chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Incorrect dose administered, Nausea
Clinical narrative: Headache; Fatigue; Nausea; When it was injected quite a bit ran down my arm; A spontaneous report was received from a 70-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and when it was injected quite a bit ran down the arm and the patient experienced headache, fatigue and nausea.   The patient's medical history was not provided. The patient current condition included autoimmune disorder. No relevant concomitant medications were reported.    On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   During the administration of the vaccine, the patient experienced when it was injected, quite a bit ran down the arm. On 12 Jan 2021, the patient woke up with a headache, fatigue and had nausea. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, when it was injected quite a bit ran down the arm, was considered resolved on 11 Jan 2021. The outcome of the events, headache, fatigue and nausea, were considered resolved on 12 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of q 70-year-old female  patient who experienced non-serious events of when it was injected quite a bit ran down the arm (Incomplete dose administered) and the patient experienced headache, fatigue and nausea to hours after administration of  mRNA-1273 (lot # 025J20-2A), Exp date-unknown). The events of headache, fatigue and nausea are temporally associated with vaccine administration and consistent with the known safety profile of the vaccine, hence a causal association cannot be excluded.  The event of when it was injected quite a bit ran down the arm is considered not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 75-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 75-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of the vaccine administered after the refrigerator lost power in vaccine clinic and lost temperature control.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, the vaccine administered after the refrigerator lost power in a vaccine clinic and lost temperature control, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old, female patient who received her first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection after a refrigerator in a vaccine clinic lost power and temperature control. There we no reported adverse events associated with the event of vaccine administered after a refrigerator in a vaccine clinic lost power and lost temperature control.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event after the vaccines lost temperature they were administered (Product storage error, out of specification product use) for mRNA-1273, lot # 027L20A), Exp date-unknown. There were no reported AEs associated with the event lost temperature they were administered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 82-year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 82-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 77-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report  was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report ) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: A spontaneous report (United States) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021.  Information on lot number/batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: woke up with the shakes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up with the shakes on an unspecified date in Jan2021 after receiving the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Headache, Malaise
Clinical narrative: received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID.; received the first dose of the vaccine on 30Dec2020 / On 07Jan2021, he tested positive for COVID / COVID symptoms; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL1284, unknown lot number), intramuscular in left deltoid on 30Dec2020 at 19:30 at a single dose for COVID-19 immunisation/to prevent getting sick, to prevent the spread. Medical history and concomitant medication reported as none. The patient received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID. His second dose is scheduled on 22Jan2021 and wants to know if he should get that or if there is any recommendation. The patient clarified that the COVID symptoms began on 06Jan2021. On the night of the 6th, he started to have chills and a headache throughout the night. He never had a fever or anything. He woke in the morning of 07Jan2021 kind of congested; runny nose, clear discharge. The patient wasn't able to taste his toothpaste, and then he couldn't smell his coffee. So, he experienced a loss of taste and smell. He was then tested for COVID (rapid test) on 07Jan2021 and tested positive. It was worse 2 days after he got sick. The patient progressively gotten better each day. The patient felt good today. He still can't taste or smell fully, some of it is coming back though. No additional vaccines administered on same date and no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room/ physician office.  The patient underwent lab tests and procedures which included COVID Rapid test: positive on 07Jan2021. The patient was recovering from the events chills, headache, "congested- runny nose, clear discharge", and Loss of taste and smell, while unknown outcome for the remaining events. The patient would consider the seriousness as not significant.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID.; received the first dose of the vaccine on 30Dec2020 / On 07Jan2021, he tested positive for COVID / COVID symptoms; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL1284, unknown lot number), intramuscular in left deltoid on 30Dec2020 at 19:30 at a single dose for COVID-19 immunisation/to prevent getting sick, to prevent the spread. Medical history and concomitant medication reported as none. The patient received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID. His second dose is scheduled on 22Jan2021 and wants to know if he should get that or if there is any recommendation. The patient clarified that the COVID symptoms began on 06Jan2021. On the night of the 6th, he started to have chills and a headache throughout the night. He never had a fever or anything. He woke in the morning of 07Jan2021 kind of congested; runny nose, clear discharge. The patient wasn't able to taste his toothpaste, and then he couldn't smell his coffee. So, he experienced a loss of taste and smell. He was then tested for COVID (rapid test) on 07Jan2021 and tested positive. It was worse 2 days after he got sick. The patient progressively gotten better each day. The patient felt good today. He still can't taste or smell fully, some of it is coming back though. No additional vaccines administered on same date and no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room/ physician office.  The patient underwent lab tests and procedures which included COVID Rapid test: positive on 07Jan2021. The patient was recovering from the events chills, headache, "congested- runny nose, clear discharge", and Loss of taste and smell, while unknown outcome for the remaining events. The patient would consider the seriousness as not significant.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever chills; Fever chills; This is a spontaneous report from a non-Contactable Consumer (patient sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose (1st dose and 2nd dose) for covid-19 immunization.  Relevant medical history included virus before she got the vaccine.  On an unspecified date, patient got the vaccine and had fever chills after it. Patient received 2nd dose took Tylenol and Zyrtec before the dose. The reporter asked if that was not recommended and if could affect the efficacy. The outcome of the events was unknown.   No follow up attempts are possible. Information on Lot/Batch number could not be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives scattered on my face, neck and arms; This is a spontaneous report from a contactable physician (patient).  A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EH9899, expiry date not reported), via an unspecified route of administration on 20Dec2020 at a single dose (1st dose) then via an unspecified route of administration on 10Jan2021 (lot no: EK9231, expiry date not reported)  at a single dose (2nd dose); both on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. To his knowledge, patient has no known allergies.  Patient had no other vaccine received in four weeks.  Patient had One a Day multivitamin in two weeks. The patient stated on 23Dec2020, "The days after the first vaccine I had a couple hives scattered on my face, neck and arms. After the second vaccine, the hives increased in size and number. It really progressed today (3 days after the second shot)". The patient took BENADRYL, PEPCID and prednisone as a treatment for the events. Patient had no prior COVID vaccination and had not tested COVID post vaccination. The outcome of the event was not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Malaise, Neck pain
Clinical narrative: feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as "I guess to protect myself from other people, to protect myself"). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as "it was 10th it was Sunday morning when I took it"). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as "yesterday" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated "When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night". When asked for the treatment, the patient answered "I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment". Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as "I guess to protect myself from other people, to protect myself"). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as "it was 10th it was Sunday morning when I took it"). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as "yesterday" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated "When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night". When asked for the treatment, the patient answered "I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment". Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: exposure to someone positive to the COVID virus; She was exposed to COVID a week ago and has tested positive; She was exposed to COVID a week ago and has tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 23Dec2020 at a single dose as she doesn't want COVID.  Medical history included occasional mild hypertension since Mar2019 and ongoing anxiety depression.  Concomitant medication included sertraline hydrochloride (ZOLOFT) since Aug2020 for anxiety depression. The patient reported that she is supposed to get the second dose of the vaccine today (13Jan2021). She was exposed to COVID a week ago and has tested positive on 06Jan2021. She does not have any symptoms.  She tested negative on 08Jan2021. She will be tested again today. She is asking if it is still ok to get the second vaccine after having exposure to someone positive to the COVID virus. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after receiving the first dose; tested positive for COVID after receiving the first dose; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient (mother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), 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 reporter mentioned that her mother tested positive for COVID after receiving the first dose. The reporter wanted to know when will the patient take the second dose since she is COVID positive.  The patient is in the nursing home. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Vigorous chills (afebrile); Some sensitivity over his nose; Painful and tender lymphadenopathy on the axillary area on the same arm as the injection site; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously had his first dose of COVID-19 vaccine on an unspecified date. It was reported that the patient had the second dose of the COVID-19 vaccine on 11Jan2021, and on 12Jan2021, he had a painful and tender lymphadenopathy on the axillary area on the same arm as the injection site. He had no issues with the first shot. He also reported that he has been taking an antihistamine and the lymphadenopathy is going away. He also had vigorous chills (afebrile) when the event first took place for 2-3 hours. He had some sensitivity over his nose which was also improving with the antihistamine. The outcome of the events "painful and tender lymphadenopathy on the axillary area on the same arm as the injection site" and "some sensitivity over his nose" was recovering, and the other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Limb discomfort
Clinical narrative: diarrhea; mild abdominal pain; tiredness on legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 70, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 11Jan2021; however, the facility didn't provide the time she should show up on 01Feb2021. She was looking for the time right here at Pfizer MI. She also stated that she has been having diarrhea, mild abdominal pain and tiredness on legs, but she doesn't attribute it entirely to the vaccine, it might be related. She mentioned that her arm was not in such expected pain. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 24Dec2020 at a single dose for him to not get COVID.  Medical history and concomitant medications reported as none.  The patient is a surgical technician who received his first dose of vaccine on 24Dec2020 and tested positive for COVID-19 on 05Jan2021.  Patient's quarantine ends tomorrow, and he is also due for his second dose, tomorrow (14Jan2021).  He is asking what to do as far as taking it or not. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS).  The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes.  The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks.  Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS).  The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes.  The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks.  Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Taste disorder
Clinical narrative: mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dry mouth
Clinical narrative: mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Taste disorder
Clinical narrative: does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 (last Friday of 13Jan2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient was calling for herself regrading side effects for the vaccine, she clarified the vaccine to be the COVID-19 Vaccine, the Pfizer one, she got the vaccine on 08Jan2021 (last Friday of 13Jan2021), she was having side effects, she was having issues with her mouth, her mouth was dry and issues with taste, she was losing it a little, she did not have much taste, she stated she had never had dry mouth before and she was trying to figure out if these are symptoms from getting the vaccine or something. The patient experienced mouth dry from 12Jan2021 and ongoing, losing taste a little on an unspecified date. She wanted to know if others had experienced these events. She stated these do not worry her too much, she then added she had heard that mouth dry is a side effect. The patient stated she did not not have a fever, no coughing, or aches. The outcome of the event mouth dry was not recovered, while unknown for the other event.  Information about Lot/Batch number is requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dry mouth
Clinical narrative: does not have much taste/losing taste a little; Mouth dry; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Jan2021 (last Friday of 13Jan2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient was calling for herself regrading side effects for the vaccine, she clarified the vaccine to be the COVID-19 Vaccine, the Pfizer one, she got the vaccine on 08Jan2021 (last Friday of 13Jan2021), she was having side effects, she was having issues with her mouth, her mouth was dry and issues with taste, she was losing it a little, she did not have much taste, she stated she had never had dry mouth before and she was trying to figure out if these are symptoms from getting the vaccine or something. The patient experienced mouth dry from 12Jan2021 and ongoing, losing taste a little on an unspecified date. She wanted to know if others had experienced these events. She stated these do not worry her too much, she then added she had heard that mouth dry is a side effect. The patient stated she did not not have a fever, no coughing, or aches. The outcome of the event mouth dry was not recovered, while unknown for the other event.  Information about Lot/Batch number is requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.