chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her face; allergic reaction from her nose down to her chin; tongue still feels heavy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported for herself.   A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0202, Expiry date: unknown) via an unspecified route of administration in Arm Left on 27Jun2021 14:45 (at the age of 57-years-old) as single dose for covid-19 immunization. Medical history included patient was diagnosed about 10 or 20 years ago for thyroid nodules from an unspecified start date and ongoing. Family medical history includes: Father has high cholesterol, no cancer in her family. Her dad has thyroid conditions. Patient didn't have any other vaccine prior to vaccination (within 4 week) and no adverse event prior vaccination. Concomitant medication included thyroid (ARMOUR THYROID) taken 0.25 one tablet daily for thyroid nodule. Sign of severe allergic reaction include swelling of face and throat, bad rash all over body. Upon follow up on 29Jun2021 patient reported that on 27Jun2021 15:20 patient experienced allergic reaction from her nose down to her chin, her face was numb like she had Novocain. And when patient woke up in morning and recovered (28Jun2021) from numbness in her face but tongue still feels heavy. Patient states she had COVID, and it was not severe and felt like it was not enough to put a vaccine in her body. She felt like with delta strain it may be more severe than the other strain. Patient feel like she was pressured to have it, took it for piece of mind. Patient received treatment for allergic reaction and numbness. The outcome of the event allergic reaction from her nose down to her chin, her face was numb like she had Novocain recovered on 28Jun2021 and tongue still feels heavy unknown.   Referred to HCP for further clinical recommendations.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Stress
Clinical narrative: slight heart palpitations; stress; This is a spontaneous report from a contactable consumer (Patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection,), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021, after her first dose patient experience slight heart palpitations that only lasted briefly and then she stated, but that could have been stress. The outcome of the event palpitations was recovered, and outcome of the event stress was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especially fingers; tiredness; some pain in calves; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 12:00 PM (Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: EW0168) (at the age of 59-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, headache, (nothing but seasonal allergies and headaches) and Known allergies: penicillin. If covid prior vaccination: No, If covid tested post vaccination: No. Facility type vaccine: Other. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; pseudoephedrine taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported.  If other vaccine in four weeks: No. The patient previously took povidone-iodine [BETADINE] and experienced drug allergies (Known allergies: penicillin, betadine). The patient experienced pain going through arms, then legs, then left side near arm (non-serious) on 18Jun2021 14:30 PM, swelling in extremities, especially fingers (non-serious) on 18Jun2021 14:30 PM, fever (non-serious) on 20Jun2021, tiredness (non-serious) on Jun2021, some pain in calves (non-serious) on Jun2021. For events, pain going through arms, then legs, then left side near arm, outcome was recovered with sequelae in unspecified date in Jun2021, swelling in extremities, especially fingers, outcome was recovered with sequelae in unspecified date in Jun2021, fever, outcome was recovered with sequelae in unspecified date in Jun2021, tiredness (non-serious), outcome was not recovered, some pain in calves (non-serious), outcome was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: patients who would like to know the amount of sodium in the Pfizer BioNTech COVID-19 vaccine because she is sensitive to it; This is a spontaneous report from a contactable other hcp. A 62-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history included allergy to metals, blood pressure measurement from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. patient who would like to know the amount of sodium in the Pfizer BioNTech covid-19 vaccine because she is sensitive to it (circumstance or information capable of leading to medication error). On an unspecified date outcome of the event was unknown.   Information on Lot/Batch information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Fatigue, Somnolence
Clinical narrative: tired; he came home, sat in front of TV, fell asleep, woke up slobbering, then slept for 14 hours; This is a spontaneous report from a contactable consumer or other non health care professional (patient) via Medical Information Team. A 67-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, Expiry date not reported), via an unspecified route of administration in Jun2021 (26Jun2021 or 27Jun2021 at 13:00 or 14:00) as single for covid-19 immunisation. Medical history included hepatitis C, blood pressure measurement from an unknown date and unknown if ongoing. The patient takes unspecified concomitant medication for blood pressure. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date in 2021 (three weeks before the second dose) for covid-19 immunisation. The patient reported that he had heard different things, about it tracking people and altering DNA. All of that information scared him. He has always thought that is immune system was good. He has Hepatitis C, so he went to get medication to treat it, and it was very expensive. He got Medicare. Now he takes medication for his blood pressure. He had a heart stress test done, and he did okay. He went back to the doctor, and they said his Hepatitis C was gone, that is immune system had cleared itself. He thought he would be okay not to get the covid vaccine, because around his area, covid is starting to go away, and is getting better. He seen a guy who had covid, he was over 20 feet away from him. The guy looked really bad and he started thinking maybe he should get the covid vaccine. He got his second dose of the covid vaccine, he came home and felt okay for a good while. He stated that he came home, sat in front of TV, fell asleep, woke up he came home, sat in front of TV, fell asleep, woke up slobbering, then slept for 14 hours. He became really tired, so he laid down and slept for 14 hours. He got up and still feels tired. Thinks he got the dose on 26Jun2021 or 27Jun2021 about 13:00 or 14:00 but is unsure. Feels like he lost a day in there, he's so tired. Wants to know if this is normal or if it's been reported. Doesn't want to go to the hospital if this is something that is expected. The patient underwent lab tests and procedures which included: heart stress test with results, he did okay. The outcome of all events was resolving.  Information about batch/lot number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Erythema
Clinical narrative: Blisters on elbow that has spread to her legs, ankles and feet; Elbow pain; it looks like she has some red things maybe on her face; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on 27Jun2021 11:00 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included   none. Family medical history relevant to AE included none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within four weeks prior to vaccination. On 27jun2021, patient experienced elbow pain. Patient woke up with the blisters on her elbow 28Jun2021. Reporter clarified they were covered on both elbows with blistery things. Patient this morning blisters covered new areas and spreading on her arms legs ankles and feet. Reporter said it has worsened because it is now in other places. Reporter said that the actual elbow pain has persisted about the same but the worsened is the blisters in other areas. On an unknown date in 2021, reporter stated that "it looks like she has some red things maybe on her face". Reporter stated that "She had called paediatrician and trying to find recommendations and she can not find anything other than to take Benadryl and Advil, she is trying to find what to do for it, does Pfizer have any recommendations for when the reaction is blisters". The events did not result in emergency room/physician office visit. patient's father and the patient's brother and sister all had the vaccine as well and no one had this reaction. The outcome of the events were not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Hypersensitivity, Oedema peripheral
Clinical narrative: edema to the lower extremities; distended abdomen; allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient's friend). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0196 and expiration date was not reported), via an unspecified route of administration on 10Jun2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. On 11Jun2021 the patient experienced edema to the lower extremities, distended abdomen and allergic reaction. It was reported that the patient had the vaccine on 10Jun2021 and was due for his second dose in two days, right after the vaccine the following day got a severe reaction which caused edema in his lower extremities and distended abdomen, the reporter asked if the adverse reactions were going to persist and if the patient should get the second dose of the Pfizer BioNTech Covid-19 vaccine. The reporter wanted to see what side effects there were for the vaccine and what they should do and if he should continue to get the next dose which is due in 2 days since the patient had this allergic reaction. The reporter was informed that in general, local side effects, the ones on the arm where the shot was given (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that are experienced throughout the rest of body (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Side effects after second shot may be more intense than the ones experienced after first shot. These side effects are normal signs that body will building protection and should go away within a few days. The vaccination provider or healthcare provider should be called if any side effects are experienced that bother or do not go away. The reporter was informed that not to get the Pfizer-BioNTech COVID-19 Vaccine if one had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The reporter was asked to speak to a healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of all the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash all over body; Developed rash on her right arm then to her both arms and legs. On Sunday, the rash spread from her arms and legs to her stomach and back; This is a spontaneous report from a contactable consumer(patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0198, Pfizer NTEC), via an unspecified route of administration in left arm on 25Jun2021 16:45 as dose 1, single for COVID-19 immunization (at the age of 36-years-old). The most recent COVID-19 vaccine was administered in pharmacy. Medical history and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that she had her 1st dose of the COVID-19 vaccine on Friday 25Jun2021 on her left upper arm and the next morning, she developed rash on her right arm then to her both arms and legs. On Sunday, the rash spread from her arms and legs to her stomach and back then come Monday the rash were on her neck and face and today, the rash spread to the palm of her hands. It was further stated that when she woke up Saturday morning (5 or 6 am), she had a rash on the opposite arm that she got the shot in. By 24 hours later, on Saturday night the rash was on both of her arms and both of her legs. The condition was reported to be worsened. Sunday (7 am), rash had spread from arms and legs to stomach and back. On Monday (6 am), rash was on her neck and face. Today, Tuesday, (29June2021), Tuesday (5 am) it was on the palms of her hands. She states she did go to the doctor (11:15 am) and she was given a steroid shot. The events lead to physician office visit for itchy rash all over body. The clinical outcome of Developed rash on her right arm then to her both arms and legs was not recovered except for event, itchy rash all over body which was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received unknown 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 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever. Reported that patient experienced a fever for 14 hours. Reporter queried Caller states that she got the Pfizer COvid-19 vaccine and only experienced a fever for 14 hours. Caller declines being transferred to fill out a safety report. The outcome of event was recovered on an unspecified date in 2021.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: tiredness; felt sleepy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jun2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patients had the first dose Pfizer Covid Vaccine on 06Jun201 at 1200Had a little bit of tiredness and sleepiness: The caller states she had the first dose Pfizer Covid Vaccine on 06Jun201 at 1200 and this started the next morning, 07Jun2021. It started in less than 24 hours of receiving the first dose Pfizer Covid Vaccine, had a little tiredness and was more sleepy, liked to sleep. This lasted maybe 3 or 4 days. She recovered with lasting effects. The outcome of the events was recovered in Jun2021.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Vision blurred
Clinical narrative: Experienced blurriness of the vision; Sore arm; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jun2021 (Lot Number: EW0179) as dose 2, single for COVID-19 immunization at the age of 13-year-old. Medical history included ongoing acne. Concomitant medication included isotretinoin (ACCUTANE) taken for acne from Apr2021 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Jun2021 (Lot Number: EW0183) as dose 1, single for COVID-19 immunization at the age of 13-year-old. On 28Jun2021, the patient experienced a sore arm but felt better after taking Tylenol. When the patient woke up the next morning, on 29Jun2021, his vision was blurred for about 15 minutes to half an hour. He was unsure if it was a side effect from the shot that he got the day before. The patient's mother mentioned that she was going to check with his dermatologist because he was on Accutane and they were forewarned of blurry vision and a headache with Accutane, but the patient said that he did not have a headache. He had been on it for two months and was put on 30 mg because of his bloodwork that came back normal after the first round. The outcome of event blurriness of vision was recovered on 29Jun2021. The outcome of event sore arm was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Inflammation
Clinical narrative: An unknown knot occurred in my back. Not a cyst or hematoma. Dr did surgery today to remove it..stated it was some sort of inflammation.; An unknown knot occurred in my back. Not a cyst or hematoma. Dr did surgery today to remove it..stated it was some sort of inflammation.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included Hypertrophic cardiomyopathy. Concomitant medication(s) included Metoprolol (METOPROLOL TARTRATE), Verapamil (VERAPAMIL), Atorvastatin (ATORVASTATIN). Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 02Mar2021, administration site (arm right), lot number EN6202 for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced an unknown knot occurred in his back. Not a cyst or hematoma. Dr did surgery today to remove it stated it was some sort of inflammation. Sample sent to Pathology on 15Apr2021 01:00 with outcome of not recovered. The patient was hospitalized for the event for 1 day. Therapeutic measures were taken as a result of events includes attempted to drain in Er Then Neuro surgeon. The clinical outcome for events was not recovered.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Overdose, Product use issue
Clinical narrative: headache; Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today; received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine; This is a spontaneous report from a contactable other health care professional (Nurse).  A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: Jul2021), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 15:04 as dose number unknown, 0.5ml single for covid-19 immunisation and meningococcal group b rlp2086 (MENINGOCOCCAL GROUP B RLP2086, Batch/Lot Number: ABXB29BA; Expiration Date: Jun2022), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 as 0.5 mL, single for an unspecified indication and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Batch/Lot Number: U6690AB; Expiration Date: 23Aug2021), via an unspecified route of administration from 29Jun2021  to an unspecified date, at 0.5 mL for an unspecified indication. The patient medical history and concomitant medications were not reported. No prior Vaccinations (within 4 weeks) other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that On 29Jun2021 the patient received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine and experiencing headache within an hour of administering. Caller just administered the Pfizer Covid vaccine to a (withheld) and gave her 0.5mL instead of 0.3mL, a vaccine error. They want to see if there is any concerns and what to tell mom about the vaccine error. States patient also received other vaccines today along with the Covid vaccine. Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today. No problems with vaccines in past and none given in the past 4 weeks. When providing product details for the Covid vaccine, caller takes off her glasses and provides details. Causality not provided. States patient has not been to emergency room or seen physician and is still there and doing just fine at the moment, hopefully. No further details provided. Yes patient took additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Reporter seriousness for gave her 0.5mL instead of 0.3mL; vaccine error, received other vaccines today Medically significant. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: The patient woke up to severe itching at night; Rash developed on the posterior side of the entire legs, around knees (front side as well), elbows and the entire insteps; This is a spontaneous report from a contactable consumer or other non hcp.  A 51-years-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ew0017), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:15 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ew0181), via an unspecified route of administration, administered in Arm Left on 04Jun2021 11:15 (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. On 28Jun2021, the patient experienced the patient woke up to severe itching at night, rash developed on the posterior side of the entire legs, around knees (front side as well), elbows and the entire insteps. No treatment was taken as a result of events. The events were considered as non serious. The outcome of the events were not recovered.  Follow-up attempts are possible. Further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Headache, Tinnitus
Clinical narrative: Hearing loss; tinnitus; I feel off balance; headache; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 03Feb2021 at age of 62-years-old for covid-19 immunization and experienced Hearing loss and tinnitus. The patient medical history was not reported. Concomitant medication included fluconazole.  The patient experienced hearing loss, tinnitus, feel off balance on an unspecified date with outcome of recovering , headache on an unspecified date with outcome of recovered.  Ear nose and throat doctor prescribed prednisone. Seriousness criteria reported as disabling and incapacitating. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced sever pain at the injection site night of the dose; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0202; Expiration Date: 12Jun2022), via an unspecified route of administration, administered in Arm Right on 12Jun2021 14:15 (at the age of 72-year old) as dose 1, single for covid-19 immunisation. Medical history included rib fracture from over a year ago, pain in extremity from Mar2021 and ongoing , hernia repair from 2017 to an unknown date, musculoskeletal stiffness from an unknown date and unknown if ongoing, injury from an unknown date and unknown if ongoing. Family history included patient sister had diabetes and was taking shots. family history relevant to event include child got very sick with his childhood shots. Concomitant medications included vitamin b complex taken for prophylaxis, start and stop date were not reported; vitamin c, start and stop date were not reported; tocopherol taken for prophylaxis, start and stop date were not reported. Patient did not take any other vaccines within four weeks prior to vaccination. On 12Jun2021, the patient experienced experienced sever pain at the injection site night of the dose.  When patient was asked if the pain at the injection site was resolved, she said that she did not know. It seemed like she felt a twinge. Patient stated that as far as she knew, she never had Covid. The events did not result in emergency room or physician office visit. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives all over her body/hives/rash; hives/rash; This is a spontaneous report from a contactable Other Health Professional. A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left at the age of 12-year-old on 28Jun2021 (Lot Number: EW0191) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient previously took first dose bnt162b2 (Lot EW0186, First administered in the Left Deltoid) at the age of 12-year-old on 04Jun2021 for COVID-19 immunisation. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe, she is wondering if it is safe to administer the second dose to the patient. Caller states that a patient received her first and second dose of the Pfizer Covid-19 vaccine, but after the second dose, the patient had hives all over her body. Caller asks, ''if a booster shot is proven to be needed later in time such as in the fall, should the patient not get it?'' When queried first dose date of the patient, at first the caller states that she is not sure, one of her other representatives put second covid vaccine dose as 28Jun2021 and because of that she is not sure. Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. ''Later on in the call, caller is able to confirm first and second dose. Caller asks for this age group is it just 2 doses or do they require a booster? Caller confirms that the first dose was given on 04Jun2021 and the second dose was given on 28Jun2021. Caller states the reason she was asking if its okay to give another is because the parent of the patient was asking if she would still get the next dose. Caller states that since the patient has already received 2 doses she is not sure why the parent was asking about another dose, caller then asks if this age group will need a 3rd shot as a booster?  '' Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day on 28Jun2021. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Rash
Clinical narrative: Skin rash; Fatigue; Body aches; This is a spontaneous report from a contactable healthcare provider reported that a 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; and palbociclib (IBRANCE), via an unspecified route of administration from 01May2021 (Batch/Lot number was not reported), at 125 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced skin rash, feeling fatigued and body aches on an unspecified date with outcome of unknown. The action taken in response to the events for bnt162b2 was not applicable, for palbociclib was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: My friends doctor blacked out with the first Pfizer vaccine injection; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient 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 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced blacked out with the first pfizer vaccine injection on an unspecified date.  The outcome was unknown.   Information on lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain after the first shot; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27May2021 (Lot Number: EW0176) via an unspecified route of administration on as single doses for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history or concomitant medications.  The parent reported that the patient went to the emergency room with the chest pain after the first shot and added that they didn't give him medicine and was advised to go home and take acetaminophen (TYLENOL). The event chest pain was considered medically significant. Outcome of the event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (02Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807831 same reporter/patient/drug (second dose), different events
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Chest discomfort, Contusion, Dyspnoea, Fatigue
Clinical narrative: pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Headache, Hypogeusia, Inappropriate schedule of product administration, Joint lock
Clinical narrative: pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Pain, Pain in extremity, Paraesthesia, Pneumonia
Clinical narrative: pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Leg pain; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose (Lot Number: EW0176; Expiration Date: 31Aug2021) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient queried if there had been any side effect reported of leg pain. The patient stated had the shot and had the side effects associated with COVID-19 on an unspecified date. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: swelling of left arm; It was red. The color changed. It was a pinkish red color, but not her normal color; It felt heavy; couldn't lift her arm up; She was feeling numbness in the finger tips.; Her arm hurt, it was very sore; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration on 27May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced swelling of left arm and had puffy whole arm. It was red. The colour changed. It was a pinkish red colour, but not her normal colour. It felt heavy. She couldn't lift her arm up. She was feeling numbness in the finger tips. Her arm hurt. It was very sore. Patient was concerned about the numbness in her hand. It was on the side she got the shot. It was for a couple of days, maybe 3 or 4 days. It took a couple of days to be back to normal. She went back yesterday to get second shot and it seemed they didn't recommend it until she spoke to CDC or spoke to her doctor because of the symptoms.The outcome of the events were recovered on an unknown date in 2021.   Follow-up attempts are needed. Further information is requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
Clinical narrative: Received first dose on 27May2021/ received second dose on 10Jun2021; he had a massive heart attack; This is a spontaneous report from a contactable consumer (patient parent). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0176, on 10Jun2021 at single dose (at the age of 36-year-old) for COVID-19 immunization. Medical history and concomitant medication were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number : EW0176, on 27May2021 and experienced chest pain. Reporter stated Pfizer drug kill the patient yesterday (28Jun2021). He had a massive heart attack in Jun2021. The outcome of massive heart attack was fatal.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: he had a massive heart attack