chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: White blood cell count
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (business manager reporting on behalf of a physician) and from contactable physician. A 6-month-old male patient received, on 11Jun2014 at 15:30, PREVNAR 13 (lot number H47689) 0.5 ml, single dose, intramuscular on left thigh, and PEDIARIX (lot number KN2FL) 1 DF, single dose, intramuscular on right thigh; both for immunization. Relevant medical history included gastrooesophageal reflux disease (GERD). After previous unspecified vaccinations, the patient experienced fussiness and fever. Concomitant medication included ZANTAC. On 11Jun2014, the patient experienced unconsolable crying and on the same day, in the evening, he experienced fever, which on the following morning (12Jun2014) increased to 104.1 degrees Fahrenheit. The patient received a OTC treatment in order to reduce fever. On 12Jun2014, the patient was also irritable with an arching back. It was further reported that the patient ended up in emergency room on 12Jun2014 due to the events however the reporter was not sure if the patient was admitted or not. The reporter mentioned that the physician believes that the reported events were either caused by PREVNAR 13 vaccine or DTAP, HIB vaccine, poliomyelitis vaccine inactivated. On an unknown date in Jun2014, the patient underwent laboratory test which included a complete blood count (CBC) of which the result were unknown. The patient recovered from fever and unconsolable crying on an unspecified date, which clinical outcome of the events irritable, and arching back was unknown. Follow-up (18Jul2014): New information reported the contactable physician includes: patient clinical course and reaction data (unconsolable crying added as additional adverse event). Follow-up (12Sep2014): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: This is a spontaneous report from a non clinical study program Pfizer from a contactable pharmacist. A 65-year-old female patient of unknown ethnicity received PREVNAR 14 (Lot # 694059), intramuscular, on 15Sep2014, at 0.5ml single, for pneumonia prophylaxis. Relevant medical history included allergy to Sulfa. The patient did not present illness at the time of vaccination. Concomitant medications were not reported. On 18Sep2014 the patient experienced severe itchy at injection site, quite good size of rash at the injection site and feel like nodule under the skin. Itching was severe, good size rash. Therapeutic measures taken in response to the events included BENADRYL 25-50mg of 4-6 as needed. On 20Sep2015 the patient recovered from the events. Pharmacist mentioned that patient considered the events a reaction to PREVNAR 13. The reporter considered the events to be related to PREVNAR 13. Follow-up (03Nov2014): New information received from a contactable pharmacist includes: medical history, PREVNAR 13 details, events details, reporter's causality assessment. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable nurse who was Clinical team lead. A 28 years old female non-pregnant patient (weight: 68.934 kg, height: 175.26 cm) received single dose of PREVNAR 13, (Lot #: H86680, Exp date: Oct2015) and PNEUMOVAX 23, both on 29Oct2014. Medical history included hypothyroidism, Sjogren's syndrome, celiac disease. The patient was also immunocompromised. Concomitant medication included MECLIZINE, SYNTHROID, PLAQUENIL, MAXALT, Vitamin D3. Nurse reported that studies came out showed the symptoms of pneumococcal 13-val conj vac and pneumococcal vaccine giving together. The patient experienced fever at 101, flu like symptoms, fatigue and muscle ache on 29Oct2014 and headache, dizziness, nausea, vomiting on unknown date. The patient was treated for flu like symptoms. The nurse mentioned that they were giving her fluid but she did not seek emergency treatment and they did not have to do anything. The patient also had risk factors (unspecified). Causality assessment could not be probed. Events outcome was unknown at the time of report. Follow-up (31Oct2014): New information from a contactable nurse included administration date, lot and expiration date of PREVNAR 13, medical history, new events of fatigue and myalgia. Follow-up (25DEC2014): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse who was Clinical team lead. A 28 years old female non-pregnant patient (weight: 68.934 kg, height: 175.26 cm) received single dose of PREVNAR 13, (Lot #: H86680, Exp date: Oct2015) and PNEUMOVAX 23, both on 29Oct2014. Medical history included hypothyroidism, Sjogren's syndrome, celiac disease. The patient was also immunocompromised. Concomitant medication included MECLIZINE, SYNTHROID, PLAQUENIL, MAXALT, Vitamin D3. Nurse reported that studies came out showed the symptoms of pneumococcal 13-val conj vac and pneumococcal vaccine giving together. The patient experienced fever at 101, flu like symptoms, fatigue and muscle ache on 29Oct2014 and headache, dizziness, nausea, vomiting on unknown date. The patient was treated for flu like symptoms. The nurse mentioned that they were giving her fluid but she did not seek emergency treatment and they did not have to do anything. The patient also had risk factors (unspecified). Causality assessment could not be probed. Events outcome was unknown at the time of report. Follow-up (31Oct2014): New information from a contactable nurse included administration date, lot and expiration date of PREVNAR 13, medical history, new events of fatigue and myalgia. Follow-up (25DEC2014): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A adult male patient received on an unknown date PREVNAR 13 (for adult population) for immunization and developed a local reaction to the shot. The patient should receive the 23-valent pneumococcal vaccine: the pharmacist asked if the patient could or not have this vaccine, due to his previous local reaction. The outcome of the event was unknown. Follow-up (14Feb2013): New information received from a contactable Pharmacist via a sales representative includes: patient age group.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A adult male patient received on an unknown date PREVNAR 13 (for adult population) for immunization and developed a local reaction to the shot. The patient should receive the 23-valent pneumococcal vaccine: the pharmacist asked if the patient could or not have this vaccine, due to his previous local reaction. The outcome of the event was unknown. Follow-up (14Feb2013): New information received from a contactable Pharmacist via a sales representative includes: patient age group.
Age: 50.0
Sex: F
Vaccine: HEPAB, HEPAB, TYP
Symptoms: Back pain
Clinical narrative: Initial unsolicited report and follow up report received from a Physician on 13-Mar-2015. A 50 years old female patient, had received a dose of TYPHIM VI (batch number: K1183-1, via intramuscular route in the left deltoid, expiry date and dose details were not provided) and TWINRIX (manufacturer: GSK, batch number: 3JR4, via intramuscular route in the left deltoid, expiry date and dose details were not provided) on 09-Mar-2015. The patient had no illness at time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions included IBS, she had increased cholesterol, was lactose intolerant, had seasonal allergies, she was allergic to ZYBAN with hives and intolerant to E Mycin: cramps, diarrhea. Concomitant medications  were not reported. On 09-Mar-2015, the patient experienced severe low back pain. She went to Emergency Room on 11-Mar-2015. It was reported that she experienced a potential adverse event with the typhoid vaccine on an unspecified date. Laboratory investigations included U/A (urinalysis). The results were negative. She was prescribed FLEXERIL and Ibuprofen as corrective treatment. At the time of this report, the patient had not recovered from the above mentioned events. List of documents held by sender: none. Follow up information received from a Physician on 20-Apr-2015. It was reported that the patient had a medical history of intolerance to erythromycin: cramps and diarrhea and had received a first dose of TYPHIM VI (expiry date: 06-Aug-2016) and TWINRIX (expiry date: 19-Feb-2016) on at 10:30 AM 09-Mar-2015.  Concomitant medications includes Pravastatin one daily, XANAX as needed, BIOTIN, Vitamin D and ALIGN OTC. On 10-Mar-2015 at 3:00 AM, one day after receiving vaccination, the patient experienced severe low back pain. Corrective treatments included Ibuprofen and FLEXERIL as prescribed. At the time of this report, the outcome of patient was reported as recovered on 13 March 2015. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: HEPAB, HEPAB, TYP
Symptoms: Back pain, Urine analysis normal
Clinical narrative: Initial unsolicited report and follow up report received from a Physician on 13-Mar-2015. A 50 years old female patient, had received a dose of TYPHIM VI (batch number: K1183-1, via intramuscular route in the left deltoid, expiry date and dose details were not provided) and TWINRIX (manufacturer: GSK, batch number: 3JR4, via intramuscular route in the left deltoid, expiry date and dose details were not provided) on 09-Mar-2015. The patient had no illness at time of vaccination. The pre-existing physician diagnosed allergies, birth defects, medical conditions included IBS, she had increased cholesterol, was lactose intolerant, had seasonal allergies, she was allergic to ZYBAN with hives and intolerant to E Mycin: cramps, diarrhea. Concomitant medications  were not reported. On 09-Mar-2015, the patient experienced severe low back pain. She went to Emergency Room on 11-Mar-2015. It was reported that she experienced a potential adverse event with the typhoid vaccine on an unspecified date. Laboratory investigations included U/A (urinalysis). The results were negative. She was prescribed FLEXERIL and Ibuprofen as corrective treatment. At the time of this report, the patient had not recovered from the above mentioned events. List of documents held by sender: none. Follow up information received from a Physician on 20-Apr-2015. It was reported that the patient had a medical history of intolerance to erythromycin: cramps and diarrhea and had received a first dose of TYPHIM VI (expiry date: 06-Aug-2016) and TWINRIX (expiry date: 19-Feb-2016) on at 10:30 AM 09-Mar-2015.  Concomitant medications includes Pravastatin one daily, XANAX as needed, BIOTIN, Vitamin D and ALIGN OTC. On 10-Mar-2015 at 3:00 AM, one day after receiving vaccination, the patient experienced severe low back pain. Corrective treatments included Ibuprofen and FLEXERIL as prescribed. At the time of this report, the outcome of patient was reported as recovered on 13 March 2015. List of documents held by sender: none.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Condition aggravated, Epistaxis
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 82-year-old female patient received on 20JAN2015 at 11:00, PREVNAR13, via an unspecified route of administration on her upper left shoulder at single dose. No other vaccine was given on the same day. Medical history included hepatitis C from 1992 which compromised her immune system; she did not take flu shots. There were no concomitant medications. On 21JAN2015, when she got up, she had a chest congestion, pain in her hips, pain in hand, pain in knee, pain in lip, pain in neck, very weak and tired and she can barely walk. She also experienced drowsiness and nose bleeds. Patient had several tests done for her liver, one performed 2 weeks before, which showed her live was normal; kidney ultrasound of her abdomen and chest x-ray were all normal. Blood work for liver was good. Patient recovered from pain (in her hips, hand, knee, lip and neck) and not recovered from chest congestion, the outcome of the other events was unknown. Follow-up (23JAN2015): New information reported from the same contactable consumer includes: reaction data (drowsiness and nose bleeds added as additional adverse event).
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Neck pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 82-year-old female patient received on 20JAN2015 at 11:00, PREVNAR13, via an unspecified route of administration on her upper left shoulder at single dose. No other vaccine was given on the same day. Medical history included hepatitis C from 1992 which compromised her immune system; she did not take flu shots. There were no concomitant medications. On 21JAN2015, when she got up, she had a chest congestion, pain in her hips, pain in hand, pain in knee, pain in lip, pain in neck, very weak and tired and she can barely walk. She also experienced drowsiness and nose bleeds. Patient had several tests done for her liver, one performed 2 weeks before, which showed her live was normal; kidney ultrasound of her abdomen and chest x-ray were all normal. Blood work for liver was good. Patient recovered from pain (in her hips, hand, knee, lip and neck) and not recovered from chest congestion, the outcome of the other events was unknown. Follow-up (23JAN2015): New information reported from the same contactable consumer includes: reaction data (drowsiness and nose bleeds added as additional adverse event).
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Asthenia, Blood test normal, Chest X-ray normal, Epistaxis
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 82-year-old female patient received on 20JAN2015 at 11:00, PREVNAR13, via an unspecified route of administration on her upper left shoulder at single dose. No other vaccine was given on the same day. Medical history included hepatitis C from 1992 which compromised her immune system; she did not take flu shots. There were no concomitant medications. On 21JAN2015, when she got up, she had a chest congestion, pain in her hips, pain in hand, pain in knee, pain in lip, pain in neck, very weak and tired and she can barely walk. She also experienced drowsiness and nose bleeds. Patient had several tests done for her liver, one performed 2 weeks before, which showed her live was normal; kidney ultrasound of her abdomen and chest x-ray were all normal. Blood work for liver was good. Patient recovered from pain (in her hips, hand, knee, lip and neck) and not recovered from chest congestion, the outcome of the other events was unknown. Follow-up (23JAN2015): New information reported from the same contactable consumer includes: reaction data (drowsiness and nose bleeds added as additional adverse event).
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Gait disturbance, Lip pain, Liver function test normal, Neck pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 82-year-old female patient received on 20JAN2015 at 11:00, PREVNAR13, via an unspecified route of administration on her upper left shoulder at single dose. No other vaccine was given on the same day. Medical history included hepatitis C from 1992 which compromised her immune system; she did not take flu shots. There were no concomitant medications. On 21JAN2015, when she got up, she had a chest congestion, pain in her hips, pain in hand, pain in knee, pain in lip, pain in neck, very weak and tired and she can barely walk. She also experienced drowsiness and nose bleeds. Patient had several tests done for her liver, one performed 2 weeks before, which showed her live was normal; kidney ultrasound of her abdomen and chest x-ray were all normal. Blood work for liver was good. Patient recovered from pain (in her hips, hand, knee, lip and neck) and not recovered from chest congestion, the outcome of the other events was unknown. Follow-up (23JAN2015): New information reported from the same contactable consumer includes: reaction data (drowsiness and nose bleeds added as additional adverse event).
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Renal function test normal, Respiratory tract congestion, Somnolence, Ultrasound abdomen normal
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 82-year-old female patient received on 20JAN2015 at 11:00, PREVNAR13, via an unspecified route of administration on her upper left shoulder at single dose. No other vaccine was given on the same day. Medical history included hepatitis C from 1992 which compromised her immune system; she did not take flu shots. There were no concomitant medications. On 21JAN2015, when she got up, she had a chest congestion, pain in her hips, pain in hand, pain in knee, pain in lip, pain in neck, very weak and tired and she can barely walk. She also experienced drowsiness and nose bleeds. Patient had several tests done for her liver, one performed 2 weeks before, which showed her live was normal; kidney ultrasound of her abdomen and chest x-ray were all normal. Blood work for liver was good. Patient recovered from pain (in her hips, hand, knee, lip and neck) and not recovered from chest congestion, the outcome of the other events was unknown. Follow-up (23JAN2015): New information reported from the same contactable consumer includes: reaction data (drowsiness and nose bleeds added as additional adverse event).
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: The patient is a 1 year 1 month old female. The patient is a 13 mo healthy female who received her 12mo vaccines (MMR mfx MSD lot # K0111189 (R) thigh Subq, HIB mfx MSD lot#K016965, PCV13 mfx WYE lot# L13518, varicella MSD lot # K018963) on 22APR 2015. She presents to clinic today with her MOP and FOP who report she initially did fine but approximately 15 hours later she was noted to have generalized erythematous plaques, severely pruritic with facial edema. She had no airway constriction, oral or tongue swelling, wheezing or cough. Her activity was normal other than scratching. She has no emesis and eating and drinking were normal. She was initially seen in a community ER on 23 APR 2015. She was treated with BENADRYL for 72 hours but as soon as they stopped the BENADRYL the lesions returned. They continued the BENADRYL. She was again seen in ER on 6 MAY and told she had varicella lesions and ZANTAC was added. She then followed up with primary care and was started on prednisone which she completed on 11 May, the histamine blockers were stopped and the lesions have not returned.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Face oedema, Pruritus, Skin plaque, Varicella post vaccine
Clinical narrative: The patient is a 1 year 1 month old female. The patient is a 13 mo healthy female who received her 12mo vaccines (MMR mfx MSD lot # K0111189 (R) thigh Subq, HIB mfx MSD lot#K016965, PCV13 mfx WYE lot# L13518, varicella MSD lot # K018963) on 22APR 2015. She presents to clinic today with her MOP and FOP who report she initially did fine but approximately 15 hours later she was noted to have generalized erythematous plaques, severely pruritic with facial edema. She had no airway constriction, oral or tongue swelling, wheezing or cough. Her activity was normal other than scratching. She has no emesis and eating and drinking were normal. She was initially seen in a community ER on 23 APR 2015. She was treated with BENADRYL for 72 hours but as soon as they stopped the BENADRYL the lesions returned. They continued the BENADRYL. She was again seen in ER on 6 MAY and told she had varicella lesions and ZANTAC was added. She then followed up with primary care and was started on prednisone which she completed on 11 May, the histamine blockers were stopped and the lesions have not returned.
Age: 13.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Hypersensitivity, Oedema, Pruritus, Urticaria
Clinical narrative: Patient develop allergy after immunized, edema in foot with itching. Was hospitalized 2 times, and later hospitalized in Hospital (6-7 days). Diagnosis urticarial. Possible adverse event to vaccination with VARIVAX.
Age: 13.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Hypersensitivity, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Patient develop allergy after immunized, edema in foot with itching. Was hospitalized 2 times, and later hospitalized in Hospital (6-7 days). Diagnosis urticarial. Possible adverse event to vaccination with VARIVAX.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Eye pruritus, Headache, Influenza like illness, Influenza virus test negative
Clinical narrative: Sore throat, headache, runny and stuffy nose, cough fever, chills, soreness of shot. Tired eyes and teeth hurt congestion moved to chest.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: Sore throat, headache, runny and stuffy nose, cough fever, chills, soreness of shot. Tired eyes and teeth hurt congestion moved to chest.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenopia, Chills, Cough, Headache, Injection site pain
Clinical narrative: Sore throat, headache, runny and stuffy nose, cough fever, chills, soreness of shot. Tired eyes and teeth hurt congestion moved to chest.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Sore throat, headache, runny and stuffy nose, cough fever, chills, soreness of shot. Tired eyes and teeth hurt congestion moved to chest.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Toothache
Clinical narrative: Sore throat, headache, runny and stuffy nose, cough fever, chills, soreness of shot. Tired eyes and teeth hurt congestion moved to chest.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Choking, Cough, Headache, Nausea
Clinical narrative: Ate lunch 30 min after vaccine. Got feverish, nauseous, headache 1 hour after vaccine, very weak and sleepy. Went to bed, propped up. Fell in deep sleep. Aspirated lunch into bronchial tubes. Could not breathe. Husband did Heimlich. Coughed for 2 days. Except, for a mild cough. Patients should be warned to not eat after vaccine until they see how they will react.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Ate lunch 30 min after vaccine. Got feverish, nauseous, headache 1 hour after vaccine, very weak and sleepy. Went to bed, propped up. Fell in deep sleep. Aspirated lunch into bronchial tubes. Could not breathe. Husband did Heimlich. Coughed for 2 days. Except, for a mild cough. Patients should be warned to not eat after vaccine until they see how they will react.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aspiration, Asthenia, Cough, Dyspnoea, Headache
Clinical narrative: Ate lunch 30 min after vaccine. Got feverish, nauseous, headache 1 hour after vaccine, very weak and sleepy. Went to bed, propped up. Fell in deep sleep. Aspirated lunch into bronchial tubes. Could not breathe. Husband did Heimlich. Coughed for 2 days. Except, for a mild cough. Patients should be warned to not eat after vaccine until they see how they will react.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Ate lunch 30 min after vaccine. Got feverish, nauseous, headache 1 hour after vaccine, very weak and sleepy. Went to bed, propped up. Fell in deep sleep. Aspirated lunch into bronchial tubes. Could not breathe. Husband did Heimlich. Coughed for 2 days. Except, for a mild cough. Patients should be warned to not eat after vaccine until they see how they will react.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Redness and swelling from elbo to shoulder, felt tired and run down for 3 days.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Redness and swelling from elbo to shoulder, felt tired and run down for 3 days.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: Redness and swelling from elbo to shoulder, felt tired and run down for 3 days.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Muscle spasms, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscle spasm and myalgias in calves.  Ascending myalgias.  Intermittent chills.  No fevers.  Mild neck stiffness and headache.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cough, Haemoptysis, Pneumonia
Clinical narrative: Pt developed severe cough, coughing up some blood at 3 days post vaccination.  Pt followed up with physician at 8 days post vaccination and was diagnosed with pneumonia.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: 9/18- redness and swelling developed on left arm only. 9/20- reaction was managed with Benadryl but redness had spread down past the elbow of the left arm and across chest. Pt taken to local ER and given prednisone which cleared the reaction.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Myalgia
Clinical narrative: Severe abdominal pain the night of followed by myalgias in arms and legs for more than 7 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After administration of 1st vaccine pt stated that he felt lightheaded.  He was then laid down and the rest of the vaccines were given. After 10 minutes the pt's B/P was 110/60 and felt ok to leave after the full 15 minutes of waiting. Juice & Granola bar were given prior to vaccines being given.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, discomfort of entire right upper extremity and extremity was hot to touch.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Extreme muscle weakness in arm, high level of pain radiating down the arm.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Fatigue, Headache, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Congestion, Neck Ache, Headache, Fatigue, Fever (100.4), Sore Throat.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Respiratory tract congestion
Clinical narrative: Congestion, Neck Ache, Headache, Fatigue, Fever (100.4), Sore Throat.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Raised, red area.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Arm continues to be painful, achy and sore now, 8 days after vaccination. It wakes my mom up several times a night. Ibuprofen is not helping.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm continues to be painful, achy and sore now, 8 days after vaccination. It wakes my mom up several times a night. Ibuprofen is not helping.
Age: 0.72
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood glucose normal, Body temperature, Seizure
Clinical narrative: TEMP 103.7 FOLLOWED BY BRIEF UNCOMPLICATED SEIZURE, ABOUT 45 SEC. 911 CALLED, PT EVALUATED AT LOCAL ED, RELEASED.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Eye pain, Eye pruritus, Headache, Ocular hyperaemia
Clinical narrative: Sore, red, itchy eyes.  Hoarse throat.  Headache.  Body aches.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sore, red, itchy eyes.  Hoarse throat.  Headache.  Body aches.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Extreme pain and swelling in the left leg surrounding site of DTAP vaccine with a limp.  Having trouble moving, walking and extreme tenderness in his thigh.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Immediately after getting the flu shot, felt pain down the L arm and numbness/tingling to fingers; numbness and tingling continues but moving from index/thumb to pinky overnight; soreness persists; afebrile, no swelling, no redness; applied ice pack and took ibuprofen orally.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Pain, Swollen tongue
Clinical narrative: Experienced SOB, fatigue, achiness approx. 4 hrs after flu shot. Client states she also ate a cookie with macadamia nuts that evening and has reacted to macadamia nuts in the past. Client took Tylenol and loratadine prior to bed on 9-17-2015. Client states she woke up with a swollen tongue early AM on 9-18-2015. Took Tylenol and swelling subsided. Client states she felt better on 9-18-2015. Client will contact her allergist to see if she needs to be evaluated. Telephone call to client on 9-21-2015. Client states she spoke with Dr. who said reaction was probably due nuts and not the flu vaccine. Client states she has received flu vaccinations in the past without any problems. Client has a follow-up appt. with Dr. on 10-12-2015 to be tested for nut allergy.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Constipation, Diarrhoea, Fatigue, Muscular weakness, Pallor
Clinical narrative: Weakness in legs, pale, fatigue, diarrhea then constipation. Patient was admitted to hospital for evaluation. The assessment could find no cause for sxs so attributed to shot.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Received flu vaccine at 06:45 on 09/21/15 1 hr later hive noted on left side of face. No other symptoms. BENADRYL 25mg po given with effect. Examined in ED cortisone given returned to work.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pallor, Pruritus, Rash macular
Clinical narrative: Pt contacted and seen by Immunization Healthcare clinic approximately 1-1.25 hours after receiving flu shot FLUARIX. She reported receiving the shot then going back to her office and within 5 minutes her face, neck and upper chest began to itch and was flushed and had small hives (chest-neck). She also stated the bottoms of both feet were itchy with hives also. Pt denied any SOB, pruritis, angioedema or tachycardia. She returned to immunization clinic where VS where wnl BP 120/88; P - 68 R-18-20; SO2 99.99% on room air; Pain-0. She was monitored for 15-20 minutes talking with staff with resolution of neck/chest hives and easing of erythema. She returned to clinic and called his office. Skin: Facial redness red to pink reported normal shading for rosacea. Chest red and later pale pink with scattered red pinpoint macules noted by tan line but no hives. She advised they had resolved. Skin normal to arms, neck, legs, feet. Reactions reported began approximately 5-30 minutes after vaccination localized to skin redness and reported hives. She reports a history of hive reactions following stress which does occur prn and once with anaphylactic reaction to allergy shots. She denied any other systemic reactions such as SOB, throat tightness, wheezing, etc.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt contacted and seen by Immunization Healthcare clinic approximately 1-1.25 hours after receiving flu shot FLUARIX. She reported receiving the shot then going back to her office and within 5 minutes her face, neck and upper chest began to itch and was flushed and had small hives (chest-neck). She also stated the bottoms of both feet were itchy with hives also. Pt denied any SOB, pruritis, angioedema or tachycardia. She returned to immunization clinic where VS where wnl BP 120/88; P - 68 R-18-20; SO2 99.99% on room air; Pain-0. She was monitored for 15-20 minutes talking with staff with resolution of neck/chest hives and easing of erythema. She returned to clinic and called his office. Skin: Facial redness red to pink reported normal shading for rosacea. Chest red and later pale pink with scattered red pinpoint macules noted by tan line but no hives. She advised they had resolved. Skin normal to arms, neck, legs, feet. Reactions reported began approximately 5-30 minutes after vaccination localized to skin redness and reported hives. She reports a history of hive reactions following stress which does occur prn and once with anaphylactic reaction to allergy shots. She denied any other systemic reactions such as SOB, throat tightness, wheezing, etc.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Patient received the vaccination in the right deltoid in the AM. Patient reported itchy red raised patches began to appear around the injection site in the evening. During the next 10 days, the rash spread to her back, neck, scalp, buttock region, and both arms, legs and feet. Patient has been self treating with oral Benadryl and topical hydrocortisone.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Malaise, Tachycardia
Clinical narrative: After receiving the flu vaccine, felt tachycardic, SOB, and sense of not feeling well, no localized reaction to injection site; she went to emergency room within 5 hours of taking vaccine, no abnormal findings; took Benadryl over the weekend.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site bruising, Injection site pain, Lymphadenopathy, Rash
Clinical narrative: Fatigue lasting 2 days. Rash on injected arm, extending to upper torso, chest, back and lower neck. Swollen glands in neck. Bruise-like pain at injection site for 4 days when touched, with no pain when untouched.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Sharp pain at injection site within 2 days reported to my PCP (retired) during visit on 2/15. Loss of range of motion and pain. Reported to new PCP on 4/15 and referred for MRI. Based on MRI, referred to orthopedic surgeon. X-ray on 6/17/15, received lidocaine 2 cc,
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site abscess, Injection site reaction, Rash erythematous
Clinical narrative: Pt arrived at the store with warm rash and red rash that was sore at the site of injection, patient said it appeared the even after receiving FLUZONE and PREVNAR 13.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cough, Respiratory tract congestion, Throat tightness
Clinical narrative: Cough, congestion, restricted throat.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Infection, Injection site erythema, Injection site rash
Clinical narrative: Large red rash at injection site. Doctor prescribed antibiotic thinking its an infection could be allergy as well, unclear.
Age: 1.86
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Pt to receive FLUZONE 0.25 ml, but received FLUARIX. MD order and electronic medical charting stated pt. received FLUZONE; however, mother of child (who is a MA) noticed the differences in syringes and stated both of them received the same vaccine. At this time, no known complications noted.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Nasopharyngitis, Pruritus, Pyrexia, Rash
Clinical narrative: 9/15/15-itching. 9/18/15-cold sx (congestion). 9/20/15 Feverish, HA rash spreaad 9/20/15-cold sx improving-rash .
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Respiratory tract congestion
Clinical narrative: 9/15/15-itching. 9/18/15-cold sx (congestion). 9/20/15 Feverish, HA rash spreaad 9/20/15-cold sx improving-rash .
Age: 40.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Cough, Oropharyngeal pain, Wheezing
Clinical narrative: Pt called office with sore throat, cough, wheezing s/p vaccines. Instructed to return to office for evaluation. Rx: MEDROL Pak and ZANTAC. Pt treated with IM DECADRON, Albuterol nebulizer. 9/17/15 MD F/U improving.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza
Clinical narrative: Received flu vaccine on 8/22/15. 2 weeks later, I got the flu, last year. Last year, I got the flu vaccine around the same time, and got the flu in Dec, 14. so that's twice now. I received flu vaccines for the past several years because my child has asthma, so I get one with him. I never got the flu for the past 5 years. Now I move here and got the flu both time. There's something wrong here. I think I got a placebo.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza, Nausea, Pyrexia, Throat irritation, Vaccination failure
Clinical narrative: Received flu vaccine on 8/22/15. 2 weeks later, I got the flu, last year. Last year, I got the flu vaccine around the same time, and got the flu in Dec, 14. so that's twice now. I received flu vaccines for the past several years because my child has asthma, so I get one with him. I never got the flu for the past 5 years. Now I move here and got the flu both time. There's something wrong here. I think I got a placebo.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cardiac stress test, Computerised tomogram head, Echocardiogram, Electrocardiogram
Clinical narrative: Because I didn't report right away, I don't recall the date exactly but I got FLUZONE vaccine in October of 2013. 3 days later, I began experiencing uncoordinated left hand, weak and achy feeling in (L) arm and (L) leg. (I rec'd vaccine in my left deltoid) symptoms went on for months requiring a month leave of absence and many medical test. ER visit.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hand-eye coordination impaired, Impaired work ability, Muscular weakness, Pain in extremity
Clinical narrative: Because I didn't report right away, I don't recall the date exactly but I got FLUZONE vaccine in October of 2013. 3 days later, I began experiencing uncoordinated left hand, weak and achy feeling in (L) arm and (L) leg. (I rec'd vaccine in my left deltoid) symptoms went on for months requiring a month leave of absence and many medical test. ER visit.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye swelling, Feeling cold, Influenza, Swelling face
Clinical narrative: Flu symptoms-chills, "freezing to death" Face/swollen around the whole head-Took BENADRYL Monday and eye swollen 6 hrs Tues am-called MD for MEDROL Dose pak.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising
Clinical narrative: Flu shot administered 9-11-15 patient developed bruise in deltoid area and arm. Patient on warfarin.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Nodule, Skin discolouration
Clinical narrative: Flu shot administered 9-11-15 patient developed bruise in deltoid area and arm. Patient on warfarin.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: 9-11-15 at 7:24 pm reports red, warm swollen arm where flu shot was given-Rec cool compress and Ibuprofen-telephone mess 9-13-15 8:21 am see in E.R. for (L) arm swelling Dx cellulitis-given BENADRYL and KEFLEX.
Sex: U
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician from the Merck National Service Center under the service request number 1-5623366185. A patient of unspecified age, ethnicity, and gender received PREVNAR via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed pneumonia. The outcome of the event, pneumonia, was unknown at the time of the report. Follow-up (14Dec2012): Follow-up attempts completed. No further information expected. Follow-up (21Dec2012): New information received from a contactable physician includes: the physician could not confirm the reported event as the physician could not confirm which patient the event was referring to. Follow-up attempts completed. No further information expected.
Age: 11.0
Sex: M
Vaccine: PNC
Symptoms: Pneumococcal infection, Pyrexia, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a non-contactable physician in market research. An 11-year-old male patient of an unspecified ethnicity received PREVENAR via an unspecified route of administration in May2012. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient developed a 103 degree fever with a low white count. The patient was diagnosed with pneumococcal disease. Therapeutic measures were taken as a result of the event and included antibiotics to which the patient responded well. The outcome of the pneumococcal disease was recovered on an unspecified date. The outcome of the low white count was unknown at the time of the report.
Sex: U
Vaccine: PNC
Symptoms: Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, gender and ethnicity received PREVNAR and PNEUMOVAX 23 on unspecified dates. The patient has an underlying lung disease. Concomitant medications were not reported. The physician reported that the patient continues to get pneumococcal pneumonia on unspecified dates. Therapeutic measures taken in response to the pneumococcal pneumonia are unknown. The clinical outcome of the pneumococcal pneumonia is unknown.
Sex: U
Vaccine: PNC
Symptoms: Pneumococcal infection
Clinical narrative: This is an initial spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received the fourth dose of PREVNAR via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, after receiving 4 doses of PREVNAR, the patient developed medically significant pneumococcal disease for which the patient was hospitalized on an unspecified date. Relevant laboratory data was unknown. The physician reported that the strain of the bacteria was unknown. Therapeutic measures were taken as a result of the event and included treatment with vancomycin. The outcome of the event was unknown at the time of the report. Follow-up (11Jun2012): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticaria, angio edema.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Pruritus generalised
Clinical narrative: Itching all over body, Sweats, and weakness.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Increased soreness in the arm that had the injection. Left side. It was found that the patient had the same vaccine less than 1 year ago. 1/27/2015 and now 9/18/2015. Administering providers mistake.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Nausea
Clinical narrative: Nausea, stated she could barely move arm, bump at injection site.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Paraesthesia
Clinical narrative: Sharp Pain, Tingles (like needles), Redness.
Sex: U
Vaccine: PNC
Symptoms: Antibody test positive, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable physician based on the information received by Pfizer from Merck (Merck Service Request Number: 1-1 3208200531). A patient of unspecified age, ethnicity and gender received an unspecified number of dosages of PREVNAR, via an unspecified route of administration, on an unspecified date(s), at an unspecified dose(s). The patient's medical history was not reported. The patient's concomitant medication were not reported. The physician reported that the patient had a titer drawn at an unspecified time after receiving the PREVNAR and the titer showed that the PREVNAR was not effective. The patient's clinical outcome was not specified. Follow-up (09Feb2015): New information received from a certified medical assistant (CMA), calling on behalf of the same reporting physician, in response to a follow up letter and questionnaire received by them: the CMA was unable to provide any information as the patient details are not known, and thus are not known to the CMA. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: FLUC3, PPV, TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Only right arm low grade fever, body aches, chills, headache and nausea. Site reaction of redness, swelling, hives localized and rash near the site. PT. has a hot-to-touch lump near immunization site-on her right arm.
Age: 41.0
Sex: F
Vaccine: FLUC3, PPV, TDAP
Symptoms: Mass, Nausea, Pain, Pyrexia, Rash
Clinical narrative: Only right arm low grade fever, body aches, chills, headache and nausea. Site reaction of redness, swelling, hives localized and rash near the site. PT. has a hot-to-touch lump near immunization site-on her right arm.
Age: 41.0
Sex: F
Vaccine: FLUC3, PPV, TDAP
Symptoms: Skin warm
Clinical narrative: Only right arm low grade fever, body aches, chills, headache and nausea. Site reaction of redness, swelling, hives localized and rash near the site. PT. has a hot-to-touch lump near immunization site-on her right arm.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Axillary pain, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Swelling; itching and pain at the sight, extends to underarm; (Pt reporting an arm where Zoster was administered).
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Swelling
Clinical narrative: Swelling; itching and pain at the sight, extends to underarm; (Pt reporting an arm where Zoster was administered).
Age: 18.0
Sex: M
Vaccine: HEP, MMR, MNQ, TD, VARCEL
Symptoms: Cold sweat, Heart rate decreased, Heart rate irregular
Clinical narrative: Pt became cold and clammy. Non verbal for a few seconds (during the onset of vagal response. Pt immediately placed in supine postion with legs elevated. BP 113/66 HR 54. Pt kept for 30 minutes after vaccine event. Pt with irregular heart rate and low HR. Pt unsure if this was normal. Pt stated had not eaten anything today. Bp 114/70 and HR 54 on discharge.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, blistering with some weeping, warm to touch, some pain and itching at injection site where Tdap and Menveo were given. on 9/16/2015, area measured 1inch by 1inch and was red and warm to touch. On 9/17/2015, area measured 6inches long by 5inches wide with blistering and weeping at injection site. Area was cleaned and dressed with TAO, 2x2 gauze and wrapped loosely because of weeping from area. Physician prescribed oral steroids for patient. Follow up call made on 9/18/2015 and mother reported that area was improving. Another follow up call made on 9/21/2015 to parent and mother reported that area was completely healed now. Noted in patient chart that reaction took place and advised caution with next dose of vaccines.