chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Feeling cold
Clinical narrative: I got a shot on 5/2018. That evening, I was sore joints and muscles. Next morning I was extremely sick with muscle pain and joint pain. My stomach and intestines, back and headache pain. Fever and flu like conditions with extreme pain. I went back to my doctor. They gave me 2 TYLENOL and sent me home. I had chills and extreme sweats and was very cold all night, suffered joint pain to where all my body felt pain as well from my head to my toes. Cramps throughout my body as well as nausea, stomach and intestine pain. This lasted for 3 days. Today is my 4th day. Headache, stomach and joint pain along with chills cramps. I will return to my doctor today! This vaccine is the worst sickness experience I have ever lived! From all information I have read, it would be less discomfort to just have the shingles for a day and taken antibiotics!! I never had the chicken pox, but was told by my doctor there was still a chance to have the shingles! There is no reason in this world to live in this much pain this long by the cause of any vaccine!!!!
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal pain, Headache, Hyperhidrosis, Influenza like illness, Muscle spasms
Clinical narrative: I got a shot on 5/2018. That evening, I was sore joints and muscles. Next morning I was extremely sick with muscle pain and joint pain. My stomach and intestines, back and headache pain. Fever and flu like conditions with extreme pain. I went back to my doctor. They gave me 2 TYLENOL and sent me home. I had chills and extreme sweats and was very cold all night, suffered joint pain to where all my body felt pain as well from my head to my toes. Cramps throughout my body as well as nausea, stomach and intestine pain. This lasted for 3 days. Today is my 4th day. Headache, stomach and joint pain along with chills cramps. I will return to my doctor today! This vaccine is the worst sickness experience I have ever lived! From all information I have read, it would be less discomfort to just have the shingles for a day and taken antibiotics!! I never had the chicken pox, but was told by my doctor there was still a chance to have the shingles! There is no reason in this world to live in this much pain this long by the cause of any vaccine!!!!
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: I got a shot on 5/2018. That evening, I was sore joints and muscles. Next morning I was extremely sick with muscle pain and joint pain. My stomach and intestines, back and headache pain. Fever and flu like conditions with extreme pain. I went back to my doctor. They gave me 2 TYLENOL and sent me home. I had chills and extreme sweats and was very cold all night, suffered joint pain to where all my body felt pain as well from my head to my toes. Cramps throughout my body as well as nausea, stomach and intestine pain. This lasted for 3 days. Today is my 4th day. Headache, stomach and joint pain along with chills cramps. I will return to my doctor today! This vaccine is the worst sickness experience I have ever lived! From all information I have read, it would be less discomfort to just have the shingles for a day and taken antibiotics!! I never had the chicken pox, but was told by my doctor there was still a chance to have the shingles! There is no reason in this world to live in this much pain this long by the cause of any vaccine!!!!
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Painful, burning rash on right side of thorax just above the belt line.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 24-APR-2018, the patient was vaccinated with an improperly stored PEDVAXHIB (strength, dose and route of administration were not reported) (lot # N003701 and expiration date: 01-NOV-2019) for prophylaxis. The vaccine was stored in between 0 degrees Celsius (C) to 1 C for 1 hour. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information was provided. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a consumer referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot# and expiration date unknown) for prophylaxis. Sometime in 2007 while using ZOSTAVAX (also reported as "after getting the shingles shot"), the patient got shingles and that the shingles got into her right eye. The patient sought medical attention and was able to be treated (treatment not specified), but later lost vision in her right eye. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not provided. Upon internal review, the events of lost vision in the patient's right eye and shingles got into right eye were considered to be medically significant.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a currently 21 year old female patient, concerning herself. The patient's concurrent conditions included an unspecified autoimmune disease. She was allergic to AUGMENTIN, MOVEX, doxycycline, and DILAUDID. No information was provided regarding her medical history. On 04-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for Human Papillomavirus prevention (dose, frequency, route of administration, lot number and expiration date were not provided). The patient reported that she found out she was pregnant, after receiving her first dose of GARDASIL 9. She was due for her next dose on 03-MAY-2018 (reported as "this Thursday"). She was not experiencing any untoward effects. The patient did not seek medical attention, and she received no treatment for the event. An unspecified pregnancy test was performed on an unknown date, however, no results were provided. The patient's last menstrual period was 08-MAR-2018.The estimated date of delivery was of 13-DEC-2018. The pregnancy outcome was pending.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 01-MAY-2018, the patient was vaccinated with an expired dose of VAQTA lot # M031806 with an expiry date on 30-MAR-2018, for prophylaxis (strength and route of administration were not reported). The Medical Assistant confirmed that the expired VAQTA had no temperature excursions prior to being administered. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative, refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date in the end of 2017, the patient was vaccinated with one dose of GARDASIL 9 (strength, dose, lot number and expiration date were unknown) intramuscularly for vaccination. On an unknown date (reported as "a few months later"), the patient had a grand mal seizure. The patient sought medical attention and received unspecified treatment at an unknown facility. No intervention to prevent serious criteria was performed. At the time of reporting, the patient has also had an unknown number of other seizures since the initial one and was not recovered from the event. The causality between GARDASIL 9 and the event was not provided. Upon internal review, the event of generalised tonic-clonic seizure was considered to be medically significant. Moreover, the reporter considered the event to be serious due to significant Disability.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV9, MENB
Symptoms: Dizziness, Fall
Clinical narrative: This spontaneous report was received from a Medical Assistant via company representative, referring to a 15 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-APR-2018, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) with lot # N022952 and expiration date 14-JUN-2020 for prophylaxis. On the same office visit the patient also was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and TRUMENBA. Medical assistant informed that the patient became dizzy, fell and was caught by patient's father, after receiving the three vaccines, the patient was given water orally, monitored in a second patient room for an unspecified period of time, until patient was fine to go home. At the time of the report, the outcome of fall and dizziness was reported as recovered. The Medical Assistant did not mention the causality assessment between the events and GARDASIL 9.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from the patient's father, referring to his daughter, a 18 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In March 2016, at her 18 years old, the patient received her first dose of GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). However, after getting that first dose, the patient ended up experiencing headache. Then, the patient's father explained that his daughter's physician still recommended the patient get the second dose of the GARDASIL 9 vaccine, which the patient received in November 2017. Although, it was very late since it was outside of the recommended 2 months dosing schedule period for the second dose administration in the series per the official Prescribing Information. At the reporting time, reported as "currently", the patient's father said that his daughter, at her 20 year-old, still had not received the third and final dose in the series; thus, the third dose had not been administered. The outcome of headache was unknown. The causality assessment between the headache and GARDASIL 9 was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included a sterile diluent (manufacturer unknown). On 02-MAY-2018, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX lot # M019641, expiration date on 20-APR-2018 (administration route and anatomical location were not reported) for prophylaxis. It was confirmed that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse reactions were reported.
Age: 16.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Headache, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 26-Apr-2018. This case involves a male patient (age was not reported), who was vaccinated with a dose of MENACTRA and HPV VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 24-Apr-2018 on Tuesday. The patient's medical history and concomitant medications were not reported. On 24-Apr-2018, same day following the vaccination (reported as just after the second vaccine given), the patient started to pass out. It was also reported that the reporter thought the MENACTRA vaccine was given first, but she was not certain about that. Lab data and corrective treatment was not reported. On an unknown date, the patient was recovered/resolved from the event. It was reported that her son was fine now. The healthcare team at the practice indicated that this happens about once a week at their practice. Upon internal review the case was considered as serious because of important medical event: patient started to pass out. Follow up report received from consumer (patient's mother)  on 26-Apr-2018. This case involves 16 years old patient. It was reported that the provider had her son lay down and he felt better and they went home. On 24-Apr-2018 in the evening same day post vaccination patient experienced headache. Patient had not recovered from headache as of 26 Apr 2018 and recovering from other event. List of documents held by sender: none. Sender's Comments: Follow up information received on 26-APR-2018: Patient experienced loss of consciousness and headache after vaccination with MENACTRA and HPV. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Swelling redness in (L) deltoid. Rash-erythematous rash on face, hives on chest and back, pruritus.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Swelling redness in (L) deltoid. Rash-erythematous rash on face, hives on chest and back, pruritus.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash erythematous, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Mother reported that the day after vaccination the girl woke up with a generalized rash, papular erythematous and itchy. Patient was treated with BENADRYL, CLARITIN and DECADRON.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Day of injection sore arm (to be expected). Day 2 - relatively strong chills -lots of shivering, necessitating warm clothing and extra blankets - on an otherwise warm spring day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash, Rash
Clinical narrative: Patient received vaccines on 5-3-18 and returned to the office on 5-4-18 with a rash on the left upper arm non-specific to Band-Aid.
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Musculoskeletal stiffness, Pyrexia, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a infant male patient who received DTPA vaccine. On an unknown date, the patient received DTPA vaccine (intramuscular). On an unknown date, less than a year after receiving DTPA vaccine, the patient experienced seizure (serious criteria GSK medically significant), fever, limbs stiffness and appetite absent. On an unknown date, the outcome of the seizure, fever, limbs stiffness and appetite absent were unknown. It was unknown if the reporter considered the seizure, fever, limbs stiffness and appetite absent to be related to DTPA vaccine. Additional details were provided as follows: The caller (mother of the patient) reported that her son had received DTPA. In 2014, the patient received DTPA. In 2014, the patient experienced seizure, fever, limbs stiffness and decreased appetite.
Sex: F
Vaccine: HEP, HEPA, VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via programs and described the occurrence of cold in a adult female patient who received HAVRIX 1440. Co-suspect products included ENGERIX B adult and SHINGRIX. On an unknown date, the patient received HAVRIX 1440 1 ml, ENGERIX B adult 1 ml and SHINGRIX .5 ml. On an unknown date, unknown after receiving HAVRIX 1440 and ENGERIX B adult and less than a year after receiving SHINGRIX, the patient experienced cold. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to HAVRIX 1440, ENGERIX B adult and SHINGRIX. Additional details were reported as follows: This case was received from the consumer via the program. The age at vaccination was not reported. The patient mentioned at the time of reporting that she had a cold. The reporter did not provide any additional information. The event did not include product complaint. The indication for product used was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain localized in a adult female 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 pain localized, erythema and swelling. On an unknown date, the outcome of the pain localized, erythema and swelling were unknown. It was unknown if the reporter considered the pain localized, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The patient received 1st dose of SHINGRIX and experienced more with local pain, redness, swelling but, systemically better tolerated as compared to 2nd dose. The reporter agreed to contact on follow up, if necessary. The case has been linked with case US2018GSK075483, reported by same reporter for same patient (for 2nd dose of SHINGRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Skin warm
Clinical narrative: Pt went to urgent care yest. Her arm was red 5 inches x 4 inches warm to touch painful - like a burn with flu like symptoms. She was told to take BENADRYL and TYLENOL, ice to the area it is better now but not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received SHINGRIX. Concomitant products included Aspirin. On 25th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved. The reporter considered the erythema and swelling arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician who himself was husband of the patient. The patient experienced arm redness and swelling after receiving SHINGRIX dose. The contact details of the physician were also provided.
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced allergic reaction and erythema. On an unknown date, the outcome of the allergic reaction and erythema were unknown. It was unknown if the reporter considered the allergic reaction and erythema to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient asked about risk of reaction to SHINGRIX after she had an allergic reaction to a tetanus vaccine years before the reporting date. The pharmacist did believe the vaccine was a Tdap and not a tetanus vaccine alone. The pharmacist only knew the patient reported an allergic reaction and mentioned redness. The pharmacist declined to provide date of birth and additional questions noting she was not sure and would contact the patient's physician for direction. The serious criteria questions were not asked due to pharmacist not continuing with report. Only questions asked are those already documented.
Sex: U
Vaccine: VARZOS
Symptoms: Pollakiuria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of urinary frequency in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced urinary frequency. On an unknown date, the outcome of the urinary frequency was unknown. It was unknown if the reporter considered the urinary frequency to be related to SHINGRIX. Additional information was received as follows: The reporter was unable to provide the patient's demographic details. The reporter asked on behalf of his wife if frequent urination was a side effect of receiving the SHINGRIX vaccine. The reporter's wife had a patient who received the SHINGRIX vaccine and experienced frequent urination after receiving the vaccine. The patient went to an urgent care to seek treatment. The reporter was unable to verify if it was dose 1st or 2nd, lot number and start or stop date of the vaccine. The reporter declined to provide additional information stating that it was his wife's patient who had reported the event to her. The reporter was not open to follow-up, but requested my sales representative's business card, in case his wife was willing to provide follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 51-year-old male patient who received SHINGRIX. On 7th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site reaction and nerve pain. In April 2018, the outcome of the injection site reaction and nerve pain were recovered/resolved. The reporter considered the injection site reaction and nerve pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist did not have lot number and expiration date. The reporting pharmacist was not aware of any medical intervention taken, and was not aware of any medical or mediation history of patient. The reporter stated that a patient experienced severe nerve pain in the injection site after receiving SHINGRIX in his right arm. The reporting pharmacist stated that symptoms began 24 hours after injection, and took 5 to 7 days to resolve. The reporting pharmacist consented to being contacted if safety had more questions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included glaucoma and osteoporosis. Concomitant products included LUMIGAN, Enalapril and Risedronate. On 26th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 27th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, chills, weakness, muscle pain and tiredness. On an unknown date, the outcome of the fever, chills, weakness, muscle pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, weakness, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included eye drops. The patient did not have this reaction after her 1st dose. At 15:00 hours, the patient received dose of SHINGRIX in left deltoid. On the day of reporting, she woke up with fever, muscle pains, tiredness, weakness and chills. The patient had denied permission to contact physician.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. There was no information on the patient's medical history, concomitant medications, drug reactions and allergies provided. On 02-NOV-2002, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (route of administration, lot number and expiration date were not provided). On 05-DEC-2002, the patient received dose of RECOMBIVAX. On 10-MAY-2003, the patient received another dose of RECOMBIVAX. On 22-OCT-2016, the patient tested negative for HBsAG. On approximately 23-APR-2018 (reported as week ago), the patient tested negative for HBsAG again. The outcome of the event was reported as not recovered. The relatedness between the event and RECOMBIVAX was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, myalgia, nausea.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Full blood count, Pyrexia
Clinical narrative: Febrile Seizure, high temp.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and soreness at injection site 4 days after injection in addition to some chills. Patient also reported taking ibuprofen for symptoms.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site rash
Clinical narrative: Pt developed a small erythema area the day after the rash. Rash increased in size to approximately 10 cm around injection site. Pt initially started on KEFLEX due to concern over cellulitis since it had been approximately 48 hours since injection. Pt improved over the weekend.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Began to break out in a rash Saturday morning accompanied by fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of thigh began day after vaccination. Continued to worsen over next 2 days.  Mom took child to clinic where she was started on a 10 day course of prednisone.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and severe body aches for 12 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling 05/07/2018.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash
Clinical narrative: Patient developed significant rash on same arm as injection site. Patient was told to contact her provider and was seen by primary physician. MD said it was bad local reaction.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reactions, patient was given MENVEO by mistake, he was not due.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Depression, Fatigue, Feeling abnormal
Clinical narrative: Extreme body aches, chills, upset stomach, extreme fatigue and sleepiness. Brain fog and depression.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: Extreme body aches, chills, upset stomach, extreme fatigue and sleepiness. Brain fog and depression.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness/Itchiness around injection site still present after 1 week of administration.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 73-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). The patient's past medical history included shingles. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site warmth was unknown. The reporter considered the injection site rash and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 14:35, the patient received SHINGRIX in left deltoid. The patient experienced a rash just below the injection site and the rash seemed to spread down the arm. Also the rash was warm to the touch.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 75-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were not recovered/not resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient received SHINGRIX and was experiencing fever and chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 61-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 20th April 2018 01:30, the patient received the 1st dose of SHINGRIX .5 ml. On 20th April 2018. several hours after receiving SHINGRIX, the patient experienced chills, headache and influenza. In April 2018, the outcome of the chills, headache and influenza were recovered/resolved. The reporter considered the chills, headache and influenza to be related to SHINGRIX. Additional details were provided as follows: The patient experienced adverse event in the evening of vaccination day. The patient described it as feeling like she had the flu. The symptoms were resolved by Sunday night of that week.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with an expired dose of VARIVAX injection (strength and dose volume were not provided) (lot # M012992, expiry: 14-MAR-2018, subcutaneously) and an expired dose of M-M-R II (strength, dose volume, and route of administration were not provided) (lot # M007277, 09-FEB-2018) for prophylaxis (expired product administered). There was no known adverse effects. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: This spontaneous report was received from a consumer (also reported as husband) regarding a female patient of an unknown age. Information on patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for vaccine booster. On 16-APR-2018, the patient felt tired in a weird way, drained at "2:24pm EST" (fatigue) and pain at the injection site. On 17-APR-2018 at 5 pm, (also reported as today), the patient's arm developed a splotchy rash not where the shot was. The patient's husband reports that it was around the front of the arm and about 6 inches down. The patient reported that the arm felt sore like someone had hit her with a baseball bat (pain in extremity). The patient reported that it was stiff (musculoskeletal stiffness). The husband reported that the doctor was contacted and the doctor recommended that the patient should put ice where it was swollen and the rash was located. The doctor said that the patient could take TYLENOL if it gets worse. The patient reported that she was nauseated from eating. Laboratory data was not reported. The outcome of the events, the patient's arm developed a splotchy rash not where the shot was, feeling stiff and feeling nauseated from eating was not recovered/not resolved. The outcome of the events, felt tired in a weird way, drained at "2:24pm EST, the arm felt sore like someone hit her with a baseball bat, swollen, pain at the injection site was unknown. Causality assessment was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash macular
Clinical narrative: This spontaneous report was received from a consumer (also reported as husband) regarding a female patient of an unknown age. Information on patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for vaccine booster. On 16-APR-2018, the patient felt tired in a weird way, drained at "2:24pm EST" (fatigue) and pain at the injection site. On 17-APR-2018 at 5 pm, (also reported as today), the patient's arm developed a splotchy rash not where the shot was. The patient's husband reports that it was around the front of the arm and about 6 inches down. The patient reported that the arm felt sore like someone had hit her with a baseball bat (pain in extremity). The patient reported that it was stiff (musculoskeletal stiffness). The husband reported that the doctor was contacted and the doctor recommended that the patient should put ice where it was swollen and the rash was located. The doctor said that the patient could take TYLENOL if it gets worse. The patient reported that she was nauseated from eating. Laboratory data was not reported. The outcome of the events, the patient's arm developed a splotchy rash not where the shot was, feeling stiff and feeling nauseated from eating was not recovered/not resolved. The outcome of the events, felt tired in a weird way, drained at "2:24pm EST, the arm felt sore like someone hit her with a baseball bat, swollen, pain at the injection site was unknown. Causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Lymphoma, Neoplasm malignant, Rash
Clinical narrative: This spontaneous report was received from a 76 year old female patient, referring to herself. The patient had a concurrent condition of diabetes and a medical history of left breast cancer in 2003 (reported as "15 years ago"). Her concomitant medications included metformin. On an unknown date in 2012 or 2013, the patient was vaccinated with a dose of ZOSTAVAX injection in the right arm (dose, lot number and expiration date were not reported) to prevent shingles. On an unknown date, "sometime after the vaccination", the patient developed a painless rash on her right leg above the knee, which was diagnosed as mild shingles and was treated by an unspecified oral medication (reported as "some type of pill"). The patient recovered from shingles approximately 2 weeks later. On an unknown date in 2015 (reported as "3 years ago"), the patient experienced a relapse of the cancer. She also stated that at the time of the report, the cancer was in her lymph nodes. The event was treated with IBRANCE (reported as "IBRANZ"), however it caused an unspecified event that "almost killed" the patient and was subsequently switched to capecitabine. The patient sought for medical attention. At the time of the report, the patient did not recover from the cancer relapse (it was still being treated). The relatedness between the events of shingles, cancer relapse and cancer in lymph nodes and ZOSTAVAX was not reported. The reporter considered the event of unspecified adverse event that "almost killed" her to be related to IBRANCE. Upon internal review, the events of breast cancer relapse and cancer in lymph nodes were considered to be medically significant.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope, Urine analysis, Vasospasm
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 15 year old female patient. The patient had a history of anxiety and did experience three fainting episodes for reason unspecified in the past. The patient drug reactions and allergies and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 for herpesvirus (HPV) prevention (dose, units, route of administration, lot # and expiration date were not reported) without incident. On the subsequent visit on 13-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 for HPV prevention (dose, units, route of administration, lot # and expiration date were not reported). On the same day, the patient experienced vasospasm syncope with convulsion. An emergency medical technician (EMT) was called to the office and the patient was taken to an Emergency Room. An urine test was performed, but the results were not available. The patient was treated with "rest and fluid hydration" and was recommended to follow up with a cardiologist. The physician reported that GARDASIL 9 would be discontinued and the patient would not receive the third dose. It was unknown by representative if the patient was admitted to the hospital once she was in the Emergency Room. On an unknown date in 2018, the patient recovered from vasospasm syncope with convulsion. The relatedness between vasospasm syncope with convulsion and GARDASIL 9 was not reported. The event of convulsion was considered by the physician to be life threatening. Upon internal review, the event of convulsion was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAY-2018, the patient was scheduled to receive the first dose of ZOSTAVAX subcutaneously, for prophylaxis (lot # and expiration date were not reported). It was stated that the patient had potentially received SHINGRIX (lot # and expiration date were not reported) instead of ZOSTAVAX. No adverse effect was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 16 week old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 16 weeks, the patient was vaccinated with ROTATEQ vial, dose one, lot number N022001 with expiration date on 03-FEB-2019, orally for prophylaxis (strength was not reported). No adverse effects reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a Nurse, concerning her 16 year old son. The patient did not have medical history, concomitant medication, drug reactions or allergies. On 27-JUL-2017, the patient received one dose of GARDASIL 9, intramuscular injection, in an administration schedule of 3 doses on 0, 2 and 6 months, for prevention of Human Papilloma Virus (HPV) (lot number and expiration date were not reported). After receiving the vaccine on 27-JUL-2017, the injection site was red, hot and it hurt terribly. The nurse also stated that the skin around the injection site was hard and raised and caused his entire arm to feel weak for seven days. The patient did not sought medical attention, no lab diagnostics or studies were performed and no treatment was given for the events. On 27-JUL-2017, therapy with GARDASIL 9 was discontinued. On 03-AUG-2017, the patient recovered from arm weakness and he recovered from the remaining events on an unknown date. The reporter did not assess the causal relationship between GARDASIL 9 and the events.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness
Clinical narrative: This spontaneous report was received from a Nurse, concerning her 16 year old son. The patient did not have medical history, concomitant medication, drug reactions or allergies. On 27-JUL-2017, the patient received one dose of GARDASIL 9, intramuscular injection, in an administration schedule of 3 doses on 0, 2 and 6 months, for prevention of Human Papilloma Virus (HPV) (lot number and expiration date were not reported). After receiving the vaccine on 27-JUL-2017, the injection site was red, hot and it hurt terribly. The nurse also stated that the skin around the injection site was hard and raised and caused his entire arm to feel weak for seven days. The patient did not sought medical attention, no lab diagnostics or studies were performed and no treatment was given for the events. On 27-JUL-2017, therapy with GARDASIL 9 was discontinued. On 03-AUG-2017, the patient recovered from arm weakness and he recovered from the remaining events on an unknown date. The reporter did not assess the causal relationship between GARDASIL 9 and the events.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case number: 00809886). A contactable pharmacist reported that a patient of unspecified age, ethnicity and gender, received PREVNAR 13, (lot number not reported), via an unspecified route of administration on an unspecified date as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had "large localized arm which blew up after receiving PREVNAR 13 (unknown lot and expiry) couple years ago, and was placed on BENADRYL (unspecified manufacturer) (for unspecified time period)." The primary reporter reported the patient had recovered on unspecified date. No additional information provided. No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site nodule, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 57-years-old, female patient received the first dose of PREVNAR 13 via an unspecified route of administration in Apr2017, single dose (in late evening, did not have exact time to provide), for routine vaccination. Vaccination Facility Type: Pharmacy/Drug Store. Relevant medical history included asthma (diagnosed 40 years prior to this report). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none; additional vaccines administered on same date of the Pfizer suspect was none. In Apr2017, the patient experienced knot at injection site, rash and flu like symptoms. The events required a visit to physician office. The outcome of the events was unknown; it was further specified that the reporter "did not know outcome since he was not sure what would be considered lasting effects". The information on the batch number has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, cough and difficulty breathing. Concomitant products included fluticasone propionate, ADVAIR DISKUS, Calcium, FLONASE, SINGULAIR, Celapram, fish oil, lisinopril, MVI, TOPROL XL, verapamil and NORVASC. On 25th April 2018, the patient received SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach. On 25th April 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness, headache, fever, chills and upset stomach were unknown. The reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot on Wednesday. The patient experienced soreness immediately that day.  The next morning, the patient's husband saw her arm was redness and swelling. The patient received the shot on the back side of her arm up toward her shoulder blade. The patient stated that her arm was increased about 2 by 2 to 3 by 4 areas, but it was not as sore. The patient also stated that the day after later in the evening experienced upset stomach, fever, chills, headache and tiredness. The patient began taking lisinopril the day before the vaccination and that day had trouble breathing and cough. The patient took it for about 2 days then contacted the physician's office, who instructed her to stop the Lisinopril. The patient denied the cough and breathing trouble being related to her SHINGRIX and she had the same issue with two other blood pressure medications verapamil and NORVASC. She was being started on another medication but had not picked it up yet. She was encouraged to notify her physician about the experience she had with the SHINGRIX, since she had not already.