chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Minutes after injection patient developed severe swelling at site of injection (left deltoid). Given liquid BENADRYL and ALEVE. The next day area still swollen but not as bad. 1 wk later 5-6-15 rechecked and had redness and hot below deltoid. Treated with Cephalexin.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient claims her arm where injection is swollen, red rash and hard to the touch - was not warm to the touch.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt states she had immediate intense pain upon immunization, followed by two days of fever and seven days of arm swelling.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pain, Pruritus
Clinical narrative: Injection site redness and raised welt, progressively spread to surrounding tissues of arm and down left side of torso; itchiness and soreness; no headache or respiratory symptoms; reported adverse reaction started morning after injection, worsened over next two days, and started subsiding in severity day 3 post injection; recommended Benadryl oral 25-50 mg q6h prn discomfort / itching.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Injection site redness and raised welt, progressively spread to surrounding tissues of arm and down left side of torso; itchiness and soreness; no headache or respiratory symptoms; reported adverse reaction started morning after injection, worsened over next two days, and started subsiding in severity day 3 post injection; recommended Benadryl oral 25-50 mg q6h prn discomfort / itching.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Injection site pain, Injection site swelling, Pain
Clinical narrative: Expected swelling and tenderness at injection site. Expected flu like symptoms of fatigue, body aches, etc. NOT expected serious and all through the night "night terrors" - worst night of sleep I've ever had.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Sleep terror
Clinical narrative: Expected swelling and tenderness at injection site. Expected flu like symptoms of fatigue, body aches, etc. NOT expected serious and all through the night "night terrors" - worst night of sleep I've ever had.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Skin reaction, Skin warm
Clinical narrative: Patient's Arm was red & warm to the touch.
Age: 0.82
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Death
Clinical narrative: No known adverse event.
Age: 28.0
Sex: M
Vaccine: FLU4, HEP, MMR, PPV, TDAP, VARCEL
Symptoms: Cellulitis, Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Ct. evaluated at Urgent Care due to developing fever, chills and (L) arm cellulitis after receiving vaccination on 5-4-15. Sx's of fever developed late in day on 5/4/15. Redness and arm swelling early on 5/5/15. Treated with KEFLEX and pain meds. Urgent care reported full recovery expected.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Photosensitivity reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of photosensitivity in a 49-year-old female patient who received FLUARIX QUADRIVALENT (batch number BT7Ag, expiry date 18th June 2015). Previously administered products included flu vaccine. Concurrent medical conditions included drug allergy (Allergy to LIPITOR) and drug allergy (Allergy to Atenolol). Concomitant products included Aspirin (Baby), CRESTOR, fish oil, Vitamin D3 and phenobarbital. On 30th October 2014, the patient received FLUARIX QUADRIVALENT (injection) .5 ml. On 30th October 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced photosensitivity. On an unknown date, the outcome of the photosensitivity was recovered/resolved. It was unknown if the reporter considered the photosensitivity to be related to FLUARIX QUADRIVALENT. Additional information received: The patient experienced sensitivity to light following the administration of the Flu vaccine. She stated that her sensitivity was to LED and Fluorescent light. The sensitivity lasted for about 2 to 3 months.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 08-APR-2015 the patient was vaccinated with RECOMBIVAX HB injection of strength 5/0.5 microgram/ml (lot t# K014548 and expiry date 27-AUG-2016) and PEDIARIX. No adverse symptoms reported. Product quality complaint was not reported. The outcome of the events was unknown. This is one of the two reports linked via sibling link (1504USA004476). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Merck) PROQUAD reported lot # K020747, expiration date: 30-APR-2016 and reported lot # K023861, expiration date: 25-MAY-2016 (dose and route were not reported), after they were exposed to temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive, Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. On 07-APR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX. Other suspect therapies included MMR II and RECOMBIVAX HB. The patient was administered (Oka/Merck) VARIVAX, MMR II and RECOMBIVAX HB on 07-APR-2015. Urine and serum pregnancy test and prenatal ultrasound performed on 07-APR-2015 confirmed pregnancy. The physician reported the patient to be 11 weeks gestation. No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to Influenza vaccine. This case is linked to case US2015057042 as same patient.
Age: 1.12
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Erythema, Injection site erythema
Clinical narrative: Rednes of arms, legs and face.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Father reports that he has felt fatigue, dizzy, and headaches since getting the vaccine.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Hyperhidrosis, Intussusception, Moaning
Clinical narrative: Diarrhea, off colored stools, screaming, moaning, groaning, knees to chest, twitching, constant unhappy movements, sweaty from pain, tossing while trying to sleep, jumpy while feeding, not feeding regularly.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Muscle twitching, Nervousness, Screaming, Sleep disorder
Clinical narrative: Diarrhea, off colored stools, screaming, moaning, groaning, knees to chest, twitching, constant unhappy movements, sweaty from pain, tossing while trying to sleep, jumpy while feeding, not feeding regularly.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Urticaria
Clinical narrative: Eye swelling and urticaria.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Fainting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Local reaction, Skin warm, Tenderness
Clinical narrative: Pt. actually seen 5/6/2015 at noon; local reaction- 8cm area of erythema, warm to the touch, very hard but not painful unless pressure was applied. No treatment required.
Age: 0.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Bed sharing, Death, Irritability
Clinical narrative: The infant received Pediarix, ActHIB, PCV13 and Rotarix on 5/4/2015 at 3:35pm. No immediate issues post-vaccination in the clinic. The infant was found deceased the next morning, 5/5/2015. The coroner reported onset of rigor mortis upon arrival to pick infant up and approximate time of death 4-6 hours previously. The infant was sent to the Medical Examiner for autotopsy. The parents reported the infant had mild irritability/fussiness about 72 hours prior to death but no fever, diarrhea, oral intolerance, flaccidity or seizures. No history of seizures. The autopsy was essentially normal with no findings that would explain an acute death. The Medical Examiner did report that the child was co-sleeping between the two parents with heavy adult sized bedding.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: Large local reaction- red, raised, warm and tender to touch per mother's report; she did not measure the size.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Cough, Dizziness, Hyperhidrosis
Clinical narrative: Pt states he has had wheezing, dizziness, weakness with dry cough and fever. Pt has taken ibuprofen for fever and reports "aches, chills and sweats". Symptoms began within 12 hrs of vaccine.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Pt states he has had wheezing, dizziness, weakness with dry cough and fever. Pt has taken ibuprofen for fever and reports "aches, chills and sweats". Symptoms began within 12 hrs of vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Blood test normal, Burning sensation, C-reactive protein increased, Hypoaesthesia
Clinical narrative: Woke up the next morning and the third digit on my left hand was swollen and could not bend finger at all. Over the period of the next few months I experienced numbness, tingling, swelling and pain in several fingers palms, wrist and toes, left knee with pain radiating up both arms. Hands were incredibly cold to the touch though felt like they were on fire. As of today I still have swelling, pain in multiple joints and cannot bend fingers or put pressure on joints because of the pain and cannot perform my job fully as a graphic artist. I was seen by my primary doctor on 5/5/2015 who ordered blood work and recommend I see a rheumatologist. She was very helpful in getting me in to a rheumatology office right away. I went to a rheumatologist, but saw a nurse practitioner, who prescribed a 7 day treatment of Prednisone, x-rays of hands and knee, and more blood work. Will start the prednisone treatment tomorrow.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Impaired work ability, Mobility decreased, Paraesthesia, Peripheral coldness, Peripheral swelling
Clinical narrative: Woke up the next morning and the third digit on my left hand was swollen and could not bend finger at all. Over the period of the next few months I experienced numbness, tingling, swelling and pain in several fingers palms, wrist and toes, left knee with pain radiating up both arms. Hands were incredibly cold to the touch though felt like they were on fire. As of today I still have swelling, pain in multiple joints and cannot bend fingers or put pressure on joints because of the pain and cannot perform my job fully as a graphic artist. I was seen by my primary doctor on 5/5/2015 who ordered blood work and recommend I see a rheumatologist. She was very helpful in getting me in to a rheumatology office right away. I went to a rheumatologist, but saw a nurse practitioner, who prescribed a 7 day treatment of Prednisone, x-rays of hands and knee, and more blood work. Will start the prednisone treatment tomorrow.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Rheumatoid factor negative, X-ray limb
Clinical narrative: Woke up the next morning and the third digit on my left hand was swollen and could not bend finger at all. Over the period of the next few months I experienced numbness, tingling, swelling and pain in several fingers palms, wrist and toes, left knee with pain radiating up both arms. Hands were incredibly cold to the touch though felt like they were on fire. As of today I still have swelling, pain in multiple joints and cannot bend fingers or put pressure on joints because of the pain and cannot perform my job fully as a graphic artist. I was seen by my primary doctor on 5/5/2015 who ordered blood work and recommend I see a rheumatologist. She was very helpful in getting me in to a rheumatology office right away. I went to a rheumatologist, but saw a nurse practitioner, who prescribed a 7 day treatment of Prednisone, x-rays of hands and knee, and more blood work. Will start the prednisone treatment tomorrow.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: High Fever, Tremors. Lasted for 3 days.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal discomfort, Cough, Headache, Pruritus, Pyrexia
Clinical narrative: Throwing up at bedtime due to upset stomach. Complaining of a headache. During the night he started coughing, over the next few days the coughing got worse. He also continued to run a between 99.9- 102 fever. Administered children's Motrin on 5/6/2015. He began to contract hives that were raised and itchy. They started from his buttocks down the backs of his legs towards the bottom of his feet, and the backs of his arms from the elbows down. Later the rash was on his hands and shoulders, on 5/6/2015 administered Benadryl for hives- hives lessened. Administered Benadryl again on 5/7/2015 for hives returning.  Coughing has continued. Hoping these reactions go away soon.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: Throwing up at bedtime due to upset stomach. Complaining of a headache. During the night he started coughing, over the next few days the coughing got worse. He also continued to run a between 99.9- 102 fever. Administered children's Motrin on 5/6/2015. He began to contract hives that were raised and itchy. They started from his buttocks down the backs of his legs towards the bottom of his feet, and the backs of his arms from the elbows down. Later the rash was on his hands and shoulders, on 5/6/2015 administered Benadryl for hives- hives lessened. Administered Benadryl again on 5/7/2015 for hives returning.  Coughing has continued. Hoping these reactions go away soon.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Full blood count, Injection site erythema, Injection site pain, Lip swelling, Pyrexia
Clinical narrative: Initial reaction was fever, swelled lips, urticarial, with injection site redness and soreness.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Urticaria
Clinical narrative: Initial reaction was fever, swelled lips, urticarial, with injection site redness and soreness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Extreme redness, swelling, soreness that has continued and is present 5 days later. Redness includes hotness at the area) and swelling is larger than the size of my palm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 24-APR-2015 the patient was vaccinate with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. On an unknown date the nurse reported that improperly stored GARDASIL (lot # J009243) .5 ml, were administered to two unspecified patients intramuscularly. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 28-APR-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth, Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 71-year-old female patient who received BOOSTRIX. Previously administered products included Flu vaccine (swelling arm, pain, redness and warmth at the injection site). On 23rd April 2015 13:00, the patient received BOOSTRIX. On 25th April 2015, 2 days after receiving BOOSTRIX, the patient experienced swelling arm, injection site warmth, injection site erythema and injection site pain. On 27th April 2015, the patient experienced tingling of extremity and numbness of upper extremities. On an unknown date, the outcome of the swelling arm and injection site pain were recovering/resolving and the outcome of the injection site warmth, tingling of extremity and numbness of upper extremities were unknown and the outcome of the injection site erythema was recovered/resolved. The reporter considered the swelling arm, injection site erythema, injection site pain, tingling of extremity and numbness of upper extremities to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the injection site warmth to be related to BOOSTRIX. Additional information: The caller reports she received a BOOSTRIX vaccine last Thursday. She reports on Saturday her arm started to swell, there was redness at the injection site, and she experienced pain as well. She reports she tried to exercise this morning and her arm started to tingle and it felt like it was going to sleep. She reports she had a flu vaccine about 8-10 years ago, manufacturer unknown and her arm started to swell up, the injection site was red and in pain, and it felt hot at the injection site after she received that vaccine. She has recovered from those events. She reports she received another flu shot about 6 months after the first flu shot. The doctor divided this second flu shot into 1/5th of the actual dose so he could try and mitigate any reactions to the shot itself. However, the same events occurred with this reduced flu shot dose.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 71-year-old female patient who received BOOSTRIX. Previously administered products included Flu vaccine (swelling arm, pain, redness and warmth at the injection site). On 23rd April 2015 13:00, the patient received BOOSTRIX. On 25th April 2015, 2 days after receiving BOOSTRIX, the patient experienced swelling arm, injection site warmth, injection site erythema and injection site pain. On 27th April 2015, the patient experienced tingling of extremity and numbness of upper extremities. On an unknown date, the outcome of the swelling arm and injection site pain were recovering/resolving and the outcome of the injection site warmth, tingling of extremity and numbness of upper extremities were unknown and the outcome of the injection site erythema was recovered/resolved. The reporter considered the swelling arm, injection site erythema, injection site pain, tingling of extremity and numbness of upper extremities to be almost certainly related to BOOSTRIX. It was unknown if the reporter considered the injection site warmth to be related to BOOSTRIX. Additional information: The caller reports she received a BOOSTRIX vaccine last Thursday. She reports on Saturday her arm started to swell, there was redness at the injection site, and she experienced pain as well. She reports she tried to exercise this morning and her arm started to tingle and it felt like it was going to sleep. She reports she had a flu vaccine about 8-10 years ago, manufacturer unknown and her arm started to swell up, the injection site was red and in pain, and it felt hot at the injection site after she received that vaccine. She has recovered from those events. She reports she received another flu shot about 6 months after the first flu shot. The doctor divided this second flu shot into 1/5th of the actual dose so he could try and mitigate any reactions to the shot itself. However, the same events occurred with this reduced flu shot dose.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with VARIVAX (Merck) lot # K011082, expiration date: 08-AUG-2016 and reported lot # K021487, expiration date: 30-JAN-2016 (dose and route were not reported), after they were exposed to temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. on 30-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of GARDASIL (route, lot# and expiration date were not reported) intramuscular, which was stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of ROTATEQ (lot# and expiration date were not reported), oral, which was stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 08-APR-2015 the patient was vaccinated with RECOMBIVAX HB injection of strength 5/0.5 microgram/ml (lot # K014548 and expiry date 27-AUG-2016) and PEDIARIX. No adverse symptoms reported. Product quality complaint was not reported. The outcome of the events was unknown. This case is one of the two reports and linked via sibling link (1505USA003005). 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 nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. The nurse stated that, on an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (route, lot# and expiration date were not provided), which were stored improperly. Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Rash, Urticaria, Varicella
Clinical narrative: Mom states she took daughter to doctor on 4-21-15 because daughter had rash, hives and inflammation to legs, knees and ankles. States doctor said it was chickenpox. Mom stated she was not convinced it was chickenpox and took daughter to ER on 4-29-15. States daughter was admitted. Then mom refused to give anymore information and asked to speak to my supervisor.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Rash
Clinical narrative: Rash, chest, back, legs, and painful at injection site.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Right after vaccines patient developed recurrent shaking in both legs at different times 30-60 seconds. Fast full leg shake. First in one leg and then the other. Continued 2-3 times a week for a full month.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Neck pain, Pain in extremity
Clinical narrative: Reproductive adverse event following the last doses of AVA. Severe pain in arm/back/neck following the last two doses of AVA. Symptoms began within a few hours of the immunizations.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to 5 unspecified patients of unknown demographics. Pertinent medical history and drug allergies were not reported. On unspecified dates, these patients received doses of improperly stored PROQUAD (Merck) (lot # L002419, expiry date: 23-JUL-2016). Concomitant medications were not provided. No adverse effect was reported. Outcome of the event, incorrect product storage was unknown. Causality assessment was not provided. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to 5 unspecified patients of unknown demographics. Pertinent medical history and drug allergies were not reported. On unspecified dates, these patients received doses of improperly stored PROQUAD (Merck) (lot # K025760, expiry date: 08-JUN-2016). Concomitant medications were not provided. No adverse effect was reported. Outcome of the event, incorrect product storage was unknown. Causality assessment was not provided. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers an unspecified number of patients of unknown ages and genders who on an unknown dates were vaccinated with included LIQUID PEDVAXHIB (lot # K019701, expiration date 17-JUL-2017) (dose and route were not reported) which was exposed to temperatures as low as 34.1 F unspecified amount of time. The vaccine was not exposed to a previous temperature excursion. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers an unspecified number of patients of unknown ages and genders who on an unknown date were vaccinated with GARDASIL (lot # K007264, expiration date 02-MAR-2017 and lot # K008931, expiration date 04-MAR-2017) (dose and route were not reported) which was exposed to temperatures as low as 34.1 F for unspecified amount of time. The vaccine was not exposed to a previous temperature excursion. No adverse effect reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site warmth in a 37-year-old female patient who received BOOSTRIX (batch number 55MT7, expiry date 14th February 2017). Concomitant products included Tuberculosis vaccine. On 29th April 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site warmth, injection site wheal and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site wheal and injection site itching were unknown. It was unknown if the reporter considered the injection site warmth, injection site wheal and injection site itching to be related to BOOSTRIX. Additional information received: On 04 May 2015, a consumer reported that she experienced hot to touch, red welts, and itchy at injection site after BOOSTRIX vaccine administration on 29 April 2015. Now, patient is in stable condition. A nurse visit has been scheduled on 05 May 2015.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 73 years old female patient with drug allergy to penicillin. The patient's medical history was not reported. On 27-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K020185, expiration date: 27-JAN-2016, 0.65 ml, subcutaneous. No concomitant therapies were reported. On 21-APR-2015, the pharmacist saw the patient, and she had a dime size nodule present under the skin at the injection site. The nodule was not causing any pain or itchiness. It was not known exactly when was the nodule developed. The reporting pharmacist stated that the patient did not sought any medical attention. There was no treatment given for the adverse event. The outcome of the injection site nodule was reported as not recovered. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Hypotension, Septic shock, Unresponsive to stimuli
Clinical narrative: Unresponsive. Hypotensive. Septic shock.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Aches, fever, fatigue, headache. Had to leave work and tried pushing fluids and sleeping. Ongoing symptoms at 9:40PM.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site pain, Pain, Peripheral swelling
Clinical narrative: Chills - Injection area severe pain - Under arm swelling - Fever - Stomach upset - Over- all body pain.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills - Injection area severe pain - Under arm swelling - Fever - Stomach upset - Over- all body pain.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autism, Crying, Opisthotonus
Clinical narrative: Opisthotonos position, high pitched crying.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Coordination abnormal, Febrile convulsion, Insomnia, Lethargy, Muscle spasms
Clinical narrative: Fever of 105, febrile seizures, loss of coordination, high pitched screaming for days, lethargy, muscle spasms, inability to sleep.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Screaming
Clinical narrative: Fever of 105, febrile seizures, loss of coordination, high pitched screaming for days, lethargy, muscle spasms, inability to sleep.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Hypersomnia, Injection site pain, Lethargy, Vomiting
Clinical narrative: Patient got her vaccine around 3pm. She hadn't taken a nap yet for the day, so she fell asleep on the ride home which can be normal. By the time 8pm came around she was still sleeping, she slept all through the night and that is uncommon. Just a month ago her sleep cycle was changed and she slept the whole evening and was up at 3am and stayed up for four hours. So she has be lethargic for 48 hours. 5/8/15 patient woke up at 6am and was vomiting, she never does that. She complained about soreness in the injection area on 5/7/15, she did however sleep more than usual on the same day. Also at daycare, the following day, she wouldn't move around actively like she usually does, she was just playing with one toy, very uncharacteristic. I am at a very thin line with watching my child go through these so called side effect from these supposed "safe and effective" vaccines. As I am writing, my daughter is going to bed rather early. Also her naps seem to have been longer the last 3 days. You need to either tell the complete truth about the vaccines, or stop producing them until you can make them "safe and effective". These people that make the vaccines are now affecting our elected officials children. Those types of people bring to light these issues to the small people.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Asthenia, Complex partial seizures, Electroencephalogram, Eye pain, Fatigue
Clinical narrative: ** Hives at site on 4/17, faded and didn't return. 4/26 At 4:30 PM complained of headache and eyes hurting. 5:00 PM fever of 100.4. Fever at highest was 101.2 that evening.  Blank stares noted 3x that evening.  Following morning fever at 100.4 again.  Complaints of weakness and inability to use legs.  * Called nurse advice line said to only monitor.  Was very sleepy and exhausted continued to complain that eyes hurt.  4/28 1:50 AM woke with violent rhythmic convulsing and unique grunting -like noises which lasted for a couple of minutes, fever was taken and was 101.4. 4/29 scheduled DR visit at 9:30.  Woke with rash, had two very evident seizures before appointment.  Had fever of 100.3 at appointment.  Dr. made follow up for EEG. EEG  4/30/15, came back abnormal.  Appointment with pediatric neurologist 5/7/15.  Confirmed Complex partial seizures in frontal lobe, with possible general seizures.  Prescribed Keppra.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Grunting, Headache, Injection site urticaria, Movement disorder, Pyrexia
Clinical narrative: ** Hives at site on 4/17, faded and didn't return. 4/26 At 4:30 PM complained of headache and eyes hurting. 5:00 PM fever of 100.4. Fever at highest was 101.2 that evening.  Blank stares noted 3x that evening.  Following morning fever at 100.4 again.  Complaints of weakness and inability to use legs.  * Called nurse advice line said to only monitor.  Was very sleepy and exhausted continued to complain that eyes hurt.  4/28 1:50 AM woke with violent rhythmic convulsing and unique grunting -like noises which lasted for a couple of minutes, fever was taken and was 101.4. 4/29 scheduled DR visit at 9:30.  Woke with rash, had two very evident seizures before appointment.  Had fever of 100.3 at appointment.  Dr. made follow up for EEG. EEG  4/30/15, came back abnormal.  Appointment with pediatric neurologist 5/7/15.  Confirmed Complex partial seizures in frontal lobe, with possible general seizures.  Prescribed Keppra.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash, Seizure, Somnolence, Staring
Clinical narrative: ** Hives at site on 4/17, faded and didn't return. 4/26 At 4:30 PM complained of headache and eyes hurting. 5:00 PM fever of 100.4. Fever at highest was 101.2 that evening.  Blank stares noted 3x that evening.  Following morning fever at 100.4 again.  Complaints of weakness and inability to use legs.  * Called nurse advice line said to only monitor.  Was very sleepy and exhausted continued to complain that eyes hurt.  4/28 1:50 AM woke with violent rhythmic convulsing and unique grunting -like noises which lasted for a couple of minutes, fever was taken and was 101.4. 4/29 scheduled DR visit at 9:30.  Woke with rash, had two very evident seizures before appointment.  Had fever of 100.3 at appointment.  Dr. made follow up for EEG. EEG  4/30/15, came back abnormal.  Appointment with pediatric neurologist 5/7/15.  Confirmed Complex partial seizures in frontal lobe, with possible general seizures.  Prescribed Keppra.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Asthenia, Blood test, Chills, Computerised tomogram
Clinical narrative: Weakness, extreme tiredness and lethargy, fever, chills, joint pain.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: Weakness, extreme tiredness and lethargy, fever, chills, joint pain.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose, Dizziness, Heart rate decreased
Clinical narrative: Pt said he felt as if he was going to faint. Laid pt down on the floor elevated his feet, checked for pulse and breathing all present but pulse was low. Called 911. EMT arrived pt was checked out by then pulse back up and BP was normal. They check the pt's blood sugars after the finger stick the pt had the same reaction. They have him in the ambulance outside monitored him. All was fine. No hospital or emergency room visit needed.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Ear swelling, Paraesthesia
Clinical narrative: 22 hrs after immunization in left arm right ear swollen and tingly no itching  no redness lasted 8 hrs did not affect hearing no pain.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot # K021934, exp 10-NOV-2016, 0.5 ml, subcutaneously in the left leg. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Lightheadedness, headache, nausea, general weakness and fatigue.
Age: 1.11
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Red swollen bump on the arm itchy and tender.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Haemolytic anaemia, Immediate post-injection reaction, Red blood cell count decreased, Swelling
Clinical narrative: Immediate symptoms consisted mainly of swelling throughout the body. A visit to the doctor resulted in a course of prednisone and Claritin, however the long term effects were not yet realized.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Mouth swelling, Pyrexia, Swelling face
Clinical narrative: Started with high fever (104 degrees), difficulty breathing and gradually turned into extreme swelling of the face (eyes tongue and mouth). Lasted for seven days, three of which I was hospitalized for. Multiple emergency room visits.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Started with high fever (104 degrees), difficulty breathing and gradually turned into extreme swelling of the face (eyes tongue and mouth). Lasted for seven days, three of which I was hospitalized for. Multiple emergency room visits.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and urticaria pruritus. Hydroxyzine 25 mg QID, Ranitidine 150 mg BID.
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician referring to a patient of unknown gender and age. The patient's medical history and drug reactions/allergies were not reported. The patient had received all three doses in the series of ROTATEQ orally (dose and lot# were not reported) on unspecified dates. On unspecified date, the patient developed rotavirus after receiving all three doses of ROTATEQ. The outcome of the event and the causality were not reported. Follow up information has been received from the physician during a phone call on 05-MAY-2015. The patient was hospitalized on an unspecified date in April 2015 via admission through the emergency room. The patient did not have a hospital stay exceeding two days and exact length of admission was unavailable. The patient "responded well" to administration of intravenous fluids (manufacturer and dosage information unavailable) and antiemetic treatment (manufacturer and dosage information unavailable). The physician did not have demographic information readily available for the patient at the time of this call. This is one of several reports received from the same reporter. Additional information has been requested. Product, event, narrative and additional information were updated.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. This case is linked to case 2015SA059671 (same reporter and vaccine with same lot number). A 69 year old female patient, whose medical history includes DM (Diabetes Mellitus), HTN (hypertension) and GI Bleed and concomitant medications were not reported had received a dose of ADACEL (batch number: C4888AA, expiry date: 11 September 2016 and route of administration was not reported) in left deltoid on 20 April 2015. On 22 April 2015, the patient was seen in emergency room and diagnosed with cellulitis at the injection site. Patient required ER/ doctor visit. The patient had no allergies and illness at the time of vaccination. The patient was treated with KEFLEX. Laboratory investigations were unknown. Upon medical review, the case was considered as serious due to important medical event: vaccination site cellulitis. At the time of this report, outcome of the event was unknown. List of Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. This case is linked to case 2015SA059671 (same reporter and vaccine with same lot number). A 69 year old female patient, whose medical history includes DM (Diabetes Mellitus), HTN (hypertension) and GI Bleed and concomitant medications were not reported had received a dose of ADACEL (batch number: C4888AA, expiry date: 11 September 2016 and route of administration was not reported) in left deltoid on 20 April 2015. On 22 April 2015, the patient was seen in emergency room and diagnosed with cellulitis at the injection site. Patient required ER/ doctor visit. The patient had no allergies and illness at the time of vaccination. The patient was treated with KEFLEX. Laboratory investigations were unknown. Upon medical review, the case was considered as serious due to important medical event: vaccination site cellulitis. At the time of this report, outcome of the event was unknown. List of Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Dizziness, Injection site cellulitis, Injection site haemorrhage, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 30 April 2015. The case linked to 2015SA058850 (same event on same drug for two different patients). A 29-year-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number- C4888AA, route of administration was not reported) into left deltoid on 25 April 2015. Illness at time of vaccination was reported as none and patient did not have history of sepsis, obesity and renal issues. On 30 April 2015, 5 days after vaccination, the patient was admitted to the hospital with a diagnosis of cellulitis. Patient was being treated with vancomycin but, they were unsure of the plan of treatment as the site was only cultured on the day of report. The Vancomycin was being provided as MRSA (Methicillin-resistant Staphylococcus aureus cellulitis) was suspected. Patient was admitted to the hospital and required ER/doctor visit. Laboratory investigations included wound cultures. At the time of this report outcome of events were unknown. Documents held by sender: none.