chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: chills; got a cold on the top of her mouth; sweating in between her thighs; she had a rapid heart rate of 99 beats per minute for almost whole night; spend a night miserable; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (coworker). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included injury, Caller also mentioned having friend of the friend who used to be her coworker (female, age 60 -65 caller not sure) that many years ago she had a car crash injury, food allergy (Stated that her coworker had a food allergies as well, that a food has to be natural without additives (caller thought that it was because her coworker overused Ibuprofen (caused her to be allergic to all sorts of stuff) in the past)). The patient's concomitant medications were not reported. On an unknown date, the patient (coworker) got a Covid shot she got chills, caller stated "she (coworker) got a cold on the top of her mouth" and sweating in between her thighs and she had a rapid heart rate of 99 beats per minute for almost whole night. Caller stated that coworker is allergic to a lot of foods now because she overused the Ibuprofen (took too much of it) in the past. Caller stated that her coworker could not take Ibuprofen to take down any fever she had, stated that she (coworker spend a night miserable and this is why she decided to call us and ask because she is on Tikosyn and knows that it regulates her heart. Stated that her coworker had a food allergies as well, that a food has to be natural without additives (caller thought that it was because her coworker overused Ibuprofen in the past) caller stated that PA told her (the caller) that what caused a rapid pulse is a fever. Caller stated that she heard that before you get a shot you have to sign a disclaimer because it is an experimental drug. The patient underwent lab tests and procedures which included heart rate: had a rapid heart rate of 99 beats per minute on an unknown date, she had a rapid heart rate of 99 beats per minute for almost whole night. The Outcome of all the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Scar
Clinical narrative: rash/predominantly in my stomach area; have scars.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that his second dose is scheduled for 10Feb2021. As per report it was reported that he talked to his medical care provider and gave him some information on some. it was not severe, he guesses it was like a moderate side effect that he had after he received vaccine, it was kind of a rash, instead of a whole body- his was predominantly in his stomach area and he have scars. The outcome of events was unknown.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; Severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection.; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), intramuscular, administered in left arm on 03Feb2021 11:30 as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 the patient experienced severe redness, swelling and warmth at injection site that is spreading across entire back over 24 hours after injection. Therapeutic measures taken for the events included treatment with Benadryl and Prednisone. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Overweight, Rash, SARS-CoV-2 test
Clinical narrative: weight is too much; she developed a rash on her body/blotches/rash on chest, small amount on arms, and a couple on legs; face very red; This is a spontaneous report from a contactable consumer(patient). A 76-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 at 15:30 into left upper arm as a 1st dose single dose for COVID-19 immunization at hospital. The patient had an allergy to penicillin. No other vaccine given the same day or 4 weeks prior. No problems with vaccines in past. On 04Feb2021, patient developed a rash on her body, blotches/rash on chest, small amount on arms, and a couple on legs and face very red. On an unspecified date, patient experienced shrinking, weight is too much. She got the first Covid-19 shot at (hospital) this past Sunday. Went to take a shower today and her face was very red so she looked at her chest and there were blotches that looked like a rash. Had a small amount on her arms, but not at the injection site. Also had a couple of blotches on the legs. Had called the doctors at (hospital name) and had a virtual visit and was told to take Benadryl. This was 4 days after and wants to know if we have found out any information about her. She asks should she get the second dose in the same arm. Mentions she and her husband did take a COVID test because her husband had a belly ache so they wanted to make sure it wasn't that or something that he ate. They suspected it was something he ate and it was, they both were negative. Clarifies this was before getting the Covid-19 shot. Later mentions she has an allergy to penicillin and was not sure if that is related. Had a reaction as a child and has not taken it since. The patient was not visited to emergency room for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date Jan2021.The outcome of the events was unknown for overweight and recovering for other events  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: vomit; lightheaded; dizzy; super nauseous; sore arm; tired; muscle soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 03Feb2021 at noon as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 03Feb2021 at noon. After 15 minutes started feeling lightheaded, dizzy and super nauseous. The nurse during the observation had her drink some water and eat a sugar candy, felt a little better and said could go home. On her way home it came back really bad, tried to eat little bit but each time she would vomit. Vomiting persisted. She could drink some water but the nausea has continued, until finally could hold something. Also experienced a sore arm, being kind of tired, muscle soreness. The main side effects are intense light headedness, dizziness, nausea. The outcome of the events nauseous and vomit was not recovered; sore arm, tired and muscle soreness was unknown while remaining outcome of the event was recovering.  Information about Lot/ Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomit; lightheaded; dizzy; super nauseous; sore arm; tired; muscle soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 03Feb2021 at noon as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 03Feb2021 at noon. After 15 minutes started feeling lightheaded, dizzy and super nauseous. The nurse during the observation had her drink some water and eat a sugar candy, felt a little better and said could go home. On her way home it came back really bad, tried to eat little bit but each time she would vomit. Vomiting persisted. She could drink some water but the nausea has continued, until finally could hold something. Also experienced a sore arm, being kind of tired, muscle soreness. The main side effects are intense light headedness, dizziness, nausea. The outcome of the events nauseous and vomit was not recovered; sore arm, tired and muscle soreness was unknown while remaining outcome of the event was recovering.  Information about Lot/ Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: chills; muscle ache; fatigue; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included arrhythmia, arteriosclerosis, COPD, COVID-19 (COVID-19 beforehand). The patient's concomitant medications were not reported. The patient experienced chills (non-serious) on an unspecified date, muscle ache (non-serious) on an unspecified date, fatigue (non-serious) on an unspecified date, loss of appetite (non-serious) on an unspecified date. Upon asking questions, it was reported as, Question: Pfizer should study the vaccine to the people who had COVID-19. Question: Caller (79yrs old) said he had he first shot of the Pfizer COVID-19 vaccine and is due for his second shot on 10Feb2021. He is concerned about the severity of the reaction of the second dose of the Pfizer COVID-19 vaccine. He said he has a number of comorbidities like having arrhythmia, arteriosclerosis, COPD. He also had COVID-19 beforehand. He said he experienced adverse events after the first shot of the COVID-19 vaccine namely chills, muscle ache, fatigue, loss of appetite which lasted for a day and a half. AE realized after the call. Question: He wanted to know the severity of the adverse reactions to people who got COVID-19 before and if they are worse. Question: Do you have the phone number of CDC. The outcome of events was recovered on an unspecified date.    Information on the lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint swelling, Skin discolouration, Vaccination site swelling
Clinical narrative: swelling of the elbow below the injection site/ left elbow and forearm are swelling quite a bit; swelling of the elbow below the injection site/ left elbow and forearm are swelling quite a bit; left elbow and forearm black and blue; This is a spontaneous report from a contactable consumer (patient)  A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3249), via an unspecified route of administration on 23Jan2021 at 08:45 am in the left upper arm as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did get a regular flu shot at least a month or more before this Pfizer BioNTech Covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. On 04Feb2021, the patient stated that his left elbow and forearm had a swelling which worsened. The patient stated that this was the first of anything that has happened. The patient stated his left elbow and forearm turned black and blue. The patient stated that he didnot know whether there was something related because he did not had any injury or puncture to the skin or any other. The patient did not visit emergency room or physician office for the events. The patient underwent lab tests and procedures which included blood work done on an unknown date in Jan2021: results were unknown. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood test, Chills, Feeling abnormal
Clinical narrative: weak; she is not well /Got it a week ago and still having side effects /it made her feel sick; had stomach pains; chills; nauseous; She started feeling a little different; This is a spontaneous report from a contactable consumer. A 84-years-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation-solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She started feeling a little different on Friday the 29Jan2021, by Saturday the 30Jan2021, she had stomach pains, chills, and was nauseous. She went to emergency room on Saturday 30Jan2021, blood work determined everything was functioning and gave her medication for nausea, but that was making her ill, don't know what the medication was. It made her feel bad. They gave her 3 doses, she took all 3, it made her feel sick as soon as she took it and she would feel a little better a little later on. I forgot to tell you she was weak. You can hear it in her voice she was not well. Today she was still the same. She got it a week ago and still having side effects. She would like to know if there is any advice for someone who is still having symptoms a week later. She stated she can do the report online. The patient underwent lab tests and procedures which included blood test: everything was functioning on 30Jan2021. The patient received treatment for nausea. The outcome of the events was unknown.  No further details provided. Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: weak; she is not well /Got it a week ago and still having side effects /it made her feel sick; had stomach pains; chills; nauseous; She started feeling a little different; This is a spontaneous report from a contactable consumer. A 84-years-old female patient (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation-solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She started feeling a little different on Friday the 29Jan2021, by Saturday the 30Jan2021, she had stomach pains, chills, and was nauseous. She went to emergency room on Saturday 30Jan2021, blood work determined everything was functioning and gave her medication for nausea, but that was making her ill, don't know what the medication was. It made her feel bad. They gave her 3 doses, she took all 3, it made her feel sick as soon as she took it and she would feel a little better a little later on. I forgot to tell you she was weak. You can hear it in her voice she was not well. Today she was still the same. She got it a week ago and still having side effects. She would like to know if there is any advice for someone who is still having symptoms a week later. She stated she can do the report online. The patient underwent lab tests and procedures which included blood test: everything was functioning on 30Jan2021. The patient received treatment for nausea. The outcome of the events was unknown.  No further details provided. Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gastrooesophageal reflux disease, Headache, Pain
Clinical narrative: Severe runny nose; achey; she had severe acid reflux and she didn't have that normally; chills; really bad sore arm; Constant joint pain and headache; Constant joint pain and headache; This is a spontaneous report from a contactable Nurse (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Jan2021 13:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Right Arm on 25Jan2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation but after this second dose no adverse events is reported. Medical history included Hypothyroid, allergies: sulfa, allergies: Latex (Known allergies: Latex sulfa). Age at vaccination: 50. Pregnant at the time of vaccination: No. Facility type vaccine: Hospital. If COVID prior vaccination: No. If COVID tested post vaccination: No. If other vaccine in four weeks: No. Other medications in two weeks: Armor thyroid estrodile VIT D ibuprofen Tylenol. Concomitant medication(s) (in two weeks) included ibuprofen taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; thyroid taken for an unspecified indication, start and stop date were not reported. On 07Jan2021 at 02:45 PM patient experienced, Severe runny nose, achey, and chills, really bad sore arm. The next day she had severe acid reflux and she didn't have that normally. Patient also experienced, Constant joint pain and headache on 07Jan2021. Patient did not receive any treatment for events. Facility information available. Ethnicity information is available. For all events, outcome was not recovered.    Information on the Lot/Batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Severe runny nose; achey; she had severe acid reflux and she didn't have that normally; chills; really bad sore arm; Constant joint pain and headache; Constant joint pain and headache; This is a spontaneous report from a contactable Nurse (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Jan2021 13:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Right Arm on 25Jan2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation but after this second dose no adverse events is reported. Medical history included Hypothyroid, allergies: sulfa, allergies: Latex (Known allergies: Latex sulfa). Age at vaccination: 50. Pregnant at the time of vaccination: No. Facility type vaccine: Hospital. If COVID prior vaccination: No. If COVID tested post vaccination: No. If other vaccine in four weeks: No. Other medications in two weeks: Armor thyroid estrodile VIT D ibuprofen Tylenol. Concomitant medication(s) (in two weeks) included ibuprofen taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; thyroid taken for an unspecified indication, start and stop date were not reported. On 07Jan2021 at 02:45 PM patient experienced, Severe runny nose, achey, and chills, really bad sore arm. The next day she had severe acid reflux and she didn't have that normally. Patient also experienced, Constant joint pain and headache on 07Jan2021. Patient did not receive any treatment for events. Facility information available. Ethnicity information is available. For all events, outcome was not recovered.    Information on the Lot/Batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; Sick to her stomach; Felt arm pain; Shortness of breath; Upper respiratory infection; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via intramuscular route, administered in left arm, on 08Jan2021 14:00 (Lot number was not reported), at the age of 56 years, as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from 13Dec2020 to unknown date. The concomitant medications were not reported. On 08Jan2021, the patient experienced upper respiratory infection. After 26 hours on 09Jan2021 16:00, the patient experienced chills, headache, fatigue, sick to her stomach and Felt arm pain. On 09Jan2021, patient had shortness of breath. For upper respiratory infection patient was treated with IC-minicyclone 100 mg once daily from 09Jan2021 for 7 days. The outcome of the event upper respiratory infection was recovering. The events chills, headache, fatigue, sick to her stomach was recovered on 10Jan2021 16:00, after 24 hours. The event felt arm pain was recovered after 3 days on 12Jan2021. The outcome of the event shortness of breath was unknown.   Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Upper respiratory tract infection
Clinical narrative: Chills; Headache; Fatigue; Sick to her stomach; Felt arm pain; Shortness of breath; Upper respiratory infection; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via intramuscular route, administered in left arm, on 08Jan2021 14:00 (Lot number was not reported), at the age of 56 years, as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from 13Dec2020 to unknown date. The concomitant medications were not reported. On 08Jan2021, the patient experienced upper respiratory infection. After 26 hours on 09Jan2021 16:00, the patient experienced chills, headache, fatigue, sick to her stomach and Felt arm pain. On 09Jan2021, patient had shortness of breath. For upper respiratory infection patient was treated with IC-minicyclone 100 mg once daily from 09Jan2021 for 7 days. The outcome of the event upper respiratory infection was recovering. The events chills, headache, fatigue, sick to her stomach was recovered on 10Jan2021 16:00, after 24 hours. The event felt arm pain was recovered after 3 days on 12Jan2021. The outcome of the event shortness of breath was unknown.   Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm/I woke up in the middle of the night and I had pain in the arm; Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 31May2021), dose 2 via an unspecified route of administration on 03Feb2021 04:00 as 2nd dose, single dose for covid-19 immunisation. Patient took ibuprofen (ADVIL [IBUPROFEN]), via an unspecified route of administration from an unspecified date to an unspecified date, (I took Advil this morning two) for an unspecified indication. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) for covid-19 immunization on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced sore arm/woke up in the middle of the night and had pain in the arm, headache. Now confused because some people say don't take anything before or after, so you don't lessen the effectiveness of the vaccine, was told yesterday that could take Advil or Tylenol if I needed today. So, want to know is the answer, can take something. Patient received treatment of advil this morning too. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: very mild slide effects remain (headache, aches, random chills or warmth feeling); very mild slide effects remain (headache, aches, random chills or warmth feeling); woke up with a 100.5 fever; sweating; aches, and soreness; chills; fatigue; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in left arm on 03Feb2021 09:00 (at the age of 31-years-old) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's (thyroid). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. No known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported.The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, lot number EL3249) via an unspecified route of administration, administrated in left arm on 13Jan2021 (at the age of 30-years-old) as 1st dose, single for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 the patient experienced fatigue (21:30), muscle aches (21:30), chills (23:30) while on 04Feb2021 patient woke up with a 100.5 fever, sweating, aches, and soreness at 01:30 AM and took Zinc quercetin and Advil, fever started going down. Finally fell asleep by 4:00AM. Again at 8:30AM patient woke up feeling much better, but still a bit weak with slight muscle aches. no more fever or chills. Patient had very mild slide effects remain (headache, aches, random chills or warmth feeling) on 04Feb2021 at 20:30 PM. With a good night's rest, patient predicted she will be back to normal tomorrow (05Feb2021). The patient underwent lab tests and procedures which included body temperature was 100.5 on 04Feb2021. Therapeutic measures were taken as a result of woke up with a 100.5 fever, sweating, aches, and soreness includes zinc quercetin and advil. However, no treatment was given for other events. The outcome of the event woke up with a 100.5 fever was recovered on 04Feb2021 while outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pain, Pyrexia
Clinical narrative: very mild slide effects remain (headache, aches, random chills or warmth feeling); very mild slide effects remain (headache, aches, random chills or warmth feeling); woke up with a 100.5 fever; sweating; aches, and soreness; chills; fatigue; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in left arm on 03Feb2021 09:00 (at the age of 31-years-old) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's (thyroid). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. No known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported.The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, lot number EL3249) via an unspecified route of administration, administrated in left arm on 13Jan2021 (at the age of 30-years-old) as 1st dose, single for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 the patient experienced fatigue (21:30), muscle aches (21:30), chills (23:30) while on 04Feb2021 patient woke up with a 100.5 fever, sweating, aches, and soreness at 01:30 AM and took Zinc quercetin and Advil, fever started going down. Finally fell asleep by 4:00AM. Again at 8:30AM patient woke up feeling much better, but still a bit weak with slight muscle aches. no more fever or chills. Patient had very mild slide effects remain (headache, aches, random chills or warmth feeling) on 04Feb2021 at 20:30 PM. With a good night's rest, patient predicted she will be back to normal tomorrow (05Feb2021). The patient underwent lab tests and procedures which included body temperature was 100.5 on 04Feb2021. Therapeutic measures were taken as a result of woke up with a 100.5 fever, sweating, aches, and soreness includes zinc quercetin and advil. However, no treatment was given for other events. The outcome of the event woke up with a 100.5 fever was recovered on 04Feb2021 while outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Vomiting
Clinical narrative: vomiting with nausea; vomiting with nausea; body aches; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EH9899) via intramuscular in left arm on 07Jan2021 11:00 as 1st dose, single for COVID-19 immunization (at the age of 53-years-old). Medical history included chronic regional pain syndrome form severe spinal cord injury. Patient had known allergies: Vicodin, sulfa. Concomitant medication(s) included gabapentin and morphine 30 mg, 1 daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient stated that after the first dose of the Covid vaccine on 04Feb2021 at 14:30 (within 2-3 hours), she was vomiting with nausea, body aches and dizziness for 3-5 days. The adverse events resulted in physician office visit. The clinical outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Fatigue, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Asthmatic reaction; Sore throat; She felt sleepy; A runny nose; Felt achy; Fatigue; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (Patient) reported.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported, Expiration date was not reported) as 1st DOSE, SINGLE DOSE for an unspecified indication.  Medical history included asthma from an unknown date and she was to have a colonoscopy and is considered high risk due to a past history of asthma. The patient's concomitant medications were not reported. First dose of the covid-19 vaccine on 24Jan2021, that night and the next day patient felt sleepy. As the week went on patient had a runny nose ,, sore throat , fatigue, and felt achy 28Jan2021 caller had an asthmatic reaction  went to the ER for a breathing treatment. On 29Jan2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. she has albuterol and nebulizer treatments that she hasn't had to use in the past year, but now is using, on 14Feb2021 caller is scheduled to have her second dose. Outcome of events was unknown.   Relayed PMI phone number for future reference, transferred to PSCC Covid AE/PCOM, relayed 11 callers ahead, will fax AE side eff  Information about lot/batch number has been requested.  Follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Asthmatic reaction; Sore throat; She felt sleepy; A runny nose; Felt achy; Fatigue; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (Patient) reported.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported, Expiration date was not reported) as 1st DOSE, SINGLE DOSE for an unspecified indication.  Medical history included asthma from an unknown date and she was to have a colonoscopy and is considered high risk due to a past history of asthma. The patient's concomitant medications were not reported. First dose of the covid-19 vaccine on 24Jan2021, that night and the next day patient felt sleepy. As the week went on patient had a runny nose ,, sore throat , fatigue, and felt achy 28Jan2021 caller had an asthmatic reaction  went to the ER for a breathing treatment. On 29Jan2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. she has albuterol and nebulizer treatments that she hasn't had to use in the past year, but now is using, on 14Feb2021 caller is scheduled to have her second dose. Outcome of events was unknown.   Relayed PMI phone number for future reference, transferred to PSCC Covid AE/PCOM, relayed 11 callers ahead, will fax AE side eff  Information about lot/batch number has been requested.  Follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Little tiredness; Last night some soreness in my arm; This is a spontaneous report from contactable consumer(patient) from a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot /Batch number: Unknown), via an unspecified route of administration on 04Feb2021 at 12:00 as 1st dose, single for COVID-19 immunization. Medical history included root canal. Patient had a dental appointment on 02Feb2021, and she was taking ibuprofen after the appointment. She is wondering when she can start taking the ibuprofen for her tooth pain. Patient stated that she was clear about if taking Advil is okay after you get the shot, it isn't okay to take it before. She had a dental procedure on Tuesday, a root canal, her mouth continues to be sore. It was reported that her dentist said she could take Advil and she didn't know at that time. Concomitant medication included ibuprofen taken for tooth pain from 02Feb2021 to 03Feb2021 16:00. It was reported that she stopped taking the ibuprofen at 4:00 on 03Feb2021. She was received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 04Feb2021 at noon and experienced: a little tiredness and last night some soreness in my arm ( Feb2021), the same as if she had a flu shot. Her second dose is scheduled for 25Feb2021. She was advised to report any possible side effects after her second dose. The outcome of the events was unknown.  No further details provided. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Injection site rash, Nausea
Clinical narrative: Heart palpitations not normal; rash around site; dizziness; low fever; nausea; sweating; body ache; fatigue; This is a spontaneous report from a non-contactable Nurse. The nurse reported for herself that a 41-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot Number: EN9581), via intramuscular route of administration at left arm on 03Feb2021 at 15:00 (at the age of 41-year-old), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Other medications in two weeks were reported as yes but not specified. Patient had no known allergies. The patient was not pregnant at the time of vaccination. It was unknown if other vaccine received by patient within four weeks. No Covid tested post as well as prior vaccination., The patient experienced heart palpitations not normal, rash around site, dizziness, low fever, nausea, sweating, body ache and fatigue on 04Feb2021 at 06:00 AM. No treatment provided for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: Heart palpitations not normal; rash around site; dizziness; low fever; nausea; sweating; body ache; fatigue; This is a spontaneous report from a non-contactable Nurse. The nurse reported for herself that a 41-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot Number: EN9581), via intramuscular route of administration at left arm on 03Feb2021 at 15:00 (at the age of 41-year-old), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Other medications in two weeks were reported as yes but not specified. Patient had no known allergies. The patient was not pregnant at the time of vaccination. It was unknown if other vaccine received by patient within four weeks. No Covid tested post as well as prior vaccination., The patient experienced heart palpitations not normal, rash around site, dizziness, low fever, nausea, sweating, body ache and fatigue on 04Feb2021 at 06:00 AM. No treatment provided for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This is a spontaneous report from a contactable consumer or other non hcp (niece's brother in law). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as UNK, single (SINGLE DOSE) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness on an unspecified date. The reporter stated the patient took the first shot and had some soreness and then took the 2nd shot and was so sick, feeling like he had the flu and other symptoms. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Malaise
Clinical narrative: sick; feeling like he had the flu and other symptoms; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's niece's brother in law).A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not Reported) via an unspecified route of administration on an unspecified date  as 2nd Dose, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated My niece told me that her brother in law took the first shot and had some soreness and then took the 2nd shot and was so sick, feeling like he had the flu and other symptoms. After the 2nd shot the patient was sick and he has the flu and other symptoms. The outcome for the events was Unknown. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer via Medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports a person in the bakery knows someone who had heart palpitations after the vaccine on an unspecified date. The governor is deciding it would be better to give everyone just one shot and then wait longer for the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Muscle soreness at injection site; Chills; This is a spontaneous report from a non-contactable consumer (patient himself). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EL3247) via an unspecified route of administration in left arm on an unspecified date in Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant drugs were not reported. No known allergies to medications and food. On an unspecified date in Feb2021 patient experienced with Muscle soreness at injection site and chills lasting roughly 6-8 hours starting about 6-8 hours after injection. Treatment received for the events was reported as no. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body pains; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on Feb2021 at 03:00 PM as 2nd dose single for covid-19 immunization. Patient's age at vaccination was 52-year. The patient medical history and concomitant medications was not reported. No covid prior vaccination. No covid tested post vaccination. Historical vaccination of BNT162B2 for COVID-19 immunization as first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: workplace clinic. The patient experienced body pains on Feb2021. The seriousness of the event was non-serious. No treatment received for AE. The outcome of the event was recovered on Feb2021.   No follow-up attempts was possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness and itching at site; Redness and itching at site; lump in arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) dose 1 via an unspecified route of administration, administered in left arm on 02Feb2021 16:30 (at the age of 42-years-old) as single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, allergies to penicillins, COVID-19 (prior vaccination). The patient was not allergic to food and other products. Concomitant medication(s) included adalimumab (HUMIRA), vitamin b complex (VIT B COMPLEX), quercetin, ergocalciferol (VIT D), and multi-vitamin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced redness and itching at site, lump in arm on 05Feb2021 06:00. No treatment was received for the adverse event. The patient had not tested for COVID-19 since vaccination. The outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.