chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Perivascular dermatitis
Clinical narrative: Superficial perivascular dermatitis on all parts of the body and face due to fixed drug (vaccine) eruption; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, shellfish allergy and COVID-19 respiratory infection. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both started on unknown dates and for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 19Apr2021 at 00:00, the patient experienced superficial perivascular dermatitis on all parts of the body and face due to fixed drug (vaccine) eruption. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with prednisone (MANUFACTURE UNKNOWN) started on unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event superficial perivascular dermatitis was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Period was delayed; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 23Feb2021 (at the age of 28-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 16Mar2021 (at the age of 28-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in Feb2021, the patient's period was delayed with 74 days between cycles (20Feb2021 to 05May2021). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event period was delayed was resolved on 05May2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Mouth injury
Clinical narrative: After the 2nd dose, her immune system was determined weak; she had cuts inside her mouth; This is a spontaneous report from a Pfizer sponsored program. This was a report combining information from duplicate reports 2021523522 and 2021530750. The current and all subsequent information will be reported under manufacturer report number 2021530750. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation, sulfamethoxazole, acyclovir [aciclovir sodium]. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 14JApr2021 for COVID-19 Immunization. The patient experienced after the 2nd dose, her immune system was determined weak, and she had cuts inside her mouth on May2021. It was reported that Caller had her 2nd dose of Pfizer Covid-19 vaccine last 5May2021 and her doctor prescribed an antibiotic to her. After the 2nd dose, her immune system was determined weak, and she had cuts inside her mouth. She was calling to know when she can start taking the antibiotic because her doctor told her that it might affect the vaccine. Her 1st dose was given 14Apr2021. Her doctor prescribed two medications before she received the Pfizer Covid 19 vaccine. Medications were an antibiotic (sulfamethoxazole) and acyclovir. The outcome for all events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00, as a single dose for COVID-19 immunisation. On 09May2021 at 11:00, the patient experienced body aches, sore arm and fatigue. 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 not taken as a result of the events. The clinical outcome of the events body aches, sore arm and fatigue was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pruritus, Vaccination site mass
Clinical narrative: got a lump at the injection site, left arm; itching a lot; he doesn't know if it's related or not, but something stung him on his thumb.; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:15 (Batch/Lot Number: 6204) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus, bronchiectasis from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; risperidone (RISPERIDONE) taken for affective disorder, start and stop date were not reported; colecalciferol (VITAMIN D3) taken for asthenia, start and stop date were not reported; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for asthenia, start and stop date were not reported. The patient experienced itching a lot on 07May2021, got a lump at the injection site, left arm on 09May2021, he doesn't know if it's related or not, but something stung him on his thumb on May2021. The outcome of the event itching a lot and got a lump at the injection site, left arm was not recovered and outcome of the event something stung him on his thumb was unknown.   Additional Context: Caller stated that he's got a lump at the injection site of the Pfizer vaccine. Caller verifies it was the Pfizer Covid Vaccine. Caller states it itches a lot too. Pfizer Covid Vaccine: First Dose he received the first one 22Feb2021. Caller provided LOT: EN6201. Caller unsure of Expiry date, NDC. Caller states received as injection in left arm. Caller received between 12 and 2pm, he doesn't really remember. Caller states he had the appointment at 10 and had to stand in line for hours to get it. Pfizer Covid Vaccine: Second Dose: Caller states he received the second dose 15Mar2021. Caller states on the card, they just wrote Pfizer scribble, the two letters are indecipherable. Caller states all it says is Pfizer 6204 and the rest is just scribbled. Caller verifies it is handwritten. Caller states no expiry date or NDC on card. Caller states received second dose at 1215pm in his left arm. Address: Caller states he must get permission from his phone to look it up. Caller states he moved so he doesn't know it yet. Caller states he doesn't live at a permanent address but can give his parents address if Pfizer needs that. Itching; lump: Caller states he started itching about 3 days ago and now it's a lump because he was scratching it. Prescribing Healthcare Professional: Caller states he doesn't have a primary care doctor, he is just starting a new job. Caller states he doesn't know if it's related or not, but something stung him on his thumb. Caller states it was like an ant bite, but serious. Caller states at first, he thought it was a brown recluse, it was the same arm, on his left thumb. Caller states it turns out it was just an ant.  No follow up attempt is needed: No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Urticaria, Vaccination site reaction
Clinical narrative: her arm(site of Covid vaccine)was itching; raised blisters and welps over her upper arm near the vaccine injection site; raised blisters and welps over her upper arm near the vaccine injection site; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen. This non-serious solicited report was reported to Amgen on 21/APR/2021 by a consumer from a commercial program.   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administrated in arm on 01Apr2021 (age at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis. The patient's concomitant medications included Etanercept (Enbrel) 50 mg weekly, from 01Mar2021 to 07Apr2021, for Rheumatoid arthritis. On an unspecified date Apr2021, the patient experienced her arm (site of COVID-19 Vaccine) was itching, and raised blisters and welps over her upper arm near the vaccine injection site. Treatment for the event injection site urticaria included Benadryl (diphenhydramine hydrochloride), Tylenol (paracetamol). Caller stated, on 01/MAR/2021, the patient took her first dose of Enbrel and noticed no reaction and was fine; second dose was also fine. On an unknown date in MAR/2021, the patient took her third dose of Enbrel and four days after the injection she developed a large, red welp five inch in diameter on her thigh. On an unknown date in 2021, the patient took fifth dose of Enbrel and the patient's reactions were coming sooner, this time within in two days and same giant welp. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: lost my appetite for food; Pain in left arm at the injection site; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I will have hot sweats; This is a spontaneous report from a contactable consumer, the patient. A 42-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 left arm on 07May2021 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to a lot of plants, allergy to grass, latex and trees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took silicones nos (MANUFACTURER UNKNOWN) (reported as silicone) for unspecified indication from unknown date and experienced drug allergy on unknown date. On 07May2021 at 15:00, after the first dose of the Pfizer vaccine, the patient experienced pain in left arm at the injection site. The patient began to feel very dizzy, fatigued and nauseous like equilibrium was off. On 11May2021, the patient still felt dizzy, fatigued, nauseous and the patient had lost appetite for food and sometimes patient had hot sweats but patient did not have a fever. The current day (this was day 4), the patient 's arm was no longer sore, but still felt fatigue, dizziness and nauseous. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event pain in left arm at the injection site was recovered on an unknown date in May2021. The clinical outcome of the events felt very dizzy, fatigued, nauseous, equilibrium was off, lost appetite and hot sweats was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: lost my appetite for food; Pain in left arm at the injection site; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I will have hot sweats; This is a spontaneous report from a contactable consumer, the patient. A 42-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 left arm on 07May2021 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to a lot of plants, allergy to grass, latex and trees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took silicones nos (MANUFACTURER UNKNOWN) (reported as silicone) for unspecified indication from unknown date and experienced drug allergy on unknown date. On 07May2021 at 15:00, after the first dose of the Pfizer vaccine, the patient experienced pain in left arm at the injection site. The patient began to feel very dizzy, fatigued and nauseous like equilibrium was off. On 11May2021, the patient still felt dizzy, fatigued, nauseous and the patient had lost appetite for food and sometimes patient had hot sweats but patient did not have a fever. The current day (this was day 4), the patient 's arm was no longer sore, but still felt fatigue, dizziness and nauseous. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event pain in left arm at the injection site was recovered on an unknown date in May2021. The clinical outcome of the events felt very dizzy, fatigued, nauseous, equilibrium was off, lost appetite and hot sweats was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 24Apr2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included systemic lupus erythematosus (SLE). The patient previously took cephalexin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 08:00, the patient experienced high pulse 190 upon marginal exercise, around 90 resting and low pulse 50/85, lasting about 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Apr2021, the patient underwent lab tests and procedures which included pulse rate and the results were 190 (units unspecified), 90 (units unspecified) and 50/85 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events, high pulse 190 upon marginal exercise, around 90 resting and low pulse 50/85 were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: My hair is falling out and I have alopecia now; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021 the patient experienced hair was falling out and had alopecia. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events (unspecified). On an unknown date, the patient underwent Sars-cov-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event hair was falling out and had alopecia was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Limb discomfort, Pain assessment, Pain in extremity, Vaccination site pain
Clinical narrative: higher part of his arm and then tapered down the arm. It feels like he has been punched in the arm; arm pain and pain at the injection site.; arm pain and pain at the injection site.It is now spreading to the underside of his arm and towards his chest.; arm pain; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm on May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  In May2021, the patient experienced higher part of his arm and then tapered down the arm. it feels like he has been punched in the arm, arm pain and pain at the injection site, arm pain and pain at the injection site.it is now spreading to the underside of his arm and towards his chest and arm pain. The patient underwent lab tests and procedures which included pain assessment: it is not 10 out of 10 pain. It was reported that the patient received the vaccine a week ago.  He was okay for the first 2-4 days.  About four and half days in, he started experiencing arm pain and pain at the injection site. It was at the higher part of his arm and then tapered down the arm. It felt like he has been punched in the arm.  It is now spreading to the underside of his arm and towards his chest. It seem to be getting worse, not better.  He spoke with his pharmacist and doctor who said it was not normal. The patient asked if the events were reported and if it was unusual as the events started few days later. He asked if he can take Tylenol. He reported first 3-4 days, 4.5 days in experiencing pain in arm, injection site into arm, higher side and taper to lower side and now all on underside of arm towards chest. the same arm that vaccine. Felt like he's been punched in the arm. Outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Lip blister, Ophthalmic herpes zoster
Clinical narrative: Two days later (the fifth day after the second shot), I had my first ever outbreak of shingles. The shingles occurred on the right side of my face and over my right eye; Fever blister breakout on upper lip for the first time in several years began three days after second shot; This all occurred after the second shot: chest tightness; Extreme difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/ batch number: unknown) via unspecified route of administration in Arm Left on 05May2021 12:00 PM (age at vaccination was 23 years) as dose 2, single for COVID-19 immunization. The patient's medical history included bipolar 1, anxiety and eating disorder. The patient has known allergy for codeine. Concomitant medication was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/ batch number: unknown) via unspecified route of administration on in Left arm 14Apr2021 04:00 PM (age at vaccination was 23 years and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunization. No other vaccine in four weeks. No other vaccine in two weeks. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. This all occurred after the second shot: on 06May2021, 01:00 PM, chest tightness and extreme difficulty breathing, which began within 24 hours of the shot then lasted another 24 hours. Fever blister breakout on upper lip for the first time in several years began three days after the second shot. Two days later (the fifth day after the second shot), she had her first ever outbreak of shingles. The shingles occurred on the right side of face and over her right eye. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with valacyclovir pills, steroid injection and pills for the events. The outcome of the events was recovering.   No follow up attempts are possible. information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05May2021, the patient experienced persistent tinnitus in both ears. 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 not taken as a result of the events. The clinical outcome of the event persistent tinnitus in both ears was not resolved at the time of this report.   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: External ear pain, Headache, Neck pain
Clinical narrative: Patient experienced sharp stabbing/throbbing pain behind her ear that lasts ~10 seconds,; Neck hurt; Pt experienced sharp stabbing/throbbing pain behind her back of head that lasts ~10 seconds, then her headhurt; This is a spontaneous report from a non-contactable pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200) via an intramuscular route of administration on 26Mar2021(at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and asthma. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), famotidine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and vitamins nos (MVI) for unknown indication on unknown dates and unknown if ongoing. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) for unknown indication on unknown date and experienced hives and facial swelling. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced nausea and vomiting. On 02Apr2021, after first dose of Pfizer COVID-19 vaccine administration on 26Mar2021, the patient experienced sharp stabbing/throbbing pain behind her ear/back of head that lasted for 10 seconds, then her head and neck hurt.  Those events occurred similarly 5 times since the initial event. She was recommended to consult her primary care physician and had been referred to neurologist for follow-up. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events which included treatment with ASPIRIN, ibuprofen (MANUFACTURER UNKNOWN) and tizanidine (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events sharp stabbing/throbbing pain behind ear/back of head, then head and neck hurt were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate; Elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 08:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 11May2021 at 17:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, anxiety and formaldehyde allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received cefprozil (CEFZIL), ibuprofen (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. Concomitant medications included ketorolac (MANUFACTURER UNKNOWN), hyoscyamine (MANUFACTURER UNKNOWN), diazepam (VALIUM), paracetamol (TYLENOL), diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), etc; all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021 at 23:30, and on 12May2021, the patient experienced elevated heart rate after both the first and second shots. The patient reported her resting heart rate was usually between 60 and 80. About 12-15 hours after the shots, it shot up to 90-130. The first time she got the shot, it went away within a few days. The patient underwent lab test and procedures which included test for heart rate on unknown date and the result was between 60 - 80 (UNSPECIFIED UNITS) and again underwent test for heart rate after the vaccinations, on an unknown date in 2021, and the result was 90-130 (UNSPECIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event elevated heart rate, after the first dose, was recovered on an unknown date in 2021 after the duration of few days and the clinical outcome of the event elevated heart rate, after the second dose, was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Tiredness; Muscle pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 13:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 13:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 09May2021, the patient experienced tiredness, muscle pain and chills which had long lasting side effects; lasting up to 5 to 6 days after injection. Tiredness increased in intensity two days after injection, lasting to 5 days after injection. The events had resulted in doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, muscle pain and chills was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged left axillary lymph nodes; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 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. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced enlarged left axillary lymph nodes. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event enlarged left axillary lymph nodes was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on left side of collarbone. Thought it was swollen lymph node but it is a large sized area but not overly swollen but it is noticeable.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 16:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. On 09May2021, the patient experienced swelling on left side of collarbone. Thought it was swollen lymph node but it was a large sized area but not overly swollen but it was noticeable. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event but the patient reported that if it does not go away within that week, will seek treatment for it. The clinical outcome of the event swelling on left side of collarbone, thought it was swollen lymph node but it was a large sized area but not overly swollen but it was noticeable was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: had swelling in elbows; Had swelling in ankles; Had swelling in knees; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 10Nov2020 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 21Oct2020 at 09:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. On 12Nov2020 at 00:00, the patient experienced swelling in ankles, elbows, and knees. The swelling in the ankles discontinued. However still have the problems with his knees and elbows. 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 the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in ankles were recovered on an unknown date in 2021, while that of the events swelling in elbows, and knees was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: Felt tired; Like she was catching a cold; This is a spontaneous report from a contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 09May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in May2021, the patient felt tired and like she was catching a cold. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events felt tired and like she was catching a cold was unknown at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache
Clinical narrative: felt tired and headaches; felt tired and headaches; brain fog/lack of concentration; brain fog/lack of concentration; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 07May2021 at 13:45 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nut. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any concomitant medication. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 13:30 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. On 08May2021 at 12:15, 2 days after second shot, the patient experienced tired and headaches. That all disappeared but the patient still had brain fog/lack of concentration 5 days later. It was also reported as that no adverse reaction after first dose, the patient just wanted to report this and was really hope the brain fog goes away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired and headaches was recovered on an unknown date in May2021 and of the event brain fog and lack of concentration was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at injection site; Swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 07May2021 at 13:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 09:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced pain and swelling at injection site which persisted for 5 days after injection. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events pain at injection site and swelling at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Fatigue; Lack of energy; Pain in left arm (vaccine arm); This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included iron supplements (MANUFACTURER UNKNOWN) and mushroom immunity supplements (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 13:00, the patient experienced fatigue and lack of energy for about 24 hours after the vaccine and had pain in left arm (vaccine arm). 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 not taken as a result of the events. The clinical outcome of the events fatigue and lack of energy were resolved on 28Apr2021; while that of the event pain in left arm (vaccine arm) was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: woke up to feet numb; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Apr2021 at 09:15 as a single dose for COVID-19 immunisation. Medical history included lung nodules and allergies to unspecified medications. 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. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. On 29Apr2021 at 09:00, on the fourth day after first shot, the patient woke up to her feet numb. As of today, the numbness was still here. It was also reported as that the patient was due for the second dose on Sunday, 16May2021 and asking for advise if the patient should take the 2nd shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event woke up to feet numb was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: Shakes; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 11May2021 at 17:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication from an unknown date and unknown if ongoing. On 12May2021 at 01:30, approximately 7 hours after receiving the shot (also reported as around 01:00), the patient experienced vomiting, chills and shakes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, chills and shakes were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.