chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events noted. Patient vaccinated with vaccine licensed for 3 years and older, and he is only 2 years old.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event reported. Patient vaccinated with vaccine licensed for 3 years old and older, and he is only 20 months old.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial unsolicited report received from a pharmacist on 14 November 2016. This case involves an elderly female patient (age at onset not reported) who was vaccinated with Fluzone HD intramuscularly (batch number: UI731AA, expiry date: 09 June 2017; dose and dose in series were not reported) in the left arm and Pneumovax (batch number, expiry date, dose and dose in series, route and site of administration were not reported) in the right arm on 04 November 2016. As per the reporter the patient did not have any allergies and was not ill at the time of vaccination. No further information was reported regarding patient's medical history. Concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient could not move her right arm. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited case received from a physician on 14 Nov 2016. This case involves a 4 year old female patient who was vaccinated with a first dose of 0.5 ml FLUZONE QIV (Batch number: UI640AB, Expiry date: 30 Jun 2017, route of administration was not reported) in left deltoid on 11 Nov 2016. The patient illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccination within four weeks of vaccination was reported as none. Patient previously had Flu Mist. The patient concomitant medications were not reported. On 12 Nov 2016, one day after vaccination the patient had a swollen reddened area the size of an adult palm at injection site (left deltoid) that was warm to touch and painful (reported by patient's mother on 13 Nov 2016). It was reported as the patient required emergency room or doctor visit. The patient lab test was reported as none. As a corrective treatment the patient was advised to take Benadryl and ibuprofen. The event redness persisted (not recovered), the event painful was recovering as it was reported as slightly painful. The outcome of other event was reported as unknown. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperchylomicronaemia, Injection site reaction
Clinical narrative: Initial information regarding this unsolicited case was received from a patient on 09-Nov-2016. This case involved a female patient of unspecified age, who complained of injection site reaction, unknown duration after starting therapy with influenza vaccine and alirocumab (Praluent). No relevant medical history, concurrent condition, past drugs and concomitant medications were reported. On an unknown date, the patient started treatment with influenza vaccine (other therapy details, lot/ batch number and expiry date: not reported). On 13-Oct-2016, the patient started therapy with subcutaneous alirocumab injection, at a dose of 75 mg every other week (strength: 75 mg/ml; other therapy details, lot/ batch number and expiry date: not reported) for hyperchylomicronemia, delivered via alirocumab prefilled pen (concomitant device). The patient reported that, she experienced an injection site reaction to a recent influenza vaccine (event onset and latency: unknown). Action Taken: unknown for influenza vaccine and no action taken for alirocumab Corrective treatment: not reported  Outcome: not reported.
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) via social media via other company (Merck) (Case Number: 00257660) on 14 November 2016. This case involves a male patient (age not reported) who was vaccinated with first dose of DTap vaccine (Batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient's condition was much worse and also developed a sore arm. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a physician on 14-Nov-2016. This case involves a 44-year-old male patient, who was vaccinated with a 0.5 ml of FLUZONE QIV (batch number: UI640AB, expiry date: 30-Jun-2017; route and dose in series not reported) at right deltoid on 30-Sep-2016. Patient received Bicillin on 04-Sep-2016. It was also reported that illness at the time of vaccination was none. Concomitant medication was not reported. It was also reported that any other vaccinations within four weeks of vaccinations was none. On 01-Oct-2016, one day after the vaccination, patient developed a red, raised, painful lesion at injection site, that increased in size to the size of patient's palm and area was very warm to touch, and appeared to have fluid in the center of the reddened area. Patient required ER/doctor visit. The patient's laboratory data was reported as none. Patient received Benadryl and Naproxen and cold compress were applied. Patient recovered from all the events on an unknown date within 48-hour of onset. List of the documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Skin lesion
Clinical narrative: Initial unsolicited report received from a physician on 14-Nov-2016. This case involves a 44-year-old male patient, who was vaccinated with a 0.5 ml of FLUZONE QIV (batch number: UI640AB, expiry date: 30-Jun-2017; route and dose in series not reported) at right deltoid on 30-Sep-2016. Patient received Bicillin on 04-Sep-2016. It was also reported that illness at the time of vaccination was none. Concomitant medication was not reported. It was also reported that any other vaccinations within four weeks of vaccinations was none. On 01-Oct-2016, one day after the vaccination, patient developed a red, raised, painful lesion at injection site, that increased in size to the size of patient's palm and area was very warm to touch, and appeared to have fluid in the center of the reddened area. Patient required ER/doctor visit. The patient's laboratory data was reported as none. Patient received Benadryl and Naproxen and cold compress were applied. Patient recovered from all the events on an unknown date within 48-hour of onset. List of the documents held by sender: none.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from physician via other company (Pfizer) on 14 November 2016. (Manufacturer report number: 2016494864). This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had allergy to vaccine. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016488442) on 14 Nov 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tetanus Diphtheria Pertussis Vaccine) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed allergies to Tetanus Diphtheria Pertussis Vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Influenza, Influenza virus test positive
Clinical narrative: Initial unsolicited report received from a physician on 17 Nov 2016. This case involves a 32-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI673AA, expiry date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 06 Oct 2016. Illness at the time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions airborne allergies. Concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had asthma attack with worsening systems and was hospitalized. On an unknown date, following the vaccination the patient was positive for flu virus (detected in nasal swab test). The patient other laboratory data and corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none. Sender's Comments: This concerns a 32 year old female patient who experienced severe asthma attack with worsening symptoms and nasal swab for flu was done and it was positive for flu virus, one week after receiving a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. As with any other vaccine influenza vaccine may not protect 100% of individuals. However, more information regarding medical history of the patient, previous vaccination and infectious work-up results (details of specific influenza strain identified in PCR) are needed to further assess this case.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Pharmacist immediately told me she "did not get needle in all the way". My L upper arm started hurting shortly after and has begun to get worse since. Feels worse than when I had a rotator cuff injury to R arm. Limited ROM, can't sleep.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at injection site.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Injection site hypoaesthesia, Intervertebral disc protrusion, Paraesthesia
Clinical narrative: Flu shot was received on 11/25/16 around 7 PM.  The following morning around 4 AM pt woke up with sharp pain in her lower back, below the waist. Pain was very sensitive to the touch. The next day pt also had back pain in the middle upper back. 11/28/16.  Back pain is still present, and has varying degrees of severity. Sometimes sitting or laying makes it worse. At around 9:30 PM pt said her left arm (the one where the shot was received) felt a little numb, and her upper back felt tingly. Pt then went to the emergency room. The doctor there was not concerned and said she has a slightly herniated disk. The pt's husband does not believe this and thinks the back pain and weird sensations are because of the flu shot. 11/29/16 (today). Pt still has back pain.
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable other hcp.  A patient of unspecified age race and gender received PREVNAR 13, at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: CSF test, Myelitis transverse, Nervous system disorder, Nuclear magnetic resonance imaging spinal
Clinical narrative: Influenza vaccine given 9/24/15. Admitted to hospital 9/26/15. Eventually diagnosed with transverse myelitis with marked neurological impairment.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Erythema and rash extending down about 2-3" from injection site, tender upon touch.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Arm swollen and redness at the site of injection. He also developed a low grade temperature. mom gave ibuprofen and Benadryl.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abasia, Aphasia, Autism, Autism spectrum disorder, Brain injury
Clinical narrative: Lethargic, limp, unresponsive to external stimuli, developed rash and inflammation behind both ears, staring spells, lost alll language, lost all gained milestones, resorted back to crawling, developed allergies, immune dysregulation. Diagnosed with brain damage and autism soon after.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Hypersensitivity, Hypotonia, Immune system disorder, Inflammation, Lethargy
Clinical narrative: Lethargic, limp, unresponsive to external stimuli, developed rash and inflammation behind both ears, staring spells, lost alll language, lost all gained milestones, resorted back to crawling, developed allergies, immune dysregulation. Diagnosed with brain damage and autism soon after.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Rash, Staring, Unresponsive to stimuli
Clinical narrative: Lethargic, limp, unresponsive to external stimuli, developed rash and inflammation behind both ears, staring spells, lost alll language, lost all gained milestones, resorted back to crawling, developed allergies, immune dysregulation. Diagnosed with brain damage and autism soon after.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Sharp shooting pain in arm, inability to lift arm and shoulder pain.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain, Vomiting
Clinical narrative: 102.5 temperature, vomiting, pain.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced cellulitis and swelling in the arm that lasted over a week on an unspecified date with outcome of recovered.  The events required treatment with antibiotics. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016541234 same reporter drug event different patient.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the 2nd of two reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced cellulitis and swelling in the arm that lasted over a week on an unspecified date. Outcome was unknown.  The events required treatment with antibiotics. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016541208 same reporter drug event different patients.
Sex: F
Vaccine: MENB
Symptoms: Malaise, Migraine, Nausea, Neck pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an adolescent female patient (his daughter) of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced migraine headaches, she felt sick, nauseous and she had neck pain. The patient recovered after a couple of days of rest. No follow-up attempts are possible. No further information is expected.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Given second lose dose flu vaccine less the 4 weeks apart. First dose given 11/15/16. Second dose given 11/29/16. No adverse reaction noted at time of event.
Age: 72.0
Sex: F
Vaccine: FLUR3
Symptoms: Decreased appetite, Dizziness, Head discomfort, Vertigo
Clinical narrative: Pt has vertigo with lightheadedness, pressure on back of head, and no appetite for 3 days following FLUBLOK IM shot.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site induration, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: 21 x 21 cm circumferential hot swollen (R) arm within 24 hours of flu vaccine. Unresponsive to BENADRYL, ZYRTEC. Required steroids. Flu vaccination Thu 11/17/site is swollen, hard to touch and inflamed. Mother says whole right arm is red and swollen shoulder to elbow/ at site of injection for influenza vaccine that he got yesterday/ no fever. Arm itchy mild pain on movement can use arm normally no numbness or tingling/ child is acting normal eating drinking and playful.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: 21 x 21 cm circumferential hot swollen (R) arm within 24 hours of flu vaccine. Unresponsive to BENADRYL, ZYRTEC. Required steroids. Flu vaccination Thu 11/17/site is swollen, hard to touch and inflamed. Mother says whole right arm is red and swollen shoulder to elbow/ at site of injection for influenza vaccine that he got yesterday/ no fever. Arm itchy mild pain on movement can use arm normally no numbness or tingling/ child is acting normal eating drinking and playful.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Lymphadenopathy
Clinical narrative: Received flu shot in right thigh. Developed dizziness, lightheadedness 15 minutes after receiving shot. Swollen glands in neck. Not fully recovered at this time. Took 37.5 mg BENADRYL with some relief.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Rash erythematous, Rash pruritic
Clinical narrative: 14.5 hours after administration woke up with chills and joint pain-developed a flat itchy red rash on chest and back.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: Extensor surface of left upper arm with clustered vesicles with scabbing in the middle. Redness, swelling, itching for 3-4 days. Treatment: oral BENADRYL or topical calamine lotion.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Burning sensation, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Stiff neck and headache on left side; 1 PM crummy stomach; 1:30 PM nausea (took Librex 2 PM); took naprosyn 5:10 PM; palms both hands and arches both feet itched and burned with tingle 7:45 PM; took diphenhydramine 8:15 PM; finally better 10:00 PM.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Stiff neck and headache on left side; 1 PM crummy stomach; 1:30 PM nausea (took Librex 2 PM); took naprosyn 5:10 PM; palms both hands and arches both feet itched and burned with tingle 7:45 PM; took diphenhydramine 8:15 PM; finally better 10:00 PM.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Arthralgia, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Was immediate sick, very dizzy, nausea, abdominal pain headaches and joint pain that lasted 2 weeks.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea
Clinical narrative: Was immediate sick, very dizzy, nausea, abdominal pain headaches and joint pain that lasted 2 weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: AT THE TIME OF ADMINISTRATION THE PATIENT WAS 2 MONTHS PREGNANT AND DID NOT INFORMED THIS TO THE PHYSICIAN.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Nerve conduction studies
Clinical narrative: Left deltoid flu vaccination as per custom on 10/26/2016 at GSB (Fluarix, left deltoid, lot#CD3TF). Notes the following week with arm numbness extending to the mid forearm which later turned into upper arm to shoulder and shoulder blade pain. Symptoms further advanced to include middle finger numbness in the tip and anterior chest pain.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR
Symptoms: Abasia, Arthropathy, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: 5 DAYS BEING UNABLE TO WALK PAIN AT THE ADMINISTRATION SITE WATER RETAINING ON THE LEG. SED RATE 57.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR
Symptoms: Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: 5 DAYS BEING UNABLE TO WALK PAIN AT THE ADMINISTRATION SITE WATER RETAINING ON THE LEG. SED RATE 57.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: ERYTHEMA, EDEMA, WARMTH IN THE LEFT THIGH OF ABOUT 25 TO 30 CM.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Pain in shoulder at time of injection. Visit to doctor indicated shot was in shoulder joint not deltoid muscle. Six weeks since shot am still experiencing acute pain in shoulder and bicep area. Limited range of motion of entire left arm. Tinging in left hand.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: Pain in shoulder at time of injection. Visit to doctor indicated shot was in shoulder joint not deltoid muscle. Six weeks since shot am still experiencing acute pain in shoulder and bicep area. Limited range of motion of entire left arm. Tinging in left hand.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Blood test, Chills, Headache, Hypersensitivity vasculitis
Clinical narrative: Minor flu-like syndrome (Headache, fever, chills) later in the day and persisting for approximately 2 days. One week later (10/31/16) developed painless purpura concentrated in both lower legs secondary to leukocytoclastic vasculitis (biopsy proven).
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Purpura, Pyrexia
Clinical narrative: Minor flu-like syndrome (Headache, fever, chills) later in the day and persisting for approximately 2 days. One week later (10/31/16) developed painless purpura concentrated in both lower legs secondary to leukocytoclastic vasculitis (biopsy proven).
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site haemorrhage, Injection site injury, Injection site pain, Pain in extremity
Clinical narrative: My mother came to the pharmacy on 11-09-16 and received a FLUZONE HD injection. At the time of injection, it was extremely painful unlike any vaccine she had ever received. When she got home, her upper arm began to swell 3x the usual size. She sent a picture to me and I was shocked at the bruising and swollen tissue. I instructed her to ice her bicep, elevate her limb and take a pain reliever. Upon inquiring about her condition the next morning, she sent another picture and conveyed the painful night that she had with her arm. It was hot to touch and the bruising had spread. She continued to ice her arm and take pain medication. After another night, she was urged to go to the ER to which she went to. This was on the 11th of November, two days' post injection. She was diagnosed with Traumatic ecchymosis of right shoulder pain at the initial site. I asked my mother how the injection was administered, and she described that the needle was introduced deeply and the injection given. The FLUZONE HD vaccine an intradermal injection. The instructions for an intradermal injection is to use your non-dominant hand to pull skin taut over the injection site. Remove needle can with non-dominant hand by pulling it straight off. Place the needle almost flat against the patient's skin, by pulling it straight off. Place the needle almost flat against the patient's skin, bevel side up. Insert the needle so that the point of the needle can be seen through the skin-only about 1/8 of an inch. This type of injection creates a wheal or blister on the skin. It is apparent that the administrator of the injections needs to be educated on the process of this type of vaccine and administration. My mother had been diagnosed with Thrombocythemia a few years ago, this condition requires multiple blood draws to calibrate the dosage of her medications. She has never had a complication such as this. This is not a reaction; it is a mechanical induced trauma to her tissues after having a vessel pierced by a needle. Not only has this event been painful, it has been extremely stressful to my mother and our family. Given her diagnoses, she is extremely careful and mindful of her safety. You will find images of her arm attached to this letter. I am hopeful that you will assess the level of education that your pharmacists receive when doing procedures. I will be waiting for your response to this matter and eager to hear your plan of action.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin warm, Stress
Clinical narrative: My mother came to the pharmacy on 11-09-16 and received a FLUZONE HD injection. At the time of injection, it was extremely painful unlike any vaccine she had ever received. When she got home, her upper arm began to swell 3x the usual size. She sent a picture to me and I was shocked at the bruising and swollen tissue. I instructed her to ice her bicep, elevate her limb and take a pain reliever. Upon inquiring about her condition the next morning, she sent another picture and conveyed the painful night that she had with her arm. It was hot to touch and the bruising had spread. She continued to ice her arm and take pain medication. After another night, she was urged to go to the ER to which she went to. This was on the 11th of November, two days' post injection. She was diagnosed with Traumatic ecchymosis of right shoulder pain at the initial site. I asked my mother how the injection was administered, and she described that the needle was introduced deeply and the injection given. The FLUZONE HD vaccine an intradermal injection. The instructions for an intradermal injection is to use your non-dominant hand to pull skin taut over the injection site. Remove needle can with non-dominant hand by pulling it straight off. Place the needle almost flat against the patient's skin, by pulling it straight off. Place the needle almost flat against the patient's skin, bevel side up. Insert the needle so that the point of the needle can be seen through the skin-only about 1/8 of an inch. This type of injection creates a wheal or blister on the skin. It is apparent that the administrator of the injections needs to be educated on the process of this type of vaccine and administration. My mother had been diagnosed with Thrombocythemia a few years ago, this condition requires multiple blood draws to calibrate the dosage of her medications. She has never had a complication such as this. This is not a reaction; it is a mechanical induced trauma to her tissues after having a vessel pierced by a needle. Not only has this event been painful, it has been extremely stressful to my mother and our family. Given her diagnoses, she is extremely careful and mindful of her safety. You will find images of her arm attached to this letter. I am hopeful that you will assess the level of education that your pharmacists receive when doing procedures. I will be waiting for your response to this matter and eager to hear your plan of action.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pt called to notify our office that he felt like "everything from his waist down was asleep". He was admitted to Emergency Dept that same day.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Psychomotor hyperactivity
Clinical narrative: UNABLE TO SLEEP AND HYPERACTIVITY.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Client reported that her left shoulder was extremely sore for two weeks after immunization given. She reported that she had never had this experience before.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Pain
Clinical narrative: Injection site is throbbing and painful since getting the injection.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Allergy to vaccine, Feeling cold, Pain in extremity, Swelling
Clinical narrative: Arm Pain, swelling, feels cold, headache, band like swelling on arm. Reactions began the evening of the 22nd and were still present on 11/28/16 as per our conversation. She said she wen to the doctor and he told her she was allergic to it. I explained that she got FLUAD which has an adjuvant in it which she should mention to her doctor.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling, Pain
Clinical narrative: Swelling at injection site and bleeding immediately after the injection. Patient iced arm daily and after 13 days swelling and pain had decreased slightly but was still there.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin reaction
Clinical narrative: Pt given a PNEUMOVAX in (R) upper arm an FLUZONE QUADRIVALVENT in (L) deltoid on 11/28/16 at 8:42 A. Pt came in the morning to show underpart of (R) upper arm slightly red and swollen. No redness at injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Patient has an enlarged lymph node under her right arm. Slight fever.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable patient reported for herself. A female patient received PREVNAR 13 at 0.5ml single dose for immunization on an unknown date in around 2011. The patient medical history and concomitant medications are unknown. On unknown date around Dec2013 the patient experienced pneumonia. The outcome of the event was reported as recovered.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Received flu shot on 10/22/16. Patient cannot lift arm for 3 weeks and arm is sore the whole time. Patient made appointment with doctor.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Patient has inflammation and pain up and down arm and in shoulder. Patient has significant decrease in range of motion in arm.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Abdominal pain upper, Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: Reported arm very swollen, red and hot to touch. Also reported headache and stomach pain. Advised him to go to urgent card or emergent dept.
Age: 79.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient had limitation of arm movement, pain and swelling at the injection site. > 1 week advised patient to contact PCP if symptoms persist. Self care - acetaminophen and ice.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Large red, swollen, hot area extending down below elbow. Arose next day after vaccine administered. Symptoms remained for 4 days before severity started to decrease.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: At time of injection, nothing unusual. Within 24 hrs slight soreness at injection - deep in arm that is still present 1 year later. Does not limit range of motion. (Approximately 1 1/2" below smallpox vaccine). Pt saw provider 11/17/16 got flu vaccine in thigh.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Edematous, erythematous deltoid area of left arm. Range of motion intact and within normal limits. No evidence of puncture, laceration or discharge.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 10 days post vaccination - client has rash (which started at administration) on her back, arms and under chin.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Biopsy skin abnormal, Joint swelling, Myalgia, Neutrophilic dermatosis
Clinical narrative: 72 hr after vaccine: myalgia, joint pain - hip and neck, low grade fever, night sweats. 10-26-16 rash progressed from thighs to calves and top of feet. 10-29-16 joint/tissue swelling in bilat ankles. TX: ALEVE 440 bid, or MOTRIN 400 mg tid, Triamcinolone for rash.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats, Pyrexia, Rash
Clinical narrative: 72 hr after vaccine: myalgia, joint pain - hip and neck, low grade fever, night sweats. 10-26-16 rash progressed from thighs to calves and top of feet. 10-29-16 joint/tissue swelling in bilat ankles. TX: ALEVE 440 bid, or MOTRIN 400 mg tid, Triamcinolone for rash.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt developed Guillain-Barre syndrome.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt complained of pain in the upper arm immediately following an influenza vaccine. Pain did not improve until Nov 19, and she continues to have mild pain in upper arm area near acromion several inches above where vaccine was given when she sleeps on that arm. Pt did lift heavy suitcases x one week while on vacation starting Oct 21, 2016. She has FROM of the extremity without visible evidence or area induration. No further follow up needed at this time.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Dizziness, Erythema, Pain in extremity, Pyrexia
Clinical narrative: States she had large red area 3 x 2", painful arm lasted 5 days 10/6/16 - not much better, had fever, dizzy first 2 days. Took OTC meds. All resolved by 10 days.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: See note.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Injection site pain, Mobility decreased, Skin warm
Clinical narrative: A few hours after receiving the influenza vaccination, started to experience pain in upper left arm. At physician visit five days after vaccine administration, patient described pain as constant soreness, worse and sharp with movement. Patient stated trouble lifting arm and states arm felt warm. Two episodes of sweating occurred, one four days and the other five days after receiving vaccine. Pain improved with lifting and stretching. Denies neck, check, or jaw pain, nausea, or palpitations.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm & shoulder.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Patient reports severe all-over body pain (10/10), headache, and fatigue starting seven hours after receiving influenza vaccination. Acetaminophen did not provide relief. Approximately 48 hours after receiving the vaccination all symptoms except headache had resolved. Intermittent headaches persisted for at least two weeks after receiving vaccination.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Inflammation occurred on upper left arm at the site of immunization. Patient noticed inflammation getting worse that Sunday on the 27th and it was painful to the touch. Review of the site showed moderate inflammation about 6 inches in diameter. Site did not show any signs of infections. Patient did not complain of fever or systemic infection. Patient was advised to use ice packs for 15 mins on and 15 mins off as needed for the pain and inflammation. Ibuprofen was not advised due to patient taking clopidogrel.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, X-ray
Clinical narrative: Pain in shoulder.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Approximately one hour after receiving the influenza vaccination, the patient complained of itching and a red, acne-like rash at the injection site.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous
Clinical narrative: Patient noticed a red, spotted, raised rash the evening of the day she received the influenza vaccination. Other causes were ruled out.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, nausea, headache, muscle aches.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Dysphagia, Rash
Clinical narrative: PATIENT HAD TEMP REPORTED BY MOTHER FOR A COUPLE OF DAYS 103.9 RASH ALL UPPER OUTSIDE OF ARM TO ELBOW AND CONTINUED TO HAVE TROUBLE SWALLOWING TILL SAT PM.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Severe pain and reduced mobility of left arm (where injection was given). MRI on November 11 showed full-thickness tear of rotator cuff tendon. No other event on or around vaccination date could explain the tear.
Age: 19.0
Sex: M
Vaccine: MENB, MEN
Symptoms: Chills, Headache, Injection site pain, Pyrexia, Swelling
Clinical narrative: Heart beat 160.  Chills.  Fever of 102.9. Bad headache.
Age: 19.0
Sex: M
Vaccine: MENB, MEN
Symptoms: Blood test, Body temperature increased, Chest X-ray, Chills, Electrocardiogram
Clinical narrative: Heart beat 160.  Chills.  Fever of 102.9. Bad headache.
Age: 19.0
Sex: M
Vaccine: MENB, MEN
Symptoms: Extrasystoles, Headache, Palpitations, Tachycardia, Urine analysis
Clinical narrative: Heart beat 160.  Chills.  Fever of 102.9. Bad headache.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: Itch around injection area, no swelling.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, HIBV
Symptoms: Crying, Pyrexia
Clinical narrative: Persistent crying, mild fever (100-100.3 F).
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 50.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Loss of consciousness, Visual acuity reduced, Vomiting
Clinical narrative: LOOSE BOWLS VOMITING AND LOSE  OF CONSONESS. PARTICAL LOOSE OF VISION.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Hep A Pediatrics dose administered instead of the Hep A Adult dose.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: PREVNAR 13 burning at time of injection.  Red hot welt appeared and grew to 8-9 inch diameter over several days with pain, itching, discomfort in entire upper left arm and later hives with itchiness continuing, chills with nightsweats first few days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Injection site warmth, Night sweats
Clinical narrative: PREVNAR 13 burning at time of injection.  Red hot welt appeared and grew to 8-9 inch diameter over several days with pain, itching, discomfort in entire upper left arm and later hives with itchiness continuing, chills with nightsweats first few days.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Arm got sore and red patient put ice on it. Next day swollen and stiff put more ice on it. Next day very stiff and swollen doctor friend told him to go to ER. Dr said patient had cellulitis. Gave him rx for KEFLEX.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Nausea, Pain in extremity
Clinical narrative: WOKE UP THAT NIGHT SICK TO HER STOMACH. ARM SORE IN A 3 INCH BAND AROUND. WAS FEELING WELL ENOUGH THE NEXT DAY (SUNDAY) TO GO TO FOOTBALL GAME & WAS RECOVERED BY TUESDAY.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Pyrexia
Clinical narrative: Swelling around eyes that resolved in 12 hours. Fever of 101-102 F.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: 102 F fever for 24 hours. Broke with tylenol and came back. Overall sick feeling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cardiovascular evaluation, Fibromyalgia, Laboratory test, Neurological examination
Clinical narrative: No tx-signs and symptoms of fibromyalgia.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Mania, Seizure
Clinical narrative: Vaccine at 330pm, during night-sleep was agitated next morning-mini seizure, manic next evening, following day full seizure in AM.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Patient reported that he was blacked out while driving after receiving two vaccinations--FLUARIX QUAD and PNEUMOVAX. Patient hospitalized due to accident.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Feeling hot
Clinical narrative: Heat sensation at upper back area, pain at back area. No hives nor itchiness. No SOB, CP not in distress. Gave a glass of H2O to drink. Monitor and seen by MD 12.15PM. Felt better 12.40pm. Asymptomatic, not in pain no more heat sensation. Discharged 12:45pm. According to patient above symptoms felt after PNEUMOVAX vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient left arm was swollen where shot was administer. It was warm to touch and redness around the area. No severe inflammation noted.
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Locked shoulder joint within 48 hrs after flu shot given. Undergoing physical therapy and prescribed MEDROL DOSE PAK.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Asthma, C-reactive protein normal, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Feeling hot, Glycosylated haemoglobin increased, Nausea, Neutrophil count increased
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.