chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Burning sensation, Vein disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vein disorder in a unk patient who received FLU QUADRIVALENT (split without adjuvant dresden). On an unknown date, the patient received FLU QUADRIVALENT split without adjuvant dresden at an unknown dose. On an unknown date, an unknown time after receiving FLU QUADRIVALENT split without adjuvant dresden, the patient experienced vein disorder and burning sensation. On an unknown date, the outcome of the vein disorder and burning sensation were unknown. It was unknown if the reporter considered the vein disorder and burning sensation to be related to FLU QUADRIVALENT split without adjuvant dresden. A director of pharmacy reported side effects for a patient. The pharmacist told him that a patient received quadrivalent flu vaccine, manufacturer unknown. The pharmacist reported two side effects: pooling and burning. She did not qualify those events to the field rep, so he does not know exactly what she meant by those events.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. On an unknown date, 2 months after the initial dose, the patient was vaccinated with the second dose of VAQTA (route of administration, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old patient of unknown gender. On 16-APR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 dose and route were not reported (lot # J014401, expiration date: 26-NOV-2014). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an unknown age female physician via a company representative referring to herself. On an unknown date in 2010 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). On an unknown date in 2013 the patient was diagnosed with a case of shingles after receiving ZOSTAVAX. The physician was treated with antiviral medication. It was not specified if the physician sought medical care outside of herself. The outcome of the event was reported as recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Rash macular
Clinical narrative: Rash noted around site of VARIVAX injection. Started 3 day after injection, has spread. Area is irregular, with erythematous macular area and some well defined papular lesions, about 1 1/2" x 1 1/2", right thigh not swollen, itchy or tender. Patient seen in office 4/30/15.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Rash noted around site of VARIVAX injection. Started 3 day after injection, has spread. Area is irregular, with erythematous macular area and some well defined papular lesions, about 1 1/2" x 1 1/2", right thigh not swollen, itchy or tender. Patient seen in office 4/30/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to two patients of unknown age and gender. On unknown dates the two patients were vaccinated with improperly stored ROTATEQ (oral, lot # K023535, expiration date: 22-MAY-2016, dose was not reported). No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Information has been received from a health worker via a company representative concerning a 66 year old patient with unknown gender. The patient was diabetic with renal complications and had high blood pressure. The patient had no drug reactions and allergies. On 31-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, strength and lot# were not reported, subcutaneously). Concomitant therapies included HUMULIN, metformin, TRADJENTA, levothyroxine sodium (manufacturer unknown), atorvastatin, LODIPIN and lisinopril (+) hydrochlorothiazide (manufacturer unknown). On approximately 31-MAR-2015 (reported as one week ago), the patient developed symptoms of redness and vesicles on cervical part of neck and back of ear. The reporter stated the patient visited office on 06-APR-2015 as the reaction was worse on 05-APR-2015. The reporter stated that the patient was to be prescribed VALTREX (1 gm, 3 times every 10 days) and gabapentin 300 mg as treatment for the events. There was no lab diagnostics performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Severe redness and swelling of upper arm/delt, fever of 103 degrees x 2 days.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PROQUAD (Merck) (lot number K003821, expiry date 17-SEP-2015) (lot number K007452, expiry date 21-NOV-2014) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality issue reported. This case is linked to case number 1505USA001724 via same reporter link. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Redness, swelling at injection site. 7.0 cm in diameter red, macualr, slightly warm to touch.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot # K004483, expiration date 16-AUG-2015, lot # K007262, expiration date 25-NOV-2015) (dose, route and site of administration were not reported) post vaccine excursion. No adverse effects were noted. Additional information has been requested. This is one of several reports from the same reporter.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Vomiting
Clinical narrative: Vomiting onset 2 hrs after vaccine administration.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker (also reported as nurse) regarding unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever; chills; soreness and swelling at injection site; headache; Lt. side neck pain; fatigue / achy.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Fever; chills; soreness and swelling at injection site; headache; Lt. side neck pain; fatigue / achy.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (Merck) VARIVAX (dose, route and lot number not provided). No adverse effects reported. This is one of several reports received from the same source. 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 certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patient were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pruritus
Clinical narrative: Shot for pneumonia was given 3:30 pm 4/29/15 at outpatient clinic in left thigh at patient request as has had previous reaction in arm w/flu shot. Hurt that evening-pain in muscle area front of thigh down to knee-5/3/15 redness 4 days whole front thigh then itching.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representatives refers to a 15 year old male patient. None of pertinent medical history, drug reactions or allergies were reported. On 19-FEB-2013 the patient was vaccinated with a first dose of GARDASIL (lot#, strength and route were not reported). Then, the patient's received his GARDASIL shots outside of the recommended time intervals: the second dose on 11-JUL-2013 and third dose on 16-SEP-2013. The patient did not seek medical attention. None of lab diagnostics studies were performed. No adverse symptoms were reported. No treatment was given for the patient. The outcome of patient's events was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: Pt received 4 shots in right upper arm on 4/29/15. Today arm is red and swollen and itchy. Right upper arm over deltoid has 7" x 3" area of redness, mild warmth. BENADRYL 1 tsp. po given and assessed by medical provider.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Swelling
Clinical narrative: Patient received the vaccine on 4/23/15. She developed swelling and redness at the time of the injection. Swelling did improve over the course of the week, but the redness seemed to spread to a large area of the left upper arm. She had been using OTC cortisone ointment as the area developed pruritus. She also developed pruritus at other sites on her body. She is being treated by the provider with cool compress as needed, OTC cortisone, MEDROL dose pack, and antibiotics in case it is cellulitis.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma
Clinical narrative: Patient developed hematoma at site of injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Groin pain, Joint swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Bilateral groin pain, upper thigh pain followed by right hand swelling then left knee swelling she also had diffuse myalgias. No fever and no local reaction.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Splotchy rash around injection site. Approximately 3 in x 3 in area. No swelling.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash to legs and arms.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Face oedema, Pruritus, Skin plaque, Varicella post vaccine
Clinical narrative: Rash to legs and arms.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Swelling at site, swollen node on (lt) clavicle pain when moving are at node site.
Age: 20.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient states she woke up the day after injection and that is when she noted the reaction. 7:00 a.,. 5-5-15. Redness, warmth and lump at site. 5-6-15 at clinic 9:30 am. 65mm x 55mm redness with induration. Patient is monitoring symptoms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site swelling, Swelling
Clinical narrative: Pt has extreme swelling on left upper arm, there is also armpit involvement and the side of the left breast, resulting in immobility of left arm to an extent.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Malaise, Urticaria
Clinical narrative: Information was received from a physician regarding a 13 year old female patient with an allergy to amoxicillin (hives). On 17-FEB-2015, the patient received a routine vaccination with her first dose of GARDASIL lot # K006960, 0.5 ml, intramuscularly in the left arm. "4 Days after" she received GARDASIL, the patient developed hives at her injection site. The patient also reported that "one month after she received GARDASIL," she became ill and developed hives on both of her legs and also at the injection site where she received GARDASIL. The patient did not report any of these adverse experiences to the physician until she came in or her second dose of GARDASIL. The patient did not receive her second dose of GARDASIL when she was scheduled to receive it because of her report of having developed hives. The outcome of the hives at her injection site, becoming ill and developing hives on both of her legs and also at the injection site were reported as recovered. No additional information was provided. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received INFANRIX (batch number N5339, expiry date March 2016). Concurrent medical conditions included food allergy, peanut allergy and penicillin allergy. Concomitant products included lisinopril, metoprolol ER and raloxifene. On 3rd April 2015, the patient received the 1st dose of INFANRIX .5 ml. On 3rd April 2015, immediately after receiving INFANRIX, the patient experienced injection site pain. On 10th April 2015, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the patient experienced inappropriate age at vaccination administration. The action taken with INFANRIX was unknown. On an unknown date, the outcome of the injection site pain was unchanged and the outcome of the inappropriate age at vaccine administration was unknown and the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to INFANRIX. Additional details were reported as follows: Pharmacist reported that she gave an INFANRIX by mistake to an adult patient. The patient experienced soreness at the injection site immediately but then it went away. However about a week later, on 10 April 2015, the patient started experiencing other symptoms at the injection site (erythema, swelling and pruritus) and the soreness at the injection site also came back.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 5 year old male patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) injection lot # K022447, exp 13-MAY-2016, 0.5 ml, subcutaneously in the right leg. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The medical assistant reported that on multiple unspecified dates these patients were administered with PNEUMOVAX 23 single-dose vials (dose, route not reported, lot # J011045 with expiration date 15-MAY-2015, lot # K006681 with expiration date 21-OCT-2015) that were exposed to a supported temperature excursion of 32F for 8 hours on six different occasions. The medical assistant stated that these vaccines were not exposed to temperatures below 32F. No adverse effect was reported. This is one of two reports received from the same reporter (other linked MARRS# 1505USA001342). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The medical assistant reported that on multiple unspecified dates these patients were administered with doses of GARDASIL (dose, route not reported, lot # H021608 with expiration date 13-AUG-2015, lot# K006191 with expiration date 02-FEB-2017, lot # K007828 with expiration date 02-MAR-2017, lot # K023432 with expiration date 18-JUN-2016) that were exposed to a supported temperature excursion of 32F for 8 hours on six different occasions. The medical assistant stated that these vaccines were not exposed to temperatures below 32F. No adverse effect was reported. This is one of two reports from the same reporter (other linked MARRS# 1505USA001498). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report a received from a physician via a company representative refers to a 67 year old male patient. Medical history and concurrent conditions were not reported. In 2013, reported as about two years ago, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. In April 2015, reported as this week, the patient went to physician's office and was diagnosed with an outbreak of shingles. The patient complained of mild pain associated with the shingles, and the patient was treated with an unspecified antiviral and unspecified steroid. The outcome of herpes zoster was reported as not recovered. The causality was not reported. No lab diagnostic studies were performed. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dysphagia, Oropharyngeal pain, Pyrexia, Speech disorder
Clinical narrative: Sudden pain in throat. Couldn't swallow. Talked with difficulty. Alternating fever and chills with trembling.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: Sudden pain in throat. Couldn't swallow. Talked with difficulty. Alternating fever and chills with trembling.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Roughly 15 minutes later, pt became pale and light-headed, and began to lean over on his mother. He was A & O, with radial pulses 1+. He was placed on an examination table with knees up. Blood pressure was 80s/40s. He was given some juice while lying down, and roughly 15 minutes later, his pulses were stronger and he felt less light-headed. BP was then 90/50. He continued to lay down for another 15 minutes, drinking juice, and continued to feel less light-headed, although his blood pressure remained roughly 90/50. He then sat up for 15 minutes, followed by standing up, and felt baseline the entire time. His BP continued to stay 90s/50s-60s, but he had 2+ pulses, his color had returned, and he did not have anymore light-headedness.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Asthenia
Clinical narrative: Generalized weakness.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Depression, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: About 4 days after the 3rd dose of HPV Vaccine my daughter experienced nausea and dizziness as well as a slight tremor and pain in her arm. One week later she was diagnosed with strep and mono.  It is now almost 8 weeks later and she still experiences nausea, dizziness, headaches and extreme fatigue.  A shadow of herself - very anxious and depressed.  Formerly VERY healthy, active and happy.  I feel this vaccine triggered something with her immune system or suppressed it greatly.  I'm hoping for a full recovery but am starting to be very concerned.  The 2nd and 3rd doses should be given 6 months apart apparently.  Her doses were given in July, November and March.  Just 4 months between the 2nd and 3rd dose.  Even since November she was not feeling right - very fatigued.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Infectious mononucleosis, Mononucleosis heterophile test positive, Nausea
Clinical narrative: About 4 days after the 3rd dose of HPV Vaccine my daughter experienced nausea and dizziness as well as a slight tremor and pain in her arm. One week later she was diagnosed with strep and mono.  It is now almost 8 weeks later and she still experiences nausea, dizziness, headaches and extreme fatigue.  A shadow of herself - very anxious and depressed.  Formerly VERY healthy, active and happy.  I feel this vaccine triggered something with her immune system or suppressed it greatly.  I'm hoping for a full recovery but am starting to be very concerned.  The 2nd and 3rd doses should be given 6 months apart apparently.  Her doses were given in July, November and March.  Just 4 months between the 2nd and 3rd dose.  Even since November she was not feeling right - very fatigued.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Streptococcal infection, Streptococcus test positive, Tremor
Clinical narrative: About 4 days after the 3rd dose of HPV Vaccine my daughter experienced nausea and dizziness as well as a slight tremor and pain in her arm. One week later she was diagnosed with strep and mono.  It is now almost 8 weeks later and she still experiences nausea, dizziness, headaches and extreme fatigue.  A shadow of herself - very anxious and depressed.  Formerly VERY healthy, active and happy.  I feel this vaccine triggered something with her immune system or suppressed it greatly.  I'm hoping for a full recovery but am starting to be very concerned.  The 2nd and 3rd doses should be given 6 months apart apparently.  Her doses were given in July, November and March.  Just 4 months between the 2nd and 3rd dose.  Even since November she was not feeling right - very fatigued.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Ageusia, Anosmia, Computerised tomogram head, Deafness unilateral, Influenza like illness
Clinical narrative: Felt as if coming down with flu like symptoms and did so 2 days later.  Then 2 more days subsequent, I lost hearing in right ear and total loss of smell and of taste. Went to primary doc. who then sent me to an ENT Spec and from ENT to a Neurologist.  To date, none of the medical doctors can or have identify why the above things happened.  Good news is that I have regained full hearing, but still cannot smell nor taste.  Have no clue if the flu vaccination properties caused these problems but after visiting, at length, with a very learned pharmacist, she advised me to make this known as a "vaccine adverse event".
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Ageusia, Anosmia, Deafness unilateral, Influenza like illness
Clinical narrative: Felt as if coming down with flu like symptoms and did so 2 days later.  Then 2 more days subsequent, I lost hearing in right ear and total loss of smell and of taste. Went to primary doc. who then sent me to an ENT Spec and from ENT to a Neurologist.  To date, none of the medical doctors can or have identify why the above things happened.  Good news is that I have regained full hearing, but still cannot smell nor taste.  Have no clue if the flu vaccination properties caused these problems but after visiting, at length, with a very learned pharmacist, she advised me to make this known as a "vaccine adverse event".
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Throat irritation
Clinical narrative: Area the size of a softball was reddened and swollen to left arm (deltoid muscle).  Mother stated that it was like a hard lump under the skin. Client also had a fever and felt like her throat was burning.  Child was seen in the ER on 4/4/25 and doctor told family to watch and report if it got larger.  Client had follow-up appointment on 4/6/15 with PA and swelling and redness had gone down substantially according to mother.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Expired product administered, Injection site erythema, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Area the size of a softball was reddened and swollen to left arm (deltoid muscle).  Mother stated that it was like a hard lump under the skin. Client also had a fever and felt like her throat was burning.  Child was seen in the ER on 4/4/25 and doctor told family to watch and report if it got larger.  Client had follow-up appointment on 4/6/15 with PA and swelling and redness had gone down substantially according to mother.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Throat irritation
Clinical narrative: Area the size of a softball was reddened and swollen to left arm (deltoid muscle).  Mother stated that it was like a hard lump under the skin. Client also had a fever and felt like her throat was burning.  Child was seen in the ER on 4/4/25 and doctor told family to watch and report if it got larger.  Client had follow-up appointment on 4/6/15 with PA and swelling and redness had gone down substantially according to mother.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash, Scar
Clinical narrative: "The evening after I got my first varicella shot I started to break out on both wrists and hands. It looked like a food allergy but then progressively got worse and blisters formed. It itched and ended up scarring both my hands and wrists.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 5 year old female patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) injection lot # K022447, exp 13-MAY-2016, 0.5 ml, subcutaneously in the left leg. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 5 year old female patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) injection lot # K020749, exp 30-APR-2015, 0.5 ml, subcutaneously in the right vastus lateralis. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Blood test, Dyspnoea, Lacrimation increased, Sneezing, Urticaria
Clinical narrative: Patient C/O wheezing, sneezing, watery eyes, difficulty breathing and hives aproximately 5 hours post vaccine administration. Went to ER and reports he was given Pepcid, Benadryl and steroids. Discharged home 4 hours later. Given a 5 day course of Prednisone 20mg PO. Reported to work 5/6 without any signs or symptoms. States he feels "great".
Age: 26.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Wheezing
Clinical narrative: Patient C/O wheezing, sneezing, watery eyes, difficulty breathing and hives aproximately 5 hours post vaccine administration. Went to ER and reports he was given Pepcid, Benadryl and steroids. Discharged home 4 hours later. Given a 5 day course of Prednisone 20mg PO. Reported to work 5/6 without any signs or symptoms. States he feels "great".
Age: 75.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Gave clinic prescription from doctor for Menomune but Menactra was given at 2 different locations 2 days apart. Client had told staff she had not recieved it yet.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: CHILLS, WHOLE BODY ACHE, LEFT ARM ACHING WHERE VACCINATED. THIS IS GOING ON FOR 3 DAYS NOW.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported pain and burning during injection of Prevnar 13 vaccine.  Then over the next 2 days developed a red, raised, warm, swollen area at injection site that was 4" in diameter.  Dr examined, no treatment ordered.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Erythema, Eye pain, Nausea, Peripheral swelling, Skin warm
Clinical narrative: Swollen red hot mass in mothe forearms. Headache behind eyes. Nausea. Given Benadryl at Dr office around 10:15 am. Mass was outlined with pen to watch for growth of the redness.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Upper extremity mass
Clinical narrative: Swollen red hot mass in mothe forearms. Headache behind eyes. Nausea. Given Benadryl at Dr office around 10:15 am. Mass was outlined with pen to watch for growth of the redness.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: High fever to 103F, sore throat, coughing.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Anxiety, Compulsive handwashing, Initial insomnia, Muscle rigidity
Clinical narrative: I started noticing an increase in odd behaviors and the appearance of new behaviors including: lining of objects, covering his ears to basic sounds, increased hand washing, trouble falling asleep at night (up to 2 hours), repeating his own and others phrases, obsessions such as color black, increased anxiety, decreased happy mood, rigid behavior such as not allowing us to put on a short sleeve shirt instead of long sleeve. These behaviors slowly started increasing over the first two weeks and were at their peak for approximately 2-3 months. Around mid March they slowly started decreasing and a few have almost disappeared, but several behaviors remain including reduced happy mood, increased anxiety, and increased rigidity.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Repetitive speech
Clinical narrative: I started noticing an increase in odd behaviors and the appearance of new behaviors including: lining of objects, covering his ears to basic sounds, increased hand washing, trouble falling asleep at night (up to 2 hours), repeating his own and others phrases, obsessions such as color black, increased anxiety, decreased happy mood, rigid behavior such as not allowing us to put on a short sleeve shirt instead of long sleeve. These behaviors slowly started increasing over the first two weeks and were at their peak for approximately 2-3 months. Around mid March they slowly started decreasing and a few have almost disappeared, but several behaviors remain including reduced happy mood, increased anxiety, and increased rigidity.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular, Rash morbilliform
Clinical narrative: Patient had fever to Tmax of 103F on 05/05/2015. Low grade fevers for a total of 5 days. Measles like mildly erythematous maculopapular rash spreading over trunk, extremities and face starting 05/04/2015. Rash continues to spread. No other symptoms.
Age: 30.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, PPV, VARCEL
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain
Clinical narrative: Patient received her vaccinations on 28 April 2015. On 02 May 2015, the patient returned to the clinic with decreased ROM and increased pain to right upper arm. Right upper arm with edematous and sensitive to palpation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Allergy test negative, Lip swelling
Clinical narrative: His upper lip started swelling. Mom gave him Ibuprofen in the afternoon - his lip got swollen after that. No problems breathing and no rashes.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abscess oral, Breath odour, Hypoaesthesia, Tooth extraction
Clinical narrative: Facial numbness 782.0: Vs occult abscess 2nd to recent tooth pulling and malodorous breath, doubt that HPV, TDaP, MCV is responsible for numbness of face but will report to VAERS.  Otherwise remainder of exam wnl.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abscess, Breath odour, Hypoaesthesia
Clinical narrative: Facial numbness 782.0: Vs occult abscess 2nd to recent tooth pulling and malodorous breath, doubt that HPV, TDaP, MCV is responsible for numbness of face but will report to VAERS.  Otherwise remainder of exam wnl.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had an adverse reaction to Pneumovax 23 which was administered on 5/5/2015. Pt reported to us that after a few hours after receiving the vaccine her upper arm became red and inflammed at night. She did apply ice as per instructions given by the pharmacist. She went to a medical clinic and saw ARNP and was prescribed Antibiotics and given an injection.
Age: 1.37
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Blood test, Crying, Fall, Gait disturbance
Clinical narrative: My 16 month old was crying in pain shortly after we returned home.  He then began limping and suddenly couldn't walk and resorted to crawling.  He doesn't have control of his gait and has been falling down for 5 days.
Age: 1.37
Sex: M
Vaccine: PNC13
Symptoms: Pain, X-ray of pelvis and hip
Clinical narrative: My 16 month old was crying in pain shortly after we returned home.  He then began limping and suddenly couldn't walk and resorted to crawling.  He doesn't have control of his gait and has been falling down for 5 days.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Extra dose administered, Injection site abscess, Staphylococcus test positive
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 16 months old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 26-MAR-2015, the patient was vaccinated with the fourth dose of PEDVAXHIB route was not reported, (lot # K015463 expiration date 07-SEP-2017) an dose of PEDVAX (manufacturer unknown) which was also administered on the same date. Concomitant therapies included sulfamethoxazole and PREVNAR. On 09-APR-2015, (reported as 2 weeks after receiving vaccine) the patient experienced injection site abscess. On 11-APR-2015, the patient was admitted to the hospital. On an unspecified date in April 2015, an abscess culture performed showed "staph moderate growth" and the patient received an unspecified intravenous IV antibiotics as treatment. On 15-APR-2015, the patient was discharged from the hospital. The outcome of injection site abscess was reported as recovering/resolving. The reported stated that she would like a lot check of PEDVAXHIB that administered. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Incisional drainage, Injection site abscess, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 16 months old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 26-MAR-2015, the patient was vaccinated with the fourth dose of PEDVAXHIB route was not reported, (lot # K015463 expiration date 07-SEP-2017) an dose of PEDVAX (manufacturer unknown) which was also administered on the same date. Concomitant therapies included sulfamethoxazole and PREVNAR. On 09-APR-2015, (reported as 2 weeks after receiving vaccine) the patient experienced injection site abscess. On 11-APR-2015, the patient was admitted to the hospital. On an unspecified date in April 2015, an abscess culture performed showed "staph moderate growth" and the patient received an unspecified intravenous IV antibiotics as treatment. On 15-APR-2015, the patient was discharged from the hospital. The outcome of injection site abscess was reported as recovering/resolving. The reported stated that she would like a lot check of PEDVAXHIB that administered. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 16 months old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 26-MAR-2015, the patient was vaccinated with the fourth dose of PEDVAXHIB route was not reported, (lot # K015463 expiration date 07-SEP-2017) an dose of PEDVAX (manufacturer unknown) which was also administered on the same date. Concomitant therapies included sulfamethoxazole and PREVNAR. On 09-APR-2015, (reported as 2 weeks after receiving vaccine) the patient experienced injection site abscess. On 11-APR-2015, the patient was admitted to the hospital. On an unspecified date in April 2015, an abscess culture performed showed "staph moderate growth" and the patient received an unspecified intravenous IV antibiotics as treatment. On 15-APR-2015, the patient was discharged from the hospital. The outcome of injection site abscess was reported as recovering/resolving. The reported stated that she would like a lot check of PEDVAXHIB that administered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Rash, Rash erythematous
Clinical narrative: Pt developed painful, red rash. Skin/tissue at injection site was also hard.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site erythema
Clinical narrative: Local erythema 4 x 5 cm at site of injection. No systemic sx.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Left arm tender when hit car door getting out of car - saw it was red, tender slightly warm to the touch. About 3 in wide - 2 days later Friday May 1st. Doctor thought was localized rx.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient's left arm became red and warm from her shoulder on down to her elbow. Patient had also had fever for approximately 3 days post injection. Patient was prescribed KEFLEX and received an injection of ROCEPHIN.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash erythematous
Clinical narrative: Red dot rashes on arms, abdominal area last more than 2 weeks.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: (L) upper arm, redness, swelling pain, baseball size lump redness down to elbow, fever.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose increased, Dry mouth, Pollakiuria, Thirst, Vomiting
Clinical narrative: Possible new onset of DM. Dry mouth. Urinary frequency. Elevated BS 545. Vomiting. Excessive thirst.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced injection site cellulitis. The outcome of the injection site cellulitis was unknown. The relatedness between injection site cellulitis and therapy with pneumococcal vaccine (manufacturer unknown) was not reported. Additional information is not expected because the reporter did not consent further follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 13-APR-2015, was vaccinated with an improperly stored dose of ROTATEQ (lot # K004921, expiration date not reproted) 2 ml, oral. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Breech presentation, Caesarean section, Foetal exposure during pregnancy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female neonate. The patient's mother was 26 year old female. On 30-JUN-2014 at 10:30 am, the patient's mother was vaccinated with her first dose of VARIVAX (Merck) (dose 0.5 ml, lot # J012150, expiry date: 28-SEP-2015 subcutaneous in the right arm). The patient's mother was not tested for varicella antibodies before vaccination with VZV (varicella zoster virus) containing vaccine. On an unspecified date in 2014, the patient's mother took a pregnancy test and was found to be pregnant. The patient's mother estimated due date (EDD) was 03-MAR-2015. LMP (Last Menstrual Period) was 28-MAY-2014 (estimated date) and Date of Conception was 11-JUN-2014 (estimated date). The neonate was exposed to the vaccine during the first trimester of the pregnancy. It was reported that the patient was born through a caesarian section. The reporter also stated that at the time of the caesarian section, the patient's mother was "about 2 weeks overdue" and that the reason for the caesarian section was due to the neonate being in a breech position. It was also reported that the baby weigted 7 pounds something. The neonate was healthy (also reported as was born as normal and no congenital abnormalities were noticed). The patient's mother was not admitted to the hospital after the delivery. The outcome of neonate being in breech position was not reported. Causality assessment between the event of neonate being in a breech position and the VARIVAX (Merck) was not provided. Upon internal review the event of neonate being in a breech position was considered to be medically significant due to the mother's caesarian section. This is one of two reports received from the same reporter. The case is linked to MARRS# 1407USA002631 with a Parent-Child Link. Additional information has been requested
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: Pain developed immediately after the vaccine. Today, the pain persist. Unable to maneuver left arm. Unable to lay or sleep on it. Unable to lift or carry with affected arm. I also feel pain whenever I place elbow on table, counter, etc. It feels like a bone chip.
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Pain developed immediately after the vaccine. Today, the pain persist. Unable to maneuver left arm. Unable to lay or sleep on it. Unable to lift or carry with affected arm. I also feel pain whenever I place elbow on table, counter, etc. It feels like a bone chip.
Age: 80.0
Sex: M
Vaccine: FLU3, FLUX, FLUX
Symptoms: Immediate post-injection reaction, Insomnia, Mobility decreased, Pain, Tenderness
Clinical narrative: Pain developed immediately after the vaccine. Today, the pain persist. Unable to maneuver left arm. Unable to lay or sleep on it. Unable to lift or carry with affected arm. I also feel pain whenever I place elbow on table, counter, etc. It feels like a bone chip.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Headache, Heart rate increased, Laboratory test abnormal
Clinical narrative: Case number PHHY2015US033477, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555454) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 360086) on 25 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 360086) on 24 Apr 2015. This report refers to a 49-year-old female patient. She had no known allergies. Concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1413401), along with PNEUMOVAX (other manufacturer, batch number: K009876) intramuscularly into the right arm on 17 Nov 2014. On the same day after vaccination, the patient had debilitating pain on the arm, headache, nausea, fast heartbeat and fever. The patient had an emergency room visit. The patient's lab data revealed cellulitis. The outcome of the events was condition unchanged. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness of the event cellulitis was upgraded based on the NVS-IME list. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 360086) on 25 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 360086) on 24 Apr 2015: Updated FLUVIRIN vaccine batch review report.