chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm is very sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Shingles vaccine. On 12th January 2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's comment: This case was reported by the patient via  interactive digital media. The reporter stated that the he/she had received his/her first shingles vaccine on the same day as reporting day.  The reported had stated that he /she would be going back in March for the second dose.  He/she was glad that he/she had got it.  The only negative on this was his/her arm was very sore, but it was well worth it. Additional supportive information: Follow-up would not possible, as no contact, details were available.  This case was linked with US2023AMR004672 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR004672:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Got 2nd shot, it itches; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus 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, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-Jan-2023. Reporter's Comment: This case was received from consumer via interactive digital media. The patient got his/her 2nd Shingles shot but was itches. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 13-JAN-2023 Reporter's Comments: The health care professional reported that a patient received an expired dose of Bexsero. The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Blisters break out; Great pain; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (patient was already getting shingles before the vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blister and pain. The patient was treated with ibuprofen (Advil), gabapentin and analgesic, nos (Pain Patch (Unknown)). On an unknown date, the outcome of the blister was unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the blister and pain to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that she received Shingrix vaccine on Monday and by Thursday she experienced blisters break out with great pain. The patient stated that it had been 9 weeks with still pain. The patient received Advil, Gabapentin and pain patches as a treatment. The patient stated that it was terrible. The physician stated that she was already getting shingles before the vaccine. The reporter considered the events might had been to be related to Shingrix. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old 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 22nd December 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 22nd 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: 09-JAN-2023 and 10-JAN-2023 Reporter's Comments: The reporter stated that vaccine was expire at time of given. The reporter stated that patient and physician were notified at the time of incident. The vaccine administration facility was the same as primary reporter. The reporter requested to have some contact to see what protocol to take or if he/she could have confirmation from the manufacturer that company was notified with this incident and what type of complications the patient may experience. The reporter consented to follow-up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: 2 adjuvants were mixed together, not administered; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.       Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The pharmacist stated that 2 vials of the Shingrix adjuvant were mixed together instead of with the antigen. The reporter wanted to know an alternative diluent be used to reconstitute the remaining Shingrix antigen. The reporter confirmed that patient had not received the combined mixed adjuvants and that they had not reconstituted the antigen with a different diluent not supplied with vaccine.  The reporter filing for a potential medication error. The reporter decided to file the AE after the call was completed so no additional information available. Additional supportive information: The 2 vials of the Shingrix adjuvant were mixed together instead of with the antigen, which led to intercepted product preparation error.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Wrong technique in product usage process
Clinical narrative: exposure on skin of patient's arm; exposure on skin of patient's arm; needle wasn't screwed on tightly; patient didn't get a full dose; This case was reported by a physician via call center representative and described the occurrence of inadvertent exposure to vaccine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine, exposure via skin contact, wrong technique in product usage process and accidental underdose. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via skin contact, wrong technique in product usage process and accidental underdose were unknown.   Additional Information: GSK receipt date: 11 JAN 2023 Reporters comment: The physician reported that the patient received 2nd dose of Shingrix, the vaccine needle was not screwed on tightly and some of the vaccine came out and the patient did not get a full dose. There was exposure of vaccine on skin of patient's arm. Reporter did not consent to follow up. Additional supportive information: As the vaccine needle was not screwed on tightly and some of the vaccine came out which had led to Inadvertent exposure to vaccine, exposure via skin contact, wrong technique in product usage process, accidental exposure.
Sex: F
Vaccine: PNC20, TD, VARZOS
Symptoms: Injection site vesicles, Pruritus, Wrong technique in product usage process
Clinical narrative: itching in the right arm; Shingrix and TDvax administered on the same day on left arm; blisters similar/like chickenpox on arm/located on the left arm; This case was reported by a nurse via call center representative and described the occurrence of injection site blisters in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis and DIPHTHERIA VACCINE TOXOID + TETANUS VACCINE TOXOID (TD VACCINE) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Shingrix, PREVNAR 20 and TD VACCINE. On 12th July 2022, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On 14th July 2022, the patient experienced injection site blisters. On an unknown date, the patient experienced itchy upper limbs. On an unknown date, the outcome of the injection site blisters and itchy upper limbs were recovered/resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site blisters and itchy upper limbs to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter stated that the patient came into clinic and stated that after she received her Shingrix dose she had blisters similar to chickenpox that started 2 days after the dose. The blisters lasted 2 months and were now resolved. The blisters were located on left arm where the patient received Shingrix, as well as TDvax on the same day. The patient also received Prevnar 20 in the right arm at the same visit. The patient also had itching in the right arm. The patient showed it to her pharmacist, who agreed the blisters looked like chickenpox and not hives or a drug reaction rash. The patient did not seek medical care. At the time of reporting, the patient had not received a second dose. It was unknown if the reporter considered the injection site blisters and itchy upper limbs to be related to Td vaccine and Prevnar 20 vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix as well as TD vaccine on the same day in the left arm, which led to wrong technique in product usage process.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Engerix B and Engerix B 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: 11 JAN 2023 Reporters comment: The reporter reported that the patient received today an expired dose of Engerix B on 11th January 2023 expiry date 27th December 2022. The reporter consented to follow up. Additional supportive information: As patient received the expired vaccine which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a female patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 12-Jan-2023 Reporter's Comments: The nurse reported that the pediatric patient received an adult dose of Havrix. The reporter consent to follow-up. Additional supportive information: A pediatric patient received an adult dose of Havrix which led to overdose and adult product administered to child.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix 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: 12-JAN-2023 Reporter's comment: The reporter asked for information regarding the administration of an expired dose of Twinrix to a patient.  The reporter asked how to proceed with the patient. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: Engerix-B administered intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received HBV (Engerix B) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2023, the patient received Engerix B (intravenous) and Engerix B Pre-Filled Syringe Device. On 13th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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:13-JAN-2023 Reporter's Comment: The reporter reported that the patient received Engerix B vaccine by intravenous route. The healthcare professional asked about the patient information, but it was declined because it was not accessible at the time of the call. The reporter did consent to follow up via email. Additional supportive information: The patient received Engerix B was by intravenous route, which led to intramuscular formulation administered by other route.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution with sterile diluent; Reconstitution with sterile diluent and administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA721A, expiry date 30th September 2023) for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Menveo. On 12th January 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date :13 JAN 2023 Reporters comment: The reporter was registered medical assistant. The reporter stated Menveo was reconstituted with a sterile diluent instead of the supplied diluent and was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. Additional supportive information: As patient received sterile diluent instead of the supplied diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th January 2023, unknown after receiving Bexsero and Bexsero 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: 17-Jan-2023 Reporter's Comments: Nurse reported that a patient was inadvertently administered an expired dose of Bexsero. The reporter consented to follow-up via email. Additional Supportive Information: The patient inadvertently received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in May of 2022, but never followed up to get the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 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: 17-JAN-2023 Reporter's Comments: The Healthcare professional (HCP) stated that she had a patient that never followed up to get the second dose. The HCP stated that, the patient would be getting the second dose as soon as possible. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Note: details provided was corresponding to the 1st dose as the 2nd dose was not received yet.
Sex: U
Vaccine: UNK
Symptoms: Overdose
Clinical narrative: Two doses administered at the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 18th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season .5 ml. On 18th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK receipt date; 18-Jan-2023 Reporter's comment: The nurse called to asked for information about the administration of two 0.5 ml doses of Flulaval quadrivalent to a patient at the same day.  The reporter asked if there was any harm expected. The reporter declined sharing patient and vaccine information since she said that they were not sure about the extra dose administration. Did not consent to follow-up. Additional supportive information: The patient received two doses of Flulaval quadrivalent on the same day, which led to overdose.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose administered to 8 YO.; Adult dose administered to 8 YO.; This case was reported by a physician via call center representative and described the occurrence of overdose in a 8-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 18-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an adult dose of Havrix, which led to underdose and adult product administered to child.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received previous one being on 21st June 2021).   On 18th January 2023, the patient received the 3rd dose of Shingrix. On 18th January 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-Jan-2023 Reporter's comment: The information was provided only for the third vaccine dose. The reporter provided details for patient and vaccine. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient had erroneously gotten a third dose of Shingrix , which led extra dose administered.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to 8 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number SKBG9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jan-2023 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult received a pediatric dose; adult received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 18th January 2023, the patient received Engerix B pediatric .5 ml. On 18th January 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 18-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Dizziness, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: PNEUMONIA; BRONCHITIS; SUSPECTED COVID-19 INFECTION; DIZZY; BRAIN FOG; HEART PUMPING FAST; This spontaneous report received from a patient concerned a 6 decade old female of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: septic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of pneumonia, bronchitis, Covid-19 and was septic before she took the J&J vaccine. She went to the emergency room and they gave the shot and then sent home because they were full. After she was vaccinated, she reported that she was sicker than a dog for 1 whole month. She could not eat nor sleep. She got sicker and sicker and sicker, had loss of taste and smell, got brain fog, could not breathe and walk to her car without shortness of breath, sweating like she had menopause and she was 67. Every once in while, it was like her heart was having a heart attack and it was pumping fast and got dizzy, as she had to stop what she was doing and sit down. She experienced joints ache. She was starving to death on the reported day, but she could not taste anything. Sometimes she did not have an appetite at all. She reported that taking a shower wears her out and she was exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and had not recovered from pneumonia, dizzy, bronchitis, brain fog, and heart pumping fast. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230134478- Pneumonia-  The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Suspected COVID-19
Clinical narrative: PNEUMONIA; BRONCHITIS; SUSPECTED COVID-19 INFECTION; DIZZY; BRAIN FOG; HEART PUMPING FAST; This spontaneous report received from a patient concerned a 6 decade old female of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: septic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of pneumonia, bronchitis, Covid-19 and was septic before she took the J&J vaccine. She went to the emergency room and they gave the shot and then sent home because they were full. After she was vaccinated, she reported that she was sicker than a dog for 1 whole month. She could not eat nor sleep. She got sicker and sicker and sicker, had loss of taste and smell, got brain fog, could not breathe and walk to her car without shortness of breath, sweating like she had menopause and she was 67. Every once in while, it was like her heart was having a heart attack and it was pumping fast and got dizzy, as she had to stop what she was doing and sit down. She experienced joints ache. She was starving to death on the reported day, but she could not taste anything. Sometimes she did not have an appetite at all. She reported that taking a shower wears her out and she was exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and had not recovered from pneumonia, dizzy, bronchitis, brain fog, and heart pumping fast. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230134478- Pneumonia-  The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was not reported whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was not reported whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine (dose number in series 2). The patient received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The product was associated with off label use (off label dosing frequency) (dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20230138443.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Therapeutic response unexpected
Clinical narrative: suffers from a large number of chronic aches, pains and joint problem. The day after the booster she notice she had no aches and pains; chills; headache; standard feeling crappy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (standard feeling crappy), THERAPEUTIC RESPONSE UNEXPECTED (suffers from a large number of chronic aches, pains and joint problem. The day after the booster she notice she had no aches and pains), CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Coronary artery bypass (20 years ago). Concurrent medical conditions included Dust allergy, Allergic rhinitis (excl hay fever), Allergic reaction to bee sting, Cardiac discomfort (Heart problem), Blood pressure high, Allergy to antibiotic (erythromycin allergy), Penicillin allergy and Allergy (perfume allergy).    On 12-Dec-2022, 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 13-Dec-2022, the patient experienced CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (standard feeling crappy) and THERAPEUTIC RESPONSE UNEXPECTED (suffers from a large number of chronic aches, pains and joint problem. The day after the booster she notice she had no aches and pains). At the time of the report, FEELING ABNORMAL (standard feeling crappy), CHILLS (chills) and HEADACHE (headache) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (suffers from a large number of chronic aches, pains and joint problem. The day after the booster she notice she had no aches and pains) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Raynaud's phenomenon, Rheumatological examination
Clinical narrative: raynaud's disease; her feet were hurting; This spontaneous case was reported by a consumer and describes the occurrence of RAYNAUD'S PHENOMENON (raynaud's disease) and PAIN IN EXTREMITY (her feet were hurting) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 028L20A, 017E21A and 022J21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced RAYNAUD'S PHENOMENON (raynaud's disease) and PAIN IN EXTREMITY (her feet were hurting). The patient was treated with ISOSORBIDE DINITRATE (NITROBIDE) at an unspecified dose and frequency. At the time of the report, RAYNAUD'S PHENOMENON (raynaud's disease) had not resolved and PAIN IN EXTREMITY (her feet were hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rheumatological examination: rheumatologist said it was Erythromelalgia. with the secondary diagnosis as Raynaud's..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that after getting the 1st dose of the Moderna Covid-19 vaccine, she noticed that her toes were getting purple and red, but she did not think too much of it. She went to see a vascular surgeon who diagnosed it as Raynaud's Disease. She did not have the symptoms in her hands. She went on to see a rheumatologist who did a battery of tests. The rheumatologist said it was Erythromelalgia with the secondary diagnosis as Raynaud's. She went to see a podiatrist after because her feet were hurting. The podiatrist said that it was Raynaud's and prescribed her with a beta blocker, but she did not take it. She went to see another rheumatologist who prescribed her with Nitrobid but it did not work. She kept putting having it seen on and off.   This case was linked to MOD-2022-673505 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult 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. AS7168B) 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 (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) 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 (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; A dose was given to a patient 26 hours after puncture on 29Dec2022; A dose was given to a patient 26 hours after puncture on 29Dec2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022), PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, 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 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022) and PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022), PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022) 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 EXPIRED PRODUCT ADMINISTERED (A dose was given to a patient 26 hours after puncture on 29Dec2022) and PRODUCT STORAGE ERROR (A dose was given to a patient 26 hours after puncture on 29Dec2022).    No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A dose was given to a patient 26 hours after puncture on 29Dec2022. It was his second booster. The patient did not report any issues or reactions after that. The lot number is AS7143C.  Vial size was 2.5 mL  The vial was initially stored in the refrigerator on 28Dec2022. The vial was first punctured was on 28Dec2022 at 3:30, almost 4 PM 7.  Date and time of administration of vaccine was 29Dec2022 at 6:10 PM.  The vial was stored in the fridge post puncture. No temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 seconds.  No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination complication
Clinical narrative: pretty strong reaction to it; HCP herself received the half dose boosters when it was first changed from full dose to half dosing boosters; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (pretty strong reaction to it) and ACCIDENTAL UNDERDOSE (HCP herself received the half dose boosters when it was first changed from full dose to half dosing boosters) in an adult 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 VACCINATION COMPLICATION (pretty strong reaction to it) and ACCIDENTAL UNDERDOSE (HCP herself received the half dose boosters when it was first changed from full dose to half dosing boosters). At the time of the report, VACCINATION COMPLICATION (pretty strong reaction to it) had resolved and ACCIDENTAL UNDERDOSE (HCP herself received the half dose boosters when it was first changed from full dose to half dosing boosters) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported. No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: currently sick with COVI-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (currently sick with COVI-19) 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. ASKU) 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)) (Intramuscular) Additional Booster. On an unknown date, the patient experienced COVID-19 (currently sick with COVI-19). At the time of the report, COVID-19 (currently sick with COVI-19) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient already received 2 boosters of Moderna COVID-19 Vaccine and last booster was a bivalent. Caller mentioned she was currently sick with COVI-19. No treatment medication was reported.