chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: PT SAID HER SYMPTOMS STARTED AROUND 2 HOURS AFTER VACCINE AND LASTED SEVERAL HOURS. SHE REPORTED FEVER, TROUBLE BREATHING, INCREASED HEART RATE, WEAKNESS, FATIGUE, HEADACHE, BODY ACHES, SORE THROAT, RUNNY NOSE. SHE CHOSE NOT TO SEEK MEDICAL ATTENTION. PATIENT CALLED PHARMACY FOLLOWING DAY (10/23/19) AND SAID HER ONLY REMAINING SYMPTOM WAS HEADACHE. PATIENT ADVISED TO GO TO HOSPITAL AND/OR CALL PHYSICIAN IF SYMPTOMS WORSEN OR RETURN. SHE SAID SHE WILL SEEK MEDICAL ATTENTION IF NECESSARY, BUT FEELS WELL TODAY OTHER THAN A HEADACHE AND DOES NOT FEEL THIS IS NECESSARY.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: PT SAID HER SYMPTOMS STARTED AROUND 2 HOURS AFTER VACCINE AND LASTED SEVERAL HOURS. SHE REPORTED FEVER, TROUBLE BREATHING, INCREASED HEART RATE, WEAKNESS, FATIGUE, HEADACHE, BODY ACHES, SORE THROAT, RUNNY NOSE. SHE CHOSE NOT TO SEEK MEDICAL ATTENTION. PATIENT CALLED PHARMACY FOLLOWING DAY (10/23/19) AND SAID HER ONLY REMAINING SYMPTOM WAS HEADACHE. PATIENT ADVISED TO GO TO HOSPITAL AND/OR CALL PHYSICIAN IF SYMPTOMS WORSEN OR RETURN. SHE SAID SHE WILL SEEK MEDICAL ATTENTION IF NECESSARY, BUT FEELS WELL TODAY OTHER THAN A HEADACHE AND DOES NOT FEEL THIS IS NECESSARY.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patients mom called hour and half after vaccine administered and said son said his arm was swollen and painful. She touched it and said it felt hard and he claimed that there was numbness that traveled to the back of the shoulder.  Told mom she could take him to emergency care for steroids. Instructed mom that she can give ibuprofen for the pain and swelling to see if it helps. Will call mom in 1 hour to check on patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles after vaccination. Shingles confirmed by MD
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Head injury, Nausea, Scratch, Syncope
Clinical narrative: Patient got light headed, nausea and fainted and hit his head and scrapped his arm
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception.  Required reduction with air enema and overnight hospitalization.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Skin warm
Clinical narrative: PATIENT IS HAVING REACTION TO VACCINE, HOT ON TOUCH RASH WITH PAINFUL AREA
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR 2 WEEKS
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Lethargy, Nausea, Visual impairment
Clinical narrative: severe dizziness, lethargy, extreme nausea and difficulty seeing. Reported about 3 days after vaccination.  WEnt to see Dr. and got ondansetron. Followed up 10/23 , pt seems to be doing better per wife.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient reported swollen arm, red, itchy, and hot to the touch. Patient went  to another pharmacy (ours was closed for Labor Day, 9/2/19), and was told to take Benadryl. Patient reports taking Benadryl and issue resolved after one week (week of 9/9/19).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Flushing
Clinical narrative: with both shots (But worse with this one)  got soreness at the site of injection,   body aches, headache, flushed, red  skin on face (hot to the touch) tiredness and feeling chilled.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: with both shots (But worse with this one)  got soreness at the site of injection,   body aches, headache, flushed, red  skin on face (hot to the touch) tiredness and feeling chilled.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Lethargy, Memory impairment, Nausea
Clinical narrative: Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This has happened several times in two days. Comes and goes.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Extreme lethargy, stomach pain, nausea, vomiting, sever headache, memory fog or forgetfulness, fever. This has happened several times in two days. Comes and goes.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Pyrexia, Rash
Clinical narrative: Rash, redness,warm feeling, fever and chills
Age: 55.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Diarrhoea, Flank pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: A patient started having fever and pain on her left arm, neck, jaw, mid waist and her back at 2 am. on 10/22/2019. By 6 am. she had nausea, vomiting and diarrhea. She kept herself hydrate  took acetaminophen 1500 mg at 3 pm. Her nausea and vomiting stop sometime in the evening of 10/22/2019. She still having pain on her left arm and continue to have loose stools.
Age: 55.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Pain in jaw, Pyrexia, Vomiting
Clinical narrative: A patient started having fever and pain on her left arm, neck, jaw, mid waist and her back at 2 am. on 10/22/2019. By 6 am. she had nausea, vomiting and diarrhea. She kept herself hydrate  took acetaminophen 1500 mg at 3 pm. Her nausea and vomiting stop sometime in the evening of 10/22/2019. She still having pain on her left arm and continue to have loose stools.
Age: 21.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Fatigue, Impaired work ability, Lacrimation increased, Nasal congestion
Clinical narrative: Sore throat, fever, chills, body ached, severe fatigue,  congestion in lungs and nose, watery eyes. Non functional at work, lived off of cold medicine, cough drops and probiotics. Occured not even 24 hours later. I've never been so sick
Age: 21.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Oropharyngeal pain, Pain, Pulmonary congestion, Pyrexia
Clinical narrative: Sore throat, fever, chills, body ached, severe fatigue,  congestion in lungs and nose, watery eyes. Non functional at work, lived off of cold medicine, cough drops and probiotics. Occured not even 24 hours later. I've never been so sick
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy Body wide Rash less than 24 hours after vaccine Administration. Benadryl 25mg orally given every 6-8 hours. Loratidine given once daily x3 days Prednisone 50mg orally 10/22/19 then daily x4 more days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Head injury
Clinical narrative: Pt felt dizzy after vaccination while exiting the office and hit head on door frame
Age: 6.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right upper arm swelling and itching noted after giving vaccination in addition to redness that has persisted for 48 hours. Parent reported that patient had a similar reaction during last dose of DTAP in 2015. Prescribed ibuprofen and diphenhydramine. Recommended continued itching of area.
Age: 90.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called to state that 1 week after receiving his influenza vaccine he is still experiencing redness and itching at the site of injection.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Antibody test, Contraindication to vaccination
Clinical narrative: Patient was given Varivax while on Humira (immunosuppressant). Connect with Pedi ID who recommended VariZig 625 Units less than 1 gram 7/26/19 and Valtrex 1000 mg tid x 21 days started approx. 7/28/19. Patient did NOT develop any clinical varicella lesions.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pain
Clinical narrative: 10/8/19 got 2nd dose shingles vaccine 10/11/19 started painful shingles @ right L3 dermatome and abd pain
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Arthralgia, Full blood count, Nausea, Neck pain, Pyrexia
Clinical narrative: Suspect transient. No spinal tap done. S mptoms (24 hours after prevnar and fluad injectio n/same da  per pt right arm=prevnar; left arm=fluad) nausea, fever, intense neck pain, generali ed arthralgia/m algia. Self-limiting (resolved  ithin  48 hrs). Self-treatment=fluids, t lenol. No medical attentio n until toda  (10 da s later).
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Spinal X-ray
Clinical narrative: Suspect transient. No spinal tap done. S mptoms (24 hours after prevnar and fluad injectio n/same da  per pt right arm=prevnar; left arm=fluad) nausea, fever, intense neck pain, generali ed arthralgia/m algia. Self-limiting (resolved  ithin  48 hrs). Self-treatment=fluids, t lenol. No medical attentio n until toda  (10 da s later).
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Tremor
Clinical narrative: Patient reported shaking violently, chills, 7 hours after injections. Next morning had headache, nausea, minor aches + pains
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: PATIENT EXPERIENCED SWELLING/REDNESS ON 22OCT2019 AFTER RECEIVING AFLURIA INFLUENZA VACCINE ON 21OCT2019. PATIENT HAD NO DIFFICULTY BREATHING OR SWELLING IN ANY OTHER AREAS. PT PRESENTED TODAY. 23OCT2019, WITH STIFFNESS, REDNESS, AND SWELLING AT INJECTION SITE, AND INJECTIONS SITE "FEELS HOT". PATIENT STATES SYMPTOMS AT AREA AFFECTED HAS GOTTEN WORSE SINCE DATE SYMPTOMS FIRST APPEARED, BUT NO NEW SYMPTOMS HAVE PRESENTED.
Age: 77.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Blister, Pain, Rash, Vaccination complication
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on left arm. The patient was diagnosed with shingles. The reporter did not have the vaccine information for this. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on left arm. The patient was diagnosed with shingles. The reporter did not have the vaccine information for this. The reporter consented to follow up.
Age: 4.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-SEP-2019, the patient was vaccinated with an improperly stored dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S009759 with expiration date on 27-SEP-2020 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 15°F to 46°F (17.6 F)for 56 hours and 40 minutes and a previous temperature excursion of 6°F to 14°F for 10 minutes.   There was no adverse effect reported.  This call was not because of a data logger.
Age: 58.0
Sex: F
Vaccine: PPV, FLUX, PPV, PPV, UNK
Symptoms: Erythema, Pain, Pruritus, Swelling, Ultrasound scan
Clinical narrative: Cellulitis; This is a spontaneous case, initially received from pharmacist via Merck (reference number: 01361291) via Communications (reference number: SEQ19-04817) on 16-Oct-2019, concerning a 58-year-old, female patient.   The patient's medical history included asthma and diabetes. The patient's past vaccine included Pneumovax 23 (Pneumococcal vaccine polysacch 23v), while the patient's concomitant medications included Flonase (fluticasone propionate), lorazepam and an unspecified inhaler; indication were not provided.   On 05-Oct-2019, the patient was administered unspecified flu vaccine [Influenza vaccine, dose reported as one dose', anatomical location: left arm, route of administration, batch number and expiration date: not reported] for an unknown indication. On the same day, the patient was administered Pneumovax 23 [dose reported as one dose', route of administration: intramuscular, anatomical location: right arm, batch number: S018140, expiration date: 02-Mar-2021] for indication reported as recommended over 50'.   On 07-Oct-2019, the patient experienced red and swollen right arm at the top which spread down to forearm. The patient went to unspecified emergency room and was diagnosed with cellulitis. The patient was treated with unspecified antibiotics.   At the time of initial reporting, the outcome of the event of cellulitis was resolving.   The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced cellulitis after vaccination in the left arm with the suspect product unspecified flu vaccine. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. Co-suspect product Pneumovax 23 was given in the right arm and on that arm, cellulitis was diagnosed, making it more plausible alternative aetiology. Considering all the above mentioned, causal role of the suspect product is assessed as not related.
Age: 58.0
Sex: F
Vaccine: PPV, FLUX, PPV, PPV, UNK
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Cellulitis; This is a spontaneous case, initially received from pharmacist via Merck (reference number: 01361291) via Communications (reference number: SEQ19-04817) on 16-Oct-2019, concerning a 58-year-old, female patient.   The patient's medical history included asthma and diabetes. The patient's past vaccine included Pneumovax 23 (Pneumococcal vaccine polysacch 23v), while the patient's concomitant medications included Flonase (fluticasone propionate), lorazepam and an unspecified inhaler; indication were not provided.   On 05-Oct-2019, the patient was administered unspecified flu vaccine [Influenza vaccine, dose reported as one dose', anatomical location: left arm, route of administration, batch number and expiration date: not reported] for an unknown indication. On the same day, the patient was administered Pneumovax 23 [dose reported as one dose', route of administration: intramuscular, anatomical location: right arm, batch number: S018140, expiration date: 02-Mar-2021] for indication reported as recommended over 50'.   On 07-Oct-2019, the patient experienced red and swollen right arm at the top which spread down to forearm. The patient went to unspecified emergency room and was diagnosed with cellulitis. The patient was treated with unspecified antibiotics.   At the time of initial reporting, the outcome of the event of cellulitis was resolving.   The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced cellulitis after vaccination in the left arm with the suspect product unspecified flu vaccine. Chronology is plausible. Medical history of diabetes may have contributed to development of the event. Co-suspect product Pneumovax 23 was given in the right arm and on that arm, cellulitis was diagnosed, making it more plausible alternative aetiology. Considering all the above mentioned, causal role of the suspect product is assessed as not related.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood iron normal, Chest X-ray normal, Haemoglobin normal, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Thrombocytopenia : extreme low blood platelet count --signs onset very quick-24hours.  Bruises all over his body--very large on abdomen.  Petechiae mouth-groin-neck-head-blood in stool.     Went to Healthcare medical assoc- Dr. immediately sent him to ER at Hospital in. Hospital took pictures in the ER.  CBC was done in ER.  He was admitted and treated in blood disorder floor- received IV-Immune globulin transfusion- platelet count was 7k at time of transfusion.  Should be 150k-450k.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Intensive care, Laboratory test, Platelet count decreased, Platelet transfusion
Clinical narrative: Thrombocytopenia : extreme low blood platelet count --signs onset very quick-24hours.  Bruises all over his body--very large on abdomen.  Petechiae mouth-groin-neck-head-blood in stool.     Went to Healthcare medical assoc- Dr. immediately sent him to ER at Hospital in. Hospital took pictures in the ER.  CBC was done in ER.  He was admitted and treated in blood disorder floor- received IV-Immune globulin transfusion- platelet count was 7k at time of transfusion.  Should be 150k-450k.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Contusion, Full blood count, Haematochezia, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: Thrombocytopenia : extreme low blood platelet count --signs onset very quick-24hours.  Bruises all over his body--very large on abdomen.  Petechiae mouth-groin-neck-head-blood in stool.     Went to Healthcare medical assoc- Dr. immediately sent him to ER at Hospital in. Hospital took pictures in the ER.  CBC was done in ER.  He was admitted and treated in blood disorder floor- received IV-Immune globulin transfusion- platelet count was 7k at time of transfusion.  Should be 150k-450k.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia : extreme low blood platelet count --signs onset very quick-24hours.  Bruises all over his body--very large on abdomen.  Petechiae mouth-groin-neck-head-blood in stool.     Went to Healthcare medical assoc- Dr. immediately sent him to ER at Hospital in. Hospital took pictures in the ER.  CBC was done in ER.  He was admitted and treated in blood disorder floor- received IV-Immune globulin transfusion- platelet count was 7k at time of transfusion.  Should be 150k-450k.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein, Hyperhidrosis, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported extreme malaise, high fever and drenching sweats. Dr's described it as a severe rare allergic reaction.  She also had localized swelling, redness and itchiness at the injection site.  She thought her life was going to end.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pyrexia
Clinical narrative: Patient reported extreme malaise, high fever and drenching sweats. Dr's described it as a severe rare allergic reaction.  She also had localized swelling, redness and itchiness at the injection site.  She thought her life was going to end.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: TINGLING IN THE ARM AND DIFFICULTY LIFTING THE ARM
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood test, Magnetic resonance imaging, Myalgia
Clinical narrative: Within hours of getting the vaccine I had severe muscle and joint pain.  Also experienced severe pain in the eye.  The injection was on my left arm and majority of the pain was also on the left side of my body.  The pain then traveled to my neck, lower back, and then the left hip where the pain continues to reside.  The pain comes and goes in waves, and feels like nerve pain.  The pain has gotten better, but it is definitely there and continues to come and go almost 6 months later.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Neuralgia, Pain
Clinical narrative: Within hours of getting the vaccine I had severe muscle and joint pain.  Also experienced severe pain in the eye.  The injection was on my left arm and majority of the pain was also on the left side of my body.  The pain then traveled to my neck, lower back, and then the left hip where the pain continues to reside.  The pain comes and goes in waves, and feels like nerve pain.  The pain has gotten better, but it is definitely there and continues to come and go almost 6 months later.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Approximately a round red sore area at site injection about 2-3 inches in diameter.  Right axillary glands swollen and tender. for about a week after injection
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site movement impairment, Pyrexia, Synovitis, Ultrasound scan
Clinical narrative: One day after receiving this vaccine in left thigh, child began to limp  on his left leg. He was seen in a ER and diagnosed with toxic synovitis. Three days later developed vomiting (10-12x)  and fever to 100.8
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: One day after receiving this vaccine in left thigh, child began to limp  on his left leg. He was seen in a ER and diagnosed with toxic synovitis. Three days later developed vomiting (10-12x)  and fever to 100.8
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chest discomfort, Fatigue, Muscular weakness, Photophobia
Clinical narrative: change in eye sight: eyes very sensitive to light, muscles weak in my legs, feeling tired and weak, feeling sleepy, tightness in chest. Slept a lot for 3 days. 3rd night starting to feel better.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Somnolence, Visual impairment
Clinical narrative: change in eye sight: eyes very sensitive to light, muscles weak in my legs, feeling tired and weak, feeling sleepy, tightness in chest. Slept a lot for 3 days. 3rd night starting to feel better.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Haematocrit normal, Haemoglobin normal, Platelet count normal, Pyrexia, White blood cell count decreased
Clinical narrative: RECEIVED FLU VACCINE ON 190CT. FEVER TO 104 ONE DAY AFTER RECEIVING THE FLU VACCINE. SEEN IN ER  AND SENT HOME. SEEN BY PCM ON  22OCT AND 23 OCT  FOR FEVER.  SENT BACK TO HOSPITAL ON 23OCT FOR REPORTED FEVER OF 40.7 C .  AND WAS ADMITTED.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports a sore spot at flu shot injection site.  She said 3 weeks later she can barely move her arm.  I advised patient to follow up with her primary care provider for more information.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Injection site pruritus
Clinical narrative: Arm red that grew in size and spread to elbow.  Felt like bruise size of softball.  Two days after the injection, got moderate case of chills.  Third day after shot, woke up with moderate itching at site of injection.  This is the fourth day after the injection and it is getting better.  Bruised feeling in smaller in size and itching is now mild.  Appears the reactions will be gone within a week.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Palpitations
Clinical narrative: dizziness, lightheadedness, and feelings of palpitations although no elevated heart rate. Began within minutes of receiving the vaccine and persisted about ah hour. Slight dizziness and lightheadedness persisted for 4-6 hours.  Never had symptoms like this before under any circumstance.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Skin warm, Swelling, Urticaria
Clinical narrative: She developed a welt, two inches in diameter that started the day of the injection.  The area was raised, hard, warm to touch, and painful.  The symptoms last one to two weeks
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Erythema, Throat tightness
Clinical narrative: Patient complain of sudden onset of redness to face, bilateral arms, chest. Stated she felt like throat was closing, difficulty swallowing Symptoms started approximately 20 minutes after injection.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient was 8 weeks pregnant at time of administration; No adverse effects reported; This spontaneous prospective pregnancy report has been received from a medical assistant referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.  On 24-SEP-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number: S006048, expiration date: 27-FEB-2021; strength and route were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: S006018, expiration date: 27-FEB-2021; strength and route were not reported), both for prophylaxis. The patient was 8 weeks pregnant at time of administration. No adverse effects reported. The patient's last menstrual period (LMP) was 30-JUL-2019 and the estimated date of delivery (EDD) was 05-MAY-2020. The pregnancy outcome was pending. The outcome of the events was unknown.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear discomfort, Erythema, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: purple splotches on her arm; her arm was so swollen and so deep red and hot to touch/ redness crept down her arm/her entire arm, not just the side; her arm was so swollen and so deep red and hot to touch; right ear completely stopped up; her arm was so swollen and so deep red and hot to touch; head roaring like an engine; Thursday, 9/26/2019" she went to pharmacy "around 6:30 PM" and got both the PNEUMOV AX23 and "FLUZONE HD" vaccines in her "left arm"./Merck should instruct pharmacists to give the "PNEUMOV AX 23 and the flu shot in separate arms"; her arm is sore to the touch; This spontaneous report was received from a 67 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapy included unspecified supplements. On 26-SEP-2019 around 6:30 PM, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left arm, for indication reported as "proactive on vaccines" (dose, route of administration, lot # and expiration date were not reported) and influenza virus split virion 3v vaccine inactivated (FLUZONE HD) in the left arm (dose, route of administration, indication, lot # and expiration date were not reported). On 27-SEP-2019 at the morning, the patient arm was "so swollen and so deep red" and "hot to the touch" that she called an unspecified pharmacist. On the same day, the patient took two pills of ibuprofen (MOTRIN), applied an "ice pack" and unspecified hydrocortisone ointment on the arm. On 27-SEP-2019, the patient also noticed that her "right ear completely stopped up" and her "head was roaring like an engine". That night (27-SEP-2019 into 28-SEP-2019), the "redness crept down her arm" and the redness was her "entire arm, not just the side". On 28-SEP-2019, the patient took two ibuprofen (MOTRIN) twice a day (for a total of 4 pills) and applied an ice pack. On 29-SEP-2019, the redness and swollenness went "down below the elbow, about 6 inches from her wrist" and the patient experienced purple splotches. On an unknown day in September 2019, the patient experienced "sore arm to the touch even underneath". The patient continued the ibuprofen (MOTRIN), ice pack and hydrocortisone ointment on 29 and 30-SEP-2019. Consumer provided feedback that the pharmacist should be instructed to give the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the flu shot in separate arms if a consumer gets both shots at the same time and that the pharmacist should tell her to "go home and try to keep a low key presence and not be active (do not exercise)".  On 30-SEP-2019, was the "first day of greater improvement", on that day patient head stopped roaring like an engine and right ear cleared up. At the time of the report, the patient arm was still swelling, redness and "sore to the touch". The outcome for the event of "arm hot to the touch" and "purple splotches" was not reported. The causality assessment was not provided.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness, Tinnitus
Clinical narrative: purple splotches on her arm; her arm was so swollen and so deep red and hot to touch/ redness crept down her arm/her entire arm, not just the side; her arm was so swollen and so deep red and hot to touch; right ear completely stopped up; her arm was so swollen and so deep red and hot to touch; head roaring like an engine; Thursday, 9/26/2019" she went to pharmacy "around 6:30 PM" and got both the PNEUMOV AX23 and "FLUZONE HD" vaccines in her "left arm"./Merck should instruct pharmacists to give the "PNEUMOV AX 23 and the flu shot in separate arms"; her arm is sore to the touch; This spontaneous report was received from a 67 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapy included unspecified supplements. On 26-SEP-2019 around 6:30 PM, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left arm, for indication reported as "proactive on vaccines" (dose, route of administration, lot # and expiration date were not reported) and influenza virus split virion 3v vaccine inactivated (FLUZONE HD) in the left arm (dose, route of administration, indication, lot # and expiration date were not reported). On 27-SEP-2019 at the morning, the patient arm was "so swollen and so deep red" and "hot to the touch" that she called an unspecified pharmacist. On the same day, the patient took two pills of ibuprofen (MOTRIN), applied an "ice pack" and unspecified hydrocortisone ointment on the arm. On 27-SEP-2019, the patient also noticed that her "right ear completely stopped up" and her "head was roaring like an engine". That night (27-SEP-2019 into 28-SEP-2019), the "redness crept down her arm" and the redness was her "entire arm, not just the side". On 28-SEP-2019, the patient took two ibuprofen (MOTRIN) twice a day (for a total of 4 pills) and applied an ice pack. On 29-SEP-2019, the redness and swollenness went "down below the elbow, about 6 inches from her wrist" and the patient experienced purple splotches. On an unknown day in September 2019, the patient experienced "sore arm to the touch even underneath". The patient continued the ibuprofen (MOTRIN), ice pack and hydrocortisone ointment on 29 and 30-SEP-2019. Consumer provided feedback that the pharmacist should be instructed to give the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the flu shot in separate arms if a consumer gets both shots at the same time and that the pharmacist should tell her to "go home and try to keep a low key presence and not be active (do not exercise)".  On 30-SEP-2019, was the "first day of greater improvement", on that day patient head stopped roaring like an engine and right ear cleared up. At the time of the report, the patient arm was still swelling, redness and "sore to the touch". The outcome for the event of "arm hot to the touch" and "purple splotches" was not reported. The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: An adult patient received a pediatric dose of VAQTA; An adult patient received a pediatric dose of VAQTA; No known adverse effects; This spontaneous report was received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose and route of administration were not reported, lot number R030115 and expiration date reported as 29-DEC-2019, and upon internal validation stablished as the same), indicated for prophylaxis (incorrect dose administered and underdose). No adverse effects were known.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA005301:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age.  No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 04-OCT-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # S012472 has been verified to be a valid lot number, expiration date 20-OCT-2020, albumin status rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot #S002638, expiration date 31-OCT-2021.  The vaccine was stored in temperature of - 12.3 Celsius degrees for 6.05 hours. There was no previous temperature excursion. Digital data logger was involved. There were no adverse effects noted.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006992: US-009507513-1910USA007211: US-009507513-1910USA007203: US-009507513-1910USA007189: US-009507513-1910USA007200: US-009507513-1910USA007375:
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects reported; 19 year old female patient was inadvertently administered a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant regarding a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 07-OCT-2019, the patient was inadvertently administered a pediatric dose (incorrect dose administered) of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S009943, expiration date 26-JUL-2020 for prophylaxis. No adverse effects reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination were reported as none. His pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).  On 06-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012240: US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 16 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (unspecified) and meningococcal acyw conj vaccine (carrier unspecified).  On 10-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012355: US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (DTAP-IPV) and "FW".  On 18-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012240: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012349: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA007637: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981:
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding an 8 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis b virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified).     On 17-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012352: US-009507513-1910USA012351: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012357: US-009507513-1910USA007637: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Hearing aid user, Pruritus, Rash vesicular, Tinnitus
Clinical narrative: bilateral sensorineural hearing loss; tinnitus; chronic itching and multiple outbreaks of a zoster-like rash on patient's left thigh; chronic itching and multiple outbreaks of a zoster-like rash on patient's left thigh; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old male patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JUL-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On unknown dates, pt suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: chronic itching and multiple outbreaks of a zoster-like rash on pt's left thigh. Pt also suffered moderate to severe bilateral sensorineural hearing loss and tinnitus in which he required a hearing aid at the time of the report. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural hearing loss was considered to be medically significant.
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding an 8 year old female patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included "FW".  On 20-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012352: US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA012349: US-009507513-1910USA012360: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012357: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received third dose in ROTATEQ series that was improperly stored; This spontaneous report was received from a registered nurse refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, dose 3 for prophylaxis with lot # 1658254 and expiry date 17-NOV-2020 (dose, route were not reported) (product storage error). The suspect product was stored at a temperature of 70 degree Fahrenheit (F) for a time frame of 5 days. There was no previous temperature excursion. The digital data logger was not involved. The patient did not experience any adverse effects.