chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.23
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Diarrhoea, Enteritis infectious, Protein total decreased
Clinical narrative: 15 months old admitted to Hospital on 12/18/15 with a four-day history of vomiting, diarrhea and a 2 day history of abdominal distention.  On admission had ascites, elevated liver enzymes and elevated LDH.  Child is still in in the hospital and is improving. Pediatric gastroenterologist diagnosis is most likely post infectious enteritis.
Age: 1.23
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: 15 months old admitted to Hospital on 12/18/15 with a four-day history of vomiting, diarrhea and a 2 day history of abdominal distention.  On admission had ascites, elevated liver enzymes and elevated LDH.  Child is still in in the hospital and is improving. Pediatric gastroenterologist diagnosis is most likely post infectious enteritis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, X-ray normal
Clinical narrative: Employee reports pain in joint at site of vaccine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient called 12/21/15.  States she started having right arm soreness and progressive weakness after flu vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Red, spotty, blistering rash all over body.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Influenza vaccine administered around 1:30 PM. Employee returned to clinic around 2:00 PM with c/o of itching and hives under right arm (vaccine given in right deltoid).
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain redness at injection site.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Rash
Clinical narrative: Patient was seen at ED 12/19/2015 for rash post vaccination.  He previously had a similar reaction to same vaccines but not as severe.  Patient was prescribed prednisone and sent home.  Patient followed up at ED 12/20/2015 for continued rash, given IM Decadron in ED, sent home with prescription for Benadryl and Tylenol and advised to continue Prednisone.  Patient seen today in clinic 12/21/2015 for follow-up.  Patient with worsening rash despite treatment with medications.  Patient was send to another ED for further evaluation and treatment.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity, Periarthritis, Tendonitis
Clinical narrative: Pain in bicep down the whole arm and unable to move the arm without the assistance of my other hand. Went to ER due to intense pain and immobility and was diagnosed with Tendonitis.  Had a follow up with my Doctor one week later who diagnosed me with Frozen Shoulder and put me on steroids.  After steroids ran out the pain and immobility are still present and I have received a referral to go to Physical Therapy.  I am also doing acupuncture and massage therapy for pain management.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of injection site that appeared the day after receiving vaccinations. Swelling and redness is slowly resolving over time.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever up to 103º, lethargic, heart rate 120, SpO2 97%.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the left thigh. Parents brought child in for re-check. Called parents today 12/21/15, left message.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling initially at injection site which spread down to elbow and up to top of shoulder. Also very painful. Called pharmacy 12/20/15 in late afternoon and stated the left arm was three times larger than right and red only on outer aspect of arm. The patient applied cold compress and took ibuprofen to help with pain and swelling. On 12/21/15 the pain has decreased and arm swelling is reduced. still not back to normal but stated he is feeling better. The patient contacted his primary physician on 12/21/15 as well.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: The injection site was red, swollen, and was itchy. The patient was running a fever a few days after. The patient took APAP and diphenhydramine for her symptoms.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Dyspnoea, Erythema, Lacrimation increased, Pruritus, Pyrexia
Clinical narrative: 4x6 redness with he middle 2x3 swollen, 99.8 fever, watery eyes, difficulty breathing, using inhaler, raised rash warm to touch, itchy when Benadryl wears off.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: 4x6 redness with he middle 2x3 swollen, 99.8 fever, watery eyes, difficulty breathing, using inhaler, raised rash warm to touch, itchy when Benadryl wears off.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Arm soreness, lump on site of injection.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: C-reactive protein, Inflammation, Lymphadenopathy, Malaise, Pain
Clinical narrative: Swollen lymph nodes, rash in face, neck, back and stomach. Malaise body ache, ears ringing, swollen face, arms, and hands with fever Tylenol for pain, Benadryl for rash and steroids for inflammation.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Peripheral swelling, Pyrexia, Rash, Swelling face, Tinnitus
Clinical narrative: Swollen lymph nodes, rash in face, neck, back and stomach. Malaise body ache, ears ringing, swollen face, arms, and hands with fever Tylenol for pain, Benadryl for rash and steroids for inflammation.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal pain upper, Anaemia, Appendicectomy, Appendicitis
Clinical narrative: I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin increased, Blood potassium decreased, Chest discomfort, Chest pain, Chills
Clinical narrative: I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Computerised tomogram abdomen abnormal, Dyspnoea, Hepatic enzyme increased, Hepatic pain
Clinical narrative: I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Hypotension, Malaise, Myalgia, Nausea
Clinical narrative: I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness 3-4 inches surrounding site, heat, knot in muscle.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea, Pruritus, Skin warm
Clinical narrative: Itchiness, warm to the touch, nausea, stiff arm.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Blood test, Cellulitis, Chills, Pain in extremity
Clinical narrative: Pt required emergency care after receiving flu and Pneumovax in her right arm.  Got fever, chills and extreme pain in her arm that ultimately prompted her to go to Emergency room. Treated her symptomatically and sent her home. She went to the local Urgent care the following day because symptoms escalated and her arm became more swollen.  At this point she was diagnosed with a bacterial infection with cellulitis and she was treated with antibiotics.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Ultrasound scan
Clinical narrative: Pt required emergency care after receiving flu and Pneumovax in her right arm.  Got fever, chills and extreme pain in her arm that ultimately prompted her to go to Emergency room. Treated her symptomatically and sent her home. She went to the local Urgent care the following day because symptoms escalated and her arm became more swollen.  At this point she was diagnosed with a bacterial infection with cellulitis and she was treated with antibiotics.
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2015US026548, is an initial spontaneous report from a consumer (patient) via Claim Management Services (claim number: 30154848910-0001) received on 14 Dec 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601, expiry date: 01 May 2016) on an unknown date. On 14 Oct 2015 the patient was diagnosed with Guillain Barre Syndrome. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of "Guillain Barre Syndrome" was upgraded based on the NVS-IMS list.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Dizziness, nausea - Injection sites swollen, pink, warm to touch. Both arms where Tdap and meningococcal were given.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site very sore. Small red area and became worse.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: On 10-7-15 pt received a immunization at hospital. Patient came into her PCP on 12-1-15 because her left deltoid has been sore since she received the influenza immunization vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student concerning a patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTACAX lot # L033311 (expiration date 01-DEC-2016) (dose and route not reported). Concomitant therapies were not provided. No adverse effects were reported. No adverse effects were reported. The was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Crying, Diet refusal, Electroencephalogram normal, Gastrointestinal disorder
Clinical narrative: Per mom patient was crying a lot after vaccine. Not wanting to eat refused bottle. Pt had a seizure a day after vaccine. No fever. Mid November had an episode of vomiting, acting weak, seemed limp. 12/1 was seen her for f/u and got flu vaccine, next day had GI sx, Mom layed down with him to take a nap, his whole body began shaking, everything deviated to the left, arms went up and to left, eyes looked to left, purple lips, lasted 2 minutes. Called 911 and transported to hospital, admitted, did an MRI and EEG, both came out normal.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Gaze palsy, Hypotonia, Lip discolouration, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Per mom patient was crying a lot after vaccine. Not wanting to eat refused bottle. Pt had a seizure a day after vaccine. No fever. Mid November had an episode of vomiting, acting weak, seemed limp. 12/1 was seen her for f/u and got flu vaccine, next day had GI sx, Mom layed down with him to take a nap, his whole body began shaking, everything deviated to the left, arms went up and to left, eyes looked to left, purple lips, lasted 2 minutes. Called 911 and transported to hospital, admitted, did an MRI and EEG, both came out normal.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Per mom patient was crying a lot after vaccine. Not wanting to eat refused bottle. Pt had a seizure a day after vaccine. No fever. Mid November had an episode of vomiting, acting weak, seemed limp. 12/1 was seen her for f/u and got flu vaccine, next day had GI sx, Mom layed down with him to take a nap, his whole body began shaking, everything deviated to the left, arms went up and to left, eyes looked to left, purple lips, lasted 2 minutes. Called 911 and transported to hospital, admitted, did an MRI and EEG, both came out normal.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On unspecified dates on or after 05-AUG-2015, the patients was vaccinated with improperly stored doses of ROTATEQ (dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported for any patient. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a multiple unspecified patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored ROTATEQ orally, lot # L008997, expiration date 04-DEC-2016 (dose was not provided). No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18=MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to unspecified number of patients. On unknown dates ranging from 15-JUN-2015 through 07-DEC-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (dose and route not reported, lot # K005177, expired date: 10-APR-2016) (Incorrect product storage). No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to unspecified number of patients. On unknown dates ranging from 15-JUN-2015 through 07-DEC-2015 the patients were vaccinated with improperly stored PEDVAXHIB (dose and route not reported, lot # L014427, expired date: 09-MAR-2018) (Incorrect product storage). No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since 02-NOV-2015, the patients were inadvertently administered with improperly stored doses of GARDASIL (lot# J010668, expiration date 29-APR-2016, lot# K007264, expiration date 02-MAR-2017, lot# K011325, expiration date 08-APR-2017, strength, dose and route unknown). No adverse effects had been reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 51 year old female patient. The patient was allergic to sulfanilamide and had no pertinent medical history. On 08-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). Concomitant therapies included omeprazole and RESTORIL. After the vaccination, on an unknown date of December 2015 the patient noted that the site of the injection was red, warm and itchy. On 10-DEC-2015, the patient came to the pharmacy for guidance. The pharmacist confirmed that it was not rash. No treatment was given for the event and no lab diagnostics was performed. The outcome of the events were not recovered. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to two unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in December 2015 (reporter as since 04-DEC-2015), the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # reported as L029466, expiration date 06-AUG-2017, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 05-NOV-2015. the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016)(dose and route not reported). The temperature excursion was 53.8 F for 10/75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concomitant condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored dose of ROTATEQ, orally (strength, dose, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 17-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K012918, Expiry date: 28-FEB-2016 (dose and route not specified). No adverse effects were reported. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Body temperature increased, Decreased appetite, Dizziness
Clinical narrative: Monday evening around 6:00 pm, I started feeling like crap. I took my temp. it was 102 degrees. I took TYLENOL. My arm was huge. It was beet red very very hot. And swollen very huge. Couldn't get no clothes to fit my arm. Was in bed from Mon. 30th night until Tues. night 11:20 pm. My fever broke. I couldn't even function, held on to all stuff to walk. Very weak. No appetite at all. I was very very sick. Went to doc on Dec. 3. She was nasty. Not a caring bone in her body. My arm was terrible. All she said you have a reaction from your shots. Oh kids get this, I couldn't stay awake any of those days. I was in La La land. Brain wouldn't work at all. I have not been this sick in years. No more shots for me! I had a nurse look at it Tues. morning too. Bad red rash. High temp. and short of air. Dizzy and aching body real bad (all over). Light headed. Very swollen (left) arm. Wasn't myself until Friday Dec. 4th was feeling better. Still couldn't think.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Gait disturbance, Hypersomnia
Clinical narrative: Monday evening around 6:00 pm, I started feeling like crap. I took my temp. it was 102 degrees. I took TYLENOL. My arm was huge. It was beet red very very hot. And swollen very huge. Couldn't get no clothes to fit my arm. Was in bed from Mon. 30th night until Tues. night 11:20 pm. My fever broke. I couldn't even function, held on to all stuff to walk. Very weak. No appetite at all. I was very very sick. Went to doc on Dec. 3. She was nasty. Not a caring bone in her body. My arm was terrible. All she said you have a reaction from your shots. Oh kids get this, I couldn't stay awake any of those days. I was in La La land. Brain wouldn't work at all. I have not been this sick in years. No more shots for me! I had a nurse look at it Tues. morning too. Bad red rash. High temp. and short of air. Dizzy and aching body real bad (all over). Light headed. Very swollen (left) arm. Wasn't myself until Friday Dec. 4th was feeling better. Still couldn't think.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Malaise, Mental impairment, Pain, Peripheral swelling, Rash erythematous
Clinical narrative: Monday evening around 6:00 pm, I started feeling like crap. I took my temp. it was 102 degrees. I took TYLENOL. My arm was huge. It was beet red very very hot. And swollen very huge. Couldn't get no clothes to fit my arm. Was in bed from Mon. 30th night until Tues. night 11:20 pm. My fever broke. I couldn't even function, held on to all stuff to walk. Very weak. No appetite at all. I was very very sick. Went to doc on Dec. 3. She was nasty. Not a caring bone in her body. My arm was terrible. All she said you have a reaction from your shots. Oh kids get this, I couldn't stay awake any of those days. I was in La La land. Brain wouldn't work at all. I have not been this sick in years. No more shots for me! I had a nurse look at it Tues. morning too. Bad red rash. High temp. and short of air. Dizzy and aching body real bad (all over). Light headed. Very swollen (left) arm. Wasn't myself until Friday Dec. 4th was feeling better. Still couldn't think.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Skin warm
Clinical narrative: Monday evening around 6:00 pm, I started feeling like crap. I took my temp. it was 102 degrees. I took TYLENOL. My arm was huge. It was beet red very very hot. And swollen very huge. Couldn't get no clothes to fit my arm. Was in bed from Mon. 30th night until Tues. night 11:20 pm. My fever broke. I couldn't even function, held on to all stuff to walk. Very weak. No appetite at all. I was very very sick. Went to doc on Dec. 3. She was nasty. Not a caring bone in her body. My arm was terrible. All she said you have a reaction from your shots. Oh kids get this, I couldn't stay awake any of those days. I was in La La land. Brain wouldn't work at all. I have not been this sick in years. No more shots for me! I had a nurse look at it Tues. morning too. Bad red rash. High temp. and short of air. Dizzy and aching body real bad (all over). Light headed. Very swollen (left) arm. Wasn't myself until Friday Dec. 4th was feeling better. Still couldn't think.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored PROQUAD (Merck) (lot # L031602, expiration date 18-FEB-2017; lot # L034933, expiration date 11-MAR-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Screaming
Clinical narrative: Episodes of crying 30 minutes at a time - difficult to console after 2 month shots - some episodes of screaming - decreased appetite.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: This initial spontaneous report was received from a physician referring to a currently 23 year-old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On an unspecified date in 2010, the patient completed the GARDASIL series (dose, route, frequency, dates of vaccinations, lot# and expiration dates were not reported). There was no concomitant medication described. On an unknown date after receiving GARDASIL, the patient developed low grade squamous intraepithelial lesion. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was unknown. The relatedness between the event to GARDASIL was not reported. Additional information is not expected as there is not consent to follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Swelling face
Clinical narrative: Patient received 2 m vax and shortly afterwards had associated facial erythema and swelling. No treatment given.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt states swelling and pain in upper arm at injection site. Primary doctor put patient on KEFLEX 25mg 1 capsule every 6 hours x6 days.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Headache, Muscle rigidity, Muscle tightness, Pyrexia
Clinical narrative: Patient received a Hepatitis A vaccine #2 at 1630 on 12/8/15. Mom reports a high fever and headaches 2 hours later. Mom states her muscles were tight and rigid. Physician on call recommended ibuprofen 800 mg which helped. Remains tired.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Received PREVNAR 13 on 12/8/15. Tuesday evening, ran fever increased to 101.0 F, body aches, small amount of redness at injection site. 12/11/15 morning redness/swelling from shoulder to elbow. Warm, itchy.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Received PREVNAR 13 on 12/8/15. Tuesday evening, ran fever increased to 101.0 F, body aches, small amount of redness at injection site. 12/11/15 morning redness/swelling from shoulder to elbow. Warm, itchy.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Electrocardiogram, Nausea, Vomiting
Clinical narrative: Pt received PREVNAR 13 in office, reports developing N/V, chest pain 2-3 days later, then again 2 days after that. No arm pain or swelling. No fever.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in with reddish, swollen and warm to the touch arm. She went to her MD and he gave her some prescriptions.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Fluid retention, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: Did not sleep for two days. Pain red and swollen at shot site. Water retention, could not breathe and heart beat rapidly. Had to call medics, they heard fluid in left lung.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Insomnia, Pulmonary oedema
Clinical narrative: Did not sleep for two days. Pain red and swollen at shot site. Water retention, could not breathe and heart beat rapidly. Had to call medics, they heard fluid in left lung.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: Pt reported onset of severe pain 10/10 in (L) deltoid muscle (injection site) beginning 1 day after vaccination. Took 1000 mg ibuprofen per pt. When she presented for 2nd vaccine dose 12/9/15, she reports still having muscle pain and limited range of motion. Encouraged to see PCP, apply heat, continue to take ibuprofen. She describes pain as "deep", not in joint/bone. Improved but still present 12/9/15.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt developed an area of redness, swelling, and pain at least 12 hours after vaccination. The are increased in size and pain, and by Tuesday pt referred to urgent care by her doctor. She was prescribed KEFLEX 500 Q 6-11 x 7 days and SEPTRA DSQ12H x 7 days. Pt to follow up with her primary MD on Thursday (12/10).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Local swelling, Pain
Clinical narrative: Pt received vaccines on 12/8/15. Returned on 12/11/15 due to localized swelling, erythema, induration, and pain. Reaction started on 12/9/15.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-SEP-2015 the patient was vaccinated with improperly stored ROTATEQ lot # L000434 and expiry date of 10-JUL-2016 orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 13-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 09-NOV-2015, the patient was vaccinated with an improperly store dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored VARIVAX (lot # K021487, expiration date 03-NOV-2016; lot # K005428, expiration date 15-APR-2016; lot # L023594, expiration date 26-JUN-2017; lot # L013826, expiration date 21-APR-2017; lot # L019124, expiration date 27-MAY-2017; lot # L026405, expiration date 15-JUL-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of VAQTA (strength, does, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.