chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Soft tissue swelling, Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative.  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number: EL9262) as 2nd dose, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced soft tissue swelling and erythema at injection site, elevated temperature, chills, headache, body aches, fatigue, mild abdominal cramping twice, bleeding/spotting in vaginal area, has not had a period in over 22 months. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date, weight: 150 (unit unspecified) on an unspecified date. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Weight
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative.  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number: EL9262) as 2nd dose, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced soft tissue swelling and erythema at injection site, elevated temperature, chills, headache, body aches, fatigue, mild abdominal cramping twice, bleeding/spotting in vaginal area, has not had a period in over 22 months. The patient underwent lab tests and procedures which included body temperature: elevated on an unspecified date, weight: 150 (unit unspecified) on an unspecified date. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that he and his wife (patient) received first dose of vaccine on 08Feb2021. The consumer reported that patient test positive for COVID-19 on 17Feb2021 and has not had a fever for 48 hours. The consumer reported he and his wife are scheduled for second dose on 01Mar2021 and would like to know if it is safe for her to get the second dose. The consumer reported that he never did test positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Feb2021. The outcome of the event was unknown. Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Neuropathy peripheral, Paraesthesia
Clinical narrative: pins and needles in her extremities, both hands and both feet; warm feeling in torso; fever/running a 101-102 fever; tired; neuropathy in all her extremities; This is a spontaneous report from a contactable consumer (patient's son). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 15:00 (Batch/Lot number was not reported) (at the age of 49-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included hashimoto's disease from 2019 to an unknown date. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknow date for covid-19 immunisation. The consumer stated his mother has been experiencing neuropathy in all her extremities since over a week ago when vaccinated on an unknown date in Feb2021, and it's getting worst. The consumer added all doctors are saying it's due to the vaccine. The consumer explained when he took her to the urgent care, they mentioned her reaction is actually pretty common post vaccination. On 16Feb2021, about 2 hours after getting the vaccine she was very tired. On 17Feb2021, patient experienced fever/ running a 101-102 fever. On 20Feb2021, she was feeling worsening pins and needles in her extremities, both hands and feet and it is freaking and warm feeling in torso. The outcome of the event fever was recovered on 18Feb2021, pins and needles in her extremities both hands and both feet was not recovered, and remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pins and needles in her extremities, both hands and both feet; warm feeling in torso; fever/running a 101-102 fever; tired; neuropathy in all her extremities; This is a spontaneous report from a contactable consumer (patient's son). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 15:00 (Batch/Lot number was not reported) (at the age of 49-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included hashimoto's disease from 2019 to an unknown date. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknow date for covid-19 immunisation. The consumer stated his mother has been experiencing neuropathy in all her extremities since over a week ago when vaccinated on an unknown date in Feb2021, and it's getting worst. The consumer added all doctors are saying it's due to the vaccine. The consumer explained when he took her to the urgent care, they mentioned her reaction is actually pretty common post vaccination. On 16Feb2021, about 2 hours after getting the vaccine she was very tired. On 17Feb2021, patient experienced fever/ running a 101-102 fever. On 20Feb2021, she was feeling worsening pins and needles in her extremities, both hands and feet and it is freaking and warm feeling in torso. The outcome of the event fever was recovered on 18Feb2021, pins and needles in her extremities both hands and both feet was not recovered, and remaining events was unknown.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown) (non-pregnant at the time of vaccination), via an unspecified route of administration on 13Feb2021 at 16:15 as single dose for COVID-19 immunization. There was no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient's medical history included hypothyroidism, IBS. Past drug event included NSAIDS, bentyl, sulfa, inhalant for allergies. Concomitant medications included levothyroxine 112 mcg and Zyrtec. After vaccination on 14Feb2021 at 02:00, the patient had muscle/joint pain (achy, light burning), mild nausea, mild headache, fatigue. The patient did not receive any treatment for the events. The outcome of events was recovered/resolved.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: moderate amount of systemic itching; This is a spontaneous report from a contactable consumer(patient).A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL0264), via an unspecified route of administration, administered in right arm on 01Feb2021 at 16:00 as 1st dose, single, for COVID-19 immunization. The patient had history of allergies. Patient's medical history included type 2 diabetes mellitus, hypertension and osteoarthritis. The other medications in two weeks included topiramate, losartan, ibuprofen and propranolol. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 23Feb2021 as 2nd dose, single, for COVID-19 immunization. The patient premeditated with 50 mg of Benadryl one hour before the second vaccination and every 5-6 hours for 3 days subsequently. As expected, itching was worse second time, but tolerable. The patient did not had Covid prior vaccination and did not tested Covid post vaccination. On 01Feb2021 at 16:30, the patient experienced moderate amount of systemic itching which was partially relieved by 25 mg of oral benadryl and local application of benadryl gel. The outcome of event was recovered in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Intermenstrual bleeding, Muscle spasms, Taste disorder, Tongue pruritus
Clinical narrative: Painful cramps; onset of period even though I no longer get periods due to my birth control (Mirena); itchy tongue; numbing of tongue; change in taste for several hours; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Feb2021 12:30 (at the age of 25-years-old) as first dose, single for COVID-19 immunisation. Medical history included food allergy (shellfish), oropharyngeal squamous cell carcinoma (HPV), obesity, migraines, and ongoing contraception (on birth control). The patient previously received glutaraldehyde (manufacturer unknown) and experienced drug hypersensitivity. Concomitant medications included bupropion (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; magnesium oxide (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported; and levonorgestrel (MIRENA); taken for contraception (birth control), from an unspecified start date and ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient also reported that she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced painful cramps, onset of period even though she no longer get periods due to her birth control (MIRENA), itchy tongue, numbing of tongue, and change in taste for several hours on an unspecified date. The patient did not received any treatment for the events reported. The outcome of all events reported was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait inability, Pain, Pyrexia
Clinical narrative: vertigo; High fever; Fatigue; Chills; Aches and pains; unable to walk; This is a spontaneous report from a contactable consumer (patient).A 70-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18Feb2021 at 1:00 PM (Batch/Lot Number: EN9581) as 2nd dose, single for covid-19 immunization.Medical history included hypertension, hypothyroidism and blood cholesterol increased. The patient had allergies to Bactrim and Levaquin. The other medications within two weeks included unspecified blood pressure, statin, thyroid medications.The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jan2021 at 1:00 PM (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunization. No other vaccine in four weeks. On 19Feb2021 at 08:00 AM, the patient experienced vertigo, high fever, fatigue, chills, aches and pains, unable to walk. It was reported that the patient had high fever and fatigue within 10 hours, chills, aches and pains and 48 hours later, severe vertigo could not left my head up and unable to walk without help. This lasted 24 hours - and is still slightly apparent 24 hours later. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; High fever; Fatigue; Chills; Aches and pains; unable to walk; This is a spontaneous report from a contactable consumer (patient).A 70-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18Feb2021 at 1:00 PM (Batch/Lot Number: EN9581) as 2nd dose, single for covid-19 immunization.Medical history included hypertension, hypothyroidism and blood cholesterol increased. The patient had allergies to Bactrim and Levaquin. The other medications within two weeks included unspecified blood pressure, statin, thyroid medications.The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jan2021 at 1:00 PM (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunization. No other vaccine in four weeks. On 19Feb2021 at 08:00 AM, the patient experienced vertigo, high fever, fatigue, chills, aches and pains, unable to walk. It was reported that the patient had high fever and fatigue within 10 hours, chills, aches and pains and 48 hours later, severe vertigo could not left my head up and unable to walk without help. This lasted 24 hours - and is still slightly apparent 24 hours later. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle was disrupted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 12Jan2021 13:30 (at the age of 44 years old) (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. Medical history included depression and sacroiliitis, both from an unknown date; known allergies: Pcn (Penicillin) from an unknown date. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO) and topiramate, all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced allergies. The patient previously received first vaccination of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 22Dec2020 02:15 PM at left arm for COVID-19 immunisation. The patient was not pregnant. It was reported that after second vaccine, on 20Jan2021 12:00 AM, the patient experienced that her menstrual cycle was disrupted and she had another full cycle one week later. This has never happened as she was usually very regular to the day. No treatment was provided. Further reported that patient has no COVID prior vaccination, no COVID test post vaccination. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed her period after receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, via an unspecified route of administration, administered in the left arm on 11Feb2021 11:00 (lot number: EM9810) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient didn't have any other vaccines within four weeks of the vaccination. The patient reported that she missed her period after receiving the vaccine. The patient did not receive any treatment for the event. The patient had no COVID prior to vaccination and was not tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test, Vaccination site irritation
Clinical narrative: experienced a reaction; irritation at the site; This is a spontaneous report from a Contactable Consumer (patient). A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and expiration date: unknown), dose 1 via an unspecified route of administration on 18Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included Covid-19 in November and does not need to be hospitalized but the patient was fairly ill and was under doctor care and on medication. The patient underwent lab tests and procedures which included SARS-Cov-2 test and had Covid positive on an unspecified date in Nov2020.The patient's concomitant medications were not reported. The patient experienced a reaction, irritation at the site of vaccination on an unspecified date. The patient stated that it was getting it all over again and was rather intense not serious. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Pain in extremity
Clinical narrative: extremely heavy flow period that lasted 20 days; mild cramping usually occurring in the late morning nearly every day resulting in heavier discharge; slightly tired; sore arm; Achy joints; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 07Feb2021 16:00 (at the age of 51-years-old) as second dose, single for COVID-19 immunisation at a workplace clinic. Medical history included perimenopause in which the patient was having longer durations between periods but relatively normal (for her) in length of four to five days, environmental allergies and a heavy menstrual bleeding in which was described as one period about 14 months prior that was longer and heavier than she typically experienced however it only lasted for just over a week with slightly heavier discharge with some clumps; all of which from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (TYLENOL) and ibuprofen; both taken for an unspecified indication, start and stop dates were not reported. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy. The patient was previously vaccinated with the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3249) administered in the left arm on 17Jan2021 16:30 for COVID-19 immunisation. Patient was not pregnant. No other vaccine was given in four weeks. Patient was not COVID positive prior vaccination and was not tested for COVID post vaccination. On 09Feb2021, the patient experienced extremely heavy flow period that lasted 20 days. It was reported that the patient started her period approximately 48 hours before receiving the second dose of the vaccine and her flow was pretty typical until a couple days after her shot at which time she developed a much heavier flow with large, thick, dark clumps of bloody discharge. The patient also experienced mild cramping usually occurring in the late morning nearly every day resulting in heavier discharge, slightly tired, sore arm and achy joints on 09Feb2021. It was also reported that since the patient has history of heavy menstrual bleeding, she was not initially alarmed by the heavier flow. The patient began to have some concern as the period wore on but felt normal in every other way. No treatment was given for the events. The outcome of the events was recovered.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Chills, Chromaturia, Constipation, Fatigue
Clinical narrative: Discolored urine; Menstrual bleeding (early period/ spotting); Lower Abdominal Right side pain; Constipation; Chills; slight fever; ichy throat; foggy; tired; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), intramuscularly (administered on the right arm) on an unspecified date in Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknowregnant at the time of vaccination. Prior to vaccination, the patient has no other medications in two weeks and has not been date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not pn diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 02Mar2021 01:00 PM, the patient experienced discolored urine, menstrual bleeding (early period/ spotting), lower abdominal right side pain, constipation, chills, slight fever, ichy throat, foggy and tired. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Menstruation irregular, Pyrexia, Throat irritation
Clinical narrative: Discolored urine; Menstrual bleeding (early period/ spotting); Lower Abdominal Right side pain; Constipation; Chills; slight fever; ichy throat; foggy; tired; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), intramuscularly (administered on the right arm) on an unspecified date in Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknowregnant at the time of vaccination. Prior to vaccination, the patient has no other medications in two weeks and has not been date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not pn diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 02Mar2021 01:00 PM, the patient experienced discolored urine, menstrual bleeding (early period/ spotting), lower abdominal right side pain, constipation, chills, slight fever, ichy throat, foggy and tired. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Chills, Chromaturia, Fatigue
Clinical narrative: Discolored urine; Menstrual bleeding (early period/ spotting); Lower Abdominal Right side pain; Constipation; Chills; slight fever; ichy throat; foggy; tired; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), intramuscularly (administered on the right arm) on an unspecified date in Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknowregnant at the time of vaccination. Prior to vaccination, the patient has no other medications in two weeks and has not been date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not pn diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 02Mar2021 01:00 PM, the patient experienced discolored urine, menstrual bleeding (early period/ spotting), lower abdominal right side pain, constipation, chills, slight fever, ichy throat, foggy and tired. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Chills, Chromaturia, Constipation, Fatigue
Clinical narrative: Discolored urine; Lower right abdominal pain; GI discomfort; 11 day early Menstruation bleeding/spotting; chills; fever; fatigue; foggy; ichy throat; This is a spontaneous report from a contactable healthcare professional (patient).   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknown date. The patient has no concomitant medications. The patient has no reported allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30 AM, the patient experienced discolored urine, lower right abdominal pain, gastrointestinal (GI) discomfort, 11 day early menstruation bleeding/spotting, chills, fever, fatigue, foggy and ichy throat. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Menstruation irregular, Pyrexia, Throat irritation
Clinical narrative: Discolored urine; Lower right abdominal pain; GI discomfort; 11 day early Menstruation bleeding/spotting; chills; fever; fatigue; foggy; ichy throat; This is a spontaneous report from a contactable healthcare professional (patient).   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknown date. The patient has no concomitant medications. The patient has no reported allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30 AM, the patient experienced discolored urine, lower right abdominal pain, gastrointestinal (GI) discomfort, 11 day early menstruation bleeding/spotting, chills, fever, fatigue, foggy and ichy throat. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Chills, Chromaturia, Fatigue
Clinical narrative: Discolored urine; Lower right abdominal pain; GI discomfort; 11 day early Menstruation bleeding/spotting; chills; fever; fatigue; foggy; ichy throat; This is a spontaneous report from a contactable healthcare professional (patient).   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknown date. The patient has no concomitant medications. The patient has no reported allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30 AM, the patient experienced discolored urine, lower right abdominal pain, gastrointestinal (GI) discomfort, 11 day early menstruation bleeding/spotting, chills, fever, fatigue, foggy and ichy throat. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: having menstruation/ period; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 11:30 (Batch/Lot Number: en6199) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Mar2021 12:00 AM, Thought was done with period. Two days after first shot started a period/ menstruation/ period. The patient did not receive treatment for the AE. The outcome of the event was unknown.  Batch/lot number already provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder
Clinical narrative: headache where her head is pounding and feels like it is going to explode; has not had a menstrual cycle or period since Jul2020; but about 1 hour after vaccine administered menstrual cycle or period started with a vengeance and has worsened since then; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EN6205, and expiration date: 30Jun2021), via an unspecified route of administration, administered on the upper left arm on 03Mar2021 12:00 (at the age of 48-years-old), as first dose, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder (thyroid) and ongoing seizure. Concomitant medications included levothyroxine (manufacturer unknown) 200 micrograms once daily, taken for thyroid disorder from an unspecified start date and ongoing (reported as roughly 6-8 months ago); and levetiracetam (KEPPRA) 1500 mg twice daily, taken for seizure from an unspecified start date and ongoing (reported as roughly 6-8 months ago). The patient did not received any other vaccines on the day of vaccination and within 4 weeks prior to the COVID vaccine. The patient has not had a menstrual cycle or period since Jul2020, but about 1 hour after vaccine was administered, menstrual cycle or period started with a vengeance and has worsened since then on 03Mar2021 13:00. Patient also had onset of headache where her head was pounding and feels like it is going to explode during call on 04Mar2021 (reported time of call was between 13:31 and 13:49). Patient asked if this event or a lot of events have been reported with the vaccine. At time of report, it was unknown if patient will or will not get second dose as scheduled. Patient did not consult physician nor urgent care for the events reported. Patient was not hospitalized as a result of the events. The outcome of menstrual disorder was not recovered and headache was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Menstrual cycle came 2 weeks early with increased cramping; Menstrual cycle came 2 weeks early with increased cramping; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 23Feb2021 12:30 (at the age of 33-year-old) (Batch/Lot Number: EM9809) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies with diclofenac. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9265), administered in the left arm on 02Feb2021 at 12:30 PM (at the age of 33-year-old) for COVID-19 immunization. On 04Mar2021 at 12:00 PM, the patient experienced menstrual cycle came 2 weeks early with increased cramping. No treatment was received for the events. It was also reported that patient was tested for COVID post vaccination via nasal swab on 04Feb2021 which was negative. The patient had not yet recovered from the events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: My period is generally very regular but currently late/My period is currently 3 days late; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (Brand: Pfizer), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 17:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included neurofibromatosis type 1 from an unknown date and unknown if ongoing. Concomitant medications included magnesium taken for an unspecified indication, start and stop date were not reported and unspecified mutivitamin. The patient had not received other vaccine in four weeks. The patient's period is generally very regular but currently late. Her period is currently 3 days late on an unspecified date with outcome of unknown. Her husband had a vasectomy over 13 years ago and gave 2 samples within the time requested by the doctor who did the procedure. Both samples yielded a 0 sperm count. No treatment given for event. The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received BNT162B2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, approximately 8:40 AM, the patient fainted while waiting after receiving the Pfizer/biotech Covid vaccine. The patient was observed and was evaluated by EMT. She was released around 9:20 AM. Outcome of the event was unknown.  Amendment : This follow-up report is being submitted to allow appropriate reporting to health authorities.  No follow-up attempts are possible; Information on the lot/batch number could not be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (COMARNITY; Lot/batch no: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 09:00 AM (at 60-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included many food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included fluticasone propionate (FLONASE) and essential amino supplements (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if ongoing. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 09:00 PM, twelve hours after the injection, the patient had severe pains in abdomen with severe muscle pain in back and legs. The patient experienced some chills, headache and fatigue which were mostly over in 24 hours. The patient did not receive any treatment for these adverse events. At the time of this report, the patient was recovering from the events abdominal pain, muscle pain, chills, headache and fatigue.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: period was about 8 days late after her first dose of the pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included lyme disease. The patient had no COVID prior vaccination, no other vaccine in four weeks, not tested for COVID post vaccination. Concomitant medication included biotin and unspecified daily vitamins. It was reported that the patient's period was about 8 days late after her first dose of the pfizer vaccine. Event onset was reported as 17Feb2021 at 22:00. The patient did not receive treatment for the event. Outcome of the event was recovered.   Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Periorbital swelling, Pruritus
Clinical narrative: Allergic reaction, lots of itching; Allergic reaction, lots of itching; Allergic reaction, lots of itching Puffy swelling of eyes a week after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 43-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 on 04Mar2021 at 16:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypertension and allergies to environmental conditions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for allergy, hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication and norethisterone (MINI PILL) for an unknown indication, all from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), in the right arm on an unspecified date for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Mar2021 at 18:00, the patient experienced allergic reaction. The patient had lots of itching and puffy swelling of eyes a week after vaccine. The events required a visit to the doctor office; however, the patient did not receive any treatment for the adverse events. The clinical outcomes of allergic reaction lots of itching and puffy swelling of eyes were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Rash on upper right arm and shoulder( Opposite injection Site).; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on his left arm on 05Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included peripheral arterial disease (PAD), chronic obstructive pulmonary disease (COPD) and hypertension. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN); all for unknown indications form unknown dates and unknown if ongoing. Patient was allergic to pseudoephedrine hydrochloride (SUDAFED). 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. One week after vaccination on 12Mar2021 at 06:00, the patient experienced rash on upper right arm and shoulder (opposite the vaccination site). It started as muscle pain, which was not itchy. It was just uncomfortable muscular pain. He did not receive treatment for the events. The clinical outcomes of the rash and muscular pain were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: period was affected/extremely heavy; This is a spontaneous report from a contactable consumer (patient's sister). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 03Mar2021 11:00 as unknown, single for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID 19 and since vaccination, patient have not been tested for COVID 19. The patient's medical history was not reported. The patient had no concomitant medications (no other medications in two weeks). The patient's period was affected, had extremely heavy on 10Mar2021 which was uncommon for her after bnt162b2. The consumer considered as non-serious as did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling and incapacitating and no congenital anomaly and birth defect. No treatment was received for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: Swelling and pain in the testicles; Swelling and pain in the testicles; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 09Mar2021 15:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. The patient medical history included asthma. Concomitant medication (in two weeks) included albuterol [salbutamol] (ALBUTEROL). The patient had no other vaccine in four weeks. The patient had no known allergies. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 10Mar2021 at 07:00am, the patient experienced swelling and pain in the testicles. The patient did not receive any treatment. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Osteitis
Clinical narrative: Headache; dull pain in the right sideof the face in the area of the rightchickbone, right mandibular joint; swelling at the right lower jaw; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), dose number 2, via an unspecified route of administration in the right arm on 05Mar2021 at 20:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included rheumatoid arthritis in full remission for 5 years without medications. Past drug of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269), dose number 1, via an unspecified route of administration in the left arm on 11Feb2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies to medication, food or other products. Concomitant medications of the patient included Advil (MANUFACTURER UNKNOWN), Vitamin D3 (MANUFACTURER UNKNOWN), Centrum (MANUFACTURER UNKNOWN) and Calcium (MANUFACTURER UNKNOWN); all for unknown indication since unknown date and is unknown if ongoing. The patient had not received any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 12Mar2021 at 07:00 (7 days after receiving 2nd dose of COVID vaccine), the patient woke up with headache, dull pain in the right side of the face in the area of the right chick bone, right mandibular joint and swelling at the right lower jaw. A painful, almond-size enduration was palpable at the middle of the lining of the lower jaw, below the gum line. No therapeutic medications were taken for the events. The clinical outcome of the events jaw inflammation, facial pain and headache was recovering at the time of this report.