chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Fatigue, Nausea
Clinical narrative: shortness of breath; loss of appetite; diarrhea; nausea; fatigue/tiredness; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not had any history of myocarditis or pericarditis. Patient did not had acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu shot (flu shot before the first booster) in 2021. Past adverse reactions to the above products included No adverse reaction with flu shot. Concurrent medical conditions included Allergic reaction to bee sting (Bumblebees).   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness). At the time of the report, DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness) had not resolved.             The patient was under a lot of concomitant and regular medications (there were a lot of them), but not provided names.  It was reported that few days after second booster patient experienced stronger symptoms coming and going. At the time of reporting symptoms were still coming and going.  The adverse event did not cause patient to seek medical care. The patient did not experience a similar event in the past.  No treatment had been given for her symptoms.   This case was linked to MOD-2022-635781, MOD-2022-635784 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: Sick in bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick in bed) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick in bed). At the time of the report, ILLNESS (Sick in bed) had resolved.            The patient had no known allergies.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the event of sick in bed was not provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Vaccination site rash
Clinical narrative: Vaccination site rash; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) and ARTHRALGIA (Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and ARTHRALGIA (Arthritic pains). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) had resolved and ARTHRALGIA (Arthritic pains) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No Concomitant medication reported.  The reporter's causality for the event(s) of PATIENT DEVELOPED RASH FROM MODERNA VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS PAIN was not provided.  No Treatment medication reported.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract infection
Clinical narrative: Respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Severe and Moderate).   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection) was resolving.            Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that  reporter's causality for the event of respiratory infection with humira(adalimumab) was no reasonable possibility. Treatment information was not provided.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM; No adverse event; Pediatric patient received dose greater than 12 hour post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received dose greater than 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received dose greater than 12 hour post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-AUG-2022 at 8:15 AM and administerd on 25-AUG-2022 at at 8:30 AM).    No relevant concomitant medications were reported.  It was reported that number of doses were 3 doses. On 03-AUG-2022 the vial was initially stored in the refrigerator. Post puncture vial was stored in the fridge. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree centigrade = 46 to 77 degree Farenheit) was 5-10 minutes just to draw up the doses.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-635837, US-MODERNATX, INC.-MOD-2022-635851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635837:Patient 1 US-MODERNATX, INC.-MOD-2022-635851:Patient 3
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the fridge for 2 weeks after puncture; No adverse event; Patients received dose greater than 12 hour post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture) and PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture).    Concomitant product use was not provided by the reporter.  Number of doses administered was 3 doses.  The vial was initially stored in the refrigerator on 03-Aug-2022.  The vial was first punctured on 04-Aug-2022 at 8:15 AM.  The vial was stored in the fridge for 2 weeks after puncture and then administered.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 5-10 minutes just to draw up the doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-635840, US-MODERNATX, INC.-MOD-2022-635837 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635840:Patient 2 US-MODERNATX, INC.-MOD-2022-635837:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Gastrointestinal disorder, Oropharyngeal pain, Parosmia, Sweating fever
Clinical narrative: My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.; Also, my sense of smell increased a lot.; Also had increase in GI issues; I did have the sharp pain in throat; Fever and soaking wet bed in morning from head to toe.; Toothpaste burned my tongue; Because my chest felt like it had a 100 pound weight on it.; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat) and SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.). At the time of the report, TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.) outcome was unknown and PAROSMIA (Also, my sense of smell increased a lot.) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder, Tongue discomfort
Clinical narrative: My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.; Also, my sense of smell increased a lot.; Also had increase in GI issues; I did have the sharp pain in throat; Fever and soaking wet bed in morning from head to toe.; Toothpaste burned my tongue; Because my chest felt like it had a 100 pound weight on it.; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat) and SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), PAROSMIA (Also, my sense of smell increased a lot.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.). At the time of the report, TASTE DISORDER (My taste increased so much that even my bland toothpaste burned my tongue and could overtaste everything.), GASTROINTESTINAL DISORDER (Also had increase in GI issues), OROPHARYNGEAL PAIN (I did have the sharp pain in throat), SWEATING FEVER (Fever and soaking wet bed in morning from head to toe.), TONGUE DISCOMFORT (Toothpaste burned my tongue) and CHEST DISCOMFORT (Because my chest felt like it had a 100 pound weight on it.) outcome was unknown and PAROSMIA (Also, my sense of smell increased a lot.) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: I was affected by second Moderna; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I was affected by second Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I was affected by second Moderna). At the time of the report, IMMUNISATION REACTION (I was affected by second Moderna) outcome was unknown.            No Concomitant medication reported.  No Treatment medication reported.   This case was linked to MOD-2022-636258 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media  (J and J corporate account) concerned multiple patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy dates were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced blood clots. As per reporter, "me either after the talcum powder lawsuit at the vaccine for Covid alot of my friends got blood clots all kinds of stuff". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220851164-covid-19 vaccine ad26.cov2.s -blood clots . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Ended up in the hospital paralyzed; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Ended up in the hospital paralyzed) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced PARALYSIS (Ended up in the hospital paralyzed) (seriousness criteria hospitalization and medically significant). At the time of the report, PARALYSIS (Ended up in the hospital paralyzed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  After the 24 hours of Moderna first dose, the patient experienced paralysis.  Treatment information was not reported.  Company Comment: This spontaneous case reported by a consumer concerns a male patient of unknown age, with no reported medical history, who experienced unexpected, serious (hospitalization, medically significant) event of paralysis, after receiving a first dose of mRNA-1273.  It was reported that 24 hours after vaccination, he ended up in the hospital paralyzed.  Further clinical course, diagnostic evaluation, concomitant medications, and treatment not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.     Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a consumer concerns a male patient of unknown age, with no reported medical history, who experienced unexpected, serious (hospitalization, medically significant) event of paralysis, after receiving a first dose of mRNA-1273.  It was reported that 24 hours after vaccination, he ended up in the hospital paralyzed.  Further clinical course, diagnostic evaluation, concomitant medications, and treatment not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: Sore arm; given almost 2ml of the product, instead of 0.3ml.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 14-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2022 as dose 3 (booster), 2 ml single (Lot number: FP7150, Expiration Date: 16Oct2022) at the age of 14 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Past history of mixed hyperlipidemia" (unspecified if ongoing); "Vitamin d deficiency" (unspecified if ongoing); "High serum cholesterol borderline" (unspecified if ongoing); "autoimmune thyroiditis", start date: 2018 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Second Dose, NDC, LOT, EXP: Unknown ), administration date: 08Jun2021, when the patient was 12-year-old, for Covid-19 immunization; BNT162b2 (First Dose, Covid-19 vaccine, purple cap NDC, LOT, EXP: Unknown), administration date: 29May2021, when the patient was 12-year-old, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 23Aug2022, outcome "unknown", described as "given almost 2ml of the product, instead of 0.3ml."; PAIN IN EXTREMITY (non-serious) with onset 24Aug2022, outcome "unknown", described as "Sore arm".  Additional Information: Caller was reporting an administration error for the Pfizer COVID vaccine gray cap that had been administered to a patient. Caller confirmed that the patient was given almost 2ml of the product, instead of 0.3ml. Caller wants to know if there was anything the patient can do or any guidance about this error and if there are side effects to look after the error. Caller also mentioned that it was for the booster dose of the patient. Reporter called because they were concerned that an employee gave the wrong Covid vaccine. Found out, the correct Covid vaccine was given but was given the wrong dosage. Dose was supposed to be 0.3ml and patient was given almost 2ml, which was too much. Patient had no reaction other than a sore arm. Patient had no additional vaccines administered on same date of the Pfizer suspect. AE(s) did not require a visit to Emergency Room or Physician Office. Patient had no prior vaccination (within 4weeks) and had no AE(s) following prior vaccinations. No family medical history relevant to AE(s). Patient had no relevant tests done.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (23Aug2022 and 24Aug2022): This is a spontaneous follow-up report received from a contactable other HCP. Updated information: new reporter, patient details, medical history, historical vaccine, vaccination details, new event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (manufacturer unknown) (Batch/Lot number: unknown) and as dose 2, single (manufacturer unknown) (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), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller mentions that she had covid now and was taking Molnupiravir 800mg twice a day for 5 days and that she had 2 days to go, she stated she had no fever and was starting to feel a little bit better. Patient stated that she was prescribed this medication instead of Paxlovid since her medications interacts with Paxlovid. She also mentions that her husband was actually on Paxlovid right now. She asked when she can get the 2nd booster dose of the Pfizer Covid 19 vaccine after recovering from covid?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got covid after receiving the first vaccine; Got covid after receiving the first vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got covid after receiving the first vaccine". Clinical course: The patient asked what was the longest time frame one can go when got first Pfizer shot and before the second shot. She asked if it was recommended 21 days apart. She stated that she had an emergency come up that past Friday, which was the day she was supposed to get her second Pfizer Covid-19 vaccine. She wondered if she can get her vaccine that day. She was not sure if she needed to wait 30 days. Caller also provided that she got covid after receiving the first vaccine. She asked how long she needed to wait to receive the second dose after having covid and In how many months was the vaccine no longer effective. She stated that given that the CDC recommends waiting 3 months to receive the second dose after covid, she asked would they give it to her then, she also asked the CDC number.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Lot number: EP7534) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (Dose: 1, Site of administration: Consumer stated, "Left arms."), administration date: 06Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "I have a very high fever temperature after each one", "Chills", "Achy all over for approximately 24 hours on each of those". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Achy all over for approximately 24 hours on each of those"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I have a very high fever temperature after each one". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain. Additional Information: Therapeutic measures was with Tylenol 100 milligram. No Follow-up attempts are possible No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (Dose 1, single; Anatomical Location: Left arm), administration date: 06Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "High fever", "Chills", "Achy all over"; BNT162b2 (Dose 2, single; Lot number: EP7534; Anatomical Location: Left arm), administration date: 27Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "High fever", "Chills", "Achy all over". The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "High fever/ high fever temperature"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "achy all over". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain. Additional information: Consumer (Patient) stated that she had a very high fever temperature after each one. She stated, "High fever, chills, achy all over for approximately 24 hours on each of those". For those 2 vaccines and the 2 boosters. Patient stated the booster is I can't read her write it's looks like Pfizer FF2580 or 89 and the last one was I can't read this; I can't read it." Patient stated, she had no laboratory tests, not within 1 or 2 weeks. She stated that she received Tylenol "100 milligram" as treatment for adverse event. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: High fever; Chills; Achy all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: EN6198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: Unknown, Anatomical location: Left arm), administration date: 06Mar2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP7534, Anatomical location:  Left arm), administration date: 27Mar2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over"; BNT162b2 (DOSE 3 (BOOSTER) SINGLE; Lot number: Unknown, Anatomical location: Left arm), administration date: 07Oct2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "High fever", "Chills", "Achy all over". The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Achy all over"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "High fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain.  Additional information: It was reported that the patient did not had other conditions. No investigations were done. The reporter wanted to know some of the questions about the side effects of Pfizer vaccine for COVID and the Pfizer booster for COVID. The patient had a very high fever temperature after each one. The patient had high fever, chills, achy all over for approximately 24 hours on each of that 2 vaccines and the 2 boosters. When the patient got last booster, the CDC was monitoring me and sending a weekly, then monthly like how the patient was doing, has been been sick and got a questionnaire on Saturday and not heard anything. The patient wanted to make sure they may have happened maybe side effects. The patients age was 70 years (Not clarified as Age at time of Adverse Event hence not captured). The patient did not underwent any laboratory tests within 1 or 2 weeks. Therapeutic measures were taken as a result if the adverse events and included treatment with Tylenol 100 milligram. The patient received the first vaccine on 06Mar2021, the next one is 27Mar2021, the next one is 07Oct2021 and the last one is 21May2022. The reporter wanted to know some other side effects.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 at 18:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: High blood pressure but being treated for it" (unspecified if ongoing), notes: Other medical history: High blood pressure but being treated for it. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 24Aug2022, outcome "not recovered", described as "feeling pretty sick again/ tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Negative, notes: I actually tested negative on 20Aug2022; (22Aug2022) Negative, notes: I actually tested negative on 20Aug2022; (24Aug2022) Positive, notes: Today the 24th I started feeling pretty sick again. Coughing worse and low grade fever. I tested this evening and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included tab Paxlovid. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: The patient received vaccine received. No other medications in two weeks. The patient took anti-viral product Paxlovid for COVID 19 Treatment starting from 15Aug2022 till 20Aug2022. No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: disease recurrence; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (Aug2022) and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 18Aug2022 at 18:00, outcome "recovered with sequelae" (24Aug2022). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: treatment of COVID-19; (20Aug2022) Negative; (21Aug2022) Positive; (22Aug2022) Negative; (23Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received Paxlovid as treatment from 10Aug2022 to 14Aug2022. After finishing Paxlovid series and finishing 5 day isolation period, the patient returned to work. On 18Aug22, started seeing symptoms return; Sore throat Congestion Slight fever Very fatigued 20Aug22 negative at home test 21Aug22 positive at home test 22Aug22 negative at home test 23Aug22 negative at home test On 24Aug22 symptoms started to resolve, still have cough. The seriousness was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Rebound 5 days after treatment and return to test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac issues. Took 1/2 dosing" (unspecified if ongoing), notes: Cardiac issues. Took 1/2 dosing. The patient's concomitant medications were not reported. Past drug history included: O, reaction(s): "known allergies: O". The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Rebound 5 days after treatment and return to test positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: COVID 19 Treatment from 11Aug2022 to 11Aug2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Rebound 5 days after treatment and return to test positive, adverse event start date: 24Aug2022, adverse event start time: 06:00 AM. Patient recovered. No treatment ae.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 as dose 1, single (Lot number: EW0164), in right arm and on 10Nov2021 as dose 2, single (Lot number: FC3183) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (Aug2022) positive, notes: positive at home test for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid from 12Aug2022 to 16Aug2022 for COVID-19. On 22AUG2022, the patient was positive at home test for COVID-19. Been feeling like I have got a cold past 2 day. Headache, stuffy nose, sore throat, cough and chills.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had a positive test on 01Aug2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: other medical history: Diabetic, Morbid obesity; "Morbid obesity" (unspecified if ongoing), notes: other medical history: Diabetic, Morbid obesity. Concomitant medication(s) included: METFORMIN; OZEMPIC; LOSARTAN; SINVASTATINA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 01Aug2022, outcome "recovering", described as "had a positive test on 01Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Jul2022) Negative; (30Jul2022) Negative; (01Aug2022) Positive; (03Aug2022) Positive; (09Aug2022) Positive; (11Aug2022) Negative; (12Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: subject had two boosters in addition to two vaccinations reported, after completing Paxlovid on 27Jul2022 and testing negative on 28Jul and 30Jul2022, had a positive test on 01Aug, 03Aug and 09Aug. Negative again on 11Aug and 12Aug. If treatment ae: No, Known allergies: No. Other medical history: Diabetic, Morbid obesity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 at 12:00 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 at 13:15 as dose 2, single (Lot number: EN6198), in left arm and on 24Aug2021 at 14:30 as dose 3 (booster), single (Lot number: EW0180) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 29Mar2022 at 14:30 as dose 4 (booster), single (Lot number: 027L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjögren's syndrome" (unspecified if ongoing), notes: controlled; "Known allergies:Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, stop date: 05Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2022) Positive, notes: Covid positive 07Aug2022; (13Aug2022) Negative, notes: Covid negative on 13Aug; (15Aug2022) Positive, notes: Covid positive, 15Aug; (20Aug2022) Positive, notes: Symptoms: fever, myalgia, arthralgia, headache, runny nose, malaise, loss of taste and smell until 20Aug - still Covid positive on test); (21Aug2022) Negative, notes: 21Aug tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took Anti-viral medications as COVID 19 Treatment from 07Aug2022 to 11Aug2022. The symptoms included fever, myalgia, arthralgia, headache, runny nose, malaise, loss of taste and smell until 20Aug2022. There were mild symptoms remained to date (25Aug2022). No treatments taken for these symptoms.
Age: 58.0
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) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 16:00 as dose 1, single (Lot number: EU00152), in left arm and on 07May2021 at 16:00 as dose 2, single (Lot number: EU000182) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 03Jan2017; NORT, start date: 03Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 of Paxlovid. Treatment start date was 23Aug2022 and stop date was 24Aug2022 of lot number G06840  Clinical course: The patient had no known allergies.  No follow-up attempts were possible. No further information was expected.