chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: nausea; significant body aches / pain; fatigue; headache; chills; injection site redness; swelling at injection site; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included liver transplant (in 2002), herpes zoster (Chronic outbreaks 8 times) and post herpetic neuralgia (8  episodes). Previously administered products included Acetaminophen. Concurrent medical conditions included immunocompromised (since 2002).   On 25th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a week after receiving Shingrix, the patient experienced nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient often respond to other injections, as well - and were alleviated by acetaminophen. The patient had history of liver transplantation and daily immunosuppression since then. The patient had chronic herpes zoster (HZ) and post-herpetic neuralgia, at least 8 episodes before receiving Shingrix. It was reported that the patient never consulted a medical professional regarding the side effects, as after 48 hours passed, the patient was fine. The patient did not receive treatment for the side effects experienced after having the Shingrix vaccines. For tolerance of 2nd dose of Shignrix, refer case US2020080780.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020080780:same patient
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain
Clinical narrative: nausea; significant body aches / pain; fatigue; headache; chills; injection site redness; swelling at injection site; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included liver transplant (in 2002), herpes zoster (Chronic outbreaks 8 times) and post herpetic neuralgia (8  episodes). Previously administered products included Acetaminophen. Concurrent medical conditions included immunocompromised (since 2002).   On 25th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a week after receiving Shingrix, the patient experienced nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the nausea, general body pain, fatigue, headache, chills, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient often respond to other injections, as well - and were alleviated by acetaminophen. The patient had history of liver transplantation and daily immunosuppression since then. The patient had chronic herpes zoster (HZ) and post-herpetic neuralgia, at least 8 episodes before receiving Shingrix. It was reported that the patient never consulted a medical professional regarding the side effects, as after 48 hours passed, the patient was fine. The patient did not receive treatment for the side effects experienced after having the Shingrix vaccines. For tolerance of 2nd dose of Shignrix, refer case US2020080780.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020080780:same patient
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 11-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 10-DEC-2019.  This case is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-2006USA005345: US-009507513-2006USA005344: US-009507513-2006USA005346:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; On 1/3/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant, referring to a 7-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, and previous drug reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported; lot number S006018 has been verified to be a valid lot number, expiration date reported and validated as 27-FEB-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported).     The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature of 15 degrees Fahrenheit (F) to 46 F (36.86 F) during a time frame of 9 hours and 49 minutes. In addition, previous temperature excursion of 15 F to 46 F (19.13F) during a time frame of 1 hour and 30 minutes. No data logger was involved. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; The 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. Information regarding the patient's pertinent medical history, concomitant medication, and drug reactions or allergies was not provided.   On 01-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number S035108, which has been verified to be valid, expiration date reported and validated as 03-MAY-2021) (dosage regimen, route of administration and anatomical location were not reported) as prophylaxis (product storage error). The sterile diluent (MERCK STERILE DILUENT) concomitantly used for reconstitution of the vaccine was properly stored.   The vaccine was exposed to a temperature of 7.9 degrees Fahrenheit (F) for 1 hour and 8 minutes as recorded by the data logger. There were no previous temperature excursions. The patient experienced no symptoms.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional Adverse effects reported; her 1st dose of MMR II vaccine was administered into her deltoid muscle; This spontaneous report as received from a female patient of unknown age, reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 10-MAY-2020, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status unknown), intramuscularly (instead subcutaneously), the frequency was reports as 2 shots (formulation, dose, lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; The nurse is reporting the patient was inadvertently administered a dose of RECOMBIVAX, on 6/10/2020, that had been improperly stored; Information has been received from a registered nurse regarding a male patient of unknown age. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 10-JUN-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) injection, for prophylaxis, lot number R028384 with expiration date in 08-JUN-2021 (route of administration, strength, frequency and anatomical location were not reported).  The hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was stored at a temperature of 10 degrees Celsius (°C) for the time frame of 7 hours and 10 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Poor quality product administered, Product quality issue
Clinical narrative: Considerable amount of bubbles in the serum; Considerable amount of bubbles in the serum; Considerable amount of bubbles in the serum; This spontaneous report was received from a health care worker referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2020 (reported as yesterday), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, batch/lot# and expiry date were not provided) for prophylaxis. On the same day, it was reported that there were considerable amount of bubbles in the serum and while tried to extract the plunger came right out of the syringe. It was not specified if this dose was administered (circumstance or information capable of leading to medication error, poor quality product administered and product quality issue). 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.; 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
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 5-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 09-DEC-2019.  This case is one of 4 cases 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.  deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1912USA004231: US-009507513-2006USA005346: US-009507513-2006USA005345:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 13-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 11-DEC-2019.  This case is one of 4 cases 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1912USA004231: US-009507513-2006USA005344: US-009507513-2006USA005346:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received an unknown number of doses of GARDASIL-9 following a temperature excursion; Information has been received from a medical assistant regarding an unknown number of patients of unknown age and gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number R029515 with expiration date in 08-JUL-2021 (strength, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a lowest temperature range below 36 degrees Fahrenheit (°F)/ 2°F (34.3F)  (multiple excursions) for the time frame of 13 days, 21 hours and 45 minutes. It was unknown if any previous temperature excursion had occurred and the digital data logger was involved.  No adverse effects were reported in any patients.  This case is non-valid due to lack of patient identifiers.  As of 12-JUN-2020, the medical assistant provided the patient's identifiers for the patients that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that underwent a temperature excursion.  The patient was a 11-years-old female patient, that received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 12-DEC-2019.  This case is one of 4 cases 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2006USA005345: US-009507513-1912USA004231: US-009507513-2006USA005344:
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever 101.3 F and Swelling and redness on ears and bridge of nose
Sex: F
Vaccine: HEP, MMR
Symptoms: Breast cancer female, Hepatitis B surface antibody negative, Measles antibody negative
Clinical narrative: Breast cancer; no antibodies no titer for measles/still showed no antibodies resulting from the vaccine; negative titres for hepatitis B,; despite the fact she bad received the hepatitis B vaccine series in the past./have no antibodies no titer for measles even though she received a dose in the past/still showed no antibodies resulting from the vaccine; This spontaneous report was received from physician via a company representative and refers to a 59-year-old female patient.  No information regarding the patient's pertinent medical history or drug reactions was provided. On an unknown date, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) reconstituted with sterile diluent for prophylaxis. On an unknown date, the patient had survived breast cancer. On an unknown date, the patient was found to have no antibodies no titer for measles event though she received a dose in the past. On unknown dates, the physician administered a second and a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) reconstituted with sterile diluent and the patient still showed no antibodies resulting from the vaccine. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) manufacturer unknown 10/1.0 microgram/ ml, 1 ml (formulation, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. Additional testing also found her to have negative titers for hepatitis B, despite the fact she bad received the hepatitis B vaccine series. The action taken with the suspect therapies and the outcome of the events were not reported.  Causality assessment between both suspect vaccines and the events was not provided.  Upon internal review, the event of breast cancer was considered to be medically significant.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: INJECTION SITE REACTION. PT HAS SLIGHT REDNESS AND SWELLING AROUND INJECTION SITE. SAYS IT FEELS LIKE HER ENTIRE ARM IS "LUMPY". PT HAS NOT ICED AREA OR TAKEN ANY PAIN MEDICATION SO ADVISED PT TO DO SO. PT DOES NOT WANT TO CALL DOCTOR
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was 2 yrs old and adult vaccine given Tdap.  Pt has not had any issues with it. Parents were notified and are aware of situation. Poison control was contacted on same day for advise.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This case was reported by a consumer and described the occurrence of adverse reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient asked the information of the ingredients to review with physician before going to have the second injection. The patient experienced adverse reaction.
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: redness; aching; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient mentioned that she had received the flu vaccine in the past and had experienced redness and aching. that lasted for couple days.  No other details were provided. The reporter consented to follow up. This case has been linked with case US2020096472, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020096472:same patient
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: redness; aching; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient mentioned that she had received the flu vaccine in the past and had experienced redness and aching. that lasted for couple days.  No other details were provided. The reporter consented to follow up. This case has been linked with case US2020096472, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020096472:same patient
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2019, the patient received the 1st dose of Shingrix. On 26th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received his 1st dose of Shingrix and experienced arm pain. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: after the first dose of Shingrix developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and developed shingles The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: temp of 101.4 on 6/13/2020, larger than golf ball size lumps on BIL thighs in injection areas that were hard, painful, red, and itchy. Lumps resolved 6/16/20, but dark, discoloration remains. No fever since 6/14/2020.  See by physician (Dr.) on 6/16/2020 and doing much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: temp of 101.4 on 6/13/2020, larger than golf ball size lumps on BIL thighs in injection areas that were hard, painful, red, and itchy. Lumps resolved 6/16/20, but dark, discoloration remains. No fever since 6/14/2020.  See by physician (Dr.) on 6/16/2020 and doing much better.
Age: 58.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema
Clinical narrative: patient reported redness in arm. I believe patient reported to rph on duty on Saturday 6/13. pt claims she was going to urgent care. rph called patient on sunday 6/14 to follow up but patient did not seek medical care yet.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Fatigue, Headache, Nausea
Clinical narrative: started with sore arm within hours.  Became very painful to even move it.  Nausea that evening. Headache, fever 100.9 aching joints, fatigue. Unbelievable pain similar to frozen shoulder but in the entire arm.  Severe burning into wrist.  Lasting until today June 16, I was finally able to get up to type.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: started with sore arm within hours.  Became very painful to even move it.  Nausea that evening. Headache, fever 100.9 aching joints, fatigue. Unbelievable pain similar to frozen shoulder but in the entire arm.  Severe burning into wrist.  Lasting until today June 16, I was finally able to get up to type.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed 1 inch sized redness day after vaccination to right upper thigh and grew daily until contact office on 6/15/20 late afternoon. Office visit on 6/16/20 found to have red, swollen area to right upper thigh measuring 28 x 14 cm. Patient denies any pain, fever or other symptoms. Dx: Cellulitis  Tx: Keflex and Prednisone
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Discomfort, Injection site erythema, Injection site rash, Injection site warmth, Irritability
Clinical narrative: Within 1-2 hours after the vaccine was given on the left thigh, the patient developed a large red rash spreading down her left leg and up her hip as well to her waist. Mother states that she was very fussy and seemed to be uncomfortable. The rash was bright red, raised and warm to the touch. It took several days for the rash to finally go away with the help of benadryl.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Decreased appetite, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: after 1 week of the shot developed injection site redness,swollen and red with induration and mild tenderness ( 06/11/2020) with out vesicles or pustules. 06/12/2020 developed fever with Tmax 101.9F ,fever runs for 4 days .mom gave tylenol 06/14/2020 Developed erythematous macular  generalized rash  and five spots of typical umbilicated red rash with central vesicles with itching. right posterior back,right arm,right hand and right anterior chest , rash is itchy. decreased appetite  but not dehydrated
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: after 1 week of the shot developed injection site redness,swollen and red with induration and mild tenderness ( 06/11/2020) with out vesicles or pustules. 06/12/2020 developed fever with Tmax 101.9F ,fever runs for 4 days .mom gave tylenol 06/14/2020 Developed erythematous macular  generalized rash  and five spots of typical umbilicated red rash with central vesicles with itching. right posterior back,right arm,right hand and right anterior chest , rash is itchy. decreased appetite  but not dehydrated
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: after 1 week of the shot developed injection site redness,swollen and red with induration and mild tenderness ( 06/11/2020) with out vesicles or pustules. 06/12/2020 developed fever with Tmax 101.9F ,fever runs for 4 days .mom gave tylenol 06/14/2020 Developed erythematous macular  generalized rash  and five spots of typical umbilicated red rash with central vesicles with itching. right posterior back,right arm,right hand and right anterior chest , rash is itchy. decreased appetite  but not dehydrated
Age: 1.5
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Swelling, Swelling of eyelid, Urticaria
Clinical narrative: The reaction started out with slow with swollen raised marks (looked like mosquito bites) as I thought they were which was about 2:00 p.m. (6/9/2020) first noticed the marks on her legs then a huge one on her arm. Later that evening I gave her Benadryl the hives got worse so I continued giving the Benadryl as prescribed (4 to 6 hours). During this time the reaction was only getting worse. Thursday I gave them a call and told them about the break out I took her to the doctor on 6/12/2020. Once we had arrived to the doctor her Left eye was swollen shut she was covered in hives and very itchy.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; on 1/13/2020 a patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, historical drug, concurrent conditions, and previous drug reactions or allegies were not reported.     On 13-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S022913, which was verified to be valid, expiration date reported and validated on 19-JAN-2021 (strength, dose, vaccination scheme, anatomical location and route of administration were not provided), as prophylaxis (product storage error). The vaccine was reconstitued with a properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The administered dose, was exposed to a temperature between 15 degrees Fahrenheit (F) to 46 degrees F (36.86 F) during a time frame of 9 hours and 49 minutes. Furthermore, there was a previous temperature excursion of 15 degrees F to 46 degrees F (19.13 F) during a time frame of 1 hour and 30 minutes. There was no digital data logger involved. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA002261:
Age: 0.42
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; patient, five months of age, received PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to a 5-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 08-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021, 0.5 milliliter, once (route of administration was not reported) for prophylaxis. No additional adverse effects 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: S029542; expirationdate: 10-JUN-2021; 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: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient experienced no symptoms; patient was administered an expired dose of Pneumovax23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 10-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route as prophylaxis (concentration, number of dose and vaccination scheme frequency were not reported; reported lot number R033080 and expiration date 06-JUN-2020)0 (expired product administered). The patient did not experience symptoms (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R033080; expirationdate: 06-JUN-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: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever / temperature of 104 F; This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female 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 6 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and fever onset rising to a temperature which lasted for 36 hours.  The patient went to Emergency room to get tested for COVID but was negative for COVID and sent home.
Sex: F
Vaccine: RV1
Symptoms: Accidental exposure to product, Exposure via skin contact, Flushing
Clinical narrative: accidentally had a skin exposure to Rotarix vaccine; exposure via skin contact; flushed skin; This case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a female patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix at an unknown dose. On an unknown date, unknown after receiving Rotarix, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asking for guidance regarding an administrator that accidentally had a skin exposure to Rotarix vaccine, which led to occupational exposure while administering product and exposure via skin contact.  The reporter consented to follow up. Any other details from vaccine or person who was accidentally exposed were provided.   Follow up information received from other helath professional on 11th June 2020: The patient demographic details were updated. The reporter stated that, after vaccination, the patienthad flushed skin which was washed with soap. The reporter reported that. the inadvertent exposure to vaccine was recovered. It was unknown, if the reporter consedered the flushing was related to Rotarix.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for pneumonia vaccine.  The patient's medical history and concomitant medications were not reported. The reporter reported for his late wife was convinced by her doctor to take Prevnar 13. Prevnar 13 was administered to his late wife a week or so before she passed away. She passed away within two weeks of pneumonia. Prevnar 13 obviously did not work and that colors his assessment of the drug.  The patient died of pneumonia on an unspecified date.  It was not reported if an autopsy was performed. Information regarding batch/lot number has been requested.; Reported Cause(s) of Death: Pneumonia
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received third dose Menactra in the left deltoid instead of Bexesero, no AE; Initial information received on 04-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 18 years old male patient who received 0.5 ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AB, expiry date:21-May-2021) via unknown route in the left deltoid on 04-Jun-2020 for prophylactic vaccination instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] not produced by Sanofi Pasteur (lot number and expiry date: not reported).  The patient past vaccination included two doses of Menactra when he was 11 year old and 16 year old. No concomitant medication received by the patient.  The patient medical history, medical treatment and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered.  It was reported that patient was given a third dose of Menactra in the left deltoid. This third dose was given by mistake instead of the intended menigococcal B vaccine, Bexsero.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MEN
Symptoms: Expired product administered
Clinical narrative: An expired vaccine of meningococcal was given to a patient which was expired 4 days/No AE; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a patient with unknown demographics who received an expired dose of MENINGOCOCCAL VACCINE [MENINGOCOCCAL VACCINE].  Medical history, medical treatment, vaccination and family history were not provided. List of concomitant medication not reported.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route and administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. It was reported that vaccine was expired 4 days.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Started with numbness and tingling from left forearm to fingers approximately 5 minutes post injection. Treatment includes ice pack to injection site and rest on left arm for 15 minutes. Instructed to replace ice pack in 20-30 minutes.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: PER MOTHERS VERBAL HISTORY, SHE  NOTICED A RED RASH BILATERALLY ON EACH THIGH AFTER VACCINE ADMINISTRATION ON 11 JUNE 2020. MOTHER MADE  AN APPT TO SEE PROVIDER ON 06/15/2020 FOR PATIENT TO BE EVALUATED BY PEDIATRIC NURSE PRACTITIONER.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaemia, Asthenia, Blood test, Chest X-ray, Computerised tomogram head
Clinical narrative: IZ given on Friday, Feb 7th. Wife reports she had to help pt. up from bed next day, Feb 8th as husband was very weak. That evening he had fallen in the bathroom and could not get up. Ambulance was called. Pt was discharged the same night, then wife reports he got better daily. ER diagnosis was anemia, fall at home, and weakness. Pt. did see his provider the following week. Provider stated pt was no longer anemic and muscle test was normal. Also HCP tended to agree with pt., that he had a reaction to the shingles vaccine. Pt refused second shingles vaccine and this was when I learned about the incident.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Fall, Incomplete course of vaccination, Urine analysis, Vaccination complication
Clinical narrative: IZ given on Friday, Feb 7th. Wife reports she had to help pt. up from bed next day, Feb 8th as husband was very weak. That evening he had fallen in the bathroom and could not get up. Ambulance was called. Pt was discharged the same night, then wife reports he got better daily. ER diagnosis was anemia, fall at home, and weakness. Pt. did see his provider the following week. Provider stated pt was no longer anemic and muscle test was normal. Also HCP tended to agree with pt., that he had a reaction to the shingles vaccine. Pt refused second shingles vaccine and this was when I learned about the incident.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Neck stiffness that started 3-5 min after vaccine. Improving, but saw Dr. today for muscle spasm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: same reaction patient had to this when first shot was given 7/11/16.  Arm got swollen by bicep and swelled to size of a baseball.  Was warm to touch and painful.  Muscle aches in arm that shot was given in.  24 hours and swelling has gone down some but not all.  the last vaccine in 2016, swelling was there for 3 days before gone.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: pt was given havrix 1st on 1/31/20 and 2nd dose 3/9/20. 2nd dose given too early. no adverse reaction for pt on either dose. recommendation by GSK to give Havrix vaccination 6 months from last dose therefore on or after 9/9/20
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever of 104 alternating tylenol &  motrin and some nausea.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient reported sore arm as well as fever and chills
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain radiating from injection site down to palm. Ice pack provided, encouraged rest and ibuprofen over the counter.  Condition unchanged.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient reported a local reaction around the injection site consisting of redness and swelling. The skin is warm to the touch. She reports itching but no pain in the area
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Mom reported that patient developed a rash over his right thigh yesterday evening after having received 2 vaccinations in the right thigh in clinic earlier.  She denied any itching, fever, or abnormal behavior.  Recommend diphenhydramine to help with resolution of the rash.  If it begins to spread or become worse please call and asked for an urgent care appointment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: 6/15/2020 In the am I noticed a small rash on my chin and neck - itchy.  The following day rash was on my forearms and cubital areas.