chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I got a headache in eye; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patients. This is the 2nd of of two reports.  A female patient of an unspecified age received 1st 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's medical history and concomitant medications were not reported. The patient got a headache in eye on an unspecified date the moment she had vaccine but it went away. Outcome of the event was recovered. The event was assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021969 same drug/similar events, different patients
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to 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 most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Hives on neck, chest, and back; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 07Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (LO LOESTRIN FE), prednisone, azithromycin (Z-PAK), and guaifenesin (MUCINEX). The patient had no known allergies. Prior to 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 most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 (10:45), the patient experienced hives on neck, chest, and back starting about 30 minutes after the vaccine was received. It is 11Jan2021 and the patient still have them. The event was considered non-serious. Treatment was received for the adverse event including diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he is infected with COVID-19; he is infected with COVID-19; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received 1st 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's medical history and concomitant medications were not reported. The patient called to find out if there should be a delay in the second dose because he was infected with COVID-19 on an unspecified date. His second dose was scheduled on 13Jan2021 and he was wondering if he should continue in 2 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: she had a little bleed in the blood vessel of her left eye; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asking if bleeding of the eye was an adverse reaction to bnt162b2. Patient received the Covid vaccine on 21Dec2020 and on the 27Dec2020, she had a little bleed in the blood vessel of her left eye. She was supposed to get the second vaccine today (11Jan2021) at 12:30. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test
Clinical narrative: got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible covid; This is a spontaneous report from a contactable pharmacist.  A 7-decade-old (65 years or 66 years) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The stated, "my uncle got the first dose of the vaccine and on 25Dec2020, he started getting symptoms of possible Covid. He got tested for covid today (11Jan2021). He's supposed to get the second dose on 15Jan2021. If he is positive for covid, what does that mean for his second dose?  If he is positive, and waits for quarantine, then he wouldn't be able to get the second dose until day 36."  The outcome of the events was unknown.   Information on the Lot/Batch Number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness in her mouth and shoulder; numbness in her mouth and shoulder; blurry vision; elevated pressure; her arm became painful; sharp pain in the middle of the chest; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 15:30 pm at single dose for covid-19 immunisation.  Medical history included rib surgery last Sep2020. She had an episode on Friday morning 08Jan2021 with a sharp pain in the middle of the chest that was so bad she had to take Ibuprofen and lie down with a heating pad to her chest. After that, she had numbness in her mouth and shoulder, and had blurry vision to which she had her son call 911. As the EMTs arrived they recorded her with elevated pressure and took a cardiogram which reported everything was 'perfect', no stroke, no heart attack. She mentioned that she had a rib surgery last Sep2020 and was still healing and took pressure medication for it, She mentioned that the EMTs told her to take the medication in the morning and not in the afternoon and that the episode was not related to the vaccine. She also reported that her arm became painful for a day after the injection but it did not cause her anything else. She knows that other ladies who received the vaccine in her building had flu-like symptoms and was asking if her symptoms were reported for the vaccine. Patient mentioned that she was calling to report her side effects and that she will receive the 2nd dose on 26Jan2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: numbness in her mouth and shoulder; numbness in her mouth and shoulder; blurry vision; elevated pressure; her arm became painful; sharp pain in the middle of the chest; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 15:30 pm at single dose for covid-19 immunisation.  Medical history included rib surgery last Sep2020. She had an episode on Friday morning 08Jan2021 with a sharp pain in the middle of the chest that was so bad she had to take Ibuprofen and lie down with a heating pad to her chest. After that, she had numbness in her mouth and shoulder, and had blurry vision to which she had her son call 911. As the EMTs arrived they recorded her with elevated pressure and took a cardiogram which reported everything was 'perfect', no stroke, no heart attack. She mentioned that she had a rib surgery last Sep2020 and was still healing and took pressure medication for it, She mentioned that the EMTs told her to take the medication in the morning and not in the afternoon and that the episode was not related to the vaccine. She also reported that her arm became painful for a day after the injection but it did not cause her anything else. She knows that other ladies who received the vaccine in her building had flu-like symptoms and was asking if her symptoms were reported for the vaccine. Patient mentioned that she was calling to report her side effects and that she will receive the 2nd dose on 26Jan2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Throat irritation
Clinical narrative: Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to 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 most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient inquired if she can she be on an antiviral when receiving her second dose of the vaccine. She is aware that our trial participants with a history of HIV were on antivirals as well. The patient mentioned that she had an outbreak of shingles which occurred after she had her first COVID vaccination. She stated that she doesn't associate it with the COVID vaccine however. She was supposed to start treatment on Valtrex shortly has not started it yet. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported event cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable (patient). A male patient of an unspecified age (reported as "51", unit not provided, pending clarification) received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not provided), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient reported that he and his brother both have G6PD. The patient's concomitant medications were not reported. The patient received the vaccine last Thursday, 07Jan2021, and experienced sore arm on an unspecified date in Jan2021. The patient was wondering if he and his brother are eligible to receive the vaccine, or if there is any data on the vaccine and people with their condition. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: congestion; headache; running nose; This is a spontaneous report from a contactable Nurse reporting for herself. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686) via an unspecified route of administration on left arm, on 06Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. On 10Jan2021, the patient experienced congestion, running nose and headache. The headache comes and goes. Outcome of the events congestion and headache was recovering at the time of the report while it was unknown for running nose.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: On (Dated) tested positive for Covid; On (Dated) tested positive for Covid; On (Dated) tested positive for Covid; Felt run down; This is a spontaneous report from a contactable other health professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose (first dose) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose on 28Dec2020 and on 07Jan2021, she felt run down so she decided to get tested for COVID. On 09Jan2021, she tested positive for COVID. Her second dose is due 18Jan2021 and she needed to know if it is ok for her to get her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID) with BNT162b2 can not be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the COVID 19 vaccine on 29Dec2020, second dose is due on 20Jan2021. Patient tested positive on 05Jan2021. Patient wanted to know if he should get the second shot and if he chooses to wait the 90 days, would he need to start over. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neck pain
Clinical narrative: had neck pain prior to receipt of the first dose of the vaccine, but it persisted and became worse after getting the vaccine; had neck pain prior to receipt of the first dose of the vaccine, but it persisted and became worse after getting the vaccine; This is a spontaneous report from a contactable physician (reporting for himself).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization.  Medical history included neck soreness/neck pain (takes a Medrol dose pack for neck pain, reporting a history of neck soreness occasionally).  The patient's concomitant medications were not reported.  In Jan2021, the patient reported that he had neck pain prior to receipt of the first dose of the vaccine, but it persisted and became worse after getting the vaccine.  The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: nausea; vomiting; light-headed; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (also reported as: 83, unit unknown) received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on 09Jan2021 at single dose for COVID-19 vaccination. Medical history included tested positive for COVID on 13Apr2020. The patient's concomitant medications were not reported. Resident received 1st dose of vaccine 09Jan2021. On 10Jan2021, resident had nausea, vomiting and "light-headed". 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Malaise, Nausea
Clinical narrative: swelling; redness injection; nausea; not feeling well; tiredness; difficulty of breathing; heart fast; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 experienced these side effects after getting the first dose: swelling, redness injection, nausea, not feeling well, tiredness, difficulty of breathing and heart fast. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema
Clinical narrative: swelling; redness injection; nausea; not feeling well; tiredness; difficulty of breathing; heart fast; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 experienced these side effects after getting the first dose: swelling, redness injection, nausea, not feeling well, tiredness, difficulty of breathing and heart fast. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes, 8cm by 5cm; This is a spontaneous report from contactable healthcare professional. 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 reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of vaccine on 23Dec2020 and displayed swollen lymph nodes on 24Dec2020, 8cm by 5cm. The patient was scheduled to receive second dose of vaccine on 13Jan2021 and asking for recommendations. The outcome of the event was unknown.  The information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is second of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is third of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive, SARS-CoV-2 test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fourth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fifth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 People, who were applied the vaccine previously, were corona positive after a week; 13 People, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 6th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 7th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 8th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 9th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 : same reporter, similar suspect drug and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive, SARS-CoV-2 test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is tenth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 11th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patient. This is the 13th of 13 report.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number unknown), 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. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dysgeusia, Pyrexia
Clinical narrative: Fever; Chills; She developed a "weird" taste in her mouth; Loss of appetite; This is a spontaneous report from a non-contactable consumer (patient sister in law) via Pfizer sales representative. A 57-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at second single dose for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 for COVID-19 immunization (1st injection). The reporter was made aware this morning that the patient received the vaccine booster shot (2nd injection) of Pfizer's COVID-19 vaccine yesterday morning (06Jan2021). After receiving the vaccine she experienced a mild fever and chills overnight which were now resolved. Furthermore, after the fever/chills resolved, she developed a "weird" taste in her mouth and loss of appetite but overall doing well. Despite the events she continued to perform her duties as an anesthesiologist today. Outcome of the event fever and chills was recovered, of events "weird" taste and loss of appetite was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid-19 a week later after receiving the first dose of the vaccine; She tested positive for Covid-19 a week later after receiving the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient took the first dose of Covid-19 vaccine on 29Dec2020. She tested positive for Covid-19 a week later after receiving the first dose of the vaccine. She is scheduled to get the second dose on 19Jan2021 and she was asking what to do. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; fever; Chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient previously took 1st dose of BNT162B2 on an unknown date for COVID-19 immunization. There were no concomitant medications. The patient wanted to report a side effect of the Pfizer COVID vaccine. Stated that she had her second dose yesterday morning at 9am. Stated that she woke up this morning 08Jan2021 at 3am with fever, chills and body aches. The reporter is a nurse's aide in ICU COVID unit. Stated that she took acetaminophen (TYLENOL) and her fever resolved at 6am this morning. Stated that the chills resolved at 6am this morning. Stated that the fatigue started at 9am this morning. Outcome of the events fever and chills was recovered on 08Jan2021 at 06:00 while not recovered for the other events.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pain, Respiratory tract congestion
Clinical narrative: tested positive for COVID; tested positive for COVID/fatigue, headache, body aches again; allergies were flaring up; Coughing; congestion; body aches; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (female) reported that a female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 31Dec2020, coughing, congestion, body aches on 24Dec2020, fatigue, headache, allergies were flaring up on 28Dec2020. The caller got her first COVID-19 injection on 21Dec2020. She didn't have symptoms until 2 days after the vaccine. She then experienced coughing, congestion, body aches, but no fever. Then the next day, she felt fine. On 28Dec2020, she thought her allergies were flaring up. She started to feel fatigue, headache, body aches again. She went and got tested for the virus. She tested positive on 31Dec2020. Caller was due for a second vaccine on 11Jan2021. She was to remain in quarantine until 10Jan2021. Caller wanted to know should she get her second shot on 11Jan2021 or should she wait. The patient underwent lab tests and procedures which included Covid-19: positive on 31Dec2020. The outcome of events for tested positive for covid, fatigue, headache and allergies were flaring up was unknown, for other events was resolving.  No further information was obtained. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and COVID-19 cannot be excluded based on a compatible temporal relation between vaccination and onset of events.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID/fatigue, headache, body aches again; allergies were flaring up; Coughing; congestion; body aches; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (female) reported that a female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 31Dec2020, coughing, congestion, body aches on 24Dec2020, fatigue, headache, allergies were flaring up on 28Dec2020. The caller got her first COVID-19 injection on 21Dec2020. She didn't have symptoms until 2 days after the vaccine. She then experienced coughing, congestion, body aches, but no fever. Then the next day, she felt fine. On 28Dec2020, she thought her allergies were flaring up. She started to feel fatigue, headache, body aches again. She went and got tested for the virus. She tested positive on 31Dec2020. Caller was due for a second vaccine on 11Jan2021. She was to remain in quarantine until 10Jan2021. Caller wanted to know should she get her second shot on 11Jan2021 or should she wait. The patient underwent lab tests and procedures which included Covid-19: positive on 31Dec2020. The outcome of events for tested positive for covid, fatigue, headache and allergies were flaring up was unknown, for other events was resolving.  No further information was obtained. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and COVID-19 cannot be excluded based on a compatible temporal relation between vaccination and onset of events.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: feel bad; he did not have the energy to do anything/ felt drained; his arms just feel like dead weight, does not know how to describe it, but they ache; This is a spontaneous report from a contactable consumer. A 75-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left deltoid (shoulder) on 06Jan2021 10:30 at a single dose for COVID-19 prophylaxis at a clinic. There were no medical history and concomitant medications. On 07Jan2021, patient stated that he knew that he would feel bad the next day of vaccination, but he was into the second day and he just does not feel good. Patient clarified that he felt drained. He said that he slept most of the day and went to the gym and he did not have the energy to do anything. Patient added that his arms just feel like dead weight, he does not know how to describe it, but they ache. The patient has not recovered from the events    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain, Vaccination site reaction
Clinical narrative: Stiffness at the vaccination site; stiffness at the vaccination site (especially when lifting his arm; felt heavy and sore); Pain at the time of syringe injection; This is a spontaneous report from a non-contactable consumer (patient). A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced pain at the time of syringe injection on 16Dec2020 at 1st administration. It was reported that on unspecified date, there was stiffness at the vaccination site (especially when lifting his arm; felt heavy and sore). No specific allergic reaction after being watched for around 30 minutes after administration.  At first dose administration there was no bleeding after the injection. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: aches; fever; chills; This is a spontaneous report from a contactable consumer (Pfizer colleague). A male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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. The reporter reported for a patient who had some side effects following receiving the second dose of the COVID vaccine. The patient experienced aches, fever, and chills on an unspecified date. The patient was aware that "the second shot in the series can be kind of bad." The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Her flare ups on her skin; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  It was reported by the patient that she got the first dose of vaccine yesterday. She was prescribed Clindamycin as needed but it seems she needs to take it again because of her flare ups on her skin. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea, SARS-CoV-2 test
Clinical narrative: Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer.  A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications.  The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating.  Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020.  The outcome of events was recovered on 08Jan2021.