chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Customer received the Moderna bivalent booster instead of the primary dose. He came in asking for the most recent dose and since only Bivalent was available he said he wanted the booster thinking that if he got the booster then he would not need the primary. Upon enquiring for the primary vaccine record he said he did not have it in his possession. As a result the pharmacist assumed that he has had his primary doses and gave him the Bivalent booster. His physician asked him to get another dose for which he came to pharmacy and that is when this got discovered that he never got the primary dose. Pharmacist looked up a pharmacy location nearby which had the primary Moderna doses using vaccine finder and referred the customer to that location to get the second dose of the monovalent (primary series).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Superficial thrombophlebitis in lower left leg
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Electrocardiogram normal, Fluid retention, Induration, Peripheral swelling
Clinical narrative: Three days after second Moderna vaccine my right leg from the knee to the foot began to swell and got hard to the touch as tissue filling with water. I went to my pcp with no outcome prescribed a water pill it didn?t reduce swelling I went to my rheumatologist, dermatologist, heart doctor, podiatrist  and orthopedic with no results.  They all said that my system was compromised by the Moderna vaccine. Cardio doctor sent me for  DVT and EKG results was there was no blockage and the valves in the leg were functioning properly . Swelling subsided Dec 2021
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Feeling cold, Oropharyngeal pain
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/7/2022. On 12/22/2022, I began sneezing and having chills. On 12/23/2022, I took a home antigen test and got a positive result. I contacted my doctor, who prescribed me PAXLOVID. On 12/23/2022, I developed a sore throat and coughing. I had severe chills and couldn't get warm enough. On 12/26/2022, I felt better, because the chills were gone, and the sore throat was better. At the time of this writing, I still have a scratchy throat and little bit of chest congestion. I saw my doctor again on 1/6/2023, and I was advised to take prednisone for the scratchy throat and congestion. I am still expelling phlegm, but no signs of pneumonia or any other serious ailment were detected. I was also tested for strep, and the outcome was negative.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, Respiratory tract congestion, SARS-CoV-2 test positive, Sneezing, Streptococcus test negative
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/7/2022. On 12/22/2022, I began sneezing and having chills. On 12/23/2022, I took a home antigen test and got a positive result. I contacted my doctor, who prescribed me PAXLOVID. On 12/23/2022, I developed a sore throat and coughing. I had severe chills and couldn't get warm enough. On 12/26/2022, I felt better, because the chills were gone, and the sore throat was better. At the time of this writing, I still have a scratchy throat and little bit of chest congestion. I saw my doctor again on 1/6/2023, and I was advised to take prednisone for the scratchy throat and congestion. I am still expelling phlegm, but no signs of pneumonia or any other serious ailment were detected. I was also tested for strep, and the outcome was negative.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat irritation
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/7/2022. On 12/22/2022, I began sneezing and having chills. On 12/23/2022, I took a home antigen test and got a positive result. I contacted my doctor, who prescribed me PAXLOVID. On 12/23/2022, I developed a sore throat and coughing. I had severe chills and couldn't get warm enough. On 12/26/2022, I felt better, because the chills were gone, and the sore throat was better. At the time of this writing, I still have a scratchy throat and little bit of chest congestion. I saw my doctor again on 1/6/2023, and I was advised to take prednisone for the scratchy throat and congestion. I am still expelling phlegm, but no signs of pneumonia or any other serious ailment were detected. I was also tested for strep, and the outcome was negative.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Headache, Oropharyngeal pain
Clinical narrative: When I woke up in the morning I had a sore throat. I then developed a lot of post-nasal drip which in turn caused a cough, chills and fever 99.9 degrees after I had already taken TYLENOL. I slept all day the 20th and 21st and after taking, PAXLOVID I started to feel better. By Christmas Eve I was feeling a lot better. I then rebound on the 29th and 30th, I only had pounding throbbing headache and a little congestion and cough. I am still continuing to recover.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: When I woke up in the morning I had a sore throat. I then developed a lot of post-nasal drip which in turn caused a cough, chills and fever 99.9 degrees after I had already taken TYLENOL. I slept all day the 20th and 21st and after taking, PAXLOVID I started to feel better. By Christmas Eve I was feeling a lot better. I then rebound on the 29th and 30th, I only had pounding throbbing headache and a little congestion and cough. I am still continuing to recover.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection. Treated with bronchiodilator and expectorant.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a bivalent pfizer 5yr to 12 yr instead of a monovalent pfizer 5yr-11 yr for first dose in primary series
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Influenza A virus test positive, Influenza B virus test positive, Oropharyngeal pain
Clinical narrative: I had my vaccination on 07/07/2022. On 12/26/2022 I went to urgent care for runny nose and sore throat. I was diagnosed with type Flu A Flu B and COVID-19 positive. This was the second time I had COVID-19 as I was first diagnosed in 12/2020. I was prescribed PAXLOVID. I presently feel better as of 01/09/2023.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 07/07/2022. On 12/26/2022 I went to urgent care for runny nose and sore throat. I was diagnosed with type Flu A Flu B and COVID-19 positive. This was the second time I had COVID-19 as I was first diagnosed in 12/2020. I was prescribed PAXLOVID. I presently feel better as of 01/09/2023.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Lymphadenopathy, Neuralgia, Oral discomfort, Pain
Clinical narrative: Swollen glands in armpits, body aches. All the nerves in head and neck were burning, mouth and lips were on fire like a cold sore outbreak was about to happen.  Did not seek treatment beyond taking acetaminophen.  Day 3 was the worst, then gradually improved over 7 days.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a bivalent pfizer 5y to 12yr instead of a monovalent pfizer 5y-11yr for the first dose in a primary series.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient developed hives and lip swelling after PROQUAD; Patient developed hives and lip swelling after PROQUAD; This spontaneous report was received from a nurse and referred to a 5-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, lot #, expiry date anatomical location and route of administration were not provided) for prophylaxis.  On an unknown date, the patient developed hives and lip swelling after measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (urticaria; lip swelling). It was not sure when it happened.  Whether the patient had sought medical attention was unknown. No other issues or concerns noted.  At the time of reporting, the outcome of all events was resolved. The causal relationship between all events and suspect vaccine was not provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximately 76-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-OCT-2016, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster. The outcome of the event was not reported.   The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: no antibodies; This spontaneous report was received from a pharmacist and refers to a 40-year-old female. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On unknown date, the patient was vaccinated with an unspecified "MMR vaccine". On 5-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient "had titers done which showed she had no antibodies" (the event of antibody test negative). At the time of reporting, the outcome of the event was not reported.  The causal relationship between the event of antibody test negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; temperature excursion/ Temperature 19.47F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 01-DEC-2022, varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored with temperature excursion. The temperature was 19.47 Fahrenheit (F) for 50 minutes. The vaccines did not experience previous temperature excursion before. On 13-DEC-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) which experienced temperature excursion (0.5 ml, lot#: W018825, expiration date: 14-JUN-2024; strength, route of administration, and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) information was provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that aricella virus vaccine live (oka/merck) (VARIVAX) was under temperature excursion (TE) on at 8.42 Fahrenheit degree 1 hour 2 minutes. On 28-JUL-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot # U015847, expiration date: 19-MAY-2023, for prophylaxis (strength, dose, and route of administration were not provided) (product storage error). There was no additional adverse event (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: I had 2 shot series and I have shingles/ suspected vaccination failure; shingles in left eye; shingles in both hands and head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had twice, once as a child and once as an adult).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient's doctor told that patient would have the shingles.  The patient had the Shingrix vaccine, 2 shot series back in late 2022. The fast forward to now the patient had shingles affecting both hands, head, and left eye.  The doctor said that because of vaccine the patient should not had a full blown case.  The patient pray that doctor was right, this was no fun. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Swollen arm; Redness on her arm; Feel crappy; Headache; Chills; Exhaustion, fatigue; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of peripheral swelling (1st dose received in September 2022, refer case US2022AMR196013).   On 26th December 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR196013   Additional Information: GSK Receipt Date: 30-DEC-2022  Reporter's Comments: The patient got 2nd shot of Shingrix on Monday and still felt crappy.      She also experienced a swollen arm, redness on her arm, exhaustion, headache, chills and fatigue which had not yet resolved. The reporter asked how long the side effects of vaccine would last? The reporter had not given consent to follow up.; Sender's Comments:  US-GSK-US2022AMR196013:Same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vaccine positive rechallenge
Clinical narrative: Swollen arm; Redness on her arm; Feel crappy; Headache; Chills; Exhaustion, fatigue; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of peripheral swelling (1st dose received in September 2022, refer case US2022AMR196013).   On 26th December 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, feeling bad, headache, chills and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR196013   Additional Information: GSK Receipt Date: 30-DEC-2022  Reporter's Comments: The patient got 2nd shot of Shingrix on Monday and still felt crappy.      She also experienced a swollen arm, redness on her arm, exhaustion, headache, chills and fatigue which had not yet resolved. The reporter asked how long the side effects of vaccine would last? The reporter had not given consent to follow up.; Sender's Comments:  US-GSK-US2022AMR196013:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   On 28th December 2022, the patient received Engerix B. On 28th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt date: 30-Dec-2022. Reporter's Comment: The patient received expired dose of engerix B. The reporter consented to follow-up. Additional Supportive Information: The patient received expired dose which led to expired vaccine used.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Improperly reconstituted administration.; Improperly reconstituted administration.; 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 MMR (Priorix) for prophylaxis.   Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Priorix and Priorix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Priorix and Priorix Pre-Filled Syringe Device, 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.   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: 30-Dec-2022. Reporter's Comment: Reporter stated that Pharmacy technician calls today December 30th to report an improperly reconstituted administration of Priorix occur. HCP was asked about information of the patient and batch number, expiration date and vaccination date for the vaccine but information was declined, hcp stated she didn't have that info. The reporter consented to Follow-up via email. Additional supportive information: The patient received improperly reconstituted administration of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was due for IPV and DTaP vaccines, and was inadvertently administered a dose of Kinrix; 9 Months old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Vaxelis (1st dose received on an unknown date) and Vaxelis (2nd dose received on an unknown date).   On 30th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine 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: 03-JAN-2023 Reporter's Comments: The patient was due for IPV and DTaP vaccines and was inadvertently administered a dose of Kinrix. The nurse stated that she monitored the patient for an additional 15 minutes after the dose and no issues were noted. The reporter spoke with the patient's family on the day of reporting and the child (patient) was doing well. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently administered a dose of Kinrix instead of IPV and DTaP vaccines below the recommended age limit, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Havrix 1440 and Havrix 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: GSK Receipt Date: 03-JAN-2023 Reporter's comments: The nurse who was also the patient, had stated that, she had received the first dose of Havrix and was informed that the vaccine was expired.  The reporter had consented to follow-up via email. Additional supportive information: The patient had received an expired dose of Havrix vaccine, which had led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Engerix B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   On 30th December 2022, the patient received Engerix B. On 30th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The licensed practical nurse (LVN) reported that, the patient received an expired dose of Engerix B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered after a year; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date over a year ago).   On 3rd January 2023, the patient received the 2nd dose of Shingrix. On 3rd January 2023, 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 Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The pharmacist reported that 2nd dose of Shingrix was given over a year after the first dose (no date available). No other information was available. The reporter did not consent to follow up.  Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose was last year; This case was reported by a other health professional 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 (1st dose received in February 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: 04-JAN-2023 Reporter's Comments: The reporter enquired if he/she could repeat the Singrix dose as one of the patients received the first dose of the vaccine, so do they just give them one more dose or start over. The health care professional (HCP) disconnected the chat after asked for the contact information and before providing any additional information about the event. The reporter did not consent 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.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: 19 month old received an adult dose; 19 month old received an adult dose; received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-month-old female patient who received HAV (Havrix 1440 adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used 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: 04-JAN-2023 Reporter's Comments: The reporter stated that the patient received an expired dose of adult Hep A (Havrix) vaccine and it was given in a thigh, not sure what side.  The reporter did not consent to follow-up. Additional Supportive Information: On the day of reporting, a 19th month old patient received an expired dose of adult Hepatitis A (HAVRIX) vaccine, which led to overdose, adult product administered to child and expired vaccine used.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Near death experience
Clinical narrative: Almost died taking the flu shot; Took the flu shot while pregnant; This prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Flu vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Flu vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and vaccine exposure during pregnancy. The patient was treated with herbals nos (Herbs). On an unknown date, the outcome of the near death experience and vaccine exposure during pregnancy were unknown. The pregnancy was lost to follow up.   The reporter considered the near death experience to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient was almost died taking the flu shot while pregnant 18 years ago. The reporter stated that, If it were not herbs it were not right. This pregnancy case was considered as lost to follow up. The reporter thought that the event might had been related to the product/device.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID REBOUND; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned an elderly of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid rebound and tested covid positive again with return of mild symptoms (Dose number in series 2). Patient was treated with unspecified drug (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 14-DEC-2022 to 19-DEC-2022 for Covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid rebound was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: SEVERE CRAMPS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe cramps was not reported. This report was non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Blood test, Dermatitis atopic, Eosinophil count, Skin test
Clinical narrative: Atopic dermatitis to face and neck; This case was reported by a consumer and described the occurrence of atopic dermatitis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included desloratadine (Clarinex).   In October 2022, the patient received the 1st dose of Shingrix. On 31st October 2022, less than a month after receiving Shingrix, the patient experienced atopic dermatitis. The patient was treated with antihistamine, tacrolimus and dexamethasone (Dexamethasone Cream). On an unknown date, the outcome of the atopic dermatitis was not recovered/not resolved.   It was unknown if the reporter considered the atopic dermatitis to be related to Shingrix.     Additional Information: GSK Receipt date: 30-Dec-2022. Reporter's Comment: The patient self-reported this case. The patient saw a dermatologist and now and allergist. Treating with antihistamine and tacrolimus after treating with dexamethasone cream and antihistamines. Had blood work done for allergies and eosinophils and had skin tests done for allergies. The symptoms were treated.
Age: 0.58
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 1st dose of primary series with Moderna Covid-19 vaccine. At another practice, same patient received Pfizer Monovalent as 2nd dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose of primary series with Moderna Covid-19 vaccine. At another practice, same patient received Pfizer Monovalent as 2nd dose.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose of primary series with Moderna Covid-19 vaccine. At another practice, same patient received Pfizer Monovalent as 2nd dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose of primary series with Moderna Covid-19 vaccine. At another practice, same patient received Pfizer Monovalent as 2nd dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INTERCHANGE OF VACCINE PRODUCTS (1st dose of primary series with Moderna Covid-19 vaccine. At another practice, same patient received Pfizer Monovalent as 2nd dose.).    No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine for the first dose in the patients primary series).    No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID in September 2022 for 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (COVID in September 2022 for 3 days). At the time of the report, COVID-19 (COVID in September 2022 for 3 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter got COVID in Sep-2022 for 3 days and was negative and had mild symptoms.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: In SEP2022 she had COVID Disease; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (In SEP2022 she had COVID Disease) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (In SEP2022 she had COVID Disease). At the time of the report, COVID-19 (In SEP2022 she had COVID Disease) had resolved.            No concomitant medications were reported.  The patient states that, she received 2 primary doses and a booster of Moderna COVID-19 Vaccine, all prior to 31-Aug-2022. In Sep-2022, she had COVID Disease, and her doctor told her to wait until Dec-2022 to receive a booster.   No treatment medications were reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Pregnancy and Lupus erythematosus.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (The patient was pregnant and received two primary series Moderna COVID-19 vaccines) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The patient received two primary series mRNA-1273 vaccine COVID-19 vaccines. The patient had recently seen her doctor who advised the patient to receive "third mRNA-1273 Vaccine".
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number - 026A21A) on 24-Mar-2021, Moderna COVID-19 Vaccine (2nd dose, lot number -017B21A) on 23-Apr-2021, Moderna COVID-19 Vaccine (1st booster dose and lot number - 033F21A) on 16-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes, Hypertension, Hypertension, High cholesterol and Diabetic foot.    On 22-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine providrr called her to inform her that the vaccine that was adminstered to her was expired.2nd booster dose - 22Nov2022, lot number AR5186C, expiration date - 17Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The patient states that, she did not have any reaction after getting the 2nd booster dose.   No treatment medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 056M21A) for COVID-19 prophylaxis.         On 15-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient accidentally received an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant Medication use information was not provided by reporter.      It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  It was unknown that the patient had any chronic or long-standing health conditions.  It was reported that no prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2023: Follow up received that contains significant information includes updated patient details, updated reporter details, added medical history, updated suspect product details, event details and update narrative.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dysphonia, Nasal dryness, SARS-CoV-2 test positive
Clinical narrative: I had dry sinuses, hoarse voice, and cough. I tested positive for COVID-19. I saw a doctor and he prescribed me PAXLOVID 12/21/2022. I still have a cough.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Inflammation, Pruritus, Rash, Skin fissures
Clinical narrative: Inflammation in my face followed by extreme rash and itching  Emergency room visit on 12/26/22 resulting in subscription of Hydroxyzine HCL 25 MG which relieved itching, but resulted in extreme inflammation of my face.  Extreme swelling and cracked skin. Visit to dermatologist on January 3, 2023 resulting in subscription for Medrol Dose Pack.  Reduced inflammation to face, but rash and itching resumed.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: Inflammation in my face followed by extreme rash and itching  Emergency room visit on 12/26/22 resulting in subscription of Hydroxyzine HCL 25 MG which relieved itching, but resulted in extreme inflammation of my face.  Extreme swelling and cracked skin. Visit to dermatologist on January 3, 2023 resulting in subscription for Medrol Dose Pack.  Reduced inflammation to face, but rash and itching resumed.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bedridden, Cough, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: I was very tired and then started coughing really badly on Saturday. I had a sinus infection, but it was gone at that point and then my daughter insisted I test for COVID-19 when I started coughing. I had a slight fever and was coughing and was so tired. I ended up being bedridden for over a month. My doctor did give me a medication and cough syrup to help with the symptoms I was having. I did have my flu vaccine on the same date as my COVID-19 shot but I do not have the information for that shot.