaccine: HPV9
Symptoms: Coma, Ligament injury
Clinical narrative: Information has been received from a nurse via a company representative referring to a female high school student. On an unknown date the patient was vaccinated with her second dose of GARDASIL 9 (dose, route and lot # were not reported). On an unknown date the patient experienced an anterior cruciate ligaments (ACL) injury, went into a coma and was dying. At the time of this report, the events outcome was unknown. The causality between the events and the vaccination was not reported. Upon internal review, coma was considered to be medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus generalised, Vaccination site swelling
Clinical narrative: Itching all over body and red, raised area at vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Pyrexia, Rash generalised
Clinical narrative: BODY ACHES, FEVER AND BODY RASH. MOTHER GAVE BENADRYL TO PATIENT. RASH DIMINISHED, BUT DID NOT RESOLVE. WAS TAKEN TO URGENT CARE AFTER CLINIC HOURS FOR CONTINUED BODY RASH.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Sleep disorder, Swelling
Clinical narrative: First symptom was left arm soreness around injection site and inability to sleep on left side. Upon waking patient noticed erythema, swelling, and bruising spanning approximately two inches in diameter from injection site.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache
Clinical narrative: Arthralgia in shoulder, wrist, and back of neck started 1 week after receiving flu shots. Headaches x 2 days in frontal lobe. Patient started taking Aleve and symptoms are getting better. Symptoms lasted approximately 2 weeks. Patient denied any injuries or increased activities.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Symptoms: moderate pain at immunization site, intense itching, body aches, headache, dizziness, fatigue. Signs: fever (100.5*F), erythema (4 inch diameter), swelling, warmth at injection site. Time course: 2 days (ongoing). Treatment: Ice massage at injection site, ibuprofen, diphenhydramine (oral).
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pruritus, Pyrexia
Clinical narrative: Symptoms: moderate pain at immunization site, intense itching, body aches, headache, dizziness, fatigue. Signs: fever (100.5*F), erythema (4 inch diameter), swelling, warmth at injection site. Time course: 2 days (ongoing). Treatment: Ice massage at injection site, ibuprofen, diphenhydramine (oral).
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dysgeusia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Very severe myalgias, tender muscles, skin and generalized fatigue and somnolence. Loss of appetite, bad taste, sore throat (one side), impaired taste and headache with delayed mentation. Felt I was going to die. Had a low grade fever of 100.4. My basal body temp is 97.6.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mental impairment, Myalgia, Oropharyngeal pain, Pain of skin, Pyrexia
Clinical narrative: Very severe myalgias, tender muscles, skin and generalized fatigue and somnolence. Loss of appetite, bad taste, sore throat (one side), impaired taste and headache with delayed mentation. Felt I was going to die. Had a low grade fever of 100.4. My basal body temp is 97.6.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Very severe myalgias, tender muscles, skin and generalized fatigue and somnolence. Loss of appetite, bad taste, sore throat (one side), impaired taste and headache with delayed mentation. Felt I was going to die. Had a low grade fever of 100.4. My basal body temp is 97.6.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Injection site reaction, Pain
Clinical narrative: We evaluated on 10/20/15 due to continued pain in left shoulder following a Flu Vaccine.  Most often achy pain but increases with movement. Diagnosis Bursitis Left Shoulder. To take ibuprofen/Advil as needed and follow up in 4 weeks at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received Zostavax on 10/15/2015 noticed arm/injection site itchy and warm-- red on exam-- presented to clinic 10/19/2015 for evaluation, had 5 cm x 2cm area redness and induration-- instructed to take antihistamine and use cool compress and follow up if not improving.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash from site of injection on left arm down to the elbow.  Raised rash.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Recieved message from patient on October 20th that she has had shoulder pain since the injection was provided. She reports decrease range of motion, difficulty lifting and sleeping. She has schedule a PCP appointment for 10/22/15. Left message with patient on 10/21 to discuss message further.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Foaming at mouth, Heart rate increased, Nausea
Clinical narrative: Patient reports nausea, white foam eruptions from mouth, chills, and increased heart rate.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: MOTHER NOTED REDNESS AT THE SITE OF INJECTION. PATIENT COMPLAINED OF TENDERNESS AT THE SITE. THE AREA OF REDNESS SPREAD BY THE NEXT MORNING TO 12CM.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain for the first two days. Numbness in arm, hand over next three weeks (to date). Limited range of motion in arm/shoulder over next three weeks (to date). Disabling pain in arm/shoulder over next three weeks (to date).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports pain in arm around site of injection, inability to raise arm due to discomfort. Onset of symptoms approximately 10-8-15. Progressive worsening of symptoms. Patient tried heating pad at home with no relief. No other symptoms reported.
Age: 17.0
Sex: F
Vaccine: FLU4, HEP, HPV4, VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Pinkish 2"x3" mild local reaction at site (L) lateral arm - resolving at time of visit.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Flu vaccine received 10-19-15. No reaction on eve of 10-20-15 site of injection became red, hot, raised and itchy. Area approx 3" diameter, 10-21-15 red.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unknown dates, the patient was concomitantly vaccinated with PNEUMOVAX 23 and unspecified influenza virus vaccine (manufacturer unknown), both for prophylaxis (strength, dose and route unknown). There was no concomitant medication reported. On unknown dates, the patient developed flu-like symptoms that required them to call out from work. The patients sought medical attention via contacting pharmacist. The outcome of the event was unknown. Causality between event and PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLUN4
Symptoms: Feeling hot, Hyperhidrosis, Sensation of foreign body
Clinical narrative: TWO MINUTES AFTER THE MEMBER RECEIVED THE FLU MIST, HE HAD A LUMP IN HIS THROAT, DIAPHORETIC, HOT BODY.