chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm.fever 99.9
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: intramuscular pain directly after (lasted approx. 24 hours); the following day, mild headache, fatigue and injection site red and slightly swollen; today is the 5th day and the area around the injection site is increasingly swollen, warm to the touch and itchy.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia
Clinical narrative: intramuscular pain directly after (lasted approx. 24 hours); the following day, mild headache, fatigue and injection site red and slightly swollen; today is the 5th day and the area around the injection site is increasingly swollen, warm to the touch and itchy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: FEVER SHIVERING  HEADACHE  ACUTE MUSCLE ACHE
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: About an hour after vaccination, started with body ache, severe chills, shaking badly. Had low grade fever ranging 99.3 - 100.7.  Patient went to urgent care that evening  and they administer COVID-19 test.  No medications were given but advised to take Tylenol.  Negative test came back on 8/19/20.  Patient went to bed early and woke up with chills again and nausea, took Ibuprofen and felt better a few hours later.  By 11 AM (24 hours after getting the shot), gradually felt better.  Now almost back to normal.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: About an hour after vaccination, started with body ache, severe chills, shaking badly. Had low grade fever ranging 99.3 - 100.7.  Patient went to urgent care that evening  and they administer COVID-19 test.  No medications were given but advised to take Tylenol.  Negative test came back on 8/19/20.  Patient went to bed early and woke up with chills again and nausea, took Ibuprofen and felt better a few hours later.  By 11 AM (24 hours after getting the shot), gradually felt better.  Now almost back to normal.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Hyperhidrosis, Injection site pain
Clinical narrative: Severe pain in injection sight, Joint pain, sweating.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness postural, Malaise
Clinical narrative: Patient received the flu shot 8/19/20 and ended up sitting down on the ground because she was not feeling well. She tried to get up and instantly felt dizzy and went down to the ground. During this moment, we put her legs up and put her on her back. We provided her ice packs and also provided her some water to cool her down. She eventually felt better and we walked her to her car. My other pharmacist also called to check up on her 1 hour post leaving the store.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: pt administered vaccine in left deltoid on Friday, 08/14/2020. On sunday she began to experience swelling and itchiness around the site of injection. She presented to pharmacy today 08/19/20 with a chief complaint of itchiness around injection site asking for further guidance. the injection site was red and warm to the touch approximately 2-3 inches in diameter from site of injection. Patient was given benadryl and tylenol. Denied fever or any other symptoms. Patients primary care physician was also notified. Patient to follow-up with physician tomorrow AM (08/20/20) for further evaluation.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Facial paralysis
Clinical narrative: 8/14/2020 developed droop of eyelid and then developed one sided facial droop.  Seen in ER 8/16/2020 and diagnosed with Bell's palsy.  Patient has had this previously, but feels it was brought on by vaccine
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Hypotension, Pain in extremity
Clinical narrative: LOW BP 111/50, WEAKNESS, SORE ARMS, HEADACHE
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms.  She got a 3rd dose.  She already received the 2 original doses in 2019
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shots were administered in right deltoid muscle on 8/17/20, administered 1 inch apart.  patient reports arm is red, swollen, and warm to touch.  Her bicep muscle of that arm is also swollen
Age: 70.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient reports experiencing chills, fever of up to 104F, redness and swelling in the arm after receiving Fluad and Pneumovax. Patient was advised to take acetaminophen or ibuprofen for fever and Benadryl to help with swelling and redness in the arm. Patient reports symptoms lasted for 48 hours. Patient presented to pharmacy on 8/18 and swelling has subsided but still can see traces of some redness on the arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Seizure, Visual impairment
Clinical narrative: Patient was administered Menveo in our office.  A few minutes later she was sitting in a chair with Dad after the vaccine was administered and then said her vision went dark on the outsides but denies feeling lightheaded and then Dad said she convulsed a few times and then she woke up not remembering her body making movements.   Dad yelled for help and clinical staff came into the room.  She was laid down on the exam table, a cool compress was applied to her forehead, vitals were taken and she was given a sucker and then examined by the doctor.  She felt better when she was laid down on the exam table.  She left the office with her father.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient had High fever 101+ for 3-4 days and had diarrhea for 5-7 days
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Initial insomnia, Irritability, Screaming
Clinical narrative: Baby is inconsolably fussy - crying and screaming more than she ever has in her life, for longer periods of time. Will not eat for long periods (only 10 min then screams) and struggles to sleep (wakes screaming or takes extra long to fall asleep).
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: had pain the night of injection, called the pharmacy the next morning. patient stated he was in a lot of pain and cannot even lift the coffee cup with his left arm. told patient to take ibuprofen and ice and massage it. have been following up with the patient throughout the week. he stated he can not bear the pain unless he takes a pain medication. he has been taking ibuprofen 600 mg alternating with Advil 200mg. took a hydrocodone left over from dental procedure but that did not help. today the patient stated he is 80% better/back to normal function. he doesn't have any tingling, swollen arm or redness
Age: 13.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Full blood count, Streptococcus test, Streptococcus test negative, Tic
Clinical narrative: Verbal + motor tics.  Put on clonidine
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right upper arm started swelling, became hot and itchy  and tender to touch. Informed MD 8-18-20 late evening  and instructed to apply cold compress, give Tylenol and Benadryl. Marked redness - symptoms spreading since started. Seen in  office 8-19-20 2:45 PM. Right upper detoid area red, swollen indurated 5x5 cm. left upper arm red 2cm  Given rx for Zyrtec and prednisone.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Right upper arm started swelling, became hot and itchy  and tender to touch. Informed MD 8-18-20 late evening  and instructed to apply cold compress, give Tylenol and Benadryl. Marked redness - symptoms spreading since started. Seen in  office 8-19-20 2:45 PM. Right upper detoid area red, swollen indurated 5x5 cm. left upper arm red 2cm  Given rx for Zyrtec and prednisone.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: red welp with hard knot at injection site (LA) slightly itchy, slight pain Notified mother to give her Tylenol for pain and Benadryl 25mg every 6 hrs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: red welp with hard knot at injection site (LA) slightly itchy, slight pain Notified mother to give her Tylenol for pain and Benadryl 25mg every 6 hrs.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Erythema, Fear, Panic reaction
Clinical narrative: After I administered the vaccines, the patient stated that she couldn't breath. She was very frantic and panicked and her face turned red. She screamed for an inhaler, but I told her we can administer Epi-pen. Once she received the dose she started breathing normal and felt better. Emergency services came and cleared her to go home. She didn't want to go to the ER. The patient came to pharmacy urging us to give her a high dose flu shot and pneumovax. The technician processed the vaccines. However, the system did not prompt or stop the tech from giving her these outside of her age restriction, as it used to in the past.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was given HD instead of Fluzone Quad
Sex: F
Vaccine: HPV4
Symptoms: Activated partial thromboplastin time prolonged, Arthralgia, Coagulopathy, Epistaxis, Fatigue
Clinical narrative: Immune Thrombocytopenia / spontaneous nose bleeds / excessive and spontaneous bruising, petechiae / uncontrolled and heavy vaginal bleeds / heavy menstrual periods; fatigue; joint pain; severe headache; The patient was inoculated with GARDASIL on 17-JAN-2012, 26-JUL-2012 and 23-JAN-2013 (Not administered within a 1-year period); This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 17-JAN-2012, after a routine wellness exam, the patient was inoculated the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported) for prophylaxis and preventing cervical cancer at a clinic. On 26-JUL-2012 (reported as approximately six months later) and 23-JAN-2013, the patient was vaccinated with the second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported), respectively. On an unknown date, following the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination schedule, the patient experienced various coagulation  and bleeding related adverse events, including, but not limited to, coagulation defects, thrombocytopenia, prolonged partial thromboplastin time, excessive and spontaneous bruising, petechiae, a substantially reduced platelet count, spontaneous nose bleeds, uncontrolled and heavy vaginal bleeds, heavy menstrual periods, and excessive bleeding. The hemorrhaging and excessive vaginal and nose bleeding were so severe. The patient was diagnosed with immune thrombocytopenia. Besides, the patient experienced severe headaches, fatigue, and joint pain. The patient was treated for the events. The outcome of the events was considered as not recovered. Causality assessment was related.
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Headache, Immune thrombocytopenia, Increased tendency to bruise, Menorrhagia
Clinical narrative: Immune Thrombocytopenia / spontaneous nose bleeds / excessive and spontaneous bruising, petechiae / uncontrolled and heavy vaginal bleeds / heavy menstrual periods; fatigue; joint pain; severe headache; The patient was inoculated with GARDASIL on 17-JAN-2012, 26-JUL-2012 and 23-JAN-2013 (Not administered within a 1-year period); This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 17-JAN-2012, after a routine wellness exam, the patient was inoculated the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported) for prophylaxis and preventing cervical cancer at a clinic. On 26-JUL-2012 (reported as approximately six months later) and 23-JAN-2013, the patient was vaccinated with the second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported), respectively. On an unknown date, following the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination schedule, the patient experienced various coagulation  and bleeding related adverse events, including, but not limited to, coagulation defects, thrombocytopenia, prolonged partial thromboplastin time, excessive and spontaneous bruising, petechiae, a substantially reduced platelet count, spontaneous nose bleeds, uncontrolled and heavy vaginal bleeds, heavy menstrual periods, and excessive bleeding. The hemorrhaging and excessive vaginal and nose bleeding were so severe. The patient was diagnosed with immune thrombocytopenia. Besides, the patient experienced severe headaches, fatigue, and joint pain. The patient was treated for the events. The outcome of the events was considered as not recovered. Causality assessment was related.
Sex: F
Vaccine: HPV4
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia, Vaginal haemorrhage
Clinical narrative: Immune Thrombocytopenia / spontaneous nose bleeds / excessive and spontaneous bruising, petechiae / uncontrolled and heavy vaginal bleeds / heavy menstrual periods; fatigue; joint pain; severe headache; The patient was inoculated with GARDASIL on 17-JAN-2012, 26-JUL-2012 and 23-JAN-2013 (Not administered within a 1-year period); This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 17-JAN-2012, after a routine wellness exam, the patient was inoculated the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported) for prophylaxis and preventing cervical cancer at a clinic. On 26-JUL-2012 (reported as approximately six months later) and 23-JAN-2013, the patient was vaccinated with the second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (route of administration, lot number and expiration date were not reported), respectively. On an unknown date, following the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination schedule, the patient experienced various coagulation  and bleeding related adverse events, including, but not limited to, coagulation defects, thrombocytopenia, prolonged partial thromboplastin time, excessive and spontaneous bruising, petechiae, a substantially reduced platelet count, spontaneous nose bleeds, uncontrolled and heavy vaginal bleeds, heavy menstrual periods, and excessive bleeding. The hemorrhaging and excessive vaginal and nose bleeding were so severe. The patient was diagnosed with immune thrombocytopenia. Besides, the patient experienced severe headaches, fatigue, and joint pain. The patient was treated for the events. The outcome of the events was considered as not recovered. Causality assessment was related.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Administration site pain, Administration site warmth, Injected limb mobility decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Symptoms started later that night. Area was sore around the administration area.  At night woke up in excruciating pain on both shoulders, all the way down arms and fingers--could barely move them.  First area was very warm and then excruciating pain started. Patient was up all night and could not move both arm and fingers.  Patient worked through pain and went to work and work sent her directly over to the hospital.   Patient went to Hospital.  Patient was not admitted. Patient doesn't remember if given shot for pain or not but given 2 braces to put on hands and sent back to work.  Doctor in the ER did not put in visit notes any reference that it could be related to the the shot. Patient when to back pain doctor that same month and doctor checked arms and was told that everything was fine, that there was no arthritis or cartel tunnel. Per patient, it took about 1.5 months for both symptoms to disappear. Patient took Ibuprofen but it did not help with pain. Paint tried putting pillows and ice-packs and did not work. Patient just had to live with the pain. On and off patient has a little bit of pain but i feels like it is gone.   Patient did not have any problems after Zostavax about 8 years ago. Patient has received a Flu vaccine in the past every year with no problems.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Symptoms started later that night. Area was sore around the administration area.  At night woke up in excruciating pain on both shoulders, all the way down arms and fingers--could barely move them.  First area was very warm and then excruciating pain started. Patient was up all night and could not move both arm and fingers.  Patient worked through pain and went to work and work sent her directly over to the hospital.   Patient went to Hospital.  Patient was not admitted. Patient doesn't remember if given shot for pain or not but given 2 braces to put on hands and sent back to work.  Doctor in the ER did not put in visit notes any reference that it could be related to the the shot. Patient when to back pain doctor that same month and doctor checked arms and was told that everything was fine, that there was no arthritis or cartel tunnel. Per patient, it took about 1.5 months for both symptoms to disappear. Patient took Ibuprofen but it did not help with pain. Paint tried putting pillows and ice-packs and did not work. Patient just had to live with the pain. On and off patient has a little bit of pain but i feels like it is gone.   Patient did not have any problems after Zostavax about 8 years ago. Patient has received a Flu vaccine in the past every year with no problems.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: administered MMR II that was improperly stored in the freezer.; This spontaneous report has been received from a physician concerning a patient of unknown age and gender.The patient's concurrent conditions, historical drugs and medical history were not reported.      On 24-JUL-2020,  the patient was vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA)  Lot # S020161 and expiration date 30-JUN-2021 for prophylaxis (strength, frequency and patient route of administration were not reported).    The temperature excursion was reported to be at -10°F, and a previous temperature excursion was reported below 36 °F (10°F) for 50 minutes.There was digital data logger involved in the report.   It was reported that  the improper storage was adverted until 04-AUG-2020 due to an updated guidance regarding the storage of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001689: US-009507513-2008USA002399:
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; the patient was administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-MAR-2020, the patient received improperly stored vaccine doses. At 11:08, the patient received an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S030093 (expiration date 24-MAR-2021), 0.5 mL subcutaneously (SC) on the right arm (RA) and at 11:10, an improperly stored dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX) lot # PP9L5 (expiration date not reported), 0.5 mL intramuscularly (IM) on the RA. Both vaccines were administered for prophylaxis.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored between -14 Celsius degrees and -10 Celsius degrees (mainly at -11.2 Celsius degrees) for 3 hours and 42 minutes and a digital data logger was involved; for diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX), no information was reported. No adverse effects were reported.  This was one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2003USA002275: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008889: US-009507513-2008USA008883: US-009507513-2008USA008890: US-009507513-2008USA008892: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.On 06-MAR-2020, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, intramuscular in the left thigh for prophylaxis(lot # reported as 747P5 with expiration date not provided).No adverse event was provided.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2003USA002275:
Sex: U
Vaccine: HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 13-MAR-2020 at 09:33, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219, expiration date on 03-MAR-2022, at a dose of 0.5 mL, intramuscular on the left thigh (LT). On that same day, the patient also received pneumococcal 13v conj vaccine (CRM197). Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported". No adverse events reported.   This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008889: US-009507513-2008USA008876: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 16-MAR-2020 at 10:34, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219, expiration date on 03-MAR-2022, at a dose of 0.5 mL, intramuscular on the right thigh (RT). On that same day, the patient also received pneumococcal 13v conj vaccine (CRM197), diphtheria toxoid, hepatitis B virus vaccine rHBsAg (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (PEDIARIX) and rotavirus G1 P1 vaccine live (89-12) (ROTARIX). Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported". No adverse events reported.   This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008889: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008905: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 23-MAR-2020 the patient was vaccinated with impoperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S023219, 0.5 milliliter, intramuscular in the right thigh for prophylaxis.  Other suspect therapies included pneumococcal conj vaccine (unspecified)(PNEUMOCOCCAL CONJ VACCINE (UNSPECIFIED)), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ).    On 23-MAR-2020 the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB).     {Additional information has been requested. / Additional information is not expected.} .; Sender's Comments:  US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2003USA002275:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.On 25-MAR-2020, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, intramuscular in the left thigh for prophylaxis(lot # reported as 747P5 with expiration date not provided).No adverse event was provided. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008889: US-009507513-2008USA008890:
Sex: U
Vaccine: HPV4, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was vaccinated with improperly stored vaccines.; This spontaneous report was received from a nurse referring to patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 05-MAR-2020 15:19, the patient was vaccinated with improperly stored dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), 0.5 milliliter, intramuscular in the right arm with lot # reported as "9139Z " (strength, frequency, and expiration date were unknown) and with an improperly stored dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP) at 15:10, 0.5 milliliter, intramuscular in the left arm with lot # reported as "9139Z " (strength, frequency, and expiration date were unknown) for prophylaxis. The temperarure excursion was no reported for the these vaccines. No adverse effects reported.; Sender's Comments:  US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008875: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2008USA008890: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The patient was vaccinated with an improperly stored doses of Hepatitis A vaccine.; This spontaneous report was received from a nurse referring to patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 02-MAR-2020 at 08.39,  the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(manufacturer unknown), 0.5 milliliter, intramuscular in the right arm (strength, frequency, and expiration date were unknown) with lot # reported as "747P5"  for prophylaxis. The temperarure excursion was no reported for the other vaccine. No adverse effects reported.  Lot number 747P5 is an invalid lot number for hepatitis a vaccine, inactivated.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008932: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904:
Sex: U
Vaccine: HEPA, HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 10-MAR-2020 at 11:09 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the right tight (RT) and with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA)  lot #  reported as 747P5 at a dose of 0.5 mL intramuscularly (IM) on the left tight (RT). Also, an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   Lot # 747P5 is not a valid number for Hepatitis A Vaccine, Inactivated.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008921: US-009507513-2008USA008933: US-009507513-2008USA008932: US-009507513-2008USA008903: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008890: US-009507513-2008USA008904: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008875:
Sex: U
Vaccine: HPV4, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:50 hours, the patinet was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with lot # reported as R036912 (product lot number issue) at a dose of 0.5 mL intramuscularly (IM) on the Left Arm (LA) and with an improperly stored dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # U6575AA; for prophylaxis, however no adverse effects reported.   Administered dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   Lot # R036912 is not a valid number for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008904: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008898: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008903: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008907: US-009507513-2008USA008906: US-009507513-2008USA008890: US-009507513-2008USA008877:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: a nurse stated that an expired PROQUAD was administered to a patient.; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 13-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot number S003862, which has been verified to be valid, expiration date reported and validated as 08-AUG-2020), as prophylaxis (expired product administered) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). Additionally, the physician stated there were no previous temperature excursions.  At the time of reporting, the outcome of expired product administered was unknown.
Age: 1.33
Sex: F
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: the patient was administered MMR II intramuscular; developed a lump on the leg at administration site / the patient still has a lump on her leg, and it is getting smaller; This spontaneous report was received from a medical assistant, referring to a 16-month-old female patient. The patient had no pertinent medical history, concurrent conditions, previous drug reactions, or allergies. Concomitant medications included albuterol. Laboratory diagnostics or studies were not performed.  On 18-JUN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, intramuscularly (strength, vaccination scheme and anatomical site of injection were not provided; lot number S023656, expiration date: 30-JUL-2021) as prophylaxis (incorrect route of product administration). The use of a sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) was also reported. On the same date, in an unspecified amount of time after the administration, the patient developed a lump on the leg at administration site. The patient still had a lump on her leg, and it was getting smaller (vaccination site mass). It was reported that the patient sought medical attention and saw the physician. In addition, acetaminophen (TYLENOL) and warm compresses were given as treatment for the adverse event.  The outcome of vaccination site mass was reported as improving. The causal relationship between the suspect therapies and the aforementioned event was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; Both live vaccines (PROQUAD and VARIVAX) were given together on 07-AUG-20.; This spontaneous report as received from a medical assistant, referring to a 12-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 07-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliters (ml) (lot number R033653 has been verified to be valid, expiration date reported and validated as 20-NOV-2020) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 ml (lot number S021732 has been verified to be valid, expiration date reported and validated as 10-JAN-2021) (strength, vaccination scheme frequency, route of administration, and anatomical location were not reported for both suspect vaccines) as prophylaxis (inappropriate schedule of product administration). There were no temperature excursions reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse (RN) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 12-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (1 dosage form, lot # S003862 with expiration date 08-AUG-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered).