chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was the reporter and refrained from providing any information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included lorazepam and DEXILANT. On 8th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, 1 days after receiving SHINGRIX, the patient experienced nerve pain and activities of daily living impaired. In April 2018, the patient experienced injection site pain. The patient was treated with ibuprofen. On 10th April 2018, the outcome of the nerve pain was recovered/resolved. On an unknown date, the outcome of the injection site pain and activities of daily living impaired were unknown. The reporter considered the injection site pain and nerve pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included INTRAROSA. At 12:40, the patient received SHINGRIX on left arm. The pharmacist reported that the patient experienced extreme nerve pain centralized to her torso. The pain was bad enough that she could not do anything that day. Less than week after vaccination, the patient also had some arm pain around the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced muscle pain, shivering, injection limb mobility decreased, fever and tremor. On an unknown date, the outcome of the injection site pain, muscle pain, injected limb mobility decreased and fever were not recovered/not resolved and the outcome of the shivering was recovering/resolving and the outcome of the tremor was unknown. The reporter considered the injection site pain, muscle pain, shivering, injected limb mobility decreased and fever to be related to SHINGRIX. It was unknown if the reporter considered the tremor to be related to SHINGRIX. Additional information was reported as follows: At 9:30, the patient received SHINGRIX in left arm. All symptoms started together at 3:00 am morning. The muscle aches are described as severe and occurring from head to toes. One hour prior to the call to GlaxoSmithKline, the fever was 101.2 degrees. She had been unable to use the left arm to grasp a glass and drink or to raise the left arm. Just moving her fingers when she tried to grasp something made her upper arm hurt worse. The injection site pain is in her left upper arm where the vaccine was administered. On the same day of vaccination she applied cold to the arm and on the next day of vaccination heat but it was still hurting. At first she could not stop shaking but she had taken a few naps on the day of reporting, and the shivering was described now as subsiding. The patient was calling GlaxoSmithKline on the day of reporting to inquire how long these symptoms might be expected to last and was referred to her healthcare professional during the call to further discuss her inquiry of next best steps regarding her current symptoms in light of her upcoming colonoscopy scheduled for this Friday 13th April 2018. She could not take aspirin, ibuprofen for fever and aches as she had colonoscopy scheduled. The reporter was asking how long clinical trials shown these symptoms to last.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced muscle pain, shivering, injection limb mobility decreased, fever and tremor. On an unknown date, the outcome of the injection site pain, muscle pain, injected limb mobility decreased and fever were not recovered/not resolved and the outcome of the shivering was recovering/resolving and the outcome of the tremor was unknown. The reporter considered the injection site pain, muscle pain, shivering, injected limb mobility decreased and fever to be related to SHINGRIX. It was unknown if the reporter considered the tremor to be related to SHINGRIX. Additional information was reported as follows: At 9:30, the patient received SHINGRIX in left arm. All symptoms started together at 3:00 am morning. The muscle aches are described as severe and occurring from head to toes. One hour prior to the call to GlaxoSmithKline, the fever was 101.2 degrees. She had been unable to use the left arm to grasp a glass and drink or to raise the left arm. Just moving her fingers when she tried to grasp something made her upper arm hurt worse. The injection site pain is in her left upper arm where the vaccine was administered. On the same day of vaccination she applied cold to the arm and on the next day of vaccination heat but it was still hurting. At first she could not stop shaking but she had taken a few naps on the day of reporting, and the shivering was described now as subsiding. The patient was calling GlaxoSmithKline on the day of reporting to inquire how long these symptoms might be expected to last and was referred to her healthcare professional during the call to further discuss her inquiry of next best steps regarding her current symptoms in light of her upcoming colonoscopy scheduled for this Friday 13th April 2018. She could not take aspirin, ibuprofen for fever and aches as she had colonoscopy scheduled. The reporter was asking how long clinical trials shown these symptoms to last.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX. On 9th April 2018 14:00, the patient received the 2nd dose of SHINGRIX. On 9th April 2018, 5 hrs after receiving SHINGRIX, the patient experienced injection site pain, exhaustion, joint pain, headache and myalgia. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the exhaustion, joint pain, headache and myalgia were unknown. It was unknown if the reporter considered the injection site pain, exhaustion, joint pain, headache and myalgia to be related to SHINGRIX. Additional details were provided as follows: The health care professional's husband (also a family practice doctor) received the 2nd dose of SHINGRIX yesterday a day before the reporting date. The patient felt wiped out for the evening. The patient took some TYLENOL and that helped a bit. The patient woke up in the middle of the night complaining of the same symptoms and took additional TYLENOL. The patient was better and went to work today.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever. MOTRIN was prescribed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient received SHINGRIX shot on 4/12/18. 3 hours later, began sweating, feeling lightheaded, and fainted for a few seconds. After resting, felt okay. Had diarrhea the next day for 1 day.
Sex: F
Vaccine: FLUR3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Ear pain, Glossodynia
Clinical narrative: Initial unsolicited report received from a Health Authority (under the reference number: 730512) on 03-Apr-2018. This case involves a 36-year-old female patient who was vaccinated with a dose of FLUBLOK TIV (dose unknown, batch number, expiry date, dose in series, route and site of administration were not reported) on 10-Nov-2017. The patient's medical history included Asthma, Latex, food and Drug allergies. Current Illnesses included Seasonal Allergies and Postnasal Drip. Concomitant medications included Benadryl, Ibuprofen, TYLENOL, IMITREX and Albuterol. On 10-Nov-2017, on the same day post vaccination, the patient experienced hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, migraines, shortness of breath, dizziness, jaw pain, ear ache and tongue pain. The patient was underwent of Medical Evaluations by Occupational Health on 16-Nov-2017, 22-Nov-2017, 04-Dec-2017 and on 08-Dec-2017. The patient was previously vaccinated with Flu Vaccine contains eggs. Relevant lab investigations and corrective treatment were not reported. The patient was not recovered from the events. This case was considered as serious by the reporter due to disability. List of documents held by sender: none. Sender's Comments: The patient experienced swollen tongue, diarrhoea, dizziness, dyspnoea, ear pain, hypoaesthesia, paresthesia, rash, urticaria and multiple other events postvaccination with FLUBLOK TIV. Time to onset was compatible. The patient had medical history of Asthma, Latex, food and Drug allergies. The condition at the time of vaccination was reported as seasonal allergies. The events are suggestive of an allergic response. Patient's lab test reports ruling out underlying alternate etiologies and allergic testing results if any should be requested. Based upon reported information the role for the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia, Migraine, Nausea, Pain in jaw, Paraesthesia
Clinical narrative: Initial unsolicited report received from a Health Authority (under the reference number: 730512) on 03-Apr-2018. This case involves a 36-year-old female patient who was vaccinated with a dose of FLUBLOK TIV (dose unknown, batch number, expiry date, dose in series, route and site of administration were not reported) on 10-Nov-2017. The patient's medical history included Asthma, Latex, food and Drug allergies. Current Illnesses included Seasonal Allergies and Postnasal Drip. Concomitant medications included Benadryl, Ibuprofen, TYLENOL, IMITREX and Albuterol. On 10-Nov-2017, on the same day post vaccination, the patient experienced hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, migraines, shortness of breath, dizziness, jaw pain, ear ache and tongue pain. The patient was underwent of Medical Evaluations by Occupational Health on 16-Nov-2017, 22-Nov-2017, 04-Dec-2017 and on 08-Dec-2017. The patient was previously vaccinated with Flu Vaccine contains eggs. Relevant lab investigations and corrective treatment were not reported. The patient was not recovered from the events. This case was considered as serious by the reporter due to disability. List of documents held by sender: none. Sender's Comments: The patient experienced swollen tongue, diarrhoea, dizziness, dyspnoea, ear pain, hypoaesthesia, paresthesia, rash, urticaria and multiple other events postvaccination with FLUBLOK TIV. Time to onset was compatible. The patient had medical history of Asthma, Latex, food and Drug allergies. The condition at the time of vaccination was reported as seasonal allergies. The events are suggestive of an allergic response. Patient's lab test reports ruling out underlying alternate etiologies and allergic testing results if any should be requested. Based upon reported information the role for the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR3
Symptoms: Paraesthesia oral, Pharyngeal oedema, Rash, Swollen tongue, Urticaria
Clinical narrative: Initial unsolicited report received from a Health Authority (under the reference number: 730512) on 03-Apr-2018. This case involves a 36-year-old female patient who was vaccinated with a dose of FLUBLOK TIV (dose unknown, batch number, expiry date, dose in series, route and site of administration were not reported) on 10-Nov-2017. The patient's medical history included Asthma, Latex, food and Drug allergies. Current Illnesses included Seasonal Allergies and Postnasal Drip. Concomitant medications included Benadryl, Ibuprofen, TYLENOL, IMITREX and Albuterol. On 10-Nov-2017, on the same day post vaccination, the patient experienced hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, migraines, shortness of breath, dizziness, jaw pain, ear ache and tongue pain. The patient was underwent of Medical Evaluations by Occupational Health on 16-Nov-2017, 22-Nov-2017, 04-Dec-2017 and on 08-Dec-2017. The patient was previously vaccinated with Flu Vaccine contains eggs. Relevant lab investigations and corrective treatment were not reported. The patient was not recovered from the events. This case was considered as serious by the reporter due to disability. List of documents held by sender: none. Sender's Comments: The patient experienced swollen tongue, diarrhoea, dizziness, dyspnoea, ear pain, hypoaesthesia, paresthesia, rash, urticaria and multiple other events postvaccination with FLUBLOK TIV. Time to onset was compatible. The patient had medical history of Asthma, Latex, food and Drug allergies. The condition at the time of vaccination was reported as seasonal allergies. The events are suggestive of an allergic response. Patient's lab test reports ruling out underlying alternate etiologies and allergic testing results if any should be requested. Based upon reported information the role for the vaccine cannot be assessed.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 01Sep2017 at single dose at arm left for immunization (pneumonia). The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 01Sep2017 for immunisation. The patient experienced arm pain at the site of injection on an unspecified date with outcome of not recovered. Patient reported that my left arm where I received the injection still bothers me whenever I move it. It affects my arm movement, muscle aches and pain (outcome unknown). Caller stated that he reported concerns to his doctor twice but had not received a clear answer.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 01Sep2017 at single dose at arm left for immunization (pneumonia). The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 01Sep2017 for immunisation. The patient experienced arm pain at the site of injection on an unspecified date with outcome of not recovered. Patient reported that my left arm where I received the injection still bothers me whenever I move it. It affects my arm movement, muscle aches and pain (outcome unknown). Caller stated that he reported concerns to his doctor twice but had not received a clear answer.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of ear pruritus in a 68-year-old female patient who received SHINGRIX. Concomitant products included CRESTOR, Hydrochlorothiazide plus Triamterene, FLOVENT Inhaler, PREVNAR and Albuterol Inhaler. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced ear pruritus and erythropapular rash. On an unknown date, the outcome of the ear pruritus and erythropapular rash were recovering/resolving. The reporter considered the ear pruritus to be possibly related to SHINGRIX. It was unknown if the reporter considered the erythropapular rash to be related to SHINGRIX. Additional details were provided as follows: The caller was a medical assistant with a dermatologist practice calling to report adverse event with SHINGRIX. The patient received the SHINGRIX along with PREVNAR on same date at a local pharmacy. The contact information for pharmacy was not available, the batch number and dosages were not available for both vaccines also the administration dates and site of injection was not available. The patient developed itchiness and red bumpy rash in front of and behind the ears approximately 3 to 4 days after vaccine administration. The events were improving and did not require intervention. The contact details of the dermatologist treating rash was provided.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Ear pruritus, Rash erythematous
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of ear pruritus in a 68-year-old female patient who received SHINGRIX. Concomitant products included CRESTOR, Hydrochlorothiazide plus Triamterene, FLOVENT Inhaler, PREVNAR and Albuterol Inhaler. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced ear pruritus and erythropapular rash. On an unknown date, the outcome of the ear pruritus and erythropapular rash were recovering/resolving. The reporter considered the ear pruritus to be possibly related to SHINGRIX. It was unknown if the reporter considered the erythropapular rash to be related to SHINGRIX. Additional details were provided as follows: The caller was a medical assistant with a dermatologist practice calling to report adverse event with SHINGRIX. The patient received the SHINGRIX along with PREVNAR on same date at a local pharmacy. The contact information for pharmacy was not available, the batch number and dosages were not available for both vaccines also the administration dates and site of injection was not available. The patient developed itchiness and red bumpy rash in front of and behind the ears approximately 3 to 4 days after vaccine administration. The events were improving and did not require intervention. The contact details of the dermatologist treating rash was provided.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Diarrhoea, Erythema, Paraesthesia oral, Peripheral swelling
Clinical narrative: On 4/12/2018 shot was very painful and stung immediately after injection. Soreness and rash at site about 4 hrs after administered. Later that night aches and pains, unable to sleep culminating in nausea, loose stool and fainting at 1:00 am. Lasted until 3 am 4/13/2018. Soreness and 5 in welt down right arm visible during Dr. exam 10:30 am on 4/13/2018. No fever but stool looseness continued as well as stomach cramps, joint and muscle aches. Dr. looked at rash on arm and did blood test. Advised not to receive second dosage due 2-5 mo from today. Arm extremely painful to touch and slightly swollen at injection site. Today 4/14/18 no visible rash improvement and still painful to touch. Slight cramping in stomach.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope
Clinical narrative: On 4/12/2018 shot was very painful and stung immediately after injection. Soreness and rash at site about 4 hrs after administered. Later that night aches and pains, unable to sleep culminating in nausea, loose stool and fainting at 1:00 am. Lasted until 3 am 4/13/2018. Soreness and 5 in welt down right arm visible during Dr. exam 10:30 am on 4/13/2018. No fever but stool looseness continued as well as stomach cramps, joint and muscle aches. Dr. looked at rash on arm and did blood test. Advised not to receive second dosage due 2-5 mo from today. Arm extremely painful to touch and slightly swollen at injection site. Today 4/14/18 no visible rash improvement and still painful to touch. Slight cramping in stomach.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Diarrhoea, Immediate post-injection reaction
Clinical narrative: On 4/12/2018 shot was very painful and stung immediately after injection. Soreness and rash at site about 4 hrs after administered. Later that night aches and pains, unable to sleep culminating in nausea, loose stool and fainting at 1:00 am. Lasted until 3 am 4/13/2018. Soreness and 5 in welt down right arm visible during Dr. exam 10:30 am on 4/13/2018. No fever but stool looseness continued as well as stomach cramps, joint and muscle aches. Dr. looked at rash on arm and did blood test. Advised not to receive second dosage due 2-5 mo from today. Arm extremely painful to touch and slightly swollen at injection site. Today 4/14/18 no visible rash improvement and still painful to touch. Slight cramping in stomach.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Insomnia, Myalgia
Clinical narrative: On 4/12/2018 shot was very painful and stung immediately after injection. Soreness and rash at site about 4 hrs after administered. Later that night aches and pains, unable to sleep culminating in nausea, loose stool and fainting at 1:00 am. Lasted until 3 am 4/13/2018. Soreness and 5 in welt down right arm visible during Dr. exam 10:30 am on 4/13/2018. No fever but stool looseness continued as well as stomach cramps, joint and muscle aches. Dr. looked at rash on arm and did blood test. Advised not to receive second dosage due 2-5 mo from today. Arm extremely painful to touch and slightly swollen at injection site. Today 4/14/18 no visible rash improvement and still painful to touch. Slight cramping in stomach.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Syncope, Urticaria
Clinical narrative: On 4/12/2018 shot was very painful and stung immediately after injection. Soreness and rash at site about 4 hrs after administered. Later that night aches and pains, unable to sleep culminating in nausea, loose stool and fainting at 1:00 am. Lasted until 3 am 4/13/2018. Soreness and 5 in welt down right arm visible during Dr. exam 10:30 am on 4/13/2018. No fever but stool looseness continued as well as stomach cramps, joint and muscle aches. Dr. looked at rash on arm and did blood test. Advised not to receive second dosage due 2-5 mo from today. Arm extremely painful to touch and slightly swollen at injection site. Today 4/14/18 no visible rash improvement and still painful to touch. Slight cramping in stomach.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aches, Ibuprofen.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Significant myalgia and severe chills (rigors) and mild flu like symptoms (weakness, headache, nausea, muscle pains, fatigue).
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Significant myalgia and severe chills (rigors) and mild flu like symptoms (weakness, headache, nausea, muscle pains, fatigue).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at site, severe nausea, headache, chills, fatigue, tired, stomach irritated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pain at site, severe nausea, headache, chills, fatigue, tired, stomach irritated.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Depressed level of consciousness, Erythema, Injected limb mobility decreased, Joint swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 66 year old female patient. On 05-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030849, expiration date 09-JUN-2019 in the left arm for prophylaxis. In approximately 2018, the patient experienced enormous pain, warmth, redness, and swelling of the left arm. The patient was unable to move her left arm and felt like she was going to pass out when she stood up. The patient was treated with unspecified antibiotic medication and fully recovered (in approximately 2018). Causality assessment was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 66 year old female patient. On 05-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030849, expiration date 09-JUN-2019 in the left arm for prophylaxis. In approximately 2018, the patient experienced enormous pain, warmth, redness, and swelling of the left arm. The patient was unable to move her left arm and felt like she was going to pass out when she stood up. The patient was treated with unspecified antibiotic medication and fully recovered (in approximately 2018). Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reaction/allergies. Concomitant medications included sterile diluent. On 22-MAR-2018, the patient was vaccinated with an expired dose of Oka-Merck PROQUAD (rHA), 0.5mL, lot# M039448 with expiration date of 20-MAR-2018, subcutaneously, for prophylaxis (frequency was not reported). It was reported that Oka-Merck PROQUAD and sterile diluent were properly stored. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' concomitant medications included MERCK STERILE DILUENT, lot # and expiration date were not provided. The patient's medical history and drug reactions/allergies were not provided. On an unspecified date in April 2018, reported as since 04-APR-2018, multiple patients were vaccinated with  improperly stored doses of Oka-Merck PROQUAD injection, lot # N025927, expiration date 18-MAR-2019 and lot # N034561 with expiration date 03-JUN-2019 or Oka/Merck VARIVAX injection, lot # N030407 with expiration date 03-OCT-2019 (also reported as 30-OCT-2019), lot # N026070 with expiration date 20-SEP-2019 and lot # N022996 with expiration date 23-AUG-2019, all for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -14°C to -10°C during 138 hours as recorded by a data logger. Additionally, the vaccines experienced a temperature excursion in the range -14°C to -10°C during 66 hours and 30 minutes and also between -9°C to -10°F during 6 hours.There was no side effects reported. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 21-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # N003536 with expiration date of 02-NOV-2019 (strength, dose, route, and anatomical location were not provided) for prophylaxis.  No adverse effects were reported. The vaccine was exposed to a temperature of 6°C, during a time frame of 5 hours and 15 minutes, which was called by a data logger. Previous temperature excursions included 1.4°C for 4 hours and 6 minutes.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 15-MAR-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot # N019924 with expiration date of 02-SEP-2018 (strength, dose, route, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccine was exposed to a temperature range between 32°F up to 35°F (33.8°F), during a time frame of 24 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1804USA006860:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 24-JUL-2013, the patient was inoculated at a hospital (by an unspecified health care professional) with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-JUL-2015, the male patient was treated (by an unspecified healthcare professional) at a medical center, for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster.  On or about 20-JUL-2015, he sought subsequent treatment at the medical center for ongoing and worsening shingles-related pain, which was diagnosed as subacute neuralgia. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, 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.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 05-APR-2007, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-MAY-2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-MAY-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 31-MAY-2016, the patient was treated at a medical facility for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin ulcer
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-JUN-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. On or about 18-AUG-2016, the patient was treated at a medical facility for a painful condition, which was diagnosed as herpetic ulcers.  As a direct and proximate result of the ZOSTAVAX vaccine, 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 22-AUG-2011 at a pharmacy as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 09-JUL-2017 the patient was treated at an urgent care for a blistering vesicular outbreak which was then diagnosed as herpes zoster, shingles. The patient was prescribed valacyclovoir and prednisone to manage his painful symptoms. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 06-FEB-2013, the patient was inoculated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 condition of herpes zoster. On or about 09-FEB-2013, the patient was treated at a physician office by Physician Assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct an 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 01-MAY-2014, the patient was inoculated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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.  On or about 21-SEP-2015, the patient was treated at physician office for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir and acyclovir to manage her painful symptoms. 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 03-APR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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. On or about 17-MAY-2016, the patient was treated at physician office for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir, gabapentin and calamine topical lotion for management of her painful symptoms and chronic pain. As a direct an 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 16-NOV-2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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.  On or about 29-MAY-2016, the patient was treated for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir, prednisone, and tramadol for management of her painful symptoms. As a direct an 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2013, the patient was inoculated with ZOSTAVAX at a physician's office 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. On or about 26-MAY-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 24-AUG-2015, the patient was inoculated at a pharmacy (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain of herpes zoster. On or about 13-MAY-2016, the male patient was treated (by an unspecified healthcare professional) at an Urgent care facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 15-MAR-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot # N019924 with expiration date of 02-SEP-2018 (strength, dose, route, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccine was exposed to a temperature range between 32°F up to 35°F (33.8°F), during a time frame of 24 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1804USA005520.
Sex: F
Vaccine: HPV9, HPVX
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old female patient. The patient had no known pertinent medical history, drug reaction or allergies and concomitant therapies. On 19-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N021571; expiry date: 29-APR-2020) for prophylaxis. Dosing details were not reported. In approximately 2018, the patient missed 2 cycles of menses since receiving GARDASIL 9. The patient did not receive any treatment for the adverse event. At the time of the report, the patient had not recovered from the event of menstruation delayed. Causality assessment was not provided by the reporter. No product quality complaint was involved.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Localized swelling and erythema at site of injection, AND Shingles outbreak in one dermatome on the left mid chest and back with pain.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Blister, Rash, Rash papular
Clinical narrative: Today (2/28/18) developed spots noted by mother who wondered if related to VARIVAX given 16 days prior. Seen by Dr.who agreed. Approximately 18-20 papules pink, 2 with blebs.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injected into left shoulder. Did push ups to make arm feel better. Woke up next day and arm was extremly sore. About a 6-8 inch diameter swollen red area visible just under the injection site from tricept to bicept. Red area stretching to armpit. Armit very tight and sore. Upper arm very achy/painful. Arm still red and swollen 4 days after shot.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity
Clinical narrative: Injected into left shoulder. Did push ups to make arm feel better. Woke up next day and arm was extremly sore. About a 6-8 inch diameter swollen red area visible just under the injection site from tricept to bicept. Red area stretching to armpit. Armit very tight and sore. Upper arm very achy/painful. Arm still red and swollen 4 days after shot.