chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Arm sore for a week   Hurt into chest   Felt extremely fatigued for about 5 days.  Ran fever over 100 for 2 days.  Felt fine after 5 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: On 11 days after getting vaccine got hives on the arm it was given on 3/22/2021
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Fever sweats chills vomiting disorientation
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Had episode of HA, N/V around 20 minutes after vaccine
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site inflammation, Injection site swelling, Peripheral swelling
Clinical narrative: localized inflammation in the arm where injection was administered; This spontaneous report was received from a consumer, via Pfizer, referring to herself, a 69-year-old female patient. Her medical history, concurrent conditions, diagnosed allergies and concomitant therapies were reported as none.    On approximately February 2016 (reported as "about 5 years ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as prophylaxis (strength, dose, frequency, route of administration, lot number, and expiration date were not provided).    Afterwards, on an unspecified date in 2016, she experienced localized inflammation on the arm where injection was administered (peripheral swelling), which was reported as lasting a couple of days. However, the specific outcome of the event was not reported.  At the reporting time, the causality assessment between the suspect vaccine and the event was unknown.
Age: 0.08
Sex: M
Vaccine: FLUX, PPV, RV5, UNK
Symptoms: Abdominal pain, Body temperature increased, Cough, Feeling abnormal, Gastrointestinal pain
Clinical narrative: Colicky; intestinal cramping; stomach gurgling; few coughs; burning up; irritable; slightly lethargic; Spaced out; Patient's leg was slightly swollen; This spontaneous report has been received from a consumer (patient's mother) concerning to a 4-month-old male patient.  The patient's concurrent conditions included gastrooesophageal reflux disease. His medical history was not reported. Drug/allergy reactions included dairy protein sensitivity. Concomitant therapies included famotidine and probiotics (unspecified).  On 16-DEC-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported), administered orally for immunization. Consequently, on 05-MAR-2021, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported) for immunization. Other suspect vaccines administered on the same day included influenza virus vaccine (unspecified), diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid, and pneumococcal vaccine (unspecified) all for immunization (strengths, doses/routes/frequencies of administration, lot numbers and expiration dates, were not reported). It was also stated that the brand names/manufactures of those vaccines were unknown.  On 05-MAR-2021, her son was colicky, had intestinal cramping, she could hear his stomach gurgling, a few coughs, and he was burning up. He was irritable and slightly lethargic. She reported that her son was staring into space for a good 5-10 minutes. The next day, 06-MAR-2021, her son was still colicky from sun up to sun down. She said the only thing that helped his symptoms was acetaminophen (TYLENOL), a warm bath, and nursing him. She did report that her son's leg was slightly swollen from where the vaccines were administered. Before the caller hung up, she did want to mention that her son received the first rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (on 16 DEC 2020) and developed similar symptoms after administration as the ones she was reporting today. The reporter did not seek medical attention.  The outcome of the reported events was reported as recovered on 09-MAR-2021 or 10-MAR-2021.  The causality assessment with the suspect vaccines was not reported.
Age: 0.08
Sex: M
Vaccine: FLUX, PPV, RV5, UNK
Symptoms: Lethargy, Peripheral swelling
Clinical narrative: Colicky; intestinal cramping; stomach gurgling; few coughs; burning up; irritable; slightly lethargic; Spaced out; Patient's leg was slightly swollen; This spontaneous report has been received from a consumer (patient's mother) concerning to a 4-month-old male patient.  The patient's concurrent conditions included gastrooesophageal reflux disease. His medical history was not reported. Drug/allergy reactions included dairy protein sensitivity. Concomitant therapies included famotidine and probiotics (unspecified).  On 16-DEC-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported), administered orally for immunization. Consequently, on 05-MAR-2021, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose/frequency of administration, lot number and expiration date, were not reported) for immunization. Other suspect vaccines administered on the same day included influenza virus vaccine (unspecified), diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid, and pneumococcal vaccine (unspecified) all for immunization (strengths, doses/routes/frequencies of administration, lot numbers and expiration dates, were not reported). It was also stated that the brand names/manufactures of those vaccines were unknown.  On 05-MAR-2021, her son was colicky, had intestinal cramping, she could hear his stomach gurgling, a few coughs, and he was burning up. He was irritable and slightly lethargic. She reported that her son was staring into space for a good 5-10 minutes. The next day, 06-MAR-2021, her son was still colicky from sun up to sun down. She said the only thing that helped his symptoms was acetaminophen (TYLENOL), a warm bath, and nursing him. She did report that her son's leg was slightly swollen from where the vaccines were administered. Before the caller hung up, she did want to mention that her son received the first rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (on 16 DEC 2020) and developed similar symptoms after administration as the ones she was reporting today. The reporter did not seek medical attention.  The outcome of the reported events was reported as recovered on 09-MAR-2021 or 10-MAR-2021.  The causality assessment with the suspect vaccines was not reported.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the 2nd dose of GARDASIL 9 26 days ofter the first dose; no adverse event; This spontaneous report was received from a physician referring to a 20 year old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis and then, 26 days later, received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported)  (inappropriate schedule of product administration).  No adverse events were reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient had an interruption in schedule regarding the administration of Gardasil 9; no adverse event; This spontaneous report was received from a physician assistant referring to a current 20 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2013 (also reported at the age of 12), the patient was vaccinated with the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration ndate were not reported). The patient had an interruption in schedule regarding the administration of the suspect therapy. No additional adverse events reported. No product quality complaint reported, and no further details were provided.
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: lied in bed and slept; very dizzy; weakness; tired; This spontaneous report was received from a pharmacist via Pfizer and refers to a 42-year-old female patient. On an unknown date in 2017, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. After the vaccination, she felt very dizzy, she was tired, had weakness and lied in bed nd slept. The outcome of the events was not reported. The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Don't take it if it is still a live virus. I did and got shingles/ suspected vaccination failure; Don't take it if it is still a live virus. I did and got shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that did not take it if it was still a live virus. The patient did receive and experienced shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Bedridden, Chills, Decreased appetite
Clinical narrative: Vomiting with blood; Throwing up; Gagging; Loss of appetite; Stomach not feeling good; Head throbbing; Bedridden; Weakness; Chills; Achy body; Puffiness; Throbbing; A spontaneous report  was received from a consumer concerning a 65-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing.   The consumer's medical history was not reported. Relevant concomitant medications included metformin, atorvastatin and levothyroxine, all were used for an unknown indication.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20AA) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Later, on the same day, the patient experienced throbbing and then puffiness at the site of injection. Then as time progressed, she became achy and she couldn't get out of bed next morning due to chills, weakness. Patient reports being bedridden all day and didn't have an a appetite. Patient drank more fluids and tea, then she ate a little. Patient then felt that her stomach was not feeling good (thought it was acid reflux) so she took an acid reflux. Patient reported lying down, falling asleep and waking up and gagging and throwing up. Chills was not disappeared and her body feels achy and head was throbbing. The patient reported that she was better than the two previous days.  Treatment provided included motrin for headache.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of the events, vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing was considered as recovering.; Reporter's Comments: Based on the 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Headache, Pain, Retching, Vaccination site pain
Clinical narrative: Vomiting with blood; Throwing up; Gagging; Loss of appetite; Stomach not feeling good; Head throbbing; Bedridden; Weakness; Chills; Achy body; Puffiness; Throbbing; A spontaneous report  was received from a consumer concerning a 65-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing.   The consumer's medical history was not reported. Relevant concomitant medications included metformin, atorvastatin and levothyroxine, all were used for an unknown indication.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20AA) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Later, on the same day, the patient experienced throbbing and then puffiness at the site of injection. Then as time progressed, she became achy and she couldn't get out of bed next morning due to chills, weakness. Patient reports being bedridden all day and didn't have an a appetite. Patient drank more fluids and tea, then she ate a little. Patient then felt that her stomach was not feeling good (thought it was acid reflux) so she took an acid reflux. Patient reported lying down, falling asleep and waking up and gagging and throwing up. Chills was not disappeared and her body feels achy and head was throbbing. The patient reported that she was better than the two previous days.  Treatment provided included motrin for headache.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of the events, vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing was considered as recovering.; Reporter's Comments: Based on the 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting with blood; Throwing up; Gagging; Loss of appetite; Stomach not feeling good; Head throbbing; Bedridden; Weakness; Chills; Achy body; Puffiness; Throbbing; A spontaneous report  was received from a consumer concerning a 65-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing.   The consumer's medical history was not reported. Relevant concomitant medications included metformin, atorvastatin and levothyroxine, all were used for an unknown indication.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20AA) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Later, on the same day, the patient experienced throbbing and then puffiness at the site of injection. Then as time progressed, she became achy and she couldn't get out of bed next morning due to chills, weakness. Patient reports being bedridden all day and didn't have an a appetite. Patient drank more fluids and tea, then she ate a little. Patient then felt that her stomach was not feeling good (thought it was acid reflux) so she took an acid reflux. Patient reported lying down, falling asleep and waking up and gagging and throwing up. Chills was not disappeared and her body feels achy and head was throbbing. The patient reported that she was better than the two previous days.  Treatment provided included motrin for headache.  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of the events, vomiting with blood, throbbing, puffiness, chills, weakness, bedridden, loss of appetite, stomach not feeling good, gagging, throwing up, achy body and head throbbing was considered as recovering.; Reporter's Comments: Based on the 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: exhaustion; headache; nausea; vomiting; chills; Low grade fever; general feeling of unwell; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient.  A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201,), intramuscularly, on 18Feb2021 at 15:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "None."  She is allergic to sulfa drugs and penicillin. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264) on 28Jan2021 at 13:30 as a single dose in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The vaccination was administered to the patient at a Public Health Clinic. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN)  and vitamin D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 07:00, the patient experienced fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, soreness at injection site. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, and vaccination site pain were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: exhaustion; headache; nausea; vomiting; chills; Low grade fever; general feeling of unwell; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient.  A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201,), intramuscularly, on 18Feb2021 at 15:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "None."  She is allergic to sulfa drugs and penicillin. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264) on 28Jan2021 at 13:30 as a single dose in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The vaccination was administered to the patient at a Public Health Clinic. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN)  and vitamin D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021 at 07:00, the patient experienced fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, soreness at injection site. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue, chills, headache, nausea, vomiting, low grade fever, exhaustion, general feeling of unwell, and vaccination site pain were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: light headed; dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included she previously tested positive for COVID-19 on 06Jan2020. Concomitant medication were not provided. On an unknown date, the patient was dizzy and lightheaded. The outcome of the events dizzy and lightheaded was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188074 same reporter, different patient/AE
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Lacrimation increased, Ocular discomfort
Clinical narrative: Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vaccination site pain
Clinical narrative: Injection site soreness; fatigue; severe headache; feeling pressure behind my eyes/eye trouble; both eyes are bright red; both eyes are bright red, watering, and aching; both eyes are bright red, watering, and aching; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 23:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 07Jan2021 at 14:00 (at the age of 46-years-old) in the left arm for COVID-19 immunisation. The patient reported that on 18Feb2021 she experienced injection site soreness, fatigue, severe headache and now (as of 21Feb2021) eye trouble. She had been feeling pressure behind her eyes and now (at of 21Feb2021) both eyes were bright red, watering, and aching. She didn't know if she would need to have her eyes treated. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The clinical outcomes of feeling pressure behind her eyes/eye trouble, injection site soreness, fatigue, severe headache, both eyes are bright red, watering and aching were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Soreness under left armpit on the second day of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9244), via an unspecified route of administration, in the left arm on 15Feb2021 at 17:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included haemophilia, congenital emphysema, pneumothorax, and allergy to adhesives on foot, all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 at12:00, the patient experienced soreness under left armpit on the second day of the vaccination. It got better, and then got worse on the 7th day following the vaccination. The patient did not receive any treatment for the event. The clinical outcome of soreness under left armpit on the second day of the vaccination was not recovered.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough (short bursts especially during sleep and has continued for 18 days); This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at 09:30 as a single dose for COVID-19 immunization. Relevant medical history included hypertension from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination, which included unspecified high blood pressure drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 23:00, the patient experienced dry cough (short bursts especially during sleep and had continued for 18 days). The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.  Information on the batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:15 (Lot Number: EL9269) at the age of 68 years old as single dose for covid-19 immunisation. Medical history included known allergies: iodine, shellfish, penicillin, Cipro, Nitrofurantoin, wool. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced sore arm, slight rash on chest on 20Feb2021 15:30. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit lymphnode; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm, on an unspecified date (at the age of 30-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and unspecified women's multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunisation. The patient experienced swollen armpit lymphnode on 19Feb2021 at 23:00, which was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of swollen armpit lymphnode was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart beat; This is a spontaneous report from a contactable consumer, the patient. A 74-year old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 at 00:30  (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included asthma; allergies to sulfur drugs, papaya and mango. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin, salbutamol sulfate (PROAIR), ergocalciferol (VIT D), montelukast, losartan. There were no other vaccines within 4 weeks of the vaccination. On an unspecified date in 2021, after the first vaccination, the patient experienced rapid heartbeat for four days. The patient was not treated for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of rapid heartbeat was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced lower back pain (non-serious). The patient received the first dose of the Pfizer vaccine on 20Feb2021 and was having lower back pain when he would bend.  The patient was having surgery the day after the initial report.  The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pain
Clinical narrative: Blood pressure has increased; Aching all over; This is a spontaneous report from a contactable physician, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-087902).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 11Feb2021 as single dose, for COVID-19 immunisation; and lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 11Feb2021 to an unspecified date, at 20 mg for C54.1 endometrial carcinoma. Medical history included ongoing C54.1 endometrial carcinoma. The patient's concomitant medications were not reported. The patient reported that her blood pressure has increased on an unknown date in 2021. The healthcare professional added Lisinopril to the patient's medication regime. The patient also advised she woke up the other night aching all over on an unknown date in 2021. She was sure if it was her COVID 19 shot or the lenvatinib mesilate. She took Tylenol and was able to go back to sleep. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea; gastrointestinal pain; extreme fatigue; pain at injection site; large red rash around the injection site; This is a spontaneous report from a contactable 44-year-old female Other HCP reported for himself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: Lot EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing Hyperthyroidism, controlled with medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced pruritus, bnt162b2 for covid-19 immunisation. The patient experienced Within 8 hours of receiving the second dose, I developed chills, 103degree fever, headache, severe myalgia, nausea, gastrointestinal pain, extreme fatigue, pain at injection site. These symptoms mostly subsided as of Sunday February 21 by 7 PM. At 10 PM on Sunday February 21 I developed a large red rash around the injection site. I also developed numerous Herpes Type 1 sores on my vulva. I know they are Type 1 as I was tested for all STDs and this is the only one I have. The sores appeared once before following an illness I had in December 2019 that was accompanied by a high fever. I was tested for Covid19 antibodies in April of 2020 and was negative. When the sores were cultured in December of 2019, they were Herpes 1 type appearing in the genital region. The patient underwent lab tests and procedures which included body temperature: 103 on 21Feb2021 degree, sars-cov-2 antibody test: negative on Apr2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Myalgia, Nausea, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea; gastrointestinal pain; extreme fatigue; pain at injection site; large red rash around the injection site; This is a spontaneous report from a contactable 44-year-old female Other HCP reported for himself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: Lot EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing Hyperthyroidism, controlled with medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced pruritus, bnt162b2 for covid-19 immunisation. The patient experienced Within 8 hours of receiving the second dose, I developed chills, 103degree fever, headache, severe myalgia, nausea, gastrointestinal pain, extreme fatigue, pain at injection site. These symptoms mostly subsided as of Sunday February 21 by 7 PM. At 10 PM on Sunday February 21 I developed a large red rash around the injection site. I also developed numerous Herpes Type 1 sores on my vulva. I know they are Type 1 as I was tested for all STDs and this is the only one I have. The sores appeared once before following an illness I had in December 2019 that was accompanied by a high fever. I was tested for Covid19 antibodies in April of 2020 and was negative. When the sores were cultured in December of 2019, they were Herpes 1 type appearing in the genital region. The patient underwent lab tests and procedures which included body temperature: 103 on 21Feb2021 degree, sars-cov-2 antibody test: negative on Apr2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: numerous Herpes Type 1 sores on my vulva; severe myalgia; chills; 103 degree fever; headache; nausea; gastrointestinal pain; extreme fatigue; pain at injection site; large red rash around the injection site; This is a spontaneous report from a contactable 44-year-old female Other HCP reported for himself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: Lot EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing Hyperthyroidism, controlled with medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced pruritus, bnt162b2 for covid-19 immunisation. The patient experienced Within 8 hours of receiving the second dose, I developed chills, 103degree fever, headache, severe myalgia, nausea, gastrointestinal pain, extreme fatigue, pain at injection site. These symptoms mostly subsided as of Sunday February 21 by 7 PM. At 10 PM on Sunday February 21 I developed a large red rash around the injection site. I also developed numerous Herpes Type 1 sores on my vulva. I know they are Type 1 as I was tested for all STDs and this is the only one I have. The sores appeared once before following an illness I had in December 2019 that was accompanied by a high fever. I was tested for Covid19 antibodies in April of 2020 and was negative. When the sores were cultured in December of 2019, they were Herpes 1 type appearing in the genital region. The patient underwent lab tests and procedures which included body temperature: 103 on 21Feb2021 degree, sars-cov-2 antibody test: negative on Apr2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I got a funny taste in my mouth; my coffee doesn't taste like coffee; This is a spontaneous report from a contactable consumer.   An 83-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisatio. Medical history and  concomitant medications were not reported.  The patient reported that " there was a got a funny taste in my mouth; my coffee doesn't taste like coffee. Consumer further stated, "It wasn't bad, I mean it just in this morning when I wake up my coffee doesn't taste like coffee, you know..."This is not a bad symptom it is, I just want to make sure that it is not a Covid symptom. What people can't taste, I can taste."The patient  further stated, "See I don't think I just going to wait and see if it goes away. You know the last time I had it went away pretty fast. This is my second chance." The outcome of the events was not reported.  Information about lot/Batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, SARS-CoV-1 test
Clinical narrative: chills; vomiting; headache; body aches; nauseous; Pain at injection site; This is a spontaneous report from a contactable health care professional also reporter as contactable consumer, the patient. A 46-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM9810),  via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 14:45  as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine in was administered was (name of facility) Clinic. The patient medical history was not reported. Concomitant medications included bupropion (BUPROPION) , clonazepam (CLONAZEPAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL),  ergocalciferol (VIT D), ascorbic acid (VIT C).  The patient previously took Imitrex and experienced allergy. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Feb2021 01:00 The patient experienced nauseous and On 20Feb2021 at 02:00 patient experienced chills, vomiting, headache, body aches  and  pain at injection site. The clinical course is as follows At approximately 1AM, I was nauseous. 2AM vomiting followed by chills, headache and body aches (no fever). Pain at injection site. The patient underwent lab tests and procedures which included sars-cov-1 test: negative  on 11Dec2020 'Nasal Swab'.  No treatment was given for the events. The clinical outcome of the event was nauseous,  vomiting, chills, headache,  body aches (no fever) and  Pain at injection site was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: chills; vomiting; headache; body aches; nauseous; Pain at injection site; This is a spontaneous report from a contactable health care professional also reporter as contactable consumer, the patient. A 46-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM9810),  via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 14:45  as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine in was administered was (name of facility) Clinic. The patient medical history was not reported. Concomitant medications included bupropion (BUPROPION) , clonazepam (CLONAZEPAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL),  ergocalciferol (VIT D), ascorbic acid (VIT C).  The patient previously took Imitrex and experienced allergy. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Feb2021 01:00 The patient experienced nauseous and On 20Feb2021 at 02:00 patient experienced chills, vomiting, headache, body aches  and  pain at injection site. The clinical course is as follows At approximately 1AM, I was nauseous. 2AM vomiting followed by chills, headache and body aches (no fever). Pain at injection site. The patient underwent lab tests and procedures which included sars-cov-1 test: negative  on 11Dec2020 'Nasal Swab'.  No treatment was given for the events. The clinical outcome of the event was nauseous,  vomiting, chills, headache,  body aches (no fever) and  Pain at injection site was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypermetropia, Palpitations, Vision blurred
Clinical narrative: Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my eyes are little bit weaker; seems like my eyes are little bit weaker; Heart feels like racing; This 56- year-old female consumer (patient) reported for herself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6201 ), via an unspecified route of administration, on 20Feb2021 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "I had my second shot of Pfizer vaccine yesterday (20 Feb 2021), today, I suffered being tired.  I put on my glasses to watch movie and screen looks fuzzy. It seems like my eyes are little bit weaker or something. My heart feels like racing. I don't think it is racing but it feels like it is. I was wondering if there is any side effects like slightly less accurate vision."  The outcome of the events looks tired, fuzzy, eyes weaker, and heart feels racing was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Vaccination site pain
Clinical narrative: swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontaneous report from a contactable Other Health Professional.  A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201), intramuscularly, on 20Feb2021 at 12:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included obesity, eustachian tube dysfunction. The patient is allergic to grass (fescue). Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), intramuscularly, on 30Jan2021 at 12:00, intramuscularly in the right arm. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "None." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 15:00 the patient experienced Injection site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.