chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral nerve neurostimulation, Postmenopausal haemorrhage
Clinical narrative: Heavy vaginal bleeding one year post menopause. It lasted about 2.5 days, but not sure if this will reoccur or not.; This is a spontaneous report from a contactable consumer and other HCP. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534 and Expiration date was not reported) via an unspecified route of administration, administered in Arm Right, on 01Apr2021 at 12:45 (at the age of 52-year-old), as single dose for COVID-19 immunisation. The patient medical history included thyroidectomy from 2006 to an unknown stop date, hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOXYL); ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL), probiotics, vit c (ASCORBIC ACID), vit d (ERGOCALCIFEROL), valtrex (VALACICLOVIR HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in right arm, on 09Mar2021 at 12:30 PM (at the age of 52-year-old), as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not allergic to medications, food, or other products. On 10Apr2021, the patient had experienced heavy vaginal bleeding one year post menopause. it lasted about 2.5 days, but not sure if this will reoccur or not. The patient visited the physician office. The patient underwent lab tests and procedures which included peripheral nerve neurostimulation was normal on 13Apr2021. The outcome of the event was reported as unknown. It was reported that the Pfizer product had no causal effect to the adverse event.  Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: My headfeels like a truck hit it; nothing worst then having a badflu type of thing; This is a spontaneous report from a contactable consumer or non health care professional (Patient). This is a report received from a Pfizer sponsored program. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient mentioned that the first shot was really easy but the second one that one was a doosy. He was kind of still reeling from that one a little bit. His head felt like a truck hit it. The day of the second shot was not too bad but the day after was really bad. The patient heard that it was very common the second shot gives you a bad reaction, nothing worst then having a bad flu type of thing. It was not pleasant but the outcome was what we are all going after. The outcome of events was unknown.  No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: It hurts to sleep on that arm; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received crizotinib (XALKORI) at 250 mg, with frequency, route of administration, therapy dates and indication unspecified; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was hurting to sleep on the arm. The action taken in response to the event for crizotinib was unknown. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fall, Feeling abnormal, Pain
Clinical narrative: itching from the neck to the waist; shaking terribly; sinuses were so plugged that could hardly breathe; keeps falling down; fuzzy headed; terrible pain; Caller received the first dose of the Covid vaccine on 19MAR2021. On 27MAR2021, caller tested positive for the Covid virus; This is a spontaneous report from a contactable other HCP (patient). This other HCP reported for herself that a 74-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 3R2613; expiry date: unspecified), via an unspecified route of administration on 19Mar2021 as 0.3ML single dose for COVID-19 immunisation. The patient had neurological problems and has trouble with holding conversations and therefore writes things down. Concomitant medications were not reported. Caller received the first dose of the Covid vaccine on 19Mar2021. On 27Mar2021, the patient tested positive for the Covid virus and was presenting many symptoms. She would like to tell that she did not have problems in the lungs. After caller's Covid-19 diagnosis, she reports that she was "not in her right mind and her head felt like it was going to explode." She explains that she had itching from the neck to the waist, pain in the head, she was shaking terribly, her head was so bad with pain that she was coughing about bringing stuff up, the stuff coming up was tenacious and coloured stuff, the colour varied from clear to brown. Her head hurt and the temperature was elevated by 3 degrees, she seldom ever has a temperature. Her sinuses were so plugged that she could hardly breathe (her glands were so swollen that she has trouble swallowing), she was sneezing so bad having trouble breathing. She keeps falling down. She doesn't know what to do for the next vaccine, she wants to know when was it okay to get the second dose, she keeps falling down. She wants to know when it safe to get the vaccine. She was experiencing fuzzy headed and in terrible pain. She had diarrhoea, then vomiting that's why she can't take anything (including her medicines), now she was so shaky and falls and has trouble writing. The patient did not receive the second vaccine due to her illness and concern for becoming more ill. She had heard she must wait 30 days after having the Covid virus to receive the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Sinusitis, Tremor
Clinical narrative: itching from the neck to the waist; shaking terribly; sinuses were so plugged that could hardly breathe; keeps falling down; fuzzy headed; terrible pain; Caller received the first dose of the Covid vaccine on 19MAR2021. On 27MAR2021, caller tested positive for the Covid virus; This is a spontaneous report from a contactable other HCP (patient). This other HCP reported for herself that a 74-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 3R2613; expiry date: unspecified), via an unspecified route of administration on 19Mar2021 as 0.3ML single dose for COVID-19 immunisation. The patient had neurological problems and has trouble with holding conversations and therefore writes things down. Concomitant medications were not reported. Caller received the first dose of the Covid vaccine on 19Mar2021. On 27Mar2021, the patient tested positive for the Covid virus and was presenting many symptoms. She would like to tell that she did not have problems in the lungs. After caller's Covid-19 diagnosis, she reports that she was "not in her right mind and her head felt like it was going to explode." She explains that she had itching from the neck to the waist, pain in the head, she was shaking terribly, her head was so bad with pain that she was coughing about bringing stuff up, the stuff coming up was tenacious and coloured stuff, the colour varied from clear to brown. Her head hurt and the temperature was elevated by 3 degrees, she seldom ever has a temperature. Her sinuses were so plugged that she could hardly breathe (her glands were so swollen that she has trouble swallowing), she was sneezing so bad having trouble breathing. She keeps falling down. She doesn't know what to do for the next vaccine, she wants to know when was it okay to get the second dose, she keeps falling down. She wants to know when it safe to get the vaccine. She was experiencing fuzzy headed and in terrible pain. She had diarrhoea, then vomiting that's why she can't take anything (including her medicines), now she was so shaky and falls and has trouble writing. The patient did not receive the second vaccine due to her illness and concern for becoming more ill. She had heard she must wait 30 days after having the Covid virus to receive the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her disabled daughter (50 year old, female) also received the first vaccine at the same time she did. Her daughter also experienced the Covid virus when she did as well.; her disabled daughter (50 year old, female) also received the first vaccine at the same time she did. Her daughter also experienced the Covid virus when she did as well.; This is a spontaneous report from a contactable Other health care professional (HCP) (patient mother). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. Medical history included disabled. The patients concomitant medications were not reported. Patient stated that her disabled daughter also received the first vaccine at the same time she did on 19Mar2021. Her daughter also experienced the Covid virus when she did as well on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: experienced the covid virus on an unspecified date. The outcome of the events were unknown.   No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal chest pain, Neck pain
Clinical narrative: 1st dose- severe ache in neck back & rib case; 1st dose- severe ache in neck/ back & rib case; 1st dose- severe ache in neck/ back & rib case; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 13:15 (at age of 46-year-old) as single dose for covid-19 immunisation. Medical history included Environmental asthma, and Allergies to cat, horse, smoke and pollen from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient did not take concomitant medications (patient did not receive any medication prior two weeks of vaccination). Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 13:15 as single dose for covid-19 immunisation and experienced fuse excruciating ache and pain in left elbow wrist and fingers. Patient was not received any other vaccine prior four weeks of vaccination. The patient experienced 1st dose- severe ache in neck, back and rib case on 15Apr2021 at 14:00. Since vaccination patient not tested for covid-19. Patient visited to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care for the events. Therapeutic measures were taken as a result of the events, treated with poison ivy Cortisone oral. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Dyspnoea, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; shortness of breath; Cough; tested positive for Covid; This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Batch/Lot Number: ER8727) intramuscular, administered in Arm Left on 02Mar2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension (ongoing). The patient concomitant medications were not reported. The caller states his mom and dad got the first Covid shot, they were due to get second shot today but caller cancelled the appointment, states his mom and dad both hospitalized and tested positive for the Covid virus after the vaccines. Caller states his dad is still in quarantine and mom is done with quarantine, he is hearing different things about when to get the second dose, everyone says to wait 90 days, getting mixed information, then he has heard 3 weeks is long enough to wait. Caller wants to know when his mom and dad can get the second dose of the vaccine after having the Covid infection. The mother got the first dose of the vaccine on 02Mar2021, states on 31Mar2021, she tested positive, caller clarifies his mother was not admitted to the hospital but was seen in the emergency room on 10APR2021 and released later that evening, his mother was told to follow up with the respiratory pulmonologist and remote patient monitoring, been taking oxygen saturations levels with pulse oximeter, shortness of breath and cough on 10Apr2021. The patient visits to emergency room on 10Apr2021. The patient tested positive post vaccination. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, other medications in two weeks and other vaccine in four weeks. The patient received unknown treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. The outcome of the event tested positive for Covid was unknown and rest events outcome was not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthropathy, Ear infection, Fatigue, Myalgia
Clinical narrative: muscular pain; anxiety problems; just came home and slept; can't even hardly write with my right hand because I cant bend my little; sinus infection; ear infections; rhinitis; but I couldn't turn my head because my neck became so sore on the left side where I got your shot; very tired; This is a spontaneous report from a Pfizer. A contactable consumer (patient herself) reported a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included back surgery, Celiac disease ongoing, fibromyalgia and Panic attacks. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and venlafaxine hcl. On an unspecified date patient stated that "she tried a bunch of the generics and she wasn't able to take them." She have panic attacks and she forgot what they call it GAD she guess they call it, anxiety problems of course things have been worse now with everything that's happens but she don't want to use that as an excuse. And she stated that now she is disabled with back surgery. Patient also shared "she has to tell you that she had the shots for the COVID and she 've had such muscular pain of course she have fibromyalgia, Celiac disease. Patient stated that she can't even hardly write with her right hand because she cant bend her little finger. Its been weird she is starting to feel better but she couldn't turn her head because her neck became so sore on the left side where she got the shot so she is trying to blame it all on the shot but she is just thinking she can live with this stuff because she won't have to be put in the hospital if she got COVID." Patient expressed how when after got shot just came home and slept patient also shared how "her immune system kind of depleted and doesn't work with things. The first shot it brought on a horrible sinus infection and ear infections. Second time it was just the (inaudible) achiness. Patient shared that tried at least 3 generics but couldn't remember the names and couldn't take any of them. Also has allergy problems rhinitis and sinusitis and doctor thinks immune system went into over drive after the vaccine. Patient also shared how very tired after the vaccine how couldn't even keep eyes open. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rhinitis, Sinusitis, Somnolence
Clinical narrative: muscular pain; anxiety problems; just came home and slept; can't even hardly write with my right hand because I cant bend my little; sinus infection; ear infections; rhinitis; but I couldn't turn my head because my neck became so sore on the left side where I got your shot; very tired; This is a spontaneous report from a Pfizer. A contactable consumer (patient herself) reported a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included back surgery, Celiac disease ongoing, fibromyalgia and Panic attacks. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) and venlafaxine hcl. On an unspecified date patient stated that "she tried a bunch of the generics and she wasn't able to take them." She have panic attacks and she forgot what they call it GAD she guess they call it, anxiety problems of course things have been worse now with everything that's happens but she don't want to use that as an excuse. And she stated that now she is disabled with back surgery. Patient also shared "she has to tell you that she had the shots for the COVID and she 've had such muscular pain of course she have fibromyalgia, Celiac disease. Patient stated that she can't even hardly write with her right hand because she cant bend her little finger. Its been weird she is starting to feel better but she couldn't turn her head because her neck became so sore on the left side where she got the shot so she is trying to blame it all on the shot but she is just thinking she can live with this stuff because she won't have to be put in the hospital if she got COVID." Patient expressed how when after got shot just came home and slept patient also shared how "her immune system kind of depleted and doesn't work with things. The first shot it brought on a horrible sinus infection and ear infections. Second time it was just the (inaudible) achiness. Patient shared that tried at least 3 generics but couldn't remember the names and couldn't take any of them. Also has allergy problems rhinitis and sinusitis and doctor thinks immune system went into over drive after the vaccine. Patient also shared how very tired after the vaccine how couldn't even keep eyes open. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted covid a couple days later; This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced contracted COVID a couple of days later. The event outcome was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Illness
Clinical narrative: breathing got bad; became sick and was not able to make 2nd Pfizer shot; This is a spontaneous report from a contactable consumer (patient's husband) from a Regulatory Authority CEP 159558.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date (reported 3 weeks ago) as dose 1, single for COVID-19 immunization. Medical history included emphysema. Concomitant medications were not reported. On an unspecified date after first dose, patient became sick and was not able to make 2nd Pfizer shot yesterday (date unspecified), because her breathing got bad due to her emphysema. Patient doctor had prescribed her a 6-day course of steroids that she has now taken for 2 days. It was not reported if the patient visited physician office. The events were reported as non-serious. Reporter would like to know if this will effect the shot, when can patient get her 2nd shot, how long does the vaccine last and how long patient needed to wait after finishing the steroids before taking the next dose of the vaccine. The 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, Heart rate increased, Hypoaesthesia, Lip swelling, Throat tightness
Clinical narrative: She had a raise in her heart rate; Lips got swollen; Her legs felt like they were sleepy for 4 days; Throat felt tight; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she had a raise in her heart rate, lips got swollen, her legs felt like they were sleepy for 4 days, throat felt tight. The patient underwent lab tests and procedures which included heart rate raise on unspecified date. The outcome of the events heart rate increased lip swelling, hypoaesthesia, throat tightness was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had received her first shot Pfizer vaccine on 25Mar2021 and then she tested positive for COVID on 01Apr2021 and then she was supposed to get her second shot the 15th which was Thursday, last Thursday (as reported) and she was unsure of, how if she had to get it or what was the current timeline on that and she could not really find information out there for people who gotten it in between and not people who would gotten it and then are trying to receive the first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug Ineffective; Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Mar2021, as single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the caller and her husband (patient) had their 1st dose on 29Mar2021 and were supposed to return on 19Apr2021, however, they were tested positive for Covid-19 virus on the same day, so they were not able to receive the 2nd shot. On 19Apr2021, the patient underwent lab tests and procedures which included covid-19 virus test (sars-cov-2 test) which showed positive result. The caller was asking how to set up an appointment for their second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455009
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Malaise, SARS-CoV-2 test
Clinical narrative: he had COVID and he just found out a week later after he received the 1st dose; he had bad chills; didn't feel good; This is a spontaneous report from contactable consumer (patient) from a male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date was not provided) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On unspecified date, patient had COVID and he just found out a week later after he received the 1st dose and he had bad chills the night after and didn't feel good. On unspecified date, patient had COVID test and result was positive. Patient was due for the 2nd dose on 13Apr2021 and wants to know if can get it right away or needs to wait for days or weeks before getting it. The outcome of events was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure increased, Blood pressure measurement
Clinical narrative: anatomical location on 31Mar2021 (age at vaccination was 68 years) as dose 1, single for COVID-19 immunization. Medical history included stent placement, clogged arteries and allergies. Concomitant medications were not reported. The caller stated that she went to the Vaccination Center on 31Mar2021, she signed up for J&J vaccine, because she had allergies and the day she went, that was the day they shut down the J&J vaccine. So they offered her Pfizer, they asked her about allergies, she had epi pens, no incident other than blood pressure going up a little bit. The caller received first dose of vaccine on 31Mar2021 and then denied second dose on 21Apr2021. The caller was questioning possible medical error. The caller stated that she was scheduled to go back on 21Apr2021, she went they would not give her the vaccine. They stated that she can expect 3 x worse than the first dose and said, they were not prepared to deal with medical emergencies. She showed her epi pens, she followed her allergist directions, because she had two weeks before getting the first dose, she had stents put in, she had clogged arteries. She saw her cardiologist as well. Sent her for angiogram and when she went for it, they just put in two stents, they were stents that release medications. She told him she had an appointment for vaccine, he said to get the vaccine after the stents. She still thinks, she does not know what was inside her, she did not understand they would walk her out of place that big. She spoke to supervisor and the answer was she was just going to get one vaccine and just have to accept that. The caller has not received her second dose of the COVID-19 vaccine yet. She received her first dose last 31Mar2021. She has the vaccination card with the date of her second dose which was last 21Apr2021. She mentioned later on the call that she thinks she may have received a Johnson & Johnson vaccine and not the Pfizer Covid19 vaccine that's why she was not given a second dose due to her name not listed on their file. The patient underwent lab tests which included angiogram: unknown result on an unspecified date and blood pressure measurement: going up a little bit on 31Mar2021. Therapeutic measures were taken as a result of blood pressure going up a little bit. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, SARS-CoV-2 test
Clinical narrative: anatomical location on 31Mar2021 (age at vaccination was 68 years) as dose 1, single for COVID-19 immunization. Medical history included stent placement, clogged arteries and allergies. Concomitant medications were not reported. The caller stated that she went to the Vaccination Center on 31Mar2021, she signed up for J&J vaccine, because she had allergies and the day she went, that was the day they shut down the J&J vaccine. So they offered her Pfizer, they asked her about allergies, she had epi pens, no incident other than blood pressure going up a little bit. The caller received first dose of vaccine on 31Mar2021 and then denied second dose on 21Apr2021. The caller was questioning possible medical error. The caller stated that she was scheduled to go back on 21Apr2021, she went they would not give her the vaccine. They stated that she can expect 3 x worse than the first dose and said, they were not prepared to deal with medical emergencies. She showed her epi pens, she followed her allergist directions, because she had two weeks before getting the first dose, she had stents put in, she had clogged arteries. She saw her cardiologist as well. Sent her for angiogram and when she went for it, they just put in two stents, they were stents that release medications. She told him she had an appointment for vaccine, he said to get the vaccine after the stents. She still thinks, she does not know what was inside her, she did not understand they would walk her out of place that big. She spoke to supervisor and the answer was she was just going to get one vaccine and just have to accept that. The caller has not received her second dose of the COVID-19 vaccine yet. She received her first dose last 31Mar2021. She has the vaccination card with the date of her second dose which was last 21Apr2021. She mentioned later on the call that she thinks she may have received a Johnson & Johnson vaccine and not the Pfizer Covid19 vaccine that's why she was not given a second dose due to her name not listed on their file. The patient underwent lab tests which included angiogram: unknown result on an unspecified date and blood pressure measurement: going up a little bit on 31Mar2021. Therapeutic measures were taken as a result of blood pressure going up a little bit. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Illness, Insomnia
Clinical narrative: feeling achy; tired; headache; bad diarrhea; fever; sick; Extreme lethargy; can't sleep; rash; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 09:15 (Lot Number: EN6206) at age of 69-years-old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High blood pressure, high blood sugar, high cholesterol. Concomitant medications included rosuvastatin calcium (CRESTOR); levothyroxine; hydrochlorothiazide, olmesartan medoxomil (OLMESARTANA + HIDROCLOROTIAZIDA).  The patient previously took codeine and experienced drug hypersensitivity.  The patient experienced feeling achy, tired, headache, bad diarrhea, fever, sick, extreme lethargy, can't sleep, rash on 06Mar2021 03:00 with outcome of recovered with sequelae.  The patient received Pepto-Bismol. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia, Rash
Clinical narrative: feeling achy; tired; headache; bad diarrhea; fever; sick; Extreme lethargy; can't sleep; rash; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 09:15 (Lot Number: EN6206) at age of 69-years-old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High blood pressure, high blood sugar, high cholesterol. Concomitant medications included rosuvastatin calcium (CRESTOR); levothyroxine; hydrochlorothiazide, olmesartan medoxomil (OLMESARTANA + HIDROCLOROTIAZIDA).  The patient previously took codeine and experienced drug hypersensitivity.  The patient experienced feeling achy, tired, headache, bad diarrhea, fever, sick, extreme lethargy, can't sleep, rash on 06Mar2021 03:00 with outcome of recovered with sequelae.  The patient received Pepto-Bismol. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Felt a little bit dizzy; Felt pain going down arm into hand after Covid-19 vaccine injection; Covid-19 vaccine injection pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0164; Expiration date: unknown) via an unspecified route of administration on 23Apr2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any history and other Products. The caller reported that she and her daughter (patient) received the COVID-19 vaccine on 23Apr2021 and on same day caller reported that the patient experienced injection pain and felt a little bit dizzy within the first 15 minutes following the injection of the COVID-19 vaccine. Caller reported that the patient felt a pain going down her arm into her hand. Caller reported that the patient described the pain like a zing type of sensation. It was reported that both she and the patient were tested for COVID-19. Caller reported that the patient tested negative. She reported that she and the patient were going to get retested for COVID-19 today on 27Apr2021. Caller self-reported on adverse events. Caller had an MI inquiry, addressed on website and stated that her daughter was being a pill. The patient underwent lab tests and procedures which included SARS-COV-2 test which was negative on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Premenstrual syndrome
Clinical narrative: PMS; stomach pain; This is a spontaneous report from a Pfizer from a contactable consumer  reported for a female patient. A female patient of unknown age received BNT162B2 (Pfizer BionTech Covid-19 Vaccine, Solution for Injection, Lot number and expiration date: Not reported), via an unspecified route on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced PMS or stomach pain since she got the vaccine. wanted to know if there is any documentation of this side effect and what to do. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose decreased, Chest discomfort, Chills
Clinical narrative: Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Disorientation, Dizziness, Ear pain
Clinical narrative: Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered.  No follow-up attempts are possible. No further information is expected.