chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hyperaesthesia, Laboratory test normal, Limb discomfort, Myalgia, Pain
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscular weakness, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Entire upper arm is swollen, red and painful.  Entire left arm is weak.  Difficultly waking, I?m afraid to go to sleep.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Death, Dizziness, Eye pain, Pain in extremity, Tinnitus
Clinical narrative: extremely sore arm, aching eyes, dizzy, strange electrical sound in ears upon standing
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Injection site reaction, Injection site swelling
Clinical narrative: Body aches, back ache Tired Swollen upper erm Red blotch where needle inserted Chills
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash macular
Clinical narrative: Body aches, back ache Tired Swollen upper erm Red blotch where needle inserted Chills
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect reported; a patient was administered a dose of improperly stored Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 29-JAN-2020, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, lot # S024364, expiration date 06-AUG-2021(exact dose and anatomical location were not reported) for prophylaxis. The vaccine was diluted with a properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of - 14 degrees Celsius to - 10 degrees Celsius (-12.6 degrees Celsius) for 9 hours and 53 minutes. Digital Data Logger was involved. The vaccine underwent previous temperature excursion of - 14 to - 10 degrees Celsius (- 13 degrees Celsius) for 14 hours and 22 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001486: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001459:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included sterile diluent (STERILE DILUENT) that did not experience a temperature excursion.  On 31-JAN-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (exact dose was not reported) (lot # S024364, expiry date 06-AUG-2021) for prophylaxis. The storage temperature range was from -14 Celsius degrees (C) to - 10 C (-12.6 C) during the time frame of 9 hours and 53 minutes. Previous temperature excursion was from -14 C to -10 C (-13.00 C) for 14 hours and 22 minutes. The digital data logger was involved. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001486: US-009507513-2002USA001358: US-009507513-2002USA001459:
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; One patient was administered improperly stored PNEUMOVAX 23; This spontaneous report was received from a medical assistant regarding a 66-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 03-FEB-2020 the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, prefilled syringe (strength, dose, route of administration and vaccination scheme were not reported; lot number S024808 was determined to be valid, expiration date 02-JUN-2021) as prophylaxis (product storage error). The storage temperature above 47 degrees Fahrenheit (°F) was 46.6 °F for a timeframe of 13 minutes. There was no previous temperature excursion and the call was made due to a digital data logger. No additional adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Facial pain, Flushing, Lip swelling, Pruritus
Clinical narrative: the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; This spontaneous report has been received from a pharmacist concerning a 73-year-old female patient.  The patient's concurrent conditions included an allergy to sulfonamide (reported as "Sulfa") and an allergy to lidocaine (LIDODERM).  Her medical history included red bumps (rash papular). The patient did not have any concomitant therapies.   On 06-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) one dosage form via subcutaneous, for prophylaxis (reported as routine vaccination) (concentration, frequency of vaccination scheme and anatomical location of vaccination were not reported). Lot Number S0009945 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), expiration date not reported, but upon internal validation, it was established as 10-AUG-2020.  Twenty minutes after vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient experienced flushing of her face, pain in her face which then turned into itching of her face (pruritus) and lip swelling. As the reaction occurred at the physician's office, the patient was treated immediately with dexamethasone (DECADRON) 8 milligram (mg) and diphenhydramine (BENADRYL) 25 mg.   The pharmacist confirmed that the event was not cancer or a congenital anomaly and that the patient did not die, nor she was hospitalized. The pharmacist also informed that the event was not life-threatening, did not cause significant disability or incapacity and that the patient did not overdose.   At the time of reporting, the patient was not recovered from the events.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) vaccination and the patient's events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age, and her spouse. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On or about 18-AUG-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported.) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination (dates unspecified), the patient was treated by a health care provider for shingles. As a direct and proximate result of the patient use of zoster vaccine live (ZOSTAVAX), she had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and cost include care for hospitalization, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation or preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: the patient received the first dose ofGARDASIL 9 and fainted; This spontaneous report has been received from a medical assistant via a company representative, concerning a 12-year-old female patient. Her concomitant medications included unspecified diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP), and unspecified Meningococcal vaccine (dates of administration not provided). Information about the patient's past drug and medical history, as well as allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 1 dosage form, as prophylaxis (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported); subsequently, she fainted (syncope), but she regained consciousness after a second or two, and was fine. It was unknown if the patient sought medical attention, if lab diagnostics or studies were performed, or if she received treatment for the event. There was no overdose or cancer information reported. The patient was recovered from the event.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the occurred event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for the long-term prevention of shingles and/or zoster related conditions. On an unknown date, subsequently to patient's inoculation, the patient experienced shingles. The patient was treated for a physician due to the events. As a direct and proximate result of the use of the vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools, Polymerase chain reaction positive, Rotavirus test positive
Clinical narrative: "PCR stool test was completed on an unspecified date and the results showed "rotavirus"; mucus and blood in their stool; mucus and blood in their stool; This spontaneous report was received from a nurse prescriber via a field employee, referring to a 6 weeks old male patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.  On 06-JAN-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot# and expiration date were unknown) orally for prophylaxis in the series.  On 08-JAN-2020, the patient began experiencing mucus and blood in their stool within 48 hours of administration. The nurse prescriber switched the patient to a hypoallergenic formula. On an unspecified date, a polymerase chain reaction (PCR) stool test was completed and the results showed "rotavirus". The patient sought medical attention by seeing at nurse prescriber's office. There was no intervention to prevent serious criteria. The outcome of the events was reported as not recovered. The causality assessments between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events were not reported.  Upon internal review, blood in stool was determined to be medically significant.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Inappropriate schedule of product administration, Mucous stools
Clinical narrative: the patient "experienced diarrhea that started on 07/01/2019 and lasted for 4 weeks, until 07/22/2019, which also had blood and mucus in it."; the patient "experienced diarrhea that started on 07/01/2019 and lasted for 4 weeks, until 07/22/2019, which also had blood and mucus in it."; was then administered the 2nd dose of ROTATEQ (unknown lot/exp date) in the series on 06/28/2019; Information has been received from a nurse prescriber via a field employee, referring to a 4 months old female patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions or allergies.  On 11-APR-2019, the patient was administered the first dose in the series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date were unknown) orally for routine vaccination with no adverse symptoms. On 28-JUN-2019, the patient was administered the second dose in the series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date were unknown) orally for routine vaccination (Inappropriate schedule of vaccine administered).  On 01-JUL-2019, the patient started experiencing diarrhea and lasted for 4 weeks, until 22-JUL-2019, which also had blood and mucus in it. Parent of the patient contacted the reporter. There was no treatment given for the events. On an unknown date, stool cultures were completed and the results were negative. The outcome of the events was recovered. The causality between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.   Upon internal review, diarrhea had blood in it was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; One patient received improperly stored PROQUAD, on 2/6/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.  On 06-FEB-2020 (also reported on 10-FEB-2020 it was identified), the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) 0.5 milliliter (ml), once for prophylaxis (strength, route of administration, and anatomical location were not reported) (lot number S030208 had been verified to be a valid number; expiration date was reported as 25-MAR-2020 and upon internal validation established as 25-MAR-2021). It was reported the use of properly stored sterile diluent (DILUENT MRK). It was reported the temperature storage range was at 47 degrees Fahrenheit (F) to 77 degrees F (9 degree Celsius (C) to 25 degrees C) (8.7 C) for a time frame of 2 hours. It was reported that no had previous temperature excursion. It was reported that the call was due to a data logger. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis, Deafness bilateral, Deafness neurosensory, Dizziness, Dyspnoea
Clinical narrative: Pneumonia; Chronic ischemic heart disease; Recurrent acute conjunctivitis; Bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.    In or around 17-MAR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered acute conjunctivitis, nausea and shorthness of breath. Later the patient was hospitalized and was diagnosed with pneumonia and chronic ischemic heart disease (myocardial ischaemia). The patient also started to experience tinnitus, dizziness and vértigo, subsequently he was diagnosed with bilateral sensorineural hearing los(deafness neurosensory) on an unknown date.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved.  The events were considered related to zoster vaccine live (ZOSTAVAX).  All the events were considered to be disabling.  Upon internal review, the events pneumonia, myocardial ischaemia and deafness neurosensory were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Myocardial ischaemia, Nausea, Pneumonia, Tinnitus, Vertigo
Clinical narrative: Pneumonia; Chronic ischemic heart disease; Recurrent acute conjunctivitis; Bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.    In or around 17-MAR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered acute conjunctivitis, nausea and shorthness of breath. Later the patient was hospitalized and was diagnosed with pneumonia and chronic ischemic heart disease (myocardial ischaemia). The patient also started to experience tinnitus, dizziness and vértigo, subsequently he was diagnosed with bilateral sensorineural hearing los(deafness neurosensory) on an unknown date.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved.  The events were considered related to zoster vaccine live (ZOSTAVAX).  All the events were considered to be disabling.  Upon internal review, the events pneumonia, myocardial ischaemia and deafness neurosensory were considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; patient received improperly stored vaccine; This spontaneous report was received from an medical assistant referring to a female patient of unknown age. Information about the patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.      On 03-FEB-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis administered via an unspecified route (concentration, number of administered dose, vaccination scheme frequency, and anatomical location of vaccination were not reported; reported lot number S033516 has been verified to be a valid lot number, expiration date was reported and validated as 29-JUN-2021) (product storage error). No adverse effects were reported for the patient.  According to the reporter, the highest temperature excursion was 52.5 degrees Fahrenheit for a time frame of fifteen minutes, with other previous temperature excursions; which were detected by a digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is not experiencing any symptoms. NO additional adverse effect reported.; a patient greater than 12 years of age with a history of liver transplant was administered a dose of PROQUAD on 2/12/2020; This spontaneous report has been received from a certified medical assistant, referring to a 16 years old patient of unknown gender. The patient's medical history included liver transplant. The patient's concomitant medication and drug reactions/allergies were not provided.  On 12-FEB-2020, the patient greater than 12 years old was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017244, expiration date 01-DEC-2020; strength, dose, frequency were unknown) subcutaneously for prophylaxis (product administered to patient of inappropriate age). The patient was not experiencing any symptoms. There was no additional adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: warts on her buttocks area went away after receiving 1st dose of GARDASIL 9; no adverse events; This spontaneous report was received from a nurse via company representative referring to a 23 year old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, lot number, expiry date and route of administration were not reported) for prophylaxis. On an unknown date, after receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), warts on the patient's buttocks area went away (therapeutic response unexpected ). No adverse events were reported. There was no product quality complaint present. The outcome of therapeutic response unexpected is unknown. The reporter's causality assessment between the event and the suspect therapy was not provided.
Age: 0.17
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: the patient "was administered a dose of Rotarix (lot and expiration unknown, manufacturer unknown) on 12/17/2019 at a different providers office and is in the office today, 02/13/2020, to receive the second dose in the series as ROTATEQ; Information has been received from a medical assistant, referring to a 4 months old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 17-DEC-2019, the patient was administered with a dose of rotavirus g1 p1 vaccine live (89-12) (ROTARIX) at a different provider office. On 13-FEB-2020, the patient received the second dose in the serious as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date unknown) orally for prophylaxis (interchange of vaccine products).
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: erythema rash; This case was reported by a physician via sales rep and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, 3 weeks after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient seen by doctor on 31st January 2020.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nasal congestion, Pain, Pyrexia
Clinical narrative: flu like reaction; Fever; Chills; Bad Aches; congestion that lasted 2 full days; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, immediately after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, pain and nasal congestion. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, pain and nasal congestion were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, pain and nasal congestion to be related to Shingrix.  Additional details were provided as follows: Minutes after vaccination the patient had flu like reaction, fever, chills, bad aches, congestion that lasted 2 full days. Batch number and expiration date were not reported as she did not received first dose in the same facility that she worked in. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sore all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date and experienced no adverse event).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovering/resolving.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient took 1st Shingrix shot and stated "it was like nothing at all" compared to the second shot. The reporter stated that after the second Shingrix shot the patient was sore all over. The reporter did not have lot number and did not wish to provide the health care provider's information. The outcome of the event was reported in source document as recovering and resolving, however it was reported as not recovered and not resolved.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective
Clinical narrative: used Prevnar 13 four times, and it has not worked.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's mother) reported that a 4-yearold female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), four times via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had used pneumococcal 13-val conj vac (dipht crm197 protein) four times, and it had not worked. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Malaise, Swelling
Clinical narrative: localized redness, swelling. This was also associated with fatigue and generalized malaise that waned over the course of the following three days
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: CELLULITIS OF LEFT UPPER THIGH 2.5CM TREATED WITH SCRIPT FOR CEPHALEXIN 250MG/5ML ORAL SUSPENSION
Age: 0.33
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: 4month old was accidentally given HepA vaccine (brother was in the room and needed this vaccine). No adverse effects have been identified as of this time.  I did call the department of health and then notified mom of the error.  they will contact us if there is any concerns for side effects or adverse outcomes.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Expired product administered
Clinical narrative: Gave expired varicella vaccine to patient.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus
Sex: M
Vaccine: PPV
Symptoms: Axillary mass, Pain, Pain in extremity
Clinical narrative: once again experiencing just pain arm pain; once again experiencing just pain arm pain; Lump in his left arm pit; Just pain, arm pain; Just pain, arm pain; This spontaneous report was received from a male consumer of 64 year old referring to himself. The patient's concurrent condition included mitral valve prolapse, diabetes mellitus and drug hypersensitivity (the patient was allergic to sulfa drugs). Concomitant therapies included metformin hydrochloride (reported as Metformin ER), sitagliptin phosphate(JANUVIA), ramipril, atorvastatin and vitamins (unspecified).   On 21-JAN-2019 (reported as for the first time), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 1 in the left deltoid (reported as in left shoulder) for prophylaxis (reported as protection) (strength, dose, lot/batch#, expiry date, route was not reported). On the same day, the patient experienced pain and arm pain for which the patient was treated with unspecified ibuprofen. The patient sought no medical attention. The events were recovered/resolved on 24-JAN-2019 (reported that it took 3 days to recover from the pain). On 22-JAN-2020 (reported as for the second time), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 2 in the left deltoid for prophylaxis (strength, dose, lot/batch#, expiry date, route was not reported). On the same day, the patient experienced pain and arm pain for which the patient was treated with unspecified ibuprofen. The events were recovered/resolved on 25-JAN-2020 (reported that it took 3 days to recover from the pain). On an unknown date in January 2020 (reported as on an unspecified date after 22-JAN-2020), the patient noticed a lump on his left armpit which was initially a size of a ping pong ball (mass). It was reported that the lump had subsided over the past 3 weeks but was still there (recovering/resolving). The patient sought medical attention. No product quality complaint was involved.   The reporter's causality assessment was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Muscular weakness
Clinical narrative: having vaccine he has been losing energy; and losing muscle strength by the day; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included atorvastatin calcium (Lipitor).   On 20th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced loss of energy and muscle weakness. On an unknown date, the outcome of the loss of energy and muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the loss of energy and muscle weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. Since, having the vaccine the patient had been losing energy and losing muscle strength by the day. The reporter limited information provided. The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hypomania
Clinical narrative: Hypomania; This case was reported by a consumer via call center representative and described the occurrence of hypomania in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included chickenpox. The patient had a Family History of chickenpox (Kids (unspecified number) had chicken pox). Concurrent medical conditions included manic depression.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Influenza vaccine Quadrivalent 2019-2020 season. On 25th September 2019, 1 hr after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced hypomania. On 9th October 2019, the outcome of the hypomania was recovered/resolved.   It was unknown if the reporter considered the hypomania to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information was provided as follows: This case was reported by patient herself. The patient received Shingrix vaccine in left arm. The patient reported within 1 hour she experienced a hypomania episode for approximately 1 to 2 weeks. The reporter inquired if patient should receive 2nd dose and if one dose was efficacious notably due to perceived belief of protection from a history of chicken pox and exposure again when her kids had chicken pox. The reporter consented to follow up. The consumer stated she had already contacted Food and Drug Administration (FDA). The outcome of the event was reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in Argus. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Oropharyngeal discomfort, Pain
Clinical narrative: body aches; flu like symptoms; she didn´t fell well; funny sensation in her throat; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced general body pain, influenza-like symptoms, feeling unwell and pharynx strange sensation of. On an unknown date, the outcome of the general body pain and influenza-like symptoms were unknown and the outcome of the feeling unwell and pharynx strange sensation of were recovered/resolved.   It was unknown if the reporter considered the general body pain, influenza-like symptoms, feeling unwell and pharynx strange sensation of to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix in end of the August 2019. The patient had a funny sensation in her throat about an hour after the administration of the vaccine that resolved. The patient also experienced body aches and flu like symptoms. The patient did not feel well for a few days.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Several patient who have experienced rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in several patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. There were several patients who experienced rash after receiving Shingrix. There were no patient at the moment who reported it. The reporter did not consent to follow up. No patient or vaccine data, health care professional mentioned he had several patients and not just one and there was no patient at the moment.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Rash, ErythemaMultiform & UrticariaPruritus
Age: 56.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain, Ear infection, Headache, Muscular weakness, Ocular discomfort
Clinical narrative: 8 hours post vaccine - vomiting x 2 (30 minutes apart) - low grade temp of 100.4, severe abdominal pain, extreme headache I have never experience before, both ears felt like I had severe ear infections, and my eye balls felt like there was so much pressure they were going to pop out - this last for 36 hours and then felt just week. At the 48 hour mark low grade temp for 8 hours with a mild headache. Woke up and headache remains and muscle weakness.
Age: 56.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: 8 hours post vaccine - vomiting x 2 (30 minutes apart) - low grade temp of 100.4, severe abdominal pain, extreme headache I have never experience before, both ears felt like I had severe ear infections, and my eye balls felt like there was so much pressure they were going to pop out - this last for 36 hours and then felt just week. At the 48 hour mark low grade temp for 8 hours with a mild headache. Woke up and headache remains and muscle weakness.
Age: 1.75
Sex: F
Vaccine: HEPA, MMR
Symptoms: Seizure
Clinical narrative: Seizure activity 4 hours following vaccinations.  Child recently diagnosed with epilepsy.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Angiogram, Cerebrovascular accident, Computerised tomogram, Injection site pain, Lumbar puncture
Clinical narrative: severe muscle pain in both upper arms followed by bilateral loss of arms and legs movement...transfered to a hospital and treated as a stroke victim for one day...MRI showed severe swelling of the spinal cord between C4-6. treated with prednisone and released from hospital for neuro surgeon and neurology follow up...10 weeks later diagnosed as transverse myelitis
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Magnetic resonance imaging spinal abnormal, Mobility decreased, Myalgia, Myelitis transverse, Spinal cord oedema
Clinical narrative: severe muscle pain in both upper arms followed by bilateral loss of arms and legs movement...transfered to a hospital and treated as a stroke victim for one day...MRI showed severe swelling of the spinal cord between C4-6. treated with prednisone and released from hospital for neuro surgeon and neurology follow up...10 weeks later diagnosed as transverse myelitis
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Daily headaches for three weeks following  Shingrix injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling within 2 minutes of injection. Dr examined site and assured patient it is an allergic reaction. Pt was then given 50 mg diphenhydramine IM to right deltoid and 250 mg methylprednisone IM to right buttock. Dr called the patient at home at the end of the shift to check on her. Patient was stable with no complaints.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Computerised tomogram head normal, Investigation, Seizure
Clinical narrative: HEALTHY, DEVELOPMENTALLY NORMAL 6 MONTH INFANT DEVELOPED 2 UNPROVOKED SEIZURES SHORTLY AFTER RECEIVING HIS 6 MONTH IMMUNIZATIONS (NON FEBRILE)
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Rash & Swelling
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site reaction, Local reaction, Swelling
Clinical narrative: local reaction to left thigh. large insize. redness and swelling. ~ 5 inch
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Musculoskeletal discomfort, Pain
Clinical narrative: musculoskeletal discomfort - achiness- and fatigue-resolved after 48hrs. Began 2/12/20 Injection given on 2/11/20
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Pentacel given without ActHIB component (Only the DTaP/IPV component given)
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Myalgia
Clinical narrative: headache, fatigue, myalgia, general malaise
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Box 17 - Shingrix   1st dose - 10/16/19 2nd dose - 02/14/20
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Injection site induration
Clinical narrative: Hard, non-tender, induration at injection site
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Pt states that his pulse is over 90 and that he has been in pain since he had the vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: PT came to the clinic on 2/11/2020 c/o hives to left arm. stated it started on 02/10/2020. No pain, no fever, no chills. Just very itchy. given a dose of cetirizine 10 mg and applied hydrocrostisone.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: no additional adverse events; the patient has not had seizures since ROTATEQ was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. They were on a keto (sucrose-restricted) diet and had seizure if had too much sucrose. No information regarding the patient's concomitant therapy and drug reactions or allergies was provided. On 22-JAN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1658806, expiration date of 06-OCT-2020; dose was no reported). Since rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administration, the patient had not had seizures. No additional adverse events were reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Pyrexia, Rash
Clinical narrative: cellulitis surrounding the injection side, shoulder and upper chest; cellulitis surrounding the injection side, shoulder and upper chest; rash-like syndrome; This spontaneous report was received from a physician assistant via company representative and refers to a 66-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029916 has been verified to be a valid lot number, expiration date 12-JUN-2021, for prophylaxis (exact dose, dose number, route and site of administration were not reported). On 06-FEB-2020, the patient sought medical attention and came to the office, as she experienced fever, rash-like syndrome and cellulitis surrounding the injection site, shoulder, and upper chest.  The patient was prescribed an unspecified steroids as a treatment for adverse events. The outcome of events was not provided. Causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, the event of cellulitis was considered to be medically significant.