chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Trigeminal neuralgia
Clinical narrative: herpes zoster; post herpetic neuralgia; trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered of herpes zoster, postherpetic neuralgia, and trigeminal neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers  and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. The outcome of the events of herpes zoster, postherpetic neuralgia, and trigeminal neuralgia was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of were considered to be disabling.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury
Clinical narrative: shingles; ill-defined disorder; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 73-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and other zoster related injuries. The outcome of shingles and other zoster related injuries were not reported. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history and concomitant therapy were nor reported. In or around 01-AUG-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a rash in left arm, fingers, shoulder blades, under the rib cage of right arm and right leg and pain within arms and legs and was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a 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 company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the shingles was not reported. The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Cardiac disorder, Eye disorder
Clinical narrative: vision loss; heart issues; issues with right eye; Information has been received from a lawyer regarding a case in litigation, concerning a patient of unknown age at the time of the events and unknown gender. The patient's past medical history, concurrent conditions and concomitant therapies were not reported. On or about 02-OCT-2012, the patient was administered zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, route of administration, and anatomical location were not reported), at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers in for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: heart issues (cardiac disorder), issues with right eye (eye disorder) and vision loss (blindness). The patient claimed damages as a result of injury to themselves and economic losses. The outcome of the events was not provided.   Upon internal review, the event blindness was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: no additional adverse event; syringe broke off; the patient did miss today's dose; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 08-APR-2021, the patient was about to be vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter, once (lot # T009743, expiry date 27-JAN-2022) for prophylaxis.   The reporter stated that during the preparation, when she went to screw the needle onto the syringe, "it just broke of'. She stated the location of where the break occurred was in the luer lock where the needle was screwed onto the syringe. She believed there was a small piece that was completely broken off from the syringe and the piece was in the needle which has been discarded as of now. She stated the syringe/needle did not touch the patient, however the patient did miss the dose due to this quality issue, because they did not have another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) available to administer on that day. The patient was going to return tomorrow to receive the dose. No additional adverse event or product quality concern were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; serialnumber: 100810826130; operatorofdevice: Pharmacist; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 12-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002996: US-009507513-2104USA002997: US-009507513-2104USA002998: US-009507513-2104USA002999: US-009507513-2104USA003000: US-009507513-2104USA003001: US-009507513-2104USA003002: US-009507513-2104USA003003: US-009507513-2104USA003004: US-009507513-2104USA003005: US-009507513-2104USA003006: US-009507513-2104USA003007: US-009507513-2104USA003008: US-009507513-2104USA003009: US-009507513-2104USA003010: US-009507513-2104USA003011: US-009507513-2104USA003012: US-009507513-2104USA003013:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 18-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. 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: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old came in to get Varicella and MMR vaccines and was given PROQUAD.; This spontaneous report was received from a nurse who was reporting on 15-year-old female patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 08-APR-2021, the patient came in to get Varicella and MMR vaccines and was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter (strength, route of administration, anatomical location, lot number and expiration date were not reported)  for prophylaxis. It was considered as product administration to patient of inappropriate age.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient who received a dose of V ARlVAX after the product was improperly stored; no adverse event; This spontaneous report was received from a unspecified reporter and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T006347 with expiration date on 20-FEB-2022, 1 dosage form (route of administration was not reported) for prophylaxis. Digital data logger was involved. The vaccine underwent the temperature excursion of -6.6 degrees Celsius or 59 minutes. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other AE; received a dose of VARlVAX after the product was improperly stored; This spontaneous report refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T006347, expiration date: 20-FEB-2022 (formulation, strength and exact dose were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at -6.6 Celsius degrees (C) for 59 minutes. There was no previous temperature reported. The call was due to digital data logger. No additional adverse event was reported.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: she has tested positive for HPV despite being vaccinated with GARDASIL; tested positive for HPV despite being vaccinated with GARDASIL; This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient. The patient's historical conditions included being sexually molested at age of 5-year-old. There was no information about the patient's concurrent conditions or concomitant therapies provided.  On an unknown date (at age of 11-year-old), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Vaccine was administered for prophylaxis.   On an unknown dates, she was informed by her obstetrician-gynecologist (OB/GYN) that she had tested positive for human papillomavirus (HPV) despite being vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (vaccination failure). The reported did not know which HPV type the patient was testes positive for. It was reported that she sought medical attention. It was unknown whether the patient received any treatment for the events. The outcome of the events was reported not recovered.  The causality assessment was not provided.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 08-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 08-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 06-APR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 18-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 23-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 26-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Heart rate increased, Nausea, Pain
Clinical narrative: High fever, chills, body aches, nausea, vomiting, extreme weakness, rapid heartbeat
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever, chills, body aches, nausea, vomiting, extreme weakness, rapid heartbeat
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Pruritus, Rash
Clinical narrative: Shingle-like rash various areas; itching, redness. No treatment as yet. Moderna COVID?19 Vaccine EUA
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Ocular hyperaemia, Tenderness
Clinical narrative: left eyes painfull and very red...left side of forehead and left top of head very tendor to touch and bad headache. since march 25th
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Achy, chills, headache.   Achiness and chills lasted till around 9 pm the same day the headache lasted for two days
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Pain, Pyrexia
Clinical narrative: Felt like I had stomach flu- body aches, headache, chills,fever and vomiting
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt like I had stomach flu- body aches, headache, chills,fever and vomiting
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Somnolence
Clinical narrative: nausea, tired, feeling sleepy
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching near injection site
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Illness, Muscle spasms, Pain, Pain in extremity
Clinical narrative: The adverse event lasted about 36 hours and involved intense soreness in left arm; high fever and chills; intense body aches; muscle cramps. Although I was very sick I did not seek medical attention as this was not unexpected. I received outstanding information pre- and post-injection from officials involved with the vaccine process at vaccination site.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The adverse event lasted about 36 hours and involved intense soreness in left arm; high fever and chills; intense body aches; muscle cramps. Although I was very sick I did not seek medical attention as this was not unexpected. I received outstanding information pre- and post-injection from officials involved with the vaccine process at vaccination site.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Ringing in my ears began gradually and has increased in loudness and severity. Now on a scale from 1 to 10 it is a 7 and is extremely uncomfortable. Most noticeable in right ear. Also some light headedness after the second shot on 4/5/21.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Nervousness, Paraesthesia
Clinical narrative: reported feeling of warmth over her right after injection and tingling sensation in arm & "anxious & nervous".  TX: mask removal ; opened car windows x 4 for air flow; emotional support for anxiety.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Injection site pain, Mobility decreased
Clinical narrative: Chills, very cold for 2-3 hrs 14 hrs after shot Tired, feverish, achy 24 - 40 hrs after shot Place of injection very sore, unable to raise arm without pain Ibuprofen provided some relief.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, very cold for 2-3 hrs 14 hrs after shot Tired, feverish, achy 24 - 40 hrs after shot Place of injection very sore, unable to raise arm without pain Ibuprofen provided some relief.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Largest flare of Rheumatoid Arthritis I've ever had in 8 years.  I could barely move fingers on either hand without a lot of pain and could only make half a fist because of swelling.  Reaction appeared to involve both hands and left elbow only.  It was very sudden and required a visit to the Rheumatologist for relief.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Lethargy, Oral herpes
Clinical narrative: my skin on my body began to become sore and agitated easily to touch within 6 hours of shot. from 9pm to 6am I had chills and a high fever.  for the next 24-48 hour I was lethargic, with a headache. I have since developed 2 small cold sores even with taking Valtrex daily, kanker sors inside of mouth, daily headache as well as pain in my right ear.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia, Sensitive skin
Clinical narrative: my skin on my body began to become sore and agitated easily to touch within 6 hours of shot. from 9pm to 6am I had chills and a high fever.  for the next 24-48 hour I was lethargic, with a headache. I have since developed 2 small cold sores even with taking Valtrex daily, kanker sors inside of mouth, daily headache as well as pain in my right ear.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling of the lips. Has had lip fillers 1 year and 4 months prior
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Insomnia, Peripheral swelling, Tinnitus
Clinical narrative: Arm swelling Headache  Tinnitus and ear pain  Insomnia
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Nerve pain for weeks at injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dry eye, Facial paralysis, Lacrimation increased, Muscle twitching
Clinical narrative: On Saturday April 10th I began to experience symptoms of dry eyes, eye twitching and watering and sensitivity to light.  It continued to progress, by monday the 12th it led to left side of my face in paralysis.  I've never experienced this before or had issues.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: On Saturday April 10th I began to experience symptoms of dry eyes, eye twitching and watering and sensitivity to light.  It continued to progress, by monday the 12th it led to left side of my face in paralysis.  I've never experienced this before or had issues.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had a stroke within a few weeks of having her second shot.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Headache, Injection site pain, Muscle fatigue
Clinical narrative: After my second Covid-19 vaccination I immediately felt fine. There was minimal injection site tenderness. It all started to worsen approximately 8 hours after my shot. I lost the capacity to regulate temperature (not to the point of hospitalization), am experiencing muscle fatigue, have severe injection site soreness, and have a massive headache.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tinnitus
Clinical narrative: Lightheaded, nausea, ringing in ears. Evaluated by EMS-Cleared
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Gait disturbance, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse,  pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Syncope, Unresponsive to stimuli, Vertigo
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse,  pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Pyrexia, Syncope
Clinical narrative: fever, syncope
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Myalgia, Nausea
Clinical narrative: This is my second shot.  Both times sore arm and injection site. However additional side effects with this second shot include overall body and muscle aches, shivering.  Very slight nausea.  I feel like I have the flu.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This is my second shot.  Both times sore arm and injection site. However additional side effects with this second shot include overall body and muscle aches, shivering.  Very slight nausea.  I feel like I have the flu.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness
Clinical narrative: never ending headache on the right side of my head, temple to jaw, ear, since about four days after receiving the vaccine on 3/27/21. The first three days were weakness and flu like symptoms
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Soreness to the arm, feels broken, a lot soar, she cannot lift arm, hurts when moving and radiates to her index finger which is also difficult to bend, all on the side she received vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: c/o dizziness without other symptoms whatsoever.   TX - mask removal / airflow to car;  seat reclined x 8 mins.  seat to up right position after return of dizziness - able to stand without dizziness.   Drove off observation lot after 25 mins. total time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: SEVERE LEG & TOE CRAMPS
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Tinnitus
Clinical narrative: Beginning of first week in February 2021 a low buzzing sound (Tinnitus) in bilateral ears. March 1, 2021 a constant louder ringing bilaterally, insomnia, headaches, and fatigue (2° lack of sleep).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports experiencing numbness in both arms, has doctor's appt scheduled for further follow-up
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Pain
Clinical narrative: Full body aches, headache, sweating & malaise. No recorded fever.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Night sweats
Clinical narrative: Fatigue, sore muscles, chills, night sweats.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cryptococcus test, Differential white blood cell count, Full blood count, Heavy menstrual bleeding, Human chorionic gonadotropin
Clinical narrative: Have had my menstrual cycle of heavy bleeding for 12 days, I was on my 4 day of a normal cycle (the day before it was supposed to end) when flow started back up  heavier then I have experienced in over 20 years.   I am still bleeding so heavily that I am unable to wear a tampon, and have to wake in the middle of the night to change an overnight pad because the feel of bleeding has woke me up.  Went to ER last night, had blood tests as well a pelvic and transvaginal ultrasound to rule out fibroid or any type of abnormalities that would cause it. Everything came back with no explanation and now I have to take a hormone, medroxyprogesterone 10mg for the next 10 days in hopes of stopping the flow.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Ultrasound Doppler, Ultrasound pelvis
Clinical narrative: Have had my menstrual cycle of heavy bleeding for 12 days, I was on my 4 day of a normal cycle (the day before it was supposed to end) when flow started back up  heavier then I have experienced in over 20 years.   I am still bleeding so heavily that I am unable to wear a tampon, and have to wake in the middle of the night to change an overnight pad because the feel of bleeding has woke me up.  Went to ER last night, had blood tests as well a pelvic and transvaginal ultrasound to rule out fibroid or any type of abnormalities that would cause it. Everything came back with no explanation and now I have to take a hormone, medroxyprogesterone 10mg for the next 10 days in hopes of stopping the flow.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia
Clinical narrative: Left face numbness, weakness, tired. Evaluated by EMS; Refusal to transport.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Severe depression. Similar cognitive feelings during Covid infection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: day 2, sore arm at injection site, slight headache - gone by day 3 day 6, rash at injection site (shoulder) and swollen. Lower back pain, could hardly walk. Has happened before but this came out of no where. No new or out of the ordinary activity to cause the onset. May or may not be related.  day 7, back pain continues. Went to my chiropractor.  Noticed some itching on breast. Injection site still red and itchy and tight. day 8, rash/bumps  on breasts. stomach, lower back, upper thighs, bumps on arms. Injection site starting to itch again and feels tight and swollen. Getting some relief on back pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pruritus, Rash, Skin tightness
Clinical narrative: day 2, sore arm at injection site, slight headache - gone by day 3 day 6, rash at injection site (shoulder) and swollen. Lower back pain, could hardly walk. Has happened before but this came out of no where. No new or out of the ordinary activity to cause the onset. May or may not be related.  day 7, back pain continues. Went to my chiropractor.  Noticed some itching on breast. Injection site still red and itchy and tight. day 8, rash/bumps  on breasts. stomach, lower back, upper thighs, bumps on arms. Injection site starting to itch again and feels tight and swollen. Getting some relief on back pain.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Pruritus, Rash, Swelling face
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient reported rash/itchiness on the chest area post vaccine shot. does not report any other symptoms and no swelling of the mouth areas (face, lips, tongue). no trouble breathing. patient had also picked up allergy medications earlier in the day for an unrelated allergy symptoms of the body. Counseled patient on benadryl and will follow up next day as well. Patient reported okay to drive home and will take benadryl when he arrives at home safely.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient reported rash/itchiness on the chest area post vaccine shot. does not report any other symptoms and no swelling of the mouth areas (face, lips, tongue). no trouble breathing. patient had also picked up allergy medications earlier in the day for an unrelated allergy symptoms of the body. Counseled patient on benadryl and will follow up next day as well. Patient reported okay to drive home and will take benadryl when he arrives at home safely.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body ache's, chills and low grade fever started approximately 11 hrs. after the shot.  Symptoms lasted approximately 18hrs and felt fine after that.  Took Advil and Tylenol.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Intermenstrual bleeding, Muscle spasms
Clinical narrative: Unsure if related. On April 10 had severe cramp/popping sensation and almost passed out. Was ok after but had mild cramping sensation sense and one day of mild spotting on 4/14. Awaiting to see PCP, about events.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Paraesthesia
Clinical narrative: abdominal pain, tingling, chest pain. Evaluated by EMS-Refusal to transport.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Malaise, Nausea
Clinical narrative: report vague symptoms of feeling unwell- little "dizzy, slight nausea" - "probably just anxiety" - onset at vaccination.  Reports c/o anxiety - takes anxiolytics PRn.  TX - mask removal - fresh air; emotional support symptoms abated with time.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Rash, Swelling, Tenderness
Clinical narrative: Pain, tenderness, muscle twitching, swelling, rash
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Lethargy, Myalgia, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Right leg pain-Medium, Systemic: Joint Pain-Mild, Additional Details: Patient states she is suffering from right leg muscle pain that started on 04/01/2021. She saw on the news about the Johnson & Johnson vaccine being paused so she is wondering if her pain is a result of her vaccine .She has an appointment to see her doctor tomorrow on 04/15/2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose normal, Electrocardiogram, Lymphocyte count increased, Malaise
Clinical narrative: 1 minutes post inoculation: Tachycardia with HR 160BPM & left arm swelling.  Pt states feeling "generally unwell."  Anxious mood. Meds administered during ED visit: Sodium Chloride 0.9% bolus 1L IV; famotidine 20mg IV; diphenhydramine 50mg IV During ED visit VS: BP 123/76, Temp 98.2F oral, HR 84, RR 16, SpO2 100% on RA.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count decreased, Peripheral swelling, Tachycardia, White blood cell count decreased
Clinical narrative: 1 minutes post inoculation: Tachycardia with HR 160BPM & left arm swelling.  Pt states feeling "generally unwell."  Anxious mood. Meds administered during ED visit: Sodium Chloride 0.9% bolus 1L IV; famotidine 20mg IV; diphenhydramine 50mg IV During ED visit VS: BP 123/76, Temp 98.2F oral, HR 84, RR 16, SpO2 100% on RA.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Headache, Laboratory test
Clinical narrative: I have had headaches off and on for the past two weeks.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Severe, Additional Details: patients wife called to say that around 1 week after vaccine pt experienced vision issues.  dr say he had a blood clot in eye which lead to partial blindess in one eye.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient reported that she developed redness to the deltoid area of her right arm on 4/14/2021 where she received Moderna vaccine.  She came to office today to have nurse to check her arm.   The area is approximately 3 inches x 2 inches.  It is slightly red but not hot.   Advised cold compresses every 2 hours and observe area.  Advised to see PCP if increased redness, swelling, or fever.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood chloride decreased, Blood creatinine normal, Blood immunoglobulin A, Blood immunoglobulin G
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood iron decreased, Blood potassium increased, Blood sodium decreased, Blood urea normal
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein decreased, Haematocrit decreased, Haemoglobin decreased, Joint swelling, Oropharyngeal pain
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Platelet count normal, Protein total normal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, Stomatitis, Streptococcus test negative, Transferrin saturation decreased
Clinical narrative: ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.