chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Scratch
Clinical narrative: Suspicious of cellulitis; Skin reaction that included, swelling; Skin reaction that included, swelling, pain; Skin reaction that included, swelling, pain, redness; Skin reaction that included, swelling, pain, redness and streaks; Injection site reactions presented with red streaks; This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   In August 2020, the patient received the 2nd dose of Bexsero. In August 2020, 1 day after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim) and antibiotics nos (Antibiotic (Details Unknown)). Rechallenge with Bexsero was positive. On an unknown date, the outcome of the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion were recovering/resolving.   It was unknown if the reporter considered the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion to be related to Bexsero.  Addiotional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero last week before date of reporting, and experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The reporter stated that, the patient treated with Bactrim sent home with antibiotics and has not contacted the doctor since. The doctor commented that the patient hdas never seen this type of reaction and that this patient never had issues with other vaccines. The reporter consented to follow up. For the tollerence of 1st dose refer case US2020AMR160420, reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160534:FU1 deleted US-GLAXOSMITHKLINE-US2020AMR160420:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: rash / spreading rash for 2 weeks; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient developed a shingles like rash (2 spots and spread over 4 weeks) noted to 6th cervical nerve area on the side of her neck down to her clavicle.   The patient continued to observe a spreading rash for 2 weeks after on her face and down the arm.  The reporter was consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. A couple of years ago, the patient had flu like symptoms and went to emergency. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Antibody test negative, Back pain, Chest X-ray normal, Crying, Gait inability
Clinical narrative: On 08/11 patient awoke with pain at 4am crying about his legs, buttocks,back and shoulders were hurting.  3 hours later he couldn't walk, I then take him to hospital ER the same day, they ran tests on him and sent us back home with hydrocodone for pain and told me if it worsens to bring him back. Thursday morning had to bring him back to the ER at Hospital and they had to admit him for a day, he had a fever and still in pain. They wanted to run more test on him and monitor him, so we stayed overnight until 08/14. We're back home with more pain medicine and he's still in the same condition. It hurts for him to walk, sit and lay down.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia, Reticulocyte percentage increased
Clinical narrative: On 08/11 patient awoke with pain at 4am crying about his legs, buttocks,back and shoulders were hurting.  3 hours later he couldn't walk, I then take him to hospital ER the same day, they ran tests on him and sent us back home with hydrocodone for pain and told me if it worsens to bring him back. Thursday morning had to bring him back to the ER at Hospital and they had to admit him for a day, he had a fever and still in pain. They wanted to run more test on him and monitor him, so we stayed overnight until 08/14. We're back home with more pain medicine and he's still in the same condition. It hurts for him to walk, sit and lay down.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pain in extremity, Syncope
Clinical narrative: Patient was in office for checkup received tdap, menveo and HPV. vaccines were given while Dr was still in room. shortly after MA walked out patient was left in room with dr and parent, patient began to feel dizzy and nauseous shortly after fainted. Patient was laying down at time of shots, and when fainted. BP and pulse was rechecked 3x, patient was monitored overall for 30min cold compress where also applied to arm as patient mentioned his arm was sore. Patient was then discharged by doctor in stable condition.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient reported feeling nauseous, arm swelling, hot to touch, joint aches, etc about 12 hours after vaccine. The next day she started to feel better but her arm was significantly swollen. She came into the store on Monday 8/17/20 (3 days after vaccine) and her arm was still very swollen, itchy, and hot and moving down her arm past her elbow.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: itching as if it were a mosquito bite for about one hour. Self-resolved.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: Received injection 11:40 A.M. At 5:00 P.M started  to experience malaise, chills 7:00 P.M. low grade fever spiking at 99.9 degree F By 10:00 P.M. next  morning general weakness & malaise. Event lasted about 36 hours.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Episodes of Vomiting  Treatment with Zofran PRN
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site vesicles
Clinical narrative: Pt's mom contacted office on 08/07/20, report pt has bLister on (R) thigh, unsure if rxn to vaccine or not. BLister is about 1 cm from injection site, pt. seems to be unaware of bLister, ~ 1/4 size of a penny. Improving by the next day, now using antibiotic ointment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Inflammation, Injection site rash
Clinical narrative: Rash on right thigh - started on Day 2 S/P DTAP-IPV. Suspect cellulitis vs inflammatory reaction to vaccine.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: SHINGLES (HERPES ZOSTER) - JULY 13, 2020  PAIN, ITCHING, BLISTERS  PRESCRIBED VALTREX 1 gram tablet BID - ONE PILL 3 TIMES A DAY FOR 7 DAY  BASICALLY CLEARED IN 3 weeks with one remaining blister  SHINGRIX - DOSE 1 - 10/22/18 LEFT ARM  DOSE 2 - 1/28/19 LEFT ARM  VARICELLA (HERPES ZOSTER) ZOSTAVAX  2011
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Extreme Fatigue starting day of shot + following day; went to bed @ 6 PM. Arm sore (injection site); some shivers; felt headache like fever but did not have latter. *For more than a week, my chest felt like it was being sat on + breasts were sore especially on right side. (July breast MRI normal). Last side effect was unusual prompting me to call provider + breast center  Do not have specific details like manufacturer, lot #, route, usually this isn't given to patients. Took time to contact my primary care provider, Dr., since she ordered taking SHINGRIX new series. (I had the old shingles shot some years back) This new incarnation was to provide better protection. Because the soreness was also in chest/breast area ofF + on for over a week, called my provider @ Breast Institute. Recent July MRI showed normal. Thank you!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Magnetic resonance imaging breast normal
Clinical narrative: Extreme Fatigue starting day of shot + following day; went to bed @ 6 PM. Arm sore (injection site); some shivers; felt headache like fever but did not have latter. *For more than a week, my chest felt like it was being sat on + breasts were sore especially on right side. (July breast MRI normal). Last side effect was unusual prompting me to call provider + breast center  Do not have specific details like manufacturer, lot #, route, usually this isn't given to patients. Took time to contact my primary care provider, Dr., since she ordered taking SHINGRIX new series. (I had the old shingles shot some years back) This new incarnation was to provide better protection. Because the soreness was also in chest/breast area ofF + on for over a week, called my provider @ Breast Institute. Recent July MRI showed normal. Thank you!
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Anosmia, Computerised tomogram, Dizziness, Headache
Clinical narrative: After 2 weeks got sick with Headache, nasua, dizzyness, neck pain, sleepness, Loss of smell & taste, Physicl Therapy
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging, Malaise, Nausea, Neck pain, Somnolence
Clinical narrative: After 2 weeks got sick with Headache, nasua, dizzyness, neck pain, sleepness, Loss of smell & taste, Physicl Therapy
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: After 2 weeks got sick with Headache, nasua, dizzyness, neck pain, sleepness, Loss of smell & taste, Physicl Therapy
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Endoscopy, Headache, Musculoskeletal stiffness, Neck pain, Sensory loss
Clinical narrative: After 2 weeks got sick with Headache, nasua, dizzyness, neck pain, sleepness, Loss of smell & taste, Physicl Therapy
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Feeling hot, Nausea
Clinical narrative: an anaphylactic reaction to Fluzone HD; extremely severe reaction of shortness of breath; very hot; palpitations; nausea; room was spinning; dizzy and holding on to the wall; Initial information received on 06-Aug-2020 regarding an unsolicited valid serious case from consumer/non-healthcare professional (patient).  This case involves a 75 years old female patient who had an anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had ongoing history of minor allergy to penicillin and Crestor drug. The patient's past medical treatment(s), vaccination(s), concomitant therapy and family history were not reported.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Injection, batch number and expiration date not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious an  anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness) , within 12 hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This 75 years old female patient developed anaphylactic reaction, 12 hours (as reported) after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Although the time to onset is compatible, there is no information regarding patient's medical condition at the time of vaccination, concomitant therapies, past vaccination and its tolerance and relevant lab tests. Thus, a causal role of the vaccine could not be assessed.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Palpitations, Vertigo
Clinical narrative: an anaphylactic reaction to Fluzone HD; extremely severe reaction of shortness of breath; very hot; palpitations; nausea; room was spinning; dizzy and holding on to the wall; Initial information received on 06-Aug-2020 regarding an unsolicited valid serious case from consumer/non-healthcare professional (patient).  This case involves a 75 years old female patient who had an anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had ongoing history of minor allergy to penicillin and Crestor drug. The patient's past medical treatment(s), vaccination(s), concomitant therapy and family history were not reported.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Injection, batch number and expiration date not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious an  anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness) , within 12 hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This 75 years old female patient developed anaphylactic reaction, 12 hours (as reported) after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Although the time to onset is compatible, there is no information regarding patient's medical condition at the time of vaccination, concomitant therapies, past vaccination and its tolerance and relevant lab tests. Thus, a causal role of the vaccine could not be assessed.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Myalgia, Nausea
Clinical narrative: an anaphylactic reaction to Fluzone HD; extremely severe reaction of shortness of breath; very hot; palpitations; nausea; room was spinning; dizzy and holding on to the wall; Initial information received on 06-Aug-2020 regarding an unsolicited valid serious case from consumer/non-healthcare professional (patient).  This case involves a 75 years old female patient who had an anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had ongoing history of minor allergy to penicillin and Crestor drug. The patient's past medical treatment(s), vaccination(s), concomitant therapy and family history were not reported.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Injection, batch number and expiration date not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious an  anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness) , within 12 hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This 75 years old female patient developed anaphylactic reaction, 12 hours (as reported) after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Although the time to onset is compatible, there is no information regarding patient's medical condition at the time of vaccination, concomitant therapies, past vaccination and its tolerance and relevant lab tests. Thus, a causal role of the vaccine could not be assessed.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Throat tightness, Vomiting
Clinical narrative: an anaphylactic reaction to Fluzone HD; extremely severe reaction of shortness of breath; very hot; palpitations; nausea; room was spinning; dizzy and holding on to the wall; Initial information received on 06-Aug-2020 regarding an unsolicited valid serious case from consumer/non-healthcare professional (patient).  This case involves a 75 years old female patient who had an anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient had ongoing history of minor allergy to penicillin and Crestor drug. The patient's past medical treatment(s), vaccination(s), concomitant therapy and family history were not reported.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Injection, batch number and expiration date not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date in 2016, the patient developed a serious an  anaphylactic reaction with the symptoms of an extremely severe reaction of shortness of breath (dyspnoea), very hot (feeling hot), palpitations, nausea, room was spinning (vertigo) and dizzy and holding on to the wall (dizziness) , within 12 hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This 75 years old female patient developed anaphylactic reaction, 12 hours (as reported) after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Although the time to onset is compatible, there is no information regarding patient's medical condition at the time of vaccination, concomitant therapies, past vaccination and its tolerance and relevant lab tests. Thus, a causal role of the vaccine could not be assessed.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered Menactra that was expired by one day/No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown age and gender) who was vaccinated with expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered)  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to expired vaccine used. Vaccine was expired by one day.  Reporter stated that patient was set to come in and get re-administered but delayed.   At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Extensive swelling of vaccinated limb, Injection site pain, Pruritus
Clinical narrative: Patient experienced large swelling in her left arm and the injection site became very painful 4-5 hours after receiving her 2nd dose of SHINGRIX. Her entire body was itching and it came very uncomfortable.  Patient thought it was a normal adverse reaction and try to put up with it but later that night it became worse and she decided to go to emergency room (ER). ER gave her high steroids dose (Prednisone) and BENADRYL. She stopped back the next morning to drop off prescription for BENADRYL 50 mg taper instructions for Prednisone 20 mg.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine. No symptoms reported.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired Afluria Quadrivalent vaccine.  Vaccine expired on 30 Jun 2020.  Patient denied any adverse reactions at this time.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TD, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a pediatric dose of vaccines Hep A and Hep B.  Patient is over the age for pediatric vaccines.  Patient will have to come back to clinic at his earliest convenience to be re-vaccinated.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Aversion, Condition aggravated, Obsessive-compulsive disorder
Clinical narrative: Vast increase in OCD symptoms, school aversion . Patient should not have received this test, even though he is over 18, he worked at that pharmacy and they told him to take it. He felt it was ok, because "everyone was taking it", but everyone DOES NOT react the way he does to vaccines, having suffered for years from the HPV vaccine he took years earlier.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient came to the pharmacy and indicated that she could not move her left arm. she states that it was after the immunization was given and believes that it was due to the vaccine
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: menveo was inadvertent given at the wrong time.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: The patient got dizzy and fainted about 5 minutes after getting the flu shot.  He was fine immediately following the immunization, but after walking out of the room he got lightheaded and passed out.  He was only out for a few seconds, but fell and hit his head.   The patient appeared to be lightheaded and pale after fainting, but was responsive and could answer questions clearly.  The patient got his vitals checked and everything was within normal range.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: The patient got dizzy and fainted about 5 minutes after getting the flu shot.  He was fine immediately following the immunization, but after walking out of the room he got lightheaded and passed out.  He was only out for a few seconds, but fell and hit his head.   The patient appeared to be lightheaded and pale after fainting, but was responsive and could answer questions clearly.  The patient got his vitals checked and everything was within normal range.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Initially developed arm soreness about 3-4 hours post vaccination.   8 hours post vaccination developed chills, fatigue, nausea, low grade temperature.   Very restless night sleeping.    The following morning symptoms continued until 12pm, then started to feel better. That evening (day1 post- vaccination) developed non-itchy maculopapular rash on trunk, thighs and upper arms.   Rash lasted that for 24 hrs.   Injection site was red, warm and sore for many days post-vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Initially developed arm soreness about 3-4 hours post vaccination.   8 hours post vaccination developed chills, fatigue, nausea, low grade temperature.   Very restless night sleeping.    The following morning symptoms continued until 12pm, then started to feel better. That evening (day1 post- vaccination) developed non-itchy maculopapular rash on trunk, thighs and upper arms.   Rash lasted that for 24 hrs.   Injection site was red, warm and sore for many days post-vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Initially developed arm soreness about 3-4 hours post vaccination.   8 hours post vaccination developed chills, fatigue, nausea, low grade temperature.   Very restless night sleeping.    The following morning symptoms continued until 12pm, then started to feel better. That evening (day1 post- vaccination) developed non-itchy maculopapular rash on trunk, thighs and upper arms.   Rash lasted that for 24 hrs.   Injection site was red, warm and sore for many days post-vaccination.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: Patient was given the menactra, bexsero, and hpv vaccine while at our office for her annual well check-up. She received her vaccines around 2:30 pm, and started to feel dizziness and started vomiting around 4pm that same day.  She vomited 4-5 times that day, 8/12/2020. She started to feel a bit better the next day but was feeling very tired.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Headache, Injection site rash, Nausea, Pyrexia
Clinical narrative: Patient was given the vaccine around 10 am on 8/12/2020. She waited 10-15 minutes before standing up and leaving our office. Approximately 2 hours later, that day, she started feeling "sick to her stomach." The following day, 8/13/20, she developed a fever of 103, a headache and an extreme rash on her left upper arm. She was seen as a curbside visit by Dr. for her symptoms. To my knowledge, the patient is recovering.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Pruritus, Skin warm, Tenderness
Clinical narrative: sore, warm, redness, soreness, tenderness, itchiness Keep skin cool and dry.  May do cool compresses Aveeno oatmeal bath/lotion Start medrol today, follow instructions Benadryl/zyrtec as needed for breakthrough itching Topical hydrocortisone as needed Follow up if symptoms worsen or persist Advised to not take second vaccine
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: The patient was given a KINRIX vaccine that expired on 6/2/20.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Patient had swollen Lymph node of her  right arm pit (opposite of vaccinated arm).
Age: 18.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was nervous about vaccine. Has history of vasovagal syncope. Patient sat down in the waiting room after vaccines. We noticed he wasn't looking well/ starting to pass out. I went out and started trying to wake him up. Shook shoulder then did sternal rub. Patient came to very quickly. We called 911 just to be safe. Got him some cold water for the back of his neck and an ice pack. He was feeling much better by the time EMS arrived. They checked him out. We had him stick around for awhile and walk around the store before he left.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis developed; admitted to hospital for IV antibiotics
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site warmth, Middle insomnia, Pain, Pain in extremity
Clinical narrative: Started with heat at the injection site, mild soreness when lifting arm,but withing 24 hours could not lay on that side, can not lift arm above shoulder ,pain wakes patient at night , Ice helps most . Today, 8/17 , the pain is the same, unable to lift her arm above her shoulder.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Pt had mild generalised rash over body.
Age: 43.0
Sex: F
Vaccine: FLUA3
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled. Swelling did not go down till 8/13/2020. 10 days later.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Patient states the day after the vaccine she developed a red, itchy, and warm rash around the injection site.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Decreased appetite, Influenza like illness, Lethargy, Myalgia, Nausea
Clinical narrative: Pt experienced flu like symptoms, nausea, loss of appetite, muscle aches, lethargy, fever blisters on face.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Oral herpes
Clinical narrative: Pt experienced flu like symptoms, nausea, loss of appetite, muscle aches, lethargy, fever blisters on face.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: severe allergy reaction with hives. Treated by doctor with inyection and cream .Two weeks later I still have hives.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Second dose of Shingrix administered on 8/15/20, pt reported having normal pain at injection site that day, but placed cold compress on arm at that time.  Pt woke up on 8/16/20 and indicated that she had a fever of 99.7, and now had a red splotchy area  around the injection site.  Pt took Motrin and temp went down to 98.2.  Pt reported temp now gone, but red splotchy area has gotten larger and is moving down the arm.  Recommended she contact her physician and call us when done.  Follow up message left for pt to call us back.  Pt reported not having this reaction with her first dose of Shingrix 5/2020.
Age: 73.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient experienced swollen and red arm taking up approximately 2/3 of upper arm
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Intussusception, Lethargy, Procedural failure, Small intestinal resection
Clinical narrative: Intussusception with symptoms of vomiting and lethargy on 6/23 with admission to hospital.  Unsuccessful reduction by enema on 6/24/20 and transferred to hospital and open reduction with resection of 15 cm of small bowel.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Intussusception with symptoms of vomiting and lethargy on 6/23 with admission to hospital.  Unsuccessful reduction by enema on 6/24/20 and transferred to hospital and open reduction with resection of 15 cm of small bowel.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: I was given the Shingrix vaccine in the late morning.  By about 7pm I was feeling unwell with fever, severe headache, shivering, pain at injection site, nausea, and tired.  This continued the entire next day and I stayed in bed all day.  I finally was able to take an aspirin (too nauseous up to this point)  the following evening which helped the headache some.  The second day, I was still weak, but able to get out of bed. I could not eat much until the third day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: I was given the Shingrix vaccine in the late morning.  By about 7pm I was feeling unwell with fever, severe headache, shivering, pain at injection site, nausea, and tired.  This continued the entire next day and I stayed in bed all day.  I finally was able to take an aspirin (too nauseous up to this point)  the following evening which helped the headache some.  The second day, I was still weak, but able to get out of bed. I could not eat much until the third day.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pruritus, Lip swelling, Pruritus, Swelling
Clinical narrative: patient developed itchy, swollen lips and torso over the course of the day- problem persisted for about 4 days
Age: 61.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Decreased appetite, Fatigue, Nodule, Pyrexia
Clinical narrative: fever for 7 days/ no appetite/ fatigue/ knot on arm the size of golf ball
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity, Pruritus
Clinical narrative: very sore arm, shoulder and neck.  Hard to lift arm , itching
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient states she developed a rash the next day after receiving Shingrix and Flublok vaccinations Advised patient to proceed to ER for further evaluation
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Patient states he was having hearing complications the following day after the vaccine. Sounded like the wind or a tornado was coming through he stated.  Lasted for 20 minutes.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Flushing, Hyporesponsive to stimuli, Mydriasis, Pallor
Clinical narrative: Post vaccination, pt became less responsive. Eyes were still open and patient still verbally responding to questions. Pt unable to give eye contact, pupils appeared dilated. Pt began to feel clammy, appeared pale. Assisted pt to wheelchair with MA. Pt's face appeared flush and pt became responsive again. Pt was provided cool juice and cold water. Pt brought to room 16 to lie down. Dr. notified of pt situation. Orthostatics completed. Dr. seen pt at bedside to discuss pt status and plan. Advised pt to continue to stay hydrated and to call SHC with any continuing worsening symptoms or concerns. Pt verbalized understanding.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia, Tinnitus
Clinical narrative: Swelling at the site that lasted a week, mild fever, and SEVERE RINGING IN THE EAR
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Condition aggravated, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Within a few hours, headache and body aches started, fever increased. By 1am the morning of 8/15 (14 hours after injection, fever was over 102 with nausea. By 8am on the morning of 8/15, the fever was over 103, breaking with Tylenol but spiking by the four hour mark after Tylenol. Body aches and headache continued through the day with no appetite and onset of diarrhea. Nausea off and on through the day. Sunday, 8/16, almost fainted after a shower, lightheaded and dizzy. Start of red spots at bra line under breasts first noted. Fever spiked over 104 overnight the morning of 8/17. Red spots increased all over torso, up neck and face, breathing started to feel restricted, chest tight.  Took Benedryl at 4:30pm and again at 9:30pm to help control the red spots. Fever, severe diarrhea and nausea continue at the time of completing this form.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Headache, Nausea, Pain, Presyncope
Clinical narrative: Within a few hours, headache and body aches started, fever increased. By 1am the morning of 8/15 (14 hours after injection, fever was over 102 with nausea. By 8am on the morning of 8/15, the fever was over 103, breaking with Tylenol but spiking by the four hour mark after Tylenol. Body aches and headache continued through the day with no appetite and onset of diarrhea. Nausea off and on through the day. Sunday, 8/16, almost fainted after a shower, lightheaded and dizzy. Start of red spots at bra line under breasts first noted. Fever spiked over 104 overnight the morning of 8/17. Red spots increased all over torso, up neck and face, breathing started to feel restricted, chest tight.  Took Benedryl at 4:30pm and again at 9:30pm to help control the red spots. Fever, severe diarrhea and nausea continue at the time of completing this form.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Within a few hours, headache and body aches started, fever increased. By 1am the morning of 8/15 (14 hours after injection, fever was over 102 with nausea. By 8am on the morning of 8/15, the fever was over 103, breaking with Tylenol but spiking by the four hour mark after Tylenol. Body aches and headache continued through the day with no appetite and onset of diarrhea. Nausea off and on through the day. Sunday, 8/16, almost fainted after a shower, lightheaded and dizzy. Start of red spots at bra line under breasts first noted. Fever spiked over 104 overnight the morning of 8/17. Red spots increased all over torso, up neck and face, breathing started to feel restricted, chest tight.  Took Benedryl at 4:30pm and again at 9:30pm to help control the red spots. Fever, severe diarrhea and nausea continue at the time of completing this form.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RECEIVED FLUAD VACCINE ON AUGUST 13TH IN THE EVENING. PATIENT RECEIVED FLUAD ON LEFT ARM AND PREVNAR 13 ON RIGHT ARM .  PATIENT HAD HIGH FEVER AT MIDNIGHT SAME DAY. HE FELT BETTER NEXT DAY. HIGH FEVER WAS ON AND OFF FOR NEXT 3 DAYS.  (FEVER RANGE# 102.5 TO 101 ) PATIENT'S LEFT ARM WERE FLUAD  INJECTION WAS GIVE WAS RED , SWOLLEN AND WARM TO TOUCH IT. PATIENT HAD MILD PAIN AND ITCHING AT INJECTION SITE.  PATIENT'S  PCP PRESCRIBED HIM AMOXIL AND BENADRY ON AUGUST 17 TH AT 8:04 PM AND HE HAS FOLLOW UP APPOINTMENT WITH PCP DR NEXT DAY.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: PATIENT RECEIVED FLUAD VACCINE ON AUGUST 13TH IN THE EVENING. PATIENT RECEIVED FLUAD ON LEFT ARM AND PREVNAR 13 ON RIGHT ARM .  PATIENT HAD HIGH FEVER AT MIDNIGHT SAME DAY. HE FELT BETTER NEXT DAY. HIGH FEVER WAS ON AND OFF FOR NEXT 3 DAYS.  (FEVER RANGE# 102.5 TO 101 ) PATIENT'S LEFT ARM WERE FLUAD  INJECTION WAS GIVE WAS RED , SWOLLEN AND WARM TO TOUCH IT. PATIENT HAD MILD PAIN AND ITCHING AT INJECTION SITE.  PATIENT'S  PCP PRESCRIBED HIM AMOXIL AND BENADRY ON AUGUST 17 TH AT 8:04 PM AND HE HAS FOLLOW UP APPOINTMENT WITH PCP DR NEXT DAY.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Rhinorrhoea
Clinical narrative: Runny nose Chills Bad headache
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Local reaction, Vaccination site pain, Vaccination site papule, Vaccination site warmth
Clinical narrative: 36 hrs after vaccine, local reaction of redness 4 inch oval, warmth, tenderness, resolved after 36 hrs to just small pink papule at vaccine site. use Motrin, ice prn
Age: 2.5
Sex: M
Vaccine: HEPA
Symptoms: Dysstasia, Injection site pain, X-ray limb normal
Clinical narrative: L knee pain can't stand on it, crawling 8/15/2020
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient had rash and swelling in left arm (flu shot high dose)
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with swollen and red left arm from injection site down to elbow. Was hot to the touch and painful. Started immediately after vaccination, unknown resolution date. Had Televisit with MD who advised ice, Advil and Benadryl. Symptoms were starting to improve when she came into the pharmacy the following afternoon.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: uticaria to face, neck, upper extremities, thorat; itchy rash; This spontaneous report has been received from a vaccine provider via Food And Drug Administration (agency # 825004) on 14-JUL-2020 referring to a 12-year-old male patient. The patient did not have any adverse event follow prior vaccinations. He did not receive any other vaccination within prior 4 weeks. He was not ill at the time of the vaccination. No information regarding other medications and concurrent conditions was reported.   On 22-JUL-2019 at 12:00 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, in the left arm (lot # R020948, expiration date was not reported, but upon internal validation established as 04-MAY-2021; dose was not reported) for prophylaxis.  On 22-JUL-2019 at 15:45, the patient experienced urticaria to face, neck, upper extremities and throat. He had itchy rash. Diphenhydramine hydrochloride (BENADRYL) was given and the patient was observed for 2 hours in clinic. The rash and itching were subsided. On 22-JUL-2019 (at the time of the report), the patient recovered from the events.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information was received from a physician on 30-JUL-2020. Not enough information was provided to perform the report. No no new clinical information was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020948; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: pain in deltoid at time of injection, persisting pain and decreased mobility the next several months.  finally improving with time and acupuncture the past couple of weeks. Pain affecting movement of arm, sleep, exercise. symptoms severe and persisting for months. Did receive 2nd shingrix in January 2020 and had no symptoms after this.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain, X-ray limb abnormal
Clinical narrative: pain in deltoid at time of injection, persisting pain and decreased mobility the next several months.  finally improving with time and acupuncture the past couple of weeks. Pain affecting movement of arm, sleep, exercise. symptoms severe and persisting for months. Did receive 2nd shingrix in January 2020 and had no symptoms after this.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: PATIENT DEVELOPED A RASH ON THE AREA OR A LITTLE BELOW THE AREA WHERE SHE RECEIVED THE SHOT. PT STATED IT DOES NOT ITCH BUT WAS TENDER THE NEXT DAY.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Exposure via eye contact, Product container issue
Clinical narrative: She states the "infant did not seemed bothered" and the mother wiped his eye with a bib./ She did not note any redness in his left eye.; the medicine started to squirt in the patients left eye; the medicine started to squirt in the patients left eye; The medicine sprayed from the "neck of the bottle, where it twists"/ she belives there may be a small hole in the bottle /it was a "pinpoint" and she cannot see the hole /Liquid was leaking out once pressure was applied.; As she was giving ROTATEQ/ The medicine sprayed from the "neck of the bottle, where it twists"/ she belives there may be a small hole in the bottle /it was a "pinpoint" and she cannot see the hole /Liquid was leaking out once pressure was applied.; This spontaneous report was received from a nurse and refers to a 6 month old male patient. The patient had none medical history, drug reactions or allergies and concomitant medications.  On 30-JUL-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally, lot # 1660989, expiration date: 15-APR-2021 ( dose number was not reported) for routine prophylaxis. While the nurse was giving the vaccine to the patient, the medicine started to squirt in the patient's left eye. It was reported that the infant did not seemed bothered and his mother wiped his eye with a bib. The nurse did not note any redness in his left eye.  The nurse believed there might be a small hole in the bottle. She did not notice any issues with the device until she applied pressure. The medicine sprayed from the "neck of the bottle, where it twists". The foil wrapper/sleeve was not sticky or wet when it was opened. There was no damage to the foil pouch. There was no product residue in the carton.  The outcome of accidental exposure to product via eye contact was unknown.