chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 19 November 2015. This case involves a 44-year-old female patient who was vaccinated with a dose of Flu VACCINE (batch number, dose, dose in series, expiration date, route and site of administration were not reported) on an unspecified date. It was reported that patient received Fluzone multiple times and had an increasing site reaction each year. Illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were unknown. On an unspecified date, following the vaccination, the patient experienced an increasing local red hot raised reaction at the injection site. Lab data was reported as none. Corrective treatments were not reported. The patient was recovered from event. List of documents held by sender: none. Follow up information received from a nurse on 28 January 2016. Patient received Flu Vaccine on 15 September 2014. It was reported that patient had received vaccines for the conservative past three years. On an unspecified date, following vaccination, patient developed site was red, swollen and pruritic. The area was indurated to the size of an orange. Patient was referred to an allergist which patient did not pursue.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 19 November 2015. This case involves a 44-year-old female patient who was vaccinated with a dose of Flu VACCINE (batch number, dose, dose in series, expiration date, route and site of administration were not reported) on an unspecified date. It was reported that patient received Fluzone multiple times and had an increasing site reaction each year. Illness at time of vaccination was unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were unknown. On an unspecified date, following the vaccination, the patient experienced an increasing local red hot raised reaction at the injection site. Lab data was reported as none. Corrective treatments were not reported. The patient was recovered from event. List of documents held by sender: none. Follow up information received from a nurse on 28 January 2016. Patient received Flu Vaccine on 15 September 2014. It was reported that patient had received vaccines for the conservative past three years. On an unspecified date, following vaccination, patient developed site was red, swollen and pruritic. The area was indurated to the size of an orange. Patient was referred to an allergist which patient did not pursue.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Band neutrophil percentage increased, Lip swelling, Monocyte percentage increased, Rash, Rash macular
Clinical narrative: Pt received the flu vaccine on 1/21/16 at 1101. Parents first noticed that his lips were swollen around 1845 that same afternoon. Was taken to the ER, where he was triaged at 1920. By this time, he had also developed a splotchy rash on his face. VS at the ER were T 97.9, HR 116, R 38, and O2 sat 98% on RA. At 1958, he was given 12.5 mg of Benadryl IV and 2 mg of Decadron IV. Dad stated that this helped his symptoms greatly, but did not completely get rid of rash or swollen lips. States that symptoms had completely disappeared by about mid-morning the next day.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Low grade fever, diarrhea, anorexia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, pain, itching at the vaccine site left thigh (where KINRIX was given) very large reaction covering almost entire front of thigh.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: He reports that yesterday afternoon/evening he had a red spot  in his right groin that was sore to touch.  He reports after 6-7 hours the  redness moved around his right hip towards his right buttock.  He reports the top of his left foot was also red.  He reports this morning when he woke up all of the sx went away.  He denies redness, pain, blisters, hives, fever, or other sx.  He reports "I feel great," and he wanted to let PCP know what happened.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Blood thyroid stimulating hormone abnormal, Condition aggravated
Clinical narrative: Immediate burning and numbness of entire arm where injection was done. Redness, heat and induration present on entire upper arm. Shortness of breath and coughing from airway swelling, and itching on chest and extremities, decrease in oxygen saturation as shown by pulse ox. Pre treated with Zyrtec due to prior severe reaction and treated with epinephrine and liquid Benadryl at time of reaction onset. After initial reaction was controlled treatment continued with oral steroids and oral Benadryl for a course of 7 days. Joint aches and weakness were present for 2 weeks after vaccination and numbness of arm and hand on the side of the vaccination. GI upset including diarrhea was experienced as well. A fever of 101.2 was noted the night of vaccination and continued off and on for 3 days. 15 days after vaccination, labs drawn by Primary MD showed a TSH of 26, Thyroid panel was normal in Sept of 2015 and no changes had been made to medication prior to the vaccine. Thyroid continues to be unregulated at this time.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Dyspnoea, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate burning and numbness of entire arm where injection was done. Redness, heat and induration present on entire upper arm. Shortness of breath and coughing from airway swelling, and itching on chest and extremities, decrease in oxygen saturation as shown by pulse ox. Pre treated with Zyrtec due to prior severe reaction and treated with epinephrine and liquid Benadryl at time of reaction onset. After initial reaction was controlled treatment continued with oral steroids and oral Benadryl for a course of 7 days. Joint aches and weakness were present for 2 weeks after vaccination and numbness of arm and hand on the side of the vaccination. GI upset including diarrhea was experienced as well. A fever of 101.2 was noted the night of vaccination and continued off and on for 3 days. 15 days after vaccination, labs drawn by Primary MD showed a TSH of 26, Thyroid panel was normal in Sept of 2015 and no changes had been made to medication prior to the vaccine. Thyroid continues to be unregulated at this time.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Immediate burning and numbness of entire arm where injection was done. Redness, heat and induration present on entire upper arm. Shortness of breath and coughing from airway swelling, and itching on chest and extremities, decrease in oxygen saturation as shown by pulse ox. Pre treated with Zyrtec due to prior severe reaction and treated with epinephrine and liquid Benadryl at time of reaction onset. After initial reaction was controlled treatment continued with oral steroids and oral Benadryl for a course of 7 days. Joint aches and weakness were present for 2 weeks after vaccination and numbness of arm and hand on the side of the vaccination. GI upset including diarrhea was experienced as well. A fever of 101.2 was noted the night of vaccination and continued off and on for 3 days. 15 days after vaccination, labs drawn by Primary MD showed a TSH of 26, Thyroid panel was normal in Sept of 2015 and no changes had been made to medication prior to the vaccine. Thyroid continues to be unregulated at this time.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Pruritus, Pyrexia, Swelling, Thyroid disorder
Clinical narrative: Immediate burning and numbness of entire arm where injection was done. Redness, heat and induration present on entire upper arm. Shortness of breath and coughing from airway swelling, and itching on chest and extremities, decrease in oxygen saturation as shown by pulse ox. Pre treated with Zyrtec due to prior severe reaction and treated with epinephrine and liquid Benadryl at time of reaction onset. After initial reaction was controlled treatment continued with oral steroids and oral Benadryl for a course of 7 days. Joint aches and weakness were present for 2 weeks after vaccination and numbness of arm and hand on the side of the vaccination. GI upset including diarrhea was experienced as well. A fever of 101.2 was noted the night of vaccination and continued off and on for 3 days. 15 days after vaccination, labs drawn by Primary MD showed a TSH of 26, Thyroid panel was normal in Sept of 2015 and no changes had been made to medication prior to the vaccine. Thyroid continues to be unregulated at this time.
Age: 72.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in rt. shoulder, deltoid and bicep. Treating with heat, cream. Little relief.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Immediate post-injection reaction, Injection site pain, Liver function test normal
Clinical narrative: Patient developed soreness in her left arm at the site of injection immediately after the vaccine administration. Four days later in the evening, she started having a productive cough and rhinorrhea and was seen in the ED on 1/19, diagnosed with pneumonia at that time. She was treated with a course of levofloxacin, with those symptoms improving. Her arm pain has persisted since then, involving both shoulders.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pneumonia, Productive cough, Red blood cell sedimentation rate normal, Rhinorrhoea
Clinical narrative: Patient developed soreness in her left arm at the site of injection immediately after the vaccine administration. Four days later in the evening, she started having a productive cough and rhinorrhea and was seen in the ED on 1/19, diagnosed with pneumonia at that time. She was treated with a course of levofloxacin, with those symptoms improving. Her arm pain has persisted since then, involving both shoulders.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count normal
Clinical narrative: Patient developed soreness in her left arm at the site of injection immediately after the vaccine administration. Four days later in the evening, she started having a productive cough and rhinorrhea and was seen in the ED on 1/19, diagnosed with pneumonia at that time. She was treated with a course of levofloxacin, with those symptoms improving. Her arm pain has persisted since then, involving both shoulders.
Age: 59.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 5 days post vaccination, client observed an increase in soreness at injection site (left deltoid), redness, inflammation and pain described as burning with tenderness and itchyness. The next morning, client observed spots of inflammation at her left bicep area approximately 4.5 inches at the widest point. the area was red, swollen, warm to the touch but without pain or soreness.
Age: 59.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site warmth
Clinical narrative: 5 days post vaccination, client observed an increase in soreness at injection site (left deltoid), redness, inflammation and pain described as burning with tenderness and itchyness. The next morning, client observed spots of inflammation at her left bicep area approximately 4.5 inches at the widest point. the area was red, swollen, warm to the touch but without pain or soreness.
Age: 78.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal discomfort, Myalgia
Clinical narrative: Injection site very sore and painful, arm restricted movement lasting several days. Recurring discomfort and tenderness in muscle site.
Age: 78.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection site very sore and painful, arm restricted movement lasting several days. Recurring discomfort and tenderness in muscle site.
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Mass, Skin warm, Swelling
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 04 Feb 2015 to correct suspect drug INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE from INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE. Initial unsolicited report received from a non-healthcare professional on 16 October 2015. This case involves a 44-year-old male patient who was vaccinated with a dose of Fluzone ID (batch number: UT5350AA, expiration date: 30 June 2016, dose, dose number were not reported) intradermally in left deltoid on 15 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient did not have illness at time of vaccination. Concomitant medication was not reported. On 15 October 2015, right following the vaccination, the patient developed redness and swelling. The patient came back to the pharmacy the next day and had lump under the skin larger than the golf ball, area is red and hot to touch. Laboratory investigations were reported as none. The patient's corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Mass, Skin warm
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 04 Feb 2015 to correct suspect drug INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE from INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE. Initial unsolicited report received from a non-healthcare professional on 16 October 2015. This case involves a 37-years-old male patient who was vaccinated with a dose of Fluzone ID (batch number: UT5350AA, expiry date: 30 June 2016) intradermally in left deltoid on 15 October 2015. The patient's illness at time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 15 October 2015, few minutes following the vaccination, the patient had developed redness and swelling. On an unknown date (next day of vaccination), following the vaccination, the patient had lump under the skin the size of a golf ball, area is red and hot to touch. Laboratory data was reported as none and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Local reaction, Oedema peripheral, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 20 October 2015. This case was linked to 2015SA169848, 2015SA169859, 2015SA169865 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone QIV (batch number: U5321BA, expiration date: 30 June 2016, dose, dose number, route and site of administration were not reported) on 9 October 2015. The patient's medical history and concomitant medication were not reported.  On an unspecified date following the vaccination, the patient experienced rash and localized reaction. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none. Follow-up information received from a nurse on 22 January 2016. This case involves a 50-year-old Patient who's family history includes heart disease and patient had no history of reaction to the flu vaccine. Patient's concomitant medication includes PAROXETINE, MICROZIDE and LOVASTATIN. On 9 October 2015, same day following the vaccination the patient experienced edema and redness to the left deltoid, patient also reported area became red with pain at injection site and had progressively gotten worse over the weekend. It was reported that patient regularly exercises does self-Brest examination, Mammogram and Pap smear.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Diarrhoea, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Based on additional information received on 28 January 2016, this case got medically confirmed and also initially this case considered as non-serious was upgraded to serious due to important medical events vaccination site cellulitis and swelling arm. Initial unsolicited report received from a consumer on 12 November 2015. This case involves a 78-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number was not reported) intramuscularly on left deltoid and also received a dose of Pneumonia vaccine (batch number, route and site of administration were not reported) on 10 November 2015. The patient's medical history includes seasonal allergies, illness at time of vaccination was reported as none and birth defects, medical conditions were not reported. The patient's concomitant medications were not reported. On 11 November 2015, one day following the vaccination, the patient had experienced swelling in both upper arms but the left deltoid was swollen worsened than the right deltoid, redness, burning sensation and it was hot to touch. The patient had also experienced pain from the deltoid area down the arm to the wrist. The patient felt dizzy and was having bouts of diarrhea. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received Levaquin (once a daily) for one week as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a health care professional on 28 January 2016. It was reported that the patient did not receive any vaccination on 20 January 2016, and stated that patient came to office after receiving both vaccines on 10 November 2015 and it was noted that patient had cellulitis to both injection sites. Patient was treated with depo Medrol 80mg which was given intramuscularly. Patient returned to follow-up on 14 November 2015, and Levaquin was continued for one week. List of documents held by sender: none. Sender's Comments: Vaccination site cellulitis is unexpected after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOCOCCAL VACCINE. Time to onset is compatible with a role of both of the vaccines. Additional information on the complementary investigation results confirming the diagnosis of cellulitis, cleansing of the vaccine injection site, patient medical history (trauma, insect/animal bite, pathologies increasing the risk of cellulitis), as well as identification of the pathogen responsible for the event is needed to further assess this case.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling, Vaccination site cellulitis
Clinical narrative: Based on additional information received on 28 January 2016, this case got medically confirmed and also initially this case considered as non-serious was upgraded to serious due to important medical events vaccination site cellulitis and swelling arm. Initial unsolicited report received from a consumer on 12 November 2015. This case involves a 78-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number was not reported) intramuscularly on left deltoid and also received a dose of Pneumonia vaccine (batch number, route and site of administration were not reported) on 10 November 2015. The patient's medical history includes seasonal allergies, illness at time of vaccination was reported as none and birth defects, medical conditions were not reported. The patient's concomitant medications were not reported. On 11 November 2015, one day following the vaccination, the patient had experienced swelling in both upper arms but the left deltoid was swollen worsened than the right deltoid, redness, burning sensation and it was hot to touch. The patient had also experienced pain from the deltoid area down the arm to the wrist. The patient felt dizzy and was having bouts of diarrhea. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received Levaquin (once a daily) for one week as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a health care professional on 28 January 2016. It was reported that the patient did not receive any vaccination on 20 January 2016, and stated that patient came to office after receiving both vaccines on 10 November 2015 and it was noted that patient had cellulitis to both injection sites. Patient was treated with depo Medrol 80mg which was given intramuscularly. Patient returned to follow-up on 14 November 2015, and Levaquin was continued for one week. List of documents held by sender: none. Sender's Comments: Vaccination site cellulitis is unexpected after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOCOCCAL VACCINE. Time to onset is compatible with a role of both of the vaccines. Additional information on the complementary investigation results confirming the diagnosis of cellulitis, cleansing of the vaccine injection site, patient medical history (trauma, insect/animal bite, pathologies increasing the risk of cellulitis), as well as identification of the pathogen responsible for the event is needed to further assess this case.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code from INFLUENZA VACCINE to INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Initial unsolicited report received from a pharmacist on 17-Nov-2015. This case involves a 75-year-old female patient, who was vaccinated with first dose of 0.5 ml PREVNAR (manufacturer: Wyeth, Batch number: M06899 expiry date: Mar-2017) and first dose of Flu shot (manufacturer: Unknown, Batch number: UI491AA) both via intramuscular route in left arm on 11-Nov-2015 at 14:30. Patient had no illness at the time of vaccination. Patient denied other medications and other medical conditions. Concomitant medication was not reported. It was reported that patient had no adverse event following prior vaccination. On 11-Nov-2015, same day within five minutes after vaccination, patient developed a bump at the PREVNAR injection site which was about the size of a quarter in diameter, rose up to about 1/2 in height and stopped. Patient had also received flu shot an inch away from the PREVNAR injection site and the patient had no reaction to the flu shot injection. Laboratory investigation and corrective treatment was not reported. At the time of this report patient was recovering from the event. Documents held by sender: none. Addendum on 5-Feb-2016: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code from 'INFLUENZA VACCINE' to 'INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE'.
Age: 26.0
Sex: F
Vaccine: HEP, HIBV, IPV, PNC13, TD
Symptoms: Expired product administered, Nausea, Vomiting
Clinical narrative: Initial unsolicited misuse report received from a nurse on 29 January 2016. This case involves a 26-year-old female patient who was vaccinated with an intramuscular dose TENIVAC (batch number U4669AA, expiration date 10 January 2016), in the right thigh, an intramuscular dose of ACTHIB (batch number UI278AA, expiry date 29-MAY-2016) in right deltoid, an intramuscular dose IPOL (batch number K1649-1, expiry date 15 November 2016) in left deltoid, HEP B in right thigh, PREVNAR 13 (batch number M35763) in right deltoid all on 28 January 2016. The patient did not had illness at time of vaccination. Patient had history of cancer, bone marrow transplant. Concomitant medications were not reported. On 28 January 2016, few hours "same day at evening" following the vaccination, the patient developed nausea and vomiting. It was also an expired vaccine used case, as Tenivac was an expired product. Lab data was reported as none. Corrective treatment was reported as unknown. Outcome of event was not recovered. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Peripheral swelling, Ultrasound Doppler normal
Clinical narrative: Cellultis left upper outer arm, starting at site where PPSV23 given on 2/3/15. Cellulitis migrated down arm and on 2/9/16 only had a ring of slight redness and swelling on left forearm about 2 inches above wrist.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb normal
Clinical narrative: Cellultis left upper outer arm, starting at site where PPSV23 given on 2/3/15. Cellulitis migrated down arm and on 2/9/16 only had a ring of slight redness and swelling on left forearm about 2 inches above wrist.
Age: 1.83
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Acute disseminated encephalomyelitis, Hypophagia, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal, Pyrexia
Clinical narrative: Fever, Decreased PO intake which started on 1/11/16. Finally diagnosed with Acute Disseminated Encephalomyelitis.
Age: 1.83
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Venogram normal
Clinical narrative: Fever, Decreased PO intake which started on 1/11/16. Finally diagnosed with Acute Disseminated Encephalomyelitis.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Musculoskeletal chest pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Body aches and pains back neck shoulder ribs x3 days. Narco not helping, today ibuprofen, Tylenol, codeine.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Felt 'light-headed', sat down on chair, turned pale, LOC, jerking movement of extremities for 5-10 seconds. Patient lay down on examining table, received blow-by O2, regained consciousness 5 minutes later.  Continued to be supine for the next 10 minutes.  Drank coconut juice (4oz). Vitals stable. Self-ambulate out of clinic without incident. Patient states that she had not eaten nor drink since previous night.
Age: 0.17
Sex: F
Vaccine: DTPIHI, MNQ, RV1
Symptoms: Irritability, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fussiness, nausea, vomit, fever, pain and body aches.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Dizziness, Headache
Clinical narrative: Nausea, stomach pain, headache, lightheadedness, dizziness.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Nausea, Urine analysis
Clinical narrative: Nausea, stomach pain, headache, lightheadedness, dizziness.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: Worsening pain at injection site beginning directly after vaccination increasing to flu-like symptoms of body aches, lethargy, and fever for 24-36 hours.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Acupuncture, Injection site pain, Pain
Clinical narrative: My arm and shoulder where the shot was given began to hurt, which I thought was normal, until, over the next few weeks, the pain became excruciating, and I couldn't move it without intense pain.  Acupuncture (12/22?) took the pain down from a 10 to a 3, but then it started increasing again over the next few days.  Now, almost 2.5 months later, although the pain has decreased, it still hurts with a number of different movements, including trying to remove shirts.  I actually can't use it to disrobe; I can barely put pressure from my right arm to lift my left arm for this task.  This is completely ridiculous.  I am never getting another flu shot again.  Just for the record, I believe the pharmacist administering it did the best job she could, and I don't feel she was negligent.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acupuncture, Injection site pain, Pain
Clinical narrative: My arm and shoulder where the shot was given began to hurt, which I thought was normal, until, over the next few weeks, the pain became excruciating, and I couldn't move it without intense pain.  Acupuncture (12/22?) took the pain down from a 10 to a 3, but then it started increasing again over the next few days.  Now, almost 2.5 months later, although the pain has decreased, it still hurts with a number of different movements, including trying to remove shirts.  I actually can't use it to disrobe; I can barely put pressure from my right arm to lift my left arm for this task.  This is completely ridiculous.  I am never getting another flu shot again.  Just for the record, I believe the pharmacist administering it did the best job she could, and I don't feel she was negligent.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Influenza like illness, Injection site pain, Lethargy, Pain
Clinical narrative: Worsening pain at injection site directly after vaccination and increasing to flu-like symptoms of body aches, fever, head ache, and lethargy.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Worsening pain at injection site directly after vaccination and increasing to flu-like symptoms of body aches, fever, head ache, and lethargy.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever on third day after receiving vaccine that improved, but was followed by intermittent episodes of generalized body rash that has continued though today, 2/9/2016.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Broke out with chicken pox bumps on neck and back and chest.
Age: 0.22
Sex: M
Vaccine: DTAP
Symptoms: Death, Eye movement disorder, Meningitis bacterial
Clinical narrative: Had to wait in waiting room because of my sons eyes rolling in back of head after shot.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injury, Joint injection, Pain, Periarthritis
Clinical narrative: Shortly after receiving the vaccine I noticed it was very painful to move my arm...when I got up the next morning to shower the pain was so severe to take clothes off and wash my hair that I was in tears....I have received the flu shot for many years before without any pain and thought it was just sore...but, the pain continued and I went to orthopedic clinic on December 4, 2015. I was seen by Dr's assistant. She did an x-ray of my shoulder and said the findings were normal, and gave me a cortisone injection in my shoulder, prescribed Piroxicam 20 mg, and sent me to clinic for therapy. I was diagnosed with a frozen shoulder from acute trauma. I have more movement now in my arm, but I still cannot take off or put on clothes over my head without pain...and I have limited arm movement, going from left to right and it can only be done with pain. I am trying to exercise my arm more...but, the nights I go to exercise class, the next morning I have more pain in my shoulder than normal. I am an avid golfer....and I am wondering now, if I will event be able to play again.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: Shortly after receiving the vaccine I noticed it was very painful to move my arm...when I got up the next morning to shower the pain was so severe to take clothes off and wash my hair that I was in tears....I have received the flu shot for many years before without any pain and thought it was just sore...but, the pain continued and I went to orthopedic clinic on December 4, 2015. I was seen by Dr's assistant. She did an x-ray of my shoulder and said the findings were normal, and gave me a cortisone injection in my shoulder, prescribed Piroxicam 20 mg, and sent me to clinic for therapy. I was diagnosed with a frozen shoulder from acute trauma. I have more movement now in my arm, but I still cannot take off or put on clothes over my head without pain...and I have limited arm movement, going from left to right and it can only be done with pain. I am trying to exercise my arm more...but, the nights I go to exercise class, the next morning I have more pain in my shoulder than normal. I am an avid golfer....and I am wondering now, if I will event be able to play again.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling at injection site. Documented latex allergy. Counseled pt to take BENADRYL and ibuprofen and see if sx's decrease. If not in 2+ days check with PCP for possible cellulitis.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan, Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient notified pharmacy on 2/9/16. Experienced enlarged and painful lymph nodes under armpits. MD was notified and informed patient that side effect is possible. Patient did not receive treatment and symptoms resolved after 2 weeks.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Patient came to pharmacy about 2 months later and said that arm still sore. About Jan. 4th she contacted store mgr and said in severe pain, and had nerve damage to her arm.
Age: 1.02
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Rash
Clinical narrative: Child has had repeated episodes of rash with all vaccines 24-48 hr after vaccine again. Mother reported this to MD on 2/5/16.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: MEA
Symptoms: Influenza
Clinical narrative: Information has been received from a pharmacist concerning a 44 year old female therapist who had had chickenpox 3 times as a child. In approximately 1996, the patient was vaccinated with a dose of measles virus vaccine, live (manufacturer unknown). On an unknown date, 1 week within vaccination the patient got the flu. Patient's outcome was not reported. Relationship between flu and vaccination with measles virus vaccine, live (manufacturer unknown) was not reported. This report is linked to MARRS 1502USA004907 from the same patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 04-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot # K026246 and expiration date 28-JAN-2017, exact dose and route of administration were not reported). On 08-OCT-2015, the patient was vaccinated with a dose of GARDASIL (lot # L031245 and expiration date 27-MAY-2016, exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly-stored dose (at 6 Fahrenheit (F) for 4 hours, because of data logger) of ZOSTAVAX, lot # L032184, expiry date 25-NOV-2016, one dose, (route of administration and frequency not reported). Previous temperature excursions was reported as 7 F for 5 hours. No adverse event (adverse symptoms) was reported. The outcome of events was unknown. Reporter inquired about vaccine stability following a temperature excursion. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 68 year old female patient. The patient's pertinent medical history included ulcerative colitis. The patient's drug reactions or allergies and concomitant medications were not specified. On an unknown date, the patient was vaccinated with a single dose of ZOSTAVAX (lot # and expiration date were not reported), 0.65 ml, subcutaneously. On an unknown date, the patient was diagnosed with cellulitis in her arm where she received the ZOSTAVAX injection. It was reported that the patient sought medical attention, she contacted her physician and unspecified antibiotics were given to her at the urgent care center. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. on 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to two 1 month old unspecified twin patients. The patients' pertinent medical history and concurrent conditions were not reported. On 03-FEB-2016, the patients were vaccinated with VAQTA 25/0.5 ml (dose, route of administration, lot number and expiration date were not provided). The patient's concomitant medications were not reported. At the time of the report, no adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration ate 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.