chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received PNEUMOVAX 23 at approximately 4pm on 10/3/16. Family reports following evening (10/4/16) pt spiked fever 104 deg, red area on R arm near where shot was given. Fever controlled w/ibuprofen/TYLENOL but continues to spike once med wears off through when pt seen for evaluation in office today. Redness of R upper arm has increased w/moderate swelling and warmth to touch. Pt complains of tenderness and itching of R upper arm, also of upset stomach. No respiratory distress. BENADRYL dose given in office.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Pt received PNEUMOVAX 23 at approximately 4pm on 10/3/16. Family reports following evening (10/4/16) pt spiked fever 104 deg, red area on R arm near where shot was given. Fever controlled w/ibuprofen/TYLENOL but continues to spike once med wears off through when pt seen for evaluation in office today. Redness of R upper arm has increased w/moderate swelling and warmth to touch. Pt complains of tenderness and itching of R upper arm, also of upset stomach. No respiratory distress. BENADRYL dose given in office.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Impaired driving ability, Nausea
Clinical narrative: Patient given HPV and Meningococcal on Monday 9-26. Tuesday 9/17 he woke up dizzy nauseated, fatigued and unable to drive. Wed felt the same. Friday sent home from school still dizzy.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt noticed red itchy skin around the tetanus injection site a few days after PREVNAR vaccination. Today seems to be better. Patient was started on 4 day course of prednisone 40 mg today taper in 4 days.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Muscle mass
Clinical narrative: Right upper arm pain after HPV injection. Swelling at injection site on same day. Swelling has decreased, but pain when moving arm. Lump in muscle.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 102 with ED visit/evaluation.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash erythematous
Clinical narrative: Raised red bumpy rash to (L) thigh/buttock, right thigh, low back.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Axillary pain, Fatigue, Injection site swelling, Mobility decreased, Pain
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of swelling arm in a 33-year-old female patient who received BOOSTRIX (batch number 7RJ98, expiry date 18th November 2018). Concurrent medical conditions included drug allergy. On 26th August 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 26th August 2016, less than a day after receiving BOOSTRIX, the patient experienced swelling arm and pain. BOOSTRIX was discontinued. On 8th September 2016, the outcome of the swelling arm and pain were recovered/resolved. The reporter considered the swelling arm and pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX on left deltoid. The patient experienced arm swelling and pain for the duration of 13 days.
Age: 33.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of swelling arm in a 33-year-old female patient who received BOOSTRIX (batch number 7RJ98, expiry date 18th November 2018). Concurrent medical conditions included drug allergy. On 26th August 2016, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 26th August 2016, less than a day after receiving BOOSTRIX, the patient experienced swelling arm and pain. BOOSTRIX was discontinued. On 8th September 2016, the outcome of the swelling arm and pain were recovered/resolved. The reporter considered the swelling arm and pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX on left deltoid. The patient experienced arm swelling and pain for the duration of 13 days.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Pruritus, Throat tightness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23L7C, expiry date 30th June 2017). Previously administered products included FLUZONE (in 2015, with no reaction). Concurrent medical conditions included fish allergy (severe) and food allergy (severe). In September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). In September 2016, 7 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant), contact dermatitis, itchy throat, throat swelling and injection site reaction. the patient was treated with BENADRYL, prednisone, PEPCID and EPIPEN (Nos). On an unknown date, the outcome of the anaphylaxis, contact dermatitis, itchy throat, throat swelling and injection site reaction were recovering/resolving. It was unknown if the reporter considered the anaphylaxis, contact dermatitis, itchy throat, throat swelling and injection site reaction to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: In September 2016 at 9:30 hours, the patient received the FLUARIX QUADRIVALENT. On the same day, at 9:37 hours, the patient had diffuse itching and swelling of throat. The patient received 50 mg of BENADRYL in employee health. Thirty minutes later the patient was still having sign and symptoms of anaphylaxis so a 60 mg of prednisone and 40 mg of PEPCID was administered. The patient went to the emergency room and they administered an EPIPEN and monitored patient and discharged. At night the patient took a BENADRYL. Less than a day, after vaccination the patient experienced contact dermatitis and injection site reaction. On 29th September 2016, the patient was still suffering from histamine response with contact dermatitis on places where the IV site was placed and the Band-Aid was placed but was in stable condition. The reporter was unsure about the injection site reaction. The reported vaccination date was unclear, it could be 28th September 2016 or 29th September 2016.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dermatitis contact, Injection site reaction, Pharyngeal oedema, Throat irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23L7C, expiry date 30th June 2017). Previously administered products included FLUZONE (in 2015, with no reaction). Concurrent medical conditions included fish allergy (severe) and food allergy (severe). In September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). In September 2016, 7 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant), contact dermatitis, itchy throat, throat swelling and injection site reaction. the patient was treated with BENADRYL, prednisone, PEPCID and EPIPEN (Nos). On an unknown date, the outcome of the anaphylaxis, contact dermatitis, itchy throat, throat swelling and injection site reaction were recovering/resolving. It was unknown if the reporter considered the anaphylaxis, contact dermatitis, itchy throat, throat swelling and injection site reaction to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: In September 2016 at 9:30 hours, the patient received the FLUARIX QUADRIVALENT. On the same day, at 9:37 hours, the patient had diffuse itching and swelling of throat. The patient received 50 mg of BENADRYL in employee health. Thirty minutes later the patient was still having sign and symptoms of anaphylaxis so a 60 mg of prednisone and 40 mg of PEPCID was administered. The patient went to the emergency room and they administered an EPIPEN and monitored patient and discharged. At night the patient took a BENADRYL. Less than a day, after vaccination the patient experienced contact dermatitis and injection site reaction. On 29th September 2016, the patient was still suffering from histamine response with contact dermatitis on places where the IV site was placed and the Band-Aid was placed but was in stable condition. The reporter was unsure about the injection site reaction. The reported vaccination date was unclear, it could be 28th September 2016 or 29th September 2016.
Age: 1.08
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Abasia, Decreased appetite, Gait disturbance, Injected limb mobility decreased, Irritability
Clinical narrative: Unable to walk using the leg were vaccine was administered and pain.
Age: 1.08
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Abasia, Injection site movement impairment, Vaccination site pain
Clinical narrative: Unable to walk using the leg were vaccine was administered and pain.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: PT STATES THAT HE FEELS CHEST PAIN AFTER HE EATS HIS DINNER.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth
Clinical narrative: At first, hot bump at site of injection. On 10/6/16, flu like symptoms.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Most Notable Symptom: Swollen lymph nodes for 3-4 days. Most severe in armpits. Dull aching pain. Other Symptoms: Injection painful when administered (burning -sensation). Injection site swollen for 3-4 days.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Skin mass
Clinical narrative: Intense pain lasting 1 to 2 weeks and mass under skin present 3 to 4 weeks after receiving first dose of Twinrix vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site reaction, Skin exfoliation
Clinical narrative: Pain, itching, peeling skin, and discoloration of injected arm slightly below injection site.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Muscular weakness
Clinical narrative: Developed dizziness, headache, and left arm weakness few minutes after vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: This spontaneous report was received via a company representative from a 73 years old female patient regarding herself. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date few years ago the patient was vaccinated with ZOSTAVAX (dosing details were not reported) subcutaneously. Recently on an unknown date the patient developed shingles. The reporter also stated that the shingles rash developed around her eyes and was very painful which lasted for 8 weeks. The patient sought medical attention by visiting physician. The patient acquired multiple very expensive medical bills as a result of the shingles. The outcome of the event ophthalmic herpes zoster was reported as recovering. The reporter did not provide the causality assessment between the event and the suspect therapy. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, raised reaction at injection site. Approximately 3 inches in diameter.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Urticaria
Clinical narrative: Urticaria and hives on large part of the body. Chills and generalized pain. This occurred approximately 6 hour after injection of the vaccine it was treated with BENADRYL (100 mg) and Prednisone 40 mg and symptoms improved after 60 min. Patient was treated by visiting home physician.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches, lasted about 36 hours.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever, pain at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Emotional distress, Fear, Screaming
Clinical narrative: Patient exhibited very strange behavior never seen before.  He started screaming before bed very shrill loud screams, shouting NO NO NO. Pointing to walls and ceilings screaming no.  Tried covering his eyes.  Was afraid to go to sleep.  Wouldn't let me close my eyes to go to sleep.  Was inconsolable.  Took 2 hrs to get him calmed down.  He woke up at 3:00 am with same symptoms.  Had to take him down stairs and sleep on couch sitting up and cradling him till he fell asleep again.  Took an hour to get him calmed down again.  He woke up the next morning doing the same thing.  I went to the bathroom and he pounded on the bathroom door so hard screaming that he put a small dent in it.  He had another episode at daycare.  He was fine when he got there, but out on the playground the teacher turned around and he was curled up in a ball crying and trying to cover his face and ears.  Took him to hospital for observation.  He has been doing this everyday since his vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Insomnia, Pyrexia, Screaming, Skin warm
Clinical narrative: Patient exhibited very strange behavior never seen before.  He started screaming before bed very shrill loud screams, shouting NO NO NO. Pointing to walls and ceilings screaming no.  Tried covering his eyes.  Was afraid to go to sleep.  Wouldn't let me close my eyes to go to sleep.  Was inconsolable.  Took 2 hrs to get him calmed down.  He woke up at 3:00 am with same symptoms.  Had to take him down stairs and sleep on couch sitting up and cradling him till he fell asleep again.  Took an hour to get him calmed down again.  He woke up the next morning doing the same thing.  I went to the bathroom and he pounded on the bathroom door so hard screaming that he put a small dent in it.  He had another episode at daycare.  He was fine when he got there, but out on the playground the teacher turned around and he was curled up in a ball crying and trying to cover his face and ears.  Took him to hospital for observation.  He has been doing this everyday since his vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Crying, Hypervigilance, Insomnia
Clinical narrative: Patient exhibited very strange behavior never seen before.  He started screaming before bed very shrill loud screams, shouting NO NO NO. Pointing to walls and ceilings screaming no.  Tried covering his eyes.  Was afraid to go to sleep.  Wouldn't let me close my eyes to go to sleep.  Was inconsolable.  Took 2 hrs to get him calmed down.  He woke up at 3:00 am with same symptoms.  Had to take him down stairs and sleep on couch sitting up and cradling him till he fell asleep again.  Took an hour to get him calmed down again.  He woke up the next morning doing the same thing.  I went to the bathroom and he pounded on the bathroom door so hard screaming that he put a small dent in it.  He had another episode at daycare.  He was fine when he got there, but out on the playground the teacher turned around and he was curled up in a ball crying and trying to cover his face and ears.  Took him to hospital for observation.  He has been doing this everyday since his vaccination.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Complained of numbness and hand going numb,
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Noticed a swelling at the site of injection, Left upper arm,  which gradually increased in size along with redness and then his whole upper arm and adjacent shoulder area was swollen, hot and firm to touch.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7X4 CM REDDENED, WARM AND SWOLLEN AT LEFT DELTOID WILL FOLLOW SEE NURSE PRACTIONER TODAY.
Age: 62.0
Sex: U
Vaccine: TDAP
Symptoms: Abasia, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Shot given 4/29/16. On 5/16/16 back for numbness in hands and feet. 5/22 in emergency could not walk or use hands. Pain was unbearable. Admitted treatment started.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness unilateral, Body temperature increased, Fatigue, Incorrect route of drug administration, Influenza like illness
Clinical narrative: Initial unsolicited misuse report received from a consumer on 26-SEP-2016. This case involves a 47-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series were not reported) subcutaneously, in left deltoid on 25-SEP-2015. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 25-SEP-2015, eight hours following the vaccination, the patient developed flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit. On 27-OCT-2015, one month following the vaccination, the patient's right eye vision loss occurred. On an unspecified date, the patient was seen by MD and eye specialist and was diagnosed with optic nerve neuritis with permanent vision loss. It was a case of incorrect route of drug administration as as the vaccine FLUZONE ID was administered subcutaneously. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. On an unspecified date, the outcome of the events flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit was reported as recovered (Symptoms lasted 4 weeks) whereas the outcome for right eye vision loss, optic nerve neuritis with permanent vision loss was unknown. Upon medical review, the case was considered as serious due to important medical event: optic nerve neuritis with permanent vision loss. List of documents held by sender: none. Sender's Comments: This case concerns 47 year old female patient who received INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE and 8 hour later developed flu like symptoms, exhaustion, body aches, temp of 100.5F. One month after vaccination patient developed optic neuritis and vision loss. Time to onset of events is compatible. However patient's medical history, concomitant medication, concurrent condition, other etiological work up, investigation results will be needed for complete assessment of case. Based on available information role of vaccine cannot be ruled out.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Optic neuritis, Pain
Clinical narrative: Initial unsolicited misuse report received from a consumer on 26-SEP-2016. This case involves a 47-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series were not reported) subcutaneously, in left deltoid on 25-SEP-2015. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 25-SEP-2015, eight hours following the vaccination, the patient developed flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit. On 27-OCT-2015, one month following the vaccination, the patient's right eye vision loss occurred. On an unspecified date, the patient was seen by MD and eye specialist and was diagnosed with optic nerve neuritis with permanent vision loss. It was a case of incorrect route of drug administration as as the vaccine FLUZONE ID was administered subcutaneously. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. On an unspecified date, the outcome of the events flu like symptoms, exhaustion, body aches and temperature of 100.5 Fahrenheit was reported as recovered (Symptoms lasted 4 weeks) whereas the outcome for right eye vision loss, optic nerve neuritis with permanent vision loss was unknown. Upon medical review, the case was considered as serious due to important medical event: optic nerve neuritis with permanent vision loss. List of documents held by sender: none. Sender's Comments: This case concerns 47 year old female patient who received INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE and 8 hour later developed flu like symptoms, exhaustion, body aches, temp of 100.5F. One month after vaccination patient developed optic neuritis and vision loss. Time to onset of events is compatible. However patient's medical history, concomitant medication, concurrent condition, other etiological work up, investigation results will be needed for complete assessment of case. Based on available information role of vaccine cannot be ruled out.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-health care professional on 28 Sep 2016. This case involves an 80-year-old male patient who was vaccinated with third dose of Fluzone HD (Batch number: UI636AB, expiration date: 27 Mar 2017, dose and route of administration were not reported) in the left deltoid on 19 Sep 2016. Illness at the time of vaccination was also reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was hypertension. Concomitant medications were reported as patient was on PLAVIX. Any other vaccinations within four weeks of vaccinations were also reported as none. On 21 Sep 2016, approximately two days following the vaccination, the patient experienced left arm soreness. on an unspecified date, following vaccination, the patient was unable to fully reach arm over his head, his range of motion was limited. He did not want to go to personal physician for this situation. It was reported that the patient was vaccinated twice with Fluzone HD in previous years. Laboratory investigations were reported as none. Corrective treatment was not reported. The patient recovered from left arm soreness on an unknown date (reported as no complaints of pain or soreness now). The patient was not recovered from other events (reported as just concerned with his lack of arm movement). List of documents held by sender: none.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 28 September 2016. This case involves an 80 years old male patient who was vaccinated with a second dose of FLUZONE HD (batch number: UI697AA, expiratory date: 06 May 2017, route and site of administration was not reported) in right side on 27 September 2016 around 15:00. Patient's illness at the time of vaccination was denied. Patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Hyperlipidemia and sleep apnea. Patient denied to report about any other vaccinations within 4 weeks of vaccinations. Concomitant medications was not reported. On 28 September 2016 (at 05:00), 14 hours following the vaccination, the patient had experienced pain from knees up to hips and muscles spasms on both sides at every muscle. On 28 September 2016, one day following vaccination, the patient experienced pain which continued all night and pain was excruciating and felt sore in the morning. Relevant laboratory data was not reported. It was reported that the patient had taken treatment with twice of extra strength Tylenol. On an unspecified date, the patient was recovered from event. List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Feeling drunk, Headache, Mental impairment
Clinical narrative: Initial unsolicited report received from a physician on 29-Sep-2016. This case involves a 59-year-old male patient, who was vaccinated with 0.5 ml of FLUZONE QUADRIVALENT (batch number: UI673AB, expiry date: 30-Jun-2017) (route and dose in series not reported) in left arm on 27-Sep-2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was also reported that patient did not received any other vaccines within four week of suspect vaccine. Concomitant medications were not reported. On 28-Sep-2016, one day following the vaccination, the patient felt dizzy, and had a headache. Patient also was not thinking clearly, and was very tired. Patient felt like drunk. As the day progressed, patient began to feel itchy all over body. Lab test was reported as none. Patient received acetaminophen as corrective treatment and took rest. On the morning of 29- Sep-2016, patient was feeling better and had a slight headache. It was also reported that the outcome of the events were unknown. Documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Initial unsolicited report received from a physician on 29-Sep-2016. This case involves a 59-year-old male patient, who was vaccinated with 0.5 ml of FLUZONE QUADRIVALENT (batch number: UI673AB, expiry date: 30-Jun-2017) (route and dose in series not reported) in left arm on 27-Sep-2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was also reported that patient did not received any other vaccines within four week of suspect vaccine. Concomitant medications were not reported. On 28-Sep-2016, one day following the vaccination, the patient felt dizzy, and had a headache. Patient also was not thinking clearly, and was very tired. Patient felt like drunk. As the day progressed, patient began to feel itchy all over body. Lab test was reported as none. Patient received acetaminophen as corrective treatment and took rest. On the morning of 29- Sep-2016, patient was feeling better and had a slight headache. It was also reported that the outcome of the events were unknown. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Dizziness, Headache, Neck pain
Clinical narrative: Initial unsolicited report received from a physician (patient's husband) on 29 September 2016. This case involves a 56-year-old female patient who was vaccinated with a dose of 0.5ml Fluzone QIV (batch number: UI673AB, expiry date of product: 30 June 2017; dose in series, route of administration were not reported) in the arm at around noon on 27 September 2016. Reportedly, she had received Fluzone QIV multiple doses over the years. The patient's medical history and concomitant medications reported as none (any other vaccinations within 4 weeks of vaccinations, Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none). On 27 September 2016, few hours after vaccination (at around 6PM) following the vaccination, the patient began to feel dizzy, had a headache and vomited one time, also had neck and upper back pain, and complained of feeling very weak. Laboratory data was reported as none. Corrective treatment included paracetamol and the patient was advised rest. The outcome of the event was unknown. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a physician (patient's husband) on 29 September 2016. This case involves a 56-year-old female patient who was vaccinated with a dose of 0.5ml Fluzone QIV (batch number: UI673AB, expiry date of product: 30 June 2017; dose in series, route of administration were not reported) in the arm at around noon on 27 September 2016. Reportedly, she had received Fluzone QIV multiple doses over the years. The patient's medical history and concomitant medications reported as none (any other vaccinations within 4 weeks of vaccinations, Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none). On 27 September 2016, few hours after vaccination (at around 6PM) following the vaccination, the patient began to feel dizzy, had a headache and vomited one time, also had neck and upper back pain, and complained of feeling very weak. Laboratory data was reported as none. Corrective treatment included paracetamol and the patient was advised rest. The outcome of the event was unknown. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 29 September 2016. This case involves 66-years-old male patient who was vaccinated with dose of Fluzone HD (Batch number: UI666AB, expiration date: 13 April 2017, route of administration was not reported) in left deltoid on 19 September 2016 early in the day. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) includes none. Concomitant medications were reported as none. On 19 September 2016, in the evening few hours following vaccination patient began to feel soreness in his Left arm and stated that pain became increased, and persisted for the next 11 days. On 29 September 2016, 10 days following vaccination patient's pain has decreased but arm hurts with movement. Lab data was reported as none. Patient received three ibuprofen each day for pain as a corrective treatment. Outcome of events was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 28 September 2016. This case involves male patient (age not reported) who was vaccinated with dose of Fluzone High Dose (Batch number, expiration date, route and site of administration was not reported) on 27 September 2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination patient experienced strange reaction. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 69 year old male patient who was vaccinated with a second dose of FLUZONE HD (batch number-UI664AA expiry date: 06 Apr 2017 and route was not reported) in left deltoid on 30 Sept 2016. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as none. The patient previously vaccinated with FLUZONE HD last year (2015) on an unspecified date. The patients Concomitant medications were not reported. On 30 September 2016, right after administration of vaccine, the patient had developed a large lump approximately the size of a nickel under the skin at the site of injection. The patient denies pain at site. The patient laboratory data was reported as none. The patient Corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site extravasation, Injection site induration
Clinical narrative: Initial unsolicited report received from a nurse on 30 Sep 2016. This case involves a 47-year-old male patient who was vaccinated with a dose of Fluzone ID (Batch number: UT5569BA, expiry date: 30 June 2017, dose, route and site was not reported) via intradermal route in left deltoid on 28 Sep 2016. Reporter denied pre-existing physician diagnosed allergies, birth defects, medical conditions, illness at the time of vaccination and concomitant medications were not provided. On 30 Sep 2016, two days post vaccination; the patient had hardness at the injection site and some leakage. Lab data and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 13.0
Sex: U
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 28-SEP-2016. This case is linked to case 2016SA182419 (same event, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Adacel and a dose of Pentacel (batch number, expiry date, route and site of administration: not reported for both administration) on an unspecified date. Patient's medical history was not reported. Information about patients pertussis immunizations was unknown. Concomitant medication was not reported. On an unspecified date, post vaccination patient was diagnosed with Pertussis. Laboratory data and corrective treatment was reported. Outcome of the event was not reported. Upon internal review, the case was considered as serious due to important medical event: pertussis. List of documents held by sender: none. Sender's Comments: Based on the information on unknown date patient received both vaccines PENTACEL and ADACEL and experienced pertussis on unknown date. Doses of pertussis received by the patient was not known, This case is therefore not a vaccination failure. The latency between the last dose of the vaccine administered and the occurrence of first symptoms is however not reported. However details regarding relevant medical history, date of vaccination for ADACEL and PENTACEL, date of occurrence of first symptoms, investigation reports confirming the diagnosis, age and gender of patient are needed for complete assessment of the case.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a Pharmacist on 30 September 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient was allergic to eggs and concomitant medications were not reported. On an unspecified date in 1978, following the vaccination, the patient had a reaction to the flu vaccine. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: Patient woke up very fatigue, dizzy, vomiting.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: The patient experienced pain in the shoulder since he received the injection.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site pain, Sleep disorder, Swelling, Tenderness
Clinical narrative: Redness near area where vaccine given, tenderness around area; By afternoon, the redness began turning puffy and aches began in left upper arm where vaccine given. That night, could not sleep on left arm for pain was severe. By 10/6/16, welt-like puffiness all along upper arm, both front and back, from shoulder to elbow. No itching, but terribly sore. By bedtime, I was able to sleep for short periods on left side.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Redness near area where vaccine given, tenderness around area; By afternoon, the redness began turning puffy and aches began in left upper arm where vaccine given. That night, could not sleep on left arm for pain was severe. By 10/6/16, welt-like puffiness all along upper arm, both front and back, from shoulder to elbow. No itching, but terribly sore. By bedtime, I was able to sleep for short periods on left side.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dizziness, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness near where vaccine was given, tenderness around area; By afternoon, the redness began turning puffy and aches began in upper arm where vaccine was given. That evening I became dizzy in shower. Had to sit down. Upon leaving shower, I had to lie down on bed and wait ten minutes in order to dry off. That night, I could not sleep on right arm for more than a few minutes as pain was severe. By 10/6/2016, welt-like puffiness, redness, heat covered much of upper right arm. By that night at shower, I noticed this red puffiness had gone to elbow of right arm, with a large swollen area right on inside elbow joint. No itching but terribly sore. By bedtime, I was able to sleep a bit more on that arm but not well.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Sleep disorder, Tenderness
Clinical narrative: Redness near where vaccine was given, tenderness around area; By afternoon, the redness began turning puffy and aches began in upper arm where vaccine was given. That evening I became dizzy in shower. Had to sit down. Upon leaving shower, I had to lie down on bed and wait ten minutes in order to dry off. That night, I could not sleep on right arm for more than a few minutes as pain was severe. By 10/6/2016, welt-like puffiness, redness, heat covered much of upper right arm. By that night at shower, I noticed this red puffiness had gone to elbow of right arm, with a large swollen area right on inside elbow joint. No itching but terribly sore. By bedtime, I was able to sleep a bit more on that arm but not well.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain
Clinical narrative: Started with headache, body aches and nausea. Treated with acetaminophen 500 mg q6h until symptoms subsided at around 10am on 10/07/2016.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chest pain, Flushing, Headache, Hypertension, Malaise
Clinical narrative: Flushed, high BP, neck pain, headache, chest pain, general malaise. No fever. Slowly getting better (almost 24 hours later).
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Staring episode and unresponsive to stimuli x 15-30 seconds.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Mouth swelling, Paraesthesia oral, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: Throat swelling. Constant swallowing as if something was stuck in throat. Mouth swelling and tingling. Sought medical care at 8:30 PM.  Adrenaline shots given at 9:45 PM. No immediate reduction of swelling so was sent to Hospital ER. Swelling was reduced by 12:00 AM and went home.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Received call from mom on 10/5/16 that child received flu shot 10/4/16 at school now (L) arm quarter-size redness and swelling. Mom call back on 10/6/16 and state redness has spread to under arm and bruise to elbow and feels hot. Patient seen by provider on 10/6/16 by Dr and redness down arm-put on antihistamines with follow up on 10/7/16.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient c/o intense shoulder pain and neck pain post vaccine. MD evaluated 48 hours post vaccine. Supportive care recommended.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Local reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Localized allergic reaction with swelling, heat, and itchiness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Mom called and stated child's right upper arm was red, swollen, painful and had blisters on it.  Patient was brought to clinic and assessed by Nurse Practitioner.  Small blisters noted below injection site.  Redness and swelling measured.  Mom told to give Benadryl and Ibuprofen and return to clinic the following day.  Go to ER immediately if symptoms worsen.  Mom called the clinic the next day and reported the child had much improved.  Child brought to clinic on 10/07/16 and assessed, redness and swelling had decreased and blisters were no longer raised or visible.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Patient calls reporting having rash and a fever of 100 along with aching. She was told to take Benadryl for the itching, and Ibuprofen for the aches. Patient was given a phone call on 10/6/2016 where she reported she was feeling better. A follow up call was made on 10/7/2016 where she reported no symptoms and feeling healthy.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness, lightheaded, fever 101 degrees.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Swelling
Clinical narrative: Pt. experiencing swelling and purple/pink bruising starting 2" above immunization site to the elbow. Pt. is not experiencing any pain and site is not warm to the touch.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Peripheral swelling, Pyrexia
Clinical narrative: Swollen hands, swollen lip, fever.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain radiating down arm, swelling and redness whole arm, warm to the touch, large knot.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Malaise
Clinical narrative: 2 hours after vaccine patient reported headache, sweating, and generally not feeling well, employer sent employee to ER via ambulance. Released shortly after.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives on (R) arm, then developed hives on face. Given 25 mg of BENADRYL by school nurse. No improvement, EMS contacted. IV placed and given 40 mg IV SOLUMEDROL. Monitored in ER > 1 hr. DC'd on PO BENADRYL and prednisone. Referred to allergist.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness unilateral, Diplopia, Dizziness, Headache
Clinical narrative: 21 hours after vaccine she developed a severe headache, dizziness, and light headedness lasting several hours. She also had a few minutes of double vision and belief loss of vision in one eye.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint stiffness, Mobility decreased, Muscular weakness, Nerve conduction studies
Clinical narrative: Flu vaccine administered to left deltoid of arm on 9-26-16, on 9-29-16 c/o rt. hand, unable to make fist, denies fever or headaches, progressed to both legs weakness, and c/o on top of both knees feels tightness. Went to Clinic to be evaluated.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash
Clinical narrative: Pt received FLULAVAL vaccine at worksite on 10/5/16. Notice swelling, redness and warmth at the site the next am (10/6/16) as well as a rash on arm spreading to chest. C/O low grade fever (100 degrees). Pt applied topical ointment that provided relief. Call received from RN at school pt works at. Advised TYLENOL/ADVIL for fever/swelling, BENADRY for rash. Advised to notify Primary MD.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 9/27/16 Received mandatory flu vaccine (FLUARIX) into left deltoid - pain, erythema, induration, limitations of range of motion of left arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Large, dark bruise at injection site still after 40 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Induration, Injection site bruising, Injection site erythema, Injection site haemorrhage
Clinical narrative: Bleeding when needle taken out. Developed large hard lump immediately after. Applied ice to site. Later in day, developed a red raised rash all around site - took BENADRYL. Large dark bruise remains. Rash resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site rash, Mass
Clinical narrative: Bleeding when needle taken out. Developed large hard lump immediately after. Applied ice to site. Later in day, developed a red raised rash all around site - took BENADRYL. Large dark bruise remains. Rash resolved.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Per mom, patient woke up the next morning w/ a red rash that extended from his left thigh above the injection site to the left shoulder.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Diffuse rash around injection site/upper left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: (L) cheek and (L) lower eyelid numbness post influenza vaccine.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash, Vomiting
Clinical narrative: Flu shot given on 10-5-16 - on 10-6-16 pt vomited x1 in am. Had a rash, was seen in office on 10-7-16 pt had 13x6cm red raised area at injection site. ZANTAC, BENADRYL, ZYRTEC started.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Loss of consciousness, Vomiting
Clinical narrative: Patient passed out and hit his head on a desk and the floor. Patient was conscious within one or two minutes. Patient was taken to the ER, but they discharged without performing a scan. Pt has vomited once.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Delayed reaction to high dose flu vaccine. Red, swollen, warm Lt upper arm. Started 10/5/16 in PM. First time patient had the high dose Flu vaccine.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin reaction, Skin warm, Tenderness
Clinical narrative: Arm was red, hot to touch, swollen and tender.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Migraine
Clinical narrative: Arm of injection broke out in a fine rash - itchy migraine headache a couple hours after injection lasted about 12 hours.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm is very painful and red, swollen, barely can lift arm. Warm to touch on shoulder area with hives.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Left arm is very painful and red, swollen, barely can lift arm. Warm to touch on shoulder area with hives.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site mass, Injection site reaction
Clinical narrative: Pt described a 102 degree F temperature days after vaccine. She complains of multiple lumps at injection site and pain that still radiates up to neck. Her MD suggested ice which only temp. helps.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came into the store on 10/7 with a large red spot where the injection had been given. Spot was dark red and had defined borders that did not look like a normal rash. Patient states that it is very itchy.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Pain radiating down arm where vaccine given, throbbing in elbow of same arm, severe headache, nausea, major swelling and erythema to the injection site for 5 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV1
Symptoms: Vomiting projectile
Clinical narrative: Mother called the office stating infant was projectile vomiting throughout the day, approximated 6 times in 12 hours.