chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Condition aggravated, Feeling hot, Joint swelling, Peripheral swelling
Clinical narrative: left knee was more swollen; right hand swollen; Left knee pain/ right elbow pain; aggreviating her immune response and worsening her rheumatoid arthritis/exacerbation of her arthritis symtoms; right hand, and left knee was more swollen and warm; This case was reported by a other health professional and described the occurrence of swelling of knees in a 23-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTP vaccine (received 7 DTP vaccines on unknown dates), DTap vaccine (received  DTap vaccines on unknown dates) and Tdap vaccine (received 1st dose in 2010). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 30th June 2020, the patient received the 2nd dose of Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth. On an unknown date, the outcome of the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth were unknown.   It was unknown if the reporter considered the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth to be related to Boostrix.  Additional details were reported as follows: The patient had a diagnosis of rheumatoid arthritis and was on Humira every 10 days. The patient did not know the name of the previous vaccines. The patient stated that she did not know the name of the 1st Tdap vaccine but the 2nd Tdap vaccine was Boostrix, which was 10 years after the 1st Tdap. The patient received the Boostrix vaccine in the left deltoid muscle.  The patient stated that the Boostrix aggravated her immune response and worsened her rheumatoid arthritis. She stated that within one day, after vaccination, she started to experience exacerbation of her arthritis symptoms in her left knee pain, right elbow pain, right hand, and left knee was more swollen and warm. This case is linked to case US2020118908, reported for same atient.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rheumatoid arthritis
Clinical narrative: left knee was more swollen; right hand swollen; Left knee pain/ right elbow pain; aggreviating her immune response and worsening her rheumatoid arthritis/exacerbation of her arthritis symtoms; right hand, and left knee was more swollen and warm; This case was reported by a other health professional and described the occurrence of swelling of knees in a 23-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTP vaccine (received 7 DTP vaccines on unknown dates), DTap vaccine (received  DTap vaccines on unknown dates) and Tdap vaccine (received 1st dose in 2010). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 30th June 2020, the patient received the 2nd dose of Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth. On an unknown date, the outcome of the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth were unknown.   It was unknown if the reporter considered the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth to be related to Boostrix.  Additional details were reported as follows: The patient had a diagnosis of rheumatoid arthritis and was on Humira every 10 days. The patient did not know the name of the previous vaccines. The patient stated that she did not know the name of the 1st Tdap vaccine but the 2nd Tdap vaccine was Boostrix, which was 10 years after the 1st Tdap. The patient received the Boostrix vaccine in the left deltoid muscle.  The patient stated that the Boostrix aggravated her immune response and worsened her rheumatoid arthritis. She stated that within one day, after vaccination, she started to experience exacerbation of her arthritis symptoms in her left knee pain, right elbow pain, right hand, and left knee was more swollen and warm. This case is linked to case US2020118908, reported for same atient.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Muscle ache spread from the arm where the shot was received throughout my body, I was very tired. Next morning dizziness and headache along with continued fatigue and body ache. Some shivering and chills while in the shower. It was all bad enough that I came home from work early and went to bed. By the following morning, I felt fine.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: Muscle ache spread from the arm where the shot was received throughout my body, I was very tired. Next morning dizziness and headache along with continued fatigue and body ache. Some shivering and chills while in the shower. It was all bad enough that I came home from work early and went to bed. By the following morning, I felt fine.
Age: 1.92
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects reported; a patient was administered there first dose of MMR II at 23 months of age on 5/28/2018 and the second dose was administered on 6/28/2019; This spontaneous report has been received from a nurse referring to a 36 months patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was unknown.  On 28-MAY-2018, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at 23 months, and the second dose was vaccinated on 28-JUN-2019 for prophylaxis (strength, dose, route, lot # and expiration date of both doses were not reported) (inappropriate schedule of vaccine administered).   The patient didn't experience adverse event (no adverse event). No additional information was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; An improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report has been received  from an office manager concerning a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, historical drugs and conditions were not reported.   On 30-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA)  subcutaneous injection, Lot # S030206 and expiration date 25-MAR-2021 for prophylaxis (strength,dose and patient route of administration were not provided). The office manager, who was in charge of vaccine storage,  stated that the vaccination took place with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD). No additional adverse effects were reported. The storage temperature was reported to be 22.3°F for a period of 4 hours and 25 minutes. A previous temperature excursion was reported with temperature at 8.6°F for 1 hour and 51 minutes. Informationwas reported via data logger.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of PEDVAXHIB following a temperature excursion; No other adverse effects were reported in the patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, 0.5 milliliter (ml) administered as prophylaxis (lot number T000886 which has been verified to be valid, expiration date reported and validated as 29-MAY-2022) (route of administration, vaccination scheme and anatomical site of injection were not reported). The administered dose of the vaccine experienced a temperature excursion of total time and highest temperature above 47 degrees Fahrenheit / 9 degrees Celsius (C) (8.8 C), during a time frame of 31 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No other adverse effects were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001492: US-009507513-2007USA001265: US-009507513-2007USA001399:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; on 9-JUN-2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 09-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) administered by subcutaneous route, as prophylaxis (lot number S031704 which has been verified to be valid, expiration date reported and validated as 06-APR-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported). The vaccine was reconstituted with properly store sterile diluent (DILUENT MERK) (lot number T001631 which has been verified to be valid, expiration date reported and validated as 11-JUN-2022). The administered dose of the vaccine experienced a temperature excursion of -13.3 degrees Celsius (C), during a time frame of 1 hour and 15 minutes, as recorded by a digital data logger. There were previous temperature excursion of -1.8 C, during a time frame of 4 hours and 27 minutes and of -13.4 C, during a time frame of 1 hour. The patient experienced no symptoms.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of PEDV AX HIB following a temperature excursion; No other adverse effects were reported in the patient; This spontaneous report was received from a medical assistant, referring to an unknown patient of age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 milliliter (ml) (vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T000886 which has been verified to be valid, expiration date reported and validated as 29-MAY-2022) as prophylaxis, following a temperature excursion (product storage error). On an unknown date, the vaccine experienced a highest temperature of above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (C) (8.8 C) for a time frame of 31 minutes, as recorded by data logger. No previous temperature excursion was reported. No other adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported.; Medical assistant reported patient received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.2 milliliters (ml) once, orally administered as prophylaxis (lot number S012679 which has been verified to be valid, expiration date reported as 17-JAN-2021, but upon internal validation established as 07-JAN-2021) (vaccination scheme was not reported). The administered dose of the vaccine experienced a temperature excursion of highest temperature above 47 degrees Fahrenheit (F) (47.2 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse effects were reported in the patient.
Age: 30.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The pharmacist reported that a 30 year old patient received a dose of PROQUAD; This spontaneous report was received from a pharmacist, via company representative, referring to a 30-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 02-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, one dose administered as prophylaxis (lot number S031703 which has been verified to be valid, expiration date reported and validated as 06-APR-2021) (dosage, route of administration, vaccination scheme and anatomical site of injection were not reported) (product administered to patient of inappropriate age).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 30-AUG-2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, he was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Age: 15.0
Sex: F
Vaccine: HIBV, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Passed out for 10 minutes; This spontaneous report was received from the patient's parent, who was a friend of the company representative, concerning a 15 year old female patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 09-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dosing, dose number in the series, frequency, route of administration, lot number and expiration date were not provided) and also with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). No laboratory diagnostics/studies were carried out and the patient did not seek medical attention. On the same date, the patient passed out for 10 minutes (loss of consciousness) while in the car as a passenger. The patient recovered from loss of consciousness on the same date. The causality assessment was not provided.        Upon internal review, loss of consciousness was determined to be a medically significant event.
Age: 37.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a pharmacy technician referring to a 37 years old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 08-JUL-2020, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose and route were unknown; lot # S007265, expiration date 07-JUL-2020) for prophylaxis (expired product administered). No additional adverse event. The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:  manufacturercountry:  devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified patientes were administered improperly stored doses of PROQUAD and VARIVAX; no patient experienced symptoms; This non-valid spontaneous report was received from a health care worker referring to an unspecified patients of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On an unspecified dates after 19-JUN-2020, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T003017 and expiration date 25-JUL-2021; lot # S027465 and expiration date 02-MAR-2021 have been verified to be valid lot numbers) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #  S031494 and expiration date 07-OCT-2021 has been verified to be a valid lot number) for prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and route and anatomical location of vaccination were not reported). The diluent used for administration of the doses was properly stored. No patients experienced symptoms.  There was no previous temperature excursion  This is a non-valid case due to a lack of patients' identifiers.
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Swelling to Face; Shortness of Breath; Initial Report Received on 03-Jun-2020.  Non-significant information received on 30-Jun-2020:  confirmation from the reporter that no additional information is or will be available.  A pharmacy technician reported that a 32 year-old female (race and ethnicity not rovided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed "swelling of the face and shortness of breath".  No relevant medical history was reported. The patient is allergic to penicillin and cephalosporin.   No relevant concomitant medications were reported.  On 28-May-2020, the patient received the first dose of HEPLISAV-B (Lot #933094, expiration date 17-Apr-2021, NDC # not reported) to the left deltoid. Concomitant vaccines administered include the second dose of Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) administered to the right deltoid on the same day.  The patient had previously received her first dose of Gardasil 9 on 01-Mar-2020 without event.   On 03-Jun-2020, 7 days after having been vaccinated with HEPLISAV-B, the patient called the pharmacy, stating that she had developed "swelling of the face and shortness of breath" on that day. The pharmacy staff directed the patient to seek medical care and to contact her Primary Care Physician.   At the time of the report, the outcome of the event was not reported.  Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: M
Vaccine: CHOL
Symptoms: Wrong technique in product usage process
Clinical narrative: consumed Vaxchora that was mixed with partial buffer component which was prepared by adding 50 ml of water to the remaining solution to obtain 100 ml again; This spontaneous case report (PVX2019-2534) was received from a nurse on 10-Oct-2019. It described a 37-year-old adult male consumer who "consumed Vaxchora that was mixed with partial buffer component which was prepared by adding 50 ml of water to the remaining solution to obtain 100 ml again" (PT: Wrong technique in product usage process), for cholera prophylaxis.  Case report: A nurse reported that while she was in the process of mixing Vaxchora for two consumer on 10-Oct-2019, she inadvertently tipped over the cup for one consumer that contained only 100 mL water and the buffer packet. She spilled about 50 mL of the mixture (buffer and water). The physician, advised her to add 50 mL of water to the remaining solution to obtain 100 mL again and to proceed with preparing the solution. The solution (with partial buffer component) was administered to the consumer that morning. The Nurse shared that the appearance of the solution given to the consumer was similar to that of the solution with the full buffer, but it did not effervesce as much as the full buffer solution.  Action taken with Vaxchora with respect to reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "consumed Vaxchora that was mixed with partial buffer component which was prepared by adding 50 ml of water to the remaining solution to obtain 100 ml again" (PT: Wrong technique in product usage process) was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "consumed Vaxchora that was mixed with partial buffer component which was prepared by adding 50 ml of water to the remaining solution to obtain 100 ml again" (PT: Wrong technique in product usage process) was considered as not applicable.
Sex: F
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GAVE VAXCHORA TO A 66-YEAR-OLD CONSUMER; This spontaneous case report (PVX2019-2555) was received from a pharmacist on 11-Oct-2019. It described a 66-year-old female consumer whose pharmacist "gave Vaxchora to a 66-year-old consumer" (PT: Product use issue). The consumer was receiving Vaxchora for an unknown indication.  Case report: A 66-year-old female consumer took Vaxchora three days ago.  Action taken with Vaxchora with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "gave Vaxchora to a 66-year-old consumer" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "gave Vaxchora to a 66-year-old consumer" was considered as not applicable.
Sex: F
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED VAXCHORA THAT WAS EXPIRED; This spontaneous case report (PVX2019-2745) was received from a nurse on 04-Nov-2019. Additional information was received on 06-Nov-2019. It described an adult female consumer who was in her mid-forties "administered Vaxchora that was expired" (PT: Expired product administered). The consumer was receiving Vaxchora (lot number: 700015 and expiry date: 31-Oct-2019) for an unknown indication.  Case report: The consumer administered Vaxchora on 01-Nov-2019 that was expired on 31-Oct-2019. It was reported that the consumer also received Japanese Encephalitis vaccine (inactivated Japanese Encephalitis virus protein) and MMR booster (measles, mumps, and rubella viruses) an unknown date.  The consumer had no medical history.  Past vaccination included typhoid vaccine and cholera vaccine, administered when she was in another country 3 years ago. The consumer stated that she travelled often.  Action taken with Vaxchora with respect to reported event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "administered Vaxchora that was expired" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "administered Vaxchora that was expired" was considered as not applicable.
Sex: M
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED VAXCHORA THAT WAS EXPIRED; PHARMACY STAFF WERE IN A HURRY AND GAVE EXPIRED VAXCHORA; This spontaneous case report (PVX2019-2893) was received from a pharmacist on 22-Nov-2019. It described an adult male consumer who was "administered expired Vaxchora" (PT: Expired product administered). It was reported that the "pharmacy staff were in a hurry and gave expired Vaxchora" (PT: Product dispensing error). The consumer received Vaxchora for an unknown indication.  Case report: The consumer was administered expired Vaxchora on 22-Nov-2019. It was reported that pharmacy intern were in a hurry and gave Vaxchora (lot# 7000015) that was expired in Oct 2019.  Action taken with Vaxchora with respect to the reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "administered expired Vaxchora" and  "pharmacy staff were in a hurry and gave expired Vaxchora" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "administered expired Vaxchora" and  "pharmacy staff were in a hurry and gave expired Vaxchora" was considered as not applicable.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: Slightly elevated temperature / Fever; Swelling about 2 &1/2 to 3 inches around the injection site; Soreness about 2 &1/2 to 3 inches around the injection site; Redness about 2 &1/2 to 3 inches around the injection site; Headache; Muscle pain; Aches; Chills; Tiredness; Fogginess; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immune system disorder.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm and had fever, swelling, soreness and redness about 2 &1/2 to 3 inches around the injection site, muscle pain, aches and chills. The patient also reported tiredness and fogginess. The patient did not had lot number or expiration date information to provide for either dose of Shingrix. For tolerances of 2nd dose, refer case US2020124819, reported by same reporter for the same patient. This case linked with US2020AMR125326 and US2020AMR125327, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR125326:Husband's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125327:Husband's case 1st dose US-GLAXOSMITHKLINE-US2020124819:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Slightly elevated temperature / Fever; Swelling about 2 &1/2 to 3 inches around the injection site; Soreness about 2 &1/2 to 3 inches around the injection site; Redness about 2 &1/2 to 3 inches around the injection site; Headache; Muscle pain; Aches; Chills; Tiredness; Fogginess; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immune system disorder.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm and had fever, swelling, soreness and redness about 2 &1/2 to 3 inches around the injection site, muscle pain, aches and chills. The patient also reported tiredness and fogginess. The patient did not had lot number or expiration date information to provide for either dose of Shingrix. For tolerances of 2nd dose, refer case US2020124819, reported by same reporter for the same patient. This case linked with US2020AMR125326 and US2020AMR125327, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR125326:Husband's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125327:Husband's case 1st dose US-GLAXOSMITHKLINE-US2020124819:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Injection site rash
Clinical narrative: site of injection rash; blister; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash and blister. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had site of injection rash over one month ago still a blister. The reporter agrees to follow up.
Sex: M
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site reaction. Bexsero was discontinued. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Physician Assistant reported that a patient was not completing the Bexsero vaccination series by refusing the 2nd dose due to a reaction to the 1st dose. The reporter stated that, she believed it was a injection site reaction. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: Started with body/muscle aches that were relatively mild.  By around 7pm, I started shivering which became uncontrollable.  I also became feverish.  The first temperature reading was 99.9 and rose to 101.9.   Called hotline and was told to take Tylenol.  The shivering subsided several hours later (around 2am) but I felt feverish for several hours more.  By around 8am the symptoms had mostly subsided and my temperature was back to normal.  Normally, I would not have been worried but with the COVID-19 pandemic I was concerned.   Ultimately, the episode resulted in nothing more than a lack of sleep for one night.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Significant sharp pain in surrounding area of injection site (temporary relief with ice packs and acetaminophen), slight headache, following morning fatigue and nausea upon awakening.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Malaise
Clinical narrative: injection site swelled; injection site swelled, got really hot; I felt sick for 3 week; Information has been received from a lawyer, which was split from a legal case regarding to a currently 67 years old female patient. The patient's current conditions, medical history and concomitant medications were not reported.  On an unknown date in August 2019, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced injection site pain and got really hot. The patient felt sick for 3 weeks. The outcome of all events was not provided. The causality between events and pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) was related.; Sender's Comments:  US-009507513-2003USA003895:
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Altered state of consciousness, Visual impairment
Clinical narrative: For 10 hours I kept feeling that I was going to pass out.  My vision would start going dark, so I would lay down quickly.
Age: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NONE PATIENT WAS NORMAL
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site mass
Clinical narrative: Large, hardened swollen lump at injection site, chills, fatigue, headache
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Large, hardened swollen lump at injection site, chills, fatigue, headache
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Body temperature increased, Dizziness, Headache
Clinical narrative: Onset of temp of 102.8 evening of vaccinations (no prior illness of vaccinations), headache, dizziness. Treatment - Tylenol and motrin, fluids, and rest
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Injection site pain, Insomnia
Clinical narrative: Several hours after became very tired, arm was very sore where the shot was given, had chills/freezing in bed and woke up every other hour, felt achy and neck hurt.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: Several hours after became very tired, arm was very sore where the shot was given, had chills/freezing in bed and woke up every other hour, felt achy and neck hurt.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Vomiting and chills began around 0300 on 07/14/20.  As of 07/15/20 at 1000, patient reports that she continues to have chills and body aches.  The injection site is red, hard, and warm to the touch per patient report.  She states that she vomited again this AM.  She denies fever; she has been checking her temperature at home.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting and chills began around 0300 on 07/14/20.  As of 07/15/20 at 1000, patient reports that she continues to have chills and body aches.  The injection site is red, hard, and warm to the touch per patient report.  She states that she vomited again this AM.  She denies fever; she has been checking her temperature at home.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Impaired work ability, Joint range of motion decreased, Ligament sprain, Vaccination site pain
Clinical narrative: Site of vaccination was sore x first few days.  Limited ROM started on June 22nd and continued into June 23rd.  Woken up by left shoulder pain on the night of June 23rd.  Went to the ER, where a "moderate sprain" of the shoulder was diagnosed.  Was given an injection of Toradol in the ER with some relief of pain.  Left arm was placed in a sling which helped with pain relief.   Continued to have limited ROM and pain of the left shoulder, and upper left arm with feeling of "big bruise" around upper left arm.  Was taking Advil every 4 hours and using ice to the shoulder every 2 hours.  ROM slowly returned.  Took off work the week of June 29th due to limited ROM. ROM returned on July 2nd or 3rd, but left shoulder is still sore.  Also, gets achiness in left elbow (started at the beginning of June 29th).  Had left elbow injury about 10 years ago. Came back to work on July 6th. Able to perform duties without problems. Following up with pcp on July 8th.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Calculus urinary, Colonoscopy, Condition aggravated, Gastrooesophageal reflux disease
Clinical narrative: Loss of bowel control with 1st Anhtrax shot 6 April 2003 leading up to Kidney pain, both kidneys stone attacks and passing. Lead to Lithotripsy in both kidneys with stones / pain remaining in both. Colonoscopy for IBS and internal continuous pain , Kidney Issues  - Still being seen by medical facility   IBS - Still being seen by Gastroenterology GURD - Seen by Primary Care Health Clinic by Dr I take an acid Reflux pill daily.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Irritable bowel syndrome, Lithotripsy, Renal colic, Renal disorder, Renal pain
Clinical narrative: Loss of bowel control with 1st Anhtrax shot 6 April 2003 leading up to Kidney pain, both kidneys stone attacks and passing. Lead to Lithotripsy in both kidneys with stones / pain remaining in both. Colonoscopy for IBS and internal continuous pain , Kidney Issues  - Still being seen by medical facility   IBS - Still being seen by Gastroenterology GURD - Seen by Primary Care Health Clinic by Dr I take an acid Reflux pill daily.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Urine analysis, X-ray
Clinical narrative: Loss of bowel control with 1st Anhtrax shot 6 April 2003 leading up to Kidney pain, both kidneys stone attacks and passing. Lead to Lithotripsy in both kidneys with stones / pain remaining in both. Colonoscopy for IBS and internal continuous pain , Kidney Issues  - Still being seen by medical facility   IBS - Still being seen by Gastroenterology GURD - Seen by Primary Care Health Clinic by Dr I take an acid Reflux pill daily.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling of body temperature change, Pain in extremity, Skin warm
Clinical narrative: Begining night of vaccine7/9/2020; arm warmth/sore, hot/cold spells, extreme tiredness. These symptoms lasted through 7/13/2020.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported.; a patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 29-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot # S001832, expiration date 12-MAY-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. No other adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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: RAB
Symptoms: Blood pressure increased, Hypertension, Incorrect dose administered, Product preparation issue, Wrong technique in product usage process
Clinical narrative: high blood pressure; HCP was reconstituting the Rabavert vaccine incorrectly and using the wrong size needle to reconstitute and administer; HCP was reconstituting the Rabavert vaccine incorrectly; using the wrong size needle to reconstitute and administer; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced blood pressure high, inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process. On an unknown date, the outcome of the blood pressure high, inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process were unknown.   It was unknown if the reporter considered the blood pressure high to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the high blood pressure but did not know if it started after receiving Rabavert injections or before.  The reporter reported that the HCP was reconstituting the Rabavert vaccine incorrectly and using the wrong size needle to reconstitute and administer, which led to preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process. The reporter refused to provide date of birth and did not want HCP contacted and was not able to provide specific information about these events and did not have lot numbers or expiration information. It was unknown if patient received Rabavert for pre or post exposure.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124275:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: pain to the left side and all the way down to the left ankle; Pain to Left Side; This case was reported by a pharmacist via call center representative and described the occurrence of pain ankle in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 8th July 2020, the patient received the 1st dose of Shingrix .5 ml. In July 2020, less than a week after receiving Shingrix, the patient experienced pain ankle and pain localized. On an unknown date, the outcome of the pain ankle and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the pain ankle and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and complained of pain to the left side and all the way down to the left ankle and the caller wanted to know if this pain was common.   Read from Shingrix PI in content and other content information on Shingrix.   The reporter did not consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash
Clinical narrative: pimply rash on the face; rash on the face; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2020, the patient received the 1st dose of Shingrix. On 8th July 2020, 2 days after receiving Shingrix, the patient experienced pimples and rash. On an unknown date, the outcome of the pimples and rash were not recovered/not resolved.   It was unknown if the reporter considered the pimples and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a pimply rash on the face. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020129042:
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting, fever
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Rash,warm to touch at injecion site
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Injection site erythema
Clinical narrative: Fever, 100.4 F; chills, body aches, headache, fatigue.  Pain, erythema, itching and swelling surrounding injection site.  Local reaction began at 4:30 PM, systemic reaction began at 6:00 PM.  Treated with APAP 1000 mg at 6:30 PM and Naproxyn 440 mg at 10:30 PM on 7/09/20.  Repeated Naproxen 440 mg at 10:00 AM 7/10/20.  Second dose of APAP 1000 mg at 10:00 PM 7/10/20.  Missed work on 7/10/20 .  Had Covid-19 test done 7/11/20, nasopharyngeal swab; result negative.  Symptoms resolved by 7/12/20 with slight lingering fatigue.  Returned to work 7/13/20.  Local reaction lasted until 7/15/20, getting milder every day
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Local reaction, Pain
Clinical narrative: Fever, 100.4 F; chills, body aches, headache, fatigue.  Pain, erythema, itching and swelling surrounding injection site.  Local reaction began at 4:30 PM, systemic reaction began at 6:00 PM.  Treated with APAP 1000 mg at 6:30 PM and Naproxyn 440 mg at 10:30 PM on 7/09/20.  Repeated Naproxen 440 mg at 10:00 AM 7/10/20.  Second dose of APAP 1000 mg at 10:00 PM 7/10/20.  Missed work on 7/10/20 .  Had Covid-19 test done 7/11/20, nasopharyngeal swab; result negative.  Symptoms resolved by 7/12/20 with slight lingering fatigue.  Returned to work 7/13/20.  Local reaction lasted until 7/15/20, getting milder every day
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever, 100.4 F; chills, body aches, headache, fatigue.  Pain, erythema, itching and swelling surrounding injection site.  Local reaction began at 4:30 PM, systemic reaction began at 6:00 PM.  Treated with APAP 1000 mg at 6:30 PM and Naproxyn 440 mg at 10:30 PM on 7/09/20.  Repeated Naproxen 440 mg at 10:00 AM 7/10/20.  Second dose of APAP 1000 mg at 10:00 PM 7/10/20.  Missed work on 7/10/20 .  Had Covid-19 test done 7/11/20, nasopharyngeal swab; result negative.  Symptoms resolved by 7/12/20 with slight lingering fatigue.  Returned to work 7/13/20.  Local reaction lasted until 7/15/20, getting milder every day