chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody negative, Blood test, Blood thyroid stimulating hormone decreased, Condition aggravated
Clinical narrative: My hands shake--a symptom I've never had. Bloodwork on November 18 shows my TSH at .46, which indicates too much thyroid hormone. In February, my TSH was 1.54. The low TSH/high thyroid is a likely cause of my shaking. My doctor will adjust my dose at my appointment next week.  The vaccine may not be related to the rapid decrease in TSH. However, I've managed my thyroid disease for 24 years and my TSH is typically stable. It's certainly never decreased so quickly. That TSH result (.46) is also a record low for me.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test normal, Thyroid disorder, Thyroid hormones increased, Thyroxine free, Tremor
Clinical narrative: My hands shake--a symptom I've never had. Bloodwork on November 18 shows my TSH at .46, which indicates too much thyroid hormone. In February, my TSH was 1.54. The low TSH/high thyroid is a likely cause of my shaking. My doctor will adjust my dose at my appointment next week.  The vaccine may not be related to the rapid decrease in TSH. However, I've managed my thyroid disease for 24 years and my TSH is typically stable. It's certainly never decreased so quickly. That TSH result (.46) is also a record low for me.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tri-iodothyronine free, Vitamin B12 normal
Clinical narrative: My hands shake--a symptom I've never had. Bloodwork on November 18 shows my TSH at .46, which indicates too much thyroid hormone. In February, my TSH was 1.54. The low TSH/high thyroid is a likely cause of my shaking. My doctor will adjust my dose at my appointment next week.  The vaccine may not be related to the rapid decrease in TSH. However, I've managed my thyroid disease for 24 years and my TSH is typically stable. It's certainly never decreased so quickly. That TSH result (.46) is also a record low for me.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: At the close of business on 11/23, a vial of moderna bivalent booster was left on the counter instead of disposed of in the sharps container. In the morning on 11/25, upon administering my first shot of the day I grabbed a new vial and put it on the counter. When I went to draw up the vaccine, I grabbed what I thought was the new vial and drew the vaccine then gave it to my technician to administer. Later in the day, I realized I had two vials on my counter and that I had drawn my first vaccine of the day from the old vial from 11/23.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Eye swelling, Eyelid margin crusting, Pruritus, Rash
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 11/21/2022 at about 1 PM. At about 4 AM on 11/22/2022, I woke up with hives on my lower abdomen. I then started itching on the upper right side of my chest. When I got up, I noticed a rash in that area, as well. The rash then spread throughout the day on both of my hips, both of my thighs, both of my flanks, my entire right arm. Later in the evening, I felt my scalp and the back of my neck itch, and I began scratching those areas. I took ZYRTEC that day, followed by BENADRYL. I didn't really have any results from the medicines. On the morning of 11/23/2022, I woke up and saw welts on my neck. Hives then appeared on my face later in morning, with my right eye becoming swollen and crusted over. The areas where the rash has appeared are mildly tender to the touch at times. I had a telehealth appointment with a doctor on 11/23/2022. I was prescribed steroids and ATARAX. The doctor also told me to continue taking ZYRTEC and BENADRYL. I began taking the steroids on 11/24/2022. I felt better most of the day afterwards. However, I did break out a little on my right arm, left flank, and left axillary area, and I had itching in those areas. I also had a breakout of itchy, burning hives on my face and neck that evening, mainly on the right lower mandible and the right posterior neck. I took BENADRYL and ZYRTEC that night. I woke up the morning of 11/25/2022, and the hives on the right lower jaw, right posterior neck, and right arm are worse; they feel like they are on fire and they look like welts. I also noticed new rashes on both legs and thighs, but they are not as severe as the ones that appeared earlier on other parts of my body. I took BENADRYL, ZYRTEC, and the morning dose of steroids. I have not yet taken the ATARAX, as it makes me sleepy. I also put on a topical steroid and topical BENADRYL cream. I have also applied ice to the rashes. None of these things have really helped. I have also taken PEPCID in the hope that it will bring some relief during this phone conversation, but I have yet to see the outcome. I have begun to see improvements in the areas of breakouts, but I am now seeing new breakouts in different areas as those improve. I am scheduled to see an allergist on 12/5/2022 if these symptoms do not improve.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tenderness, Urticaria
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 11/21/2022 at about 1 PM. At about 4 AM on 11/22/2022, I woke up with hives on my lower abdomen. I then started itching on the upper right side of my chest. When I got up, I noticed a rash in that area, as well. The rash then spread throughout the day on both of my hips, both of my thighs, both of my flanks, my entire right arm. Later in the evening, I felt my scalp and the back of my neck itch, and I began scratching those areas. I took ZYRTEC that day, followed by BENADRYL. I didn't really have any results from the medicines. On the morning of 11/23/2022, I woke up and saw welts on my neck. Hives then appeared on my face later in morning, with my right eye becoming swollen and crusted over. The areas where the rash has appeared are mildly tender to the touch at times. I had a telehealth appointment with a doctor on 11/23/2022. I was prescribed steroids and ATARAX. The doctor also told me to continue taking ZYRTEC and BENADRYL. I began taking the steroids on 11/24/2022. I felt better most of the day afterwards. However, I did break out a little on my right arm, left flank, and left axillary area, and I had itching in those areas. I also had a breakout of itchy, burning hives on my face and neck that evening, mainly on the right lower mandible and the right posterior neck. I took BENADRYL and ZYRTEC that night. I woke up the morning of 11/25/2022, and the hives on the right lower jaw, right posterior neck, and right arm are worse; they feel like they are on fire and they look like welts. I also noticed new rashes on both legs and thighs, but they are not as severe as the ones that appeared earlier on other parts of my body. I took BENADRYL, ZYRTEC, and the morning dose of steroids. I have not yet taken the ATARAX, as it makes me sleepy. I also put on a topical steroid and topical BENADRYL cream. I have also applied ice to the rashes. None of these things have really helped. I have also taken PEPCID in the hope that it will bring some relief during this phone conversation, but I have yet to see the outcome. I have begun to see improvements in the areas of breakouts, but I am now seeing new breakouts in different areas as those improve. I am scheduled to see an allergist on 12/5/2022 if these symptoms do not improve.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, Body temperature increased, Dizziness, Drooling
Clinical narrative: Within 30 minutes dizzy, faint and weak.  Within 45 minutes numb nose to numb cheeks to numb face to numb lips to numb mouth to numb throat. Difficulty swallowing and drooling noted. Halted with 25 mg Benadryl liquid oral dose. 24 hours after vaccine noted body aches, muscle and joint soreness. Low grade fever 99.8 p.o.  36 hours after temp climbing- peaked at 102 p.o. 48 hours later.  All s/s resolves in 72 hours
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Myalgia, Pain
Clinical narrative: Within 30 minutes dizzy, faint and weak.  Within 45 minutes numb nose to numb cheeks to numb face to numb lips to numb mouth to numb throat. Difficulty swallowing and drooling noted. Halted with 25 mg Benadryl liquid oral dose. 24 hours after vaccine noted body aches, muscle and joint soreness. Low grade fever 99.8 p.o.  36 hours after temp climbing- peaked at 102 p.o. 48 hours later.  All s/s resolves in 72 hours
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: Within 30 minutes dizzy, faint and weak.  Within 45 minutes numb nose to numb cheeks to numb face to numb lips to numb mouth to numb throat. Difficulty swallowing and drooling noted. Halted with 25 mg Benadryl liquid oral dose. 24 hours after vaccine noted body aches, muscle and joint soreness. Low grade fever 99.8 p.o.  36 hours after temp climbing- peaked at 102 p.o. 48 hours later.  All s/s resolves in 72 hours
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Photopsia
Clinical narrative: Shooting light in right eye vertical and lateral light shines.
Sex: U
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: scalp tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of scalp tenderness in a 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 scalp tenderness. On an unknown date, the outcome of the scalp tenderness was unknown.   It was unknown if the reporter considered the scalp tenderness to be related to Shingrix.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient wanted to ask if Shingrix vaccine could cause scalp tenderness. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Headache, Pyrexia
Clinical narrative: difficulties breathing; terrible headache; fever; This case was reported by a consumer and described the occurrence of difficulty breathing in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7LH5G, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event (had several flu shots in the past and never experienced anything like this.).   On 15th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th November 2022, immediately after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced difficulty breathing. In November 2022, the patient experienced headache and fever. On an unknown date, the outcome of the difficulty breathing was recovering/resolving and the outcome of the headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing, headache and fever to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: The case was reported by the patient's husband. The patient was provided the following flu vaccine at last evening Flulaval Influenza Vaccine. Immediately after receiving this vaccination she was walking out of the health center and began experiencing difficulties breathing.  She returned and the staff immediately took her vitals and continued to watch her.  After a short time she began to feel better. On the day of reporting the patient she awoke (morning) with a terrible headache and a fever.  She was still experiencing the headaches and fever this afternoon and was in contact with her doctor. The reporter said provide information with regarding this vaccine and any anticipated side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Body aches; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were unknown.   It was unknown if the reporter considered the chills, general body pain and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had second shingles shot your brand and had chills, body aches all over and slight fever. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number 5Y9N9, expiry date unknown) for prophylaxis.   Concomitant products included PEDIARIX and HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX).   On 11th October 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171025   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots on skin after receiving Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: This was 1 of 19 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number EK5Y2, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR) for prophylaxis.   On 8th June 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On an unknown date, the patient received PREVENAR. On an unknown date, less than 3 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171039, US2022AMR171042   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots that have been noted on patient's legs after receiving Pediarix in the right thigh and Hiberix. The reporter consented to follow up. Additional supportive information: It was unknown if the reporter considered the skin discoloration to be related to Prevenar, For tolerance to the 2nd and 3rd dose refer case US2022AMR171039 and US2022AMR171042. This was 1 of 19 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Skin discolouration
Clinical narrative: Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   On 19th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 21st October 2022, 63 days after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving Pediarix, Hiberix The reporter was consented to follow up. Additional supportive information: The patient received 2nd dose of Pediarix (batch number T5425) and Hiberix ( 5Y9N9) on 21st October 2022 This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149560: US-GSK-US2022AMR149561:
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2 doses of the liquid adjuvant only given at one time; 2 doses of the liquid adjuvant only given at one time; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 9K2MA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: the patient received 2 doses of liquid adjuvant and no lyophilized antigen.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix given without mixing the vaccine; Shingrix given without mixing the vaccine; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 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 Information: GSK Receipt Date : 17-NOV-2022 Reporter's Comment:  The reporter did not have patient's initials, gender and date of birth. the reporter stated that Shingrix was given without mixing the vaccine to two different patients. Only the adjuvant part was received by patient. The reporter consented to follow up.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR172096:Same reporter. Patient 2.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix given without mixing the vaccine; Shingrix given without mixing the vaccine; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 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 Information: GSK Receipt Date : 17-NOV-2022 Reporter's Comment:  The reporter did not have patient's initials, gender and date of birth. the reporter stated that Shingrix was given without mixing the vaccine to two different patients. Only the adjuvant part was received by patient. The reporter consented to follow up.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR172088:Same reporter. Patient 1
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: arm is red; arm is swollen; the pain in arm; headache; aches/pain; chills; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm, headache, pain and chills. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were not recovered/not resolved and the outcome of the headache, pain and chills were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm, headache, pain and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments:  The patient received her dose of Shingrix and had experienced chills, aches, headaches, pain, and her arm was red and swollen.  The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm is red; arm is swollen; the pain in arm; headache; aches/pain; chills; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm, headache, pain and chills. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were not recovered/not resolved and the outcome of the headache, pain and chills were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm, headache, pain and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments:  The patient received her dose of Shingrix and had experienced chills, aches, headaches, pain, and her arm was red and swollen.  The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 year old was given Infanrix instead of Boostrix; 9 year old was given Infanrix instead of Boostrix; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: GSK receipt date: 15-NOV-2022 Reporter's comment: The reporter reported that 9 years old patient was given Infanrix instead of Boostrix.  No other information shared.  The reporter was consented to follow up. Additional Supportive Information: The patient received Infanrix instead of Boostrix at 9 years of age, which led Inappropriate age at vaccine administration and Wrong vaccine administered.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Unreconstituted dose adminsitered; Unreconstituted dose adminsitered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 23YJ7, expiry date 12th October 2023) for prophylaxis.   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, 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 Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an unreconstituted Shingrix second dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 20Sep2022, 2nd on 14Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number B97G2, expiry date 26th January 2024) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 14th November 2022, the patient received the 2nd dose of Shingrix. On 14th November 2022, 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: GSK receipt date: 15-Nov-2022 Reporter's comment: The pharmacist stated that the patient came in stated that she had not received the first dose of Shingrix and a dose was administered. When the pharmacist checked the patient had received 1st dose and 2nd dose one day before reporting date. The reporter consented to follow-up via postal. Additional supportive information:  The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, never got the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years back).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The pharmacist reported that the patient never got the 2nd dose. No other information was available. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 01Mar2022, 2nd dose vaccine hadn't been administered at the moment of the call; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 1st March 2022).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 15-Nov-2022 Reporter's comment: From what the health care professional told the patient that the vaccine had not been administered at the moment of the call.  The reporter wanted information on how to proceed since second dose was not administered on time. The health care professional wanted to remain anonymous and wanted to remain anonymous, did not have consent to follow-up and dropped the call before it could be transferred.  The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.5
Sex: F
Vaccine: RV1, RV1
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 3rd dose administered; Rotarix administered to a 6-month-old; 1st dose 24 Jun 2022, 2nd dose on 30 Aug 2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 24th June 2022).   On 1st November 2022, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 30th August 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 30th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced drug dose administration interval too long. On 1st November 2022, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too long, extra dose administered and inappropriate age at vaccine administration were 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: GSK receipt date: 15-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Rotarix later than the recommended interval, which led to lengthening of vaccine schedule. The patient received 3rd dose of Rotarix at inappropriate age, which led to extra dose administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 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 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 Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received only the adjuvant AS01B of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: Within moments of the injection, patient lost consciousness. Left sitting with no support, she fell from table and started convulsions on the floor.
Age: 52.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: On-Call Doctor was contacted to receive immediate care instructions after vaccinator discovered second dose of bivalent pfizer booster provided to the patient. Per MD no adverse effects to be expected per CDC guidelines. At the time of administration the patient did not have any side effects, symptoms, signs that indicated adverse reaction.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Blood thyroid stimulating hormone decreased, Hyperthyroidism, Thyroxine increased, Tri-iodothyronine increased
Clinical narrative: hyperthyroidism, leading to development of graves disease
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site joint inflammation, Injection site pain, Insomnia, Magnetic resonance imaging abnormal, Muscle twitching
Clinical narrative: -Left shoulder pain after immunization  -Developed throbbing/aching pain in the left shoulder within 24 hours of immunization  -transient twitching in his left hand  -pain and stiffness in left arm interfering with sleep  -Aspirin and topical biofreeze have given slight relief
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: -Left shoulder pain after immunization  -Developed throbbing/aching pain in the left shoulder within 24 hours of immunization  -transient twitching in his left hand  -pain and stiffness in left arm interfering with sleep  -Aspirin and topical biofreeze have given slight relief
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No Adverse as of now, will monitor patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Limb discomfort, Mobility decreased, Pain
Clinical narrative: Not sure which Pfizer I got, but it was my updated second booster.  About 12 hours later, my body started to ache, I than had trouble catching my breath, and my legs were almost paralyzed.  I could barely turn over in bed.  I wanted to call emergency, but could not even move or think clearly.  Broke out into a sweat.  The next morning, I was able to make it to the chair, my legs felt very heavy.  Took until about Noon to start to feel better.  Lasted about 12-14 hours.  The first booster I got, my legs did same thing for about 6 hours, but to a much less extent than this time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Not sure which Pfizer I got, but it was my updated second booster.  About 12 hours later, my body started to ache, I than had trouble catching my breath, and my legs were almost paralyzed.  I could barely turn over in bed.  I wanted to call emergency, but could not even move or think clearly.  Broke out into a sweat.  The next morning, I was able to make it to the chair, my legs felt very heavy.  Took until about Noon to start to feel better.  Lasted about 12-14 hours.  The first booster I got, my legs did same thing for about 6 hours, but to a much less extent than this time.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chills, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated initial warmth and pain and swelling at injection site along with fever and chills. now 3 days out, there is pain with movement and touch under arm, along with burning on bottom of arm and top.  Pt may seek urgent care or call md if not resolved or worsening in am
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Pt stated initial warmth and pain and swelling at injection site along with fever and chills. now 3 days out, there is pain with movement and touch under arm, along with burning on bottom of arm and top.  Pt may seek urgent care or call md if not resolved or worsening in am
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received the regular Pfizer adult vaccine for the booster rather than the bivalent booster. No adverse effects was reported
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received the regular Pfizer adult vaccine for the booster rather than the bivalent booster. No adverse effects was reported
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received the regular Pfizer adult vaccine for the booster rather than the bivalent booster. No adverse effects was reported
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Mucosal disorder, Rash, Rash papular, Target skin lesion
Clinical narrative: Papular rash over the entire body, appears consistent with erythema multiforme with targetoid lesions. Specific lesions darker in the center. Mucosal involvement. Well appearing male.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear swelling, Feeling hot, Skin warm, Swelling face
Clinical narrative: Patient called after couple hours later since she left pharmacy, she feels swollen and warm cheek first then it goes to ear and neck area,
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Laboratory test, Type 1 diabetes mellitus
Clinical narrative: My son received his 2nd COVID vaccine shot on 12/1/2021. He was diagnosed with type 1 diabetes on 2/14/2022. After he was diagnosed, in retrospect, it became clear that his diabetic symptoms started during the last week of December (four weeks after his vaccine). There is no way to know for sure, but it seems highly possible that the COVID vaccine triggered his type 1 diabetes to express itself.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Urticaria
Clinical narrative: Broke out in hives. Have had hives off and on ever since. If takes Benadryl and Zyrtec daily then hives gone but come back if miss a dose. No other prior issues or problems with hives before. Been to dermatologist who said just continue Benadryl and Zyrtec for a few weeks.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomit, diarrhea.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: 2 Patients were scheduled for COVID-19 BOOSTER and Shingrix vaccines. Patient who was scheduled to receive COVID BOOSTER erroneously received Shingrix vaccine. Error was discovered when second patient was to receive Shingrix vaccination. The volume in the syringe was 0.3ml instead of 0.5ml. Another vial of Shingrix vaccine was reconstituted and administered to second patient.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site reaction, Myalgia, Pain, Pain in extremity
Clinical narrative: Typical arm pain as with other Covid shots, but on and off I am experiencing mild to moderate myalgias at site of injection despite that the shot was given 1 month ago. I have never experienced this with prior COVID vaccines (all moderna), or any other vaccines. It is quite a noticeable pain
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Blood test abnormal, Confusional state
Clinical narrative: 3 or 4 weeks after the  4/17/2021 shot I had difficulty walking I was in extreme pain in my knees and legs rendering me almost unable to walk. I used the walls to steady myself. I didn't know what was happening to me. I was clueless that the shots I was told it was safe to take, was doing this to my body. I was very tired and confused as I had never experienced anything such as this. By 6/2/2021 I saw Dr. who ordered bloodwork. Compared to the 3/6/21 Bloodwork the inflammation in my body doubled. Not long after I had to purchase a cane and order a wheelchair service at the airport. Over time I began noticing I couldn't taste, or smell and something is very wrong with my vocal cords.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Inflammation, Pain in extremity, Vocal cord disorder
Clinical narrative: 3 or 4 weeks after the  4/17/2021 shot I had difficulty walking I was in extreme pain in my knees and legs rendering me almost unable to walk. I used the walls to steady myself. I didn't know what was happening to me. I was clueless that the shots I was told it was safe to take, was doing this to my body. I was very tired and confused as I had never experienced anything such as this. By 6/2/2021 I saw Dr. who ordered bloodwork. Compared to the 3/6/21 Bloodwork the inflammation in my body doubled. Not long after I had to purchase a cane and order a wheelchair service at the airport. Over time I began noticing I couldn't taste, or smell and something is very wrong with my vocal cords.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: 3 or 4 weeks after the  4/17/2021 shot I had difficulty walking I was in extreme pain in my knees and legs rendering me almost unable to walk. I used the walls to steady myself. I didn't know what was happening to me. I was clueless that the shots I was told it was safe to take, was doing this to my body. I was very tired and confused as I had never experienced anything such as this. By 6/2/2021 I saw Dr. who ordered bloodwork. Compared to the 3/6/21 Bloodwork the inflammation in my body doubled. Not long after I had to purchase a cane and order a wheelchair service at the airport. Over time I began noticing I couldn't taste, or smell and something is very wrong with my vocal cords.