chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: syringe failed and the patient did not receive the full dose; syringe failed and the patient did not receive the full dose; A spontaneous report was received from a nurse concerning a 69-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced event like syringe failed and the patient did not receive the full dose.  The patient's medical history was not provided. Concomitant medications were not reported.  The patient received their first of two planned dose of mRNA-1273 on 27-jan-2021. On 27-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unkown) intramuscularly for prophylaxis of COVID-19 infection.    On 27 Jan 2021, the patient experienced event like syringe failed and the patient did not receive the full dose.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, syringe failed and the patient did not receive the full dose is unknown.; Reporter's Comments: This report refers to a case of a 69-year-old patient of unknown gender who experienced nonserious unexpected events of Syringe issue and Incorrect dose administered for mRNA-1273, lot # unknown, with no associated adverse events. The syringe failed and the patient did not receive the full dose.  Event considered resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Burning sensation, Dyspepsia, Feeling abnormal, Loss of consciousness
Clinical narrative: All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding  a  63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn  and Nausea.   The patient's medical history was not reported.  Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12.  On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly  for prophylaxis of COVID-19 infection.    On 12- Feb-2021, the patient experienced the event like Passed out.  On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea.  Laboratory details not provided.      No treatment information was provided.      Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events Passed out, Face was tingling  is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding  a  63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn  and Nausea.   The patient's medical history was not reported.  Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12.  On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly  for prophylaxis of COVID-19 infection.    On 12- Feb-2021, the patient experienced the event like Passed out.  On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea.  Laboratory details not provided.      No treatment information was provided.      Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events Passed out, Face was tingling  is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: when the patient can receive the next dose given that the dose they received is expired; A spontaneous report was received from an Other Health Professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the patient can receive the next dose given that the dose they received is expired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, it was reported, when the patient can receive the next dose given that the dose they received is expired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was not reported.; Reporter's Comments: This report refers to a case of a patient who received Moderna's COVID-19 vaccine (mRNA-1273) (Lot # not provided) and reported that the patient can receive the next dose given that the dose they received is expired. No associated AEs were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the Moderna COVID vaccine past the 6 hours mark; A spontaneous report) was received from a nurse concerning a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Moderna COVID vaccine past the 6 hours mark/expired product administered.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, a nurse reported a patient received their first dose of the Moderna COVID-19 vaccine after the 6 hour mark. Per the reporter, the patient did not report any side effects.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, received the Moderna COVID vaccine past the 6 hours mark/expired product administered, was considered resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 042L20A)  with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna vaccine administered on day 22; A spontaneous reportwas received from a healthcare professional (medical director) concerning two patients, age and gender not provided, who received Moderna's COVID-19 Vaccine, and who experienced receiving the second dose vaccine on day 22 (Inappropriate schedule of product administration).    The patients' medical histories were not provided. Concomitant product use was not provided by the reporter.   The patients received their first of two planned doses of mRNA-1273 (Batch number not provided) on 05-JAN-2021 (route of administration unknown). On 27-JAN-2021, the patients received their second of two planned doses of mRNA-1273 (Batch number not provided), route of administration unknown for prophylaxis of COVID-19 infection.  A medical directer reported that at one of his facilities, two employees received their first dose of the mRNA-1273 vaccine on 05-JAN-2021.  They were supposed to receive their second dose of mRNA-1273 the week of 01-FEB-2021 but got it instead on 27-JAN-2021 (day 22). The reporter questioned if the dose would be effective or would the patients need to be revaccinated.   Treatment information was not provided.    The patients received both doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The event, second dose of Moderna vaccine administered on day 22, was considered recovered/resolved; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated adverse events. The event occurred when the second dose was administered 23 days after the first dose of mRNA-1273. Event resolved.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Body temperature, Fatigue, Headache, Heart rate increased
Clinical narrative: She thinks she had Afib; Heart rate went up; Symptoms were similar to when she had COVID; Temperature of 99 degrees; Severe Headache; Very fatigued, which is unlike her; A spontaneous report was received from a Consumer concerning a unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms.   The patient's medical history includes Covid-19, she was on a pacemaker.  Relevant concomitant medications reported include patient was taking Diltiazem 120 ER.    On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe headache, had a temperature of 99 degrees, was very fatigued, which was unlike her, she thinks she had atrial fibrillation (seriousness criteria- medically significant) and increased heart rate. She said her symptoms was similar to when she had Covid-19. Patient is on a pacemaker   Laboratory details include she had a body temperature of 99 degrees.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms was considered unknown.; Reporter's Comments: This case concerns a 72 year old, female patient, COVID (March 2020) and has a pacemaker, who experienced a serious unexpected event of Atrial fibrillation among others, 1 day after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Symptom recurrence
Clinical narrative: She thinks she had Afib; Heart rate went up; Symptoms were similar to when she had COVID; Temperature of 99 degrees; Severe Headache; Very fatigued, which is unlike her; A spontaneous report was received from a Consumer concerning a unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms.   The patient's medical history includes Covid-19, she was on a pacemaker.  Relevant concomitant medications reported include patient was taking Diltiazem 120 ER.    On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe headache, had a temperature of 99 degrees, was very fatigued, which was unlike her, she thinks she had atrial fibrillation (seriousness criteria- medically significant) and increased heart rate. She said her symptoms was similar to when she had Covid-19. Patient is on a pacemaker   Laboratory details include she had a body temperature of 99 degrees.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events- severe headache, had a temperature of 99 degrees, was very fatigued, atrial fibrillation, increased heart rate and recurrence of Covid-19 symptoms was considered unknown.; Reporter's Comments: This case concerns a 72 year old, female patient, COVID (March 2020) and has a pacemaker, who experienced a serious unexpected event of Atrial fibrillation among others, 1 day after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient accidentally received the moderna covid-19 vaccine; A spontaneous report  was received from a HCP  concerning a 16-years-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a 16-year-old patient accidentally received the Moderna Covid-19 vaccine (Product administered to patient of inappropriate age).   The patient's medical history was not reported. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient experienced product administered to patient of inappropriate age.  Laboratory details not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event is unknown.; Reporter's Comments: This case concerns a 16-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: not all the solution was injected; A spontaneous report ) was received from a healthcare provider  concerning a 19-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the administration of less than 0.5mL of vaccine. The event was reported as: not all the solution was injected.   The patient's medical history was not reported. No relevant concomitant medications were reported.  On 20-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient stated that all the solution was not injected.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the event vaccine underdose is resolved/recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Peripheral swelling
Clinical narrative: Second Moderna vaccine was injected in wrong location; swollen arm; A spontaneous report was received from a nurse concerning a 50- year-old patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was injected in wrong location (inappropriate route of vaccination) and developed swollen arm(peripheral swelling).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknow date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 JAN 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route not in the deltoid muscle for prophylaxis of COVID-19 infection.  On 26 JAN 2021, it was reported that the patient received second Moderna vaccine in an area that may not have been injected in deltoid muscle (injected in wrong location) and developed swollen arm (far back of arm) on the same day.   On 28 JAN 2021, the patient consulted an HCP who advised patient to monitor the affected area and prescribed Benadryl, which was not applied.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The event,  injected in wrong location (inappropriate route of vaccination)  was considered recovered/resolved and the outcome of swollen arm(peripheral swelling) was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of peripheral swelling, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; the vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of a dose in my other arm; A spontaneous report  received from a health care professional concerning, 39-year-old age female patient who received second dose of the Moderna COVID-19 vaccine and vaccine dripped out in my arm and it was on my hand. Then they give me a very small dose about a quarter of dose in my other are.    The patient's medical history was not included. Patient's concomitant was not included.  On 22 Jan 2021 date, the patient received their second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated that she was vaccinated with her second dose of the Moderna COVID-19 vaccine on 22 Jan 2021. Patient stated that the vaccine dripped out of her arm and it was on her hand. Patient stated they then gave her a very small dose about a quarter of a dose in her other arm. Patient wants to know if the dose was enough.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of 39-year-old female who experienced nonserious unexpected events of Exposure via skin contact and Incomplete dose administered for mRNA-1273, lot # 012L20A with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Nausea, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Lymph node enlarged at the base of neck near the shoulder; Chills; Nausea; Sore arm; patient received vaccine right below shoulder bone; A spontaneous report was received from a nurse, a 60 year old female patient who received Moderna's COVID-19 mRNA-1273 vaccine at inappropriate site of vaccination and who experienced chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy).  The patient's medical history included prior dose of Covid-19 vaccination. No adverse event was reported in the medical history of the patient.  Concomitant medications were not reported.  On 05 Jan 2021, the patient received first of the two planned doses of mRNA-1273 (Batch number:011L20A) for the prophylaxis of Covid-19 infection. No adverse event was reported related to the first dose.  On 02 Feb 2021, the prior to the onset of the events, the patient received second of their two planned doses of mRNA-1273 (Lot number:007M20A) at inappropriate site of vaccination (right below the shoulder bone).  On 03 Feb 2021,the patient reported to experience chills(Chills), nausea(Nausea), sore arm(pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy).  Treatment for the events were not reported.  The outcome of the event inappropriate site of vaccination was considered to be resolved on 08 Feb 2021.  The outcome of the events chills (Chills), nausea (Nausea), sore arm (pain in extremity) and enlarged lymph nodes at base of neck and shoulder (Lymphadenopathy) was considered not resolved.; Reporter's Comments: This case concerns a 60-year-old female who had a nonserious unexpected Product administered at inappropriate site along with nonserious expected pain in extremity, lymphadenopathy, nausea, and chills.  Event onset was 1 day after second dose and 29 days after first dose of mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 18 days after 1st dose; A spontaneous report report was received from  pharmacists concerning a male patient  (age unknown) who received the 2nd dose of the vaccine 18 days after 1st dose/inappropriate schedule of product.  The patient's medical history was not provided. No current illness was reported. Concomitant product use was not provided by the reporter.  On 11 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch# 007M20A) intramuscularly for prophylaxis of covid-19 infection.  On 29 Jan 2021, 18 days following the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of covid-19 infection.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, 2nd dose of the vaccine 18 days after 1st dose, was considered resolved on 29 Jan 2021; Reporter's Comments: This report refers to a case of inappropriate schedule of product for mRNA-1273, Batch # 007M20A  with no associated AEs. Causality for the medication error is not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever 102.1; Chills; achy; This is a spontaneous report from two contactable healthcare professionals. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) at the age of 61 years, intramuscular on the left arm on 27Jan2021 16:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure, COVID-19 and allergies to quinolones. The patient's concomitant medications were not reported. The patient is not pregnant. The patient previously took celecoxib (CELEBREX) and experienced allergies. The patient experienced fever 102.1, chills and achy on 28Jan2021 08:00. The patient did not received any treatment for the events. The outcome of the events was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Chills; fever; nausea; vomiting; body aches/pains; fatigue; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), (at the age of 37-years-old) intramuscular in the left arm on 25Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history and allergies to medications, food, or other products/known allergies: were reported none.  The patient's concomitant medications were not reported. The vaccine was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. On 28Jan2021 at 10:30 AM, the patient experienced chills, fever, nausea, vomiting, body aches/pains, fatigue. The events were considered non-serious. The events resulted in emergency room/ department or urgent care. There was no treatment received for the adverse events. The patient has not been tested for COVID since the vaccination. The outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; fever; nausea; vomiting; body aches/pains; fatigue; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), (at the age of 37-years-old) intramuscular in the left arm on 25Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history and allergies to medications, food, or other products/known allergies: were reported none.  The patient's concomitant medications were not reported. The vaccine was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has not received any other medications within 2 weeks of vaccination. On 28Jan2021 at 10:30 AM, the patient experienced chills, fever, nausea, vomiting, body aches/pains, fatigue. The events were considered non-serious. The events resulted in emergency room/ department or urgent care. There was no treatment received for the adverse events. The patient has not been tested for COVID since the vaccination. The outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (mother of the patient). A female patient of an unspecified age (age: 66, units: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her daughter (age 66) got a little sick after she got her vaccine. She was sick in stomach, diarrhea really bad. She didn't eat breakfast just had coffee. She had a hamburger after the vaccine and made a mess at the consumer's house. So the consumer was worried. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; On Saturday morning I woke up with a large rash on my left shoulder and my upper left chest. It itches.; First dose on 11Jan2021 and second dose on 28Jan2021; First dose on 11Jan2021 and second dose on 28Jan2021; ached all over my body; I felt very weak; I had a temperature of 100.7.; This is a spontaneous report from a contactable consumer. A 30-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on his left arm, via an unspecified route of administration on 28Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included allergies to sulfa medicine. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 07:00AM for COVID-19 immunization (first dose). It was reported that approximately 12 hours after the 2nd shot, the patient felt very weak and ached all over her body. She had a temperature of 100.7. This lasted from late Thursday night until late Friday Morning. On Saturday morning, she woke up with a large rash on her left shoulder and her upper left chest. No treatment was received for the events. The outcome of all event fever was recovered on an unspecified date while recovering for the remaining events.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 3247, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:45 at a single dose in the right arm for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient had no known allergies. Patient had no covid prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR); ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER); and fish oil. The patient had no other vaccine in four weeks. On 28Jan2021 22:30, patient had fever, body aches, and fatigue. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The patient recovered from the events fever, body aches, and fatigue in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had diarrhea since an unspecified date for two weeks after getting the first dose of Pfizer COVID vaccine. She took a whole bottle of Pepto Bismol. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Mother has an internal itch; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 99, unit unknown) received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller wanted to know if there will be an interaction between the Pfizer COVID-19 vaccine and betamethasone injection. Reporter is calling for her mother who has received the first dose of the COVID-19 vaccine and is scheduled for the second dose a week from today. Because her mother has an internal itch, her mother's doctor gives her betamethasone. She had conflicting recommendations from her mother's doctors and wanted to know Pfizer's recommendations. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Off label use, Product use issue
Clinical narrative: Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient is taking anastrazole for breast cancer; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient, who was also 53-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL3247, via an unspecified route of administration on left leg on 29Jan2021 14:45 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer, stroke, migraines is situ melanoma, penicillin allergy, and COVID-19 prior vaccination. Concomitant medication included atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), anastrozole, and colecalciferol (VITAMIN D). On 30Jan2021 04:30, the patient experienced Joint aches (hips), tiredness, and fever 102 (unknown unit). The outcome of the events was recovering. No treatment given for the events. The patient has COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient is taking anastrazole for breast cancer; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient, who was also 53-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL3247, via an unspecified route of administration on left leg on 29Jan2021 14:45 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer, stroke, migraines is situ melanoma, penicillin allergy, and COVID-19 prior vaccination. Concomitant medication included atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), anastrozole, and colecalciferol (VITAMIN D). On 30Jan2021 04:30, the patient experienced Joint aches (hips), tiredness, and fever 102 (unknown unit). The outcome of the events was recovering. No treatment given for the events. The patient has COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very mild sore arm; This is a spontaneous report from a contactable consumer or (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 17Jan2021 as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced very mild sore arm on an unspecified date with outcome of unknown.    Information about batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Palpitations, Vaccination site pain
Clinical narrative: Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Peripheral swelling, Vaccination site pain
Clinical narrative: patient had pain in the arm that she received the vaccine; patient had pain in the arm that she received the vaccine. It was also a little swollen; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included covid-19 diagnosed prior vaccination. Concomitant medication included spironolactone, linaclotide (LINZESS), paracetamol (TYLENOL) and caffeine, paracetamol (EXCEDRIN). On 30Jan2021, 20:45, the patient had pain in the arm that she received the vaccine. It was also a little swollen. As well as the lymph nodes under that same arm was really swollen and there was some pain and discomfort along with it. Outcome of events was not recovered. Patient did not receive treatment due to the events.  Follow-up attempts are completed. The following information on the batch number has been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: smoked cigarettes for nearly 30 years and the day after the vaccine she lost the mental aspect of craving them; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN5318), via an unspecified route of administration into right arm on 22Jan2021 19:45 (at the age of 49-year-old) at a single dose for COVID-19 immunisation. Medical history included ongoing cigarette smoker and smoked cigarettes for nearly 30 years. Patient was not pregnant. Concomitant medication included calcium (VIACTIV), evening primrose oil [oenothera biennis oil] (EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL]), linum usitatissimum seed (FLAXSEED) and multivitamin. The patient previously took demerol and codeine and experienced drug allergy to both drugs. It was reported that the patient has smoked cigarettes for nearly 30 years and the day after the vaccine (also reported as 30Jan2021 07:00), she lost the mental aspect of craving them. She have gone from a pack a day to four or five because her body still craves them. The event was reported as non-serious. The patient has not received treatment from the event reported. Outcome of event was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Nasopharyngitis
Clinical narrative: became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence, X-ray
Clinical narrative: became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Took advil due to her sore arm after shot.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a  contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unspecified), via an unspecified route of administration in the arm on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced sore arm. It was reported that patient took Advil due to her sore arm after shot and inquired if that would have an effect on the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feels dizzy and woosey; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine this morning, on an unspecified date in Jan2021, and felt dizzy and woosey - wondering if that was normal. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Body ache; Fever about 100; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had body ache and fever at about 100 (unit was not reported). The outcome of the events, 'body ache' and 'fever', was unknown. The patient wanted to know if he could get his second dose, or if he has to start over.  Information on the lot/batch number has been requested.