chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye swelling, Hypersensitivity, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Once I picked up the prescription for the eye issue, I had him one dose which was around 4pm. After that he played like normal. But then he strated showing red rashes on his face. I called children's nurse hotline at 8:50PM. The told me to take him to the urgent care. The doctor on site that night said she believed that he was allergic to the prescribed medication for his eye and/or the flu nasal spray. She told me to stop giving him the medication for his eye issue and to monitor his rash. The rash she believed to be hives that was due to the allergic reaction. Once we got back home his hives had spread to his eyes, the back of his neck, legs, arms, and he complained that his feet hurt and they were red and swollen. I gave him a cool bath and put some Aveeno lotion on him. But then he woke up the next morning (1/16/2016) with his left eyelid swollen shut, although the hives went away. He complained about his eyes hurting, his tummy, and his back hurting. I have him a dose of ibuprofen around 5pm. It is now 10:50pm on 1/16/2016 that my son is covered again in hives.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Once I picked up the prescription for the eye issue, I had him one dose which was around 4pm. After that he played like normal. But then he strated showing red rashes on his face. I called children's nurse hotline at 8:50PM. The told me to take him to the urgent care. The doctor on site that night said she believed that he was allergic to the prescribed medication for his eye and/or the flu nasal spray. She told me to stop giving him the medication for his eye issue and to monitor his rash. The rash she believed to be hives that was due to the allergic reaction. Once we got back home his hives had spread to his eyes, the back of his neck, legs, arms, and he complained that his feet hurt and they were red and swollen. I gave him a cool bath and put some Aveeno lotion on him. But then he woke up the next morning (1/16/2016) with his left eyelid swollen shut, although the hives went away. He complained about his eyes hurting, his tummy, and his back hurting. I have him a dose of ibuprofen around 5pm. It is now 10:50pm on 1/16/2016 that my son is covered again in hives.
Age: 71.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Left arm/deltoid where flu shot was administered was quite sore for weeks after shot. Is still numb ever since he got immunized.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Swelling in lips and hands. 1/14/16 at 8am BENADRYL given, prednisone 20mg x 3 days.
Sex: F
Vaccine: HEP
Symptoms: Eczema, Rash erythematous, Rash pruritic
Clinical narrative: Severe eczema started on face and "spread" through the entire body. Red itch rash.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site, warm to touch and itchy. Came in to show pharmacist on 1/17/2016 and pharmacist instructed use of hydrocortisone cream and Zyrtec or Claritin. Unknown outcome at this time.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site streaking, Mass, Skin warm
Clinical narrative: Red lump the size of a nickel. Area warm to touch. Had 1/2 inch streaks around the site that extended to under his arm towards the arm pit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Numbness on left side of face from 10AM to 2PM on 1/4/15, light redness on left side of face from 9AM to 4PM on 1/5/16, intermittent from 1/5/16 to 1/11/16 headache, throat constriction, tingling throughout body, swollen glands and extreme tiredness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Numbness on left side of face from 10AM to 2PM on 1/4/15, light redness on left side of face from 9AM to 4PM on 1/5/16, intermittent from 1/5/16 to 1/11/16 headache, throat constriction, tingling throughout body, swollen glands and extreme tiredness.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Feeling abnormal, Muscle spasms
Clinical narrative: Patient states that she had severe cramping and a severe episode of diarrhea on the evening of 1/16/16 that was only relieved by taking Immodium. She states that she has no other symptoms of illness and still feels "off" but has not had any diarrhea as of noon on 1/17/16. She believes it may have been related to the Prevnar vaccine she received on 1/13/16 since that was the only thing she has changed in her lifestyle recently.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Cellulitis at injection site-redness, 3 inch induration, pain, fever.
Age: 1.25
Sex: F
Vaccine: FLUX, MMR, FLUX, MMR
Symptoms: Blood test, Decreased appetite, Influenza virus test, Lethargy, Pyrexia
Clinical narrative: Started w a fever of 103.7. The fever continued for 5 days. She also developed a rash on her face and swollen face. She was also very lethargic and had no appetite.
Age: 1.25
Sex: F
Vaccine: FLUX, MMR, FLUX, MMR
Symptoms: Rash, Respiratory syncytial virus test, Swelling face
Clinical narrative: Started w a fever of 103.7. The fever continued for 5 days. She also developed a rash on her face and swollen face. She was also very lethargic and had no appetite.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Autoimmune disorder, Balance disorder, Disturbance in attention, Fatigue
Clinical narrative: Healthy child - 3 mo post shot, simple infection triggered non-typical autoimmune response that intensified over the next 18 months.  Stomach pain, headache/migraine, sensitivity to light, extreme fatigue, nausea, unsteadiness, concentration problems, clogged lymphatics.  Condition worsened saw GI & pain specialists, Hospitalized 2x, entered pediatric pain program. Problems focused around GI Track, Autoimmune & neurological issues) Drs. explored possible diagnosis (Functional Abdominal Pain, Visceral Hyperalgesia, Parasites, Mono, Dysautonomia, CRPS, PCOS.  Appears vaccine may have "woke up" her autoimmune system and affected its reactions to infections, Epstein Barr, parasites & food sensitivities. Over last 5 years, pain & symptoms ebbed and flowed typically trigged by infection. Aggressive support of Methylaton Cycle and detox & supplements improved c
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal disorder, Headache, Infection, Lymphatic obstruction, Migraine
Clinical narrative: Healthy child - 3 mo post shot, simple infection triggered non-typical autoimmune response that intensified over the next 18 months.  Stomach pain, headache/migraine, sensitivity to light, extreme fatigue, nausea, unsteadiness, concentration problems, clogged lymphatics.  Condition worsened saw GI & pain specialists, Hospitalized 2x, entered pediatric pain program. Problems focused around GI Track, Autoimmune & neurological issues) Drs. explored possible diagnosis (Functional Abdominal Pain, Visceral Hyperalgesia, Parasites, Mono, Dysautonomia, CRPS, PCOS.  Appears vaccine may have "woke up" her autoimmune system and affected its reactions to infections, Epstein Barr, parasites & food sensitivities. Over last 5 years, pain & symptoms ebbed and flowed typically trigged by infection. Aggressive support of Methylaton Cycle and detox & supplements improved c
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nervous system disorder, Photophobia
Clinical narrative: Healthy child - 3 mo post shot, simple infection triggered non-typical autoimmune response that intensified over the next 18 months.  Stomach pain, headache/migraine, sensitivity to light, extreme fatigue, nausea, unsteadiness, concentration problems, clogged lymphatics.  Condition worsened saw GI & pain specialists, Hospitalized 2x, entered pediatric pain program. Problems focused around GI Track, Autoimmune & neurological issues) Drs. explored possible diagnosis (Functional Abdominal Pain, Visceral Hyperalgesia, Parasites, Mono, Dysautonomia, CRPS, PCOS.  Appears vaccine may have "woke up" her autoimmune system and affected its reactions to infections, Epstein Barr, parasites & food sensitivities. Over last 5 years, pain & symptoms ebbed and flowed typically trigged by infection. Aggressive support of Methylaton Cycle and detox & supplements improved c
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Moderate to severe pain at injection site. Right shoulder pain is getting worse after 5 weeks. Called doctor and told to try ice. Doesn't help.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Rash on left arm that received the injections. Swelling and soreness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Since flu shot, I have had off and on pain, dull ache, occasional burning and stinging in my left shoulder and surrounding muscles. Have not seen a doctor for this yet, hoping it will go away on its own.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction, Pruritus
Clinical narrative: Hello, I am a provider. I have a case to present.  I am having a hard time calling the 800 # as I only have personal cell phone access out in the field. Here is the case: 25 yo male received anthrax vaccine in left deltoid x 48 hours ago. This was his third shot in the series and he was on schedule. No previous reactions. At 24 hours, he had erythema, warmth and edema at 13cm x 9cm at the local injection side. He also c/o pruritus. No lymphadenopathy, no numbness and tingling, no systemic symptoms. He was diagnosed with a local severe reaction and treated with ibuprofen and Benadryl.  Today, at 48 hours, the swelling and erythema has gotten worse; at 19cm x 17cm; still no other symptoms. Pruritus resolved with Benadryl. The rash does not extend beyond the elbow. Vitals are normal minus a slightly elevated pulse (but his normal sits in the 90s/100s). Pulse is 107; afebrile.  He is following up every 24 hours.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Swelling
Clinical narrative: Hello, I am a provider. I have a case to present.  I am having a hard time calling the 800 # as I only have personal cell phone access out in the field. Here is the case: 25 yo male received anthrax vaccine in left deltoid x 48 hours ago. This was his third shot in the series and he was on schedule. No previous reactions. At 24 hours, he had erythema, warmth and edema at 13cm x 9cm at the local injection side. He also c/o pruritus. No lymphadenopathy, no numbness and tingling, no systemic symptoms. He was diagnosed with a local severe reaction and treated with ibuprofen and Benadryl.  Today, at 48 hours, the swelling and erythema has gotten worse; at 19cm x 17cm; still no other symptoms. Pruritus resolved with Benadryl. The rash does not extend beyond the elbow. Vitals are normal minus a slightly elevated pulse (but his normal sits in the 90s/100s). Pulse is 107; afebrile.  He is following up every 24 hours.
Age: 0.61
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Chest X-ray, Cough, Dyspnoea, Hypopnoea, Lethargy
Clinical narrative: Fever of 102, lethargy, cough, difficulty breathing, shallow breathing, rapid and labored breathing started Monday around 4pm. Fever continued overnight. Visited doctor 12/22 at 4pm. Had chest X-Ray done, Doctor heard 'rales' in lungs, pulse ox at 97%, considered hospitalization due to age for diagnosis of pneumonia. However, I was going to be home from work so we're able to keep her out of the hospital. Started on amoxicillin 3 mL twice a day for 10 days. 1/6/2016 back to Doctor for another round of antibiotics, cefdinir 2 mL once a day for 10 days.
Age: 0.61
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pneumonia, Pyrexia, Rales, Respiratory rate increased
Clinical narrative: Fever of 102, lethargy, cough, difficulty breathing, shallow breathing, rapid and labored breathing started Monday around 4pm. Fever continued overnight. Visited doctor 12/22 at 4pm. Had chest X-Ray done, Doctor heard 'rales' in lungs, pulse ox at 97%, considered hospitalization due to age for diagnosis of pneumonia. However, I was going to be home from work so we're able to keep her out of the hospital. Started on amoxicillin 3 mL twice a day for 10 days. 1/6/2016 back to Doctor for another round of antibiotics, cefdinir 2 mL once a day for 10 days.
Sex: U
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an unspecified reporter referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with HPV (manufacturer unknown)(lot#, strength, dosage, frequency and route unspecified). It was reported that the vaccine was causing death, permanent disability and damage to children around the world. It was ineffective and dangerous. The aluminum content far surpasses all safety levels (PQC). The outcome of the events was not reported. Additional information is not expected since there was no contact details provided.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Patient reported pain and redness around the injection site which the next day turned into hives. Pt is using BENADRYL and hydrocortisone cream.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: One week post vaccination of PREVNAR-13 pt. reported unexplained, sudden redness, swelling, inflammation, pain and decreased mobility of arm that received the vaccine. No adverse symptoms the previous 7 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot# L029469, expiry date: 06-AUG-2017) (dose, strength, route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Inflammatory bowel disease
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with an unspecified number of doses of M-M-R II (strength, dose, lot#, expiration date and route were unknown). On an unknown date the patient experienced an inflammatory bowel disease. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of ZOSTAVAX lot # L012476 (expiration date 10-JUL-2016), which were improperly stored at -14.7 C for 1 hour and 30 minutes (incorrect product storage). There was no previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. The patient's medical history, concurrent condition and concomitant medication was not reported. On 29-OCT-2015, 09-NOV-2015, 10-NOV-2015, 11-NOV-2015, 13-NOV-2015, 16-NOV-2015, 20-NOV-2015 and 08-DEC-2015, multiple unspecified patients received improperly stored product VAQTA lot # L002717 with expiration date of 02-JUN-2017 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain Barre syndrome in a 34-year-old female patient who received FLUARIX QUADRIVALENT (batch number 57C93, expiry date 30th June 2015). On 7th October 2014, the patient received FLUARIX QUADRIVALENT. On 7th October 2014, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced Guillain Barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the Guillain Barre syndrome was recovering/resolving. The reporter considered the Guillain Barre syndrome to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter had a patient that developed Guillain Barre after receiving the FLUARIX QUADRIVALENT vaccine. The patient began to experience symptoms within 1 to 2 hours after receiving the vaccination. She was admitted to the hospital and was intubated. She was in the hospital for one month. The reporter was unable to provide any further details at the time of the call. He wanted to be connected with Medical Information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Injection site discolouration, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to penicillin, metronidazole, she is not allergic to prednisone but she was feeling jittery when she took the drug. On 13-OCT-2015, the patient was vaccinated with ZOSTAVAX, lot #L020482 with an expiry date of 02-SEP-2016, 0.65 ml subcutaneously in the right arm (frequency and strength were not provided). Concomitant therapies included metoprolol 25mg, NORVASC 5mg and estradiol 1mg. On 13-OCT-2015 (reported as the same evening of the date of receiving the vaccine), the patient experienced severe soreness at the injection site of the right arm and on 14-OCT-2015 (reported as next day), the patient had a bit swollen bump at the injection site. On 15-OCT-2015, the patient went to the pharmacy and the reporter said that she had red, swollen welts at the injection site that was approximately 3 inches in diameter; the reporter stated that since an unspecified date in October 2015 there was a huge spot at the injection site and it was warm to touch. The reporter mentioned also without specifying the date (in October 2015) that the patient was weak, had shivers, feverish and experienced flu like symptoms. Patient sought medical attention via visiting a pharmacy. In addition, because of the events, the patient required intervention to prevent serious criteria via visiting urgent care center (unspecified name), the healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested. The case was upgraded to be serious. Reported, events and narrative were updated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to penicillin, metronidazole, she is not allergic to prednisone but she was feeling jittery when she took the drug. On 13-OCT-2015, the patient was vaccinated with ZOSTAVAX, lot #L020482 with an expiry date of 02-SEP-2016, 0.65 ml subcutaneously in the right arm (frequency and strength were not provided). Concomitant therapies included metoprolol 25mg, NORVASC 5mg and estradiol 1mg. On 13-OCT-2015 (reported as the same evening of the date of receiving the vaccine), the patient experienced severe soreness at the injection site of the right arm and on 14-OCT-2015 (reported as next day), the patient had a bit swollen bump at the injection site. On 15-OCT-2015, the patient went to the pharmacy and the reporter said that she had red, swollen welts at the injection site that was approximately 3 inches in diameter; the reporter stated that since an unspecified date in October 2015 there was a huge spot at the injection site and it was warm to touch. The reporter mentioned also without specifying the date (in October 2015) that the patient was weak, had shivers, feverish and experienced flu like symptoms. Patient sought medical attention via visiting a pharmacy. In addition, because of the events, the patient required intervention to prevent serious criteria via visiting urgent care center (unspecified name), the healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested. The case was upgraded to be serious. Reported, events and narrative were updated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient's medical history was not reported. Patient's concurrent condition included hypertension. Patient was allergic to penicillin, metronidazole, she is not allergic to prednisone but she was feeling jittery when she took the drug. On 13-OCT-2015, the patient was vaccinated with ZOSTAVAX, lot #L020482 with an expiry date of 02-SEP-2016, 0.65 ml subcutaneously in the right arm (frequency and strength were not provided). Concomitant therapies included metoprolol 25mg, NORVASC 5mg and estradiol 1mg. On 13-OCT-2015 (reported as the same evening of the date of receiving the vaccine), the patient experienced severe soreness at the injection site of the right arm and on 14-OCT-2015 (reported as next day), the patient had a bit swollen bump at the injection site. On 15-OCT-2015, the patient went to the pharmacy and the reporter said that she had red, swollen welts at the injection site that was approximately 3 inches in diameter; the reporter stated that since an unspecified date in October 2015 there was a huge spot at the injection site and it was warm to touch. The reporter mentioned also without specifying the date (in October 2015) that the patient was weak, had shivers, feverish and experienced flu like symptoms. Patient sought medical attention via visiting a pharmacy. In addition, because of the events, the patient required intervention to prevent serious criteria via visiting urgent care center (unspecified name), the healthcare worker placed a demarcation around the injection site and the patient was told if the bump swelled beyond that area he should begin BACTRIM DS therapy. Reporter stated that he was told by the patient that the swelling increased and she had started the therapy with BACTRIM DS. Pharmacists stated that prednisone was not prescribed by the health care provider because the patient gets jittery if she takes the product. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. This is one of the two reports refers to same patient. Additional information has been requested. The case was upgraded to be serious. Reported, events and narrative were updated.
Age: 0.36
Sex: F
Vaccine: HEP
Symptoms: Seizure
Clinical narrative: Seizure.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patients concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, unit, frequency and route not reported, lot # L038018 with Exp. date 13-SEP-2017 and lot # L027733 with Exp. date 13-SEP-2017. Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact the physician.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 06-JAN-2016, the patient was vaccinated with an expired PNEUMOVAX23 (lot # K007262, expiration date 25-NOV-2015). No concomitant medication was reported. No adverse effect has been reported. The reporter stated that no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning an elderly female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient received a dose of ZOSTAVAX (strength, unit, frequency, lot # and exp. date not reported) subcutaneously at unspecified time in 2012. On 28-DEC-2015, she inadvertently received the second dose of ZOSTAVAX subcutaneously (lot # L026415 and exp. date 15-OCT-2016) (Extra dose administered). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On 09-NOV-2015, 23-NOV-2015, and 09-DEC-2015, multiple unspecified patients received improperly stored product GARDASIL 9 lot # K026246 with expiration date of 28-JAN-2017 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse via a company representative referring to multiple patients of unknown age and gender. The patients concurrent and historical conditions were not reported. The nurse stated that some people had been vaccinated with PNEUMOVAX23 (subcutaneous, dose, lot # and expiration date were not reported) within 5 years on unspecified dates and had been re-administered inappropriately (inappropriate schedule of vaccine administered). On unknown dates the patients reported severe injection site reactions. They reported sensations of heat, erythema, soreness, and swelling. Health department had generally been stating that in time the symptoms would resolve. The final outcome of the events was unknown. Additional information is not expected as we have no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) lot # L030586 (expiration date 10-FEB-2017), lot # L024125 (expiration dare 30-DEC-2016), which were improperly stored at -14.7 C for 1 hour and 30 minutes. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Bursa injury, Injection site reaction, Pain in extremity
Clinical narrative: Arm pain for >7 days, sought medical treatment at clinic (out of state and therefore did not go to PCP). Received prednisone and Norco. Pt was told by clinic "shot hit bursa" although I'm not sure how they could determine where shot placed. Pt still having arm pain after 10 days when called pharmacy to report.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L015048, expiry date of 29-APR-2017 and M-M-R II lot # L002873, expiry date of 27-JAN-2017. No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 52 year old female patient enrolled in a market research, reporting on herself. Patient's concurrent condition included diabetes mellitus. Information regarding her medical history and concomitant therapy was not provided. On 29-OCT-2015 the patient was administered with ZOSTAVAX (dosing details unspecified). On 30-OCT-2015, the patient experienced redness, swelling and pain at the vaccine injection site. Outcome of the events were reported as recovering. Reporter considered the events to be non-serious and related to ZOSTAVAX. Additional information is not expected. There was no consent for follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # L014428, expiry date 12-MAR-2018, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Throat irritation, Wheezing
Clinical narrative: Wheezing; labored breaths; itchy throat.
Age: 52.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pyrexia
Clinical narrative: Client stated she experience a low grade fever until the 2nd week of November. Experienced "horrible muscle pain all over by body" 10 days after vaccination. Hx: sclera derma last orthostatic injection 9/30/25.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiry date 30-JUL-2017, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L008053, expiry date 30-NOV-2016, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an approximately 19 year old male patient. No medical history or concurrent conditions were reported. In January 1996, the patient was initially vaccinated "properly, according to recommended schedule", with RECOMBINANT (manufacturer unknown) (dose, route, lot # and expiration date were not reported). No concomitant medication was reported. On 17-JUN-2015, the patient had titers drawn for hepatitis b antibodies which came back non-reactive, because of that, the patient who was still 19 years old at the time, was administered 2 additional doses (4th and 5th doses) of pediatric Hepatitis B vaccine (manufacturer unknown) spaced 1 month apart on unspecified dates in approximately 2015. The reporter also stated that the patient who had turned 20 years old would receive an additional (6th dose) with the adult formulation of Hepatitis B Vaccine on an unspecified date. It was also reported that no product quality complaint was involved. At the time of the report, the outcome of hepatitis b antibodies which came back non-reactive was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to about 3 patients. Ages, genders, medical history or concurrent conditions were not reported. On 05-DEC-2015, doses of M-M-R II (lot # L024267, rHA, expiration date 01-JUL-2017) were improperly exposed to 19C for 23  hours, then on unspecified dates between 05-DEC-2015 and 05-JAN-2016, about 3 patients each received a dose of this improperly exposed M-M-R II. No known adverse effects have been reported. The reporter stated that was not product quality complaints involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (strength, unit and frequency not reported, oral route, lot # L010126 with Exp. date 22-JAN-2017 and lot # L026741 with Exp. date 18-MAY-2017). Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact the physician.
Age: 0.74
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a 21 year old non pregnant female patient with exercise induced asthma. The patient did not have any drug reactions or allergies. On 09-NOV-1994, the patient was vaccinated with the first dose  RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). On 06-DEC-1994 and on 07-AUG-1995, the patient was vaccinated with the second and the third dose of RECOMBIVAX HB, respectively (dose, route of administration, lot # and expiration date were not reported). The patient was not taking any concomitant medications. On 22-DEC-2015, the patient's Hepatitis B titers were drawn and the results showed a less than therapeutic level (units not provided). The outcome of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical  nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # L019124 (expiration date 27-MAY-2017), lot # L017144 (expiration date 13-MAY-2017), which were improperly stored at -14.7 C for 1 hour and 30 minutes (incorrect product storage). There was no previous temperature excursion. No adverse effects 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 was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose, frequency and route of administration were not reported, lot # reported as L027432 with expiration date: 27-JUL-2017, L015282 with expiration date: 30-APR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report has been received from a healthcare student referring to a currently 24 years old female patient. The patient's pertinent medical history, concurrent conditions and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (strength, dose, frequency lot number, expiration date and indication were not provided). Concomitant therapies were not provided. On an unknown date, approximately seven days after vaccination the patient developed swelling at the injection site. The patient sought medical attention as she contacted a pharmacist. The patient did not require any prescription drug for the experience and she was not hospitalized, the reporter stated that the events were not considered to be life threatening, overdose, disabling or medically significant. On an unspecified date the patient recovered from her injection site swelling. The causal relationship between the injection site swelling and GARDASIL was not reported. PQC was not involved. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Back pain, Blood test normal, Computerised tomogram normal, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Day after pt received 2mo vax, pt with T101, given Tylenol which was vomited. Parents noted pt with seizure like activity; stiffening of arms, eye deviation, arching of back. Brought to ED with 2 more episodes in ED. Treated with IV Keppra. Discharged after neg CT.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure like phenomena, Urine analysis normal, Vomiting
Clinical narrative: Day after pt received 2mo vax, pt with T101, given Tylenol which was vomited. Parents noted pt with seizure like activity; stiffening of arms, eye deviation, arching of back. Brought to ED with 2 more episodes in ED. Treated with IV Keppra. Discharged after neg CT.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 100degrees evening of injection than swelling, redness, stinging and burning at injection site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Excessive swelling and soreness at injection site and possible increased difficulty breathing, although pt has pre existing breathing difficulty.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008621, expiration date 04-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008621, expiration date 04-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow-up.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient called 1/12/16 complaining about an injection site reaction of pain since the date of the administration. Patient had not seen the doctor and just called the pharmacy suggested to patient to see personal doctor.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called 1/12/16 complaining about an injection site reaction of pain since the date of the administration. Patient had not seen the doctor and just called the pharmacy suggested to patient to see personal doctor.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to 4 unspecified patients. Patient's medical history and concurrent condition were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX that had been improperly stored (strength, dose, frequency, route, expiration date and lot number were not reported). There was no concomitant medication reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Endotracheal intubation, Intensive care, Positive expiratory pressure therapy, Respiratory distress
Clinical narrative: Cough and wheezing noted 1/5, seen by PMD 1/15, worsened and sent to ED 1/16 - admitted resp distress and code blue that night, intubated and transferred to PICU, currently on oscillator.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Wheezing
Clinical narrative: Cough and wheezing noted 1/5, seen by PMD 1/15, worsened and sent to ED 1/16 - admitted resp distress and code blue that night, intubated and transferred to PICU, currently on oscillator.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Soon after administration of ZOSTAVAX, pt. developed 4x6in redness and swelling around injection site, lasting 48 hrs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth measuring 6.5 cm x 10.5 cm in the area of the left deltoid.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # L023434, expiration date: 22-MAR-2017, orally (exact dose was not reported) (2 boxes). There were no concomitant medications provided. There were no adverse effects reported.  Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as reporter refused additional contact.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rashes over her abdomen and trunk.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: (1) Tired-stay in bed for 2 days. (2) Arm hurt real bad-couldn't move arm. (3) Bruised-(only on Aspirin)- Not any other anticoagulant. (4) Headache-dizziness-No fever
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: (1) Tired-stay in bed for 2 days. (2) Arm hurt real bad-couldn't move arm. (3) Bruised-(only on Aspirin)- Not any other anticoagulant. (4) Headache-dizziness-No fever
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 12 x 10 erythematous region including approximately 80% of (L) upper arm. Influenza immunization administered in (L) deltoid area. Area of erythematous/tenderness resolved 01/12/16.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K010574, expiration date 08-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a patient who received Influenza vaccine. In 2015, the patient received Influenza vaccine. In 2015, an unknown time after receiving Influenza vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine. Additional details provided were as follows: The healthcare professional reported that,, the patient might had experienced an adverse event after the vaccination.