chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received first dose of vaccine and then tested positive for SARs-Cov-2; received first dose of vaccine and then tested positive for SARs-Cov-2; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration 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 received first dose of vaccine and then tested positive for SARs-Cov-2 on an unspecified date. The patient was asking about the efficacy. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.
Sex: F
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 non-contactable consumer. This consumer reported similar events for two patients (husband and wife). This is the first of two reports (for the wife).  A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), 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, she had no cough, no fever, received azithromycin, got tested and tested positive. She wanted to know if they can receive the second dose and the timing of the second dose of vaccine. The patient underwent laboratory tests and procedures which included SARS-CoV-2 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-2021046180 same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (patient).  This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 11Jan2021, the patient started developing symptoms such as loss of smell and, on 12Jan2021, she tested positive for COVID from 2 rapid tests and a PCR test. The outcome of the events was unknown.  The 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 "positive COVID-19 test with symptoms" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021; supposedly on 13Jan2021 but was rescheduled to 19Jan2021; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; strength: 30 mcg, lot number: EK9231) via an unspecified route of administration in the left deltoid on 23Dec2020 at 0.3mL, single dose for covid-19 immunisation. There were no medical history and no concomitant medications. The patient received the first dose on 23Dec2020 and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021. The outcome of the event was not recovered. Her second vaccine was scheduled supposedly on 13Jan2021 but was rescheduled to 19Jan2021 because they didn't allow her to go to the hospital while she was positive. She wanted to know if this was recommended. She just wanted some advice on getting the second vaccine, and how does it affect efficacy because she didn't get it on day 21.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and tested positive for COVID RNA test nasopharyngeal swab on 11Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Erythema of eyelid, Hypersensitivity, Ocular hyperaemia
Clinical narrative: experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Swelling of eyelid
Clinical narrative: experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lethargy, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; lethargic; cough; arm hurt; This is a spontaneous report from a non-contactable consumer. A female 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 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter tested positive for COVID 19 this past Wednesday after receiving the first shot on 04Jan2021. She is due for her second shot on 25Jan2021 and is wondering if she can take the second dose if it is already past her quarantine time? The night of receiving her first shot (04Jan2021), her arm hurt that night and went away the following day. She felt a little lethargic and it had gone away. She then wounded up with a cough, went into a walk-in clinic to check the chest and everything was normal. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events arm hurt was recovered on 05Jan2021, lethargic was recovered on an unspecified date, while of the rest was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion
Clinical narrative: pleural effusion; This is a spontaneous report from a contactable health care professional (patient).  A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 0142) in the hospital via an unspecified route of administration on 06Jan2021 at 11:15 AM at a single dose on the right arm for COVID-19 immunization.  The patient's medical history was not reported.  Concomitant medication included escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) and ibuprofen (manufacturer unknown) which was given 8 hours before (as reported). The patient previously took morphine and experienced allergies. The patient did not have COVID-19 prior to vaccination. The patient reported that she ended up on the ER on the day of the report diagnosed with a pleural effusion which was reported to have started on 14Jan2021 at 08:00 AM. The doctors are unsure whether it could be related to the vaccine, but she was only 39 years old and have never had something like this happen before. The patient was given azithromycin as treatment for the event. The patient had not recovered from the event.  The patient had not been tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received their second 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, their first dose, via an unspecified route of administration on an unspecified date; both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with a COVID-19 infection 2 days after the second dose of the Pfizer's COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with a covid-19 infection on an unspecified date (2 days after the second dose of the Pfizer's COVID-19 vaccine). The reporter inquired if the patient could be administrated with a monoclonal antibody infusion for the management of mild COVID-19 symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Cough, Dry throat, Headache
Clinical narrative: body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 28Dec2020, but on 04Jan2021, she tested positive for Covid-19. She said she has been quarantined since and was asymptomatic. Patient said she was due to receive the 2nd dose on the 18th of January and wants to know if that was okay. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The patient received the single dose of BNT162B2 on 28Dec2020, and was diagnosed with COVID-19 on 04JAN2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 infection is more pre-existing infection prior to vaccine use, and unrelated to BNT162B2.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 28Dec2020, but on 04Jan2021, she tested positive for Covid-19. She said she has been quarantined since and was asymptomatic. Patient said she was due to receive the 2nd dose on the 18th of January and wants to know if that was okay. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The patient received the single dose of BNT162B2 on 28Dec2020, and was diagnosed with COVID-19 on 04JAN2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 infection is more pre-existing infection prior to vaccine use, and unrelated to BNT162B2.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from the Pfizer-sponsored program. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine last 28Dec2020 and then last 04Jan2021, she was positive for COVID-19. She wanted to know if it is okay for her to take her second dose. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.; 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: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) from the Pfizer-sponsored program. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine last 28Dec2020 and then last 04Jan2021, she was positive for COVID-19. She wanted to know if it is okay for her to take her second dose. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.; 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on the left arm on 28Dec2020 16:00 at a single dose for safety for herself working with COVID patients. The patient's medical history and concomitant medications were reported as none. The patient asked how she should proceed with her second vaccine dose now that she is positive for covid. The patient received the first dose of the vaccine on 28Dec2020. She was looking for recommendations of what to do about the second dose. She began having symptoms on 09Jan2021 and she had a positive test on 12Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive test/having symptoms based on the known safety profile. However the short duration  since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: the redness came back but it was itchy, hot to touch, and hard; the redness came back but it was itchy, hot to touch, and hard; With my first vaccine I had redness to the site the day after injection; It was probably about a quarter to half dollar in size and was red and inflamed; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the right arm on 21Dec2020 17:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADD), eczema, and psoriasis; all from an unknown date. Patient was not pregnant. Concomitant medications included vitamin b complex, ergocalciferol (VIT D), and birth control. It was reported that with patient's first vaccine, the patient had redness to the site the day after injection (22Dec2020). It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine (reported as '27Dec2020 19:00'), the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large. The patient visited a physician, and was placed on an oral antibiotic and it slowly began to fade and go away. The outcome of the events was recovered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: rash on his right arm and right leg; it is like little red bumps that kind of itch; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left arm (top of shoulder) on 12Jan2021 at a single dose for Covid-19 immunization. The patient had no relevant medical history, stated that he is perfeclty healthy.  There were no concomitant medications. There were no prior vaccination within 4 weeks.The patient received the first dose of the Covid 19 vaccine on 12Jan2021. It was administered in his left arm; however, he has developed a rash on his right arm and right leg. It's kind of large but it is not oozing or anything. The patient wanted to know if this is a normal side effect. He wanted to know if this a serious allergic reaction. He stated that he got the first dose Tuesday and he is beginning to have, he does not know if it is a mild allergic reaction or just a symptom but he has a rash on his right arm right around the elbow and one his leg it is like little red bumps that kind of itch. In his paperwork it is saying one symptoms that could be severe allergic reaction is a rash all over the body so he is wondering if this is a mild reaction of some sort and also if there are any other cases like this. He first noticed the rash on his arm yesterday (14Jan2021) after he took a shower he looked on his arm and seen a trail going down and today he noticed one on his leg. He noticed the area on his arm yesterday and today he noticed the area on his leg. He says they are little red bumps that itch. He does not know if it was kind of wet but there was a little trail going down and its itchy, it is only the 2 spots that he has noticed are really bad. He says is has persisted he thinks it has remained about the same, he definitely won't say they have gotten worse, they may have swelled up a little bit, he is trying not to scratch but he has scratched a little bit so that is probably why it has swollen up a little bit. The patient has not taken anything for the events; other than using lotion, he was putting lotion on when he first noticed it. The patient had not recovered from the events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Malaise, Migraine, Muscle spasms
Clinical narrative: malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Palpitations, Renal pain
Clinical narrative: malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Vaccination site swelling, Vision blurred
Clinical narrative: malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Condition aggravated, Disturbance in attention, Hypoaesthesia
Clinical narrative: have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization.  Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Malaise, Mobility decreased, Myalgia, Nerve compression
Clinical narrative: have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization.  Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization.  Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; Caller received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot of the COVID vaccine on 07Jan2021 however tested positive on the 13Jan2021. Scheduled for her second dose on 27Jan2021. She asked that will it help or harm to get the second dose of the COVID vaccine with her history of a COVID positive test? She would like to know if she should get her second dose of the COVID vaccine after testing positive for the COVID infection, or not. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: tested positive on 14Jan2021; tested positive on 14Jan2021; This is a spontaneous report from a contactable nurse (Patient's wife). A male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Dec2020 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She states that her husband, who is also an RN, got first dose of the vaccine on 26Dec2020, was exposed to Covid on 09Jan2021, experienced symptoms on 12Jan2021, and tested positive on 14Jan2021. She wants to know if he can still get the 2nd dose which he was originally scheduled to receive on 16Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Tested positive symptomatic COVID-19 on 04Jan2021.; Tested positive symptomatic COVID-19 on 04Jan2021.; High grade fever up to 104F after booster dose on first 24 hours with headache; High grade fever up to 104F after booster dose on first 24 hours with headache; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EK5730), intramuscularly on left arm on 23Dec2020 at 08:45 AM at single dose for COVID-19 immunization. Medical history included hyperuricaemia and hypertriglyceridaemia. Concomitant medication included fenofibrate and febuxostat. The patient was tested positive symptomatic COVID- 19 on 04Jan2021. Symptoms started 01Jan2021: recovered at home. High grade fever up to 104F after booster dose on first 24 hours in Dec2020 with headache. The patient received other vaccine same date (reported as) on 13Jan2021 as second dose on IM left. The patient did not receive any treatment from events. The outcome of events was recovered on unknown date.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numbness on left leg; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 14Jan2021 10:30 at single dose in Left arm for COVID-19 immunization. Medical history included hypertension, covid prior to vaccination. Concomitant drug included unspecified products which the patient received in two weeks.  There were no other vaccines received in four weeks. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergies.  The patient did not have COVID tested post vaccination. Approximately 10 hours after the patient got the vaccine on 14Jan2021 21:00, she felt numbness on her left leg. It got worse this afternoon so she left work to go to urgent care. She had diminished sensation on the lateral aspect of her left leg from knee below and her whole left foot on 14Jan2021 21:00. The reported adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of events 'diminished sensation on the lateral aspect of left leg from knee below and whole left foot', 'felt numbness on left leg'. The patient underwent lab tests which included blood works with unknown result on an unspecified date. The outcome of the event was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.