chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, MMR
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. On 25-JAN-2019, the patient was vaccinated with LIQUID PEDVAXHIB, subcutaneous for prophylaxis (dose, lot number and expiration date were not reported) diluted with the sterile diluent (lot number and expiration date were not reported) of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (product preparation error). The nurse stated the reason for the confusion was the LIQUID PEDVAXHIB was in a bag with M-M-R II written on the front by the facility (interchange of vaccine products). The nurse also reported, the patient had received three doses (each on a separate unspecified date) of LIQUID PEDVAXHIB (inappropriate schedule of product administration). The outcome of all the aforementioned events was not provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, muscle ache all night. With ADVIL, fever and chills diminished but muscle ache still present.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Nausea, Pallor, Peripheral coldness
Clinical narrative: Student with symptoms of nausea, skin cold with pallor in lips and face area. Red patches to neck  posterior and anterior and upper arms. S/S started within 10 minutes of administration. V/S taken and noted. B/P 90/60. Student was assisted to lying position withlegs elevated. BENADRYL 25 mg IM to Rt. Deltoid administered at 11:35 am. By 11:50 am student verbalized feeling better no nausea reported and skin patches were noticeable to neck anterior in light pink color. No visible skin marks noted to upper arms, face or posterior neck.
Age: 57.0
Sex: F
Vaccine: HEPA, IPV, MMR, MNQ, TDAP, TYP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: Malaise, vomiting, body aches.
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Dyskinesia, Eye movement disorder, Generalised tonic-clonic seizure, Somnolence
Clinical narrative: Previously seen by Neurology and told she likely had breath holding spells. However, after her vaccines today, pt had a 60-second generalized tonic clonic seizure. Eyes rolled back in head, and upper and lower extremities were jerking in a rhythmic movement. RN retrieved MD from another exam room. I arrived to room to find patient as described above. Placed patient supine on the exam table. CV RRR and Pulm CTA B. Episode subsided on it's own within that 60-second timeline, as described by RN to MD. Patient drowsy afterward, but resting comfortably in mom's arms. Spoke with Dr. in Neurology, who advised this can occur after immunizations. She said that a certain percentage of children will have these episodes after immunization, and that we should "treat it like a febrile seizure or breath holding spell," meaning it was a provoked incident that likely does not signify any underlying pathology.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2018 (reported as within the last year), the patient was vaccinated with GARDASIL 9 intramuscular (dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date (reported as afterwards), he developed dizziness. The outcome of dizziness was unknown. The causality was not reported.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pustule, Rash pustular
Clinical narrative: PUSTULE SPREAD FROM LEFT DELTOID TO RIGHT WRIST. PATIENT PRESCRIBED ANTIBIOTICS AND A F/U ON MONDAY 04FEB19.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had redness, pain and swelling to entire upper left arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head, Electrocardiogram, Full blood count, Head injury, Metabolic function test
Clinical narrative: Episode of syncope and collapse at school; hit head, followed by 4-5 episodes of vomiting the following few hours.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: Episode of syncope and collapse at school; hit head, followed by 4-5 episodes of vomiting the following few hours.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dry skin, Rash, Swelling
Clinical narrative: After patient was given the above mentioned vaccines mother was redressing patient when she noted what she called a "rash" on both the patient's back and stomach. No rash was noted on the stomach. On the back there were a few slightly raised areas the same color as the skin with scattered dried areas noted. No shortness of breath. No problems breathing. Patient kept under close observation for 30 minutes. No increase in areas of concern. No problems breathing. No shortness of breath. Mother is planning to take patient to his pediatrician for further evaluation when leaving clinic. Phone call to patient's mother to check on patient. Mother took patient to his pediatrician after vaccines today. Mother states patient is "fine". Pediatrician gave her a prescription for a combination of BENADRYL and TYLENOL to give to him through out the rest of today and gave her a list of symptoms to look for.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Chest discomfort, Chills, Dysphagia, Feeling abnormal
Clinical narrative: After 4 hours after vaccine administration, patient felt chills and didn't feel right, then pt had dinner but he couldn't hold spoon, pt called pharmacy, advised him to take TYLENOL then will feel better. Then they called doctor, Dr advised to take BENADRYL. Friday pt felt a little bit better with something bother pt on throat with difficulty swallowing. Saturday pt started to feel tightness in chest then blood pressure 80/50 and pulse 220. Sunday pt felt the same but worse toward night. Early Monday pt went to Dr then MD sent him to hospital. Before going to hospital MD did couple tests -> MD said he has pericarditis condition then MD sent him to hospital. Pt stay at hospital for 3 days. Sodium level was low.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Laboratory test, Pericarditis
Clinical narrative: After 4 hours after vaccine administration, patient felt chills and didn't feel right, then pt had dinner but he couldn't hold spoon, pt called pharmacy, advised him to take TYLENOL then will feel better. Then they called doctor, Dr advised to take BENADRYL. Friday pt felt a little bit better with something bother pt on throat with difficulty swallowing. Saturday pt started to feel tightness in chest then blood pressure 80/50 and pulse 220. Sunday pt felt the same but worse toward night. Early Monday pt went to Dr then MD sent him to hospital. Before going to hospital MD did couple tests -> MD said he has pericarditis condition then MD sent him to hospital. Pt stay at hospital for 3 days. Sodium level was low.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired MMR vaccine given.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Extremity tender, pain, redness.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: CSF test abnormal, Demyelinating polyneuropathy, Dysphonia, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Hypokinesia, Laboratory test, Lumbar puncture, Malaise
Clinical narrative: Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Nausea, Nerve conduction studies abnormal, Paraesthesia, Speech disorder
Clinical narrative: Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Injection site pain
Clinical narrative: Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Lumbar puncture, Nerve conduction studies, Paralysis, Vaccine positive rechallenge
Clinical narrative: Patient received two doses of SHINGRIX vaccine. The first dose (lot # pk9by) was given on 9/28/18 and the second dose (lot # gz29l) was given on 1/17/19. After the first dose, the patient's family reported having a fever along with chills and malaise. After the second dose, the patient's family reported numbness at the tip of his fingers and toes for a few days that was followed by malaise, nausea, muscle weakness, decreased movement and decreased speech.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Henoch-Schonlein purpura, Pyrexia, Ultrasound abdomen, Urine analysis
Clinical narrative: Fever, HSP type reaction, treatment ibuprofen as needed.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Laboratory test abnormal
Clinical narrative: 10/03/18 PATIENT had vaccination in Left arm. Both vaccines were injected into the same deltoid per patient request. On 10/5/18 the patient was treated in a local hospital for Cellulitis.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: SLIGHT REDNESS AT INJECTION SITE WITH TENDERNESS, INDURATION AND INCREASED HEAT IN AREA. CEPHALEXIN 500 MG 1 TAB PO BID FOR 5 DAYS, AND IBUPROFEN 400 MG PO Q6H.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Biopsy skin, Blister, Chlamydial infection, Eczema, Inflammation
Clinical narrative: About a month after the 3rd and final dose of GARDASIL I started getting a rash on my hands, which stayed there for a year and would only crop up when I had my period. But then a year later, I had a sexual partner and caught chlamydia, which was fixed, but the rash came back with a force which quickly spread to my torso and to my face, and I went to the ER for that, they prescribed me antibiotics and antivirals and nothing helped until I was given a steroid which took down the inflammation. I couldn't eat or drink because my lips were so swollen and I took 2 trips to the ER, went to several immediate cares, and then had 3 dermatologists look at me in 10 years. No one is able to tell me what the rashes are, which up till now other than that first time have been concentrated on my fingers. All doctors say eczema or staph. It is resistant to antibiotics. It always comes back. I am constantly itchy. My children itch themselves constantly as well and have similar blisters like I get on their backs and their genitals. The symptoms are horrible for a week and then the blisters heal and are replaced by long cuts which scab and scar. I can rarely use my hands for anything, I can't wash dishes, and I wear gloves when I have a break-out so the pus from my hands doesn't get on my children or my furniture. I will never be able to have a normal career because of this. The symptoms became unbearable again last week because I discovered I had a sulfa allergy, but now this blistery rash is here all over my body again and it won't go away. I don't expect anything to come of this just please don't let this happen to anyone else.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Lip swelling, Loss of personal independence in daily activities, Pruritus, Purulent discharge, Rash
Clinical narrative: About a month after the 3rd and final dose of GARDASIL I started getting a rash on my hands, which stayed there for a year and would only crop up when I had my period. But then a year later, I had a sexual partner and caught chlamydia, which was fixed, but the rash came back with a force which quickly spread to my torso and to my face, and I went to the ER for that, they prescribed me antibiotics and antivirals and nothing helped until I was given a steroid which took down the inflammation. I couldn't eat or drink because my lips were so swollen and I took 2 trips to the ER, went to several immediate cares, and then had 3 dermatologists look at me in 10 years. No one is able to tell me what the rashes are, which up till now other than that first time have been concentrated on my fingers. All doctors say eczema or staph. It is resistant to antibiotics. It always comes back. I am constantly itchy. My children itch themselves constantly as well and have similar blisters like I get on their backs and their genitals. The symptoms are horrible for a week and then the blisters heal and are replaced by long cuts which scab and scar. I can rarely use my hands for anything, I can't wash dishes, and I wear gloves when I have a break-out so the pus from my hands doesn't get on my children or my furniture. I will never be able to have a normal career because of this. The symptoms became unbearable again last week because I discovered I had a sulfa allergy, but now this blistery rash is here all over my body again and it won't go away. I don't expect anything to come of this just please don't let this happen to anyone else.
Age: 18.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Rash generalised, Rash vesicular, Scab, Scar, Staphylococcal infection
Clinical narrative: About a month after the 3rd and final dose of GARDASIL I started getting a rash on my hands, which stayed there for a year and would only crop up when I had my period. But then a year later, I had a sexual partner and caught chlamydia, which was fixed, but the rash came back with a force which quickly spread to my torso and to my face, and I went to the ER for that, they prescribed me antibiotics and antivirals and nothing helped until I was given a steroid which took down the inflammation. I couldn't eat or drink because my lips were so swollen and I took 2 trips to the ER, went to several immediate cares, and then had 3 dermatologists look at me in 10 years. No one is able to tell me what the rashes are, which up till now other than that first time have been concentrated on my fingers. All doctors say eczema or staph. It is resistant to antibiotics. It always comes back. I am constantly itchy. My children itch themselves constantly as well and have similar blisters like I get on their backs and their genitals. The symptoms are horrible for a week and then the blisters heal and are replaced by long cuts which scab and scar. I can rarely use my hands for anything, I can't wash dishes, and I wear gloves when I have a break-out so the pus from my hands doesn't get on my children or my furniture. I will never be able to have a normal career because of this. The symptoms became unbearable again last week because I discovered I had a sulfa allergy, but now this blistery rash is here all over my body again and it won't go away. I don't expect anything to come of this just please don't let this happen to anyone else.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Immediate post-injection reaction, Lethargy, Speech disorder developmental, Still's disease
Clinical narrative: Speech regression immediately, lethargy immediately. Joint pain weeks and months following. Long term: food allergies; wheat, dairy, peanuts. Diagnosed Systemic Juvenile idiopathic Arthritis. 11/2015.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Full blood count, Neuralgia
Clinical narrative: Emergency room visit for trouble breathing and throat swelling, loss of sensation and nerve pain radiating from finger up into neck.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal swelling, Sensory loss
Clinical narrative: Emergency room visit for trouble breathing and throat swelling, loss of sensation and nerve pain radiating from finger up into neck.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hyperaesthesia, Urticaria
Clinical narrative: Patient experienced hives and burning sensation all over the body (hyperesthesia) within 24 hours of vaccination. Mother of patient noted that patient also swam in a public pool that same day and have consulted with pool facility to determine if chemicals in the pool could be ruled out as well. Patient had no reaction at injection site other than the hives all over the body.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Sore arm starting around 3:00, an hour or so after shot; then starting around 11:00pm day of shot, fever (101.5), chills, headache, arm pain, over by noon the next day; red rash (about 4 in. in diameter) and swelling of arm started the morning after the shot; arm still has red rash (about 5 in. in diameter) and soreness today, 3 days after shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Sore arm starting around 3:00, an hour or so after shot; then starting around 11:00pm day of shot, fever (101.5), chills, headache, arm pain, over by noon the next day; red rash (about 4 in. in diameter) and swelling of arm started the morning after the shot; arm still has red rash (about 5 in. in diameter) and soreness today, 3 days after shot.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient came in today with overt shingles rash few days after vaccination for shingles.
Age: 42.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Client returned to have TST read on 1/31/19 and reported left arm pain and swelling.  Client went to ER on evening of 1/31/19 where they Dx her with Cellulitis and gave her one dose of Clindamycin. A 10 day course of Clindamycin was prescribed. As of this writing on 2/1/19 at 4pm, this RN spoke with client and she had not yet filled Rx. She denied fevers/chills. She reported continued redness, pain, and swelling to the left arm.
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Nausea, stomach pain, diarrhea, loss of appetite. Began a few hours after first dose, continued throughout duration of all doses.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Swelling of eyelid
Clinical narrative: Eye swelling and puffiness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Large local area of redness, minimal swelling.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a 13 months old male patient with no illness at time of vaccination. The patient's historical vaccines and concomitant therapies were not reported. The historical conditions included neonatal jaundice due to delayed conjugation from breast milk inhibitor, and left sided facial paisy noted at one month visit. The patient's concurrent conditions included hypermetropia  bilateral and Marcu Gunn jaw-winking syndrome evidenced with ptosis of eyelid left side noted at birth with some molding on that side. On 14-SEP-2018, the patient was vaccinated with an improperly stored first dose of M-M-R II, subcutaneously (SC) in the left thigh, lot # N026828 (expiration date: 27-SEP-2019, albumin status: rHA); with an improperly stored first dose of VARIVAX, SC, in the right thigh lot # R003300 (expiration date: 01-FEB-2020); with an improperly stored first dose of VAQTA intramuscularly (IM) in the left thigh, lot # R013858 (expiration date: 12-JUN-2019) and with an improperly stored fourth dose of PREVNAR IM, in the right thigh, lot # W11306 (expiration date not reported). The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None patient experiences were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002764: US-009507513-1901USA002765.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a currently 21 year old male patient. The patient medical history included chicken pox whose was "never vaccinated". The patient had none concomitant medications, drug reaction or allergies. On 05-SEP-1998, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, route of administration and expiration date unknown by reporter), on 29-OCT-1998, the patient received the second dose of RECOMBIVAX HB, lot# 2712B2 (route of administration and expiration date unknown by reporter) and on 15-MAR-1999, the third dose of RECOMBIVAX HB lot# 272612 (route of administration and expiration date unknown by reporter) for prophylaxis. On an unknown date, in January 2019, the patient had a negative Hepatitis B titer (Anti-HBs antibody negative). On 31-JAN-2018, the patient was vaccinate with a pediatric dose of RECOMBIVAX HB (lot number, dose, route of administration and expiration date were not reported). An unspecified treatment for the event was given at the time of this report the patient had not recovered from the events. The patient sought medical attention and no overdose or hospitalization were reported. Lots# 2712B2 and 272612 are invalid for RECOMBIVAX HB.
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot # and expiration date were not reported). On an unknown date, the patient experienced rash in an unspecified area of the body. It was unknown if the patient sought medical attention, received any treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of rash was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Death
Clinical narrative: This initial spontaneous report was received from an on-line article that was posted on social media and concerns an unspecified amount of patients who were vaccinated with GARDASIL. The article mentioned that the GARDASIL vaccine causes autoimmune problems that cause sudden debilitation and/or death. It was also noted that to date, it was believed that GARDASIL was responsible for the death of 121 young women (cause not specified) and for 57,520 reports of adverse events obtained by the Vaccine Adverse Events Reporting System (VAERS).  All of the events were considered related to GARDASIL. Upon internal review, autoimmune problems and death of 121 young women were considered to be medically significant. Autoimmune problems were considered disabling. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-0807USA02497:; Reported Cause(s) of Death: death; autoimmune disorder.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a year after receiving SHINGRIX, the patient experienced rash and scab. On 16th January 2019, the patient experienced shingles. The patient was treated with famciclovir and acyclovir. On an unknown date, the outcome of the shingles, rash and scab were unknown. It was unknown if the reporter considered the shingles, rash and scab to be related to SHINGRIX. Additional details were received as follows: The patient received a dose of SHINGRIX in the right arm. Recently one of the mornings, the patient woke up with bumps and scabs underneath right eye and her cheeks. On 16th January 2019, after 173 days the patient called her dermatologist and she was diagnosed with Shingles. The patient started on Famciclovir 500mg. Then, on 18th January 2019, she went to see her eye doctor and was diagnosed for Shingles. The patient was then started with Acyclovir since it was cheaper than Famciclovir. At the time of reporting, the patient was taking the Acyclovir. The reporter consented to follow up. No further details were provided. The patient requesting reimbursement due to her experience on the vaccine.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 22-year-old male patient who received BEXSERO for prophylaxis. In November 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In November 2018, several hours after receiving BEXSERO, the patient experienced pain, feeling abnormal and feeling unwell. On an unknown date, the outcome of the pain, feeling abnormal and feeling unwell were recovered/resolved. The reporter considered the pain, feeling abnormal and feeling unwell to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. At the end of November 2018, the patient received a dose of BEXSERO at school in the health clinic. The reporter could not be confirmed which arm the vaccine was given and did not have the exact date and time in November 2018. Just a couple of hours, after receiving BEXSERO the patient experienced very achy, felt out of it and he did not feel well. These symptoms lasted for 24 hours and then resolved on their own. The reporter provided limited information regarding the 1st vaccine but information provided had been documented. Unable to obtain the physician's name and phone number. This case was not associated with a product quality complaint (PQC).
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a adult male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad. SHINGRIX was discontinued. On an unknown date, the outcome of the feeling bad was unknown. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling bad after the 1st dose of SHINGRIX. Badly enough that they had put off getting the 2nd dose and are now after the 6 month window.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Swelling
Clinical narrative: 12 mo vaccines done 11 days ago on 1/21 - got Varicella and PREVNAR on right side, MMR and Hep A on left noticed swelling 2 days ago, marked yesterday fever today at daycare. Extrem - indurated area 3x3 cm right outer thigh, erythema and sl. warmth at area, no fluctuance, NT to palp., no vesicles or papules at area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Eye swelling, Impaired work ability, Nausea
Clinical narrative: According to patient, she received the SHINGRIX vaccine at around 5 pm on 1/22/19 and symptoms started around 10 am on 1/23/19. Patient reports fever, cold chills, diarrhea, nausea, rash on face, and swollen eyes. She had to miss 3 days of work due to her adverse effects. When patient reported to pharmacy, on 2/1/19, her symptoms were all resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: According to patient, she received the SHINGRIX vaccine at around 5 pm on 1/22/19 and symptoms started around 10 am on 1/23/19. Patient reports fever, cold chills, diarrhea, nausea, rash on face, and swollen eyes. She had to miss 3 days of work due to her adverse effects. When patient reported to pharmacy, on 2/1/19, her symptoms were all resolved.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Blood test, Contusion, Immune thrombocytopenic purpura
Clinical narrative: AFTER APPOX 1 WEEK STARTED WITH EASY BRUISING, PROGRESSED TO EXCESSIVE BRUISING AND RED SPOTS ALL OVER BODY AFTER THE NEXT FEW DAYS BROUGHT TO LOCAL PEDIATRIC CENTER, LABS TEST WERE DONE AND TRANSFERRED TO MEDICAL CENTER, WHERE A DIAGNOSIS OF IDIOPATHIC THROMBOCYTOPENIC PURPURA WAS MADE, SHE WAS GIVEN AN IMMUNOGLOBULIN AND REPEATED BLOOD TEST TO MAKE SURE THE PLATLET COUNT WAS COMING UP. (FOLLOWED UP BY A YEAR OF BLOOD MONITORING) HER HOSPITAL STAY WAS 2 OR 3 DAYS. IT WAS ALSO DETERMINED THAT THE LIKELY CAUSE WAS VARICELLA VACCINE AND BECAUSE IT WAS GIVEN WITH THE FIRST MMR VACCINE BOTH WOULD BE CONTRAINDICATED FOR HER.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Oral disorder, Oral mucosal blistering, Oral pain
Clinical narrative: Outbreak of large, blistering, painful internal mouth lesions located upper and lower buccal tissue. The lesions were diagnosed by oral surgeon as atypical aphthous stomatitis.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms. HA, chills, body aches, joint pain.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Has bumpy irritated rash at each lateral thigh, not hot, not apparently tender, not indurated. Pt had a little fever the night of her vaccines on 1/24 up to 100, then she had a mild rash on both injection sites developed about three hours after the injections. The rash is itchy. Per mother this is the 2nd time this occurred after vaccinations. The mother reports, the first time it lasted for a couple of days, this time it has been over a week. Mother feels it has improved today, although yesterday it had peaked. We are uncertain if this is related to rubbing alcohol used to clean injection site. We applied rubbing alcohol to top of foot at visit today, mother to call if Pt. develops a rash.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Musculoskeletal stiffness, Pain, Paraesthesia
Clinical narrative: Developed fever overnight - unknown how high, body aches and stiffness, headache and entire body was numb/tingling. Took ADVIL after breakfast and symptoms got better by mid-afternoon. Unsure if 2nd dose should be taken.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Developed fever overnight - unknown how high, body aches and stiffness, headache and entire body was numb/tingling. Took ADVIL after breakfast and symptoms got better by mid-afternoon. Unsure if 2nd dose should be taken.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Chills, fever x 3 days, joint pain, generalized muscle pain, soreness at injection site x 3 days. Symptoms resolving after 3 days and ibuprofen q4 hours x3 days.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient reported additional swelling outside of the left deltoid. The swelling began to extend down into his front breast and side of chest. Patient noticed this the next day after his vaccination. Reported no other changes in BP, HR, dizziness, itching or flu symptoms, but was concerned about the large area of swelling. Informed to use an ice pack to reduce swelling and take BENADRYL to help as well. Warned if continued swelling or changes in BP/HR or dizziness to go to ER.
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMRV, MNQ, HEP, HPV9, IPV, MMRV, MNQ
Symptoms: Erythema, Swelling face
Clinical narrative: Patient woke up on day 2 (2-1-2019) with right side of face red and swollen. The symptoms went away after 5 hours. Reported by Mother. The pt did not take any treatment.
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMRV, MNQ, HEP, HPV9, IPV, MMRV, MNQ
Symptoms: Erythema, Product administered to patient of inappropriate age, Product prescribing error, Swelling face
Clinical narrative: Patient woke up on day 2 (2-1-2019) with right side of face red and swollen. The symptoms went away after 5 hours. Reported by Mother. The pt did not take any treatment.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Tremor
Clinical narrative: Shivers, uncontrollable shaking and aches.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: In the middle of the night of the day I got the shot- I woke up with an aching back. Then I woke up early morning hours with a terrible headache. When I got up in morning, I was stiff and achy all over. My hips and back really ached. I came home from work at lunchtime, I was totally exhausted. I stayed on the sofa for rest of the Wednesday and Thursday. I was so tired I could not move. It was like a bad flu. My arm had a bruise at the injection site, was very swollen, hot to touch and a red patch below injection site Thursday I woke up on the sofa and my throat was starting to get sore and a small portion of my face was numb. Numbness did not last long but sore throat got worse and I went to urgent care.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: In the middle of the night of the day I got the shot- I woke up with an aching back. Then I woke up early morning hours with a terrible headache. When I got up in morning, I was stiff and achy all over. My hips and back really ached. I came home from work at lunchtime, I was totally exhausted. I stayed on the sofa for rest of the Wednesday and Thursday. I was so tired I could not move. It was like a bad flu. My arm had a bruise at the injection site, was very swollen, hot to touch and a red patch below injection site Thursday I woke up on the sofa and my throat was starting to get sore and a small portion of my face was numb. Numbness did not last long but sore throat got worse and I went to urgent care.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: In the middle of the night of the day I got the shot- I woke up with an aching back. Then I woke up early morning hours with a terrible headache. When I got up in morning, I was stiff and achy all over. My hips and back really ached. I came home from work at lunchtime, I was totally exhausted. I stayed on the sofa for rest of the Wednesday and Thursday. I was so tired I could not move. It was like a bad flu. My arm had a bruise at the injection site, was very swollen, hot to touch and a red patch below injection site Thursday I woke up on the sofa and my throat was starting to get sore and a small portion of my face was numb. Numbness did not last long but sore throat got worse and I went to urgent care.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chronic fatigue syndrome, Condition aggravated, Influenza like illness, Malaise
Clinical narrative: In the middle of the night of the day I got the shot- I woke up with an aching back. Then I woke up early morning hours with a terrible headache. When I got up in morning, I was stiff and achy all over. My hips and back really ached. I came home from work at lunchtime, I was totally exhausted. I stayed on the sofa for rest of the Wednesday and Thursday. I was so tired I could not move. It was like a bad flu. My arm had a bruise at the injection site, was very swollen, hot to touch and a red patch below injection site Thursday I woke up on the sofa and my throat was starting to get sore and a small portion of my face was numb. Numbness did not last long but sore throat got worse and I went to urgent care.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature, Lip blister, Mobility decreased
Clinical narrative: Patient woke up around 1am on 01/30/2019 with a temperature, her lips had blisters on them and she could hardly move her arm. She went to the emergency room and was given norflex 100mg and norco 5/325. She was in the emergency room for 2 hours before being released.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Hives and red welts on back and face 24-48 hours following vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: Bruising-approximately 3inches by 3 inches- rash, itching.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR
Symptoms: Agitation, Diet refusal, Dyskinesia, Epistaxis, Facial paralysis
Clinical narrative: High fever, seizures (2), rash, fussy, nosebleed, won't eat, projectile vomiting, spaced out, agitated, right side mouth droops, constantly flapping hands, sick, not happy.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR
Symptoms: Feeling abnormal, Irritability, Pyrexia, Rash, Seizure
Clinical narrative: High fever, seizures (2), rash, fussy, nosebleed, won't eat, projectile vomiting, spaced out, agitated, right side mouth droops, constantly flapping hands, sick, not happy.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR
Symptoms: Vomiting projectile
Clinical narrative: High fever, seizures (2), rash, fussy, nosebleed, won't eat, projectile vomiting, spaced out, agitated, right side mouth droops, constantly flapping hands, sick, not happy.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling of entire upper arm down to the elbow and redness. Patient was going to take Benadryl and ibuprofen.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had localized redness and some inflammation about 4 to 6 inches around injection site. Patient first noticed this on 1/20/2019 when he wakes up around 9am. Patient was advised to go see his primary physician as precaution and also to verify his ongoing rash on his face since March 2018 prior to SHINGRIX immunization. Dr. confirmed the adverse localized redness at his left around the injection site. Dr. also diagnosed the rash on the face to be an ongoing shingles rash that has been first documented back in March 2018. Provider prescribed antiviral treatment for the shingles rash on the face. Patient was counseled to continue to monitor localized adverse effects.
Age: 52.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain in extremity
Clinical narrative: Client called clinic at about 0859 1/28/19 with complaint of sharp pain on the right arm and mild on the left arm. Client reported taking ibuprofen which helps but still had the discomfort. Client was seen at about 1440 in the clinic same day. She told writer that the left was better, kind of mild and the right still has a sharp pain. On examination both arms appear normal, no edema, no swollen area, no red area. Client was told to rest and apply ice pack to both arms and follow up with writer. Client was also told to contact her PCP if it does not resolve in 2 days. 2/1/2019 at 10 am client report she is better, the pain has completely resolved.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called the pharmacy on 1/25/19 to report to the staff pharmacist that she has had persistent arm pain after her Flu shot on 10/25/18. The pharmacy manager called the patient back later that day at 2:30pm to get more information and again on 1/29/19 at 1:54pm. The patient returned the call on 2/1/19. She stated that she has had pain in her left arm and sometimes throbbing pain when she turns her arm certain ways. She stated that she was referred by her PCP to PT and had her first appt on 1/28/19 with Rehab Center. The pharmacy mgr called Dr. office on 2/1/19 to find out when the patient reported the arm pain. Per staff the office notes do not specifically mention arm pain related to a vaccine. The patient was seen on 1/14/19 and was referred to PT. Patient stated at that PCP visit that she likes to work out in the pool at the gym three times a week.
Age: 18.0
Sex: M
Vaccine: JEV
Symptoms: Dizziness, Headache, Nausea, Pruritus
Clinical narrative: Headache, nausea, dizziness, itching.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Itching, redness, swelling/hardness, pain and bruising at the injection site. Site is also bumpy like a localized rash and is warm to the touch.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Itching, redness, swelling/hardness, pain and bruising at the injection site. Site is also bumpy like a localized rash and is warm to the touch.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after vaccine. Monitored, gave apple juice, felt better.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Contusion, Epistaxis, Full blood count, Haematocrit normal, Haemoglobin normal
Clinical narrative: Thrombocytopenia with bruising and mild epistaxis and petechiae likely ITP.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Immune thrombocytopenic purpura, Lymphocyte percentage increased, Neutrophil percentage decreased, Petechiae, Platelet count decreased
Clinical narrative: Thrombocytopenia with bruising and mild epistaxis and petechiae likely ITP.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Thrombocytopenia, White blood cell count normal
Clinical narrative: Thrombocytopenia with bruising and mild epistaxis and petechiae likely ITP.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day after vaccination patient experience swollen painful and red right deltoid muscle. Treatments: ice and MOTRIN. Will follow up with patient next week.
Age: 0.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Baby received tDap. Should have gotten Hep B.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: Weakness, dizzy, aches, very tired, slight nausea, soreness at injection site.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Weakness, dizzy, aches, very tired, slight nausea, soreness at injection site.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: High fever, rash all over abdomen and chest.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Bowel movement irregularity, Insomnia, Nausea
Clinical narrative: Patient experienced nausea, bowel irregularity and insomnia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Fatigue, Headache, Myalgia, Oral herpes
Clinical narrative: Approx. 15 hours after dose, headache, very sore arm, extreme tiredness, felt like my entire coating of skin on my body was about to break out in Shingles (I have had them twice before), entire body simply hurt. About 20 hours after dose, fever of 100.4. On Saturday, Feb 2nd, noticed huge cold sore on upper lip. Also canker sore in mouth under tongue. By Wednesday, Jan 30,  fever and sore muscles and hurting body gone. Sore arm continued. Herpes breakout on upper lip continues as of this report. Canker sore still in mouth as of time of this report.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Skin discomfort
Clinical narrative: Approx. 15 hours after dose, headache, very sore arm, extreme tiredness, felt like my entire coating of skin on my body was about to break out in Shingles (I have had them twice before), entire body simply hurt. About 20 hours after dose, fever of 100.4. On Saturday, Feb 2nd, noticed huge cold sore on upper lip. Also canker sore in mouth under tongue. By Wednesday, Jan 30,  fever and sore muscles and hurting body gone. Sore arm continued. Herpes breakout on upper lip continues as of this report. Canker sore still in mouth as of time of this report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Extremely tired, headache, muscle aches (especially at night), joint pain in large and small joints, nausea, redness, swelling, and extreme pain at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea
Clinical narrative: Extremely tired, headache, muscle aches (especially at night), joint pain in large and small joints, nausea, redness, swelling, and extreme pain at injection site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure, Echocardiogram abnormal, Hip fracture, Myalgia, Pain
Clinical narrative: Patient was vaccinated and reports systemic side effects of muscle and body aches for about 1 week post vaccination. Patient was admitted for a broken hip and heart failure was incidentally found with an echocardiogram that was previously normal in 2017.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: She has a sore achy arm .. almost like a Charlie horse in her left arm every so often. Its been over a month and the pain comes and goes at times.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Confusional state, Headache, Nuclear magnetic resonance imaging brain
Clinical narrative: Optic Neuritis, vertigo, weakness, confusion, severe headaches.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging neck, Nuclear magnetic resonance imaging thoracic, Ophthalmological examination, Optic neuritis, Optical coherence tomography
Clinical narrative: Optic Neuritis, vertigo, weakness, confusion, severe headaches.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo, Visual field tests
Clinical narrative: Optic Neuritis, vertigo, weakness, confusion, severe headaches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Lip swelling, Swollen tongue
Clinical narrative: Patient has Herpes-like symptoms. Her lips and tongue are slightly swollen.