chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-AUG-2023, the patient received Arexvy (intramuscular). On 21-AUG-2023, 3 days after receiving Arexvy, the patient experienced covid-19 (Verbatim: tested positive for COVID).The outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Arexvy.   It was unknown if the company considered the covid-19 to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-SEP-2023 The patient reported that she received the Arexvy vaccines at a local pharmacy.  The lot and expiration date were unknown.  The patient reported that she tested positive for Covid. No additional information was provided. Not all information was available.  The customer did not provide consent to follow up with healthcare professional.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of an expired Bexsero dose 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 17-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 08-SEP-2023, the patient received Bexsero. On 08-SEP-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administration of an expired Bexsero dose 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: 08-SEP-2023 The reporter called to report that the administration of an expired Bexsero dose to a patient, which led to expired vaccine used.  The healthcare professional asked if the patient had to receive a repeat dose of Bexsero. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix dose with sterile water instead of the supplied saline diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Hib (Hiberix) (batch number H43J7, expiry date 13-JUN-2024) for prophylaxis.   On 08-SEP-2023, the patient received Hiberix. On 08-SEP-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix dose with sterile water instead of the supplied saline diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-SEP-2023 At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter Nurse reported one of their newer nurses reconstituted Hiberix dose with sterile water instead of the supplied saline diluent and administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter consented to follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender 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.    In 2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 05 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:master case
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging normal, Vaccination site pain
Clinical narrative: pain in the left arm (injected arm).; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (pain in the left arm (injected arm).) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor of the patient was reported as none.     In January 2023, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2023, the patient experienced VACCINATION SITE PAIN (pain in the left arm (injected arm).). At the time of the report, VACCINATION SITE PAIN (pain in the left arm (injected arm).) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: did not reveal anything abnormal.         Concomitant product use was not provided by the reporter.  It was reported that patient had received another 4 doses of Moderna COVID-19 vaccine (Lot number and Exp. Date was unknown). The last shot was administered on Jan-2023 at a local pharmacy. Since Jan-2023 patient was having pain in the left arm (injected arm). Vaccination card was not handy at the time of reporting. Patient had visited a magnetic resonance imaging (MRI) was performed which did not reveal anything abnormal.  Treatment information was not provided.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy, Blister, Pruritus, Rash, Rash vesicular
Clinical narrative: Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area; Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) in a 27-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 12-Dec-2022. Concomitant products included PREDNISONE for an unknown indication.    On 06-Aug-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 07-Aug-2023, the patient experienced BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area). At the time of the report, BLISTER (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) and PRURITUS (Skin blistering and itching beginning as single small blister-like bumps, spread from five lesions to all over the left arm, left leg, upper back and collarbone area) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: did not show a chronic autoimmune condition. On an unknown date, Blood test: confirmed it is not a viral infection.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       The patient did not experience any additional symptoms/events.  There were no additional lab data/results available.  No treatment medications were provided.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested "positive"; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested "positive") in an adult patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In August 2023, the patient experienced COVID-19 (I tested "positive"). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested "positive") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2023, SARS-CoV-2 test: Positive. In September 2023, SARS-CoV-2 test: (Negative) 15 days later tested negative., (Negative) 15 days later tested negative and (Negative) 15 days later tested negative..     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received latest COVID booster. It has been reported that patient had received 4 of the recent Moderna vaccines, last one was around last October. Two weeks ago, patient tested positive, and took 5 days of treatment medication. And it has been reported that now about 15 days later patient tested negative 3 times on Sep-2023.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2023: Live follow up has been appended.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: She drove it right into the bone and the patient went "ouch"; Intravenous in the arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 05Mar2020 as dose 2, single (Lot number: FJ8157) intravenous, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Equilibrium issue" (ongoing); "High blood pressure" (ongoing); "Injury" (unspecified if ongoing). Concomitant medications included: AMLODIPINE oral taken for hypertension (ongoing); MECLIZINE [MECLOZINE] oral taken for balance disorder (ongoing). Vaccination history included: bnt162b2 (dose 1, single; lot number: EN6200; site: arm; time; AM), administration date: 12Feb2020, for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Mar2020, outcome "unknown", described as "Intravenous in the arm"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2020, outcome "unknown", described as "She drove it right into the bone and the patient went "ouch"". Additional information: The patient had all 3 shots of Pfizer COVID-19 vaccine and booster and it worked. The first two doses were given at the patient's residence. Route was intravenous in the arm, injection in the arm. The time for administration of dose 2 of BNT162b2 was in the morning. The Pfizer vaccines that the patient received for COVID worked well. The only time he had a problem was when one of the people that administered it, she drove it right into the bone and the patient went "ouch, what are you doing". But other than that, the patient had no triggered effects. The patient got the booster when it was available for extra protection. The patient reported that the doses 1, 2 and 3 were wonderful. He would like to have some more this year.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from a contactable consumer. Updated information included: Reporter information, patient detail (name and age group), medical history and concomitant drugs.  Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2023): This is a spontaneous follow-up report received from a contactable consumer (patient), Program ID. Updated information includes: event (added gender), medical history (added injury), event (added vaccination site pain), and additional information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263533 same patient and vaccine; different dose (4) and event; US-PFIZER INC-202300263551 same patient and vaccine; different dose (3) and event; US-PFIZER INC-202300263549 same patient and vaccine; different dose (1) and event;
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Pruritus
Clinical narrative: Flushing of the face; Muscle ache in the body; Headache; Itchy feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), 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: FLUSHING (non-serious), outcome "unknown", described as "Flushing of the face"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache in the body"; HEADACHE (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchy feeling". Additional information: patient is calling about side effects she's experiencing with the Pfizer Covid Vaccine such as flushing of the face, muscle ache in the body and headache. When clarified about the flushing of the face, she said there's itchy feeling but no rash.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swelling about 2 inches below the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received pf-06928316 (ABRYSVO), on 10Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 11Sep2023, outcome "unknown", described as "red swelling about 2 inches below the injection site". Additional information: The patient reported she just got RSV (vaccination) today and now has a huge red swelling about 2 inches below the injection site. The patient would like to know if this is a normal reaction.  The information on the batch/lot number for pf-06928316, has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No reports of patients having signs/symptoms of adverse effects.; multiple patients had received improperly stored vaccines after the TE on 08/17/2023.; This spontaneous report was received from a registered nurse regarding an unknown number of patients (reported as "multiple") of an unspecified age and gender. Their medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-AUG-2023, an improperly stored vaccines of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion.  On unknown dates in August 2023, 12 patients were vaccinated with the improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided). On unknown dates in August 2023, 17 patients were vaccinated with the improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided). On unknown dates  in August 2023, 8 patients were vaccinated with the improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided). It was reported that some of the patients received two of the improperly stored vaccines on the same day (unspecified). No reports of patients having signs/symptoms of adverse effects.  This is a Non-valid case due to lack of patients' identifiers.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Raynaud's phenomenon, Systemic lupus erythematosus
Clinical narrative: Lupus; Raynaud's disease; Rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On or about 08-SEP-2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at  her local Pharmacy as recommended for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, was treated by providers for rash, Raynaud's disease and Lupus(Systemic lupus erythematosus)( dates unspecified date). As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment.   As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages. The outcome of the events was unknown.  Causality for the events were considered related to zoster vaccine live (ZOSTAVAX) vaccine   Upon internal review Lupus(Systemic lupus erythematosus) was considered were considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; the patient received a pediatric dose instead of an adult dose of VAQTA.; This spontaneous report was received from a registered nurse and refers to a patient of unreported age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, intramuscular injection, 50/1.0 u/ml, lot #1989614, expiration date: 23-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that the patient received a pediatric dose instead of an adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age). It was also reported that the patient would receive "the other half today". No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Nausea, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Pain in chest; Jaw pain; Nausea; Hand pain; Feeling very aches/Body aches; This non-serious case was reported by a consumer and described the occurrence of chest pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-SEP-2023, the patient received Shingrix. On 06-SEP-2023, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Pain in chest), jaw pain (Verbatim: Jaw pain), nausea (Verbatim: Nausea), pain in hand (Verbatim: Hand pain) and general body pain (Verbatim: Feeling very aches/Body aches).  The outcome of the chest pain, jaw pain, nausea, pain in hand and general body pain were not resolved.   It was unknown if the reporter considered the chest pain, jaw pain, nausea, pain in hand and general body pain to be related to Shingrix.     It was unknown if the company considered the chest pain, jaw pain, nausea, pain in hand and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient was not pregnant. After administration of Shingrix vaccine, the patient was feeling very aches, pain in chest was like the ribs area. The patient just felt extremely terrible. The symptoms were not treated. No other products were administered by the patient. The reporter gave permission to contact.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose; Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV926A, expiry date 30-MAY-2024) for prophylaxis.   On 14-AUG-2023, the patient received Menveo (left deltoid). On 14-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose) and inappropriate dose of vaccine administered (Verbatim: Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-Sept-2023 Licensed practical nurse called to inquired that the patient would need to be revaccinated and how to proceed. Did not consent to follow-up. The nurse reconstituted the Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a month ago, the patient received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose in 2016).   In AUG-2023, the patient received the 2nd dose of Engerix B. In AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: a month ago, the patient received the second dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Sept-2023 A pharmacist asked if the first dose was considered valid and if so, what was the recommended interval between the second and third dose. The reporter declined to share patient information and had no data of the first Engerix-B dose administered (lot number, expiry date). Did not consent to follow-up. The patient received second dose of Engerix-B (a month ago) later than a recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: allergic reaction to Prevnar 13; whole arm swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic reaction to Prevnar 13"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "whole arm swelled up".  Additional information: The patient had an allergic reaction to Prevnar 13 where her whole arm swelled up.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 70.0
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Erythema, Feeling hot, Headache, Malaise
Clinical narrative: Covid Booster shot on Wednesday of this week and I had it in my right arm and then in my left arm I received the flu shot; did not feel so great the rest of the day; Had a massive headache and finally it went away; My right arm started to get red and hot not really where the injection was but below it; it is like that still today; it's grown; My right arm started to get red and hot not really where the injection was but below it; it is like that still today; it's grown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GL2042, Expiration Date: 29Feb2024) at the age of 70 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization serious complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Covid Booster shot on Wednesday of this week and I had it in my right arm and then in my left arm I received the flu shot; did not feel so great the rest of the day"; HEADACHE (non-serious), outcome "recovered", described as "Had a massive headache and finally it went away"; ERYTHEMA (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "My right arm started to get red and hot not really where the injection was but below it; it is like that still today; it's grown".  Additional information: The patient reported of having COVID booster shot on Wednesday and had it in right arm and in left arm, received flu shot. The patient did not feel so great the rest of the day maybe because of having two shots so the patient was not really concerned about it. The next day, the patient had a massive headache which went away but the right arm started to get red and hot. Explained that it was not really where the injection was but below it. It was still like that today, and it's grown. The patient was not sure whether to be concerned about this.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A female patient received bnt162b2 (BNT162B2), in 2022 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in rehab and they had a COVID 19".  Clinical course: The caller mentioned that he is calling regarding the availability of the new COVID-19 vaccine, and he would also like to know where he can get it in his area. The caller also said that he and his wife took the COVID-19 vaccine a year ago. The caller mentioned that her wife is in (place name withheld) and they had a COVID 19. The caller would like to know if his wife can have the vaccine. The caller also stated that he had heart surgery and diabetes. I created two manual AE forms because his wife and took the vaccine. Also, the caller had heart surgery and diabetes, and he also took the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: 1252) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jan2021 at 11:00 as dose 1, single (Lot number: 9261), in left arm, on 12Feb2021 at 11:00 as dose 2, single (Lot number: 9265), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 1623), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 1606), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "chronic gastritis" (unspecified if ongoing); "Ankylosing Spondilitis" (unspecified if ongoing); "Known allergies: peanut" (unspecified if ongoing), notes: Known allergies: peanut; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: IV Iodine" (unspecified if ongoing), notes: Known allergies: IV Iodine. Concomitant medication(s) included: ALLERTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2018; CARAFATE, start date: 01Jan2010; LIPITOR, start date: 01Jan2010; NORVASC, start date: 01Jan2016; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: 01Jan2018; ZOLOFT, start date: 01Jan2010. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 5 (booster), single (Lot number: Gs3275) at the age of 69 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Sep2023) negative, notes: I had two negative test 48 hours apart; (Sep2023) negative, notes: I had two negative test 48 hours apart; (Sep2023) positive, notes: I tested positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid from 31Aug2023 to 05Sep2023.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: Gj5342) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: Er8732), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: Fw0172), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, Diarrhoea, Fatigue
Clinical narrative: fatigue; diarrhea; brai fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 86-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fell out of chair" (unspecified if ongoing); "fractured hip" (unspecified if ongoing); "rehab" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Behtelovimab. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunisation, reaction(s): "covid-19", "drug ineffective"; Comirnaty (Dose 2), for COVID-19 immunisation, reaction(s): "covid-19", "covid-19"; Comirnaty (Dose 3), for COVID-19 immunisation, reaction(s): "covid-19", "drug ineffective"; Comirnaty (Dose 4), for COVID-19 immunisation, reaction(s): "drug ineffective", "drug ineffective". The following information was reported: BRAIN FOG (non-serious) with onset 2023, outcome "unknown", described as "brai fog"; DIARRHOEA (non-serious) with onset 2023, outcome "unknown", described as "diarrhea"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300153749 same patient, different events and doses;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "Well control type 2 diabetes" (unspecified if ongoing); "slightly elevated blood pressure" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2009. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on treatment with Paxlovid from 31Aug2023 to 05Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298972 same patient, different drug/event (Paxlovid case);
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single at the age of 55 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (12Sep2023) positive, notes: Rebound positive text on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine and medication in two weeks. Paxlovid was taken as treatment for COVID-19 from 02Sep2023 to 07Sep2023.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Sep2023, outcome "not recovered" and all described as "Tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299588 Same reporter, patient, product, different dose and events;
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Other medical history: Breast cancer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 03Sep2023 to 07Sep2023 were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Local reaction
Clinical narrative: Local injection site reactions consisting of erythema/in size, maybe 1cm; Local injection site reactions consisting of induration/in size, maybe 1cm; Local injection site reactions consisting of significant pruritus/itching; This spontaneous case was received on 09-Sep-2023 from a physician (consumer) (reference number: SEQW23-02125) and concerned a 67-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included annual flu vaccinations for over the past 20-30 years without any adverse events (AEs).  On 06-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm; dose, route of administration, and indication: not reported). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent, the patient had local injection site reactions consisting of erythema, induration, and significant pruritus. The patient had attached a photo of the patient's wife's arm. The patient's was significantly smaller in size, maybe 1cm, but still itching.  At the time of initial reporting, the patient had not recovered from all events. As reported, the patient was three days out and still had the reaction.  The reporter did not provide a causality assessment. As reported, this was the first time receiving this vaccine. The patient read product information (PI) and knew that AE rates were comparable to the comparators in trials, but the patient wanted to alert to these two personal cases.  This case was assessed as non-serious.  This case is linked with the case 202303957 (the same reporter).  Company comment: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Local injection site reactions consisting of erythema/in size, maybe 1cm; Local injection site reactions consisting of induration/in size, maybe 1cm; Local injection site reactions consisting of significant pruritus/itching; This spontaneous case was received on 09-Sep-2023 from a physician (consumer) (reference number: SEQW23-02125) and concerned a 67-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included annual flu vaccinations for over the past 20-30 years without any adverse events (AEs).  On 06-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm; dose, route of administration, and indication: not reported). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent, the patient had local injection site reactions consisting of erythema, induration, and significant pruritus. The patient had attached a photo of the patient's wife's arm. The patient's was significantly smaller in size, maybe 1cm, but still itching.  At the time of initial reporting, the patient had not recovered from all events. As reported, the patient was three days out and still had the reaction.  The reporter did not provide a causality assessment. As reported, this was the first time receiving this vaccine. The patient read product information (PI) and knew that AE rates were comparable to the comparators in trials, but the patient wanted to alert to these two personal cases.  This case was assessed as non-serious.  This case is linked with the case 202303957 (the same reporter).  Company comment: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.