chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse referring to  a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 11-DEC-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA)(PROQUAD) lot # T021302 (also reported with lot # T011302), expiration date 19- DEC-2020, 0.5 milliliter, subcutaneous for immunisation (vaccination scheme frequency and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -5 degree Celsius (°C) for 10 hours (also reported with timeframe 20 hours) as recorded by a data logger. There was no previous temperature excursion reported.  Lot # T011302 has been verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number T011302 is a valid lot number for sitagliptin phosphate (XELEVIA).
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Ill-defined disorder, Lip swelling, Tuberculin test positive, Tuberculosis
Clinical narrative: She had to be given epinephrine; This spontaneous information has been received from a female patient of unknown age via Pfizer. The patient had history of multiple vaccine allergies which was reported as follows: smallpox and rubella vaccine caused an adverse event that made her went to the hospital and got a spinal tap. She received 2 rounds of anthrax vaccine and her lip got very swollen the next day, therefore she received diphenhydramine (BENADRYL). Typhoid vaccine got her arm swollen more than regular and meningococcal made her had a small reaction. Patient's concurrent conditions included rhabdomyolysis, malignant hyperthermia and tuberculosis (TB) positive. It was reported that she did not complete her isoniazid (INH) treatment because her joints hurt. Patient's concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a booster of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).   On an unknown date, the patient had to received epinephrine after the vaccine (ill-defined disorder). The outcome of the ill-defined disorder was not provided.  The causal relationship between ill-defined disorder and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE; Temperature excursion; This spontaneous report was received from a nurse referring to a 6-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 16-DEC-2020, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) 1 dosage form, lot number T021638, expiration date 21-DEC-2021 (route of administration not provided) for prophylaxis. No other adverse event details were reported.  The vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for 4 hours and 15 minutes. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several reports reported by the same nurse.; Sender's Comments:  US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2012USA013603:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other AE; Temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      In March 2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number T017688, expiration date 21-MAY-2022 (route of administration not provided) for prophylaxis. No other adverse event details were reported.  The vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for 4 hours and 15 minutes. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several reports reported by the same nurse.; Sender's Comments:  US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013603:
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiovascular disorder, Myelitis, Post herpetic neuralgia
Clinical narrative: myelitis; postherpetic neuralgia; cardiovascular event; balance problems; Information has been received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 15-MAY-2008, at the age of approximately 70 years old, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: postherpetic neuralgia, myelitis, cardiovascular event and balance problems. The outcome of the events was not reported.   Upon internal review, myelitis was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE details available at this time; Caller reported temperature excursion; This spontaneous report as received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 07-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA)) (strength and route were not reported, lot # T021638 has been verified as valid, expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 ml for prophylaxis.  The administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced product storage error with temperature excursion: minus 13.3 degree Celsius, time frame: 4 hours and 15 minutes. There were no previous temperature excursions. The digital data logger was involved. No other adverse event details available at the reporting time.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE details available at this time.; Caller reported temperature excursion.; This spontaneous report as received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 25-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA)) (strength and route were not reported, lot # T021638 has been verified as valid, expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 ml for prophylaxis.  The administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced product storage error with temperature excursion: minus 13.3 degree Celsius, time frame: 4 hours and 15 minutes. There were no previous temperature excursions. The digital data logger was involved. No other adverse event details available at the reporting time.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebral infarction, Cerebrovascular accident, Haemorrhage
Clinical narrative: hemorrhage; stroke; intracranial infarction; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 22-FEB-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as after zoster vaccine live (ZOSTAVAX) inoculation), the pt suffered hemorrhage, stroke and intracranial infarction. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Th pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 of zoster vaccine live (ZOSTAVAX), the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events hemorrhage, stroke and intracranial infarction was not recovered.   The reporter considered the events hemorrhage, stroke and intracranial infarction to be disability.  Upon internal review, the events hemorrhage, stroke and intracranial infarction were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/ or administered by a healthcare provider at the medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by healthcare providers at the medical office for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue 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 will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 66.0
Sex: U
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 elderly patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 2014, the patient was administered the zoster vaccine live(ZOSTAVAX) vaccine by a pharmacist (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a doctor for the following injury resulting from zoster vaccine live(ZOSTAVAX) use: shingles. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live(ZOSTAVAX).
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 57-year-old patient with unknown gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 09-SEP-2015, the patient was administered the ZOSTAVAX vaccine at a pharmacy (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on or about 21-SEP-2015, patient was treated at a hospital and, then, by a doctor for the following injury resulting from ZOSTAVAX use: shingles. The outcome of shingles was not provided. The reporter considered the event to be related to ZOSTAVAX.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE details.; administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to  a patient (age and gender unspecified) .There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)prefilled syringe, dose:0 .5 milliliter, lot # 1637651, expiration dste:09-JUN-2022 for prophylaxis (dose number, and  route of administration were not reported) during the excursion. The administered dose of the vaccine experienced a temperature excursion was below 2 degrees Celsius 1.3, and 1.6 degrees Celsius for 24 minutes, as recorded by a data logger. No product quality complaint reported combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 28-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 2 milliliter (mL), administered by oral route, as prophylaxis (formulation, strength and  vaccination scheme were not provided, lot number 1658255, which has been verified to be valid, expiration date reported and validated as 07-FEB-2021). The vaccine administered experienced a temperature excursion below 2 degrees Celsius (C) (1.3C) for 0 hours 24 minutes (product storage error). There was previous temperature excursion below 2C (1.6C) for 24 minutes, as recorded by a data logger. Other lot numbers involved included: 1684157 and 1660998, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021 and 03-MAY-2021, correspondingly.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T021824, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of 16.1 degrees Fahrenheit (product storage error), for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000916:Case number 01835180 US-009507513-2101USA000954:Case number 01835185
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; administered to patient during the excursion; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S026371, expiration date on 01-APR-2022, 0.5 milliliter (administration route and anatomical location were not reported)for prophylaxis.  The reporting nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion, the excursion were as follow: Two times temperatures below 2 Celsius degrees (C) (1.3 C) for 24 minutes and previous temperature excursion below 2 C (1.6C) for 24 minutes.No adverse events were reported. It was confirmed that a digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026371; expirationdate: 01-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a medical assistant, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T021824, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of 16.1 degrees Fahrenheit (product storage error), for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000920:Case number 01835185 US-009507513-2101USA000916:Case number 01835180
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; temperature excursion; This spontaneous report has been received from an unspecified source referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637648 and lot # S010729 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature range between 32.9 F and 34 °F, during a time frame of 16 hours which was called by a data logger (product storage error). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: had a severe reaction to PNEUMOVAX 23; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant medication were not provided.       On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.         On an unknown date, the patient had a severe reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) previously and was hospitalized. No additional adverse event details provided due to consumer being unable to be transferred to agent. The outcome of vaccination complication was unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Heart rate increased, Inappropriate schedule of product administration, Laboratory test abnormal, Parapsoriasis
Clinical narrative: broke out / confirmed to be Pleva; Heart issues / has a heart monitor and reports extra beat; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of pityriasis lichenoides in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had past medical history included shingles). Previously administered products included Shingrix with an associated reaction of parapsoriasis (1st dose received on 14th August 2020, refer case for 1st dose US2020199106).   On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 7th October 2020, the patient experienced pityriasis lichenoides and heart rate increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pityriasis lichenoides, heart rate increased and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pityriasis lichenoides and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had break out after 2nd dose administration. The patient saw dermatologist and breakout was biopsied and confirmed to be Pleva. The patient reported extra beat happened at the same time as Pleva breakouts. The reporter did not confirmed if heart issue related to Shingrix. The reporter stated that, the patient received 2nd dose earlier than the recommended schedule (2-6 months) which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199106:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pityriasis lichenoides et varioliformis acuta, Vaccine positive rechallenge
Clinical narrative: broke out / confirmed to be Pleva; Heart issues / has a heart monitor and reports extra beat; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of pityriasis lichenoides in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had past medical history included shingles). Previously administered products included Shingrix with an associated reaction of parapsoriasis (1st dose received on 14th August 2020, refer case for 1st dose US2020199106).   On 6th October 2020, the patient received the 2nd dose of Shingrix. On 6th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 7th October 2020, the patient experienced pityriasis lichenoides and heart rate increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pityriasis lichenoides, heart rate increased and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pityriasis lichenoides and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had break out after 2nd dose administration. The patient saw dermatologist and breakout was biopsied and confirmed to be Pleva. The patient reported extra beat happened at the same time as Pleva breakouts. The reporter did not confirmed if heart issue related to Shingrix. The reporter stated that, the patient received 2nd dose earlier than the recommended schedule (2-6 months) which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199106:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Shivers; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shivering and nausea. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved.   It was unknown if the reporter considered the shivering and nausea to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced some shivers and nausea with the first dose but it resolved quickly.  The patient followed up with disease control and prevention guidelines.  The reporter did not consent to follow-up and declined to provide HCP information. For tolerance of 2nd dose of Shingrix, refer case US2020232824.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020232824:Same reporter. 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria, Vein disorder
Clinical narrative: veins in my feet are. bulging; there are whelps; This case was reported by a consumer via interactive digital media and described the occurrence of vein disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (allergic to penicillin and all its derivatives). Concomitant products included rasagiline mesilate (Azilect).   On 20th November 2020, the patient received Shingrix. On 24th November 2020, 4 days after receiving Shingrix, the patient experienced vein disorder and welts. On an unknown date, the outcome of the vein disorder and welts were not recovered/not resolved.   It was unknown if the reporter considered the vein disorder and welts to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself. The age group was not reported but was selected as adult as per vaccine indication. It was reported that on the night of  24th November 2020 the patient's veins in feet were bulging and there were whelps.  The patient could not find what the ingredients were for the vaccine.  The patient said some medicines react to Azilect.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discomfort, Injection site swelling, Pain
Clinical narrative: Headache; Discomfort  / at injection site; Small swelling at injection site; Body aching (not severe); This case was reported by a nurse via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020 09:00, the patient received the 1st dose of Shingrix. On 18th September 2020, less than a day after receiving Shingrix, the patient experienced headache, injection site discomfort, injection site swelling and general body pain. On an unknown date, the outcome of the headache, injection site discomfort and general body pain were recovered/resolved and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the headache, injection site discomfort, injection site swelling and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporting retired nurse was the concerned patient. The age at vaccination was not reported but it could be 70 or 71 years. In the evening, the patient developed headache, discomfort and small swelling at injection site, and body aching (not severe). The patient reported not having fever neither chills. All symptoms were gone after 48 hours. No other information was provided. Lot number and Expiry date was not available at time of reporting. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better.  He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering.  No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered.   No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics  and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: tested positive within 2-4 days of the vaccine; tested positive within 2-4 days of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of 2 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse had questions about patients that received the first dose of the COVID 19 vaccine. One patient tested positive within 2-4 days of the vaccine and this patient had a known exposure to a COVID positive person. The nurse wanted to know if this patient should receive the second dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520414 Same reporter, drug, and events; different patients
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 18Dec2020, and was tested positive for COVID yesterday, 29Dec2020. States that she knows she only has had the first dose and states her exposure level was high, states that she cannot believe she made it this far before testing positive. Second dose scheduled for 08Jan2021, wanting to know if she should get the second dose since she was now positive. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: positive Covid results with symptoms; positive Covid results with symptoms; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension (diagnosed 3-4 years ago), hyperlipemia (diagnosed 3-4 years ago), supraventricular tachycardia since 2017, and asthma; all ongoing. Family history included hypertension. She has no history of adverse reactions or allergies to any vaccines received previously. The patient's concomitant medications were not reported. The patient explains that she got the COVID-19 vaccine on 20Dec2020. Afterward she had some coughing, so she went for a rapid test and found she tested positive after the vaccine. The patient was wondering if this has been reported previously, where someone tested positive after getting the vaccine. She has never tested positive before. She got the results on 28Dec2020 that she was positive. She was now in a hotel quarantining. She was looking trying to find information on this occurring. Since she was in the hotel, she would prefer to use email as communication for follow-up. The patient noticed the cough on 25Dec2020. She works nights so she stayed home on the 26Dec2020. Then on 27Dec2020 she had the test done and on 28Dec2020 the results were given to her and she was positive. Her second dose was due on 10Jan2020 and it was before the 14 days of quarantine will be up. She was checking to see is there anywhere else she can get the second dose. The patient explains that she has been researching and she wanted to get it because she was with elderly family members. She wanted to know how she was tested positive, what test was used as she had the rapid test. There were no treatments for the events. The caller patient was also experiencing a cough, sore throat, and nasal congestion. There was no shortness or anything else going on at this point. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive person for Covid after receiving the Covid vaccine; positive person for Covid after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date were unknown), via an unspecified route of administration on unknown date at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was a positive person for Covid after receiving the Covid vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19  cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Confusional state, Dizziness, Thinking abnormal
Clinical narrative: Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', "couldn't gather my thoughts or write what I wanted to say", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am; arms had some pain; chills; headache; a stiff neck pain at the back of her neck; a stiff neck pain at the back of her neck; a trembling pain; This is a spontaneous report from a contactable consumer.  This is the 1st of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated on Dec2020, "she reported that she herself felt fine but her arms had some pain. She was having chills, a headache, a stiff neck pain at the back of her neck, and a trembling pain. Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am. Her pulse was at 62 bpm, Caller is asking for recommendations". The outcome of "her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am" was recovering and other events was unknown.   Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520380 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am; arms had some pain; chills; headache; a stiff neck pain at the back of her neck; a stiff neck pain at the back of her neck; a trembling pain; This is a spontaneous report from a contactable consumer.  This is the 1st of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated on Dec2020, "she reported that she herself felt fine but her arms had some pain. She was having chills, a headache, a stiff neck pain at the back of her neck, and a trembling pain. Her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am. Her pulse was at 62 bpm, Caller is asking for recommendations". The outcome of "her measured blood pressure at 7:35 am was 180/80 but came down to 146/62 at 9:37 am" was recovering and other events was unknown.   Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520380 same reporter/drug, different patient/event