chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Rash
Clinical narrative: Pt got a rash on her chest as well as redness and injection site pain/redness. Rash on arms too, lower arms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Pt. arm got very hot, red and swollen. She had pain and the reaction site progressed within a day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site-Right deltoid area-with erythema/warmth and induration - less than 10 cm-approx. 8cm. Per PCP, apply ice to the area, Ibuprofen and expect resolution over the next few days.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Concussion, Dehydration, Dental implantation, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fall, Feeling abnormal, Full blood count, Haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Impaired work ability, Influenza like illness, Laceration, Middle insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Suture insertion, Syncope, Tooth fracture, Tooth loss, Tooth repair
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Dizziness, Erythema, Face injury, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loose tooth, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Suture insertion, Tooth extraction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of passed out in a 55-year-old female patient who received SHINGRIX (batch number 5942P, expiry date 30th January 2020). On 13th March 2018, the patient received SHINGRIX. On 13th March 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities and pain in arm. In March 2018, the patient experienced passed out (serious criteria GSK medically significant), influenza like illness, contusion, influenza, jaw injury and loose tooth. The patient was treated with ADVIL. In March 2018, the outcome of the influenza like illness and influenza were recovered/resolved. On an unknown date, the outcome of the passed out, contusion, jaw injury and loose tooth were unknown and the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. The reporter considered the passed out, swelling arm, influenza like illness, contusion, erythema of extremities, pain in arm and influenza to be related to SHINGRIX. It was unknown if the reporter considered the jaw injury and loose tooth to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient. The patient could not provide exact dosage she received. The patient noted her left arm was swollen, red and painful at 15:00 on 13th March 2018. Redness, swelling, and pain in left arm resolved after several days, no exact date was provided. The patient took ADVIL and applied ice for events with arm at 21:00. In the middle of the night the patient woke for more ADVIL, went to the bathroom, and felt flu like. Flu like described as dizzy with the flu. Flu like feeling resolved after 2 to 4 days, exact date was not provided. She woke up on the floor of her kitchen after having passed out. Passed out described as splitting her jaw, loosing a tooth, bruising her chest, and facial bruising. Facial bruising resolved in the last week, exact date was not provided. The patient denied hospitalization. Stiches placed to repair split jaw. Dentist pulled the tooth. The patient denied any concomitant medications or vaccinations. The reporter noted she could not finish entire report, was unable to inquire about healthcare professional demographics, vaccine responsible MD. The reporter was not able to provide last name of the pharmacist who administered the vaccine. The reporter noted that these events were reported by a Pharmacist from Pharmacy, she could not provide a name. The reporter noted that these events were reported by the physician of the center where she sought treatment, no contact details of center was provided. The reporter noted that she reported events via VAERS and the events had not been reported to GSK, as per her knowledge.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 62-year-old male patient who received SHINGRIX (batch number 54K24 ?, expiry date 30th April 2020). The patient's past medical history included chemotherapy (2 years and 2 months before the date of reporting) and radiation therapy (2 years and 2 months before the date of reporting). Concurrent medical conditions included neuropathy peripheral. Concomitant products included gabapentin. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, 1 days after receiving SHINGRIX, the patient experienced pain (serious criteria disability). In April 2018, the patient experienced mass (serious criteria disability), pain in arm (serious criteria disability) and injected limb mobility decreased. On an unknown date, the outcome of the pain, mass and pain in arm were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain, pain in arm and injected mobility decreased to be related to SHINGRIX. The reporter considered the mass to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported on behalf of the patient that the patient experienced soreness in his right arm the day after he received the SHINGRIX injection. The healthcare professional reported that patient was experiencing pain in his right arm when he lifts his arm up over his head. The healthcare professional stated that the patient was disabling because the patient could not move his arm. The healthcare professional stated that patient also had a lump on the right arm that looked like cellulitis, but she was not sure what it was. The healthcare professional stated that the lump was not red and stated that the patient reported that the lump was not painful, but the spot next to the lump was painful. The healthcare professional stated that she was not sure if it was the medication or the way the injection was administered.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb mass, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 62-year-old male patient who received SHINGRIX (batch number 54K24 ?, expiry date 30th April 2020). The patient's past medical history included chemotherapy (2 years and 2 months before the date of reporting) and radiation therapy (2 years and 2 months before the date of reporting). Concurrent medical conditions included neuropathy peripheral. Concomitant products included gabapentin. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, 1 days after receiving SHINGRIX, the patient experienced pain (serious criteria disability). In April 2018, the patient experienced mass (serious criteria disability), pain in arm (serious criteria disability) and injected limb mobility decreased. On an unknown date, the outcome of the pain, mass and pain in arm were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain, pain in arm and injected mobility decreased to be related to SHINGRIX. The reporter considered the mass to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported on behalf of the patient that the patient experienced soreness in his right arm the day after he received the SHINGRIX injection. The healthcare professional reported that patient was experiencing pain in his right arm when he lifts his arm up over his head. The healthcare professional stated that the patient was disabling because the patient could not move his arm. The healthcare professional stated that patient also had a lump on the right arm that looked like cellulitis, but she was not sure what it was. The healthcare professional stated that the lump was not red and stated that the patient reported that the lump was not painful, but the spot next to the lump was painful. The healthcare professional stated that she was not sure if it was the medication or the way the injection was administered.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Dyskinesia, Pyrexia, Seizure like phenomena
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 72-year-old female patient who received SHINGRIX (batch number T5242, expiry date 26th March 2019). The patient's past medical history included surgery (had an operation on her left hand a few weeks before the date of reporting). Previously administered products included pneumonia vaccine and influenza vaccine with an associated reaction of pain in extremity (refer case). Concomitant products included Aspirin, Atorvastatin and Chlorthalidone. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced upset stomach, fever and chills. In April 2018, the patient experienced seizure (serious criteria GSK medically significant) and motor dysfunction. The patient was treated with TYLENOL. On an unknown date, the outcome of the seizure, fever, chills and motor dysfunction were unknown and the outcome of the upset stomach was recovered/resolved. It was unknown if the reporter considered the seizure, fever, chills and motor dysfunction to be related to SHINGRIX. The reporter considered the upset stomach to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. Less than a week after vaccination, the patient stated that her chills were so severe that it felt like she had a seizure since she was out of control of her limbs. The patient woke up with a temperature of 102 degrees. The patient took a TYLENOL and the next day she was fine. This case has been linked with case US2018GSK069090 (same patient).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Dyskinesia, Motor dysfunction, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 72-year-old female patient who received SHINGRIX (batch number T5242, expiry date 26th March 2019). The patient's past medical history included surgery (had an operation on her left hand a few weeks before the date of reporting). Previously administered products included pneumonia vaccine and influenza vaccine with an associated reaction of pain in extremity (refer case). Concomitant products included Aspirin, Atorvastatin and Chlorthalidone. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced upset stomach, fever and chills. In April 2018, the patient experienced seizure (serious criteria GSK medically significant) and motor dysfunction. The patient was treated with TYLENOL. On an unknown date, the outcome of the seizure, fever, chills and motor dysfunction were unknown and the outcome of the upset stomach was recovered/resolved. It was unknown if the reporter considered the seizure, fever, chills and motor dysfunction to be related to SHINGRIX. The reporter considered the upset stomach to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. Less than a week after vaccination, the patient stated that her chills were so severe that it felt like she had a seizure since she was out of control of her limbs. The patient woke up with a temperature of 102 degrees. The patient took a TYLENOL and the next day she was fine. This case has been linked with case US2018GSK069090 (same patient).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 72-year-old female patient who received SHINGRIX (batch number T5242, expiry date 26th March 2019). The patient's past medical history included surgery (had an operation on her left hand a few weeks before the date of reporting). Previously administered products included pneumonia vaccine and influenza vaccine with an associated reaction of pain in extremity (refer case). Concomitant products included Aspirin, Atorvastatin and Chlorthalidone. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced upset stomach, fever and chills. In April 2018, the patient experienced seizure (serious criteria GSK medically significant) and motor dysfunction. The patient was treated with TYLENOL. On an unknown date, the outcome of the seizure, fever, chills and motor dysfunction were unknown and the outcome of the upset stomach was recovered/resolved. It was unknown if the reporter considered the seizure, fever, chills and motor dysfunction to be related to SHINGRIX. The reporter considered the upset stomach to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included Vitamins. Less than a week after vaccination, the patient stated that her chills were so severe that it felt like she had a seizure since she was out of control of her limbs. The patient woke up with a temperature of 102 degrees. The patient took a TYLENOL and the next day she was fine. This case has been linked with case US2018GSK069090 (same patient).
Age: 8.0
Sex: M
Vaccine: CEE
Symptoms: Fatigue, Inappropriate schedule of drug administration, Vomiting
Clinical narrative: Patient is receiving the FSME (TBE) series. He had #1 11032017, #2 02122018. He was supposed to get the #3 5 months after second dose but instead the #3 dose was mistakenly given on 04122018 (Thursday). Mom claimed that patient vomited night of Sunday, April 15 and was really tired the following day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Pyrexia
Clinical narrative: Started with an uncomfortable feeling. I could not get comfortable anywhere. By 9:00 pm I was running a slight fever and had chills. Fever rose to 101.6 within 3 hours and remained until appx 1 am. It seemed to break and lower to 99.3 shortly after that. By 3 am temperature was normal. At 9 pm I took an EXCEDRIN migraine.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Myalgia, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: High fever, vomiting, muscle pain, cellulitis-like rash around injection site, severe arm pain in injected arm.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site nodule, Injection site swelling
Clinical narrative: Injection site was immediately red. She had a full body rash within an hour that lasted about 4 hours. The injection site still has a red one inch ring around it after 4 days and a hard lump/knot. Last night around 100 hours after the vaccination the redness began fading and by 109 hours it has finally left. The swelling is about half the size currently.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Injection site was immediately red. She had a full body rash within an hour that lasted about 4 hours. The injection site still has a red one inch ring around it after 4 days and a hard lump/knot. Last night around 100 hours after the vaccination the redness began fading and by 109 hours it has finally left. The swelling is about half the size currently.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient was vaccinated with a dose of improperly stored Oka/Merck (VARIVAX) injection, lot # M039317 with expiration date 20-SEP-2018 or lot# N030407 with expiration date 30-OCT-2019 (exact dose, frequency and route of administration were unknown), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours and 22 minutes. It was unknown if any previous temperature excursion occurred. The digital data logger was not involved in recording the temperature excursion details. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1804USA008657:US-009507513-1804USA008658.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to an approximately 31 years old female patient. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown. On 26-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. Reporter stated that on an unknown date after vaccination, the patient developed soreness in her arm. She took ADVIL to treat the soreness. Outcome of the event was reported as not recovered. Reporter considered the event to be related to PNEUMOVAX 23.
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 20 year old patient of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 01-MAR-2018, 20 year old patient was inadvertently vaccinated with a dose of Oka-Merck PROQUAD injection, therapy type: rHA, lot # N013864 (expiry date: 31-OCT-2018) subcutaneously (dose not reported) for prophylaxis (Inappropriate age at vaccine administration). It was reported that this would be the patient's first dose of  Oka-Merck virus PROQUAD per patient's medical chart. The nurse believed that the patient was to receive another unspecified vaccine, Oka-Merck PROQUAD (Wrong vaccine administered). No adverse effects reported. No product quality complaint (PQC) was involved.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Arthralgia, Gastrointestinal disorder, Muscle disorder
Clinical narrative: This spontaneous report was received from a physician, via company representative, concerning an approximately 15 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 06-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for HPV prevention, lot #N035486 (strength, dose, frequency and expiration date were not reported). On an unknown date in November 2017 (reported as around 6 months following the first dose of GARDASIL 9), the patient experienced joint pain, severe anxiety, muscle issues, and abdominal issues. At the time of reporting, the outcome of joint pain, severe anxiety, muscle issues and abdominal issues was unknown. The causal relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporting physician. This is one of two reports received from the same reporter; who had a concern that this would suggest something hereditary. Lot Number N035486 not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1804USA008466.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-APR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. On or about 01-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from an office manager, referring to two 12 months old patients of unknown gender. It was reported none concomitant medications, none medical history and none drug reactions or allergies. On an unspecified date in 2018 (reported as "in the last 3 weeks"), the patients were vaccinated with (wistar ra 27-3) M-M-R II and Oka/Merck VARIVAX both subcutaneously in the same leg (strength, doses, dose numbers, lot numbers and expiration date were not reported), for prophylaxis. Other suspect therapies included a DILUENT MRK INJ (lot number and expiration date were not reported). In 2018, each patient reported tenderness, warmth, swelling and a lump at injection site. It was reported that treatment was not given for the adverse events; however, it was also stated that the treatment given was ice to the injection site for each patient. Lab diagnostics or studies were not performed and patients sought medical attention by contacting the office. The outcome of injection site mass, injection site swelling, injection site pain and injection site warmth was unknown. The causality assessment between (wistar ra 27-3) M-M-R II, Oka/Merck VARIVAX, the DILUENT MRK INJ and the aforementioned events was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1804USA008467.
Age: 7.0
Sex: U
Vaccine: IPV, VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from an office manager via company representative referring to a 7 year old patient of unknown gender. The patient had no medical history, concomitant therapies or past drug reactions/allergies. The patient's concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a Oka/Merck VARIVAX, in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported) for prophylaxis.  Other suspect therapies included MERCK STERILE DILUENT in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported); and poliovirus vaccine inactivated (unspecified) in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2018 (also reported as "At an unspecified time in the last 3 weeks"), the patient experienced tenderness, warmth, swelling and a "hard" lump at injection site (injection site pain, injection site induration, injection site mass, injection site swelling and injection site warmth). Per office manager, the company representative stated that treatment was given and it was ice on the injection site. The outcome of injection site mass, injection site induration, injection site swelling, injection site pain and injection site warmth was unknown at the time of the report. The reporter did not assess a causal relationship between the aforementioned events and Oka/Merck VARIVAX or MERCK STERILE DILUENT.
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Arthralgia, Gastrointestinal disorder, Muscle disorder
Clinical narrative: This spontaneous report was received from a physician, concerning female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 06-MAY-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration lot number and expiration date were not reported). On an unknown date the patient experienced joint pain, severe anxiety, muscle issues, and abdominal issues. At the time of reporting, the outcome of joint pain, severe anxiety, muscle issues and abdominal issues was unknown. The causal relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporting physician. This is one of two reports received from the same reporter; who had a concern that this would suggest something hereditary. Sender's Comments: US-009507513-1804USA006142.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA lot # N012324 with expiration date: 05-APR-2018 (dosing details and route of administration was not reported) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA injection, 50/1.0 U/ml (lot # M018767, 01-FEB-2018) (dosing regimen and frequency unknown) intramuscularly in left arm for prophylaxis (expired product administered). No adverse events were reported. There was no product quality compliant reported. This case is linked to case number 1804USA008643 via same reporter link. Sender's Comments: US-009507513-1804USA008643.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA 50/1.0 U/ml (lot # M018767, 01-FEB-2018) (dosing regimen and frequency unknown) for prophylaxis (expired product administered). No adverse events were reported. There was no product quality compliant reported. This case is linked to case number 1804USA008569 via same reporter link. Sender's Comments: US-009507513-1804USA008569.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Hives/Redness on left arm (opposite arm of injection site), buttocks, and under bra area. (Patient called and spoke with doctor already).
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: Hives/Redness on left arm (opposite arm of injection site), buttocks, and under bra area. (Patient called and spoke with doctor already).