chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen left armpit after the 1st shot, but it wasn't too noticeable. The second dose did create a bigger lump under the same armpit.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on 22Jul2021 at 12:00 (at the age of 41-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on 12Aug2021 at 13:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in 2021, after the first shot, the patient experienced swollen left armpit but it was not too noticeable. After the second dose, on 13Aug2021 at 20:00, the patient had a bigger lump under the same armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) through blood test and the result was negative. The clinical outcome of the event after the first shot, swollen left armpit but it was not too noticeable and the second dose it did create a bigger lump under the same armpit was not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 13Aug2021 at 08:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received epinephrine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 15Aug2021 at 09:30, the patient experienced persistent shortness of breath at hour 49 that lasted for 10 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of breath was resolved on 15Aug2021 at 19:30 after a duration of 10 hours.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Laryngeal pain, Lymphadenopathy
Clinical narrative: Lymph node on neck swelled up on the left side; Left side of throat was hurting and then as the days progressed it started to get more sore; made things difficult to swallow bc of the pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F3181) via an unspecified route of administration in the left arm on 09Aug2021 at 12:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, asthma, post-traumatic stress disorder (C-PTSD), known allergy to environmental and treenuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL); all for an unknown indication from an unknown start date and unknown if ongoing. On 12Aug2021 at 17:00, the patient experienced lymph node on neck swelled up on the left side and left side of throat was hurting. As the days progressed it started to get more sore and made things difficult to swallow because of the pain. The patient had fibromyalgia and was not sure if her condition didn't react well to this vaccine. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node on neck swelled up on the left side, left side of throat was hurting and difficult to swallow was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: I got a patch of redness on my injection arm; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Aug2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included acne and known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included minocycline (MANUFACTURER UNKNOWN) and azelaic acid (MANUFACTURER UNKNOWN); both for acne from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 17Aug2021, the patient got a patch of redness on her injection arm that looks like an independent country. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event patch of redness on her injection arm that looks like an independent country was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Menstrual disorder, Pain in extremity, Pyrexia
Clinical narrative: Menstrual period change; sore arm; fever 101F; chills; This is a spontaneous report from a Non-contactable Consumer (Patient). A 43-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 43 years old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications include Zyrtec, Bupropion, Multivitamin taken for unspecified indication, start dates and stop dates were not mentioned. 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 did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in left arm on 20Mar2021 at 14:15 (at the age of 43 years old) for covid-19 immunisation and experienced Sore arm and Menstrual period change. On unspecified date the patient experienced that Menstrual period change - arrived day after vaccines (both with 1st and 2nd doses). Sore arm with first dose. Sore arm, fever 101F and chills with second dose (started at 14hrs post vaccine and lasted for 24hrs). The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 101F on unspecified date. Reporter reported the events as non-serious at the time of this report. The outcome of the events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness within 10 minutes of shot; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Aug2021 at 13:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The medical history included allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Aug2021 at 14:00, the patient experienced dizziness within 10 minutes of shot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of dizziness which included treatment with water and observation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Maternal exposure during pregnancy
Clinical narrative: Fever of 102; Chills; Headache; Muscle aches; Nausea; Sweating; Pregnant : yes, gestational age 27 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old and 27 weeks pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Aug2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC) and unspecified prenatals(MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The last menstrual period (LMP) of the patient was 08Feb2021. On 17Aug2021 at 11:00, the patient experienced maternal exposure during pregnancy second trimester, fever 102, chills, headache, muscle aches, nausea and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Aug2021 at 11:00, the patient underwent body temperature test and the result was found to be 102 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event maternal exposure during pregnancy second trimester was unknown however the clinical outcome of the events fever 102, chills, headache, muscle aches, nausea and sweating were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 102; Chills; Headache; Muscle aches; Nausea; Sweating; Pregnant : yes, gestational age 27 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old and 27 weeks pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Aug2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC) and unspecified prenatals(MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The last menstrual period (LMP) of the patient was 08Feb2021. On 17Aug2021 at 11:00, the patient experienced maternal exposure during pregnancy second trimester, fever 102, chills, headache, muscle aches, nausea and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Aug2021 at 11:00, the patient underwent body temperature test and the result was found to be 102 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event maternal exposure during pregnancy second trimester was unknown however the clinical outcome of the events fever 102, chills, headache, muscle aches, nausea and sweating were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Fever; Aching muscles; Rapid heart beat; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Aug2021, the patient experienced fever, aching muscles and rapid heart beat. On the same day, the patient underwent heart rate and the result was rapid. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, aching muscles and rapid heart beat was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Stopped menstruating for 5 months after second shot (not pregnant); This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant 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 an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 28Apr2021, the patient stopped menstruating for 5 months after the second shot and was not pregnant. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stopped menstruating for 5 months after second shot was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration
Clinical narrative: Headaches; Light dizziness; Dose 1:31Jul2021, Dose 2: 14Aug2021; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 14Aug2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0202) via an unspecified route of administration on 31Jul2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Aug2021 at 01:00, the patient experienced headaches and light dizziness when she stood up. It was reported that it had been six days and she was still getting it. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches and light dizziness were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Feet and legs swelling; Hands stiff; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Aug2021 at 08:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 18Aug2021 at 05:00, the patient experienced feet and legs swelling and hands stiff. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feet and legs swelling and hands stiff were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast disorder, Breast pain, Breast swelling, Limb discomfort
Clinical narrative: 10-15 minutes after injection - tingling fingers on left hand; Joint pain at wrist, elbow, and shoulder, significant joint pain (knees especially 8.5/10 scale); 6 days after (still present); Same day and for the next 4 days heaviness in arms and legs, general sense of being run down/over; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 13Aug2021 at 11:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid/betacarotene/biotin/calcium/chromium/copper/folic acid/iron/magnesium/manganese/nicotinic acid/pantothenic acid/pyridoxine hydrochloride/retinol/riboflavin/selenium/vitamin b1 nos/vitamin b12 nos/vitamin d nos/vitamin e nos/vitamin k nos/zinc (ONE A DAY TEEN ADVANTAGE FOR HER) and lactobacillus nos (CULTURELLE) probiotics; both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 13Aug2021 at 11:45, 10-15 minutes after injection, the patient experienced tingling fingers on left hand, joint pain at wrist, elbow, and shoulder; same day and for the next 4 days and heaviness in arms and legs, general sense of being run down/over, significant joint pain (knees especially 8.5/10 scale); 6 days after (still present) and onset of pain, swelling, pink rash, and bump near center of left breast. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of the event joint pain at wrist, elbow, and shoulder/ significant joint pain was not resolved and of the events tingling fingers on left hand, heaviness in arms and legs, general sense of being run down/over and onset of pain, swelling, pink rash, and bump near center of left breast was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Paraesthesia, Rash erythematous
Clinical narrative: 10-15 minutes after injection - tingling fingers on left hand; Joint pain at wrist, elbow, and shoulder, significant joint pain (knees especially 8.5/10 scale); 6 days after (still present); Same day and for the next 4 days heaviness in arms and legs, general sense of being run down/over; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; onset of pain, swelling, pink rash, and bump near center of left breast.; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 13Aug2021 at 11:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid/betacarotene/biotin/calcium/chromium/copper/folic acid/iron/magnesium/manganese/nicotinic acid/pantothenic acid/pyridoxine hydrochloride/retinol/riboflavin/selenium/vitamin b1 nos/vitamin b12 nos/vitamin d nos/vitamin e nos/vitamin k nos/zinc (ONE A DAY TEEN ADVANTAGE FOR HER) and lactobacillus nos (CULTURELLE) probiotics; both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 13Aug2021 at 11:45, 10-15 minutes after injection, the patient experienced tingling fingers on left hand, joint pain at wrist, elbow, and shoulder; same day and for the next 4 days and heaviness in arms and legs, general sense of being run down/over, significant joint pain (knees especially 8.5/10 scale); 6 days after (still present) and onset of pain, swelling, pink rash, and bump near center of left breast. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of the event joint pain at wrist, elbow, and shoulder/ significant joint pain was not resolved and of the events tingling fingers on left hand, heaviness in arms and legs, general sense of being run down/over and onset of pain, swelling, pink rash, and bump near center of left breast was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea
Clinical narrative: Chest pain; Shortness of breath; Coughing; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant 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 an unknown date (at the age of 28-year-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. On 16Aug2021 at 16:45, the patient experienced chest pain, shortness of breath and coughing. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, shortness of breath and coughing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Immune system disorder, Immunisation, Off label use, Pain in extremity
Clinical narrative: received her 3rd dose of the Pfizer-Biontech Covid19 vaccine, yesterday (19Aug2021); received her 3rd dose of the Pfizer-Biontech Covid19 vaccine, yesterday (19Aug2021); felt a little heat in her body; my arm was sore; immune compromised; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 19Aug2021 as dose 3, single for covid-19 immunization. Medical history included immune disorder and alcohol abuse (has a drink after work) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) as dose 1, single and dose 2, single both via an unspecified route of administration on an unspecified date for covid-19 immunization and experienced sore arm for both the doses. It was reported that, Patient received her 3rd dose of the Pfizer-Biontech Covid19 vaccine, yesterday (19Aug2021) and she was immune-compromised and "my arm was sore" no other symptoms on an unspecified date in Aug2021. She absolutely felt fine on the day. She also felt a little heat in her body on 19Aug2021, but she did not have a fever. She knew it could be normal to have a little temperature after getting the COVID 19 vaccine.  Reporter stated that her mother, who had the same immune disorder, received a 3rd dose the same day but at a different location, and was told not to drink for at least the first day. Also stated she was definitely one of those people who had a drink or two every night, she went to a party last night and had 3 glasses of wine that night after receiving her 3rd dose. She would like to know if consuming alcohol would affect the vaccines efficacy. After the party she was feeling revved up so she took a sleeping pill and slept. Outcome of the events "my arm was sore", felt a little heat in her body and immune compromised was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  Follow up (02Sep2021): New information received from a contactable consumer. This consumer reported in response to non-HCP letter sent via telephonic follow-up activity which included that: Consumer provided mailing address.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (13Oct2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: After vaccine injection a tingling sensation spread down my left arm into my finger tips, and up my deck leaving me with a sharp headache. However, it has been 7 days since the vaccine and my left arm is still tingling as if it has "fallen asleep"; Sharp headache; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the arm left on 13Aug2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient was 33 weeks pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication were not reported. On 13Aug2021 at 16:15, after vaccine injection the patient experienced a tingling sensation spread down left arm into finger tips, and up deck leaving with a sharp headache. The patient took Tylenol for the headache and the headache was gone within 24 hours. However, it has been 7 days since the vaccine and the patient's left arm is still tingling as if it has "fallen asleep". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sharp headache was recovered on 14Aug2021, after the duration of 24 hour, while the event after vaccine injection a tingling sensation spread down my left arm into my finger tips, and up my deck leaving me with a sharp headache. However, it has been 7 days since the vaccine and my left arm is still tingling as if it has "fallen asleep" was not recovered at the time of this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a small pain on the upper side of my right arm and thats it.; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Aug2021 at 21:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Jul2021 at 21:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, the patient experienced just a small pain on the upper side of his right arm and thats it. The clinical outcome of the event small pain on the upper side of right arm was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle length and intensity changes ever since and hast gone back to its normal pattern; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history includes allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced menstrual cycle length and intensity changes ever since and has not gone back to its normal pattern. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle length and intensity changes ever since and has not gone back to its normal pattern was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: My following cycle was then about a week late (still not on birth control); My cycle started the day after receiving my second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 22Jun2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) on an unknown date and experienced drug allergy. The COVID vaccine seemed to effect her menstrual cycle (while not on birth control). On 23Jun2021, her cycle started the day after receiving her second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start. On 02Aug2021, her following cycle was then about a week late (still not on birth control). Her cycle was typically very regular when not on birth control. On 15Aug2021, the patient underwent lab test and procedures which included nasal swab test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events her cycle started the day after receiving her second dose of the Pfizer vaccine, which was a little over a week ahead of when it was supposed to start and her following cycle was then about a week late (still not on birth control) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation time, Fibrin D dimer, Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: Several cramps occurred in both right and left calf muscles; Left calf muscle tight; Left calf muscle sore/ soreness in left calf; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Aug2021 at 16:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 13Aug2021 at 00:00, 4 days after the first Pfizer shot, the patient experienced several cramps occurred in both right and left calf muscles. Left calf muscle remained tight and sore. (It had been 1 week of tightness). The patient went to the ER to check for blood clot in leg-nothing found. Went back to get a D-Dimer to see if something was missed due to continued tightness / soreness in left calf. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event.  The clinical outcome of the events several cramps occurred in both right and left calf muscles, left calf muscle tight and left calf muscle sore was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscular weakness, Peripheral swelling, Pyrexia
Clinical narrative: Began to have headaches; Muscles began to feel weak; Chills throughout body; A fever overnight; Left arm is beginning to swell up and that is the arm that received the shot on; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Aug2021 at 13:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included no allergies but mainly environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Aug2021 at 21:30, one week after receiving the vaccine, the patient began to have headaches and muscles began to feel weak. He got chills throughout the body and a fever overnight. His left arm was beginning to swell up and that was the arm which had received the shot. The events did not result in a visit to doctor or other healthcare professional office/clinic, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of events which included treatment with over the counter medicine like naproxen sodium (FLANAX). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began to have headaches and muscles began to feel weak, got chills throughout the body and a fever overnight and the left arm was beginning to swell up and that was the arm which had received the shot were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Upper arm, back and abdominal rash; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN) and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received azithromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11Aug2021, the patient experienced upper arm, back and abdominal rash. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event upper arm, back and abdominal rash was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Sore at injection site; Headache; Fatigue; pregnant and Gestation period was 24 weeks; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 18Aug2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), endometriosis and known allergies to gluten. The patient's last menstrual date was 03Mar2021 and delivery due date was reported as 07Dec2021. The gestation period was 24 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prenatal (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), calcium/magnesium (MANUFACTURER UNKNOWN) and vitex agnus-castus (CHASTE TREE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Aug2021 at 17:00, the patient experienced sore at injection site, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore at injection site, headache and fatigue was resolved on an unknown date in Aug2021.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Exposure via breast milk, Respiratory disorder, Rhinorrhoea
Clinical narrative: My nursing 8 month old infant developed symptoms; Upper respiratory disease (nasal discharge, cough); Upper respiratory disease (nasal discharge, cough); Upper respiratory disease (nasal discharge, cough); This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 8-month-old infant patient (reporter's child) that a 8-months-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via transmammary route of administration on Apr2021 as dose 1, single for covid-19 immunisation. Medical history included infant has congenital heart disease. The patient's concomitant medications were not reported. On an unspecified date in Apr2021 reporter nursing 8 month old infant developed symptoms of upper respiratory disease (nasal discharge, cough) the evening of the date she received her first dose. Reporter considered events as non-serious. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417489 maternal/child
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: I immediately started having menstrual cycle changes after my fianc received the vaccine; This lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow; This lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant 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 12Feb2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 12Feb2021, the patient immediately started having menstrual cycle changes after her fiance received the vaccine. Or there after anytime she was around a group of vaccinated and she would get her period 24- 48 hours after. The periods lasted 5-6 months of excruciating cramps, bleeding 50% of each month with heavy flow. Prior to this, the patient had a light period once a month 3-4 days, no cramping. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she immediately started having menstrual cycle changes after her fiance received the vaccine and this lasted 5-6 months of excruciating cramps, bleeding 50% of the each month with heavy flow was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.