chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Influenza like illness, Malaise
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 09-NOV-2023 The reporter is the patient. The patient received shingrix 2 dose series. The reporter developed a sore arm after receiving the first dose. The reporter confirmed she received shingrix and not other vaccine for shingles but she did not recalled the dates. No other information was provided. Did not consented to follow-up.
Age: 0.17
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the one vial presentation of Menveo in a 2 month old patient; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 2R7L7, expiry date 31-DEC-2024) for prophylaxis.   On 09-NOV-2023, the patient received the 1st dose of Menveo. On 09-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: the one vial presentation of Menveo in a 2 month old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 09-NOV-2023 A nurse reported to inquiring about Menveo and what information was available about the information available for the use of the one vial presentation of Menveo in a 2-month-old patient.  HCP reported that the wrong formulation of Menveo vaccine was administered to a 2 months old male infant.  Menveo comes in two formulations, the single vial pre-mixed formulation was approved for ages 10 through age 55. The two-vial formulation (requiring reconstitution) was approved for ages 2 months through 55 years of age.  Since this patient was an infant this patient should had received the two-vial formulation but instead received the single vial pre-mixed formulation.  The reporter stated that the child was under observation and no adverse reactions were observed. The one vial presentation of Menveo received a 2 month old patient which led to inappropriate age at vaccine administration.  The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Electroencephalogram, Encephalitis autoimmune
Clinical narrative: LEUCINE-RICH GLIOMA-INACTIVATED PROTEIN (LGI1) ANTIBODY ENCEPHALITIS; This spontaneous report was received from physician via literature. The objective of this article was to describe a case of suspected post-vaccine autoimmune encephalitis associated with leucine-rich glioma-inactivated protein (LGI1) antibodies with significant clinical improvement after initiation of immunotherapy nearly a year after symptom onset. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was previously healthy and highly independent.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 9 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced abnormal posture and spasm of the right shoulder 2 to 3 weeks after vaccination. The abnormal movements progressed to involve the right side of patient face and were refractory to multiple ASMs (Anti-seizure medication). EEG (Electroencephalogram) captured multiple events without epileptiform correlate. Several months later patient had developed paranoia, delusions, and hallucinations. Autoimmune encephalopathy panel returned positive for the LGI1-antibody (leucine-rich glioma-inactivated protein) around nine months after the onset of FBDS (Faciobrachial Dystonic Seizures). The patient had a fluctuating level of arousal, impaired recall of recent events, and was tangential in conversation. There were frequent, brief, repetitive, dystonic movements of the right side of the face consistent with FBDS. Admission was arranged for immunotherapy (intravenous methylprednisolone and intravenous immunoglobulin). Upon follow-up four weeks later, there was significant improvement in patient arousal and concentration with resolution of FBDS and delusions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leucine-rich glioma-inactivated protein (lgi1) antibody encephalitis. The authors concluded that case highlights a classic case of LGI1 encephalitis after vaccination presenting with FBDS and progressive cognitive changes. Despite immunotherapy being delayed, there was marked clinical improvement. It was important to recognize this entity and that it typically had a favorable outcome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231129709-leucine-rich glioma-inactivated protein (lgi1) antibody encephalitis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation reaction
Clinical narrative: barely walk; Slowly getting reactions; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (barely walk) and IMMUNISATION REACTION (Slowly getting reactions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 prophylaxis.     The patient's past medical history included Sneezing. Concurrent medical conditions included Thyroid disorder (taking medication for it) and Seasonal allergy (allergic in the beginning of the summer and they start sneezing.).   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (barely walk) and IMMUNISATION REACTION (Slowly getting reactions). At the time of the report, GAIT DISTURBANCE (barely walk) and IMMUNISATION REACTION (Slowly getting reactions) had not resolved.            It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient had the Moderna vaccination for Covid 2 years ago and slowly getting reactions and now the patient can barely walk.  No treatment medication was reported.   This case was linked to MOD-2023-749086, MOD-2023-749084.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749086:Bivalent case
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Gait disturbance, Immunisation reaction
Clinical narrative: can barely walk/dragging their feet; slowly getting reactions; covid-19; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (can barely walk/dragging their feet), IMMUNISATION REACTION (slowly getting reactions) and COVID-19 (covid-19) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient was in good health.  The patient's past medical history included Sneezing. Concurrent medical conditions included Thyroid disorder (Patient had thyroid and was taking medication for it.) and Seasonal allergy (Patient was allergic in the beginning of the summer and they start sneezing).    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions). At the time of the report, GAIT DISTURBANCE (can barely walk/dragging their feet) and IMMUNISATION REACTION (slowly getting reactions) had not resolved and COVID-19 (covid-19) outcome was unknown.            Concomitant product included unspecified medication for thyroid.  It was reported that patient had Moderna vaccination for Covid 2 years ago and slowly getting reactions and at the time of reporting patient could barely walk. Patient was having trouble walking. Patient got the vaccine 2 years ago and it was affecting their walking. Patient was dragging, had no numbness, just dragging her feet. Patient went to the hospital to check and see if she had Parkinson and she did not. Patient got covid 1 year go.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749084, US-MODERNATX, INC.-MOD-2023-749085. This case was linked to MOD-2023-749084, MOD-2023-749085.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749084:Spikevax NOS case US-MODERNATX, INC.-MOD-2023-749085:Bivalent case
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Vaccination site pain
Clinical narrative: 2 days after the shot they had the usual pain where the got the shot and it disappeared; some stuffiness that changes between the nostrils; minor sore throat; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (some stuffiness that changes between the nostrils), OROPHARYNGEAL PAIN (minor sore throat) and VACCINATION SITE PAIN (2 days after the shot they had the usual pain where the got the shot and it disappeared) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (2 days after the shot they had the usual pain where the got the shot and it disappeared). In November 2023, the patient experienced NASAL CONGESTION (some stuffiness that changes between the nostrils) and OROPHARYNGEAL PAIN (minor sore throat). At the time of the report, NASAL CONGESTION (some stuffiness that changes between the nostrils) and OROPHARYNGEAL PAIN (minor sore throat) had not resolved and VACCINATION SITE PAIN (2 days after the shot they had the usual pain where the got the shot and it disappeared) had resolved.            Patient had no allergies, no medical conditions and not on any medications.  Patient had all Moderna vaccine.  It was reported that patient got a minor sore throat and some stuffiness that changes between the nostrils. 2 days after the shot they had the usual pain where the got the shot and it disappeared. Patient got the shot 2 to 3 weeks ago. patient did not do anything for a week and then went somewhere days after. Not gotten tested yet for covid. No other vaccines received within 4 weeks.   No treatment medication information was provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Pain in extremity, Retching
Clinical narrative: dry heaves; dry cough; nauseated/she feels like throwing up; she experienced sore arm during approximately 3 day; This spontaneous case was reported by a patient and describes the occurrence of RETCHING (dry heaves), COUGH (dry cough), PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day) and NAUSEA (nauseated/she feels like throwing up) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Blood cholesterol abnormal. Concurrent medical conditions included Type 2 diabetes mellitus and Blood pressure high. Concomitant products included METFORMIN, EMPAGLIFLOZIN (JARDIANCE), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), SPIRONOLACTONE, LISINOPRIL, HCTZ, ATORVASTATIN, AMLODIPINE BESYLATE and INSULIN GLARGINE (LANTUS SOLOSTAR) for an unknown indication.    On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 12-Nov-2023, the patient experienced RETCHING (dry heaves), COUGH (dry cough) and NAUSEA (nauseated/she feels like throwing up). In November 2023, the patient experienced PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day). In November 2023, PAIN IN EXTREMITY (she experienced sore arm during approximately 3 day) had resolved. At the time of the report, RETCHING (dry heaves), COUGH (dry cough) and NAUSEA (nauseated/she feels like throwing up) had not resolved.       Reported patient already received all her 3 or 4 Moderna shots but did not remember dates. For the previous vaccines she did not experience any adverse events. She received recent dose on 2-Nov-2023. she experienced sore arm during approximately 3 days and then it stopped, but on 12-Nov-2023 she started feeling nauseated dry cough, dry heaves, she feels like throwing up when she does not, and this was still ongoing, but patient did not know if this was related to the vaccine.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Glucose tolerance impaired, Sjogren's syndrome, Small fibre neuropathy
Clinical narrative: Sjogren syndrome; diabetes; prediabetes; small fiber neuropathy / small diameter neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogren syndrome) and DIABETES MELLITUS (diabetes) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 SJOGREN'S SYNDROME (Sjogren syndrome) (seriousness criterion medically significant), DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), GLUCOSE TOLERANCE IMPAIRED (prediabetes) and SMALL FIBRE NEUROPATHY (small fiber neuropathy / small diameter neuropathy). At the time of the report, SJOGREN'S SYNDROME (Sjogren syndrome), DIABETES MELLITUS (diabetes), GLUCOSE TOLERANCE IMPAIRED (prediabetes) and SMALL FIBRE NEUROPATHY (small fiber neuropathy / small diameter neuropathy) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter told that she wanted to talk with a scientist and or the research people about the adverse events that she had after the vaccine. She reported these conditions but did not specifically state if these were the side effects she wanted to talked about with the scientist include small fiber neuropathy, small diameter neuropathy, diabetes, prediabetes and Sjogren syndrome. Concomitant medications were not reported.  No treatment information was provided by the reporter. Company comment: This is a spontaneous case concerning a female patient of unknown age, with no medical history reported, who experienced the serious (medically significant) unexpected events of Sjogren's syndrome and diabetes mellitus which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination and events onset dates unknown. It was provided that the patient called to talk with a scientist and/or the research people about the adverse events that the patient had after the vaccine. Mentioned conditions included small fiber neuropathy, small diameter neuropathy, diabetes, prediabetes, Sjogren syndrome; however, it was not specifically stated if these were the side effects the patient wanted to talk about with the scientist. There is no information disclosed on events clinical course, etiologic and diagnostic work up, any accompanying circumstances and/or risk factors, treatment received. Events outcome as unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Palpitations
Clinical narrative: Heart racing and high anxieties for a week; Heart racing and high anxieties for a week; dizzy; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032229) for COVID-19 prophylaxis.     Allergic to Radiation Therapy- hives after several treatments. Had cancer twice.  The patient's past medical history included Tetanus and Hives. Previously administered products included for Product used for unknown indication: Flu vaccine on 11-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Cancer, Allergy to intravenous contrast media (Allergic to CAT contrast which caused similar reactions), Allergy to vaccine (Tetanus shots) and Drug allergy (Blood pressure medications).    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 03-Nov-2023, the patient experienced PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Dizziness, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart racing and high anxieties for a week), ANXIETY (Heart racing and high anxieties for a week) and DIZZINESS (dizzy) had not resolved.            Concomitant medication was not reported.  The patient had heart racing and high anxieties. The patient also faced dizzy on 9th day. It was unknown if the patient had any additional symptoms or events.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Eructation, Flatulence, Pain in extremity
Clinical narrative: Patient had pain around his heart; Patient started having pain in his arm about a day after the shot, and it lasted about a week; Gas; Burping; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Patient had pain around his heart), PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week), FLATULENCE (Gas) and ERUCTATION (Burping) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Diabetes (under control) and COPD (mild).    On 29-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Oct-2023, the patient experienced FLATULENCE (Gas) and ERUCTATION (Burping). On 30-Oct-2023, the patient experienced PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week). In November 2023, the patient experienced CHEST PAIN (Patient had pain around his heart). In November 2023, PAIN IN EXTREMITY (Patient started having pain in his arm about a day after the shot, and it lasted about a week) had resolved. At the time of the report, CHEST PAIN (Patient had pain around his heart), FLATULENCE (Gas) and ERUCTATION (Burping) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   The patient had pain around his heart, and it was worse some days than others.  Treatment medication was not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pneumonia
Clinical narrative: pneumonia; abdominal cramps; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 25-Oct-2023, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and ABDOMINAL PAIN (abdominal cramps). At the time of the report, PNEUMONIA (pneumonia) and ABDOMINAL PAIN (abdominal cramps) had not resolved.            No concomitant medications were reported. Patient experienced upper respiratory and also lower abdominal cramps. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. Company Comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Pneumonia, which occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine (unknown COVID-19 vaccination schedule). The outcome of the event was reported as not recovered. It was reported that patient experienced upper respiratory and lower abdominal cramps. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: Palpitations; Burning sensation; felt Faint; Headache; Fatigue; Pain at the injection site; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 07-Nov-2023, the patient experienced PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain). On 11-Nov-2023, PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.  Within 20 minutes of receiving Spikevax, the patient had a mild headache and felt somewhat faint. Within 6 hours, she had fatigue and pain at the injection site. At approximately 22 hours after the injection, she experienced heart palpitations that continued for approximately 11 hours more. At approximately 30 hours after injection, the patient also felt a burning sensation in her feet and intense joint pain that lasted about 6 hours. Fatigue continued for approximately 72 hours total.   It was unknown if the patient experienced any additional symptoms or events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Palpitations
Clinical narrative: Palpitations; Burning sensation; felt Faint; Headache; Fatigue; Pain at the injection site; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 07-Nov-2023, the patient experienced PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain). On 11-Nov-2023, PALPITATIONS (Palpitations), BURNING SENSATION (Burning sensation), DIZZINESS (felt Faint), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.  Within 20 minutes of receiving Spikevax, the patient had a mild headache and felt somewhat faint. Within 6 hours, she had fatigue and pain at the injection site. At approximately 22 hours after the injection, she experienced heart palpitations that continued for approximately 11 hours more. At approximately 30 hours after injection, the patient also felt a burning sensation in her feet and intense joint pain that lasted about 6 hours. Fatigue continued for approximately 72 hours total.   It was unknown if the patient experienced any additional symptoms or events.
Age: 75.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Lip swelling, Pruritus
Clinical narrative: Body itching; swollen lip; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Body itching) and LIP SWELLING (swollen lip) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031281) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 02-Jan-2023.   On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In November 2023, the patient experienced PRURITUS (Body itching) and LIP SWELLING (swollen lip). At the time of the report, PRURITUS (Body itching) and LIP SWELLING (swollen lip) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that vaccine was given by shot. Simultaneously with seasonal flu vaccine. Patient had Allergy-like reaction. Body itching and swollen lip.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment information was provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness, swelling and itching at injection site; redness, swelling and itching at injection site; redness, swelling and itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site) in a 59-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059068) for COVID-19 prophylaxis.     The patient had no concomitant disease or risk factor.  The patient's past medical history included COVID-19 in January 2023.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (redness, swelling and itching at injection site), VACCINATION SITE ERYTHEMA (redness, swelling and itching at injection site) and VACCINATION SITE SWELLING (redness, swelling and itching at injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  The patient did not experience any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate
Clinical narrative: Terrible headache for 2 full days (much worse than with her first two shots); This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Apr-2021.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)). On 18-Nov-2021, HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Heart rate: 20-30 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had terrible headache for 2 full days (much worse than with her first two shots) and an elevated heart rate by 20-30 bpm for 2 -3 days. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 72 hours after receiving that vaccine she started experiencing vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot, COVID-19 VACCINE (Dose 3), COVID-19 VACCINE (Dose 2) and COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and Flu shot.    On 28-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo). At the time of the report, VERTIGO (72 hours after receiving that vaccine she started experiencing vertigo) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient received 3 prior COVID-19 vaccines before receiving her first Moderna COVID-19 vaccine. 72 hours after receiving that vaccine she started experiencing vertigo which has been persisting until today. She has not taken any medications or treatments to help with her symptoms. Online she read 60 percent of people reporting side effects were also reporting vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2023: Follow-up information included dosage text updated and reference number added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for covid two weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for covid two weeks ago) in a  patient of an unknown age and gender 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 29-Oct-2023, the patient experienced COVID-19 (I tested positive for covid two weeks ago). At the time of the report, COVID-19 (I tested positive for covid two weeks ago) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2023, SARS-CoV-2 test: (Positive) positive for covid. In November 2023, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2023: Significant live follow up added: Reporter information, lab data and event details updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Received Novavax 17-OCT-2023; tested positive again 02-NOV-2023; Developed a cough; Tested positive for COVID-19; On 02-NOV-2023, this serious, initial spontaneous safety report was received from a consumer via a pharmaceutical company, and was received by Novavax on 07-NOV-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 5 on 17-OCT-2023 at 11:00 AM.  Medical history included Drug hypersensitivity.  The individual was not taking any concomitant medications.  On 17-OCT-2023, the individual experienced vaccination failure (PT: Vaccination failure).  On 01-NOV-2023 18:00:00, 15 days after vaccination, the individual developed a cough (PT: Cough). On 02-NOV-2023, 16 days after vaccination, the individual tested positive for COVID-19 (PT: COVID-19), resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically significant) on 17-OCT-2023. Treatment of COVID-19 included Paxlovid (nirmatrelvir, ritonavir) from 23-OCT-2023 to 27-OCT-2023.  Relevant lab tests included a negative SARS-CoV-2 test on 29-OCT-2023 and 30-OCT-2023, and a positive SARS-CoV-2 test on 02-NOV-2023.  On 17-OCT-2023, the event of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Cough and COVID-19 were unknown.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, Cough and COVID-19 after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Cough and COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; 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 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "laryngitis" (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 "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: THROMBOSIS (disability, medically significant), outcome "unknown", described as "blood clot". Patient had the covid vaccine and all boosters... until now. He got a blood clot.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366229 Same reporter/ drug/ patient, different AE;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: still got covid; still got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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 "not recovered" and all described as "still got covid". The patient had the covid vaccine and all boosters.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366228 Same reporter/ drug/ patient, different AE;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "HBP" (unspecified if ongoing); "Parox AF" (unspecified if ongoing); "Iodine Dye allergy" (unspecified if ongoing), notes: Known allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Oct2023 to 03Nov2023.  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: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300366064 Same patient/reporter, different drug/Event;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HG4629) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 bivalent (DOSE 6 (BOOSTER), SINGLE, Vaccine lot number: AS7643E,, Vaccine location: Left arm), administration date: 22Jun2023, when the patient was 67-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023, outcome "unknown" 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; (31Oct2023) Positive, notes: 31Oct I tested positive to Covid and started taking Paxlovid for 5 days; (10Nov2023) Positive, notes: 10Nov, I tested positive to Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination Failure; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Oct2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Oct2023 to 01Nov2023. Clinical course: Patient had no known allergies.  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-202300365986 Same patient, different product, different dose/event;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Lot number: GJ6796) at the age of 54 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 21Apr2021 as dose 2, single (Lot number: FR8735), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anxiety induced High BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "allergies to food and medications" (unspecified if ongoing); "allergies to food and medications. Sulfer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies to codeine"; Erithmycin, reaction(s): "Allergies to erithmycin"; Epinephrine, reaction(s): "Allergies to epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of Covid-19 from 03Nov2023 to 07Nov2023.  Based on Investigational results for Batch/lot number FH8028 and EP7534: The complaint for lack of effect of the Pfizer biontech Covid-19 Vaccine lot FH8028 and EP7534 were investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, fill lot FH4341 and the bulk formulated drug product lot FH4347. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366134 Same patient, different drug/events;