chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 84-year-old, female patient of an unknown ethnicity was injected PREVNAR 13 vaccine 0.5 ml (one syringe) on 10Nov2015 in the right arm (deltoid region). The lot number was reported as M20639, expiration date was Apr2017 and NDC number was 00005-1971-05. The frequency and route of administration were unknown. The relevant medical history included diabetes, allergic reaction to iodine and penicillin on an unknown date. The concomitant medication and past drug history were unknown. On 10Nov2015, the patient experienced cellulitis in the right arm. The relevant lab data was unknown. The action taken with PREVNAR 13 in response to the event was unknown. Therapeutic measures taken were unknown. As of 22Dec2015, the clinical outcome of the event cellulitis in the right arm was unknown.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Chest pain
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug hypersensitivity, Eye swelling, Eyelid oedema, Fatigue
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Gingival discolouration, Headache, Hypersensitivity, Hypertension, Hypotension
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Neurological examination, Ophthalmological examination, Oral pustule, Pyrexia
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Specialist consultation, Splenomegaly, Stomatitis, Throat tightness
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Yellow skin
Clinical narrative: Eyes puffed, throat closing, dizziness, weak, rash over whole body - coming and going for months. White pus in mouth, bad sores in mouth, gum white for two weeks, joint pain, back aches, spleen enlarged, chest pain, body rash, yellow skin, very tired, headache, 104 fever, high blood pressure go to low blood pressure. The GARDASIL vaccine was such a horrible experience for my daughter, almost causing her to lose her life. Even today she still endures allergic reactions to medicines and headaches (this is something she encountered only after the vaccine). She lost 3 months of her life to being severely sick from this vaccine. Her health has never been the same. The past 7 1/2 years make me very sorry for having her vaccinated. Many of her friends have had rashes, headaches and tiredness, but it seems her reaction was severe. I sincerely thank you for allowing me to share this experience with you.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Mobility decreased, Myelitis transverse, Plasmapheresis
Clinical narrative: Patient was diagnosed with transverse myelitis. Lost almost all physical ability. He was given steroids (6 doses) and had 6 plasmapheresis treatments.
Age: 0.82
Sex: M
Vaccine: FLU4
Symptoms: Autopsy, Death, Pyrexia, Rhinorrhoea
Clinical narrative: According to parents, child developed some fever and runny nose 2 days after vaccine. Was doing OK - had a bottle at 3 AM on 12-24-2015 and was put back to bed and found dead in crib in morning. Autopsy by County coroner found no cause.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Eczema, Injection site erythema, Pruritus
Clinical narrative: Overnight at vax site of injection is red is 1 inch-1 1/2 inch. Days later, eczema started, pharmacist recommended cortisone and AQUAPHOR. On 10/30 went to doctor who sent pictures to dermatologist who prescribed prednisone for the itchiness and hydroxyzine as an antihistamine. This morning already feeling better and redness reduced.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: HPV 9 Vaccine was administered inadvertently to 11 week old infant. No immediate injection reaction.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood glucose normal, Chills, Dyspnoea, Headache
Clinical narrative: Severe shaking, nausea, chilling, fever, weakness, shortness of breath, headache.  Most symptoms ended at approx. 7:30 PM, but still some weakness. Totally OK next day.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Severe shaking, nausea, chilling, fever, weakness, shortness of breath, headache.  Most symptoms ended at approx. 7:30 PM, but still some weakness. Totally OK next day.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reported on 12/24/2015 that he still has some pain at the injection site and sometimes when he tries to swing his arm he feels sharp pain.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, swelling of arm, warmth in adjacent area. BENADRYL.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Skin discolouration
Clinical narrative: After vaccines were given approximately 35 minutes dad exited the room and asked me to look at the child because she had turned grey. Myself and another nurse witnessed to complexion change and told Dr.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Injection site pain, feeling of numbness down the arm. limited motion in the arm. Patient took OTC pain relievers to help the pain. As of today pain is gone but some numbness remains, motion has returned to almost full range.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Feeling cold, Mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Severe chills and feeling of cold for 6 hours. 7 blankets applied and TYLENOL taken. Severe pain in arm/inability to loft arm. Vomiting after 36 hours w/severe pain.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Received flu vaccine 10/07/15 at 11:55 am. States arm was sore at site but on 10/10/15 at 7:30 am when she woke up the (L) arm was more sore and was swollen down past the elbow. Went to the ER and was given NAPROSYN and a shot.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states arm is sore and it is hard to lift the arm. She has been in physical therapy and has been given exercises to help the arm.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Fatigue, Irritability, Joint stiffness, Nausea
Clinical narrative: Joints were stiff, pain, irritability, blurred vision, confusion, fatigue, nauseous.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Vision blurred
Clinical narrative: Joints were stiff, pain, irritability, blurred vision, confusion, fatigue, nauseous.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at site of injection.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Nausea, Tinnitus
Clinical narrative: Patient develop hypotension BP 62/31 w/in 3-5 minutes after vaccination of GARDASIL 9 over left deltoid (IM). Patient had nausea, dizziness, tinnitus. The patient was closely observed and monitored, BP improved to 72/35 after 10 mins. Further improved to 95/50 after 5 min HR 64-70/min. So patient completely felt better after 20 minutes total. Discharged after.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. awoke at 2 am with c/o (L) deltoid pain, redness, swelling, feels like knot in arm. Can't lift arm and muscle ache. (no fever) sl. warm to touch.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Pt. awoke at 2 am with c/o (L) deltoid pain, redness, swelling, feels like knot in arm. Can't lift arm and muscle ache. (no fever) sl. warm to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site mass, Peripheral swelling
Clinical narrative: Pt. reported red swollen hive 2-4 hr. after shot, pt. called clinic 12/24 in pm. to report swelling size of golf ball and redness and warmth of upper arm. She was advised by provider on call to use ZANTAC and ZYRTEC and ibuprofen on 12/26 patient presented to ER with redness, swelling of arm. She was treated with BENADRYL - allergic reaction and KEFLEX for cellulitis. By 12/24 patient reported decreased swelling and redness and small lump at inject. site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Pt. reported red swollen hive 2-4 hr. after shot, pt. called clinic 12/24 in pm. to report swelling size of golf ball and redness and warmth of upper arm. She was advised by provider on call to use ZANTAC and ZYRTEC and ibuprofen on 12/26 patient presented to ER with redness, swelling of arm. She was treated with BENADRYL - allergic reaction and KEFLEX for cellulitis. By 12/24 patient reported decreased swelling and redness and small lump at inject. site.
Age: 13.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4
Symptoms: Dizziness, Feeling abnormal, Pallor
Clinical narrative: 2-3 minutes after the GARDASIL injection, patient felt "funny" and looked pale. He felt faint. He was put in a supine position. BP 105/62 after 5 mn. BP 110/68. Patient observed for 40 minutes and remained stable. Pt called next day 24 hour later and he was normal.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Staring
Clinical narrative: SAME AS ABOVE.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Activities of daily living impaired, Blood immunoglobulin E increased, Blood test, Cow's milk intolerance
Clinical narrative: Was tired about a week after shot.  I assumed this was either standard reaction to shot or allergies.  However, symptoms just kept worsening. Eyes became itchy and red on 4/16/15; red patch of skin running down from both eyes (width of eyes) with small bumps within the patches.  Called allergist and he prescribed eye drops by phone.  The following week, his teacher told me that he was trying to be attentive in class but that as she was watching him his eyes would roll to the back of his head.  Listless and lethargy continued.  Told his friends he couldn't play until he was better.  Never cries and loves school and was crying before school b/c he was tired, after school b/c he didn't want to do homework (has only ever complained of homework twice), and cried before bed b/c he was so tired.  Took to Dr. on May 7th and his liver was enlarged and IgE was 3 times normal levels.  We have run from doctor to doctor since trying to figure out what is wrong as he still has abdominal pain.  We have eliminated foods that he has become sensitive to since shot was administered.  These are certainly dairy and gluten and we are still testing a list of other foods.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Erythema, Eye movement disorder, Eye pruritus, Fatigue
Clinical narrative: Was tired about a week after shot.  I assumed this was either standard reaction to shot or allergies.  However, symptoms just kept worsening. Eyes became itchy and red on 4/16/15; red patch of skin running down from both eyes (width of eyes) with small bumps within the patches.  Called allergist and he prescribed eye drops by phone.  The following week, his teacher told me that he was trying to be attentive in class but that as she was watching him his eyes would roll to the back of his head.  Listless and lethargy continued.  Told his friends he couldn't play until he was better.  Never cries and loves school and was crying before school b/c he was tired, after school b/c he didn't want to do homework (has only ever complained of homework twice), and cried before bed b/c he was so tired.  Took to Dr. on May 7th and his liver was enlarged and IgE was 3 times normal levels.  We have run from doctor to doctor since trying to figure out what is wrong as he still has abdominal pain.  We have eliminated foods that he has become sensitive to since shot was administered.  These are certainly dairy and gluten and we are still testing a list of other foods.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Food allergy, Hepatomegaly, Lethargy, Listless, Milk allergy
Clinical narrative: Was tired about a week after shot.  I assumed this was either standard reaction to shot or allergies.  However, symptoms just kept worsening. Eyes became itchy and red on 4/16/15; red patch of skin running down from both eyes (width of eyes) with small bumps within the patches.  Called allergist and he prescribed eye drops by phone.  The following week, his teacher told me that he was trying to be attentive in class but that as she was watching him his eyes would roll to the back of his head.  Listless and lethargy continued.  Told his friends he couldn't play until he was better.  Never cries and loves school and was crying before school b/c he was tired, after school b/c he didn't want to do homework (has only ever complained of homework twice), and cried before bed b/c he was so tired.  Took to Dr. on May 7th and his liver was enlarged and IgE was 3 times normal levels.  We have run from doctor to doctor since trying to figure out what is wrong as he still has abdominal pain.  We have eliminated foods that he has become sensitive to since shot was administered.  These are certainly dairy and gluten and we are still testing a list of other foods.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Ocular hyperaemia, Rash, Stool analysis
Clinical narrative: Was tired about a week after shot.  I assumed this was either standard reaction to shot or allergies.  However, symptoms just kept worsening. Eyes became itchy and red on 4/16/15; red patch of skin running down from both eyes (width of eyes) with small bumps within the patches.  Called allergist and he prescribed eye drops by phone.  The following week, his teacher told me that he was trying to be attentive in class but that as she was watching him his eyes would roll to the back of his head.  Listless and lethargy continued.  Told his friends he couldn't play until he was better.  Never cries and loves school and was crying before school b/c he was tired, after school b/c he didn't want to do homework (has only ever complained of homework twice), and cried before bed b/c he was so tired.  Took to Dr. on May 7th and his liver was enlarged and IgE was 3 times normal levels.  We have run from doctor to doctor since trying to figure out what is wrong as he still has abdominal pain.  We have eliminated foods that he has become sensitive to since shot was administered.  These are certainly dairy and gluten and we are still testing a list of other foods.
Age: 0.18
Sex: F
Vaccine: DTAP
Symptoms: Crying, Gastrooesophageal reflux disease
Clinical narrative: Infant began crying after every feeding with symptoms most closely related to acid reflux.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swollen tongue
Clinical narrative: After the Patient went home, she saw a rash develop on her arm with the vaccination. It than begin to spread and now she states that it caused some swelling on her tongue. She took 2 Benadryl 25mg tabs that night. 2 days later 12/30/15 she came to the pharmacy to show me the reaction, it has improved but the rash is still there and spreading.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and burning at injection site.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at the site of injection.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Administration site inflammation, Injection site erythema, Mobility decreased
Clinical narrative: Noticed redness and inflammation and administration site, difficulty to raise arm. Redness gradually spread and became larger, came to LBVA to have evaluated. Advised to gentle stretch, apply cold pack take Motrin.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Muscle spasms, Nausea, Pyrexia
Clinical narrative: I experienced fever of 100.9, chills, nausea, muscle cramps in left calf, and inability to raise left arm which was the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Headache, Itching at injection site, swelling, redness, induration, pain, warmth all at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Headache, Itching at injection site, swelling, redness, induration, pain, warmth all at injection site.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, Pain in Left Arm which was pink color. No treatment other than cold compress and one Advil. Condition subsided on 12/7/2015, but began again on 12/9/2016.  Patient was seen by a doctor on 12/10/2015 who prescribed Keflex and condition improved.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Skin warm
Clinical narrative: I contacted my physician and I have a varicella like rash. So far I do not have any blisters, but I have about four bumps within a very large bump taking up the back side of my arm, which look like they may blister up. I was told to take further action if I had more than ten blisters in the large bump. It is extremely painful, and hot to the touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Arm sore, could not move it, swelling down to elbow and across chest, bright red rash. Sore for 3 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Arm sore, could not move it, swelling down to elbow and across chest, bright red rash. Sore for 3 days.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Limb discomfort, Pain, Pyrexia
Clinical narrative: Fever up to 100.2, pain, itchiness at site, arm feels heavy, pressure on arm, then pain all over body few days later. Doctor prescribed hydroxyzine and triamcinolone and OTC Tylenol.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: This spontaneous report was received from a consumer referring to two patients of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patients were vaccinated with zoster vaccine live (manufacturer unknown) (dosage, route, lot# and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified) (dosage, route, lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer stated that on an unknown date the patients developed Guillain-Barre syndrome which they had not recovered from, also informed that they experienced severe complications such as paralysis. Upon internal review Guillain-Barre syndrome was determined to be medically significant. The outcome of Guillain-Barre syndrome was reported as not recovered at the time of this report. This is one of two reports received from the same reporter. Additional information is not expected since there are no contact details for the reporter.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. experienced on injection. Pt continued ongoing pain and swelling. Saw an M.D. who said that nothing could be done.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Pyrexia
Clinical narrative: 3 days after administration patient develops fever and lethargy - ER visit after 4 days hospital admission 7 days after.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated arm became swollen and red at injection site. Pt started on 2 antibiotics and an antifungal after seeking medical attention.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Loss of consciousness, Syncope, Vomiting
Clinical narrative: Client went out to hallway to get a drink of water where he went unconscious to the floor. Witnesses suggested client had a seizure when he awoke he vomited. Examining physician suggests client fainted
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L020189, expiration date: 03-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: 44 yo patient developed a red rash and swelling over the right shoulder two days after receiving a pneumococcal 23 vaccine. Patient expressed pain in shoulder with movement.  Red rash and swelling of the right shoulder, hives on the right shoulder. Ibuprofen 800 mg UD.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 20-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 09-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via company representative, refers to a adolescent, female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The physician reported that on an unknown date the patient received the first two doses of GARDASIL (dosage, route, lot# and expiration date were not reported) and was not specified if the doses were given together or not. Then on 18-DEC-2015 the patient received the third dose of the vaccine but was given GARDASIL 9 subcutaneous, (dosage, lot# and expiration date were not reported). There was not concomitant therapy. On an unspecified date in December 2015, the patient experienced injection site erythema, nausea, pyrexia, injection site pain and injection site swelling. The outcome of the injection site erythema, nausea, pyrexia, injection site pain and injection site swelling was reported as not recovered at the time of this report. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 18-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 09-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports 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 practitioner regarding unspecified number of patients whose demographics were unknown. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2015 (also reported as unspecified dates starting on or after 06-NOV-2015) unspecified number patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot/batch # L023594, expiry date 26-JUN-2017; lot/batch # L029469, expiry date 06-AUG-2017, lot/batch # L032395, 26-AUG-2017) dose, route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports reported by 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-DEC-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # L021214, expiry date 10-JUN-2017 (strength, dose, route of administration and anatomical location were not reported). No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 05-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). NO adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effect reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2014 (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L008684, expiration date: 13-MAR-2017). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 02-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 04-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 23-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Blood test, Pain in extremity, X-ray
Clinical narrative: Three days after the shot I started having pain in both my hands and lower back.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding unspecified number of patients whose demographics were unknown. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2015 (also reported as unspecified dates starting on or after 06-NOV-2015) unspecified number patients were vaccinated with unspecified number of improperly stored doses of PROQUAD (Merck) (lot/batch # L040412, expiry date 13-APR-2017) dose, route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On 01-OCT-2015 the patient was vaccinated with a dose of GARDASIL (lot#, strength, dose, dose# and route unknown). On 30-OCT-2015 the patient was confirmed to be pregnant via a urine screening (exposure during pregnancy). The last menstrual period (LMP) was on 10-SEP-2015 and estimated due date (EDD) was on 16-JUN-2016. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 04-DEC-2015 the patient was vaccinated with improperly stored doses of MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Information has been received from a pharmacist referring to a 72 year old female patient. The patient had penicillin allergies. Medical history was reported as none. Concomitant therapies included VENTOLIN, SPIRIVA and FLOVENT. On 23-DEC-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # L034335 with expiration date of 18-MAY-2014, 0.5 ml, intramuscular). On 23-DEC-2015 a couple of hours after receiving the PNEUMOVAX 23, the patient's arm began to swell. The patient reported to the pharmacist that on 24-DEC-2015 her arm was red, sore, hot and swollen from the shoulder to the elbow, but that the symptoms were beginning to resolved (recovering). Pharmacist reported that he instructed the patient to ice the area and take BENADRYL. There was no lab diagnostics studies performed. Action taken with PNEUMOVAX 23 and causality of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-201). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017 (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 19-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 02-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of 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 has been received from a pharmacist referring to a patient of unknown age. On 01-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 71-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 14-DEC-2015, the patient was vaccinated intramuscularly with one dose of PNEUMOVAX 23 (dose: 0.5ml, route of administration: left deltoid, lot # K010466, expiration date: 23-MAR-2016) which was stored improperly. There were no adverse effects reported. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Injection site pain, Injection site swelling, Pregnancy test positive
Clinical narrative: This spontaneous prospective was as received from a 36 year old female patient who was reporting on herself. The patient had no pertinent medical history, no drug reactions or allergies nor concomitant therapies. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (via subcutaneous route, lot # and expiration date were not reported). On an unknown date, the patient experienced injection site pain and swelling within 24 hours of VARIVAX (Merck) injection. On 08-DEC-2015, the patient was vaccinated with the second dose of VARIVAX (Merck) (via subcutaneous route, lot # and expiration date were not reported). In December 2015, the patient experienced injection site pain and swelling within 24 hours of VARIVAX (Merck) injection. On 28-DEC-2015, the patient discovered she was pregnant (the day when the pregnancy test was performed). The patient notified her physician and did not receive any treatment. The last menstrual period (LMP), estimate due date (EDD), estimated conception date (ECD) and trimester of exposure were unknown. The outcome of injection site pain and swelling was unknown. The relatedness between the events of injection site pain and swelling and VARIVAX (Merck) was not provided. Additional information is not expected as no contact details of HCP was provided.