chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm bump at injection site; Red bump at injection site; Red bump at injection site; Prickly rash feeling on arm; Prickly rash feeling on arm; Bone pain; Achy feeling; Sore arm; Nerve pain; Not feeling great; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st November 2021, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad. On 4th November 2021, the outcome of the injection site warmth, injection site swelling, tingling skin, prickly heat and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the bone pain, pain, nerve pain and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the first dose of Shingrix vaccine and  within about 2 hours experienced warm red bump at injection site, prickly rash feeling on arm, bone pain, achy feeling, sore arm, nerve pain and just not felt great. The warm red bump, sore arm and prickly rash feeling had resolved on the day of reporting. The patient was still experiencing bone pain, achy feeling, nerve pain and not feeling great.   The patient asked if the second injection was required. The patient was referred to health care professional and advised Shingrix was a 2 dose vaccine.   No lot number or expiration date for vaccine was known. Patient declined to provide health care professional information. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Miliaria, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Warm bump at injection site; Red bump at injection site; Red bump at injection site; Prickly rash feeling on arm; Prickly rash feeling on arm; Bone pain; Achy feeling; Sore arm; Nerve pain; Not feeling great; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st November 2021, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad. On 4th November 2021, the outcome of the injection site warmth, injection site swelling, tingling skin, prickly heat and pain in arm were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the bone pain, pain, nerve pain and feeling bad were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site erythema, tingling skin, prickly heat, bone pain, pain, pain in arm, nerve pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the first dose of Shingrix vaccine and  within about 2 hours experienced warm red bump at injection site, prickly rash feeling on arm, bone pain, achy feeling, sore arm, nerve pain and just not felt great. The warm red bump, sore arm and prickly rash feeling had resolved on the day of reporting. The patient was still experiencing bone pain, achy feeling, nerve pain and not feeling great.   The patient asked if the second injection was required. The patient was referred to health care professional and advised Shingrix was a 2 dose vaccine.   No lot number or expiration date for vaccine was known. Patient declined to provide health care professional information. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Headache, Injection site pain, Pain, Urticaria
Clinical narrative: Pain; Hives; Left arm was sore at the injection site; Headache; Developed a bruise; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female 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 injection site pain, headache, contusion, pain and hives. On an unknown date, the outcome of the injection site pain, headache, pain and hives were recovered/resolved and the outcome of the contusion was not recovered/not resolved.  It was unknown if the reporter considered the injection site pain, headache, contusion, pain and hives to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient reported that, she received a dose of the shingrix vaccine and she developed a headache, her left arm was sore at the injection site, she developed a bruise, pain, and hives, which were resolved with Benadryl. Her headache was resolved, the hives had resolved and the arm pain has resolved. The bruise was the only symptom that had not resolved. Patient was advised to speak to health care professional. No other information was reported. The reporter did not consented to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count abnormal, Platelet count decreased
Clinical narrative: Platelets being a lot lower now; This case was reported by a consumer via call center representative and described the occurrence of platelet count low in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 month after receiving Shingrix, the patient experienced platelet count low. On an unknown date, the outcome of the platelet count low was not recovered/not resolved.   It was unknown if the reporter considered the platelet count low to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix and stated a month later when her labs were drawn, the results came back abnormal and also mentioned her platelets being a lot lower now. Referred to health care professional. Phone number was provided. The reporter consented to follow-up.
Age: 0.08
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 weeks old received Menveo; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 6-week-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 7th October 2021, the patient received Menveo. On 7th October 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The 6 weeks old patient who received a dose of Menveo, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: administration of frozen vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The unknown number of patients had been receiving Shingrix vaccine doses that had a previous temperature excursion on which they were frozen, which led to incorrect storage of drug. No more information was available at the time of reporting. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of KINRIX to a  2 YO; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2154, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 2 years old patient received dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 07Sep2021, additional dose on 17Sep2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 20th January 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 17th September 2021, the patient received the 2nd dose of Shingrix. On 17th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: On 7th September 2021, the patient received 1st dose of Shingrix. The patient was administered with the first dose of Shingrix vaccine but the dose was not documented in system and an additional dose was administered at an interval shorter than the recommended, which led to shortening of vaccination schedule. The reporter stated that the patient was doing fine and had not had any issues. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 an unknown date, the patient received Shingrix. On an unknown date, unknown 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 reporter was the patient's wife.  The age at vaccination was not reported. She asked questions regarding Shingrix because she was thinking about getting it.  She stated that, the patient had Shingrix in the past and he only had a sore arm.  She spoke per content, sending PI, referred to her healthcare, MI phone number was given. Limited information was provided.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E40, expiry date 1st October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th November 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received an expired dose of Boostrix which led to expired vaccine used. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a dose, however she already got 2; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (the patient already got 2 shot of a Shingles vaccine).   On 5th November 2021, the patient received Shingrix (intramuscular) .5 ml. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional details were reported as follows: The niece stated that her aunt received a dose of Shingrix today (on the day of reporting) from her pharmacy. However, the aunt was concerned that she already got 2 shot of a Shingles vaccine.  The niece stated that aunt was unsure if her previous vaccines were the Shingrix or the zoster live vaccine, which led to extra dose administered. The patient was referred to health care professional for follow up and provided caller with medical information number to give to the patient's health care professional for further information.  The niece did not wish to give anymore demographics other than phone number and supplied all she knew in regards to the aunt's vaccine.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first vaccination September 1 2019, has not received second vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient's wife.  The age at the vaccination was not applicable. The till the time of reporting the patient did not receive second dose, which led to incomplete course of vaccination. Wife asked if Shingrix should be restarted or if boosters were necessary since he was late.  No demographics shared by the reporter and consent was not given for follow up. The reporter did not consent to follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: receive as the 2 dose only a half dose; 1 dose: 1/15/2020 and 2 dose: 3/5/2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th January 2020).   On 5th March 2021, the patient received the 2nd dose of Shingrix. On 5th March 2021, unknown after receiving Shingrix, the patient experienced underdose and drug dose administration interval too long. On an unknown date, the outcome of the underdose and drug dose administration interval too long were unknown.   Additional details were reported as follows: The pharmacist reported a patient claimed to receive as the 2 dose only a half dose of SHINGRIX later than the recommended interval, which led to underdose and lengthening of vaccination schedule. The patient reported this situation now.  While being on hold pharmacist hang up, tried to call but didn´t answered.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Inappropriate schedule of product administration
Clinical narrative: Felt some of the vaccine go down her arm; Not administered at time with second dose; Felt some of the vaccine go down her arm; Inadverdant exposure; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date more than 6 moths ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, drug dose administration interval too long, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, drug dose administration interval too long, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The case was reported by patient who was nurse. The age at vaccination was not reported The patient was late on the 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The nurse, stated when she received the 2nd dose, she felt some of the vaccine go down her arm, but the pharmacist who administered the vaccine does not recall this happening, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.  The health care professional was asking if they could go ahead and administer another dose (possibly a 3rd dose) or was this dose valid. The patient had not received another dose at the time of reporting. The reporter was consented to follow.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: got only half the vial of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 49NM5, expiry date 6th April 2023) for prophylaxis.   On 7th November 2021, the patient received the 1st dose of Shingrix. On 7th November 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient moved the arm while being vaccinated with first dose of Shingrix.. The reporter thought, the patient got only half the vial of the vaccine, which led to accidental underdose. The reporter did not feel comfortable providing patients initials.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix in October 2019 / wants to get second dose.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The registered nurse wanted to know how the patient should proceed with schedule if wants to get second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose. The reporter did not consent to follow-up. The reporter provided limited information, no demographic details from patient were provided, Lot number neither expiration date were provided since information was not available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix on 02Feb2018 / 2nd dose on 11Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd February 2018).   On 11th September 2021, the patient received the 2nd dose of Shingrix. On 11th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No symptoms reported.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: administered after frozen,  0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 7-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, FluLaval administered after frozen at temperature of minus 0.45 degree C, which led to incorrect product storage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230177:Same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was given a dose of Shingrix adjuvant only; was given a dose of Shingrix adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 4th November 2021, the patient received the 1st dose of Shingrix. On 4th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The practice manager reported that, the patient was given a dose of Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Administered after frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 11-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter given FluLaval after being frozen at minus 0.45C for 15 minutes, which led to incorrect product storage. The reporter consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230173:Same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: given FluLaval after being frozen; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: given after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 24R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter gave Pediarix after being frozen at minus 0.45 C for 15 minutes , which led to incorrect product storage. The reporter consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: given Pediarix after being frozen .; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given Pediarix after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter (master case)
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Product storage error
Clinical narrative: given FluLaval and Pediarix after being frozen; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number 24R9R, expiry date 14th May 2023) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given Pediarix, FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, no information on 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient inquired if she could receive the 2nd dose of the Shingrix vaccine if 1st dose received 2 years ago, which led to incomplete course of vaccination. The patient declined to provide patient demographic information. The patient did not consent to follow up. This case has been linked to US2021AMR231093, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231093:Same reporter
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Administered after frozen.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 24R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given Pediarix after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 9-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Dizziness, Dyspnoea, Malaise, Maternal exposure during pregnancy
Clinical narrative: COULD NOT SEE; MATERNAL EXPOSURE DURING PREGNANCY; COULD NOT BREATHE; DIZZINESS; FEELING UNWELL; MUSCLE PAIN; This solicited pregnancy report received from a consumer concerned a 38 year old female of unknown race and ethnicity. The patient was enrolled in a non-company sponsored study.  The patient's height, and weight were not reported. The patient's past medical history included: miscarriage (one), and concurrent conditions included: multigravida (four previous pregnancies, three resulting in a live baby).  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total was administered on 12-OCT-2021 for covid-19 immunisation. No concomitant medications were reported. The first day of the last menstrual period (LMP) was calculated to be 06-Mar-2021. The estimated delivery date (EDD) was reported to be 11-Dec-2021. Type of pregnancy was not reported. On 12-Oct-2021 (at the time of vaccination), patient was at gestational age of 31 weeks and three days. On 12-OCT-2021, the patient experienced maternal exposure during pregnancy, muscle pain, dizziness, was feeling unwell and could not see or breathe. All reported events led to emergency room and subsequently hospital admission. The patient received intravenous infusion and medical attention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not see, could not breathe, dizziness, feeling unwell, and muscle pain on 13-OCT-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and could not see, could not breathe, dizziness, feeling unwell, and muscle pain was related.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211118554-COVID-19 VACCINE AD26.COV2.S- Could not see, Could not breathe, Dizziness. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211118554-COVID-19 VACCINE AD26.COV2.S-Maternal exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211118554-COVID-19 VACCINE AD26.COV2.S- Feeling unwell, Muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.