chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 1st of 7 patient.   A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that 7 coworkers was tested positive for Covid after receiving first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : 2021045638 same drug/AE, different patient;2021045639 same drug/AE, different patient;2021045643 same drug/AE, different patient;2021045641 same drug/AE, different patient;2021045642 same drug/AE, different patient;2021045640 same drug/AE, different patient;US-PFIZER INC-2021045639 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 2nd of 7 patients.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that patient tested positive for COVID after receiving the first dose of the vaccine on an unspecified date. The outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported same event for seven patients. This is the third of 7 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that seven (7) coworkers tested positive for COVID after receiving 1st dose of the Pfizer Covid vaccine on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported the same event for seven (7) patients. This is the fourth of the seven (7) reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that seven (7) coworkers/ patients tested positive for Covid on an unspecified date after receiving the first dose of the Pfizer Covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; his is a spontaneous report from a contactable consumer. This consumer reported similar events for seven patients. This report is for the sixth of seven patients.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Pfizer Covid vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after receiving the first dose of the Pfizer Covid vaccine on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045622 same drug/AE, different patient.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: both have COVID; both have COVID; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (patient's wife and patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient's wife) reported similar events for two patients. This is the second of two reports.    A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, unknown expiration), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization in a clinic. Medical history included prostate cancer, off rapid radiation (over two years ago by robotic surgery. He followed all the recommendations for rapid off radiation, no side effects. He took hormone therapy. He is cured), acid reflux, allergies (takes antihistamine when allergies act up; his allergies blossomed because of the leaves), and he used to be five nine, but he shrunk a little. Concomitant medications included rosuvastatin, acetylsalicylic acid (BABY ASPIRIN), losartan, pantoprazole for he had a bout with acid reflux, and tadalafil.  The patient's wife and the patient both received the COVID-19 vaccine on 04Jan2021 and stated they have a mild case; they did not have any severe symptoms of the COVID and did not have a fever. The patient's oxygen level was normal. The patient's wife confirmed that she and her husband both had the vaccine on the same day and they both have COVID. The patient got a cough and was going to go the (clinic name). They went there and had lungs checked. Their lungs were clear and oxygen level was good. They both have been tested a few times. The patient's wife and the husband quarantined for two weeks and test were negative. When they were there this past Monday, they were asked if they wanted to be tested. They both got the results on Wednesday and were shocked; they were now quarantining again. COVID testing was done on 11Jan2021 and got the positive results on 13Jan2021. The patient's wife and the husband gave them a card, for when to come back. It was given at a drive through clinic in (county name). The patient feels fine and is sleeping well.  The patient recovered from the event in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045610 same reporter/drug, similar events in different patients
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic reaction with welts on the body and face; allergic reaction with welts on the body and face; severe itching; This is a spontaneous report from a contactable pharmacist (patient's husband).   A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021, NDC number: 59267100002), intramuscular on 15Jan2021 ("8:30 8:45 PM ") at 0.3 mL, single on "left hip" (as reported) for COVID-19 immunization. Medical history included none. There were no concomitant medications. The first dose of the vaccine was given on 15Jan2021. The pharmacist (patient's husband) drew it up at the pharmacy and took the syringe home and gave it to her at home. He had been doing some of the clinics so he wanted her to get vaccinated just in case. Patient experienced an allergic reaction with welts on the body and face, and severe itching. The whelps on the body started Friday 15Jan2021 and they have resolved completely at this time. Patient's husband says her severe itching started 15Jan2021 and have also resolved completely at this time (also reported as "whelps and itching developed about 10 PM 18Jan2021"). The outcome of the events was recovered on an unspecified date. The adverse events did not require a visit to emergency room or physician office. The seriousness and causality were not provided. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lethargy
Clinical narrative: a background headache all day; lethargy; bit of fogginess; This is a spontaneous report from a  consumer, the patient.  A 69-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the right arm on 15Jan2021 at 15:30PM (at the age of 69-year-old) as a single dose for COVID-19 immunization. Medical history included just sensitivities, not allergies, to NSAIDS and some pain meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medication taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that on the first day nothing. On 16Jan2021, the second day (as reported), the patient experienced lethargy and a bit of fogginess. The third day, 17Jan2021, the patient had a background headache all day. The events were reported as non-serious. The patient finally took (acetaminophen) TYLENOL before bed, for the headache, waking on the fourth day feeling normal. The clinical outcome of the events lethargy, bit of fogginess, a background headache all day was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first shot a couple of weeks ago but tested positive later that day. The patient wanted to know how effective the vaccine was. The patient underwent lab test and procedure which included COVID: positive on unspecified date. Outcome of the event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: There is not a reasonable possibility that event "tested positive" is related to BNT162B2.  The event occurred on the same day the patient got vaccination, when the vaccine is not expected to achieve the protection.  The event is most likely intercurrent medical condition.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid symptoms the 28th and tested positive; covid symptoms the 28th and tested positive; This is a spontaneous report from a Pfizer sponsored program from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 around 2 pm at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 28Dec2020 the patient experienced covid symptoms the 28th and tested positive. The patient underwent lab tests and procedures which included covid test positive on unknown date. The outcome was unknown.    The information on the batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 test positive on the same day.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: his lymph nodes to his neck are swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 19Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's lymph nodes in his neck were swollen on 19Jan2021 at 17:30. It was more on the left side. The patient has not recovered from the event.  Information on the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash and hives all over body; rash and hives all over body; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685; expiry date: not known), intramuscular in the left arm on 17Jan2021 08:30 at single dose for COVID-19 immunization. There was no medical history. The patient is not pregnant. No known allergies. Concomitant medication included unspecified medication (other medication given in two weeks). No other vaccine in four weeks. No COVID prior to vaccination and not tested with COVID post vaccination. The patient experienced rash and hives all over body on 18Jan2021 11:00. These resulted in physician's clinic visit. Therapeutic measures were taken as a result of rash and hives all over body with prednisone, Benadryl, and Kenalog. The outcome of the events was recovered in Jan2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via intramuscular route of administration on 08Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021, the patient experienced itchy rash on bilateral elbow. The patient did not receive any treatment for the reported event. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Urinary incontinence
Clinical narrative: stated she felt broke, clarified she was having all over joint pain that was very bad; no control of her kidneys/she has messed the bed up twice since yesterday; This is a spontaneous report from a contactable consumer, reporting for herself. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing urinary incontinence (stated she has always had a little trouble). There were no concomitant medications. The patient got a shot yesterday, 14Jan2021, stated she felt broke, clarified she was having all over joint pain that was very bad, stated she has no control of kidneys, states she has always had a little trouble, but since yesterday it just wont stop, stated she has messed the bed up twice since yesterday. She was taking Tylenol for the pain and that was all she knows to do. She was encouraged to reach out to her HCP for any medical advice if she has concerns. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other Health Professional (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiry date unknown, via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that the patient got the first dose of vaccine 28Dec2020 and tested positive for COVID on 04Jan2021 but mentioned that her quarantine period is already over. She stated that she is scheduled to get the 2nd dose of the vaccine tomorrow, but wants to know if she should still proceed to receiving it. The patient underwent lab tests and procedures which included covid: positive on 04Jan2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (7 days in this case). However, a causal relationship between event "tested positive for Covid " (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Diabetes mellitus, Diabetes mellitus inadequate control
Clinical narrative: blood sugar has been out of control ranging from 250-300; This is a spontaneous report from a contactable consumer.  A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right arm, on 14Jan2021 at a single dose for Covid-19 immunization. Medical history included type 2 diabetes mellitus from Sep2019 and ongoing. There were no concomitant medications. On 14Jan2021, it was reported that 8-10 hours after getting the vaccine, his blood sugar was out of control ranging from 250-300. On 15Jan2021, he has taken his blood sugar twice at the time of report. He took it when he woke and it was 207. Two hours after eating a light breakfast it was 242. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia, Paraesthesia oral, Pruritus, Sensory disturbance
Clinical narrative: little tachycardic; I felt anxious about what I was feeling; she felt her lip and cheek tingling; felt kind of itchy but under her skinitchy sensations all over her body that come and go; felt a quick weird sensation under scapula; tingling sensation going down the side of her back that she got the vaccine on/all of her left side was tingling/woke up to a weird tingling all over her body/tingling on her hands; This is a spontaneous report from a contactable other health professional. An adult (18-64 years) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248) via an unspecified route of administration, in the left arm, on 18Jan2021 07:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma. Patient had BNT162B2 on 28Dec2020 in the left arm for COVID-19 immunization (first dose with lot number: EL1284). Concomitant medication included ibuprofen, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and norethisterone (NORA-BE).  On 18Jan2021 08:00, about 15 min after vaccination, the patient felt a quick weird sensation under scapula and a tingling sensation going down the side of her back that she got the vaccine on. Maybe 30 min after vaccine (18Jan2021, 08:15), she felt her lip and cheek tingling. An hour after (08:45), all of her left side was tingling and felt kind of itchy but under her skin. She had just finished working night shift and fell asleep. She slept 9 hours and woke up to a weird tingling all over her body. She was a little tachycardic because she felt anxious about what she was all feeling (19Jan2021). Once she had calm herself down, her heart rate was back to her baseline. She had no difficulty breathing, no rashes, and otherwise felt fine. She had dinner and was awake for few hours before sleeping another 8 hours. It was now about 33 hours after and she still have random tingling/itchy sensations all over her body that come and go and tingling on her hands that has never stopped.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: little tachycardic; I felt anxious about what I was feeling; she felt her lip and cheek tingling; felt kind of itchy but under her skinitchy sensations all over her body that come and go; felt a quick weird sensation under scapula; tingling sensation going down the side of her back that she got the vaccine on/all of her left side was tingling/woke up to a weird tingling all over her body/tingling on her hands; This is a spontaneous report from a contactable other health professional. An adult (18-64 years) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248) via an unspecified route of administration, in the left arm, on 18Jan2021 07:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma. Patient had BNT162B2 on 28Dec2020 in the left arm for COVID-19 immunization (first dose with lot number: EL1284). Concomitant medication included ibuprofen, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and norethisterone (NORA-BE).  On 18Jan2021 08:00, about 15 min after vaccination, the patient felt a quick weird sensation under scapula and a tingling sensation going down the side of her back that she got the vaccine on. Maybe 30 min after vaccine (18Jan2021, 08:15), she felt her lip and cheek tingling. An hour after (08:45), all of her left side was tingling and felt kind of itchy but under her skin. She had just finished working night shift and fell asleep. She slept 9 hours and woke up to a weird tingling all over her body. She was a little tachycardic because she felt anxious about what she was all feeling (19Jan2021). Once she had calm herself down, her heart rate was back to her baseline. She had no difficulty breathing, no rashes, and otherwise felt fine. She had dinner and was awake for few hours before sleeping another 8 hours. It was now about 33 hours after and she still have random tingling/itchy sensations all over her body that come and go and tingling on her hands that has never stopped.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm  on an unspecified date. Outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: her hands were cold; Her hand went numb/ feels the tingling/numbness for the most part from the wrist down; her left hand has been tingly/ Her hand tingling started almost immediately after getting the vaccine/ feels the tingling/numbness for the most part from the wrist down; This is a spontaneous report from a contactable consumer (patient [dental hygienist]). A 39-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration  (injection in left upper arm) from 15Jan2021 13:15 as COVID Vaccine. Vaccination Facility Type: Clinic. Medical history included hands were sometimes cold. Concomitant medication included cyanocobalamin (VITAMIN B12) given as self-injections in upper leg once a week on Sundays. The patient was previously given seasonal flu vaccine on Oct2020. No prior vaccinations within 4 weeks. Patient received her first dose of the COVID Vaccine today around 1:15PM or so the day of reporting and almost immediately started to experience event: She drove off from the waiting area; he was taking pictures; she commented her hands were cold, but her hands were sometimes cold anyway. She received the injection in her left upper arm. Since getting the injection in her left upper arm her left hand has been tingly. It was like it was asleep. She was wondering if they possibly hit a nerve or something when administering. She has called her doctor as well. Her hand tingling started almost immediately after getting the vaccine. She had to wait 15 minutes to be observed if any symptoms occurred. She waited, took selfies and also mentioned she contacted her doctor she works with. Her hand went numb and cold. She thought it was weird. At first, she thought it was just like her hand getting cold, but it never went away. She still feels it and it is like hand went asleep like if lay on it too long. She added she has on a watch and that was around the area where she feels the numbness so during the call she took it off. She feels the tingling/numbness for the most part from the wrist down, but she also feels it higher up as well, but mainly from the wrist down. She was hoping that does not happen where she has to go. She has called the doctor already and was advised what to do. No emergency room visit/ physician office visit was made for the events. Outcome of hand tingly was not recovered (ongoing at the time of reporting) and unknown for the other events.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on back, arm, knee, toe and hands; Itching on different parts of body; This is a spontaneous report from a contactable consumer, the patient.  A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3248), via intramuscular route of administration on 13Jan2021 at 13:35 (at the age of 25-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included asthma that is fairly mild (the patient has rescue inhaler that she does not use very often, she uses it once every few months as needed.  Diagnosed in early childhood when she was 4-5 years old). The patient had no relevant family medical history.  Concomitant medications included an unspecified medication, the patient reported she has been taking it for years, but did not provide further information. Historical vaccine included flu shot in Nov2020, which was greater than 4 weeks prior to receiving the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jan2021 at 15:00-16:00, the patient experienced itching on different parts of body. On 14Jan2021 at 10:00, the patient experienced hives on back, arm, knee, toe and hands. The reported clinical course was as follows: Initially, on the first day, she had itching not at injection site.  It was on different parts of her body.  The following day, she developed hives on her back, arm, knee, toe and hands.  The patient reported it is not very severe, she did not have any fever, swelling, or shortness of breath. The patient reported some of the areas have gone down and some have inflamed more. The patient did not undergo any relevant test and reported just visual examination. The patient went to urgent care (physician office) and they said it was potentially caused by the COVID-19 vaccination.  The patient was prescribed steroids by the urgent care as treatment for the events. The patient received one steroid injection of Methyl Prednisone into her buttocks and then was prescribed prednisone 10 mg tablets. The clinical outcomes of the itching on different parts of body and hives on back, arm, knee, toe and hands were not recovered. The patient was inquiring if she should get the second dose.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: The patient received the vaccine on 31Dec2020 and then tested positive a week later; The patient received the vaccine on 31Dec2020 and then tested positive a week later; This is a spontaneous report from a contactable other HCP (healthcare professional) via a Pfizer-Sponsored Program,. A 41 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 31Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 31Dec2020 and then tested positive a week later. The patient stated that she was supposed to receive the vaccine this Thursday and she wanted to know if she could receive the vaccine. The clinical outcome of the event "the patient received the vaccine on 31Dec2020 and then tested positive a week later" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lethargy, SARS-CoV-2 test positive
Clinical narrative: got tested and tested positive; Got tested and tested positive; lethargic; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (husband and wife). This is the second of two reports (for the husband).  A 74-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, reported as two days after, the patient was lethargic. A week ago on an unspecified date, reported as past Monday, the patient had no cough, no fever, received azithromycin, got tested and tested positive. The patient underwent laboratory tests and procedures which included COVID-19 test: positive on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. Information about the lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034433 same reporter, same drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Condition aggravated
Clinical narrative: This is a spontaneous report received from a non-contactable consumer via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included ongoing blood pressure (BP) increase (BP was already going up). The patient's concomitant medications were not reported. It was reported that the patient received first dose of COVID vaccine and then his blood pressure went up for a day or two on an unspecified date. The patient's BP was already going up as he keeps track of it and thinks it's a coincidence but was just checking if this can happen. The outcome of the event was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller got first vaccine dec 28th, tested positive jan 4th; Caller got first vaccine dec 28th, tested positive jan 4th; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 28Dec2020 at Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got first vaccine on 28Dec2020, tested positive 04Jan2021. The patient wanted to know if she needed to wait to get second dose or if she should wait. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Paranasal sinus discomfort
Clinical narrative: Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This is a spontaneous report from a contactable other hcp.  A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: El3248), intramuscular, in the left arm, on 08Jan2021 16:45 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. 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 hasn't been tested for COVID-19.  The patient experienced "left eye ball/socket soreness when moving side to side, up and down" and sinus pressure left eye on 10Jan2021 10:00. the outcome of events was recovering.  Therapeutic measure taken as a result events included Sufdafed.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I'm happy to say I got the second dose and had no side effects other than a sore arm.; This is a spontaneous report received from a contactable Nurse (patient).   A female patient of unspecified age received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was unspecified) on unspecified date as single dose for COVID-19 immunisation. Medical history included being immunosuppressed. Historical vaccine included first dose of BNT162B2. Concomitant medication was not reported.  The patient reported 'I'm happy to say I got the second dose and had no side effects other than a sore arm' on unspecified date. A week after getting the first shot, my daughter got Covid. My son and husband were positive shortly after her. I did get some very mild symptoms, but throughout the weeks of quarantine, I've tested about every 4 days and consistently have been negative.  Lab data included Covid test which was negative on unspecified date ('but throughout the weeks of quarantine, I've tested about every 4 days and consistently have been negative').  Outcome of event sore arm was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Very sore arm; Headache; Very tired; This is a spontaneous report from a contactable healthcare professional (reporting for herself).  A non-pregnant 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 16Jan2021 05:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very sore arm, headache and very tired in Jan2021. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight tenderness at injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age:78; unit: unknown) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient is scheduled 4 weeks out for second dose of Covid Vaccine and wanted to know if thats okay. She experienced a slight tenderness at injection site. The patient  and her husband received the vaccine. They scheduled the 2nd dose in 4 weeks instead of 3 weeks, they were asking if it was ok. They went to the clinic. It was very well organized. She asked if the next appointment going to be 3 weeks where they administered the vaccine. They were told that they are getting the Pfizer one and it's going to be 4 weeks. Then they waited for 15 minutes and went to the open computers for scheduling of the 2nd shot. The next shot is scheduled for 15Feb or 16Feb whichever one is a Wednesday works better for them. This morning her husband was reading the newspaper and it stated it cannot be given more than 23 days, this is going to be 32 days. They asked if they can reschedule. They will call the hospital or maybe change their appointment using the website/app. They were asking what is the timing of the 2nd dose of vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hive in the middle of her chest, it is swollen and raised; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9231), via an unspecified route of administration (left upper arm) on 14Jan2021 (15:30) at single dose for Covid-19 immunization. The patient's medical history included blood cholesterol abnormal, anxiety, high blood pressure, sleep disorder, and obesity. Concomitant medication included amlodipine besilate (NORVASC) for high blood pressure been on it for years and ongoing, hydroxyzine for anxiety been on this medication for 10 years and ongoing, trazodone for sleep taking for 10 years and ongoing, pravastatin sodium (PRAVACHOL) for cholesterol taking for 12 years and ongoing, and colecalciferol (VITAMIN D) from 2019 and ongoing. In November, she received her shingle shot and croup shot. The patient reported that got she the vaccine yesterday (14Jan2021S). She woke up with a hive on 15Jan2021 (8:30 am). She has a hive in the middle of her chest, it is in between her boobs. She added that it is swollen. There is nothing else anywhere. She is going to take Benadryl. She didn't have a prescribing doctor. Her boss set up the appointment for them. The hive has stayed, it is swollen and raised. Her second dose is scheduled on 04Feb2021. The outcome of event was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Palpitations
Clinical narrative: slight heart palpitations like quivering which went on for 18 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old male patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: 5/31 EL 3249 (as reported), unknown expiration), via an unspecified route of administration in right arm on 13Jan2021 at 14:00 (02:00 PM) at a single dose for COVID-19 immunization in a hospital.  Medical history included known allergies to shellfish.  Concomitant medications included enalapril, metformin, insulin, and clopidogrel. Four hours later that evening of 13Jan2021 at 06:30 PM (18:30), the patient experienced slight heart palpitations like quivering which went on for 18 hours. He went to a hospital for 3 hours EKG, chest x-ray, and some two blood tests, all of which came back normal (Jan2021). He had no issues like this before or since. The event resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient did not receive treatment for the event.  The patient recovered from the event in Jan2021.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cognitive disorder, Confusional state, Disturbance in attention, Wound
Clinical narrative: anxious; cognition has degraded; wounded; his confusion was the worst I've ever seen. He was totally inattentive; totally inattentive; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 16Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes, CHF, impaired kidney function, atrial fibrillation, multiple strokes, dementia/memory issues, confusion. Concomitant medications were not reported (unspecified 15 meds). The patient previously took blood thinners. It was reported that the patient suffered from memory loss and dementia, and on 19Jan2021 his confusion was the worst the reporter had ever seen. He was totally inattentive - like, he kept tuning out until she said, Dad, Dad. Then he'd listen and it was as if he couldn't remember the sentence from 2 minutes ago. He was having difficulty putting together a coherent thought. He was not in any pain. The patient still functioned well. She said since receiving the 1st dose of the vaccine, she noticed that her dad's cognition has degraded in a very concerning way. He was very confused and anxious. She said this was all new behavior, and just started to happen after her dad received the vaccine. Then last night on 19Jan2021, apparently he wandered, which he never does, and he tried to push a nurse or aide, and tried to go into a neighbor's room, a friend, so he was looking for a safe place, and he was hitting a doorknob, and he is on a blood thinner, so he wounded himself and bled, he is on blood thinners, he didn't bleed out, she wrapped his wrist and it's fine. No treatment was received for the events 'his confusion was the worst I've ever seen. He was totally inattentive'. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event 'his confusion was the worst I've ever seen. He was totally inattentive' was not recovered while unknown for the other events.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea exertional, Headache, Malaise, Off label use
Clinical narrative: Chill like sensations; Aches; Dyspnea on Exertion; General Malaise; Fever; Persistent headache that is not relieved with pain killers; other vaccine same date vaccine date 22Dec2020, dose number 1; other vaccine same date vaccine date 22Dec2020, dose number 1; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date not reported), intramuscular in the right arm on 22Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL IR), vitamin d3, calcium ascorbate (VITAMIN C), vitamin b complex, magnesium, cynara cardunculus extract (ARTICHOKE EXTRACT), and vaccinium macrocarpon (CRANBERRY EXTRACT). On 23Dec2020 07:00, the patient experienced chill like sensations, aches, dyspnea on exertion, general malaise, fever, persistent headache that is not relieved with pain killers. It was also reported that other vaccine with same date vaccine date on 22Dec2020, dose number 1. The patient underwent lab tests and procedures which included salivary sample (SARS-cov-2 test): negative on 01Dec2020  . No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.