chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen and tender lymph nodes; swollen and tender lymph nodes; coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age (reported age: 62; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after first vaccine, the patient experienced swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms. With second dose, she had similar symptoms, but not the swollen and tender lymph nodes, no chills or fever. She stated that she felt like she was going all over this again. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nasopharyngitis, Nausea, Rhinorrhoea
Clinical narrative: swollen and tender lymph nodes; swollen and tender lymph nodes; coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age (reported age: 62; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after first vaccine, the patient experienced swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms. With second dose, she had similar symptoms, but not the swollen and tender lymph nodes, no chills or fever. She stated that she felt like she was going all over this again. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: swollen and tender lymph nodes; swollen and tender lymph nodes; coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age (reported age: 62; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after first vaccine, the patient experienced swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms. With second dose, she had similar symptoms, but not the swollen and tender lymph nodes, no chills or fever. She stated that she felt like she was going all over this again. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller's husband experienced arm swelling after the vaccine.; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (patient wife). A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date was unknown), via an unspecified route administration on an unspecified date as a single dose COVID-19 immunisation. Medical history and concomitant drugs were not reported. On an unspecified date, patient experienced arm swelling after the vaccine. The outcome of the event was unknown.  Information about lot and batch number was requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site erythema
Clinical narrative: Redness at the injection site; body aches; nausea; This is a spontaneous report from a contactable consumer (who is the patient, self reported).  This 43-Years-old (not pregnant) female patient received second dose of BNT162B2 (Solution for injection, lot number: EL3247 expiry date: unknown) via an unspecified route of administration in Left arm on 11Feb2021 at 14:30, as single dose for Covid-19 immunization. The patient had no Known allergies. The patient did not receive other vaccine in four weeks, was not having COVID prior vaccination. Concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (Solution for injection, lot number: EL3247 expiry date: unknown) via an unspecified route of administration in Left arm on 21Jan2021 14:30 PM, as single dose for Covid-19 immunization.  On 12Feb2021 at 04:00, (post second dose) the patient experienced redness at the injection site, body aches and nausea. Patient did not receive any treatment for the adverse events. Patient was not tested for COVID post vaccination. Events, Redness at the injection site, body aches and nausea were non-serious. Outcome of the events was reported as recovering.   No other information was available.     No other information was available.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: rash on left arm is gone now; arm achy at injection site; coughing up old mucus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included rash and patient states that her whole life she had asthma and allergies, had hypereosinophilia syndrome, and year round allergies, normally her lungs are pretty congested, sinuses are normally they are swollen shut, normally her eyes have a lot of discharge and are watery and they are not watering, her lungs are clear and her sinuses are clear. The patient's concomitant medications were not reported. The patient experienced rash on left arm is gone now on 03Feb2021, coughing up old mucus on 02Feb2021, arm achy at injection site on 03Feb2021. Patient knows she read that there is an RNA teacher cell is what she calls it and wants to know it, it taught her body to not fight the other stuff. Has this been reported before. Other thing that happened, got vaccine yesterday around lunch, both last night when she came home and early this morning, was coughing up little nodules of mucus. States another thing that is interesting, yesterday when she got the injection, she asked to have it in the right because she had a rash on her left arm and today it is gone. Only thing she got was arm at injection site was a little achy. started this morning. States that she remembers hearing in clinical trials they did not test the vaccine on pregnant people or people with allergies so she thought they would like to hear from someone with severe allergies.   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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flatulence
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269), via intramuscular route, administered in Arm Left on 09Feb2021 10:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was 77-years-old at the time of vaccination. Time the vaccination was given was 10:30. The patient medical history included diabetes from 2012 to an unknown date, high blood pressure from 2012 to an unknown date and thyroid problems. Family medical history: All of family have high blood pressure and thyroid problems, thyroid surgery on 2012. No concomitant medications prior to Vaccinations (within 4 weeks). On 11Feb2021, Patient reported that she felt that there was lots of gas in her stomach after she had the 1st dose - She described it that there are lots of gases in her stomach and once she goes to the bathroom it suddenly disappears. She never had gas like this. The gas fell down in her stomach all of a sudden. If she has gas, she takes pills or something. This is like more progressive. She doesn't hardly have any irritation in bottom of stomach. She never had it. She would like to know if her stomach problems are a side effect from the vaccine. No relevant test. Events were assessed as non-serious. The outcome of event was not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Vaccination site reaction
Clinical narrative: she had an injection site reaction; she did get really bad mouth sores and they're pretty severe; This is a Spontaneous report based on the information received by Pfizer. A contactable female consumer reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization. The patient medical history and Concomitant drugs were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were unknown) on an unknown date for COVID-19 immunization. On an unspecified date, the patient experienced she had an injection site reaction, she did get really bad mouth sores and they are pretty severe. On an unknown date, she had taken her second Pfizer COVID vaccine, she had spoke to her doctor and took the COVID vaccine. Two days later after she took her second COVID vaccine, it was time to take her Kevzara injection which she did. No treatment reported for she had an injection site reaction (unknown if from Kevzara injection or from the COVID vaccine); and she did get really bad mouth sores and they are pretty severe. Unknown treatment for she felt the Kevzara did not work like it usually does for her RA pain. The doctor knows about the consumer taking the COVID vaccine and the mouth sores but does not known that consumer felt the Kevzara did not work like it usually does for her RA pain. Consumer does follow-up with her physician this week. Consumer will have her next injection of Kevzara this Monday, 15Feb2021. At the time of the report, Kevzara is continued. The outcome of the events was recovered.  Information about lot/ batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash over right upper thigh and buttocks; This is a spontaneous report from a contactable male consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 23Feb2021 10:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. The concomitant medications included atenolol (ATENOLOL), simvastatin (SIMVASTATIN, lisinopril (LISINOPRIL), and hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Feb2021 14:00, the patient experienced skin rash over right upper thigh and buttocks. The patient did not receive any treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Pruritus, Skin swelling, Syncope
Clinical narrative: fainted; swelling in the area /skin around pacemaker; real bad lymph node swelling; had an itch on the skin; vomiting; This is a spontaneous report from a contactable consumer (patient). A female patient of age 32 (units: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on unspecified date as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received bnt162b2, dose 1 on an unspecified date for COVID-19 immunization. The patient had Pfizer vaccine and had a question about the side effects because she couldnt find any information on it and her doctor hadnt heard of it. On an unspecified date, the patient experienced swelling in the area/skin around pacemaker, real bad lymph node swelling and had an itch on the skin. She went to emergency room with vomiting and fainted about 20 minutes after receiving the vaccine. Patient underwent lab test and procedures include work up: there was all negative. The patient questioned about the side effects because she couldn't find any information on it and her doctor hadn't heard of it. The outcome of all the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fainted; swelling in the area /skin around pacemaker; real bad lymph node swelling; had an itch on the skin; vomiting; This is a spontaneous report from a contactable consumer (patient). A female patient of age 32 (units: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on unspecified date as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received bnt162b2, dose 1 on an unspecified date for COVID-19 immunization. The patient had Pfizer vaccine and had a question about the side effects because she couldnt find any information on it and her doctor hadnt heard of it. On an unspecified date, the patient experienced swelling in the area/skin around pacemaker, real bad lymph node swelling and had an itch on the skin. She went to emergency room with vomiting and fainted about 20 minutes after receiving the vaccine. Patient underwent lab test and procedures include work up: there was all negative. The patient questioned about the side effects because she couldn't find any information on it and her doctor hadn't heard of it. The outcome of all the events was unknown.  Information about lot/ batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: I now have two lumps; This is a spontaneous report received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in left arm on 27Feb2021 13:30 as 2nd dose, single dose and first dose of bnt162b2 (Batch/Lot number was not reported) via an unspecified route of administration on unknown date as 1st dose, single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received other medications in two weeks. On 06Feb2021, the patient experienced I now have two lumps which have come up within one hour of receiving the vaccine. One lump came up after the first vaccine and the second came up after receiving the second dose. Lumps were on my right arm between wrist and elbow. Lumps were not painful unless hit or bumped. The first bump has reduced in size by about 25% since it first appeared. The events assessed as non-serious. No treatment was received for the events. Patient visited doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal pain
Clinical narrative: Severe stomach and intestinal pain on day two after the shot; Severe stomach and intestinal pain on day two after the shot; This is a spontaneous report from a contactable consumer, the patient (reported for self).  A 57-years-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318; Expiration date: UNKNOWN), via an unspecified route of administration, administered in right arm on 28Feb2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included known allergies, Allergic to several antibiotics. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN318; Expiration date: UNKNOWN), via an unspecified route of administration, administered in right arm on  07Feb2021 at 14:30 as a single dose for COVID-19 immunization. The patient had not received other vaccine within four weeks. Prior to the vaccination the patient was not diagnosed with COVID-19.   On 02Mar2021 at 03:00, the patient experienced severe stomach and intestinal pain on day two after the shot. It was unknown, whether the patient received any treatment for the events. Patient was not tested for COVID post vaccination. Events severe stomach and intestinal pain were non-serious. Outcome of the events severe stomach and intestinal pain was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at left arm where first dose vaccine was administered; This is a spontaneous report from a non-contactable consumer(Patient).   A 30-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:15 as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccine. The patient medical history and concomitant medications was not reported. It was reported that, Pain at left arm where first dose vaccine was administered. Pain has persisted for greater than 14 hours at time of reporting. No treatment was received. Outcome of the event was resolving.    No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included triamterene taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient had experienced tiredness/extremely tired and headache. Patient received first dose of the PFIZER COVID-19 vaccine last week on Wednesday. Had a reaction of tiredness and headache. Just uncomfortable. Since patient had that should she take the second shot. On 02Mar2021 09:29 patient stated that she had reported her side effects already. Upon follow-up 02Mar2021, it was reported that patient had got the first vaccine (clarified as PFIZER COVID-19 Vaccine) last Wednesday and patient did have the reaction to it. Patient reaction was like, she was extremely tired and headache. Now, since patient had that, It was wise for her to take the second one. Height and Weight: Patient stated, probably about 5 feet 5 inch, patient was not sure as you know when you get older you shrink and body weight. The patient underwent lab tests and procedures which included body height: probably about 5 feet 5 inch on an unspecified date. Patient received the tylenol as treatment for tiredness/extremely tired and headache. The outcome of event was unknown. Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that new information included: lab data and clinical information added. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: congestion; fatigue; runny nose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself.  The female patient (age 39, unit unknown) received second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on 26Feb2021 as a single dose for covid-19 immunization. Medical history included autoimmune disease. Concomitant medications included SULFASALAZINE for autoimmune disease. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for covid-19 immunization. On 01Mar2021, it was stated that she did not feel great over the weekend, but then a day prior to this report, she had to call out of work and had all the side effects of the vaccine including fatigue and she experienced congestion and a runny nose. She does have an autoimmune disease in which she takes sulfasalazine but thinks she should be on something stronger. The outcome of the events of fatigue, congestion and a runny nose was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: Sleeplessness; This is a spontaneous report from a contactable Other-HCP (patient). A 65-years-non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration in Arm Left on 22Feb2021 as single dose for covid-19 immunization. Facility type vaccine was School or Student Health Clinic. Patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. Historical vaccination included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration in arm right on 01Feb2021 at 10:00 as single dose for covid-19 immunization. Concomitant medication included vitamin D nos (VITAMIN D NOS) and vitamin B nos (VITAMIN B NOS) within 2 weeks of vaccination. The patient has allergies to sodium lauryl sulfate. It was reported that Sleeplessness starting about 8 days after shot two. Not consuming any caffeine or alcohol. Adverse event date was reported as 27Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Pcr test): negative on 24Feb2021. Patient didn't receive any treatment for event. Outcome of the event were not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This is a spontaneous report from a contactable consumer (patient). A female patient (age:72, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that caller received the Pfizer covid vaccine last Wednesday and since last Thursday she has been experiencing lower back pain. The outcome of the event was unknown. Patient questioned if her symptoms after receiving the 1st dose of the covid vaccine will be the same after the 2nd dose. Patient would like to know if lower back pain was related to the covid vaccine and if her post vaccine symptoms will run their course. No follow-up attempts were possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia
Clinical narrative: muscle pain; chest pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: EL9266), via an unspecified route of administration, administered in Left Arm on 17Feb2021 09:00 (at the age of 66-years old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No information reported about history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. On 18Feb2021 02:00 the patient experienced chest pain and on an unspecified date the patient experienced muscle pain. The outcome of event chest pain was recovered on 21Feb2021 while, the outcome of event muscle pain was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient received second dose BNT162B2 (Solution for injection, Lot number was not reported), via an unspecified route of administration on Feb2021 at 01:30 as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior vaccination, the patient had not COVID-19. Post vaccination, the patient had not tested COVID-19. No other vaccine received in four weeks. The patient previously took BNT162B2 (COVID-19) at first dose for COVID-19 immunization. It was reported that within 24 hours of receiving second dose, individual developed a fever of 101.8 F that was reduced with medication and resolved within 48 hours. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit on Feb 2021. Therapeutic measures were taken as a result of developed a fever of 101.8 f. The outcome of the event was resolved in Feb 2021. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Electrocardiogram, Heart rate
Clinical narrative: heart would start beating really really fast; like someone was pouring air in my chest like my chest was going to explode; a hard time breathing; getting sick "really sick; tremendous anxiety; having insomnia; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and was sick. Patient reported that following administration of her first Pfizer Covid vaccine dose on 22Feb2021, she experienced a terrible reaction, with tremendous anxiety and insomnia that started 3 days after getting the vaccine in Feb2021. Patient reported feeling fine for the first 2 days after the vaccine but then on the 3rd day in Feb2021 she started getting sick, really sick, when she ate all the sudden heart would start beating really really fast like someone was pouring air in her chest like her chest was going to explode, even with a tiny bit of food. Patient went on to report that, she had an oximeter in the house that tests oxygen and counting heart beats and her heart went from 83 to 104 so heart was beating fast then was having a hard time breathing the first time and tremendous anxiety and been having insomnia. Patient reported that she did go to the doctor and they took an electrocardiogram which was fine. Then she went to a cardiologist yesterday and they planned to do an echo an electrocardiogram, stress test and heart monitor. Reportedly, consumer was asking, what happened when you have a reaction to the vaccine or an ingredient in the vaccine, does it create antibodies, is there a blood test to find out if I have antibodies after a reaction. Patient also was asking how long does PEG stay in the body and should she get the second dose after having a reaction. Patient reported that the only other time she had experienced this type of reaction was when she took Cipro antibiotic which has a common ingredient of PEG. Stating 3 years ago patient got very very sick from a product, Cipro, the only ingredient that the Pfizer vaccine has that Cipro has, the only common ingredient is PEG. Caller reported that she initially didn't want to get the vaccine reporting that she was supposed to have it on Feb 3rd but when she arrived she left because she was scared. She reported that she got different advice from her doctors 2 said to get it and 2 others said no. She reported that she has followed up with her doctor after her reaction but can't get any answers about her reaction or how long PEG will stay in her body. The patient underwent lab tests and procedures which included electrocardiogram: 0.83/1.04 seconds on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Insomnia
Clinical narrative: heart would start beating really really fast; like someone was pouring air in my chest like my chest was going to explode; a hard time breathing; getting sick "really sick; tremendous anxiety; having insomnia; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 22Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and was sick. Patient reported that following administration of her first Pfizer Covid vaccine dose on 22Feb2021, she experienced a terrible reaction, with tremendous anxiety and insomnia that started 3 days after getting the vaccine in Feb2021. Patient reported feeling fine for the first 2 days after the vaccine but then on the 3rd day in Feb2021 she started getting sick, really sick, when she ate all the sudden heart would start beating really really fast like someone was pouring air in her chest like her chest was going to explode, even with a tiny bit of food. Patient went on to report that, she had an oximeter in the house that tests oxygen and counting heart beats and her heart went from 83 to 104 so heart was beating fast then was having a hard time breathing the first time and tremendous anxiety and been having insomnia. Patient reported that she did go to the doctor and they took an electrocardiogram which was fine. Then she went to a cardiologist yesterday and they planned to do an echo an electrocardiogram, stress test and heart monitor. Reportedly, consumer was asking, what happened when you have a reaction to the vaccine or an ingredient in the vaccine, does it create antibodies, is there a blood test to find out if I have antibodies after a reaction. Patient also was asking how long does PEG stay in the body and should she get the second dose after having a reaction. Patient reported that the only other time she had experienced this type of reaction was when she took Cipro antibiotic which has a common ingredient of PEG. Stating 3 years ago patient got very very sick from a product, Cipro, the only ingredient that the Pfizer vaccine has that Cipro has, the only common ingredient is PEG. Caller reported that she initially didn't want to get the vaccine reporting that she was supposed to have it on Feb 3rd but when she arrived she left because she was scared. She reported that she got different advice from her doctors 2 said to get it and 2 others said no. She reported that she has followed up with her doctor after her reaction but can't get any answers about her reaction or how long PEG will stay in her body. The patient underwent lab tests and procedures which included electrocardiogram: 0.83/1.04 seconds on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Slight fever -- 100.9; extremely tired; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Pfizer and expiration date: not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 09:45 (at the age of 77 years) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications (No other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and not covid tested post vaccination. No known allergies. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection, Batch/Lot Number: EN6201 and expiration date: not reported), via an unspecified route of administration, administered in arm left on 06Feb2021 09:15 (at the age of 77 years) as single dose for covid-19 immunisation. The patient experienced slight fever - 100.9, was extremely tired and had diarrhea on 28Feb2021 at 06:00. No treatment given for any event. The patient's lab data included fever: 100.9. The Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Seroma
Clinical narrative: Right arm pit, a fluid pocket the size of my palm. It is painful when I try to lie down, burns if pushed during the day; Right arm pit, a fluid pocket the size of my palm.. It is painful when I try to lie down; burns if pushed during the day; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in arm right on 26Feb2021 17:45 (at an age of 63-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included known allergies from heparin, lidocaine, roxilox, percocet, Lortab, breast cancer from 2001, fleash eating bacteria from an unspecified date in 1997. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; levothyroxine sodium (LEVOTHYROXIN) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; vitamin D2 (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; hydrochlorothiazide (HYDROCHLOROTH) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 27Jan2021 06:30 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 01Mar2021 the patient experienced right arm pit, a fluid pocket the size of my palm. It is painful when I try to lie down, burns if pushed during the day. It appeared on the third day and has not gone down on the 7th day. I am calling the doctor today. The patient did not receive any treatment for the events. The clinical outcome of the right arm pit, a fluid pocket the size of my palm. It is painful when I try to lie down, burns if pushed during the day was not resolved.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Incorrect route of product administration, Mass
Clinical narrative: the nurse giving the vaccine she squeeze to get soft tissue of my upper arm and injected the COVID vaccine subcutaneously; fatigue; chills; lump in the arm; This is a spontaneous report from a contactable other healthcare professional (patient) via medical information team. A female patient (who was a respiratory therapist) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via subcutaneous, administered in Arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 for covid-19 immunisation. Patient was a respiratory therapist and she stated that she had a second dose of vaccination on Saturday, and she know the instructions that it supposed to be given into the muscle, the deltoid muscle, intramuscularly, unfortunately when she got her second dose the vaccinator, the nurse giving the vaccine she squeezed to get soft tissue of her upper arm and injected the COVID vaccine subcutaneously and it did not go into the muscle. Patient was not worried about her arm, but what she worried about was the fact that the protection from the vaccine, comes from the vaccine going into the muscle which was highly vascularized, if her vaccine just went in to the fatty adipose tissue of the upper arm and not into the muscle would patient be still getting any protection from the second dose of the vaccine. Patient said that thousands and thousands of people had been received the vaccine incorrectly. She was concerned about one person in particular who had inadvertently received the vaccine subcutaneously instead of intramuscularly. She said that the person she was concerned about had been locked up for a year and now that he had taken the vaccine, he had a chance to go out but because of the AE, she was afraid the person may still be locked up. Patient also mentioned that this person had developed fatigue and chills after getting the vaccine. The person also had a lump in the arm. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: nausea; Threw up; felt tired and 'washed out'; This is a spontaneous report from a contactable Consumer (patient reported for himself). The 70-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot No: EN6201 expiry date: unknown) via an unspecified route of administration in left arm on 20Feb2021 12:00 PM, as a single dose for Covid-19 Immunization. The patient did not have any medical history or known allergies. He was not on any concomitant medications in two weeks. The patient did not receive other vaccine in four weeks of suspect. He was not having covid prior vaccination and was not tested post vaccination. On 28Feb2021 04:00 PM on Sunday, (7 days after 1st vaccine dose), the patient developed nausea threw up that day, felt tired and 'washed out' the day after and not a lot better on the day of this report. The patient did not receive any treatment for events. The outcome of the events was resolving.   No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: feeling light-headed/this morning feeling dizzy; shooting headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 01Mar2021 as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was feeling light-headed and shooting headache. Patient reported that feeling light-headed on the short drive home, patient slept great last night then woke up this morning as feeling dizzy and every now and then a shooting headache. Outcome of the events was unknown. It was reported that patient was also on an extremely low carb diet as she doesn't eat more than 40 a day, patient means assuming grams of carbohydrates.  No follow-up attempts were possible. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Parosmia, Taste disorder
Clinical narrative: change in my sense of smell; Change in sense of smell and taste; This is a spontaneous report from a Pfizer sponsored program. A 34-year-old contactable other healthcare professional, male consumer (patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3302) intramuscularly into the left arm on 14Jan2021 09:30 AM (at the age of 34-year-old) as single dose for COVID-19 immunisation. The patient medical history included that the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products, penicillin. Concomitant medications were not reported. On 15Jan2021, the next day, the patient noticed a change in his sense of smell, particularly in-regards to tap water. Not sure if it actually was vaccine related or not, but he was curious if there have been any other complaints of this, as well as looking to share the information to help further the knowledge of how the vaccine effects different patients. Change in sense of smell and taste beginning day after first dose of vaccine. Decrease in ability to smell and most things that he can still smell had a very foul smell. He would describe the smell as a corrosive metallic smell. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatments received for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine nor any other medications received within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, he has been tested for COVID-19. Outcome was not resolved for both the events.  Follow up #1 (02Mar2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included reporter contact address updated.  Follow up #2 (07Apr2021): This is a follow up-spontaneous report from a contactable other healthcare professional consumer. This other HCP consumer (patient) reported in response to HCP letter via follow-up letter which included age at vaccination (34 years), race and ethnicity information, vaccine details, reported events, relevant medical history, lab data and clinical course of events.  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Bowel movement irregularity, Myalgia, Nausea
Clinical narrative: Abdominal and lower back pain; Abdominal and lower back pain/Major back and muscle pain; felt like a bowel movement that wouldn't happen; Constant feeling of having to pee, and very little urine; Constant feeling of having to pee, and very little urine; Nausea; Major back and muscle pain; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 27Feb2021 10:00 (Lot Number: EN6198, expiration date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported (as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. On 28Feb2021, 01:00, the patient experienced major back and muscle pain, abdominal and lower back pain, and felt like a bowel movement that wouldn't happen, had constant feeling of having to pee, and very little urine and had nausea. The patient recovered. No treatment for any events. Outcome for all events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Urine output, Urine output decreased
Clinical narrative: Abdominal and lower back pain; Abdominal and lower back pain/Major back and muscle pain; felt like a bowel movement that wouldn't happen; Constant feeling of having to pee, and very little urine; Constant feeling of having to pee, and very little urine; Nausea; Major back and muscle pain; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 27Feb2021 10:00 (Lot Number: EN6198, expiration date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported (as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. On 28Feb2021, 01:00, the patient experienced major back and muscle pain, abdominal and lower back pain, and felt like a bowel movement that wouldn't happen, had constant feeling of having to pee, and very little urine and had nausea. The patient recovered. No treatment for any events. Outcome for all events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.