chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Anorectal discomfort, Diarrhoea, Flatulence
Clinical narrative: Severe stomach pain; Cramping; Gas; Bloating; Rectal irritation and pain; Rectal irritation and pain; Headache; Diarrhea; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 15Mar2021 at 12:15 (at the age of 52-years-old) as single dose for covid-19 immunization. Medical history included small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), fruit allergy (tomatoes) and allergic to spices (chili peppers) all from an unknown date and unknown if ongoing. Prior to 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. Concomitant medications included estradiol (ESTROGEN); hydroxyprogesterone caproate (PROGESTONE); pregnenolone (PREGNENOLONE) all taken for an unspecified indication, start and stop date were not reported. On 15Mar2021 at 16:00, the patient experienced severe stomach pain, cramping, gas, headache, diarrhoea, bloating, rectal irritation and pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of all the events was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Proctalgia
Clinical narrative: Severe stomach pain; Cramping; Gas; Bloating; Rectal irritation and pain; Rectal irritation and pain; Headache; Diarrhea; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 15Mar2021 at 12:15 (at the age of 52-years-old) as single dose for covid-19 immunization. Medical history included small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), fruit allergy (tomatoes) and allergic to spices (chili peppers) all from an unknown date and unknown if ongoing. Prior to 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. Concomitant medications included estradiol (ESTROGEN); hydroxyprogesterone caproate (PROGESTONE); pregnenolone (PREGNENOLONE) all taken for an unspecified indication, start and stop date were not reported. On 15Mar2021 at 16:00, the patient experienced severe stomach pain, cramping, gas, headache, diarrhoea, bloating, rectal irritation and pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of all the events was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: After dose 1 I had a heavier than usual period two weeks early; After dose 1 I had a heavier than usual period two weeks early; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 16:00 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroid, polycystic ovarian syndrome (PCOS) (but consistently controlled for 10 years with weight loss and metformin). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN), all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. After dose one the patient had a heavier than usual period two weeks early on 04Apr2021. Therapeutic measures were not taken as a result of the events. The events 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 after dose one had a heavier than usual period two weeks early was resolved on an unknown date in Apr2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Insomnia, Irritability, Pyrexia
Clinical narrative: Vaccine exposure via breastmilk; irritable; difficulty sleeping; fever; This is a spontaneous report from a contactable Nurse and other health professional. This Nurse reported information for herself and a female patient (baby). This is the baby report   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via trans mammary on an unspecified date as an unspecified dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The nurse (mother) reported that the baby was taking vitamin d drops. The nurse (mother) also reported that currently she was exclusively breastfeeding and after both the first and second vaccine her daughter became irritable and had difficulty sleeping. After the second vaccine her daughter had a low-grade fever on 22Apr2021 at 14:00. The patient did not receive any treatment for the reported event. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467100 same reporter/drug, different patient and event.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: On 21Apr21, (Name) reported to me (Name) that he has had joint pain since his first shot 27Mar.; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613), via an unspecified route of administration, administered in left arm (reported as unsure) on 27Mar2021 (at the age of 51 years) as dose 1, single for COVID-19 immunization. The patient's medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient's other medications in two weeks were unknown. It was unknown if COVID tested post vaccination. On 21Apr2021 the patient mentioned having joint pain since his first shot on 27Mar2021. The patient did not receive any treatment for the event. The outcome of the event was unknown.  No follow-up attempts are required. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: fever for one day; Severe headache; New rash resembling insect bites on shins, thighs, forearms starting 3-4 days after second shot; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in arm right on 19Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, sleep apnoea, arthritis, rosacea, transient ischaemic attack, rubber sensitivity and COPD overlap syndrome, seasonal and environmental allergies and Known allergies with Tetracycline, Latex. The patient's concomitant medications were not reported.  Historical vaccines included first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration, administered in Arm Right on 26Feb2021 at 15:00 as a single dose for COVID-19 immunisation and on 03Mar2021 at 07:00 patient experienced rash resembling insect bites on shins and forearms starting 4-5 days after first shot. Patient did not receive any other vaccine in four weeks. On an unknown date in Mar2021, 3-4 days after second shot patient experienced new rash resembling insect bites on shins, thighs, forearms. It is not completely gone yet after three weeks. Severe headache and fever for one day, five days after second shot (24Mar2021). Patient did not receive any treatment for the events. The clinical events outcome was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: i got a rash on the right leg; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 Adverse Event Self-Reporting.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/Lot Number: EN6198), via an unspecified route of administration, administered in right arm on an unknown date in FEB-2021 at 12:00 PM, (age at the time of vaccination: 74-year-old) as DOSE 1, SINGLE for COVID-19 immunisation administered in Health Clinic. Medical history included penicillin allergy from an unknown date and unknown if ongoing (Known Allergies: Penyciline as reported), allergy to Insect bites (big time) from an unknown date and unknown if ongoing, deodorant allergy (Dehodorants as reported) from an unknown date and unknown if ongoing. The patient concomitant medication(s) included tadalafil (CIALIS), atorvastatin (ATORVASTATIN), ageless male (AGELESS MALE) and loratadine (CLARITINE) for an unknown indication and start and stop dates not reported. The patient did not received other vaccine in four weeks. There were no covid prior to vaccination and not being tested for covid post vaccination. On an unknown date in Mar2021, the patient got a rash on the right leg. Adverse event resulted into physician office visit to the patient. Treatment not received for the event. The clinical outcome of the event was not recovered.  No Follow-up attempts are needed. No Further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Laboratory test, Maternal exposure during pregnancy
Clinical narrative: Pregnant at the time of vaccination?: Yes Gestation period: 2 weeks; Metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 30-years-old female patient (patient was pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12Feb2021 (age at vaccination was 30 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included COVID-19 on an unknown date. Concomitant medications included prenatals. The patient previously took naproxen and experienced known allergy to it. The patient's last menstrual date was reported to be 05Jan2021. The gestation period at the time of vaccination was reported as 2 weeks. The patient's expected delivery due date was 12Oct2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient started having a metallic taste in mouth and it had not gone away. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the event metallic taste in mouth. The patient underwent lab work and the result was unknown on an unspecified date. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Parosmia, Pruritus
Clinical narrative: Sulfur body smell to self & Others for a few days,smelled sulfur in urin next day; arm pain; sharp pain to little fingers on both hands for a few days; headache; itchy face & neck & torso for several days; This is a spontaneous report from a contactable consumer (patient). A 57 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Ew0150) via an unspecified route, administered in Left Arm on 31Mar2021 (at the age of 57-years-old) as Dose 1, Single for Covid-19 immunization. The patient's medical history included spinal stenosis, fibromyalgia and known allergy to molds. The patient's concomitant medications included fentanyl patch; hydrocodone bitartrate, paracetamol (NORCO) tablet and methocarbamol (ROBAXIN) within two weeks of vaccination. The patient previously received amoxicillin, Neurontin and experienced allergy to all. The patient was not diagnosed with COVID prior to the vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On an unspecified date in 2021, the patient experienced sulfur body smell to self and others for a few days, smelled sulfur in urine next day, arm pain for 3 weeks, sharp pain to little fingers on both hands for a few days, slight headaches for 3 weeks, itchy face and neck and torso for several days. Post vaccination, the patient was not tested to Covid. No treatment received for resulted events. The outcome of the events was not recovered. No follow-up attempts were required. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives over chest. then over next 7 days it spread to abdomen, back, left forearm and back of my neck; Minimally itchy; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 54-years-old) as Dose 1, single for COVID-19 immunisation. Medical history includes high cholesterol from an unknown date and COVID-19 (diagnosed prior to the vaccination). The patient had no known allergies. Concomitant medications included lovastatin (MANUFACTURER UNKNOWN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication; acetylsalicylic acid (ASPIRIN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication; famotidine (MANUFACTURER UNKNOWN), via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication and gummies vitamins, via unspecified route of administration from unknown date to unknown date at unknown dose and frequency for an unspecified indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Apr2021 at 08:00, day 2 after the vaccine, the patient experienced hives over chest, then over next 7 days it spread to abdomen, back, left forearm and back of her neck and was minimally itchy. The events 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. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine hydrochloride (BENADRYL) at home once which had no effect. The clinical outcome of the events hives over chest and minimally itchy were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), age at the time of vaccination: 56, via an unspecified route of administration, in left arm, on Mar 29, 2021, at 15:30, single dose, for COVID-19 immunization. The patient's medical history included ulcerative colitis and COVID-19 prior vaccination. The patient's concomitant medications included levothyroxine sodium and Lialda both taken in two weeks of vaccination. The patient did not receive any other vaccine in four weeks. The patient did not test for COVID-19 post vaccination. On Apr 23, 2021, at 06:30, patient had very sharp pains in right hip joint and abdomen only occasionally for 2 days. The patient did not receive any treatment for the events. The outcome of the events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: nausea; dizzy; felt injection site pain, red and swelling; felt injection site pain, red and swelling; felt injection site pain, red and swelling; This is a spontaneous report from a contactable pharmacist (patient). A 28-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0150 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Apr2021 at 15:30 hours as dose 1, single (at the age of 28-years-old) for COVID-19 immunisation. The patient medical history included polycystic ovaries (PCOS) and allergy to penicillin (both from an unknown date and unknown if ongoing). Patient had no other vaccine in four weeks. The patient previously took ibuprofen and experienced allergy to Ibuprofen. The patient concomitant medications/other medications in two weeks included birth pill and Flo vitamin. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 02Apr2021, patient had nausea while the nurse was applying the vaccine. On an unspecified date of 2021, after the vaccination, patient felt a little bit dizzy, but it was recovered after 15 minutes. On an unspecified date of 2021, patient felt injection site pain, redness and swelling for 2 weeks. The injection site redness was all around where the vaccine was applied. Patient received no treatment for the events. All the symptoms were recovered after 2 weeks. The outcome of all the events was recovered on an unspecified date of 2021.  No follow-up attempts are required. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: minor bloody nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 20-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 24Apr2021 12:45 (at the age of 20 years old) as dose 2, single dose for covid-19 immunization. No covid prior vaccination. The patient's medical history included anxiety from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 03Apr2021 at 12:45 (at the age of 20 years old) as dose 1, single dose for covid-19 immunization. On 24Apr2021 20:15, The patient experienced minor bloody nose. Patient not tested for covid post vaccination. No treatment received for the adverse events. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, SARS-CoV-2 test
Clinical narrative: Numerous spontaneous nosebleeds/gushing blood that has taken hours to stop after holding my nose; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8723), via an unspecified route of administration, administered in Arm Right on 26Mar2021 at 12:15 PM (age at vaccination was 65 years), as DOSE 2, SINGLE for covid-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Concomitant medications included Atorvastatin calcium (LIPITOR), Procaterol hydrochloride (PRO-AIR) and Nortriptyline; all taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Left arm on 04Mar2021 at 01:45 PM (age at vaccination was 65 years), as DOSE 1, SINGLE for covid-19 immunization. No other vaccines were received within four weeks prior to the administration of Covid vaccine. On 27Mar2021 at 08:00 AM, the day after the second shot, the patient experienced 4 spontaneous nosebleeds (numerous spontaneous bleeding). These had continued for the weeks since, with 2-3 incidents per week. The ones the last few weeks had involved gushing blood that had taken hours to stop after holding the patient's nose. No treatment was received for the events. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (Nasal Swab) on 22Apr2021. The outcome of the events was not resolved at the time of this report.  No follow-up attempts are needed. no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Woke up next day with 100.8 fever with headache.; Woke up next day with 100.8 fever with headache.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. Medical history included celiac disease, generalized anxiety disorder, depression, allergy to gluten (gluten sensitivity), allergy to wheat (food allergy) and computer vision syndrome (CVS eye fatigue). Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), desvenlafaxine (MANUFACTURER UNKNOWN); for unknown indication and CVS eye fatigue vitamin (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation and experienced skin discoloration on left arm at injection site (also reported from 25Mar2021). On 21Apr2021 at 06:00, the patient experienced raised, swollen, red skin, painful to touch at injection site on right arm. Woke up next day with 100.8 fever (unspecified units) with headache. The patient underwent lab tests and procedures which included Body temperature: 100.8 (unspecified units) on 21Apr2021. 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 not been tested for COVID-19. The clinical outcome of the event raised, swollen, red skin, painful to touch at injection site on right arm, 100.8 fever (unspecified units) and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Raised, swollen, red skin, painful to touch at injection site on right arm.; Woke up next day with 100.8 fever with headache.; Woke up next day with 100.8 fever with headache.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in the right arm on 20Apr2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. Medical history included celiac disease, generalized anxiety disorder, depression, allergy to gluten (gluten sensitivity), allergy to wheat (food allergy) and computer vision syndrome (CVS eye fatigue). Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), desvenlafaxine (MANUFACTURER UNKNOWN); for unknown indication and CVS eye fatigue vitamin (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation and experienced skin discoloration on left arm at injection site (also reported from 25Mar2021). On 21Apr2021 at 06:00, the patient experienced raised, swollen, red skin, painful to touch at injection site on right arm. Woke up next day with 100.8 fever (unspecified units) with headache. The patient underwent lab tests and procedures which included Body temperature: 100.8 (unspecified units) on 21Apr2021. 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 not been tested for COVID-19. The clinical outcome of the event raised, swollen, red skin, painful to touch at injection site on right arm, 100.8 fever (unspecified units) and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: developed severe throbbing headache; fever; chills; This is a spontaneous report from a contactable Physician (patient, self-reported).  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9266 and expiry date was not reported), intramuscularly, administered in Arm left, on 04Mar2021, as DOSE 1, SINGLE for COVID-19 immunization (Age at vaccination: 70 years). The patient medical history included supraventricular tachycardia and history of NSTEMI. The patient had no known allergies. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and salicylic acid, sulfur (SAS CARE). The patient was tested for COVID post vaccination. The patient was not diagnosed with COVID prior vaccination. On 04Mar2021, after 12 hours the patient had developed severe throbbing headache, fever and chills last 24 hrs. The patient underwent lab test and procedure which included covid test type post vaccination, nasal Swab with covid test result negative on an unspecified date. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Rash, Skin irritation, Swelling
Clinical narrative: Swollen armpit; Swollen armpit causing pain when lifting arm; Armpit skin felt irritated; Severe headache; Rash on legs (appears like individual dots) not itchy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: ER 8736), dose 2 via an unspecified route of administration, administered in left arm on 22Apr2021 at 09:00 (at the age of 50-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included heart murmur and penicillin allergy(Known allergies: penicillin) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine includes received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left leg on 18Mar2021 at 15:30 (at the age of 50-year-old) as DOSE 1, SINGLE for covid-19 immunisation. On 22Apr2021 at 09:15, the patient experienced swollen armpit causing pain when lifting arm, armpit skin felt irritated, severe headache, rash on legs (appeared like individual dots) not itchy. The events did not result in doctor or other health care professional office or clinic visit and emergency room department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen armpit causing pain when lifting arm, armpit skin felt irritated, severe headache, rash on legs (appeared like individual dots) not itchy was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tinnitus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling in injection sight; Swelling in injection sight and pain; Fever; Body aches; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 27-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 on an unknown date (at the age of: 27-years-old) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history and 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 concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on an 16Apr2021 as a dose 2, single for COVID-19 immunisation. On 03Apr2021, the patient experienced swelling in injection sight and pain which lasted for 4 days, fever and body aches for 3 days. Tinnitus is noticeably worse, 5 days after when reported and still present. Therapeutic measures were not taken as a result of the events. The events 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 events fever and body aches that lasted for 3 days was resolved on 06Apr2021, while that of swelling in injection sight and pain that lasted for 4 days was resolved on 07Apr2021, tinnitus is noticeably worse was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Erythema, Headache
Clinical narrative: had a fever of 103; chills and severe body aches (flu-like); chills and severe body aches (flu-like); sweating; now my arm is swollen, red; now my arm is swollen, red; the lymph nodes in the left side of my body are active / painful; dizzy; achy; headache; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:15 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension, factor v leiden and pre-diabetic. Concomitant medication(s) included spironolactone, triamcinolone, biotin and paracetamol (TYLENOL). Patient previously received first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 at 4:45 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation and experienced sore arm for a few hours. Patient did not receive any other vaccine within four weeks. On 19Apr2021 19:30, the patient reported within 2 hours, I was getting dizzy and achy. Later that evening, had a headache and body aches. Next day, on 20Apr2021, I thought I was getting better, but had a fever of 103, chills and severe body aches (flu-like), fever broke, am sweating and now my arm was swollen, red, and the lymph nodes in the left side of my body are active / painful. The patient underwent lab tests and procedures which included body temperature: 103 on 20Apr2021. Patient did not receive any treatment for events. Patient did not had covid prior to vaccination and not tested positive since vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Lymph node pain, Pain, Peripheral swelling
Clinical narrative: had a fever of 103; chills and severe body aches (flu-like); chills and severe body aches (flu-like); sweating; now my arm is swollen, red; now my arm is swollen, red; the lymph nodes in the left side of my body are active / painful; dizzy; achy; headache; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:15 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension, factor v leiden and pre-diabetic. Concomitant medication(s) included spironolactone, triamcinolone, biotin and paracetamol (TYLENOL). Patient previously received first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 at 4:45 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation and experienced sore arm for a few hours. Patient did not receive any other vaccine within four weeks. On 19Apr2021 19:30, the patient reported within 2 hours, I was getting dizzy and achy. Later that evening, had a headache and body aches. Next day, on 20Apr2021, I thought I was getting better, but had a fever of 103, chills and severe body aches (flu-like), fever broke, am sweating and now my arm was swollen, red, and the lymph nodes in the left side of my body are active / painful. The patient underwent lab tests and procedures which included body temperature: 103 on 20Apr2021. Patient did not receive any treatment for events. Patient did not had covid prior to vaccination and not tested positive since vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a fever of 103; chills and severe body aches (flu-like); chills and severe body aches (flu-like); sweating; now my arm is swollen, red; now my arm is swollen, red; the lymph nodes in the left side of my body are active / painful; dizzy; achy; headache; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received second dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:15 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension, factor v leiden and pre-diabetic. Concomitant medication(s) included spironolactone, triamcinolone, biotin and paracetamol (TYLENOL). Patient previously received first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 at 4:45 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation and experienced sore arm for a few hours. Patient did not receive any other vaccine within four weeks. On 19Apr2021 19:30, the patient reported within 2 hours, I was getting dizzy and achy. Later that evening, had a headache and body aches. Next day, on 20Apr2021, I thought I was getting better, but had a fever of 103, chills and severe body aches (flu-like), fever broke, am sweating and now my arm was swollen, red, and the lymph nodes in the left side of my body are active / painful. The patient underwent lab tests and procedures which included body temperature: 103 on 20Apr2021. Patient did not receive any treatment for events. Patient did not had covid prior to vaccination and not tested positive since vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Er8733, Expiration date: Unknown), via an unspecified route of administration in right arm on 31Mar2021 at 10:30 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. The patient's medical history included latex sensitivity. The patient's other medical history was none. The patient was not pregnant at the time of the vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. There were no concomitant medications. The patient did not receive any other medications in two weeks of the vaccination. The patient did not receive any other vaccine in four weeks of vaccination. On 03Apr2021, the patient experienced full body rash. It was reported that the patient had full body rash 3 days following first dose. The event lasted approximately 3 weeks. The patient did not receive any treatment in response to the event. The outcome of the event was recovered on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Pain in extremity
Clinical narrative: Shortness of breath; Severe headache unresolved by Ibuprofen, Naratriptan, Tylenol, Anacin, Ubrelvy, Ajovy. Shortness of breath. Also the expected arm pain, chills, fever, body ache, fever.; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; This is a spontaneous report from a contactable Consumer (patient). A 50-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in Arm Left on 26Apr2021 at 13:45 (01:45 PM) as DOSE 2, SINGLE (at the age of 50-years-old) for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility type vaccine was at Hospital. Medical history included migraine from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no covid prior vaccination, was not covid tested post vaccination. Concomitant medication included (other medications taken in two weeks)Ibuprofen, Fioricet, Ajovy, Ubrelvy, Toradol all taken for unspecified indication and start and stop date were not reported. Patient took no other vaccine in four weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 01:45 PM as DOSE 1, SINGLE at the age of 50-years-old for COVID-19 immunisation. It was reported that on 27Apr2021 at 04:30 AM, the patient experienced Severe headache, Shortness of breath, also the expected arm pain, chills, fever, body ache, fever. Treatment was taken for adverse event Severe headache, but it was unresolved by Ibuprofen, Naratriptan, Tylenol, Anacin, Ubrelvy, Ajovy. No treatment was received for other adverse event. Outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortness of breath; Severe headache unresolved by Ibuprofen, Naratriptan, Tylenol, Anacin, Ubrelvy, Ajovy. Shortness of breath. Also the expected arm pain, chills, fever, body ache, fever.; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; Also the expected arm pain,chills, fever, body ache, fever; This is a spontaneous report from a contactable Consumer (patient). A 50-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in Arm Left on 26Apr2021 at 13:45 (01:45 PM) as DOSE 2, SINGLE (at the age of 50-years-old) for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility type vaccine was at Hospital. Medical history included migraine from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no covid prior vaccination, was not covid tested post vaccination. Concomitant medication included (other medications taken in two weeks)Ibuprofen, Fioricet, Ajovy, Ubrelvy, Toradol all taken for unspecified indication and start and stop date were not reported. Patient took no other vaccine in four weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 01:45 PM as DOSE 1, SINGLE at the age of 50-years-old for COVID-19 immunisation. It was reported that on 27Apr2021 at 04:30 AM, the patient experienced Severe headache, Shortness of breath, also the expected arm pain, chills, fever, body ache, fever. Treatment was taken for adverse event Severe headache, but it was unresolved by Ibuprofen, Naratriptan, Tylenol, Anacin, Ubrelvy, Ajovy. No treatment was received for other adverse event. Outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Right eye turned blood red; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) that:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date the patient's right eye turned blood red. The outcome for the reported event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Right eye turned blood red/ Both my father, a family friend and another patient at same doctor's office all experienced same thing.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right eye turned blood red/ Both my father, a family friend and another patient at same doctor's office all experienced same thing. The reporter stated that the right eye turned blood red, no pain though. Next day the eyeball itself was swollen, especially at the interior corner of eye. Still no pain. No discharge. Eye doctor could find no indication of anything in eye. Not allergies. Left eye was fine. This occurred 2 wks past 1st vaccine. Doctor finally put her on Prednisone which helped. The reporter stated that both my father, a family friend and another patient at same doctor's office all experienced same thing. We wouldn't have attributed it to the vaccine if we hadn't been talking and realized we all had same symptoms, same time frame past vaccine for symptoms to show up and Pfizer vaccine. Adverse event resulted in physician office visit. Outcome of the event was unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.