chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; GARDASIL 9 was stored improperly and then administered on 10/27/23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-OCT-2023, the patient could be vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965044 was valid for formulation pre-filled syringe, expiration date: 07-JAN-2026, two or three dose series, administered for prophylaxis (Product storage error). Nurse stated that since October 2023, their data logger for their refrigerator has had discrepancy of the temperature output, in which it is unclear if the GARDASIL 9 was stored outside the recommended temperature range. Nurse confirmed no reports of medical concerns or symptoms from patient involved. No adverse event (AE) or product quality complaint (PQC) reported.
Sex: F
Vaccine: HPV9
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: HCP was transferred from CRT resolution team to further assist on GARDASIL 9. HCP stated there was a contamination of GARDASIL 9 PFS. HCP stated the medical assistant while prepping the GARDASIL 9 PFS, stabbed herself accidently and the product was c; HCP was transferred from CRT resolution team to further assist on GARDASIL 9. HCP stated there was a contamination of GARDASIL 9 PFS. HCP stated the medical assistant while prepping the GARDASIL 9 PFS, stabbed herself accidently and the product was c; HCP was transferred from CRT resolution team to further assist on GARDASIL 9. HCP stated there was a contamination of GARDASIL 9 PFS. HCP stated the medical assistant while prepping the GARDASIL 9 PFS, stabbed herself accidently and the product was c; Product was mishandled during preparation from the medical assistant; This spontaneous report was received from a physician and refers to a female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-DEC-2023, the patient (medical assistant) was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X014788, expiration date: 07-MAR-2025 while prepping the GARDASIL 9 Pre-filled syringes (PFS), stabbed herself accidently (Injury associated with device, Occupational exposure to product and Accidental exposure to product) and the product was contaminated by the Medical Assistants' blood. Product was mishandled during preparation from the medical assistant (Wrong technique in product usage process).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic events were reported; HCP called to state that a patient was inadvertently administered an expired dose of MMR II. The product did not have any previous TE's. The product was supported by the post expiry memo. No symptomatic events were reported. No further information w; This spontaneous report was received from a nurse and refers to a patient of unspecified age or gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 05-DEC-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (lot # W009106, expiration date: 04-DEC-2023, stablished as valid with therapy type rHA) (route of administration, anatomical location not provided) as prophylaxis. It was reported that the vaccine did not underwent any temperature excursion (TE) and it was supported by the post expiry memo. No symptomatic events were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC; Medical Assistant reported that expired ROTATEQ was administered on 12/7/2023 to a 4 month old patient. Expiration date was 10/21/2023; This spontaneous report has been received from a medical assistant and refers to a 4-month-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 07-DEC-2023 (48 days post expiry), the patient was vaccinated with the second dose of an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (expired product administered), at a dose of 2 milliliter (mL) (lot number W021163 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and validated as 21-OCT-2023), administered orally for prophylaxis (strength was not provided). It was reported that this was the second oral dose of the three dose series. It was confirmed the patient had not presented with symptoms or side effects.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No additional AE/PQC; HCP reported AE on behalf of a patient who was administered an expired dose of ROTATEQ on 12/18/2023; This spontaneous report has been received from a medical assistant, regarding a 2-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 18-DEC-2023, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dose of 0.5 milliliters (ml) orally as prophylaxis (lot number: 1912561, which was determined to be valid, with an expiration date on 10-DEC-2023) (Expired product administered).  No temperature excursions supported via post-expiry memo  No additional symptoms or adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: malaise, pyrexia, fatigue; malaise, pyrexia, fatigue; malaise, pyrexia, fatigue/ feeling dull; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pyrexia in a patient who received Herpes zoster (Shingrix) for antiviral prophylaxis.   Concurrent medical conditions included sickness.   On 23-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, less than a week after receiving Shingrix, the patient experienced malaise (Verbatim: malaise, pyrexia, fatigue/ feeling dull). On 23-SEP-2023, the patient experienced pyrexia (Verbatim: malaise, pyrexia, fatigue) and fatigue (Verbatim: malaise, pyrexia, fatigue). The outcome of the pyrexia, fatigue and malaise were not reported.   The reporter considered the pyrexia, fatigue and malaise to be related to Shingrix.     The company considered the pyrexia, fatigue and malaise to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2023 The patient age and age at the vaccination were not reported. The patient's gender was unknown. The lot number was unknown. A thought occurred to the patient, and the patient received Shingrix (First of two). The patient had been told for a long time that Shingrix should be administered, but since the patient got illness, the patient had been afraid of anything that might upset the balance of the immune system and refused to take it anyway, but it would be coming to nothing if herpes zoster developed. The vaccine is free in this country. And the vaccine can be reserved right away at a pharmacy and received the same day. So the patient received it early afternoon the day before this posting.  As a result, the patient had a hard time with fatigue and pyrexia that night.  September 24, 2023 21:31 At the time of this posting, the patient still felt dull.  No further information will be provided due to the lack of patient's cooperation.
Sex: M
Vaccine: VARZOS
Symptoms: Diaphragmatic disorder, Epigastric discomfort, Myoclonus
Clinical narrative: Epigastric pulsation, a feeling of pulsation between the xiphoid process and the umbilicus; Diaphragmatic myoclonus, a flutter of the diaphragm.; This non-serious case was reported by a consumer and described the occurrence of epigastric discomfort in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-DEC-2023, the patient received Shingrix. On 07-DEC-2023, 2 days after receiving Shingrix, the patient experienced epigastric discomfort (Verbatim: Epigastric pulsation, a feeling of pulsation between the xiphoid process and the umbilicus) and diaphragmatic disorder (Verbatim: Diaphragmatic myoclonus, a flutter of the diaphragm.). The outcome of the epigastric discomfort and diaphragmatic disorder were not resolved.   It was unknown if the reporter considered the epigastric discomfort and diaphragmatic disorder to be related to Shingrix.     It was unknown if the company considered the epigastric discomfort and diaphragmatic disorder to be related to Shingrix.   Additional Information: RA Receipt Date: 10-DEC-2023. This report was submitted via the online direct entry reporting system. The reporter said to process using the related sop. This report was submitted by site public reporting. The reporter was the patient. The patient had epigastric pulsation, a feeling of pulsation between the xiphoid process and the umbilicus and diaphragmatic myoclonus, a flutter of the diaphragm from 7-DEC-2023 the event was ongoing and no symptoms were treated. This preventative vaccine recommended by primary care physician. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Injection site swelling was reported as worsened.; Injection site redness was reported as worsened; aching; Fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-DEC-2023, the patient received the 1st dose of Arexvy (left arm). On 09-DEC-2023, 1 days after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Injection site swelling was reported as worsened.), injection site erythema (Verbatim: Injection site redness was reported as worsened), pain (Verbatim: aching) and fatigue (Verbatim: Fatigue). The outcome of the injection site swelling, injection site erythema, pain and fatigue were not resolved.   The reporter considered the injection site swelling, injection site erythema, pain and fatigue to be related to Arexvy.     The company considered the injection site swelling, injection site erythema, pain and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 10-DEC-2023 The reporter was the consumer. Reporter reported that she had received the 1st dose of Arexvy vaccine and she experienced aching, fatigue, injection site swelling and injection site redness. The injection site swelling and injection site redness were reported as worsened. The reporter stated that she did not taken other product. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Only 1 vials was given instead of 2/green cap was given and that's the Adjuvant; Only 1 vials was given instead of 2/green cap was given and that's the Adjuvant; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only 1 vials was given instead of 2/green cap was given and that's the Adjuvant) and inappropriate dose of vaccine administered (Verbatim: Only 1 vials was given instead of 2/green cap was given and that's the Adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 10-DEC-2023 The pharmacist stated patient received only 1 vial instead of 2. The pharmacist believed the green cap was given and that was the adjuvant. The pharmacist wants to confirm if the patient received only adjuvant since the repeat dose was in 4 weeks. The pharmacist reported possible medication error on Shingrix. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Had a nurse give Shingrix instead of varivax; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 40-year-old female patient who received Herpes zoster (Shingrix) (batch number 274YD, expiry date 15-SEP-2025) for prophylaxis.   On 11-DEC-2023, the patient received Shingrix. On 11-DEC-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Had a nurse give Shingrix instead of varivax) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 The nurse gave Shingrix instead of varivax and wanted to know if would they still need a Varivax, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via mail.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: A patient received Arexvy in September 2023 and in December the patient received a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   Previously administered products included Arexvy (in SEP-2023, the patient received the 1st dose of Arexvy).   In DEC-2023, the patient received the 2nd dose of Arexvy (intramuscular). In DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: A patient received Arexvy in September 2023 and in December the patient received a second dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 It was reported that healthcare professional called to report that a patient received Arexvy in SEP-2023 and in DEC-2023 the patient received a second dose, which led to extra dose administered. The healthcare professional asked for safety information regarding an extra dose of Arexvy. The healthcare professional declined permission to follow up.  The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: male patient received the 1st dose of Shingrix on 11Dec2021 and is late for 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th December 2021).   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: male patient received the 1st dose of Shingrix on 11Dec2021 and is late for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 11-Dec-2023 The reporter reported that the patient received the 1st dose of Shingrix vaccine on 11th December 2021 and reporter wanted to know if the patient was late for 2nd dose. The reporter stated that at the moment of the reporting the reporter mentioned that the patient was seen the previous week and called for general information to verify if the series had to be restarting after receiving the first dose of Shingrix on 2021. The reporter did not mentioned that the 2nd dose was administered. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: 32 week pregnant patient inadvertently received Arexvy; received Arexvy instead of Abryvso; 36 years old received Arexvy; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-DEC-2023, the patient received Arexvy. On 07-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: received Arexvy instead of Abryvso) and inappropriate age at vaccine administration (Verbatim: 36 years old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 32 week pregnant patient inadvertently received Arexvy). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 32 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 Physician reported that a 32 week pregnant patient inadvertently received a dose of Arexvy instead of Abryvso which led to wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. The reporter could not provide lot number and expiration date at this time.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: States an expired dose of BOOSTRIX was given to a patient; 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 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2zf9n, expiry date 24-SEP-2023) for prophylaxis.   On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: States an expired dose of BOOSTRIX was given to a patient). 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-DEC-2023 The reporter stated that an expired dose of Boostrix was given to a patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired Boostrix(exp:12/9/23) dose on 12/10/23.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 78-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 72D7L, expiry date 09-DEC-2023) for prophylaxis.   On 10-DEC-2023, the patient received Boostrix. On 10-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired Boostrix(exp:12/9/23) dose on 12/10/23.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date:11-DEC-2023 The pharmacist called to inquire, how to proceed? The Registered pharmacist (RPH) reported a patient was inadvertently administered an expired Boostrix, which led to expired vaccine used. The health care professional (HCP) wanted to recheck the lot and expiration date with NDC number for the Boostrix, warm transferred to agent for further assistance. The reporter did not consent to follow-up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got my first Shingrix shot October 18. Then approximately Nov 20 I developed Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 20-NOV-2023, 33 days after receiving Shingrix, the patient experienced shingles (Verbatim: Got my first Shingrix shot October 18. Then approximately Nov 20 I developed Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: RA Receipt Date: 11-DEC-2023 On 18-OCT-2023, the patient got his first Shingrix shot. Then approximately 20-NOV-2023, the patient developed shingles (small case on my scalp). The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Exposure during pregnancy, Headache, Injection site pain
Clinical narrative: BLEEDING AFTER DELIVERY; VERY HEAVY BLEEDING; 2 DOSES IN ONE VERY PAINFUL; HEADACHES; STOMACH PAIN ALOT OF CRAMPING; DIARRHEA; VACCINE EXPOSURE DURING PREGNANCY; HEAVY THROW UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. Para and gravida information was not reported. It was not reported whether the patient had been pregnant before. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported) administered in 21-SEP-2020 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bleeding after delivery, very heavy bleeding, 2 doses in one very painful, headaches, stomach pain alot of cramping, diarrhea, vaccine exposure during pregnancy, and heavy throw up. Following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced very heavy bleeding in one month can bleed up to 21 days straight stomach pain alot of cramping uncomfortable feeling headaches for days can not get good night sleep because of the diarrhea, heavy throwing up constantly very sick all the time. When i got to the emergency room for delivery, was in so much pain the doctor and helpers does not believe me so they left me in the room for about 1 hour did not check on me , keep calling for help. Son was slip out of my vagina almost feel on the, but the grabbed head, neck, back and legs , after that they could not stop very bleeding for about 45 minutes (Dose number in series 1).   Patient received 2 doses previously and in one was very painful and patient had illness at the time of vaccination with throwing up headaches, cramping, stomach aches and throwing diarrhea was developed after previous vaccinations. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from vaccine exposure during pregnancy, and the outcome of 2 doses in one very painful, headaches, stomach pain alot of cramping, diarrhea, very heavy bleeding, heavy throw up and bleeding after delivery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Postpartum haemorrhage, Vaginal haemorrhage. The event has an 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: Postpartum haemorrhage, Vaginal haemorrhage, Vomiting
Clinical narrative: BLEEDING AFTER DELIVERY; VERY HEAVY BLEEDING; 2 DOSES IN ONE VERY PAINFUL; HEADACHES; STOMACH PAIN ALOT OF CRAMPING; DIARRHEA; VACCINE EXPOSURE DURING PREGNANCY; HEAVY THROW UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. Para and gravida information was not reported. It was not reported whether the patient had been pregnant before. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported) administered in 21-SEP-2020 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bleeding after delivery, very heavy bleeding, 2 doses in one very painful, headaches, stomach pain alot of cramping, diarrhea, vaccine exposure during pregnancy, and heavy throw up. Following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced very heavy bleeding in one month can bleed up to 21 days straight stomach pain alot of cramping uncomfortable feeling headaches for days can not get good night sleep because of the diarrhea, heavy throwing up constantly very sick all the time. When i got to the emergency room for delivery, was in so much pain the doctor and helpers does not believe me so they left me in the room for about 1 hour did not check on me , keep calling for help. Son was slip out of my vagina almost feel on the, but the grabbed head, neck, back and legs , after that they could not stop very bleeding for about 45 minutes (Dose number in series 1).   Patient received 2 doses previously and in one was very painful and patient had illness at the time of vaccination with throwing up headaches, cramping, stomach aches and throwing diarrhea was developed after previous vaccinations. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from vaccine exposure during pregnancy, and the outcome of 2 doses in one very painful, headaches, stomach pain alot of cramping, diarrhea, very heavy bleeding, heavy throw up and bleeding after delivery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Postpartum haemorrhage, Vaginal haemorrhage. The event has an 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Patient also mentioned she is currently having a real bad cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Patient also mentioned she is currently having a real bad cold) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Cancer surgery on 01-Apr-2022. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) on 15-Apr-2021, Pfizer vaccine (Dose 2) on 06-May-2021, Pfizer vaccine (Dose 3) on 18-Nov-2021 and Pfizer vaccine (Dose 4) on 11-Jul-2022. Past adverse reactions to the above products included Breast cancer with Pfizer vaccine; and No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Breast cancer (On 23FEB2022 patient was diagnosed with breast cancer and undergone surgery on 1-Apr-2022, she also got radiation treatment but it was finished currently. For cancer treatment patient was currently taking a pill of Zoledronic Acid (Zometa) every 6 months and treatment lasts 3 years, and also taking vitamin C and B1, Calcium, and Anastrozole 1 mg tablet.) since 23-Feb-2022. Concomitant products included ZOLEDRONIC ACID MONOHYDRATE (ZOMETA), VITAMIN C [ASCORBIC ACID], THIAMINE HYDROCHLORIDE (VITAMIN B1), CALCIUM and ANASTROZOLE for Breast cancer.    In September 2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Patient also mentioned she is currently having a real bad cold). At the time of the report, NASOPHARYNGITIS (Patient also mentioned she is currently having a real bad cold) had not resolved.            Patient receives his fifth dose as Moderna vaccine on 19-Sep-2022.  It was reported that patient was currently having a real bad cold and she would go to urgent care as soon as possible to be treated because she did not know if she had bronchitis or what else could be.  Treatment information was not provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo
Clinical narrative: Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium; Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium. It started 11 pm; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium) and BALANCE DISORDER (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium. It started 11 pm) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in 2022.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 13-Dec-2023, the patient experienced VERTIGO (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium) and BALANCE DISORDER (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium. It started 11 pm). At the time of the report, VERTIGO (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium) and BALANCE DISORDER (Approximately 36 hours after dose, I experienced vertigo, including loss of equilibrium. It started 11 pm) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant and treatment medication were reported.  It was reported that approximately 36 hours after dose, she experienced vertigo, including loss of equilibrium. It started 11 pm. The next morning it was worse. The patient wobbled when she walked and kept drifting off to the right. By 4 pm that same day she was better.   The patient did not experience any additional symptoms or events. The patient had no medical history, concomitant disease or risk factor. There were no lab data or results available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I have been infected with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I have been infected with Covid) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunosuppression.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I have been infected with Covid). At the time of the report, COVID-19 (I have been infected with Covid) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient was vaccinated last year with the Moderna version. The patient didn't made antibodies because the patient immunosuppressed. (RXs the patient was taking for Kidney Transplant). The patient was fortunate enough to get Evusheld injections by AstraZeneca. No adverse reactions resulted. The patient was infected with Covid. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: recurring diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (recurring diarrhea) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 06-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIARRHOEA (recurring diarrhea). At the time of the report, DIARRHOEA (recurring diarrhea) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The only thing they have experienced is a real sore arm each time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU, ASKU, ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy.   On 06-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time). At the time of the report, PAIN IN EXTREMITY (The only thing they have experienced is a real sore arm each time) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Caller reported they want to stay with Moderna because they had it before. The only thing they have experienced is a real sore arm each time. Nothing else. Just a little soreness after the shot was given. Patient had sore arm but it was not that bad. It was for one day.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: did have some symptoms after getting the shot.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (did have some symptoms after getting the shot.) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (did have some symptoms after getting the shot.). At the time of the report, IMMUNISATION REACTION (did have some symptoms after getting the shot.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that, Caller did not have any additional details on the adverse reactions her son experienced, but she did say that his symptoms only lasted one or two days.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-753900 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753900:Same reporter, different patient
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: He says that his lip was tingling after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (He says that his lip was tingling after receiving the vaccine.) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031488) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Batch no- 010M20A, Dose 1) on 05-Feb-2021, Moderna covid-19 vaccine (Batch no- 031M20A,  Dose 2) on 05-Mar-2021, Moderna covid-19 vaccine (Batch no- 939904,  Dose 3) on 26-Oct-2021, Moderna covid-19 vaccine (Batch no- 056A22A and  Dose 4) on 08-May-2022. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 18-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 18-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PARAESTHESIA ORAL (He says that his lip was tingling after receiving the vaccine.). At the time of the report, PARAESTHESIA ORAL (He says that his lip was tingling after receiving the vaccine.) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient did not have any allergy, concomitant diseases and risk factor.  He did not have any issues with his throat and there is no soreness in his arm.  The lip tingling sensation started 5 to 10 minutes after receiving the Spikevax and is now already diminishing.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: pain in his upper chest/he had pain in the upper part of his chest; I had bilateral palm pain at the same time as I was experiencing the chest pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "pain in his upper chest/he had pain in the upper part of his chest"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had bilateral palm pain at the same time as I was experiencing the chest pain". Therapeutic measures were taken as a result of chest pain, pain in extremity.  Additional information: Bilateral upper chest pain near clavicles, both palms, both arms at exertion and non exertion. Caller demanded stress test.  Good ejection and refraction. No sign of infarction. Symptoms were abating at this time, probably 98% gone. Responded well to ibuprofen and "broke the pain cycle" with no recurring pain. Stated Pfizer would be unable to make a diagnosis or give a long term prognosis and referred caller to HCP to discuss.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Death
Clinical narrative: Got vaccinated; passed away a few hours later; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Dec2023 as dose number unknown, single (Lot number: HE6172) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 07Dec2023, outcome "fatal", described as "Got vaccinated; passed away a few hours later". The patient date of death was 07Dec2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The reporter mentioned that one of their patients got vaccinated with a Prevnar 20 vaccine and passed away a few hours later.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Got vaccinated; passed away a few hours later
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Depression anxiety" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergies: Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 04Dec2023 to 09Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: experienced hives and welts covering chest, breasts, back, thighs, buttocks, and soles of feet; Soreness in upper arm as expected; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Dec2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin, Clindamycin" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; VALTREX; SINGULAIR; PROTONIX [OMEPRAZOLE]; SPIRIVA [TIOTROPIUM BROMIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Dec2023 at 10:00, outcome "recovered" (Dec2023), described as "Soreness in upper arm as expected"; URTICARIA (medically significant) with onset 12Dec2023 at 10:00, outcome "recovered" (Dec2023), described as "experienced hives and welts covering chest, breasts, back, thighs, buttocks, and soles of feet". The events "experienced hives and welts covering chest, breasts, back, thighs, buttocks, and soles of feet" and "soreness in upper arm as expected" required physician office visit. Therapeutic measures were taken as a result of urticaria, pain in extremity. Clinical Course: Soreness in upper arm as expected; experienced hives and welts covering chest, breasts, back, thighs, buttocks, and soles of feet for 56 hours that would not respond to antihistamines or hydrocortisone. Patient received treatment for adverse events with Zyrtec with Pepcid. Prior to vaccination she was not diagnosed with COVID-19, Since the vaccination she had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid (5-day treatment).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: Feb2021, stop date: Dec2023; METOPROLOL SUCCINATE, start date: Jan2023, stop date: Dec2023; PREGABALIN, start date: Jun2023, stop date: Dec2023. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, BATCH/LOT NUMBER: GL0447, ANATOMICAL LOCATION: LEFT ARM), administration date: 26Apr2023, when the patient was 74-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Nov2023, outcome "unknown", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Nov2023, outcome "unknown", described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 29Nov2023 to 03Dec2023. Clinical course: The patient had no known allergy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.