chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Eye movement disorder, Malaise, Syncope, Tremor
Clinical narrative: 5 mins after immunization, pt walked to elevator, vision went dark, mom held pt in arms near floor, eyes rolled back, body arched/shook for 15 sec, then resolved and seconds later patient asking what happened. Pt lightheaded/pale.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Blood test, Dizziness, Electrocardiogram, Gaze palsy, Opisthotonus
Clinical narrative: 5 mins after immunization, pt walked to elevator, vision went dark, mom held pt in arms near floor, eyes rolled back, body arched/shook for 15 sec, then resolved and seconds later patient asking what happened. Pt lightheaded/pale.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Pallor, Tremor, Visual impairment
Clinical narrative: 5 mins after immunization, pt walked to elevator, vision went dark, mom held pt in arms near floor, eyes rolled back, body arched/shook for 15 sec, then resolved and seconds later patient asking what happened. Pt lightheaded/pale.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Papule, Pruritus, Rash
Clinical narrative: Patient described to prescriber-itching, redness and bumps.  Prescriber on 6-6-16 described as bright red, warm with small papules and diagnosis of cellulitis of upper limb.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient described to prescriber-itching, redness and bumps.  Prescriber on 6-6-16 described as bright red, warm with small papules and diagnosis of cellulitis of upper limb.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash around injection site on right arm. No treatment needed.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Localized erythema, induration.  Complaints of pain/ itching.  Not a systemic reaction.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Localized erythema, induration.  Complaints of pain/ itching.  Not a systemic reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Both arm redness and warm to touch c slight redness.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site urticaria, Malaise, Tenderness
Clinical narrative: Large hive at injection site (back of upper right arm). Tenderness in right armpit. Tiredness malaise.
Age: 47.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Patient noticed some pain in right shoulder (location of vaccine administration) the evening the day the vaccine was administered. He presented with more severe symptoms the next day. The symptoms included severe pain in the right shoulder as well as mild muscular pain throughout his body.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain, Chest pain, Dizziness, Hyperhidrosis, Vomiting
Clinical narrative: Patient stated that she was vomiting, having severe abdominal pain, dizziness, sweating, and chest pain.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 16-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # reported as L040460, expiry date 27-MAY-2017; dose and route of administration were not reported). The dose was stored under temperature of 30.5 F for 47 hours and the temperature came back in range. There was no previous temperature excursion and data logger was involved. No adverse events were reported. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left thigh with 1 cm area of erythema and induration at site of immunization. No warmth. Full ROM. Rx: BENADRYL as needed.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Tenderness
Clinical narrative: Local erythema, tenderness to palpation over (R) deltoid at injection site with minor extension to neck and chest. NSAIDs rx'ed . Patient to follow up in 1-2 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Erythema
Clinical narrative: Shortly after vaccination, patient's face became very red, she felt  lightheaded and had problems breathing. Symptoms resolved within minutes and blood pressure was found to be stable, thus no treatment was given. EMT arrived and agreed to no treatment.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Dizziness, Nausea
Clinical narrative: Nausea, chills, cold sweats, lightheaded.
Age: 25.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Rash
Clinical narrative: Vaccinated on 5/23/16 with HPV9 and Varicella. Developed rash (L) forearm on 5/26/16. No previous treatment. Referred to PCP for follow-up prn.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: 4 hours after HPV child became lightheaded and tired and remained that way till the next morning then returned to normal. No sx since.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. had PREVNAR 13 on 5/24/16 - had redness and swelling with hot to touch it has continued to expand at the border. Measured 16 x 8 cm rt deltoid.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Headache, Migraine, Oral mucosal blistering, Tongue blistering
Clinical narrative: (1) Headache (frontal) progressed to migraine several hrs after immunization. (2) watery diarrhea (10+ episodes in 24 hours)-Began 5/31/16. (3) Blisters- inside mouth (both sides) and on tongue Began 5/31/16. (4) "Knot" and warmth at site of vaccination (began 6/2/16) (upper right arm).
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site nodule, Vaccination site warmth
Clinical narrative: (1) Headache (frontal) progressed to migraine several hrs after immunization. (2) watery diarrhea (10+ episodes in 24 hours)-Began 5/31/16. (3) Blisters- inside mouth (both sides) and on tongue Began 5/31/16. (4) "Knot" and warmth at site of vaccination (began 6/2/16) (upper right arm).
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Patient began to lose color in her face and fainted after receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema of eyelid, Eyelid oedema, Injection site reaction, Local reaction, Rhinorrhoea
Clinical narrative: 4 yr old child presented with redness and swelling on eyelids, sneezing and runny nose. Mild local reaction on (R) leg. BENADRYL 1 tsp given PO per provider.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Sneezing
Clinical narrative: 4 yr old child presented with redness and swelling on eyelids, sneezing and runny nose. Mild local reaction on (R) leg. BENADRYL 1 tsp given PO per provider.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Pt. woke to fever, fatigue, malaise for one week.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: (L) arm red, warm and swollen. Pt c/o SOB and fever. Brought pt into clinic for exam by physician. Prednisone prescribed.
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tingling in a adult male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 2 days after receiving BEXSERO, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were unknown. It was unknown if the reporter considered the tingling and numbness to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. Field representative reported that, a doctor reported an unknown patient experienced severe tingling and numbness in arm up to neck 48 hours after receiving BEXSERO vaccination in arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site rash
Clinical narrative: 06/10/2016 patient presented with raised rash measuring 6.5 cm x 7 cm at vaccine site.
Age: 0.53
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Wrong vaccine administer to 6 mo old. Not approved for use under age 4 y.o.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Ear injury, Fall, Loss of consciousness
Clinical narrative: Pt got up to walk out of the room several minutes after vaccine, he fell forward onto carpeted floor striking his right ear. He awoke within 10 seconds. Was lead into room to lay down for about 15 minutes.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm
Clinical narrative: Localized erythema and warmth, no induration.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Headache, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, headache, nausea/vomiting, lethargy.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, headache, nausea/vomiting, lethargy.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Fatigue, Injection site pain, Limb discomfort
Clinical narrative: Soreness and feeling heavy on arm where the shot was given and feeling very tired overall, had no energy to do anything.  A day later, noticed redness on arm above midarm  up to shoulder.  Symptoms are improving on 6/10/16 when patient came into store to report.  Redness in arm can be seen and was more localized to upper arm and soreness had gone down but not completely resolved.  Patient was going to seek MD care if not better by Monday 6/13/16.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Localized erythema, pruritus.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extensive redness, pain and swelling as well as bruising near the injection site. Redness measures approximately 10.5cm x 14 cm on 6/10/2016.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site cellulitis
Clinical narrative: Large bruise and area of cellulitis around the injectin site.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Patient experienced major swelling, bruising and pain described as a 5 on a 1-10 scale.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Dizziness, Dry throat, Peripheral swelling, Pyrexia
Clinical narrative: Pt had vaccine about 12:50 pm on 6/10/2016. That evening she her symptoms started swollen arm, vomiting, dizziness, low grade fever, increased thirst, dry throat, drowsiness. She called pharmacy 6/11/2016 advised pt to got to ER. Pt went to patient first and then by ambulance to er due to AFIB. ER gave fluids and cartia xt 120/24, tramadol, and metformin prescriptions.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence, Thirst, Vomiting
Clinical narrative: Pt had vaccine about 12:50 pm on 6/10/2016. That evening she her symptoms started swollen arm, vomiting, dizziness, low grade fever, increased thirst, dry throat, drowsiness. She called pharmacy 6/11/2016 advised pt to got to ER. Pt went to patient first and then by ambulance to er due to AFIB. ER gave fluids and cartia xt 120/24, tramadol, and metformin prescriptions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Somnolence
Clinical narrative: Woke up and the injection site above left elbow, is swollen/red and very warm to the touch.  I used a ice pack for the entire day, rested all day, did not go to work. Napping and did not feel well. 6/11/2016 still red/swollen and not feeling well/ sleeping more than usual, less warm at the site. I do not have allergies, I am physically in good shape for my age.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Cellulitis, Hypersensitivity, Local swelling, Pyrexia, Swelling face
Clinical narrative: 9 pm Neck and face swollen - had similar allergic reaction in past to poison ivy. 5/9/16 went to Urgent Care - Rx for prednisone for 8-10 days and self medication with ZYRTEC and ibuprofen. Swelling got worse and developed fever and was hospitalized for IV antibiotics for cellulitis and treated 3 days with.
Age: 17.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Urticaria
Clinical narrative: 6/9/16 (3 days after vaccine) - hives starting head and trunk. Next day started to clear on trunk and break out on arms and legs. No wheeze. No fever. Was treated immediately with BENADRYL 50mg and Prednisone 20 mg and several times after.
Age: 0.34
Sex: M
Vaccine: 6VAX-F
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: 2 inch diameter bump on right leg, and dime size bump on left leg where vaccines were administered. Still there 3 weeks later.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, tender, knot at injection site approximately 4 inches in diameter started on 6/11/2016...still present on 6/12/2016 at 11 am.
Age: 25.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Patient reports pain in LEFT upper arm, difficulty moving arm and pain extending down to fingers. Patient cannot sleep on affected arm and requires help dressing and brushing hair etc. that requires raising arm.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Started as rash/itching on thighs, spread to legs and ankles.  By next day was developing on arms and hands and lumbar area. Patient took Benadryl and Claritin and used diphenhydramine cream. By 2 pm the next day the rash kept spreading and the itch was intolerable. What had appeared to be petechiae/purpura now looked more like hives on ankles and lower legs. Patient went to an urgent care and was given a steroid shot and prescribed hydrocortisone 1% ointment.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: As soon as tdap was injected, pt experienced an injection site reaction. Area where immunization was injected swelled to size of gumball and after 5 minutes pt reported feeling slightly itchy around the injection site.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Balance disorder, Fatigue, Headache, Myalgia
Clinical narrative: Marked loss of balance (not vertigo), muscle pain, mild headache, lassitude; took acetaminophen.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient stated that she did have abdominal pain which was present prior to vaccination (the patient never stated that she experienced abdominal pain as result of the vaccine, but attributed it to a condition she had had since 1976, reported as "for 40 years or so", whenever she ate specific foods). On an unknown date the patient received ZOSTAVAX (dose, strength, route, lot# and expiration date were not reported). Concomitant drug was not reported. At unspecified time, when the customer was seated waiting to pay for the vaccine, she experienced loss of consciousness. The patient's husband stated the time of passing out was two or three minutes. The causality was not reported. Follow up information has been received from the patient on 08-JUN-2016. The dose of ZOSTAVAX the patient received was 0.65 ml. Upon internal review, loss of consciousness is considered to be medically significant. Additional information has been requested. Reporter, product, event and narrative have been updated.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Agitation, Feeling abnormal, Hyperventilation, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a physician and refers to a non-pregnant female patient of unknown age without pertinent medical history, drug reactions, or allergies. On 09-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # L044475 with expiration date 12-MAY-2017) (strength, dose, route and anatomical location were not reported). There were not concomitant therapies. On the same day, right after the injection, the patient stated "this feels weird" and "started hyperventilating" (anxiety); she was also agitated for an hour and a half. It was reported that the patient did not sought medical attention, laboratory diagnostic studies were not performed, and treatment was not given for the adverse events. The patient recovered from agitation on 09-MAY-2016, and from anxiety on an unspecified date in May 2016. The relatedness between agitation and anxiety and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Agitation, Anxiety, Feeling abnormal, Hyperventilation
Clinical narrative: This spontaneous report was received from a physician and refers to a non-pregnant female patient of unknown age without pertinent medical history, drug reactions, or allergies. On 09-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # L044475 with expiration date 12-MAY-2017) (strength, dose, route and anatomical location were not reported). There were not concomitant therapies. On the same day, right after the injection, the patient stated "this feels weird" and "started hyperventilating" (anxiety); she was also agitated for an hour and a half. It was reported that the patient did not sought medical attention, laboratory diagnostic studies were not performed, and treatment was not given for the adverse events. The patient recovered from agitation on 09-MAY-2016, and from anxiety on an unspecified date in May 2016. The relatedness between agitation and anxiety and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Condition aggravated, Decreased appetite, Drug screen negative
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dyspnoea, Flushing, Full blood count normal, Gait disturbance, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Malaise, Metabolic function test normal, Migraine, Pharyngeal oedema, Rash
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram, Drug screen, Dyspnoea, Flushing
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Injection site pain, Migraine
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Abasia, Asthenia, Computerised tomogram normal, Drug screen negative, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Eating disorder, Flushing, Full blood count normal, Injection site pain, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Metabolic function test normal, Migraine, Neurological examination normal, Pharyngeal oedema, Rash
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity started to receive TRUMENBA at single dose, HPV 9 and MENACTRA, all via an unspecified route of administration on an unspecified date. Medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant medication included FOCALIN for ADHD. On an unspecified date, the patient experienced shortness of breath, weak, flush, migraine headache and later stated that the symptoms also include pain at the injection site and it required ER (Emergency Room) visit on 21Apr2016. After the ER visit, the patient was admitted to the hospital from 21Apr2016 to 22Apr2016. At the ER, they did administered Epinephrine, they did run a CAT scan and urine drug analysis. Physician believed that shortness of breath, weak, flush, migraine headache was related to vaccines. The outcome of the events was unknown.
Age: 71.0
Sex: M
Vaccine: IPV, PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Two days after (L) deltoid IM injection of PREVNAR 13 vaccine, area became sore, progressing to swelling/increased pain/erythema of dorsal arm, spreading 10 inches in max diameter, accmp. by malaise, no fevers/vomiting/chills.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Pain
Clinical narrative: Initial unsolicited misuse report received from consumer via other company (Pfizer) on 31 May 2016. This case involves a 58-year-old male patient who was vaccinated with a second dose of TETANUS TOXOID, second dose of HEPATITIS VACCINES and second dose of PREVENAR 13 (batch number, expiration date, route and site of administration was not reported for all vaccines) on 19 May 2016 around at 3 or 3:30 in the afternoon. It was reported that patient received first dose of Tetanus Shot, Hepatitis Shot and PREVENAR 13 on an unspecified date (reported as 13 April 2016, 14 April 2016, 14 May 2016). It was also reported that patient was dealing with kidney issue for past year. It was reported that patient was in the last stages of renal failure and the preliminary requirement to get a kidney transplant required him to get a first shot of PREVNAR 13. It was reported that patient was taking unknown medications for blood pressure. On 20 May 2016, at 04:30 in the morning, one day following vaccination, patient experienced Heaviness on his chest and Stabbing pain. It was reported patient was taken to the emergency room. On an unspecified date, patient was hospitalized. It was wrong vaccine administered case. It was reported that nurse gave patient by mistake second dose of PREVNAR 13 along with Tetanus Shot, Hepatitis Shot. Lab data included whole series of blood work, the test for the blood clots where they used the isotopes instead of the dyes, the chest X-ray thing. It was reported that they checked for a heart attack and for blood clots and there was nothing. Corrective treatment was not reported. On 20 May 2016, patient was recovered from stabbing pain (duration: 05 minutes). On an unspecified date, patient was recovered from other event. On an unspecified date, patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Based on the available information, patient experienced Heaviness on his chest and Stabbing pain after receiving TETANUS TOXOID, simultaneously with hepatitis vaccine and PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. As patient received 3 vaccines simultaneously making it difficult to assess the role of one vaccine in particular.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test, Cardiac monitoring, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Initial unsolicited misuse report received from consumer via other company (Pfizer) on 31 May 2016. This case involves a 58-year-old male patient who was vaccinated with a second dose of TETANUS TOXOID, second dose of HEPATITIS VACCINES and second dose of PREVENAR 13 (batch number, expiration date, route and site of administration was not reported for all vaccines) on 19 May 2016 around at 3 or 3:30 in the afternoon. It was reported that patient received first dose of Tetanus Shot, Hepatitis Shot and PREVENAR 13 on an unspecified date (reported as 13 April 2016, 14 April 2016, 14 May 2016). It was also reported that patient was dealing with kidney issue for past year. It was reported that patient was in the last stages of renal failure and the preliminary requirement to get a kidney transplant required him to get a first shot of PREVNAR 13. It was reported that patient was taking unknown medications for blood pressure. On 20 May 2016, at 04:30 in the morning, one day following vaccination, patient experienced Heaviness on his chest and Stabbing pain. It was reported patient was taken to the emergency room. On an unspecified date, patient was hospitalized. It was wrong vaccine administered case. It was reported that nurse gave patient by mistake second dose of PREVNAR 13 along with Tetanus Shot, Hepatitis Shot. Lab data included whole series of blood work, the test for the blood clots where they used the isotopes instead of the dyes, the chest X-ray thing. It was reported that they checked for a heart attack and for blood clots and there was nothing. Corrective treatment was not reported. On 20 May 2016, patient was recovered from stabbing pain (duration: 05 minutes). On an unspecified date, patient was recovered from other event. On an unspecified date, patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Based on the available information, patient experienced Heaviness on his chest and Stabbing pain after receiving TETANUS TOXOID, simultaneously with hepatitis vaccine and PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. As patient received 3 vaccines simultaneously making it difficult to assess the role of one vaccine in particular.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Extra dose administered, Pain
Clinical narrative: Initial unsolicited misuse report received from consumer via other company (Pfizer) on 31 May 2016. This case involves a 58-year-old male patient who was vaccinated with a second dose of TETANUS TOXOID, second dose of HEPATITIS VACCINES and second dose of PREVENAR 13 (batch number, expiration date, route and site of administration was not reported for all vaccines) on 19 May 2016 around at 3 or 3:30 in the afternoon. It was reported that patient received first dose of Tetanus Shot, Hepatitis Shot and PREVENAR 13 on an unspecified date (reported as 13 April 2016, 14 April 2016, 14 May 2016). It was also reported that patient was dealing with kidney issue for past year. It was reported that patient was in the last stages of renal failure and the preliminary requirement to get a kidney transplant required him to get a first shot of PREVNAR 13. It was reported that patient was taking unknown medications for blood pressure. On 20 May 2016, at 04:30 in the morning, one day following vaccination, patient experienced Heaviness on his chest and Stabbing pain. It was reported patient was taken to the emergency room. On an unspecified date, patient was hospitalized. It was wrong vaccine administered case. It was reported that nurse gave patient by mistake second dose of PREVNAR 13 along with Tetanus Shot, Hepatitis Shot. Lab data included whole series of blood work, the test for the blood clots where they used the isotopes instead of the dyes, the chest X-ray thing. It was reported that they checked for a heart attack and for blood clots and there was nothing. Corrective treatment was not reported. On 20 May 2016, patient was recovered from stabbing pain (duration: 05 minutes). On an unspecified date, patient was recovered from other event. On an unspecified date, patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Based on the available information, patient experienced Heaviness on his chest and Stabbing pain after receiving TETANUS TOXOID, simultaneously with hepatitis vaccine and PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. As patient received 3 vaccines simultaneously making it difficult to assess the role of one vaccine in particular.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Radioisotope scan normal, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from consumer via other company (Pfizer) on 31 May 2016. This case involves a 58-year-old male patient who was vaccinated with a second dose of TETANUS TOXOID, second dose of HEPATITIS VACCINES and second dose of PREVENAR 13 (batch number, expiration date, route and site of administration was not reported for all vaccines) on 19 May 2016 around at 3 or 3:30 in the afternoon. It was reported that patient received first dose of Tetanus Shot, Hepatitis Shot and PREVENAR 13 on an unspecified date (reported as 13 April 2016, 14 April 2016, 14 May 2016). It was also reported that patient was dealing with kidney issue for past year. It was reported that patient was in the last stages of renal failure and the preliminary requirement to get a kidney transplant required him to get a first shot of PREVNAR 13. It was reported that patient was taking unknown medications for blood pressure. On 20 May 2016, at 04:30 in the morning, one day following vaccination, patient experienced Heaviness on his chest and Stabbing pain. It was reported patient was taken to the emergency room. On an unspecified date, patient was hospitalized. It was wrong vaccine administered case. It was reported that nurse gave patient by mistake second dose of PREVNAR 13 along with Tetanus Shot, Hepatitis Shot. Lab data included whole series of blood work, the test for the blood clots where they used the isotopes instead of the dyes, the chest X-ray thing. It was reported that they checked for a heart attack and for blood clots and there was nothing. Corrective treatment was not reported. On 20 May 2016, patient was recovered from stabbing pain (duration: 05 minutes). On an unspecified date, patient was recovered from other event. On an unspecified date, patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: Based on the available information, patient experienced Heaviness on his chest and Stabbing pain after receiving TETANUS TOXOID, simultaneously with hepatitis vaccine and PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. As patient received 3 vaccines simultaneously making it difficult to assess the role of one vaccine in particular.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Heart rate increased, Nausea, Rash, Respiratory rate increased
Clinical narrative: Nausea, rash, dizzy, rapid pulse, rapid breathing.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local reaction, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case is linked with 2015SA169848, 2015SA169857, 2015SA169859, 2015SA169865 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number:U5321BA, expiry date: 30 June 2016, dose, dose in series, site and route of administration were not reported) on 16 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed rash and localized reaction. Laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from nurse on 30-Dec-2015. The patient details were amended and age of onset was reported as 58 years. It was reported that patient had no allergies and experienced pneumonia in Nov-2014. Father of the patient had a medical history of neck cancer. During the last 12 months patient's previous medication included multi-vitamins, ATIVAN and RESTORIL and patient had also performed physical examination by physician, mammogram, breast self-exam and Pap smear. It was reported that the patient did regular exercise. It was reported that patient had monthly medicine refill and visited urologist every 3 months. On 16-Oct-2015, same day following vaccination, patient also experienced slight pink left deltoid with minimal edema and pain. The outcome of the events were not reported. No additional information was provided. Follow up information received from nurse on 20 May 2016. On 16 October 2015 same day post vaccination the patient experienced rash and localized reaction. No additional information was reported.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection sight, warm to the touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a Nurse Practitioner (N.P) concerning a 50 year old non pregnant female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (Lot # and dose were not provided), subcutaneously. Concomitant therapies were not reported. On 03-JUN-2016, 3 days after onset of therapy, the patient experienced severe swelling from her shoulders down past her elbows, redness, severe heat, itching and fluid filled blisters across the swollen region. It was reported that on the same day, the patient received treatment for the events; she was taken to the emergency room of an unspecified hospital for an unspecified length of time. At the time of the report, some of the symptoms had improved, but not all of them, however, the patient present status was reported as recovering. The events did not involve cancer, overdose or a product quality complain. Additional information is not expected as there is no permission to contact the physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear abrasion, Facial paralysis
Clinical narrative: This spontaneous report as received from a physician refers to an around 70 years old female patient. The patient's medical history and drug reactions or allergies were not reported. On an unknown date, a few years ago, the patient was vaccinated with ZOSTAVAX (dosage information and lot number were not reported). Concomitant medications were not reported). On an unknown date approximately in May 2016, reported as "a month ago", the patient experienced Bell's palsy with legions (ear abrasion) in an unspecified ear for which the patient sought attention by calling the physician. At the reporting time, the outcome of Bell's palsy and ear abrasion was unknown as well as the causality assessment between them and ZOSTAVAX. No product quality complaint was involved. Upon internal review "Bell's palsy" was determined to be medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Abasia, Feeling hot, Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: This solicited report was received from a consumer (reported as "neighbor") via market research agency regarding a 12 year old female subject enrolled in a market research program. The subject's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date (reported March) the subject was vaccinated with HPV vaccine dose 3 in the arm (route and lot details unknown) (manufacturer unknown). Around 01-MAR-2016 the subject started having leg pain with heat. From an unknown date in June 2016 (reported as now) the patient has no leg muscle strength and could not walk. All these events occurred after the last dose of vaccine. On an unknown date unspecified lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to HPV vaccine (manufacturer unknown). The reporter considered "could not walk" as disabling. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced pain, redness, and swelling to left upper arm and area was warm to the touch after vaccine administration on 6/01/16. Area was red and swollen on back side of upper arm approximately 2 inches above elbow and coming around inner arm under axilla. Patient had taken BENADRYL, applied compresses and taken TYLENOL for pain. Onset of symptoms were reported to have occurred within a few hours after administration. No changes occurred over night to next morning (6/2/16). As day progressed to later in the evening, redness, pain, and swelling continued down arm making arm numb and tingly. Client preceded to ER for treatment as instructed by local health department if symptoms worsened. At ER patient was given bolus IV 0.9% 1000ml, BENADRYL 25 mg IVP, TORADOL 30 mg IVP, SOLU-MEDROL 40 mg IVP, and CLARITIN 10 mg Oral. Patient was sent home with prescriptions for PERCOCET 5-325 1 tablet by Oral route every 6 hours as needed and Prednisone 20 mg 2 tablets by Oral route once daily for 2 days. Patient to continue as needed for symptoms, BENADRYL, CLARITIN, and may use ibuprofen 800 mg every eight hours as needed for pain. Patient to follow-up with Primary Care Physician in 5-6 days. 6/6/16 Patient reports symptoms are resolved as of Sunday 6/5/16.