chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first one hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: first one hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR043601   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by the patient via interactive digital media. The patient stated that first one hurt, but hopefully he/ she would not get shingles. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2023AMR043601, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR043601:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Vaccine positive rechallenge
Clinical narrative: miserable pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date, refer link case US2023AMR043599).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: miserable pain). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR043599   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by the patient via interactive digital media. The patient got the shots, first one hurt but second one was miserable pain.  But hopefully he/ she would not get shingles. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR043599:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Irritability, Pain
Clinical narrative: It was more irritating than painful; It was more irritating; Shingles from groin to neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles from groin to neck), pain (Verbatim: It was more irritating than painful) and irritability (Verbatim: It was more irritating). The outcome of the shingles was recovered/resolved (duration 6 months) and the outcome of the pain and irritability were recovered/resolved.   It was unknown if the reporter considered the shingles, pain and irritability to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain and irritability to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles, it was about a week after second shot.  The patient said shingles was off and on from groin to neck for 6 months and it was more irritating than painful. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: Shingles; Nerve pain down the arm; Blisters; Painful shot, intense pain; Came me the shot wrong, took her awhile to inject it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), nerve pain (Verbatim: Nerve pain down the arm), blister (Verbatim: Blisters), injection site pain (Verbatim: Painful shot, intense pain) and wrong technique in drug usage process (Verbatim: Came me the shot wrong, took her awhile to inject it). Shingles vaccine was discontinued. The outcome of the shingles, nerve pain, blister and injection site pain were not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, it's a two shot series and very painful shot, will not be getting the second shot.  The patient had shingles, it started with nerve pain down my arm for first couple days then throwing up, then blisters. The patient got shingles but 6 months later doctor said to get the shot got the first shot, will not get the second The patient  don't know if doctor came her/his the shot wrong but it was very intense pain when she did and it can handle sore arm patient use to pain but the shot was different. she probably did it wrong  The follow-up could not be possible as no contact details were available. The patient shot wrong, took doctor awhile to inject it, which led to wrong technique in drug usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: Shingles; Nerve pain down the arm; Blisters; Painful shot, intense pain; Came me the shot wrong, took her awhile to inject it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles), nerve pain (Verbatim: Nerve pain down the arm), blister (Verbatim: Blisters), injection site pain (Verbatim: Painful shot, intense pain) and wrong technique in drug usage process (Verbatim: Came me the shot wrong, took her awhile to inject it). Shingles vaccine was discontinued. The outcome of the shingles, nerve pain, blister and injection site pain were not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles, nerve pain, blister and injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, it's a two shot series and very painful shot, will not be getting the second shot.  The patient had shingles, it started with nerve pain down my arm for first couple days then throwing up, then blisters. The patient got shingles but 6 months later doctor said to get the shot got the first shot, will not get the second The patient  don't know if doctor came her/his the shot wrong but it was very intense pain when she did and it can handle sore arm patient use to pain but the shot was different. she probably did it wrong  The follow-up could not be possible as no contact details were available. The patient shot wrong, took doctor awhile to inject it, which led to wrong technique in drug usage process.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3YO received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z1A024M, expiry date 17-FEB-2024) for prophylaxis.   Previously administered products included Pediarix (1st dose received on 25th September 2019), Pediarix (2nd dose received on 26th November 2019), Pediarix (3rd dose received on 6th February 2020) and Dtap (received on 28th October 2020).   On 06-OCT-2022, the patient received Kinrix. On 06-OCT-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3YO received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAR-2023  The medical assistant (MA) enquired on how to proceed with the Kinrix series when the patient turned 4 years old. Kinrix was the 5 dose of DTap and 4th dose of IPV. A 3 year 2 month old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Given Infanrix instead of Boostrix; 11 YO received infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 21-FEB-2023, the patient received Infanrix. On 21-FEB-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Given Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 YO received infanrix). 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: 06-MAR-2023 The Clinic Manager called to enquire on how to proceed for the patient as, 11 year old patient was inadvertently administered Infanrix instead of Boostrix. The patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 27-FEB-2023, the patient received the 1st dose of Havrix. On 07-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 02-MAR-2023  A medical assistant asked how they should proceed if an expired dose of Havrix was given to a patient. Information about the patient and vaccine was provided.  The medical information was accepted and they asked to receive it via e-mail. The vaccine administration facility was the same as primary reporter. The reporter interrupted whilst giving the information. The patient received expired dose of Havrix, which led to expired vaccine used. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: left bicep site feels warm; left bicep, site is red.; Arm pain; radiating pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin warm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 09-MAR-2023, 6 days after receiving Shingrix, the patient experienced skin warm (Verbatim: left bicep site feels warm), erythema of extremities (Verbatim: left bicep, site is red.) and pain in arm (Verbatim: Arm pain). In MAR-2023, the patient experienced radiating pain (Verbatim: radiating pain). The outcome of the skin warm, erythema of extremities and pain in arm were not recovered/not resolved and the outcome of the radiating pain was not reported.   It was unknown if the reporter considered the skin warm, erythema of extremities, radiating pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the skin warm, erythema of extremities, radiating pain and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 10-Mar-2023 The paitent received her first dose of Shingirx vaccine and the area on her left bicep below the injection site feels warm and was red. The patient reported that she feels radiating pain that comes and goes. Less than a week after vaccination, the patient had arm pain. The patient did not gave permission to call the health care professional. The patient said she called the health care professional this morning and they told her to call the pharmacist that gave her the vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, hadn't received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, hadn't received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-Mar-2023 The reporter did not consent to follow-up. Till the time of reporting  the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.5
Sex: F
Vaccine: RVX
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: infant got an extra dose; Patient age: 6 Months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rotavirus vaccine for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).   On 10-MAR-2023, the patient received Rotavirus vaccine. On 10-MAR-2023, an unknown time after receiving Rotavirus vaccine, the patient experienced extra dose administered (Verbatim: infant got an extra dose) and inappropriate age at vaccine administration (Verbatim: Patient age: 6 Months). The outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 10-Mar-2023. The reporter stated that it was unknown what brand name vaccine the Rotavirus was received. Patient was also given Pediarix and Prevnar at this doctor's visit today. The reporter consent to follow up. Patient received an extra dose of Rotavirus vaccine, which led to extra dose administered. Patient received an extra dose of Rotavirus vaccine at 6months, which led to inappropriate age at vaccine administration.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Sharp shooting burning pain from left deltoid to bottom of neck; Sharp shooting burning pain from left deltoid to bottom of neck; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25-SEP-2023) for prophylaxis.   On 19-JAN-2023, the patient received Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sharp shooting burning pain from left deltoid to bottom of neck) and pain burning (Verbatim: Sharp shooting burning pain from left deltoid to bottom of neck). The outcome of the injection site pain and pain burning were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain burning to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain burning to be related to Shingrix.   Additional Information: GSK receipt date: 10-Mar-2023 The nurse practitioner called to inquired that any information available on what patient was experiencing. The reporter reported that a patient received the first dose of Shingrix back and experienced a sharp shooting burning pain from left deltoid to bottom of neck.  The reporter reported another batch number as 752BN and expiry date 20th May 2024. Then the patient came back for the second dose on 19th January 2023 and was still experiencing the adverse events from the first dose that had never gone away. The reporter consented to follow-up.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix given instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   Previously administered products included IPV (received a series of 3 doses on an unknown date) and Hepatitis B (received a series of 3 doses on an unknown date).   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix given instead of Infanrix). The outcome of the wrong vaccine administered 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: 10-MAR-2023 The reporter reported that a patient was given a Pediarix in error instead of Infanrix.  This was the patient's 4th dose of IPV and Hepatitis B.  The reporter consented to follow up via email.  At the time of reporting, the patient was given Pediarix in error instead of Infanrix, which led to wrong vaccine administered. Extra dose administered was not coded in this case because a 4th dose of IPV and Hepatitis B was allowed in individuals.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: tiredness; Chills; Right arm terrible sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness), chills (Verbatim: Chills) and pain in arm (Verbatim: Right arm terrible sore). The outcome of the tiredness, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, chills and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-Mar-2023 The reporter was the patient who stated she received first dose of Shingrix vaccine in December 2022, then she developed tiredness, chills and right arm was terrible sore.  Timing of events was not specified by patient.  Symptoms did not last very long.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st dose in 2020 bc COVID did not get the 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: 1st dose in 2020 bc COVID did not get the 2nd). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 10-Mar-2023 Reporter was a female patient that reports that she received her 1st dose of Shingrix in February 2020 (she did not have an exact date), and she was supposed to get her 2nd dose of Shingrix 6 weeks later, but Covid happened, and her pharmacy quit giving vaccines during this time.  The patient never got her 2nd dose of Shingrix. The patient also reports that she received her Pneumonia vaccine (unknown product and details about this vaccine were unavailable) at the same time as her 1st dose of Shingrix. The patient did not have a lot number or remember the location where the injection of Shingrix was administered. The reporter consented to follow up. It was unknown whether patient experienced covid or reporter meant covid situation. Therefore, conservatively capture as social problem event.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Received an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 2sx5d, expiry date 24-FEB-2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose). 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: 10-MAR-2023 The nurse reported that a patient received an expired dose of Havrix which led to expired vaccine used. The reporter did not consent to follow up.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 10Nov2022, 2nd 10Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) (batch number 2YZ9B, expiry date 07-DEC-2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 10th November 2022).   On 10-MAR-2023, the patient received the 2nd dose of Havrix. On 10-MAR-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 10Nov2022, 2nd 10Mar2023). The outcome of the drug dose administration interval too short 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: 10-MAR-2023 The provider gave information about the vaccine and agreed to be contacted by a second line agent. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. The patient received 2nd dose after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses.
Age: 11.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was given Pediarix; 11 year old patient was given Pediarix instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) for prophylaxis.   On 10-MAR-2023, the patient received Pediarix. On 10-MAR-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old patient was given Pediarix) and wrong vaccine administered (Verbatim: 11 year old patient was given Pediarix instead of Boostrix). 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: 10-MAR-2023 The reporter was a medical assistant. The reporter was consented to follow up. The 11 year old patient was given Pediarix instead of Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Off label use, Therapeutic response unexpected, Vaccination failure
Clinical narrative: Received a prescription for a 3rd dose; Prescription from her doctor for a third dose of Shingrix; After Shingrix, her (PHN) went away; had shingles / Suspected vaccination failure; Mild case of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia. Previously administered products included Capsaicin, Lidocaine, Gabapentin, Zostavax and Steroids. Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Mild case of shingles). On an unknown date, the patient experienced off label use (Verbatim: Received a prescription for a 3rd dose), extra dose administered (Verbatim: Prescription from her doctor for a third dose of Shingrix) and unexpected therapeutic effect (Verbatim: After Shingrix, her (PHN) went away). The outcome of the vaccination failure, off label use, extra dose administered and unexpected therapeutic effect were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was the patient.  The reporter believed she received her full series of Shingrix in 2017 and almost immediately after receiving Shingrix, her post herpetic neuralgia (PHN) went away.  The reporter reported that she might had experienced a mild case of shingles in September of 2022.  The reporter reported that because she felt that the PHN was coming back, she had received a prescription from her doctor for a third dose of Shingrix.  The reporter consented to follow up with healthcare professional. This case was considered as suspected vaccination failure as details regarding laboratory confirmation of shingles was unknown at the time of reporting. At the time of reporting, the patient received a prescription for a 3rd dose of Shingrix, after Shingrix, her (PHN) went away, which led to off label use and extra dose administrated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Multiple sclerosis, Suspected COVID-19
Clinical narrative: MS FLARED; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (MS), and other pre-existing medical conditions included: patient stated he is a sleeping giant. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) 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.  On an unspecified date, the patient experienced covid-19 (suspected covid-19 infection) (Dose number in series 1).  The patient also received booster dose of non-company suspect vaccine- Pfizer Biontech covid-19 Vaccine (tozinameran) (Dose number in series 2) (suspension, intramuscular, batch number: FE3592, expiry: UNKNOWN) dose was not reported (strength: 2 milliliters, multiple dose vial x 1) administered on 30-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). No concomitant medications were reported.  On an unspecified date, after booster dose, the patient experienced MS flared and he had been suffering since (Dose number in series 2). Patient stated that, this did not occur after he had the J and J vaccine and also he did not know if his MS flared due to the vaccine or having covid-19. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from MS flared, and the outcome of revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20230352094-MS flared. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, and drug allergy (unspecified), and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. 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. Non-company suspect drugs included: nirmatrelvir/ritonavir ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 03-MAR-2023 to 08-MAR-2023 for covid-19 treatment. No concomitant medications were reported. On 2023, the patient experienced confirmed covid-19 infection. On MAR-2023, Laboratory data included: COVID-19 virus test Negative. On 11-MAR-2023, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 35 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808979 expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 34 years old.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received second dose of non-company suspect vaccine included: Pfizer Biontech (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FF2587 expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with second dose of non-company suspect vaccine Pfizer Biontech (dose number in series 2).  The patient additionally received third dose of Pfizer Biontech (tozinameran) (dose number in series 3) (form of admin, route of admin were not reported, batch number: GJ3277 expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3). Concomitant medications included guaifenesin (Mucinex) and  pseudoephedrine hydrochloride (Sudafed). On an unspecified date in 2023, the patient experienced covid-19 infection (suspected covid-19 infection) (dose number in series 3).  The patient started taking treatment with unspecified suspect drug (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 01-MAR-2023 to 05-MAR-2023 for treatment of covid-19. On 10-MAR-2023, after treatment with unspecified drug the patient experienced rebound covid-19 infection, after what he felt like a complete recovery. Symptoms were mild (runny nose, congestion, sneezing, headache) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and tozinameran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure abnormal, Feeling abnormal
Clinical narrative: Feels like she is dieing; She did not have a problem with blood pressure before; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Feels like she is dieing) and BLOOD PRESSURE ABNORMAL (She did not have a problem with blood pressure before) in an 8-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 FEELING ABNORMAL (Feels like she is dieing) and BLOOD PRESSURE ABNORMAL (She did not have a problem with blood pressure before). At the time of the report, FEELING ABNORMAL (Feels like she is dieing) and BLOOD PRESSURE ABNORMAL (She did not have a problem with blood pressure before) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that if the patient did not take the blood pressure medicine exactly correct on time, she felt like she is dying. Patient did not have a problem with blood pressure before.  Treatment information was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: patient had a bad reaction to it; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (patient had a bad reaction to it) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 IMMUNISATION REACTION (patient had a bad reaction to it). At the time of the report, IMMUNISATION REACTION (patient had a bad reaction to it) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent dose, was documented by HCP to expire on 17-Mar-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent dose, was documented by HCP to expire on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (Bivalent dose, was documented by HCP to expire on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent dose, was documented by HCP to expire on 17-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (Bivalent dose, was documented by HCP to expire on 17-Mar-2023).    Concomitant medication was not provided.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-716687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716687:Master case (Patient no 1 - with patient initial L-G) US-MODERNATX, INC.-MOD-2023-716751:(Patient no 2 - with patient initial R-S)
Age: 51.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product container issue
Clinical narrative: Have cracked vaccine vial that was administered; Vaccine administered from cracked vial.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) and NO ADVERSE EVENT (no adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.) 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 assessments were provided for PRODUCT CONTAINER ISSUE (Have cracked vaccine vial that was administered) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered from cracked vial.).    No concomitant medications were reported. The crack was discovered after the administration of the vaccine, crack was just enough for the vaccine to start leaking. The vial was cracked or broken on base of the vial. Upon receipt of the shipment, it was stored in the freezer right away. Stored in the refrigerator for 2 weeks now and it might have been that someone stacked the separate container individual vial carton for 2 weeks set into a separate cardboard container 2 days ago. The temperature of freezer was set at -21C. The temperature of refrigerator was set at 3C. The vials transported to the site by courier, no they stay in the fridge they are moved from shelf to shell. They got the shipment on 06-Feb-2023 and they inspected the vials and no issues were noted. They stored the 40 vials in the freezer right away. The vial with a crack was moved to the fridge 2 weeks ago and it was moved to a container inside the same fridge 2 days ago. The crack might have happened when someone returned the container in the fridge with a strong force. The vial had been disposed, no pictures were taken. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Mar-2023: Live follow-up received contains narrative part updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness, Pain, Vaccination site pain
Clinical narrative: flu like symptoms; soreness and achiness; localized symptoms like pain, in the injection site; administered 1 dose of Moderna COVID-19 Vaccine to a patient on 20MAR2023 after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 20MAR2023 after the expiration date.), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (soreness and achiness) and VACCINATION SITE PAIN (localized symptoms like pain, in the injection site) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Again in Nov-2022 patient got COVID-19.) in October 2021.    On 20-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 20MAR2023 after the expiration date.). On 21-Mar-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (soreness and achiness) and VACCINATION SITE PAIN (localized symptoms like pain, in the injection site). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 20MAR2023 after the expiration date.), PAIN (soreness and achiness) and VACCINATION SITE PAIN (localized symptoms like pain, in the injection site) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It is unknown if patient was under any concomitant or regular medication. No treatment was given.
Age: 67.0
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: bivalent dose, was documented by HCP to expire on 3-17-23; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23) 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 EXPIRED PRODUCT ADMINISTERED (bivalent dose, was documented by HCP to expire on 3-17-23).    No concomitant medications were reported. It was reported that 2 vials from the lot number was used to administered vaccines to 3 Patients. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716687, US-MODERNATX, INC.-MOD-2023-716749 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716687:Master case US-MODERNATX, INC.-MOD-2023-716749: