chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling, Skin irritation
Clinical narrative: arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain in extremity, Peripheral swelling
Clinical narrative: arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Magnetic resonance imaging, Sinus polyp, Tinnitus
Clinical narrative: a polyp in the sinuses; His ears started ringing but one ear was like the siren like it was almost unbearable; it was just ringing like a Siren going off in his ear;  got the second one and it came back full force again; He got something going on with his brain; This is a spontaneous report from a contactable consumer (patient's wife). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 at 11:30 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 11:30 (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as single dose for covid-19 immunization. The patients medical history was not reported. The patients concomitant medications were not reported. On an unspecified date in 2021 the patient experienced he got something going on with his brain, his ears started ringing but one ear was like the siren like it was almost unbearable; it was just ringing like a siren going off in his ear; got the second one and it came back full force again. The patient experienced both thing few days after he received both the first and the second vaccine. No other vaccine was administered. The patient was not still experiencing adverse events. The patient went and got an MRI because he got something going on with his brain and went to a neurologist but now it was gone, it went away. He just had a polyp in the sinuses but not any polyps in the sinuses on an unknown date in May2021. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown on an unknown date in May2021. The outcome of event polyp in the sinuses was unknown, the outcome of other events was recovered on an unknown date in 2021.  Information on Lot/Batch number is available; Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: After the first shot had mild hot flash like symptoms; soreness at injection site; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 36-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 30Apr2021 09:00 (age at vaccination: 36-year-old) as first dose, single for covid-19 immunization. (Vaccination facility). Patient had no Medical history. The patient concomitant medications were not reported. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was not diagnosed with COVID-19. It was reported that After the first shot patient experienced mild hot flash like symptoms and soreness at injection site. Since the vaccination, patient has been not tested for COVID-19. outcome for the events was reported as unknown.   No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: joint discomfort; Swelling joint, fingers, feet and knee; Swelling joint, fingers, feet and knee; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date (NDC/UPC number: Unknown, Expiry date: Unknown) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for Covid-19 immunization. On an unspecified date, the patient experienced joint discomfort, swelling of hands and swelling joint, fingers, feet and knee. Consumer stated, "got the 2nd Pfizer Shot (unspecified medication) last Saturday, had joint discomfort and swelling in the hands. Reporter wanted to know whether it was a normal side effect". Reporter seriousness for the events was reported as unspecified. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable consumer (patient himself).   A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0187), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unknown date after receiving second dose of the Pfizer vaccine (reported as on Friday), the patient experienced nosebleed and since then he has three (times) nosebleed and want to know if there are any reports of that being a possible side effect from the people. After he had his first dose about a week later, he had 2 times nosebleed, so he doesn't know if this is the side effect from the vaccine. The outcome of the event was unknown.  Follow up attempts are needed. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer via Pfizer. (The consumer, Grand mother who is also a patient reported for her grand son).  A male of an unspecified age, received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Reason for no lot number of Pfizer vaccine: Caller unwilling to complete the report. The patient medical history and concomitant medications were not Provided. Patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date for covid-19 immunisation. While the reporter was reporting on her own symptoms after the Pfizer COVID-19 vaccine, she mentioned that her grand kids had pain after the second shot as well, and had the Pfizer vaccine. The reporter confirmed that her grandson experienced joint pain. She just keeps telling her grandson(patient), that they got spoiled with the first one. Declined to complete report (Unspecified information), stated that she was sure he did it at his job. Reporter seriousness for the Joint pain was unspecified. Outcome of the event was unknown.  Information about lot/batch number is requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021690717 Same reporter/drug, different AE/ patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Woke up in a lot of pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing fibromyalgia. The patient concomitant medications were not reported. The patient reported that two weeks ago (from the day of the report) she got the Pfizer Covid-19 vaccine shot, no exact date provided, and for about a week she did not have any side effects, but on 01Jun2021, she woke up in a lot of pain, has not improved and it has been 10 days. The patient said that she does have fibromyalgia, which was a pain disorder, was feeling quite well before she got the vaccine. The patient stated she was going to go see a doctor for the second time tomorrow. The patient also said that she feels like she had a bad case of the flu, took a lot of courage to get the vaccine, was so happy not to have side effects until now (as reported). The outcome of the event was not recovered.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: My body is like blowing up like a balloon, like my dad used to take cortisone and prednisone his body will blow up; sometimes people who take contraception or birth control their body blows up; arm was swollen; The only normal side-effect I got in the area they shot it, I had little bit of pain for few days; This is a spontaneous report from a contactable consumer (patient). This is the first case out of two cases in which the reporter is reporting for himself.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient's body was like blowing up like a balloon and in the area, they shot it had little bit of pain for few days. Clinical course included: consumer stated that patient took the vaccine probably about a week or two ago (05Jun2021) and all of a sudden body seems to be like blowing up. Now, patient was not eating an overly amount, anything out of ordinary, but everything was getting tight on patient and cannot figure out why, except that the only difference was that the patient took the vaccine. It does not hurt or anything but wanted to know, was that a possible side effect, so it's more like body getting swelling. Like patient's dad took prednisone or cortisone and his body blew up and like sometimes women who takes contracepts or whatever, birth control, it happens to them too. So, patient do not understand like patient was trying to figure out why was patient body, why pants are getting tighter. Why did patient felt like body was getting swollen like blowing up and wanted to know if that was a possible side effect. The patient's arm was swollen and that was it, patient felt fine, but pants kept getting tighter and tighter (like way more tighter than usual and thinking of rest of the body, all clothes, why it was tightening) and felt like blowing up like a balloon and cannot figure it out, it was not like that patient eating any differently, patient just cannot figure it out. So, patient was just asking, was that a possible side effect that will go away. The only normal side-effect the patient got in the area they shot it, patient had little bit of pain for few days, but it was not all of this, so cannot understand why patient body was blowing up. The patient second dose was on the 26Jun2021. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Joint discomfort; Swelling of hands; Swelling joint, fingers, feet and knee; Swelling joint, fingers, feet and knee; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date patient experienced joint discomfort, swelling in the hands and swelling joint, fingers, feet and knee. Patient asked if that is a normal side effect. Patient was informed about the Pfizer medical department. Patient said she will call them and now just concern about her husband side effects. The outcome of the events was unknown.  Follow-up attempts are possible. Further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypersomnia
Clinical narrative: Yesterday she slept for 36 hours; her head was just killing her; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 11Jun2021 15:40 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at clinic (61-years-old at the time of vaccination). The patient medical history concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. It was reported that, she had her second Pfizer shot on Friday(11Jun2021) and at night she had such a bad headache, yesterday (12Jun2021) she slept for 36 hours and her head was just killing her. She did not knew was that normal or not. Consumer was informed about the Pfizer medical information department. The clinical outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: Second (which was today), now my throat is really hurting. I was fine prior to injection/I really am not seeing that sore throat is a symptom only "flu like"; Flu like; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 12Jun2021 12:00 (at the time of 48-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included, migraine, arthritis, fibromyalgia (chronic pain), known allergies: Latex from an unknown date and unknown if ongoing. The patient's concomitant medications were none reported (other medications in two weeks No). The patient previously received first dose of BNT162B2 on 22May2021 for COVID-19 Immunization and experienced severe headache. Patient was not pregnant at the time of vaccination. The patient previously received theophylline, Flexeril, bactrim DS and experienced drug hypersensitivity, flexeril [cefixime] and experienced drug hypersensitivity, bactrim DS, minocycline and codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient stated ''On 12Jun2021 14:30 (which was today), now my throat is really hurting. I was fine prior to injection. I was really not seeing that sore throat was a symptom only flu like'' Patient took Advil, been drinking hot tea. Therapeutic measures were taken as a result of ''second (which was today), now my throat is really hurting. I was fine prior to injection, flu like'' The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear pain, Ear swelling, Illness
Clinical narrative: They are very ill today; Swelling behind his ear; They are both very sore; Dizziness; Fever; Chills; This is a spontaneous report received from a contactable consumer or other non-health acre professional. A patient of unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Jun2021 14:00 as 2 nd dose single for COVID-19 immunization. The patient previously received first 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 1 st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced  very ill, swelling behind his ear, very sore, dizziness, fever and chills on 12Jun2021. The outcome of event was unknown.  Reporter was informed about Pfizer Medical Information Department and provided with the number.  Limited information was available over the call as reporter hung up abruptly. Hence, product details (NDC#, UPC#, LOT# and expiration date) and further details are unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Swelling
Clinical narrative: They are very ill today; Swelling behind his ear; They are both very sore; Dizziness; Fever; Chills; This is a spontaneous report received from a contactable consumer or other non-health acre professional. A patient of unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Jun2021 14:00 as 2 nd dose single for COVID-19 immunization. The patient previously received first 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 1 st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced  very ill, swelling behind his ear, very sore, dizziness, fever and chills on 12Jun2021. The outcome of event was unknown.  Reporter was informed about Pfizer Medical Information Department and provided with the number.  Limited information was available over the call as reporter hung up abruptly. Hence, product details (NDC#, UPC#, LOT# and expiration date) and further details are unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: just a fever for one day; This is a spontaneous report from a contactable consumer. This Consumer reported for a patient (reporters' husband) that: A male patient of an unspecified age received 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 as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just a fever for one day on unspecified date in 2021. The outcome of the event was reported as recovered on unspecified date in 2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: mild pain after first shot, as soon as she got the shot, she kept exercising her arm; mild pain after first shot; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration in left arm, high up in arm on 03May2021 around 10:30 or 11:00 (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes (under control, under 7), high blood pressure and knee surgery (her knees have been bad, so she is going for steroids. So many of her friends and relatives had knee surgery and it was botched so, she has continued with the shots and her knees hurt so bad), thyroid condition, blood pressure abnormal, chronic back condition from car accident, depression and she doesn't have a lot of energy. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride, manganese ascorbate (COSAMIN) taken for joint health, for her knees and it doesn't work right away, have to keep taking it. Has been taking a while and starts and stops taking it when she needs to, hydrocodone taken for chronic back condition from car accident and started quite a few years ago. Only takes a half of one, depending on the rate of pain. It was powerful stuff. Gets the prescription from the pain doctor and was monitored, sitagliptin (JANUVIA) taken for diabetes mellitus and has not been taking that long. Was on Metformin for two years. Has been taking maybe 6 months, just refilled the second time, and it was every 3 months, metoprolol taken for blood pressure abnormal and has been taking quite a while, about 10 years, maybe not that long, so 5 years, vitamins nos (MULTIVITAMINS), curcuma longa (TURMERIC), ascorbic acid (VITAMIN C), fish oil (OMEGA-3 FISH OIL) and still ongoing, cyanocobalamin (B12 ) taken for thyroid condition and sometimes, the doctor gives her a shot that has multivitamin and B12, gives her a boost. Patient takes vitamins for depression and she doesn't have a lot of energy because of her thyroid condition, she was on B12. Patient has blood work every 3 months for diabetes and have been normal. The patient did not receive any vaccine, within 4 weeks prior vaccinations and not had any vaccines in a while, at least 6 months. On 03May2021, the patient experienced mild pain after first shot, it was awful. As soon as she got the shot, she kept exercising her arm. With the first one, she just kept putting ice on it when it hurt, then it went away. Events did not result in emergency room or physician office. The outcome of the event mild pain after first shot was unknown, rest of the event was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Illness, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. This is second case out of two split cases. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 11Jun2021 (reported as yesterday) at around 14:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jun2021, after the second shot, the patient was very ill today (as reported), had dizziness, very sore, fever and chills. Reporter inquired that patient cab be given with Aspirin or something for the events. The outcome of all the events was unknown. Information about batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Diarrhoea, Dizziness, Nausea
Clinical narrative: Nauseous for about a week; two days later I started getting nauseated; Light-headed feeling; Upset stomach; Loose stools; It seems to have either caused or brought back some anxiety issues; This is a spontaneous report from a contactable consumer (patient, reported herself) or other Non-health care professional.  A 59-years-old female patient received BNT162B2(CONMINTARY, Solution for injection, Lot No: EW0185), via an unspecified route of administration, administered in left arm (It was in the left upper forearm) on 26May2021 12:15 (pretty sure it was like early part of afternoon) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks patient had not received any other vaccines not event for flu or anything. On 27May2021 patient experienced light-headed feeling, and on 28May2021 she was nauseous for about a week; two days later i started getting nauseated, on unspecified date in May2021 patient experienced upset stomach everyday since and loose stools, it seems to have either caused or brought back some anxiety issues. Patient was scheduled for second dose on 16Jun2021. Patient had not received any treatment for the events reported. Outcome of the events were not recovered (It just persists everyday).  Information about batch/lot number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Having trouble with pins and needles and tingling in the hand; I started feeling the tingling in my hand and pins and needles and they are all really very sore; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration in Arm Left on 11Jun2021 as dose 2, single for COVID-19 immunization. Medical history included blood pressure measurement and Irregular heartbeat. Concomitant medications included atenolol (ATENOLOL) and  flecainide (FLECAINIDE), 50mg once a day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient reported that it was only 24 hours and on the sheet here was lists some of the side effects. The patient was little bit concerned about her hand the arm they used was the left arm and had trouble with pins and needles and tingling in the hand and they are all really very sore on 11Jun2021. she was wondering if she should be concerned about that or wait another day and to see if it still, if it doesn't go away and then to be concerned about it. It was reported that events were persisting. They haven't got any worse and they haven't gotten any better. It's just about the same. The patient had not yet recovered from the event.  Follow up attempts are needed. Further information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: I am experiencing my worst period; my period is extremely high; I have severe back pain and abdominal got hurt; I am experiencing my worst period; my period is extremely high; I have severe back pain and abdominal got hurt; I am experiencing my worst period; my period is extremely high; I have severe back pain and abdominal got hurt; I am experiencing my worst period; my period is extremely high; I have severe back pain and abdominal got hurt; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0179) via unspecified route of administration in right arm on 21May2021 as single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had no family medical history (all the women in her family had got it so far or and they were like 80s 60s they all had menopause, they didn't have periods anymore). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731) via unspecified route in right arm on 30Apr2021 for COVID-19 immunization. Patient did not receive any prior vaccinations (within 4 weeks). It was reported that the patient got the COVID vaccine (Pfizer Covid-19 Vaccine) about a month ago and she was experiencing her worst period then. Her period was extremely high. She had severe back pain and abdominal got hurt and the only thing thats being in last month was the vaccine. Patient stated, It was on the 10th (10Jun2021), its been 3 days since it started. The patient took Tylenol as treatment. When asked for dose of Tylenol she stated she did not even know, it was, all she knew was 2 Tylenol, she did not even know how many milligrams, she had let her look at out there and stated, so, 500 milligrams sorry 1000 milligrams per day, every 2, every 4 hours to a couple of days. Outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: He is now having a slight fever; the fever is 100.2 , he just threw up in his bed; he is not able to hold anything any food in his stomach; He is now having a slight fever; the fever is 100.2 , he just threw up in his bed; he is not able to hold anything any food in his stomach; He is now having a slight fever; the fever is 100.2 , he just threw up in his bed; he is not able to hold anything any food in his stomach; This is a spontaneous report from a contactable consumer (patient's parent). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that, patient had just got his vaccine dose on Friday (second shot) and on an unspecified date he was having a slight fever, the fever was 100.2, he just threw up in his bed, he was not able to hold anything any food in his stomach. It was enquired when they should take him to the hospital. Patient was laying over on the couch and he has the slight fever, patient's parent was not in the mood to be talking to anyone and parent was enquiring what could be done for child. The outcome of all events was unknown.  Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Vaccination site pain
Clinical narrative: Nausea; Migraines; Usual fatigue; Injection site pain after the second shot; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second 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 06May2021 (at the age of 35-years-old) as a 1ST DOSE, single dose for COVID-19 immunisation. The patient's medical history was not reported, and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced usual fatigue and injection site pain after the second shot. On 16May2021, she experienced nausea and migraines. The consumer reported that "starting on 16May2021 she started experiencing worsen fatigue, nausea and migraines. These have not resolved since. It was further reported that event took place after use of product". The outcome of events usual fatigue, nausea and migraines was not recovered whereas the outcome of event injection site pain after the second shot was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Eye swelling, Mouth swelling
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported difficulty breathing/throat closing and swelling of tongue 10 minutes after getting the vaccine. I immediately gave Epinephrine 0.3 mg injection and a 25 mg benadryl tablet and called 911 immediately. Patient reported feeling better after 10 minutes. Emergency Medical services arrived within 10 minutes. They checked her vitals and all vitals were normal. Patient refused to be taken to ER and the EMT documented her refusal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported difficulty breathing/throat closing and swelling of tongue 10 minutes after getting the vaccine. I immediately gave Epinephrine 0.3 mg injection and a 25 mg benadryl tablet and called 911 immediately. Patient reported feeling better after 10 minutes. Emergency Medical services arrived within 10 minutes. They checked her vitals and all vitals were normal. Patient refused to be taken to ER and the EMT documented her refusal.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest pain, Computerised tomogram kidney, Computerised tomogram thorax
Clinical narrative: I had chest pain, racing heart, high heart rate. I went to the ER where I receive fluids, but no diagnoses. I continue with the symptoms for 2 months intermitting, I was put on a heart monitor for 2 weeks. The results were inconclusive.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Palpitations
Clinical narrative: I had chest pain, racing heart, high heart rate. I went to the ER where I receive fluids, but no diagnoses. I continue with the symptoms for 2 months intermitting, I was put on a heart monitor for 2 weeks. The results were inconclusive.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  After receiving the first dose of Pfizer vaccine, patient experienced tingling to the last two fingers of her right hand. VS include BP 115/69, P 64, O2 100%. Cetirizine 10mg PO administered at 1621.  Before leaving clinic, patient felt comfortable with no additional or worsening symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Cardiac imaging procedure abnormal, Chest X-ray normal, Chest pain, Echocardiogram normal
Clinical narrative: Patient is a previously healthy fully-vaccinated 12 yo presenting with fever and chest pain. He had fevers to 101-102 6/17-6/19 that were responsive to antipyretics, then the chest pain started 6/20 and has been constant 5/10 pain since. It is burning and located substernal/between the scapula. Activity/breathing doesn't worsen the pain, but it is worst at night. He also reports a mild headache today that has since resolved. He went to his PCP today and had an EKG concerning for diffuse precordial ST elevations, so he was referred to the ED with concern for myo/pericarditis.   Of note, Patient received a second dose of the Pfizer COVID vaccine on 6/11.  He also travels every week and has removed ticks from himself that were unattached.  No known bites and no rashes.  He has not had any n/v/d, no abdominal pain, no cough/congestion/rhinorrhea, no syncope, no palpitations.   In the ED, he was well-appearing but tachycardic to the 120s with otherwise normal vitals. He developed fever to Tmax 38.3 that improved with Motrin. On exam he had rash concerning for erythema migrans with multiple satellite lesions. He an EKG with ST elevations in the inferolateral leads. POC US did not show any pericardial effusion. Cardiology was consulted (see consult note) and recommended troponin, which was 1.08, and CRP, which was 7.52.  CXR showed clear lungs and normal cardiac contours.  Hospital Course: Patient was admitted for further workup and management of his perimyocarditis. Given his erythema migrans rash and positive history of recent multiple tick exposure, we were concerned about Lyme disease (Lyme antibody pending) and sent testing for co-infection (Anaplasma, Ehrlichiosis) with smear negative for Babesia. We treated him empirically with doxycycline (given antibiotic allergies) and his rash improved. We also considered myocarditis following COVID vaccination. He had serial EKG's done which showed low-normal function, with EF=55.2%. He had serial troponins sent and they were downtrending at the time of discharge. He had chest pain that improved with PRN ibuprofen. He did not require steroids or IVIG. Cardiac MRI was completed prior to discharge and showed normal function and an area of subepicardial LV myocardial late gadolinium enhancement. consistent with myocarditis. At the time of discharge, he had no chest pain, was eating and drinking normally, and family was in agreement with plan for close Cardiology and Infectious Disease follow-up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation, Erythema migrans, Exposure via direct contact, Headache, Magnetic resonance imaging heart
Clinical narrative: Patient is a previously healthy fully-vaccinated 12 yo presenting with fever and chest pain. He had fevers to 101-102 6/17-6/19 that were responsive to antipyretics, then the chest pain started 6/20 and has been constant 5/10 pain since. It is burning and located substernal/between the scapula. Activity/breathing doesn't worsen the pain, but it is worst at night. He also reports a mild headache today that has since resolved. He went to his PCP today and had an EKG concerning for diffuse precordial ST elevations, so he was referred to the ED with concern for myo/pericarditis.   Of note, Patient received a second dose of the Pfizer COVID vaccine on 6/11.  He also travels every week and has removed ticks from himself that were unattached.  No known bites and no rashes.  He has not had any n/v/d, no abdominal pain, no cough/congestion/rhinorrhea, no syncope, no palpitations.   In the ED, he was well-appearing but tachycardic to the 120s with otherwise normal vitals. He developed fever to Tmax 38.3 that improved with Motrin. On exam he had rash concerning for erythema migrans with multiple satellite lesions. He an EKG with ST elevations in the inferolateral leads. POC US did not show any pericardial effusion. Cardiology was consulted (see consult note) and recommended troponin, which was 1.08, and CRP, which was 7.52.  CXR showed clear lungs and normal cardiac contours.  Hospital Course: Patient was admitted for further workup and management of his perimyocarditis. Given his erythema migrans rash and positive history of recent multiple tick exposure, we were concerned about Lyme disease (Lyme antibody pending) and sent testing for co-infection (Anaplasma, Ehrlichiosis) with smear negative for Babesia. We treated him empirically with doxycycline (given antibiotic allergies) and his rash improved. We also considered myocarditis following COVID vaccination. He had serial EKG's done which showed low-normal function, with EF=55.2%. He had serial troponins sent and they were downtrending at the time of discharge. He had chest pain that improved with PRN ibuprofen. He did not require steroids or IVIG. Cardiac MRI was completed prior to discharge and showed normal function and an area of subepicardial LV myocardial late gadolinium enhancement. consistent with myocarditis. At the time of discharge, he had no chest pain, was eating and drinking normally, and family was in agreement with plan for close Cardiology and Infectious Disease follow-up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Parasitic blood test negative, Pyrexia, Tachycardia, Troponin T increased
Clinical narrative: Patient is a previously healthy fully-vaccinated 12 yo presenting with fever and chest pain. He had fevers to 101-102 6/17-6/19 that were responsive to antipyretics, then the chest pain started 6/20 and has been constant 5/10 pain since. It is burning and located substernal/between the scapula. Activity/breathing doesn't worsen the pain, but it is worst at night. He also reports a mild headache today that has since resolved. He went to his PCP today and had an EKG concerning for diffuse precordial ST elevations, so he was referred to the ED with concern for myo/pericarditis.   Of note, Patient received a second dose of the Pfizer COVID vaccine on 6/11.  He also travels every week and has removed ticks from himself that were unattached.  No known bites and no rashes.  He has not had any n/v/d, no abdominal pain, no cough/congestion/rhinorrhea, no syncope, no palpitations.   In the ED, he was well-appearing but tachycardic to the 120s with otherwise normal vitals. He developed fever to Tmax 38.3 that improved with Motrin. On exam he had rash concerning for erythema migrans with multiple satellite lesions. He an EKG with ST elevations in the inferolateral leads. POC US did not show any pericardial effusion. Cardiology was consulted (see consult note) and recommended troponin, which was 1.08, and CRP, which was 7.52.  CXR showed clear lungs and normal cardiac contours.  Hospital Course: Patient was admitted for further workup and management of his perimyocarditis. Given his erythema migrans rash and positive history of recent multiple tick exposure, we were concerned about Lyme disease (Lyme antibody pending) and sent testing for co-infection (Anaplasma, Ehrlichiosis) with smear negative for Babesia. We treated him empirically with doxycycline (given antibiotic allergies) and his rash improved. We also considered myocarditis following COVID vaccination. He had serial EKG's done which showed low-normal function, with EF=55.2%. He had serial troponins sent and they were downtrending at the time of discharge. He had chest pain that improved with PRN ibuprofen. He did not require steroids or IVIG. Cardiac MRI was completed prior to discharge and showed normal function and an area of subepicardial LV myocardial late gadolinium enhancement. consistent with myocarditis. At the time of discharge, he had no chest pain, was eating and drinking normally, and family was in agreement with plan for close Cardiology and Infectious Disease follow-up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: Patient is a previously healthy fully-vaccinated 12 yo presenting with fever and chest pain. He had fevers to 101-102 6/17-6/19 that were responsive to antipyretics, then the chest pain started 6/20 and has been constant 5/10 pain since. It is burning and located substernal/between the scapula. Activity/breathing doesn't worsen the pain, but it is worst at night. He also reports a mild headache today that has since resolved. He went to his PCP today and had an EKG concerning for diffuse precordial ST elevations, so he was referred to the ED with concern for myo/pericarditis.   Of note, Patient received a second dose of the Pfizer COVID vaccine on 6/11.  He also travels every week and has removed ticks from himself that were unattached.  No known bites and no rashes.  He has not had any n/v/d, no abdominal pain, no cough/congestion/rhinorrhea, no syncope, no palpitations.   In the ED, he was well-appearing but tachycardic to the 120s with otherwise normal vitals. He developed fever to Tmax 38.3 that improved with Motrin. On exam he had rash concerning for erythema migrans with multiple satellite lesions. He an EKG with ST elevations in the inferolateral leads. POC US did not show any pericardial effusion. Cardiology was consulted (see consult note) and recommended troponin, which was 1.08, and CRP, which was 7.52.  CXR showed clear lungs and normal cardiac contours.  Hospital Course: Patient was admitted for further workup and management of his perimyocarditis. Given his erythema migrans rash and positive history of recent multiple tick exposure, we were concerned about Lyme disease (Lyme antibody pending) and sent testing for co-infection (Anaplasma, Ehrlichiosis) with smear negative for Babesia. We treated him empirically with doxycycline (given antibiotic allergies) and his rash improved. We also considered myocarditis following COVID vaccination. He had serial EKG's done which showed low-normal function, with EF=55.2%. He had serial troponins sent and they were downtrending at the time of discharge. He had chest pain that improved with PRN ibuprofen. He did not require steroids or IVIG. Cardiac MRI was completed prior to discharge and showed normal function and an area of subepicardial LV myocardial late gadolinium enhancement. consistent with myocarditis. At the time of discharge, he had no chest pain, was eating and drinking normally, and family was in agreement with plan for close Cardiology and Infectious Disease follow-up.