chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Middle ear effusion, Muscle atrophy, Neuropathy peripheral
Clinical narrative: Within 48 hours total neuropathy of both feet from ankles to toes with muscle wasting. Preceded by and by the next morning of receiving vaccine fluid in ears causing loud sounds in ears for 4 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program [Pfizer First Connect]. A contactable nurse reported that a 17-years-old American female patient (her daughter) of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on the left bicep at the physicians office on 10Aug2017 at 15:00 at single dose for immunisation. Medical history included allergy from 2007 and ongoing (environmental, grass, mold, pollen), asthma type symptoms from 2013 and ongoing (exercised induced). Concomitant medication included salbutamol sulfate (PROAIR) from 2013 and ongoing used as needed for asthma symptoms and birth control pills from 2016 and ongoing) for birth control. The patient developed hives and swelling after receiving injectionon and was extremely hot and tired after receiving injection, both on 10Aug2017. The patient had a Trumenba shot. She developed hives and swelling from shoulder to the middle of her back. She was extremely hot and is extremely tired. The reporter wanted to know what were the ingredients.The outcome of the events was recovered on 13Aug2017. The reporter considered the events related to TRUMENBA.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program [Pfizer First Connect]. A contactable nurse reported that a 17-years-old American female patient (her daughter) of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on the left bicep at the physicians office on 10Aug2017 at 15:00 at single dose for immunisation. Medical history included allergy from 2007 and ongoing (environmental, grass, mold, pollen), asthma type symptoms from 2013 and ongoing (exercised induced). Concomitant medication included salbutamol sulfate (PROAIR) from 2013 and ongoing used as needed for asthma symptoms and birth control pills from 2016 and ongoing) for birth control. The patient developed hives and swelling after receiving injectionon and was extremely hot and tired after receiving injection, both on 10Aug2017. The patient had a Trumenba shot. She developed hives and swelling from shoulder to the middle of her back. She was extremely hot and is extremely tired. The reporter wanted to know what were the ingredients.The outcome of the events was recovered on 13Aug2017. The reporter considered the events related to TRUMENBA.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Feeling hot, Swelling, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program [Pfizer First Connect]. A contactable nurse reported that a 17-years-old American female patient (her daughter) of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on the left bicep at the physicians office on 10Aug2017 at 15:00 at single dose for immunisation. Medical history included allergy from 2007 and ongoing (environmental, grass, mold, pollen), asthma type symptoms from 2013 and ongoing (exercised induced). Concomitant medication included salbutamol sulfate (PROAIR) from 2013 and ongoing used as needed for asthma symptoms and birth control pills from 2016 and ongoing) for birth control. The patient developed hives and swelling after receiving injectionon and was extremely hot and tired after receiving injection, both on 10Aug2017. The patient had a Trumenba shot. She developed hives and swelling from shoulder to the middle of her back. She was extremely hot and is extremely tired. The reporter wanted to know what were the ingredients.The outcome of the events was recovered on 13Aug2017. The reporter considered the events related to TRUMENBA.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 169701A, expiry date 31st January 2019). On 10th July 2017, the patient received the 1st dose of BEXSERO. On 10th July 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced pain, described as more painful than the other shots she received. For tolerance after 2nd dose please check the case US2017GSK129036.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO (batch number 169701A, expiry date 31st January 2019). On 10th July 2017, the patient received the 1st dose of BEXSERO. On 10th July 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced pain, described as more painful than the other shots she received. For tolerance after 2nd dose please check the case US2017GSK129036.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Chills, Injection site cellulitis, Injection site discolouration, Injection site pain
Clinical narrative: On August 15th at about 7:31pm patient was given the Tdap shot at pharmacy. That evening she went to bed with a slight fever of 99.8 and her left arm being a little sore. The morning of August 16th at about 9:30 am I had noticed that patient was extra tired, running a fever of 101.2 and was still in pain so I administered Ibuprofen and alternated between hot and cold compresses for the rest of the day and into the evening. At about 1:40 AM on August 17th I was awoken by cries and moans coming from patient. She said the pain was so unbearable and I checked out her arm I noticed that there was a red mark that looked  slightly like a rash that was below the injection site so I took a picture. Once again I administered Ibuprofen and alternated between hot and cold compresses until she fell asleep. Around 730 to 8 AM I had looked at her arm again and noticed that the red rash had gotten significantly bigger so once again I took a photo to compare sizes. Throughout the day on the 17th I took pictures and decided it would be best to make a mark around the site with the time on it to see how much it was spreading. By 9:30 PM the redness had spread throughout her shoulder and she was having trouble breathing and feeling like there was vomit in her throat but nothing was there, and her glands were quite swollen so I rushed her to the hospital and checked in at 10:17pm and at 11:23 she was seen by a nurse and was given BENADRYL due to her having trouble breathing. Patient was finally seen by the emergency room doctor and was diagnosed with cellulitis and was given KEFLEX at 1:00 am now August 18th. She was discharged with a prescription for KEFLEX and BENADRYL and we were home by 1:45am. It's now August 21st and the redness is gone but she has welts instead.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: On August 15th at about 7:31pm patient was given the Tdap shot at pharmacy. That evening she went to bed with a slight fever of 99.8 and her left arm being a little sore. The morning of August 16th at about 9:30 am I had noticed that patient was extra tired, running a fever of 101.2 and was still in pain so I administered Ibuprofen and alternated between hot and cold compresses for the rest of the day and into the evening. At about 1:40 AM on August 17th I was awoken by cries and moans coming from patient. She said the pain was so unbearable and I checked out her arm I noticed that there was a red mark that looked  slightly like a rash that was below the injection site so I took a picture. Once again I administered Ibuprofen and alternated between hot and cold compresses until she fell asleep. Around 730 to 8 AM I had looked at her arm again and noticed that the red rash had gotten significantly bigger so once again I took a photo to compare sizes. Throughout the day on the 17th I took pictures and decided it would be best to make a mark around the site with the time on it to see how much it was spreading. By 9:30 PM the redness had spread throughout her shoulder and she was having trouble breathing and feeling like there was vomit in her throat but nothing was there, and her glands were quite swollen so I rushed her to the hospital and checked in at 10:17pm and at 11:23 she was seen by a nurse and was given BENADRYL due to her having trouble breathing. Patient was finally seen by the emergency room doctor and was diagnosed with cellulitis and was given KEFLEX at 1:00 am now August 18th. She was discharged with a prescription for KEFLEX and BENADRYL and we were home by 1:45am. It's now August 21st and the redness is gone but she has welts instead.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Crying, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: On August 15th at about 7:31pm patient was given the Tdap shot at pharmacy. That evening she went to bed with a slight fever of 99.8 and her left arm being a little sore. The morning of August 16th at about 9:30 am I had noticed that patient was extra tired, running a fever of 101.2 and was still in pain so I administered Ibuprofen and alternated between hot and cold compresses for the rest of the day and into the evening. At about 1:40 AM on August 17th I was awoken by cries and moans coming from patient. She said the pain was so unbearable and I checked out her arm I noticed that there was a red mark that looked  slightly like a rash that was below the injection site so I took a picture. Once again I administered Ibuprofen and alternated between hot and cold compresses until she fell asleep. Around 730 to 8 AM I had looked at her arm again and noticed that the red rash had gotten significantly bigger so once again I took a photo to compare sizes. Throughout the day on the 17th I took pictures and decided it would be best to make a mark around the site with the time on it to see how much it was spreading. By 9:30 PM the redness had spread throughout her shoulder and she was having trouble breathing and feeling like there was vomit in her throat but nothing was there, and her glands were quite swollen so I rushed her to the hospital and checked in at 10:17pm and at 11:23 she was seen by a nurse and was given BENADRYL due to her having trouble breathing. Patient was finally seen by the emergency room doctor and was diagnosed with cellulitis and was given KEFLEX at 1:00 am now August 18th. She was discharged with a prescription for KEFLEX and BENADRYL and we were home by 1:45am. It's now August 21st and the redness is gone but she has welts instead.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site rash, Lymphadenopathy, Moaning, Pain in extremity, Pyrexia
Clinical narrative: On August 15th at about 7:31pm patient was given the Tdap shot at pharmacy. That evening she went to bed with a slight fever of 99.8 and her left arm being a little sore. The morning of August 16th at about 9:30 am I had noticed that patient was extra tired, running a fever of 101.2 and was still in pain so I administered Ibuprofen and alternated between hot and cold compresses for the rest of the day and into the evening. At about 1:40 AM on August 17th I was awoken by cries and moans coming from patient. She said the pain was so unbearable and I checked out her arm I noticed that there was a red mark that looked  slightly like a rash that was below the injection site so I took a picture. Once again I administered Ibuprofen and alternated between hot and cold compresses until she fell asleep. Around 730 to 8 AM I had looked at her arm again and noticed that the red rash had gotten significantly bigger so once again I took a photo to compare sizes. Throughout the day on the 17th I took pictures and decided it would be best to make a mark around the site with the time on it to see how much it was spreading. By 9:30 PM the redness had spread throughout her shoulder and she was having trouble breathing and feeling like there was vomit in her throat but nothing was there, and her glands were quite swollen so I rushed her to the hospital and checked in at 10:17pm and at 11:23 she was seen by a nurse and was given BENADRYL due to her having trouble breathing. Patient was finally seen by the emergency room doctor and was diagnosed with cellulitis and was given KEFLEX at 1:00 am now August 18th. She was discharged with a prescription for KEFLEX and BENADRYL and we were home by 1:45am. It's now August 21st and the redness is gone but she has welts instead.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Sensation of foreign body, Urticaria
Clinical narrative: On August 15th at about 7:31pm patient was given the Tdap shot at pharmacy. That evening she went to bed with a slight fever of 99.8 and her left arm being a little sore. The morning of August 16th at about 9:30 am I had noticed that patient was extra tired, running a fever of 101.2 and was still in pain so I administered Ibuprofen and alternated between hot and cold compresses for the rest of the day and into the evening. At about 1:40 AM on August 17th I was awoken by cries and moans coming from patient. She said the pain was so unbearable and I checked out her arm I noticed that there was a red mark that looked  slightly like a rash that was below the injection site so I took a picture. Once again I administered Ibuprofen and alternated between hot and cold compresses until she fell asleep. Around 730 to 8 AM I had looked at her arm again and noticed that the red rash had gotten significantly bigger so once again I took a photo to compare sizes. Throughout the day on the 17th I took pictures and decided it would be best to make a mark around the site with the time on it to see how much it was spreading. By 9:30 PM the redness had spread throughout her shoulder and she was having trouble breathing and feeling like there was vomit in her throat but nothing was there, and her glands were quite swollen so I rushed her to the hospital and checked in at 10:17pm and at 11:23 she was seen by a nurse and was given BENADRYL due to her having trouble breathing. Patient was finally seen by the emergency room doctor and was diagnosed with cellulitis and was given KEFLEX at 1:00 am now August 18th. She was discharged with a prescription for KEFLEX and BENADRYL and we were home by 1:45am. It's now August 21st and the redness is gone but she has welts instead.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: At the injection site, patient developed a rash.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information concerning the patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 04-APR-2017, the patient was vaccinated with VARIVAX (lot # M027346, expiration date and dose were not reported), intramuscularly, at a 90 degree angle, instead of a 45 degree angle. Other suspect therapies included a sterile diluent (STERILE DILUENT) (intramuscularly; dose, frequency, lot number and expiration date were not reported). No adverse effect was reported. No product quality complaint was involved. Follow up information was received from  the reporter on 02-AUG-2017. The patient was 10 months old female. The patient was vaccinated with VARIVAX into left tight. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Viral titre decreased
Clinical narrative: Information has been received from a pharmacy intern referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in January 2017, the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route not reported) for prophylaxis. On an unknown date in 2017, the patient had low titre to varicella. The patient was on a "organ transplant list" for an unknown reason. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event "the patient was on a organ transplant list for an unknown reason" was considered to be medically significant as the patient might need organ transplant.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Peripheral swelling, Tenderness
Clinical narrative: Information has been received from a male patient of unknown age referring to himself.  On 25-JUL-2017 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date were unknown) intramuscularly instead of subcutaneously for prophylaxis (Subcutaneous injection formulation administered by other route). On an unknown date in July 2017 the patient experienced "redness and swelling" in his arm and it was "sore to the touch".  The outcome of the events was unknown. Causality between ZOSTAVAX and the events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Product quality issue, Rash erythematous
Clinical narrative: This spontaneous report was received from a female pharmacist of unknown age, who was reporting on herself. The patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies were not provided. On 19-JUL-2017, the patient got some of the reconstituted ZOSTAVAX (lot # N010494 with expiration date on 16-MAR-2017) on her hand when it leaked from the vial. No diluent information was reported. On 31-JUL-2017, in the evening, the patient noticed she had small raised bumps around her forehead and hairline. The outcome of the event was reported as not recovered at the time of this report. Product quality complaint was filed for this case. She thought there might be some correlation to being exposed to the ZOSTAVAX, because she did not wash her hands. However, she also recalled that she was wearing gloves and really did not think she got any of the product on her skin. The patient also stated that she was uncertain about the relatedness between the event of small raised bumps and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-AUG-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported). The patient received less than a full dose of ZOSTAVAX because during the administration, the vaccine started to leak out of the tip of the syringe. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. Patient's concurrent condition, pertinent medical history, drug reactions and allergies were not reported. On 14-AUG-2017, the patient was vaccinated with an expired dose of PROQUAD (lot # M006103, expiry date: 01-AUG-2017) subcutaneously for prophylaxis (expired product administered). Dosing details were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). It was reported that no temperature excursion occurred for this dose of PROQUAD. No adverse effects reported. No product quality complaint (PQC) was involved. No additional information was provided.
Age: 1.75
Sex: F
Vaccine: HEPA, HIBV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-JUN-2017 the patient was vaccinated with VAQTA lot # N005274 for prophylaxis. Concomitant therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown.The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507:
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown demographics. The patient's medical history was not reported. It was unknown if the patient had any drug reactions/allergies. On an unspecified date, approximately in 2012 (Also reported as five years ago), before the age of 65 (units unspecified), the patient was vaccinated with PNEUMOVAX 23 (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for prophylaxis. There were no concomitant therapies reported. On an unknown date, the patient experienced swelling in the arm and could not bend the arm for an unknown period of time. It was unknown if the patient received treatment. It was unknown if lab diagnostics/studies performed. The patient did not seek medical attention. There was no product quality complaint involved. The outcome of the events was unknown. The causality assessment was not provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This spontaneous report as received from a other refers to a 65 year old male patient. On 14-AUG-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On 15-AUG-2017, 2 days after onset of therapy the patient experienced tinnitus. The outcome of tinnitus was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown dates the patient experienced herpes zoster (6 times). The outcome of herpes zoster is unknown.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 year old male patient. On 16-AUG-2017 the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L020000, expiry date on 02-JUN-2017, which was reconstituted with an expired sterile diluent with lot # reported as K016130, expiry date on 21-JUL-2017, for prophylaxis. No adverse effects. Lot number K016130 is an invalid lot number for sterile diluent.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified patients of unknown age and gender. From 24-JUL-2017 to 16-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M042853 and expiration date on 17-JUL-2019 for prophylaxis. No adverse event was reported. The doses of GARDASIL 9 were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C during a time frame of 1 hour 39 minutes which was detected by the data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA008321:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse (LPN), referring to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot number N002914, expiration date 04-NOV-2019, for prophylaxis. The data logger registered a temperature excursion of 47.49 Fahrenheit (F) for 13 minutes. There was not previous temperature excursion. No adverse effects were reported in any patients. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1708USA007603.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # N011305 for prophylaxis. No adverse effects were reported.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 2 year old male patient. On 20-JUL-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M023823 for prophylaxis. On 20-JUL-2017, 5 hrs 42 min after onset of therapy the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown demographics. On an unknown date, the patient had been vaccinated with improperly stored dose of one of the following vaccines: VAQTA lot # N008823, expiration date: 26-MAY-2018; ROTATEQ lot # N000172, expiration date: 10-JUN-2018, oral; RECOMBIVAX HB lot # M032649, expiration date: 11-NOV-2018 or VARIVAX lot # N008829, expiration date: 16-MAR-2019 for prophylaxis. The reporter was not sure about which vaccine the patient had received. Temperature for VARIVAX, in the range (-9 °C to 8 °C); for VAQTA, ROTATEQ, and RECOMBIVAX HB, in the range (9 °C to 25 °C). Time frame for VARIVAX, 7 hours and 20 minutes, for the VAQTA, ROTATEQ, and RECOMBIVAX HB, 5 hours and 37 minutes. No previous temperature excursion. Data logger was involved. No adverse effect reported. No product quality complaint involved. No additional information was provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a 21 years old female patient referring to herself. The patient's pertinent medical history and concomitant medications were reported as none. The patient was not allergic to any medication. On 12-JUL-2017 (also reported as 5 weeks ago) the patient was vaccinated with first dose of GARDASIL 9 (dosing details were not reported) for prevention (prophylaxis). At the time the patient was administered the GARDASIL 9 she did not know she was pregnant (exposure during pregnancy). The patient became pregnant with LMP (last menstrual period) of 14-JUN-2017 and EDD (estimated date of delivery) of 21-MAR-2018. The patient's gestational age was 9 weeks today. The pregnancy outcome was pending. The outcome of exposure during pregnancy was unknown. The date the pregnancy was confirmed could not be confirmed. Initially, the patient was told by her physician's office that she would still be able to receive the second and third dose in the GARDASIL 9 series even though she was pregnant. The patient went to the physician's office for the second dose. They would not administer the second dose and provided her with information to call the Pregnancy Registry. There was no product quality complaint involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M024698 with expiration date of 27-JUN-2017, reconstituted with sterile diluent (manufacturer unknown). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA008744.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a vaccine professional refers to multiple unspecified patients of unknown age and gender. On 15-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N000682, lot #N008077 and N014369, as prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (MRK INJ). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect dose administered and syringe issue.  On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA008322.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot number L044917 with expiration date of 05-OCT-2018, for prophylaxis, and the administered doses were exposed to a temperature higher than 47 F (Fahrenheit degrees) but lower than 77 F (Fahrenheit degrees) for 4 days 6 hours and 3 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004450: US-009507513-1707USA004449: US-009507513-1707USA004419.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # L046900 for prophylaxis. On 17-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified patients of unknown age and gender. From 24-JUL-2017 to 16-AUG-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # N001348, expiration date on 31-OCT-2019 and lot # N000238, expiration date on 25-OCT-2019. No adverse event was reported. The doses of PEDVAXHIB were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C during a time frame of 1 hour 39 minutes which was detected by the data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007499.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot # M015735, M049127, M015735 and N014366) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA008563: US-009507513-1708USA008564.
Sex: U
Vaccine: PPV
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from a pharmacist via company representative and refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, it was reported that the patient was vaccinated with PNEUMOVAX 23 injection (dose, frequency were not provided) for preventing pneumonia. On an unknown date, the patient experienced diarrhea for three days. No product quality compliant (PQC) was involved. Many of the fields were marked, unknown by reporter, because the caller did not have the information to answer the questions within this report. No further adverse event information was there to report. The outcome of diarrhoea was reported as recovered. The reporter did not report the causal relation of event with respect to PNEUMOVAX 23.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with VARIVAX lot # M008171, .5 ml, subcutaneous instead of intended ZOSTAVAX. Other suspect therapies included sterile diluent (lot number:N006322 expiry date:11-JUL-2019). No adverse effects were reported. No product quality complaint was reported. The outcome of wrong drug administered and no adverse event was unknown.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to three unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. From 03-AUG-2017 to 17-AUG-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # M029681, expiration date 22-JAN-2018, for prophylaxis. The vaccine was exposed to 32 Fahrenheit degree to 35 Fahrenheit degree for 39 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (lot # M036296, M041182 and N012493) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several cases from the same reporter. Sender's Comments: US-009507513-1708USA008361: US-009507513-1708USA008564.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Lot# M022402, M044019 and N012616) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several cases from the same reporter.; Sender's Comments: US-009507513-1708USA008563: US-009507513-1708USA008361:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M024698 with expiration date of 27-JUN-2017, reconstituted with sterile diluent (manufacturer unknown). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA008061.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Client's father called 8/10/2017 states son developed a raised hive like rash under arms and on the back of both legs from knee folds to buttock folds. States that son C/O itching in the middle of the night the same day shots were administered. No other symptoms. Rash remains present with BENADRYL and hydrocortisone creams. There has been no improvement or advancement. Denies cashew exposure or changes in soaps, foods or laundry detergent. Father is concerned if child should receive further vaccines in future.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Headache, Muscular weakness
Clinical narrative: Child was at his usual speed and agility class that evening. While climbing up the ropes he felt a pop in his head and had a severe left sided headache with arm and leg weakness. He went to urgent care and then to the ER
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Hive like rash appeared first on left leg then on right leg within 5 minutes of giving immunizations, mom advised to go home and give some Benadryl-by later that evening, rash had all but disappeared.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient in her fifties. The patient's medical history included herpes zoster (two outbreaks). On an unknown date in 2010 (reported as "about 6 or 7 years ago"), the patient was vaccinated with ZOSTAVAX reconstituted with sterile diluent (MRK) for prophylaxis. On 07-AUG-2017, the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Disability, Headache, Laboratory test, Neck pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiry date were not reported) for immunisation. On 14-AUG-2017, the patient experienced severe neck pain (disability) and head pain (disability) the patient seek medical attention went to hospital. The patient spent 3 hours in the emergency room where unspecified labs were taken and the patient was prescribed an unspecified pain medication. The reporter stated that this was a significant disability for the patient as she was stating her head and neck pain were excruciating. The reporter stated that the patient was feeling better the pain was not as bad but she still has some lingering effects. The outcome of neck pain and headache was reported as not recovered. Causality assessment was not reported for the events.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with M-M-R II recombinant human albumin (rHA ) or human serum albumin (HSA) (Strength, dose, frequency, route, anatomical location, lot/batch # and expiry date were not reported) for prophylaxis. Other suspect therapies included VARIVAX (Strength, dose, frequency, route, anatomical location, lot/batch # and expiry date were not reported) and sterile diluent. There were no concomitant therapies reported. On an unspecified date, the patient was administered M-M-R II and VARIVAX when the patient was 11 months old due to international travel. No adverse effects reported. Product quality complaint was not involved.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # M007762, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to LIQUID PEDVAXHIB. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-1707USA001815: US-009507513-1708USA008731: US-009507513-1708USA008730:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with PROQUAD lot # M038227, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to PROQUAD. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1707USA001815: US-009507513-1708USA008731: US-009507513-1708USA008729.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with VARIVAX lot # M010480, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1707USA001815: US-009507513-1708USA008729: US-009507513-1708USA008730.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin discolouration, Vaccination complication
Clinical narrative: Patient came to the clinic on the 17 of August and got two shots, TDaP, and MENVEO. Shots was given on left deltoid. Pt came back on the 21 of August with a moderate reaction. The pt skin turned green and red. Pt said that he went to the ER and came back on 21 of August to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: The patient was in the clinic for his 6 month immunizations. The other nurse taking care of the nurse-only visits was busy at the time, and the mom had stated that she had somewhere to be soon. I had some time, so I helped draw up the vaccines. Since the mom had somewhere to be, the other nurse and I decided to wait until after we gave them to document them in our immunization log (which helps us keep track of our counts as well). I took the PENTACEL vaccine box out of the fridge and grabbed one of the vials from the box. The vial I grabbed happened to be the Hib portion, which is a powder. I didn't see that there was a specific diluent portion of the vaccine (the DTap-IPV part), and reconstituted it with 0.5 mL of the sterile diluent used for other vaccines. The other nurse and I went to administer the vaccines. I administered the "PENTACEL" IM into the left thigh. The patient tolerated it well with no immediate reactions. He left the clinic with his mother. I went back into the med room where we had drawn up the vaccines. I was documenting the immunizations when I realized my mistake. The PENTACEL count number in the log was not matching up with the number of vials. The vials were tipped over in the box, and when I took a better look, I saw that there was also a diluent part of the vaccine. I immediately informed my supervisor of the incident and called the HD and spoke with staff. She informed me that the entire vaccine was invalid, and the patient would have to return for a repeat immunization. Staff stated that this would cause no harm or adverse reactions. I called the mother to inform of the situation. She was understanding of the situation. No harm had been caused. The mother brought the child back for the proper immunization on 8/17/17.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Cold sweat, Dizziness, Hyperhidrosis, Hypoaesthesia oral
Clinical narrative: Approximately 10 min after patient received immunization she began to complain of numbness around her mouth. She progressively became dizzy, anxious, diaphoretic, skin became cool and clammy, developed tremors and developed hives on right flank area. 911 was called and patients status was assessed continuously until EMS arrived and took over care of the patient. The patient was transported to a local emergency room in stable condition.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Tremor, Urticaria
Clinical narrative: Approximately 10 min after patient received immunization she began to complain of numbness around her mouth. She progressively became dizzy, anxious, diaphoretic, skin became cool and clammy, developed tremors and developed hives on right flank area. 911 was called and patients status was assessed continuously until EMS arrived and took over care of the patient. The patient was transported to a local emergency room in stable condition.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient experienced generalized muscle aches for 2 days (48 hours) Patient used Tylenol/aspirin during this time period.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site erythema, Insomnia
Clinical narrative: Onset of severe arm pain prohibiting movement within 2 hours. Next AM, when awoke had 5cm area of redness down arm from injection site. Redness lasted 4 days. Headache and fatigue starting 8-9/17. Lasting 1 week.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Onset of severe arm pain prohibiting movement within 2 hours. Next AM, when awoke had 5cm area of redness down arm from injection site. Redness lasted 4 days. Headache and fatigue starting 8-9/17. Lasting 1 week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient fainted.