chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLUC4, RSV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to pharmacy with red, warm, swollen left arm on 10/24/23, 3 days after the vaccines were administered. It was recommended for her to follow up with her primary care physician because it appeared the patient had developed cellulitis.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Directly after the immunization, patient experienced dizziness. Then the patient experienced dizziness, only at night, when turning over in bed for the proceeding 4-5 days.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Tdap last administered 7/23/2021, not yet due for repeat. Patient not pregnant.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient administered Bexsero (meningitis serogroup B) instead of Menactra (meningitis ACYW). No further adverse effects were reported by patient's mother. No medical follow-up was required.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt was supposed to get mmr and varicella separate. Pt got varicella by itself but proquad instead of mmr individually. Therefore, pt got 2 doses of varicella. Parents advised.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported/No additional AE/No PQC.; Improperly stored; This spontaneous report was received from a medical assistance and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reaction and allergies were not reported.  On 13-JUL-2023, the patient was vaccinated with a improperly stored a varicella virus vaccine live (oka/merck) (VARIVAX), injection, 0.5 milliliter, lot #W018825, expiration date: 14-JUN-2024, (strength, dose#, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Age: 61.0
Sex: M
Vaccine: HPV9
Symptoms: Dyspnoea, Interstitial lung disease, Off label use, Respiratory papilloma
Clinical narrative: Was given Gardasil 9 without symptomatic recurrence of RRP/ research that secondary prevention may be achieved with gardasil 9 (on goin Trials); Literature Report  This literature marketed report had been received from the authors of a published article, titled as stated above, and referring to a 61-year-old male. The patient's medical history included COVID-19, intubation, mechanical ventilation, and tracheostomy tube insertion. The patient's concurrent conditions included nasal cannula oxygen therapy, and respiratory papillomatosis (otherwise reported as previously healthy). Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as treatment for recurrent respiratory papillomatosis (RRP) as secondary prevention after the procedural removal of papillomas (off label use) (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: FLUN4
Symptoms: Drug hypersensitivity
Clinical narrative: PATIENT MENTIONED THAT SHE EXPERIENCED SEVERE ALLERGIC REACTIONS TO ANOTHER UNSPECIFIED MEDICATION, SOMETIME AFTER HAVING RECEIVED FLUMIST WHICH WAS BEFORE 2016; PATIENT REPORTS THAT SHE IS ALLERGIC TO POLYETHYLENEGLYCOL AND HAS HAD TO GO TO THE ER TWICE FOR REACTIONS, SPECIFIC START DATES UNKNOWN; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) 1 df once/single administration, via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016 (preferred term: Drug hypersensitivity). On an unknown date, the patient experienced patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown (preferred term: Polymers allergy).     The outcome of the event(s) of patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016 and patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown and patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016.  The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): patient reports that she is allergic to polyethyleneglycol and has had to go to the er twice for reactions, specific start dates unknown and patient mentioned that she experienced severe allergic reactions to another unspecified medication, sometime after having received flumist which was before 2016.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 24-Oct-2023: Unticked the Include in E2B box in ALL files. Narrative updated.
Sex: U
Vaccine: FLUN4, FLUN4
Symptoms: Hypersensitivity, Polymers allergy, Product administered to patient of inappropriate age
Clinical narrative: ALLERGIC REACTION TO POLYETHYLENE GLYCOL AFTER PATIENT HAD RECEIVED DOSES OF FLUMIST; RECEIVED DOSES OF FLUMIST AFTER AGE OF 49; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.   A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced allergic reaction to polyethylene glycol after patient had received doses of flumist (preferred term: Polymers allergy). On an unknown date, the patient experienced received doses of flumist after age of 49 (preferred term: Product use issue).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed. It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of allergic reaction to polyethylene glycol after patient had received doses of flumist and received doses of flumist after age of 49 was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): allergic reaction to polyethylene glycol after patient had received doses of flumist. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): allergic reaction to polyethylene glycol after patient had received doses of flumist.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 23-Oct-2023: Populated applicable null flavors for ALL events and Patient Ethnic Group and Ethnic Classification dropdowns with applicable information or valid Null Flavor. Added valid null flavors to ALL Fields of ALL Reporters. Narrative updated.    Minor correction on 24-Oct-2023: Ticked the Reporter name (Vaccination facility) for the suspect Product. Unticked the Include in E2B box in ALL files. Narrative updated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 05-OCT-2023) for prophylaxis.   On 13-OCT-2023, the patient received Pediarix. On 13-OCT-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: expired drug used). 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: 16-OCT-2023 The registered nurse reported that an expired dose of Pediarix was administered to a patient which led to expired vaccine used. The reporter to consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL per vial instead of 0.25mL/ vial.
Age: 26.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthritis, Joint swelling
Clinical narrative: Left knee swollen/inflamed
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product label issue
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pain, Vision blurred
Clinical narrative: I experienced blurred vision both eyes; like looking through fog.  I had  pain in my left eye
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Vertigo
Clinical narrative: Vertigo  - onset 2 days after vaccine with inability to walk/stand; sudden onset
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Blood test, Helicobacter test, Injection site rash
Clinical narrative: Rash under injection site. Vomiting the evening of the injection. Abdominal pain so severe an ambulance was called and taken to the ER. Medication prescribed by ER doctor. Subsequent testing done 2 days later at urgent care for continued abdominal discomfort.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: Rash under injection site. Vomiting the evening of the injection. Abdominal pain so severe an ambulance was called and taken to the ER. Medication prescribed by ER doctor. Subsequent testing done 2 days later at urgent care for continued abdominal discomfort.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness, Photosensitivity reaction, Visual impairment
Clinical narrative: 10/5 UC with dizziness, 10/9 symptoms of dizziness decreasing with Meclizine, 10/13 Dizziness increases with photosensitivy, 10/16 Dizziness with vision changes sent to ER
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast fibrosis, Heavy menstrual bleeding, Menstrual clots
Clinical narrative: Extremely heavy periods with blood clots and fibroids in the breast area that did not exist previously
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: no symptoms shown
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Double polio dose/the patient received another dose of polio; 2-year-old patient that was supposed to receive DTap and polio doses received Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24-NOV-2023) for prophylaxis.   Co-suspect products included POLIO VACCINE for prophylaxis.   On 18-OCT-2023, the patient received Pediarix and POLIO VACCINE. On 18-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Double polio dose/the patient received another dose of polio) and wrong vaccine administered (Verbatim: 2-year-old patient that was supposed to receive DTap and polio doses received Pediarix). The outcome of the overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter called to inform that earlier that day, a patient was supposed to receive DTap and polio doses received Pediarix. However, shortly after the administration of Pediarix, the patient received another dose of polio, from the manufacturer Sanofi, which led to overdose and wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Manufacturing issue
Clinical narrative: Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL. The manufacture provided 0.5mL per vial instead of 0.25mL/ Vial.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Dose was not diluted and resulted in higher than dose recommended.  Unsure if any adverse effects were experienced by the patient.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: no symptoms yet.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .50ml and is labeled as "single dose."  Staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml.  Adverse reactions not yet reported.
Age: 6.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect dose administered
Clinical narrative: Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mLper Vials instead of 0.25 mL/ vial.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dehydration, Electrocardiogram abnormal
Clinical narrative: - Arm pain (sharp and severe with movement in upper arm, constant and aching down through fingers), worsened on days 2-3 and then taped off on 4th day after shot - Chest pain/discomfort (worse when lying down flat or on right side), worst on 2nd day, present on 3rd day, mostly gone by 4th day - Low grade fever - Fatigue - Headache - Nausea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: - Arm pain (sharp and severe with movement in upper arm, constant and aching down through fingers), worsened on days 2-3 and then taped off on 4th day after shot - Chest pain/discomfort (worse when lying down flat or on right side), worst on 2nd day, present on 3rd day, mostly gone by 4th day - Low grade fever - Fatigue - Headache - Nausea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: - Arm pain (sharp and severe with movement in upper arm, constant and aching down through fingers), worsened on days 2-3 and then taped off on 4th day after shot - Chest pain/discomfort (worse when lying down flat or on right side), worst on 2nd day, present on 3rd day, mostly gone by 4th day - Low grade fever - Fatigue - Headache - Nausea
Age: 73.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Dizziness, Fall, Fatigue, Headache
Clinical narrative: Patient called and said she got the vaccine on 10/23 but as soon as she got home she got dizzy and fall on floor but she said she didnt break anything in her body and today she was feeling better and has some headache and felt tiered. so l told patient to monitor her symptoms and if she is doing better than no need to do anything but if she still has dizziness than to call Doctor and let us know or head to urgent care. patient said she was doing better. she had gotten shingles and prevnar 20 so I'm not sure what exactly caused this. she said that pharmacist didnt tell her to wait 15 minutes after so she left right away and I said I'm sorry  and she was not mad or anything.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain and large red swelling. Pain lasted, gradually diminishing, for three days; soreness lasted another three days. Redness lasted five days.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Death
Clinical narrative: Per patient's daughter-   Patient presented to the ED on 10/8/23 and was discharged with a prescription for Keflex. He presented to ED again the next day and was admitted. The patient was found to have developed Autoimmune Hemolytic Anemia secondary to vaccine and passed away on 10/12/23. Prior to this Moderna vaccine, the patient had received 5 Pfizer Covid vaccines and opted to receive Moderna as that was the vaccine in stock at the time.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Oral herpes, Stomatitis
Clinical narrative: Patient reporting multiple oral sores and fever blisters on lips  3 days after co-administration of flu and covid vaccine
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HD flu shot given to someone under 65 at vaccination clinic. No adverse events reported
Sex: U
Vaccine: UNK
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: With Moderna my upper arm was sore for days.; I also had flu like symptoms for 3 - 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (All Pfizer shots). Past adverse reactions to the above products included Injection site pain with Pfizer.    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 PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days). At the time of the report, PAIN IN EXTREMITY (With Moderna my upper arm was sore for days.) and INFLUENZA LIKE ILLNESS (I also had flu like symptoms for 3 - 4 days) outcome was unknown.            Concomitant medication was not provided. Patient went to get Vax '23 where patient got all other Covid shots (all Pfizer). The pharmacist said there wasn't a difference between the 2 vaccines and got Moderna.  Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Vaccination site urticaria
Clinical narrative: she had a welt the size of her finger on the site of the injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) 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 VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection). At the time of the report, VACCINATION SITE URTICARIA (she had a welt the size of her finger on the site of the injection) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746010:Reporter's case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Joint swelling, Rash, Rash erythematous, Rash papular
Clinical narrative: Elbows were swollen; Patient got like an allergic reaction, small red bumps, raised up and covered all hands, legs all over their body. It looks like the chicken pox with big bumps; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Patient got like an allergic reaction, small red bumps, raised up and covered all hands, legs all over their body. It looks like the chicken pox with big bumps) and JOINT SWELLING (Elbows were swollen) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8092) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 12-Oct-2023 to an unknown date for an unknown indication.    On 12-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 12-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HYPERSENSITIVITY (Patient got like an allergic reaction, small red bumps, raised up and covered all hands, legs all over their body. It looks like the chicken pox with big bumps). On an unknown date, the patient experienced JOINT SWELLING (Elbows were swollen). At the time of the report, HYPERSENSITIVITY (Patient got like an allergic reaction, small red bumps, raised up and covered all hands, legs all over their body. It looks like the chicken pox with big bumps) had not resolved and JOINT SWELLING (Elbows were swollen) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   By Saturday patient could not handle it and called the doctor. Patient got a steroid to get it calmed down and the patient was still getting the reaction. Reaction started the evening they received the vaccine. It started in the arm of the Moderna and then spread. The flu vaccine was given on a different arm.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nasopharyngitis
Clinical narrative: The patient was also very cold; sore injection site arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 012L20A and 939905) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (The patient was also very cold), INJECTION SITE PAIN (sore injection site arm) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-746386 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old female patient (not pregnant) 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: Moderna covid-19 vaccine (dose 2), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 09Oct2023 to 14Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Malaise
Clinical narrative: had a reaction the same thing freezing and ended up in bed all day; did not feel good; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 17Oct2023, outcome "unknown"; MALAISE (non-serious) with onset 17Oct2023, outcome "unknown", described as "did not feel good"; FEELING COLD (non-serious) with onset 17Oct2023, outcome "unknown", described as "had a reaction the same thing freezing and ended up in bed all day". Additional information: Caller stated that her sister-in-law had on Monday afternoon the Pfizer Covid 19 and woke up on Tuesday morning she had a reaction the same thing freezing and ended up in bed all day. Did not feel good. She was freezing, had a headache and was in bed all day.   The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid in Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling at injection sited; injection sited redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single; ELIQUIS; COREG; CALCIUM+D3; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at injection sited"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "injection sited redness".  Additional information: There was no covid prior vaccination. Did not covid tested post vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body height, Diarrhoea, Weight
Clinical narrative: Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4629) at the age of 61 years, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history included: "Frozen shoulder", start date: Jun2023 (unspecified if ongoing), notes: Frozen shoulder started in Jun2023. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 10Oct2023, outcome "recovering", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional information: Took Imodium as treatment.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseousness; 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 bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2022, for COVID-19 immunisation; Bnt162b2 (DOSE 2 , SINGLE), administration date: Apr2022, for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), administration date: Dec2022, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Nauseousness".  Additional information: A female patient was asking if nausea was one of the side effects of Pfizer Covid vaccine. Said she got it about a week ago, her doctor seems concerned. Said does not mind the fever and the chills but she had nauseousness for about 10 hours afterwards. But last year it was not bad and does not remember having a nauseousness like this. Stated that she had the original two of Pfizer and the booster from the previous years. She got the original 2 series March or April and then got a booster in December that was bad, and this year was bad. Does not remember having side effects last year. This year that she got the nauseousness for 10 hours. And so, she gets nervous every time she had to take it because she does not want to feel that nauseousness again. And also wanted to confirm if it was for all of them or just for this year.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Muscle tightness, Pain in extremity, Sleep disorder due to a general medical condition
Clinical narrative: He woke up this morning with pain in his front chest; pain in his leg/pain in my front shin; tight muscles/tense muscles; losing sleep because of the pain; 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 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1 0.3 ml, single (Lot number: HG2649) at the age of 59 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "upset stomach" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for abdominal discomfort. Vaccination history included: covid-19 vaccine Janssen (DOSE 1, SINGLE, Batch/lot number: 202A21A), administration date: 08Apr2021, for COVID-19 immunisation; covid-19 vaccine Janssen (DOSE 2 (BOOSTER), SINGLE, Batch/lot number: 213D21A), administration date: 08Dec2021, for COVID-19 immunisation. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 07Oct2023, outcome "unknown", described as "tight muscles/tense muscles"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset Oct2023, outcome "unknown", described as "losing sleep because of the pain"; PAIN IN EXTREMITY (non-serious) with onset 18Oct2023, outcome "unknown", described as "pain in his leg/pain in my front shin"; CHEST PAIN (non-serious) with onset 19Oct2023, outcome "unknown", described as "He woke up this morning with pain in his front chest". The events "tight muscles/tense muscles", "pain in his leg/pain in my front shin", "he woke up this morning with pain in his front chest" and "losing sleep because of the pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle tightness, pain in extremity, chest pain, sleep disorder due to a general medical condition.  Additional information: The patient got the shot late afternoon Friday. Saturday he had tight muscles just below his shoulder blades on both sides in his back. Throughout the week he started getting "a muscular thing" on his lower ribs just below his chest in the front. He was losing sleep because of the pain. He think it was from the vaccine. Last night his legs were really bothering him. He woke up with pain in his front chest. It tends to come and go. He knows its muscular because he can use a foam roller to roll on and it loosens up his muscles. He tried cold and heat: hot tub, ice packs, hot showers to loosen up his muscles but the roller gave him the most relief. X-rays have also been taken of his chest.
Age: 25.0
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) (Nurse). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Stenosis as an infant that has been corrected through 2 heart surgeries" (unspecified if ongoing); "2 heart surgeries" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sudafed, reaction(s): "Allergies: Sudafed"; Zithromax, reaction(s): "Allergies: zithromax"; Fentynal, reaction(s): "Allergies: Fentanyl". 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 were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date: 06Oct2023, treatment stop date: 11Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective and COVID-19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain, Peripheral swelling, Swelling
Clinical narrative: Pain; swelling in right arm; armpit is swollen; still swollen lymph node there; Armpit painful/ armpit is where the pain is; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "blood pressure is high" (ongoing); "sugar is high" (ongoing); "prediabetes" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, single, Anatomical Location: Arm Left), administration date: Dec2020, for COVID-19 immunization, reaction(s): "my armpit, it is swollen and painful, it happened to me the last time", "Swollen lymph/ Swollen lymph node", "pain went away", "noticed swelling/my armpit, it is swollen and painful, it happened to me the last time". The following information was reported: AXILLARY PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "Armpit painful/ armpit is where the pain is"; PAIN (non-serious) with onset Oct2023, outcome "not recovered"; SWELLING (non-serious) with onset Oct2023, outcome "not recovered", described as "armpit is swollen"; LYMPHADENOPATHY (non-serious) with onset Oct2023, outcome "not recovered", described as "still swollen lymph node there"; PERIPHERAL SWELLING (non-serious) with onset Oct2023, outcome "unknown", described as "swelling in right arm". The events "pain", "swelling in right arm", "armpit is swollen", "still swollen lymph node there" and "armpit painful/ armpit is where the pain is" required physician office visit. Therapeutic measures were taken as a result of pain, peripheral swelling, swelling, lymphadenopathy, axillary pain.  Additional information: Patient woke up from sleep with pain. The pain was terrible. The pain and swelling in right arm was worse this morning and she had taken ibuprofen and applied warm compress. To clarify, patient's arm was swollen but her armpit was where the pain was. Consumer stated about 210 (pounds), 210 to 212 around that (Consumer was not sure of the weight. Patient reported that time of vaccination consumer thought got it around 12 in the afternoon. Around 12:30-12:45 (pm). Consumer stated it happened every time she got it, she got this shot .  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334408 Same reporter/patient, different events/vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache; muscle ache; chills; joint pain; fatigue; 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 bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, 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: HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; CHILLS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FATIGUE (non-serious), outcome "unknown".  Additional information: She got the shot yesterday and woke up with an excruciating headache, muscle aches, chills, fatigue, and joint pain. She wanted to know that how long would it take for side effects to go away and if these were common side effects or should she be concerned. she called regarding the Pfizer Covid vaccine 2023-2024 for adults.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Pain at the injection site and arm; Pain at the injection site and arm; body chills and aches; body chills and aches; Mild headache; Mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Graves' Disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, on 21Sep2023 as dose number unknown, single; ALTAVERA; ESCITALOPRAM; BUSPIRONE. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen; Lamb, reaction(s): "known allergies: lamb", notes: known allergies: lamb. 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, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild headache"; NAUSEA (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild nausea"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "Pain at the injection site and arm"; CHILLS (non-serious), PAIN (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "body chills and aches". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, chills, pain, headache, nausea. Additional information: Patient did not have COVID prior vaccination and was not COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site and arm; Pain at the injection site and arm; body chills and aches; body chills and aches; Mild headache; Mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Graves' Disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, on 21Sep2023 as dose number unknown, single; ALTAVERA; ESCITALOPRAM; BUSPIRONE. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen; Lamb, reaction(s): "known allergies: lamb", notes: known allergies: lamb. 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, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild headache"; NAUSEA (non-serious) with onset 18Oct2023 at 18:00, outcome "recovering", described as "Mild nausea"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "Pain at the injection site and arm"; CHILLS (non-serious), PAIN (non-serious) all with onset 18Oct2023 at 18:00, outcome "recovering" and all described as "body chills and aches". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, chills, pain, headache, nausea. Additional information: Patient did not have COVID prior vaccination and was not COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.