chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Off label use, Product use issue, Vaginal haemorrhage
Clinical narrative: exclusively breast feeding; exclusively breast feeding; Started vaginally bleeding; Started vaginally bleeding on the day of my second vaccine very heavily.; This is a spontaneous report from a contactable 29-year-old female consumer reported for herself. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via unspecified route of administration, on 30Aug2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Patient had no medical history. The patient concomitant medication was not reported. Patient had not taken any other vaccine in four weeks. Patient had not COVID prior to the vaccination and was not tested post COVID vaccination. Patient had no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0202), via an unspecified route of administration, in right arm on 09Aug2021 at 15:00 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Other vaccine administered on the 09Aug2021 was Pfizer (unknown manufacturer, Lot number: FC3184) administered in the right arm. On 30Aug2021 at 15:00, patient started vaginally bleeding on the day of her second vaccine very heavily. She was only 2.5 weeks postpartum and exclusively breast feeding. The patient has not received any treatment for the reported events. The clinical outcome for started vaginally bleeding on the day of her second vaccine very heavily was recovering and other events unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218839 Maternal case
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: she was in bed "for 4 days" after booster; This is a spontaneous report from Regulatory Authority via pharmacy. A contactable nurse and consumer (patient) reported that a 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ, Expiration date: 30Jun2023), oral from 12Aug2021 to an unspecified date, at 5 mg, twice a day (60/BTL) for an unspecified indication. Medical history included allergy to penicillin, allergy to animal, allergy to horse Products. Concomitant medication(s) included temazepam (capsule, strength: 15 mg) at 15 mg; methotrexate (tablet, strength: 2.5 mg) at 2.5 mg; tramadol HCL (tablet, strength: 50 mg) at 50 mg; vitamin B complex tablet; vitamin D3 (capsule, strength: 10 ug) at ug; estrogens conjugated (PREMARIN, tablet, strength: 0.3 mg) at 0.3 mg; leucovorin calcium (Tablet) at 5 mg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 1, single for Covid-19 immunization, received second dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route on an unknown date as dose 2, single for Covid-19 immunization. Patient states that doctor stopped Xeljanz for 2 weeks due to Pfizer Covid booster shot, Patient was scheduled for vacation and did not miss work but states she was in Bed "for 4 days" after booster. The action taken in response to the event for tofacitinib citrate was temporarily withdrawn on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Feeling hot, Off label use
Clinical narrative: Two minutes after getting it I got a major heat wave; Pressure in my chest; difficult to breath; Really bad chill; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 16Sep2021 at 4'O clock(at the age of 22-year-old) as dose 1, single for covid-19 immunisation and Influenza vaccine via an unspecified route of administration on 16Sep2021 4'O clock (Batch/Lot number was not reported) as dose number unknown for immunization. No relevant medical history reported. There were no concomitant medications. Patient reported, on 16Sep2021, two minutes after getting her first shot she got a major heat wave and like pressure in her chest like it was kind of difficult to breath and then right after that it was really bad chill and she just have not a heard of anybody that she know that has had a reaction so quickly after getting it. So, she was kind of concern and scared her. Patient took Influenza vaccine at the same time of Pfizer vaccine on 16Sep2021. Outcome of the events was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Two minutes after getting it I got a major heat wave; Pressure in my chest; difficult to breath; Really bad chill; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; Pfizer vaccine and Influenza vaccine administered on 16Sep2021; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 16Sep2021 at 4'O clock(at the age of 22-year-old) as dose 1, single for covid-19 immunisation and Influenza vaccine via an unspecified route of administration on 16Sep2021 4'O clock (Batch/Lot number was not reported) as dose number unknown for immunization. No relevant medical history reported. There were no concomitant medications. Patient reported, on 16Sep2021, two minutes after getting her first shot she got a major heat wave and like pressure in her chest like it was kind of difficult to breath and then right after that it was really bad chill and she just have not a heard of anybody that she know that has had a reaction so quickly after getting it. So, she was kind of concern and scared her. Patient took Influenza vaccine at the same time of Pfizer vaccine on 16Sep2021. Outcome of the events was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: headache; low fever; muscle aches; fatigue; Not able to function as normal for 1 day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EL1283 and expiry date was not reported), via intramuscular route of administration in right upper arm, on 04Feb2021, approximately 09:30 am (age at vaccination: 79 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes angioedema (date: Started many years ago- ongoing), hypothyroidism (date: many years ago, 1985- ongoing), macular degeneration (date: Many years- ongoing). Reportedly in the past the patient tested positive for COVID-19 (21Dec2020 to Mid Jan2021). The patient concomitant medications include levothyroxine for thyroid (start date unspecified to ongoing), ascorbic acid, fish oil, vitamin e nos, xantofyl, zeaxanthin, zinc (Ocuvite) for macular degeneration, VITAMIN C [ASCORBIC ACID] and Vitamin D3 (Vitamin C+D3), Probiotic, Stamets 7 for immune booster. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EK5730 and expiry date was not reported), via intramuscular route of administration in left upper arm, on 14Jan2021, approximately 10:30 am, as a dose 1, single for COVID-19 immunization and experienced headache, low fever, muscle aches, fatigue, GI tract Symptoms, not able to function as normal for 1 day. On 04Feb2021, within 08-10 hours of vaccine shots the patient experienced all the same symptoms she had during 3 weeks of COVID symptoms. The patient COVID had from late Dec2020 to Mid Jan2021 the exception of GI tract symptoms. Reportedly for the 24 hours the patient had headache, low fever, muscle aches, fatigue. It was reported that the patient was not able to function as normal for 1 day. The events assessed as non-serious. After second vaccine patient took Narco 5-325 mg few hours after the shot because the patient was miserable for 24 hours after first vaccine. The patient did not received treatment for the events. On 05Feb2021, after 24 hours outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: big lump on the bottom of her armpit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 20Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big lump on the bottom of her armpit on an unspecified date. Caller received a booster dose of the Pfizer COVID-19 vaccine on September 20, 2021. She noticed a big lump on the bottom of her armpit on the side where she got the vaccine. Caller wanted to know if this is a normal side effect or has anybody reported such side effect post vaccination. She got the injection and was wondering if anybody had the same issue and what could she do to get it to ease out or anything; caller aware Pfizer unable to offer treatment recommendations or medical advice. Dates and seriousness for has a big lump on the bottom of her armpit on the side she got the injection was reported as unspecified. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mass, Urticaria
Clinical narrative: like a mass that was just like a few mass break; really bad hives; she can't do her job and it's ruining her; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 03Mar2021 (at the age of 38 years old) as DOSE 2, SINGLE for COVID-19 immunisation; patient received dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration administered in right arm on 10Feb2021 (at the age of 38 years old) as DOSE 1,SINGLE for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medication included levothyroxine sodium for thyroid disorder. The patient experienced really bad hives on 11Mar2021, she can't do her job and it's ruining her on 2021, like a mass that was just like a few mass break on 28Mar2021. The patient reported that she developed really bad hives since in 11Mar2021 had gone through 6 different doctors was on antihistamines, Pepcid, lupus meads, was already took thyroid medication. They were telling her that probably Chronic Urticaria and people are getting this from the vaccine and that was how it's going to be from now on. The patient also reported that she is a teacher, and she could not do her job and it's ruining her, she thought it would go away in a few months, but she was still dealing with it. The patient had broken out in massive hives; she never had anything like this before and that had been her reaction since she got the vaccine. She had dislocated her ability to do pretty everything much that she could easily do. She reported that on her 'cab' and they were just like bug bite or something and they had migrated up all over her body little by little. They created themselves anywhere and everywhere they wanted to at least three weeks out of four weeks months and it had like 'face to face' and dislocated her ability to do pretty everything much that she could easily do. So, she did not know what to do at that point she never had anything like this before and that had been her reaction since she got the vaccine, so she guess she was looking for advice and next step where she was supposed to go. It like a mass that was just like a few mass break on 28Mar2021. The patient received Antihistamines, Prednisone, Xolair, Zyrtec, Allegra, Claritin, Pregamet, Pepcid combination and mucous medication for treatment of hives. Outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary mass, Decreased appetite, Fatigue, Gastritis
Clinical narrative: weakness; fatigue; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; loss of appetite; gastritis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported) via an unspecified route of administration in arm left, on an unspecified date in Sep2021 at 03:30 PM (age at the time of vaccination: 45 years), as a dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history includes auto immune disorder. The patient concomitant medications received within 2 weeks of vaccination was reported as 1. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration in arm left, on 01Sep2021 at 07:00 PM, as a dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 23Sep2021 the patient experience swollen and painful lumps and rash in armpit, loss of appetite, gastritis, weakness, fatigue. It was reported that the patient received treatment for the adverse event. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: weakness; fatigue; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; loss of appetite; gastritis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported) via an unspecified route of administration in arm left, on an unspecified date in Sep2021 at 03:30 PM (age at the time of vaccination: 45 years), as a dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history includes auto immune disorder. The patient concomitant medications received within 2 weeks of vaccination was reported as 1. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration in arm left, on 01Sep2021 at 07:00 PM, as a dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 23Sep2021 the patient experience swollen and painful lumps and rash in armpit, loss of appetite, gastritis, weakness, fatigue. It was reported that the patient received treatment for the adverse event. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Persistent fatigability; Myalgia; This is a spontaneous report from a contactable physician, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Sep2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Sep2021 at 16:30, the patient experienced persistent fatigability and myalgia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fatigability and myalgia was resolved with sequelae on an unknown date in Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headedness; This is a spontaneous report from a non-contactable pharmacist. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via intramuscular route of administration in the right arm on 25Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced light headedness. The patient drank 2 cups of water and light headedness went away. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were taken as a result of the event and included drinking two cups of water. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event light headedness was resolved on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Breast mass, Breast swelling, Breast tenderness, Fear
Clinical narrative: Inflammation swelling, sensibility of breasts (both); swelling, sensibility of breasts (both); sensibility of breasts (both); found lumps; Psychological fear; This is a spontaneous report from a contactable consumer(patient). A 36-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number:EWO161), via an unspecified route of administration, administered in right arm on 28May2021 13:00 (at the age of 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included resin allergy and covid-19. Concomitant medications included spirulina [spirulina spp.] (SPIRULINA), camellia sinensis extract (GREEN TEA). The patient previously took cefadroxil and experienced drug hypersensitivity. The patient was not pregnant at time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had covid prior vaccination and has not been covid tested post vaccination. On 31May2021, patient experienced inflammation, swelling, sensibility of breasts (both). patient was checked by obstetrician-gynecologist, who found lumps, then patient got a mammogram and ultrasound and it looks normal for now not cancer. After the vaccine patient had to go into all these check ups and costly procedures and the psychological fear that accompanied them is also a cause of huge concern for patient. Patient has received treatment for the adverse event. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Ultrasound scan
Clinical narrative: Inflammation swelling, sensibility of breasts (both); swelling, sensibility of breasts (both); sensibility of breasts (both); found lumps; Psychological fear; This is a spontaneous report from a contactable consumer(patient). A 36-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number:EWO161), via an unspecified route of administration, administered in right arm on 28May2021 13:00 (at the age of 36 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included resin allergy and covid-19. Concomitant medications included spirulina [spirulina spp.] (SPIRULINA), camellia sinensis extract (GREEN TEA). The patient previously took cefadroxil and experienced drug hypersensitivity. The patient was not pregnant at time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had covid prior vaccination and has not been covid tested post vaccination. On 31May2021, patient experienced inflammation, swelling, sensibility of breasts (both). patient was checked by obstetrician-gynecologist, who found lumps, then patient got a mammogram and ultrasound and it looks normal for now not cancer. After the vaccine patient had to go into all these check ups and costly procedures and the psychological fear that accompanied them is also a cause of huge concern for patient. Patient has received treatment for the adverse event. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Magnetic resonance imaging, Vaccination site mass, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Her left arm is still hurting; She could not even raise her left arm up without it hurting her; her shoulder swell up like a big knot in it/ got a big knot at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm left on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid-19 Vaccine on 05May2021 in her left arm. Her left arm was still hurting. It felt like she was getting a shot into it all over again. She needed to take Tylenol and Ibuprofen to stop the pain, but she did not want to do that forever. It was her second vaccine, and it made her shoulder swell up like a big knot in it. That took six weeks to go away. She could not even raise her left arm up without it hurting her. Her doctor did a Magnetic Resonance Imaging (MRI) on her arm, but she could not finish the test because she felt like she was in a casket. The outcome of the events Her left arm is still hurting was not recovered, her shoulder swell up like a big knot in it/ got a big knot at the injection site was recovered on an unknown date and She could not even raise her left arm up without it hurting her was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Her left arm is still hurting; She could not even raise her left arm up without it hurting her; her shoulder swell up like a big knot in it/ got a big knot at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm left on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid-19 Vaccine on 05May2021 in her left arm. Her left arm was still hurting. It felt like she was getting a shot into it all over again. She needed to take Tylenol and Ibuprofen to stop the pain, but she did not want to do that forever. It was her second vaccine, and it made her shoulder swell up like a big knot in it. That took six weeks to go away. She could not even raise her left arm up without it hurting her. Her doctor did a Magnetic Resonance Imaging (MRI) on her arm, but she could not finish the test because she felt like she was in a casket. The outcome of the events Her left arm is still hurting was not recovered, her shoulder swell up like a big knot in it/ got a big knot at the injection site was recovered on an unknown date and She could not even raise her left arm up without it hurting her was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: lump at injection site; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0169), via intramuscular route of administration, administered in left arm on 26Apr2021 at 10:30 (at the age of 55-years) as single dose for COVID-19 immunization. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8732), via intramuscular route of administration, administered in left arm on 03Apr2021 at 10:30 (at the age of 55-years) as single dose for COVID-19 immunization and had experienced shingles, lumps on back of head which was hurting along with her hair. The patient medical history included cholesterol, shingles. The patient had a positive family history for ovarian cancer, colon cancer and heart disease. The patient had known allergies including food allergies to Soy (highly), peanuts, tomato, wheat; and previous allergies to medications including Nickel, Gold, Formaldehyde, Bacitracin, Neomycin, Thimerosal, Dimethylaminopropylamine, Methyl dibromo glutaronitrile, Bronopol. The patient's concomitant medications included ongoing cetirizine hydrochloride taken for allergies and rosuvastatin taken for cholesterol. Following second dose vaccination on 26Apr2021, the patient had experienced lump at injection site. The patient had not received any treatment for the event. The outcome of the event was recovered on an unspecified date in 2021 at the time of report.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Lymphadenopathy, Off label use
Clinical narrative: Patient had headache after first day and swollen lymph nodes receiving 3rd covid booster(Pfizer); Patient had headache after first day and swollen lymph nodes receiving 3rd covid booster(Pfizer); headache; swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) received by Pfizer from Sanofi. A 16-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation, Dupilumab (DUPIXENT, Solution for injection, Batch/Lot number and expiry date not reported) via subcutaneous route from 04Jun2020 and ongoing, at 300 mg, every other week for severe persistent asthma, uncomplicated. Medical history included Asthma, family history was not reported. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA), Salbutamol (ALBUTEROL HFA), Montelukast (MONTELUKAST) taken for an unspecified indications, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and then took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced headache after first day and swollen lymph nodes. It was not reported if the patient received a corrective treatment for the events. The action taken for Dupilumab was dose not changed. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lethargy, Vaccination site pain
Clinical narrative: Pain at injection site; Chills; Extreme leg weakness; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 27Sep2021 11:00 (Lot Number: FC3184) as dose 3 (booster), single for COVID-19 immunization (at the age of 78-year-old). Medical history included ongoing back pain from 2014 (Pertinent details: regenerative therapy 21Sep2021). Concomitant medication included paracetamol (TYLENOL). The patient previously received 1st dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 10Feb2021 (Lot Number: EL9269) as dose 1, single for COVID-19 immunization (at the age of 78-year-old) and experienced pain. She also received 2nd dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 14Mar2021 (Lot Number was not reported) as dose 2, single for COVID-19 immunization (at the age of 78-year-old) and experienced pain. On 27Sep2021 15:00, the patient experienced pain at injection site, chills, extreme leg weakness and lethargy. Seriousness of the events reported as disability. No treatment received for adverse events. As of 29Sep2021, the clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: sudden severe pain L foot four days after injection(10/4); sudden severe pain in R knee; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF8849, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Left on 30Sep2021 (age at vaccination: 77years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included blood pressure measurement and hypothyroidism from an unknown date and unknown if ongoing. Patient received influenza vaccine (Lot number was not reported) administered in Right Deltoid on 08Sep2021. Historical vaccine include bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF8839, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 12:00 PM as dose 1, single and dose 2 (Lot number: EL9267) administered in Arm Left on 30Sep2021. Patient had no known allergies. Patient did not receive any other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient was not pregnant at the time of vaccination. It was reported that developed sudden severe pain in R knee two days following injection of third Pfizer,(02Oct2021), & sudden severe pain L foot four days after injection(04Oct2021). No treatment received for the event. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Oct2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroparesis, depression, anxiety and COVID-19, which was diagnosed prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received isopropanol/chlorhexidine gluconate (CHLORAPREP) and experienced drug allergy. On 02Oct2021 at 04:00, about 12 hours after injection, the patient experienced vomiting and diarrhea. 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 events vomiting and diarrhea was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: about two weeks after the second vaccine, his psoriasis flared and appeared in previously unaffected areas on body (scalp, ears, elbows); This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration on an unknown date May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 62-year-old) for covid-19 immunisation. Medical history included hypertension and allergy both from an unknown date and unknown if ongoing and ongoing localized plaque psoriasis (many years history of localized plaque psoriasis for decades, usually mild and involving the hands). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medication received within 2 weeks of vaccination) included amlodipine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on an unknown date of Apr2021 (Batch/lot number: Unknown) as a dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient about two weeks after the second vaccine, his psoriasis flared and appeared in previously unaffected areas on body (scalp, ears, elbows) on unknown date in May2021. The event caused physician office visit. The patient received treatment for psoriasis (topical steroid cream) but may need systemic medication to clear. Since the vaccination, the patient was not tested for COVID-19. The outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid pain, Herpes virus infection, Penile swelling, SARS-CoV-2 test
Clinical narrative: Never was diagnosed for Herpes or had any symptoms. But a month after started getting severe symptoms; swelling on penis tip; sores on eye lids; This is a spontaneous report from a non-contactable consumer (reported for himself). A 39-year-old male patient received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on 28Apr2021 (at the age of 39-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 29Jun2021 Patient Never was diagnosed for Herpes or had any symptoms. But a month after started getting severe symptoms including swelling on penis tip, sores on eye lids. Have since been getting all symptoms and ashamed of himself. The only time he had sexual encounter was 12years ago never since. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result. Outcome of all the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: I had bloodwork on 28Jul2021-CRP cardiac-and the result was 9.64 on a scale of 0.00-3.00; My naturopath said it was cardiac inflammation from the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 23Jul2021 10:00, at 60-year-old, as single dose (Lot Number: FW6780) for covid-19 immunisation. Medical history included Raynaud's, osteoarthritis, Mitral valve prolapse (MVP). Known allergies was erythromycin and augmentin. No other vaccine in four weeks. Prior vaccination the patient had no covid. The patient had no covid tested post vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 23Jul2021 at 10:00AM, at 60-year-old, as single dose (Lot Number: FW6780) for covid-19 immunisation. Concomitant drugs included curcuma longa rhizome (TURMERIC), calcium and vitamins. The patient stated she had bloodwork on 28Jul2021 included Protein C (CPR) cardiac: the result was 9.64 on a scale of 0.00 to 3.00. The patient' naturopath said it was cardiac inflammation from the vaccine on 23Jul2021(as reported). Those events resulted in physician office visit. The patient got no treatment. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Investigation, Polymerase chain reaction
Clinical narrative: high blood pressure and am on medication for it.; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 21Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 01May2021 12:00 (Lot Number: EW0172) as dose 2, single at the age of 55 years old for COVID-19 immunization. Medical history included diverticulitis. There were concomitant medications within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. Historic vaccine was bnt162b2 administered in left arm received on 10Apr2021 16:15 (Lot No: EP7533) as dose 1, single at the age of 55 years old for Covid-19 immunization. On 06Sep2021 14:00, the patient had high blood pressure and was on medication for it. The seriousness of event was hospitalization/prolongation of hospitalization. Event resulted in emergency room/department. Treatment received which included losartan presenbed, testing then admitted. 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 has not been tested for COVID-19. Node results: negative on 23Nov2020. Repeating node results negative on 30Nov2020. Nasal swab: negative on 30Mar2021. Nasal swab: negative on 06Sep2021. The outcome of high blood pressure was recovered/resolved with sequel in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Inflammation, Vision blurred
Clinical narrative: yeast infections; blurry vision; inflammation; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in right arm on 26Jan2021 at 13:15 (at the age of 43-year-old) as dose 2, single for covid-19 immunisation at hospital. Medical history included covid-19 and allergy to unspecified drug from an unknown date and unknown if ongoing. Patient received no medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot No: EL0142) via intramuscular, administered in right arm on 05Jan2021 at 13:00 (at the age of 43-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan2021 at 12:00, the patient experienced yeast infections, blurry vision and the doctor said it was due to inflammation. The adverse events resulted in visit to emergency room visit and physician office visit. No prolonged hospitalization was reported. Patient gone to numerous doctors and they can't figure out the cause and she have been on multiple treatments. Outcome of the events was not recovered at the time of reporting.   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; diarrhea; tired all weekend; This is a spontaneous report from a contactable consumer (patient). A 53-years-old nonpregnant female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EWO151), via an unspecified route of administration, administered in Arm Left on 08Oct2021 16:15 (at the age of 53 years old) as dose 3 (BOOSTER), single for covid-19 immunisation. Medical history included colitis ulcerative. The patient had no known allergy. 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 medication included mesalazine (APRISO). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VAC-CINE, Lot number: ER8735) in left arm on 31Mar2021 (at the age of 53 years old) for single dose, received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6208) in left arm on 10Mar2021 (at the age of 53 years old) for covid-19 immunisation. On 08Oct2021 at 20:00, the patient experienced Swelling and hard knot at injection site; itching and painful to the touch, diarrhoea , tired all weekend. No treatment was received for the events. The outcome of the events was recovering  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; diarrhea; tired all weekend; This is a spontaneous report from a contactable consumer (patient). A 53-years-old nonpregnant female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EWO151), via an unspecified route of administration, administered in Arm Left on 08Oct2021 16:15 (at the age of 53 years old) as dose 3 (BOOSTER), single for covid-19 immunisation. Medical history included colitis ulcerative. The patient had no known allergy. 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 medication included mesalazine (APRISO). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VAC-CINE, Lot number: ER8735) in left arm on 31Mar2021 (at the age of 53 years old) for single dose, received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6208) in left arm on 10Mar2021 (at the age of 53 years old) for covid-19 immunisation. On 08Oct2021 at 20:00, the patient experienced Swelling and hard knot at injection site; itching and painful to the touch, diarrhoea , tired all weekend. No treatment was received for the events. The outcome of the events was recovering  Follow-up attempts are completed. No further information is expected.