chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's pertinent concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. On 25-MAR-2016, the patient was vaccinated with the first dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). On 27-MAY-2016, the patient was vaccinated with the second dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). On 08-AUG-2016, the patient was vaccinated with the third dose od ROTATEQ, administered orally (strength, lot number and expiration date were not reported) and on 28-OCT-2016, the patient was vaccinated with an extra dose of ROTATEQ, administered orally (strength, lot number and expiration date were not reported). Additionally, no adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Aphasia
Clinical narrative: Vaccine was giving on 8/23/2016. Per mom a few days after receiving vaccine patient stop talking for about 30 days.
Age: 17.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Arthralgia, Dyspnoea, Epstein-Barr virus antibody negative, Fatigue, HIV test negative
Clinical narrative: Patient is a 17 -year-old-dependent male with no significant past medical history who presents to Healthcare Office by referral from his primary care provider for further evaluation and management of an adverse event following immunizations. Patient, who was  accompanied to  the clinic by his mother, describes receiving four vaccination  on 30 August 2016 (MCV 4, MMRV.,  Tdap  and IPV) as described below who initially did well without any immediate adverse reactions. However, just over 2 weeks later, the patient began to develop significant myalgias, arthralgias, fatigue, malaise, as well as associated dyspnea and sore throat. On the morning of 19 September 2016 the patient awoke with significantly worse symptoms and his mother took  him to the emergency department. Evaluation at that time revealed a significant neutropenia with an ANC of 100. The patient was admitted to the hospital for neutropenia and a workup was initiated. Patient denies any significant drug/medication use other than vaccines described above. Patient denies any international travel. He denies any other recent preceding infections. Workup while hospitalized included viral cultures, HIV serology, EBV titers, Monospot, CMP, influenza A.  and B.  testing, and rickettsial titers which were all essentially negative/within normal limits. Patient was referred to our clinic for further consideration of vaccine-induced neutropenia. Patient denies any previous adverse reactions to vaccines.
Age: 17.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Laboratory test normal, Malaise
Clinical narrative: Patient is a 17 -year-old-dependent male with no significant past medical history who presents to Healthcare Office by referral from his primary care provider for further evaluation and management of an adverse event following immunizations. Patient, who was  accompanied to  the clinic by his mother, describes receiving four vaccination  on 30 August 2016 (MCV 4, MMRV.,  Tdap  and IPV) as described below who initially did well without any immediate adverse reactions. However, just over 2 weeks later, the patient began to develop significant myalgias, arthralgias, fatigue, malaise, as well as associated dyspnea and sore throat. On the morning of 19 September 2016 the patient awoke with significantly worse symptoms and his mother took  him to the emergency department. Evaluation at that time revealed a significant neutropenia with an ANC of 100. The patient was admitted to the hospital for neutropenia and a workup was initiated. Patient denies any significant drug/medication use other than vaccines described above. Patient denies any international travel. He denies any other recent preceding infections. Workup while hospitalized included viral cultures, HIV serology, EBV titers, Monospot, CMP, influenza A.  and B.  testing, and rickettsial titers which were all essentially negative/within normal limits. Patient was referred to our clinic for further consideration of vaccine-induced neutropenia. Patient denies any previous adverse reactions to vaccines.
Age: 17.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Myalgia, Neutropenia, Neutrophil count decreased
Clinical narrative: Patient is a 17 -year-old-dependent male with no significant past medical history who presents to Healthcare Office by referral from his primary care provider for further evaluation and management of an adverse event following immunizations. Patient, who was  accompanied to  the clinic by his mother, describes receiving four vaccination  on 30 August 2016 (MCV 4, MMRV.,  Tdap  and IPV) as described below who initially did well without any immediate adverse reactions. However, just over 2 weeks later, the patient began to develop significant myalgias, arthralgias, fatigue, malaise, as well as associated dyspnea and sore throat. On the morning of 19 September 2016 the patient awoke with significantly worse symptoms and his mother took  him to the emergency department. Evaluation at that time revealed a significant neutropenia with an ANC of 100. The patient was admitted to the hospital for neutropenia and a workup was initiated. Patient denies any significant drug/medication use other than vaccines described above. Patient denies any international travel. He denies any other recent preceding infections. Workup while hospitalized included viral cultures, HIV serology, EBV titers, Monospot, CMP, influenza A.  and B.  testing, and rickettsial titers which were all essentially negative/within normal limits. Patient was referred to our clinic for further consideration of vaccine-induced neutropenia. Patient denies any previous adverse reactions to vaccines.
Age: 17.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Oropharyngeal pain, Typhus rickettsia test, Viral test negative
Clinical narrative: Patient is a 17 -year-old-dependent male with no significant past medical history who presents to Healthcare Office by referral from his primary care provider for further evaluation and management of an adverse event following immunizations. Patient, who was  accompanied to  the clinic by his mother, describes receiving four vaccination  on 30 August 2016 (MCV 4, MMRV.,  Tdap  and IPV) as described below who initially did well without any immediate adverse reactions. However, just over 2 weeks later, the patient began to develop significant myalgias, arthralgias, fatigue, malaise, as well as associated dyspnea and sore throat. On the morning of 19 September 2016 the patient awoke with significantly worse symptoms and his mother took  him to the emergency department. Evaluation at that time revealed a significant neutropenia with an ANC of 100. The patient was admitted to the hospital for neutropenia and a workup was initiated. Patient denies any significant drug/medication use other than vaccines described above. Patient denies any international travel. He denies any other recent preceding infections. Workup while hospitalized included viral cultures, HIV serology, EBV titers, Monospot, CMP, influenza A.  and B.  testing, and rickettsial titers which were all essentially negative/within normal limits. Patient was referred to our clinic for further consideration of vaccine-induced neutropenia. Patient denies any previous adverse reactions to vaccines.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Back pain, Injection site pain, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing and running noses. Lower middle back ache at level 8 in a scale of 1-10. Tenderness at injection site, no swelling or redness. Patients referred to Primary Care Physician for lower back ache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever began on the night after receiving immunization. As of 11/21/16, symptoms are improving - according to patient.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pruritus, Rash
Clinical narrative: Pt. given hydrocortisone cream 1% and 25 mg BENADRYL PO. Rash, urticarial pruritus and patient has a round 5 cm in diameter red welt  left bicep with itching.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Pt. given hydrocortisone cream 1% and 25 mg BENADRYL PO. Rash, urticarial pruritus and patient has a round 5 cm in diameter red welt  left bicep with itching.
Age: 42.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Asthenia, Dizziness, Pallor, Presyncope
Clinical narrative: Approx. 22 min post MMR/Hepatitis B vaccine. Pt was light headed, near syncopal episode, pale, weak. This vaccines was pt's. #2 MMR and #2 of #3 Hepatitis B series. Pt. stated he done great with the first MMR and Hep B.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 02-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M005971, expiry date: 02-FEB-2018) (dose and route not reported). Vaccine was improperly stored at temperature of 48.2 F for 21 hours and 57 minutes. Previous temperature excursion was reported at 57.6F 20 hours 27 minutes. Data logger was involved. No adverse effect was reported. Outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stools.
Age: 30.0
Sex: M
Vaccine: ANTH, FLUX, TYP
Symptoms: Eye pain, Fatigue, Headache, Injection site erythema, Pain
Clinical narrative: 30 yo (at time of 1st anthrax vaccine) male received anthrax vaccines on 7 Nov 2015 and 17 Feb 2016. Patient reports receipt of 3rd anthrax vaccine, but third dose not reflected in vaccine history. (Because of interval of 2 vaccines given (interval just > 3 months), assume these were anthrax #1 and #2; 3rd anthrax vaccine should have been given no earlier than 17 Jul 2016, but patient does not recall receipt of vaccine around this time.) Within one hour of receiving his first anthrax vaccine, patient noted a sharp, pressure-type pain across his forehead, on the top of his head and behind his eyes. Pain intensity was about 5/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Activity, especially "working out", made the pain worse. Pain was associated with increased sensitivity to light. No nausea and vomiting, visual changes, or changes in mental status. Patient increased his fluid intake and rested and headache resolved after a few hours. However, over the next 2 days, he experienced recurrence of similar headaches. He did not self-treat or seek evaluation. After receipt of his 2nd and 3rd anthrax vaccines, patient experienced similar headaches accompanied by photophobia within hours of vaccine receipt. Pain intensity was increased (6-8/10) with subsequent vaccine receipt. Patient did not seek evaluation or self-treat headaches, other than increasing fluids and avoiding physical activity. Headaches intermittently continued for several weeks following patient's 2nd anthrax vaccine, and after his 3rd anthrax vaccine, headaches continued intermittently for almost 2 months. Patient has no history of chronic headaches and has not experienced any headaches over the past several months. In addition to experiencing headaches after receipt of anthrax vaccine, patient also reports experiencing redness, warmth, tenderness, and swelling surrounding his anthrax vaccination sites within 24 hours of vaccine receipt. After his first anthrax vaccine the affected area was about the diameter of a 12-ounce soda can and symptoms resolved after a few days. After his subsequent anthrax vaccines, the affected area extended from near his shoulder almost to his elbow and resolved after about a week. He did not experience any numbness and tingling or weakness of the affected upper extremity. He also denied dyspnea, hives, nasal discharge, facial swelling, dysphagia, N/V and lightheadedness. Following his 2nd and 3rd anthrax vaccines, he recalls experiencing mild body aches and fatigue lasting 2-3 days. Patient was feeling well on day of vaccine receipt and is unable to identify any other possible factors contributing to development of symptoms. He reports a negative health history, and was not taking routine medication at the time of vaccine receipt. Patient has no allergies to medications, foods, latex, and insect stings. He denies history other vaccine adverse events. He received IIV in Sep 2016, without adverse events.
Age: 30.0
Sex: M
Vaccine: ANTH, FLUX, TYP
Symptoms: Photophobia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 30 yo (at time of 1st anthrax vaccine) male received anthrax vaccines on 7 Nov 2015 and 17 Feb 2016. Patient reports receipt of 3rd anthrax vaccine, but third dose not reflected in vaccine history. (Because of interval of 2 vaccines given (interval just > 3 months), assume these were anthrax #1 and #2; 3rd anthrax vaccine should have been given no earlier than 17 Jul 2016, but patient does not recall receipt of vaccine around this time.) Within one hour of receiving his first anthrax vaccine, patient noted a sharp, pressure-type pain across his forehead, on the top of his head and behind his eyes. Pain intensity was about 5/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Activity, especially "working out", made the pain worse. Pain was associated with increased sensitivity to light. No nausea and vomiting, visual changes, or changes in mental status. Patient increased his fluid intake and rested and headache resolved after a few hours. However, over the next 2 days, he experienced recurrence of similar headaches. He did not self-treat or seek evaluation. After receipt of his 2nd and 3rd anthrax vaccines, patient experienced similar headaches accompanied by photophobia within hours of vaccine receipt. Pain intensity was increased (6-8/10) with subsequent vaccine receipt. Patient did not seek evaluation or self-treat headaches, other than increasing fluids and avoiding physical activity. Headaches intermittently continued for several weeks following patient's 2nd anthrax vaccine, and after his 3rd anthrax vaccine, headaches continued intermittently for almost 2 months. Patient has no history of chronic headaches and has not experienced any headaches over the past several months. In addition to experiencing headaches after receipt of anthrax vaccine, patient also reports experiencing redness, warmth, tenderness, and swelling surrounding his anthrax vaccination sites within 24 hours of vaccine receipt. After his first anthrax vaccine the affected area was about the diameter of a 12-ounce soda can and symptoms resolved after a few days. After his subsequent anthrax vaccines, the affected area extended from near his shoulder almost to his elbow and resolved after about a week. He did not experience any numbness and tingling or weakness of the affected upper extremity. He also denied dyspnea, hives, nasal discharge, facial swelling, dysphagia, N/V and lightheadedness. Following his 2nd and 3rd anthrax vaccines, he recalls experiencing mild body aches and fatigue lasting 2-3 days. Patient was feeling well on day of vaccine receipt and is unable to identify any other possible factors contributing to development of symptoms. He reports a negative health history, and was not taking routine medication at the time of vaccine receipt. Patient has no allergies to medications, foods, latex, and insect stings. He denies history other vaccine adverse events. He received IIV in Sep 2016, without adverse events.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient described tingling/numbness of (L) arm.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and with a dose of PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported) (both vaccines were administered on the same day). Since the day of vaccines administration (unknown date), the patient felt a little sick for a week. The patient did not seek medical attention. The outcome of the event was unknown at the time of the report. The relatedness between the aforementioned event and the vaccination with PNEUMOVAX 23 and PREVNAR 13 was not assessed. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Feeling hot, Pain, Pain in extremity
Clinical narrative: Severe itching, red; swelling, pain (stabbing) hot feeling of weakness. Shot 11-9-16. Feverish, arm hurts at upper arm still. 11/17/16 Still red.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Severe itching, red; swelling, pain (stabbing) hot feeling of weakness. Shot 11-9-16. Feverish, arm hurts at upper arm still. 11/17/16 Still red.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Patient has red, swelling, and painful area at elbow area, not at the injection site. Patient was advised to take BENADRYL on 11/17/2016. Injection date is 11/15/2016.
Age: 1.08
Sex: M
Vaccine: HBHEPB, HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: My son received 4 vaccines 3-6-13. He received 2 vaccines in his (R) thigh. Later, within weeks, his right thigh swelled up so much, it looked like there was a golf ball under the skin. Red, swollen and very tender. I took him in to see the doctor said he has rarely seen this. The Dr. was going to lance it later when it would come to a head, but it never did. Within time, it just became "spongy" and absorbed from the inside, and went away.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: My son received the second chicken pox vaccine on 2-25-15. He did not reaction at all to the first one. But 2 days after this one, he broke out with a case of the itchy hives on his (R) thigh. Went away in about 15 minutes. These hives would come back in the evening before he had to go to bed, about 5 times a week. The hives would sometimes appear on his legs, abdomen, or arm. Always itchy. This recurrent rash finally, slowly went away after about 9 months.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Hypersensitivity, Injected limb mobility decreased, Injection site erythema
Clinical narrative: 34 year old female received PNEUMOVAX (L deltoid) and AFLURIA (R deltoid) influenza vaccine at PCP appointment on 10/11/16. Presented to ER on 10/13/16 complaining of left deltoid pain, swelling, and redness. Pt also c/o chills, nausea, and aching and joint pain. Pt states she cannot raise her left arm. WBC elevated at 17 (H). Diagnosed with allergic reaction to pneumonia vaccine and discharged home in stable condition with prescriptions for hydroxyzine pamoate 25 mg QID PRN itching, OTC ibuprofen 200 mg QID as need for pain, ondansetron 4 mg PO QID PRN nausea, and triamcinolone 0.1% ointment topically BID. Myalgia, Arthralgia and Erythema; left arm swelling; nausea; chills.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Nausea, Pain
Clinical narrative: 34 year old female received PNEUMOVAX (L deltoid) and AFLURIA (R deltoid) influenza vaccine at PCP appointment on 10/11/16. Presented to ER on 10/13/16 complaining of left deltoid pain, swelling, and redness. Pt also c/o chills, nausea, and aching and joint pain. Pt states she cannot raise her left arm. WBC elevated at 17 (H). Diagnosed with allergic reaction to pneumonia vaccine and discharged home in stable condition with prescriptions for hydroxyzine pamoate 25 mg QID PRN itching, OTC ibuprofen 200 mg QID as need for pain, ondansetron 4 mg PO QID PRN nausea, and triamcinolone 0.1% ointment topically BID. Myalgia, Arthralgia and Erythema; left arm swelling; nausea; chills.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: 34 year old female received PNEUMOVAX (L deltoid) and AFLURIA (R deltoid) influenza vaccine at PCP appointment on 10/11/16. Presented to ER on 10/13/16 complaining of left deltoid pain, swelling, and redness. Pt also c/o chills, nausea, and aching and joint pain. Pt states she cannot raise her left arm. WBC elevated at 17 (H). Diagnosed with allergic reaction to pneumonia vaccine and discharged home in stable condition with prescriptions for hydroxyzine pamoate 25 mg QID PRN itching, OTC ibuprofen 200 mg QID as need for pain, ondansetron 4 mg PO QID PRN nausea, and triamcinolone 0.1% ointment topically BID. Myalgia, Arthralgia and Erythema; left arm swelling; nausea; chills.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Rash, Rash erythematous
Clinical narrative: Vaccine given on 11/1/16 patient presented to pharmacy on 11/19/16 with red raised rash on back (lower) said slight difficulty breathing (not in distress) was advised to go to ER. Pt returned 11/20/16 with prescription for medications for antiviral.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored ROTATEQ, oral route, lot number M014318 with expiration date 30-SEP-2017 (dose and strength were not reported). The temperature was 50.7 F with a time frame of 30.5 hours and data logger was involved. No adverse experience was reported. This is one of two reports from the same reported (MARRS 1611USA010654). Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Gait disturbance, Influenza virus test negative, Injection site reaction, Peripheral swelling, Rash
Clinical narrative: Child with leg swelling from ankle to hip with severe rash and refusal to walk on leg. Symptoms began 36 hours after MMR vaccine. Majority of lesions were at the injection site.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Skin lesion, Streptococcus test negative
Clinical narrative: Child with leg swelling from ankle to hip with severe rash and refusal to walk on leg. Symptoms began 36 hours after MMR vaccine. Majority of lesions were at the injection site.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches x2 days. No Tx needed.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Eye irritation, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Hives, itching since evening of injection "eyes bothering", face tingly. Patient self treated with BENADRYL, will continue BENADRYL.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Injection site erythema
Clinical narrative: Ten minutes after shots given, mom c/o left leg red. Noted LAT red to above knee and spreading to lateral side. Cool pack applied. BP 92/?. P 152. Crying. No other symptoms. Tc to Dr and recd order to give BENADRYL 6.25mg orally and done. Redness decreased before BENADRYL given and resolved by 2:25 pm.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient received PREVNAR 13 on 11/17/2016. Patient states that injection "hurt" when going in. On 11/19/16, noticed rash on upper part of arm-warm to touch-no itch on 11/21/16. Rash moved below injection site-not painful.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: Patient came to pharmacy as MD recommended she get the shingles shot. Later that day she felt light-headed, fainted x 2, aches, pains. Cleared up. Next day developed cough, cold, congestion, wheeze. Sought medical attention 6 days later. MD stated possible viral syndrome from injection but may also have SX of increased serum reaction. Still minor congestion and sore throat. MD recommended SX management and feels should resolved without incident.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion, Syncope, Viral infection, Wheezing
Clinical narrative: Patient came to pharmacy as MD recommended she get the shingles shot. Later that day she felt light-headed, fainted x 2, aches, pains. Cleared up. Next day developed cough, cold, congestion, wheeze. Sought medical attention 6 days later. MD stated possible viral syndrome from injection but may also have SX of increased serum reaction. Still minor congestion and sore throat. MD recommended SX management and feels should resolved without incident.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient received PNEUMOVAX 23 on 11/12/2016. She the presented to ER with swollen, hot to touch. Presented on 11/15/16 ER prescribed KEFLEX 500 one cap 4 x daily for 10 days.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Impaired driving ability, Muscular weakness, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A 18-year-old female patient of an unknown ethnicity received on 25Jul2016 around 09:30 in the morning a single dose of TRUMENBA (lot number M68769) intramuscular and MENACTRA. Medical history and concomitant medications were not reported. On 25Jul2016 around 01:30 afternoon, the patient experienced that legs felt like jelly, she was nauseated and she was unable to drive home from the school. She needed to call her mom to have ride from the school. Outcome was unknown. The reporting nurse mentioned that it was hard to determine causality because there was another vaccine administered at the same day. No Follow-up attempts are possible. No further information expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Chills, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: This is a spontaneous report from a contactable other health professional. A 17-year0old female patient received first dose of TRUMENBA (Lot# M68769, Exp date 30Apr2017), via an unspecified route of administration in the left deltoid, on 29Jul2016 at 11:20 AM, at single dose, for immunisation and second dose of GARDASIL (Lot# M011840), via an unspecified route of administration in the right deltoid, on 29Jul2016, at single dose, for immunisation. Relevant medical history included ongoing asthma (for years), Concomitant medications included ASMANEX, from an unspecified date and ongoing (for years), at 220 ug, 1x/day (per inhalation), for asthma and PROAIR inhaler, from an unspecified date and ongoing, as needed. About half an hour after vaccination the patient experienced myalgia, fever, headache and chills on 29Jul2016, with outcome of unknown. The patient went to the emergency room and received a dose of Prednisone and BENADRYL and TYLENOL. Follow-up (16Sep2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional. A 17-year0old female patient received first dose of TRUMENBA (Lot# M68769, Exp date 30Apr2017), via an unspecified route of administration in the left deltoid, on 29Jul2016 at 11:20 AM, at single dose, for immunisation and second dose of GARDASIL (Lot# M011840), via an unspecified route of administration in the right deltoid, on 29Jul2016, at single dose, for immunisation. Relevant medical history included ongoing asthma (for years), Concomitant medications included ASMANEX, from an unspecified date and ongoing (for years), at 220 ug, 1x/day (per inhalation), for asthma and PROAIR inhaler, from an unspecified date and ongoing, as needed. About half an hour after vaccination the patient experienced myalgia, fever, headache and chills on 29Jul2016, with outcome of unknown. The patient went to the emergency room and received a dose of Prednisone and BENADRYL and TYLENOL. Follow-up (16Sep2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional. A 17-year0old female patient received first dose of TRUMENBA (Lot# M68769, Exp date 30Apr2017), via an unspecified route of administration in the left deltoid, on 29Jul2016 at 11:20 AM, at single dose, for immunisation and second dose of GARDASIL (Lot# M011840), via an unspecified route of administration in the right deltoid, on 29Jul2016, at single dose, for immunisation. Relevant medical history included ongoing asthma (for years), Concomitant medications included ASMANEX, from an unspecified date and ongoing (for years), at 220 ug, 1x/day (per inhalation), for asthma and PROAIR inhaler, from an unspecified date and ongoing, as needed. About half an hour after vaccination the patient experienced myalgia, fever, headache and chills on 29Jul2016, with outcome of unknown. The patient went to the emergency room and received a dose of Prednisone and BENADRYL and TYLENOL. Follow-up (16Sep2016): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain
Clinical narrative: Serious pain when lifting and/or rotating arm. Has not gone away or gotten any better as of this date.
Age: 34.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Serious pain when lifting and/or rotating arm. Has not gone away or gotten any better as of this date.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Nightmare, Pain in extremity, Pollakiuria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. The patient's historical drug included PREVENAR 13 administered in approximately November 2015 (reported as "about a year ago") with no reaction. The patient was pretty active, healthy and tough. The patient's concomitant medications, drug reactions, allergies and pertinent medical history was not reported. On 14-NOV-2016, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 in arm, lot # M032635 and expiry date: 05-MAY-2018. On the same day, in the same arm as the PNEUMOVAX 23, the patient received a dose of unspecified high-dose influenza vaccine. Later, on the same day, the patient began to experience excessive chills and tremors, and when he went to bed that night was up every two hours urinating and experienced severe nightmares what really laid him out for about two days. On an unknown date in November 2016, the patient also experienced soreness in the injection arm. The patient returned to the pharmacy on 16-NOV-2016, and stated that he was experiencing less soreness in his arm. No treatment was given for the events. No lab diagnostic studies were performed. On 16-NOV-2016, the patient recovered from the event of laying out. The outcome of the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Nightmare, Nocturia, Pain in extremity, Pollakiuria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. The patient's historical drug included PREVENAR 13 administered in approximately November 2015 (reported as "about a year ago") with no reaction. The patient was pretty active, healthy and tough. The patient's concomitant medications, drug reactions, allergies and pertinent medical history was not reported. On 14-NOV-2016, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 in arm, lot # M032635 and expiry date: 05-MAY-2018. On the same day, in the same arm as the PNEUMOVAX 23, the patient received a dose of unspecified high-dose influenza vaccine. Later, on the same day, the patient began to experience excessive chills and tremors, and when he went to bed that night was up every two hours urinating and experienced severe nightmares what really laid him out for about two days. On an unknown date in November 2016, the patient also experienced soreness in the injection arm. The patient returned to the pharmacy on 16-NOV-2016, and stated that he was experiencing less soreness in his arm. No treatment was given for the events. No lab diagnostic studies were performed. On 16-NOV-2016, the patient recovered from the event of laying out. The outcome of the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. The patient's historical drug included PREVENAR 13 administered in approximately November 2015 (reported as "about a year ago") with no reaction. The patient was pretty active, healthy and tough. The patient's concomitant medications, drug reactions, allergies and pertinent medical history was not reported. On 14-NOV-2016, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 in arm, lot # M032635 and expiry date: 05-MAY-2018. On the same day, in the same arm as the PNEUMOVAX 23, the patient received a dose of unspecified high-dose influenza vaccine. Later, on the same day, the patient began to experience excessive chills and tremors, and when he went to bed that night was up every two hours urinating and experienced severe nightmares what really laid him out for about two days. On an unknown date in November 2016, the patient also experienced soreness in the injection arm. The patient returned to the pharmacy on 16-NOV-2016, and stated that he was experiencing less soreness in his arm. No treatment was given for the events. No lab diagnostic studies were performed. On 16-NOV-2016, the patient recovered from the event of laying out. The outcome of the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Began with very watery diarrhea followed by vomiting. Intermittent vomiting and diarrhea persisted for at least one week.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eye swelling, Strabismus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 62-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9335Y, expiry date 30th June 2017). On 17th November 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 17th November 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced eye swelling and sticky eye. on 18th November 2016, the patient experienced squint. On an unknown date, the outcome of the eye swelling, sticky eye and squint were unchanged. The reporter considered the eye swelling, sticky eye and squint to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. At 12 hours, the patient received a dose of FLUARIX QUADRIVALENT in her left deltoid. Later in the evening after receiving the flu shot, the patient reported that her left eye began to have gunk in it and was swollen. On the day of reporting (Friday), when she woke up, her both eyes had gunk in them and they were swollen. On the same day, she had squint eyes. The reporter's call was transferred to medical information.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abasia, CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Day 1: fever, Day 2 onset of spasmodic retrocollis and inability to walk; spasmodic retrocollis continued x6 weeks, currently still present but improved.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging thoracic normal, Pyrexia, Torticollis
Clinical narrative: Day 1: fever, Day 2 onset of spasmodic retrocollis and inability to walk; spasmodic retrocollis continued x6 weeks, currently still present but improved.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Dizziness, Presyncope, Syncope, Visual impairment
Clinical narrative: Pre-Syncopal Symptoms of Dizziness, Vision changes and weakness with assisted collapse to floor after walking approximately 30 feet from clinic room to waiting room.  Pt was transferred to Wheel Chair then Gurney with assistance where he rested and was monitored for approximately 30 minutes. Symptoms subsided and Patient was ambulatory to leave clinic with his family friend who was driving.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Wheelchair user
Clinical narrative: Pre-Syncopal Symptoms of Dizziness, Vision changes and weakness with assisted collapse to floor after walking approximately 30 feet from clinic room to waiting room.  Pt was transferred to Wheel Chair then Gurney with assistance where he rested and was monitored for approximately 30 minutes. Symptoms subsided and Patient was ambulatory to leave clinic with his family friend who was driving.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain at injection site.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE REACTION. THE AREA IS RED, SWOLLEN, HOT AND HAS STRIKING.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia, Tremor
Clinical narrative: Child was described as fine at one moment and then suddenly began shaking uncontrollably and taken to the ER. Was found to have 102 degree temp. Once fever began to lower the shaking subsided. Was evaluated in the ER and told that sometimes vaccines can cause fever and to just monitor the child for further problems.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, Redness, Itching.  OTC HYDROCORTISONE CRM 1% 3 TIMES A DAY FOR 5 DAYS.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for two weeks after vaccination.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Electroencephalogram, Fall, Fractured coccyx
Clinical narrative: Woke up middle of night (1-2am) 11-5-16 complete paralysis in hands and feet and increased weakness. Patient spent 1 week back at home getting multiple tests to diagnose problem, had multiple falls and was admitted after broken tailbone. Admitted on 11-11-16.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Middle insomnia, Muscular weakness, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Woke up middle of night (1-2am) 11-5-16 complete paralysis in hands and feet and increased weakness. Patient spent 1 week back at home getting multiple tests to diagnose problem, had multiple falls and was admitted after broken tailbone. Admitted on 11-11-16.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to the physician's wife a 60-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date in an approximately November 2015 (reported as "1 year ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiry date were not reported). On an unknown date in an approximately November 2015, 4 days after receiving ZOSTAVAX, the patient developed myelitis. The outcome of myelitis was reported as fully recovered on an unknown date. The relatedness between the event of myelitis and ZOSTAVAX was not reported. Upon internal review, the event of myelitis was considered to be medically significant. Additional information is not expected because there was no consent to contact the physician.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Pruritus, Rash
Clinical narrative: FLUZONE (influenza) vaccine was administered on 11/22/2016 at 2:29 pm. At approx midnight, ten hours later, she woke with pruritus and rash to her neck, chest and shoulder. She took oral BENADRYL with some improvement, but rash and pruritus remain. For worsening or lack of improvement will go to ER.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Rash
Clinical narrative: Rash developed within 15 minutes of getting vaccines. Patient observed for 1 hour without any other symptoms. He was given a dose of BENADRYL.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Pain, Palpitations
Clinical narrative: Body aches. Increased heart rate. Heart palpitations. Possible fever.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: Full-blown symptoms of influenza; sore throat, fever (101 degrees), sinusitis, complete nasal congestion,severe productive cough, weakness and general aching muscles and joints.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, Sinusitis
Clinical narrative: Full-blown symptoms of influenza; sore throat, fever (101 degrees), sinusitis, complete nasal congestion,severe productive cough, weakness and general aching muscles and joints.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm leading to urgent care visit and prednisone RX.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm is extremely stiff and sore.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reports 2-3" of redness and swelling at injection site 2 days after injection. She will treat with 12.5 mg of BENADRYL q 4-6 hrs PRN. Resolved in one week.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Contusion, Erythema, Heart rate increased, Induration
Clinical narrative: Heart rate increased, pale and very weak with 2 hours of vaccine, bruising, swollen, hot, hard and very sore even under my arm very red for over 1 week.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Pallor, Skin warm, Swelling
Clinical narrative: Heart rate increased, pale and very weak with 2 hours of vaccine, bruising, swollen, hot, hard and very sore even under my arm very red for over 1 week.
Age: 55.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm red, hot and swollen below point of PPV23 injection. Treated with MEDROL and Cephalexin monohydrate.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Pt. saying she has a humming and whooshing sound in left ear. Started after receiving flu vaccine. Started day after.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient received flu vaccine and HPV9 vaccine. In waiting area after vaccine administered and because dizzy, pale & diaphoretic with c/o nausea. Mom picked child up and imms staff pulled a w/c over. Child placed in w/c and brought to treatment room. No LOC. Cool compresses to head and neck. She had an emesis of about 50 ml green fluid. Afterwards she said her stomach felt better but she still felt funny. Assisted to treatment bed with head elevated at 30 degrees. Had not eaten anything today. Took a few sips of water without difficulty. Eating a lollipop. BP 92/58 and per her mom, her BP normally low. Remained lying down for 10 minutes. Slowly sitting up then sitting for 3 minutes. No c/o dizziness or nausea. Skin warm and dry. Color pink. Accompanied to waiting area and allowed to go home after sitting another 15 minutes. Instructed to remind us this happened when she comes for next dose and will administer it with her in the lying down position.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vomiting
Clinical narrative: Patient received flu vaccine and HPV9 vaccine. In waiting area after vaccine administered and because dizzy, pale & diaphoretic with c/o nausea. Mom picked child up and imms staff pulled a w/c over. Child placed in w/c and brought to treatment room. No LOC. Cool compresses to head and neck. She had an emesis of about 50 ml green fluid. Afterwards she said her stomach felt better but she still felt funny. Assisted to treatment bed with head elevated at 30 degrees. Had not eaten anything today. Took a few sips of water without difficulty. Eating a lollipop. BP 92/58 and per her mom, her BP normally low. Remained lying down for 10 minutes. Slowly sitting up then sitting for 3 minutes. No c/o dizziness or nausea. Skin warm and dry. Color pink. Accompanied to waiting area and allowed to go home after sitting another 15 minutes. Instructed to remind us this happened when she comes for next dose and will administer it with her in the lying down position.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt reported a warm slightly swollen/raised area around where the injection was given.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Eye discharge, Influenza like illness, Myalgia, Oropharyngeal pain
Clinical narrative: Fever, myalgias, flu-like discomfort, sore throat, abdominal pain, discharge from eyes.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, myalgias, flu-like discomfort, sore throat, abdominal pain, discharge from eyes.
Age: 13.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Dysuria, Micturition urgency, Pollakiuria, Urine analysis normal
Clinical narrative: Dysuria, urgency and frequency. Negative Urinalysis 11/18/16. Symptom persisted till 11/21/16 to resolve without treatment other than fluids and cranberry juices.