chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Joint range of motion decreased
Clinical narrative: limited use of her arm and fingers; hit me in knee, shoulder, rotary cuff; This is a spontaneous report from consumer via Pfizer-sponsored programmed . A 81-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a SINGLE DOSE for COVID-19 immunization. The patient previously took first dose of BNT162B2 vaccine for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced limited use of her arm and fingers, and hit me in knee, shoulder, rotary cuff. It was reported that patient was not sure if its a possible side effect due to the second dose of the covid-19 she had about two or three weeks ago. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral herpes
Clinical narrative: headache dull after second vaccine; Cold sore, on the bottom of her lip, after second vaccine/Cold sore, upper lip, but larger, after second vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in left arm on 23Apr2021(at the age of 62-years-old) as a 1st single dose for covid-19 immunisation. Patient had no medical history and concomitant medications. Patient did not administer any other vaccine prior to 4 weeks of vaccination. Patient did not administer any additional vaccines on same date of the pfizer suspect. Patient had no adverse reactions following prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732) via intramuscular administered in upper left arm on 24Mar2021 around 14:00 (at the age of 62-year-old) as 1st single dose for covid-19 immunisation. Patient informed that side effects occurred after the second dose of vaccine on 23Apr2021. On 25Apr2021, patient experienced a cold sore on the bottom of lip that was for a couple of days. The patient noticed it probably when she got up in the morning and it didn't last for too long. The patient stated that she would get a cold sore, usually, about once a year. On past Monday, 03May2021, patient got a cold sore on her upper lip, but larger and she was on the path to healing and the cold sore has peaked. The patient works in a hospital, reclarified, and the nurses told her that she should, report her event. Patient also had a headache around noon time with this cold sore and she was taking medication. The headache as dull, and it was ongoing and patient took a couple of Motrin which was effective for her headache. Patient stated she usually gets a headache, when she gets a cold sore. Patient was taking a prescription medication for cold sore Cyclovir and it was shortening the length of time for healing and the cold sore was not lasting as long as it normally would, as when she doesn't take the medication. Patient thinks it was unusual that she got both cold sores after the second vaccine. The adverse event did not require emergency room or physician office visit. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dry eye, Product dose omission issue
Clinical narrative: This is a spontaneous report from a contactable other hcp. Pfizer Sponsored Program. A contactable Other healthcare professional and contactable female consumer (patient) reported that: A 62-years-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown single dose for COVID-19 immunization. Tofacitinib citrate (XELJANZ XR), oral from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 11 mg, 1x/day for rheumatoid arthritis.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble with allergies and dry eyes, and patient missed doses. Patient reported that, she started xeljanz in February 2021 with samples from doctor and after start of therapy states she got covid and then subsequently got COVID-19 vaccine and was off Xeljanz (dates unknown of missed doses)and restarted Xeljanz last Monday (03May2021 to ongoing). md aware. patient reported currently has "trouble with allergies and dry eyes" and eye doctor prescribed erythromycin ointment and steroid drops for eyes, reports primary care doctor prescribed antibiotic for possible sinus infection with congestion, "sore throat due to drainage". encouraged to notify rheumatologist. Outcome of the events were unknown. No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Headache, Insomnia, Tinnitus
Clinical narrative: 3 weeks later he developed Tinnitus/Tinnitus was reported as worsened; cannot sleep; headache; anxiety; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729, patient was 24 years old at the time of vaccination), via an unspecified route of administration in Arm Left on 17Apr2021 at 13:00(Patient age at time of vaccination: 24 years) as a single dose for covid-19 immunisation at pharmacy. The patient's medical history and concomitant medications were not reported. There was no Family Medical History Relevant to AEs. There was no Prior Vaccinations (within 4 weeks) and no associated AEs following prior vaccinations. The reporter stated that patient gets a flu shot every year and is ok. The patient experienced tinnitus 3 weeks later. Upon follow up (11-may-2021), it was reported that on 06May2021, the patient experienced slight side effect in his ear like Tinnitus, Cannot sleep (ongoing), ongoing Headache, ongoing Anxiety and seriousness for Tinnitus was reported as worsened, whereas reporter seriousness for all other events was unspecified. The patient tinnitus did not stop for 5 continuous days and sounds like tinnitus all the way. The patient visited the ENT on 10May2021 and the patient's ear was clear and there was no other physical damage whatsoever to the patient's ear and he did not have any problems in his ear before vaccinating with the Covid-19 vaccine. The reporter reported that the patient's tinnitus seems like it's louder and sound is very low and that the patient cannot do low sounds. The patient anxiety and headache are from the tinnitus. The reporter unable to provide NDC number or expiry date of the Covid-19 vaccine as it was not included on the patient's vaccination paperwork. The event Tinnitus resulted in Physician Office visit. The outcome of reported events was not recovered.  Follow-Up (11May2021): Upon follow up, new information included:  Time of vaccine administration details, Anatomical site location details, lot details, Reported seriousness of the event Tinnitus details.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes, Pain in extremity, Paraesthesia
Clinical narrative: Sore Arm after second dose of vaccine; Almost felt like she was getting shingles again; Cold sores on and in mouth; Nerves tingling; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included herpes from 1970 to an unknown date. Patient had been treated for Herpes on and off since the 1970s. Patient had undergone 3 surgeries in 2016 for knee revision. Patient had shingles three times in her life and received her shingles vaccine 3 years ago. Family history included that her husband had heart valve replacement in 2016. She stated that her husband had heart valve replacement in 2016 and they were both getting up there in age. Her daughter has one lung and she wanted to be able to be around her. They have been staying at home; would like to get out more. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: ER8734) as 1st DOSE, SINGLE for covid-19 immunization. On 02Apr2021, the patient experienced sore arm and felt cold after the first dose of the vaccine. It was reported that the patient had sore arm after second dose of vaccine from unknown date in Apr2021 till unknown date in Apr2021. On 06May2021, about three days after the second vaccine she noticed the cold sores on and inside her mouth and also had nerves tingling. It was stated she has had this before and has been being treated for herpes on and off since the 1970s. She started Valtrex for this on 10May 2021 and also had been using a topical cream. Stated the sores were improving before these medications and have continued to improve. It was asked if anyone else has had something like this happen after the vaccine. It was also stated that she thought it almost felt like she was getting shingles again. She has had shingles before and said that since then though she has had the shingles vaccine. Her arm was a little sore after the second vaccine and it wasn't bad. The outcome of the events Oral herpes and Paranesthesia was recovering. The outcome of the event pain in extremity was recovered. The outcome of the event Herpes zoster in extremity was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: has shingles; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: herpes; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as single for COVID-19 immunization. The patient's medical history included developed herpes in 1978 although patient had developed resistance thru out the years and outbreaks were once in a while and basically mild after the shot outbreaks have been constant almost like patient body's attention has been diverted to fight this virus. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 15:00 the patient experienced herpes. The event was reported as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; This is a spontaneous report from contactable consumer via Pfizer sponsored program. A 55-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Reporter state that her husband received his second Pfizer Covid vaccine dose 04May2021. On 05May2021, he developed redness, swelling, and itching at the injection site. it is improving. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days).  No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; runny nose; fatigue; This is a spontaneous report from a contactable consumer (patient's mother).  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, on 20Apr2021 for COVID -19 immunization and experienced fatigued/tiredness, headache, fever, sore throat, nasal congestion, "now sick at the urgent care", not been feeling well, flu symptoms, still coughing and has seasonal allergies. The patient's mother reported that the patient has been sick for 5 days following first dose. The patient experienced sore throat, runny nose and fatigue on an unspecified date. The patient's mother confirmed that events were previously reported. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: developing a rash from head to toe noted as "welts the size of a half-dollar."; developing a rash from head to toe noted as "welts the size of a half-dollar."; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother informed that her daughter received the first Pfizer COVID vaccine dose on 22Apr2021 and 4 days (26Apr2021) after the vaccine dose, the patient started developing a rash from head to toe noted as "welts the size of a half-dollar". The reporter informed that her daughter was supposed to get the second dose of the vaccine yesterday 13May2021, but the pharmacist did not want to give it to her without consulting with Pfizer first. The reporter wanted to know if her daughter could get the second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Limb mass, Skin irritation
Clinical narrative: it is swollen right below her neck where the neck and shoulder meets there is a lump; it is swollen right below her neck where the neck and shoulder meets there is a lump; Been noticing irritation in that area; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 2 via an unspecified route of administration, in left arm on 10May2021 (at the age of 58-years-old) (Lot Number: EW0170) as 2nd dose, single dose for COVID-19 immunization at a mass vaccination site. The patient had no medical history and no concomitant medications. The patient did not receive other vaccine in four weeks. The patient previously took first dose (at the age of 58-years-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: ER8731) on 19Apr2021 for COVID-19 immunization. On 13May2021, the patient informed that she noticed after the second shot a couple days after she had noticed it is swollen right below her neck where the neck and shoulder meets there is a lump. The patient clarified that this is more at the top of her shoulder close to the neck. In May2021, the patient also reported that  she has been noticing irritation in that area and she thought maybe she slept on the wrong side but she noticed the feeling 2 or 3 days ago but then she went to feel it yesterday and noticed there was a lump. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Allergy to vaccine, Flushing, Urticaria
Clinical narrative: hives; face flushed; allergic to vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021, at 09:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. The patient has an allergy to muscles. However, it was also reported that patient had no medical history, family history, and concomitant medications. The patient had no other vaccines four weeks prior vaccination. On 01Apr2021, the patient experienced hives and face flushed that developed within 5 minutes after vaccination. She said it could have been sooner than 5 minutes but that was when she pushed her sleeves up and the hives were there when she did that. The patient also reported that her face flushed and all of it went away in minutes. The patient went to see an allergist and got an allergy test and it showed that she is allergic to the vaccine and they told her she could get the second dose, but they would be there with epinephrine (reported as Epi). It was reported that the allergist put fresh eye drops under her skin and told that she was allergic to the vaccine itself and PEG and polysorbate. The patient further stated that they did not provide her with a preservative name, the physician just said she was allergic to the preservative. The patient said she is not going to do the second one, but she is trying to find out if the company is going to come out something without the preservative because that was what they told her she was allergic to. The patient underwent lab tests and procedures which included allergy test: allergy to BNT162B2, PEG, and polysorbate on an unspecified date. The patient did not receive treatment in response to the events. The patient said that they were busy, so she did not tell anyone and just sat down for her waiting time; the events faded away while she was sitting. The patient recovered from the events on 01Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Erythema, Rash, Urticaria
Clinical narrative: hives; face flushed; allergic to vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021, at 09:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. The patient has an allergy to muscles. However, it was also reported that patient had no medical history, family history, and concomitant medications. The patient had no other vaccines four weeks prior vaccination. On 01Apr2021, the patient experienced hives and face flushed that developed within 5 minutes after vaccination. She said it could have been sooner than 5 minutes but that was when she pushed her sleeves up and the hives were there when she did that. The patient also reported that her face flushed and all of it went away in minutes. The patient went to see an allergist and got an allergy test and it showed that she is allergic to the vaccine and they told her she could get the second dose, but they would be there with epinephrine (reported as Epi). It was reported that the allergist put fresh eye drops under her skin and told that she was allergic to the vaccine itself and PEG and polysorbate. The patient further stated that they did not provide her with a preservative name, the physician just said she was allergic to the preservative. The patient said she is not going to do the second one, but she is trying to find out if the company is going to come out something without the preservative because that was what they told her she was allergic to. The patient underwent lab tests and procedures which included allergy test: allergy to BNT162B2, PEG, and polysorbate on an unspecified date. The patient did not receive treatment in response to the events. The patient said that they were busy, so she did not tell anyone and just sat down for her waiting time; the events faded away while she was sitting. The patient recovered from the events on 01Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Paraesthesia
Clinical narrative: Developed tingling in his right arm mostly the end and then he developed tingling in his right leg; Chest pain; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 18 years old) at first dose, single dose for COVID-19 immunization at the pharmacy. There were no medical history and concomitant medications. On an unspecified date on the same day of vaccination, the reporter stated that the patient developed tingling in his right arm mostly the end and then he developed tingling in his right leg. The patient then developed chest pain; because of chest pain, the patient was brought to the emergency room on an unspecified date. The patient underwent electrocardiogram (EKG) that was reportedly normal. The physician brought up the concern that the patient's mother needed guidance as far as her son should get the second shot or not. The physician stated that patient had extensive treatment for chest pain which is that patient was brought to the emergency room and had an EKG. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough for 30 days; This is a spontaneous report from a contactable consumer(spouse) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cough since receiving Covid 19 vaccine. The patient has had the cough for 30 days. The event resulted to a physician office visit. The patient has been to the doctor and the doctor can't figure out what's causing her cough. The outcome of the event was unknown. The reporter has questions regarding the patient's cough.   No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: aggravated tinnitus, ringing in the ears; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported same events for 3 patients. This is the third of three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunisation. Medical history included tinnitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced aggravated tinnitus, ringing in the ears. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021546995 same reporter/drug/event, different patient;US-PFIZER INC-2021548332 same reporter/drug/event, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain
Clinical narrative: Hyperesthesia of front surface of left shin (below the knee); Darting pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 14:00 (Batch/Lot number: 0183) (at the age of 52 years) as 2ND DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. There were no other medications in two weeks. Patient was not pregnant at time of vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Apr2021 (Batch/Lot number: WE 0161) (at the age of 52 years) as 1ST DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hyperesthesia of front surface of left shin (below the knee) and darting pain, both on 13May2021 with outcome of not recovered. There was no treatment received for the events.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: spent two days in bed with everything - a headache and all the symptoms; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced spent two days in bed with everything - a headache and all the symptoms on an unspecified date. It was reported that the patient had the vaccine in April and she will be travelling to another county so the airlines wanted proof of her vaccination which has to be official and they have to be able to scan it, and they cannot use the card. The patient stated that she received the vaccine at the parking lot and that nurses gave the vaccine. She also stated that she had two vaccines and needed proof. The patient reported that on the first vaccine she had spent two days in bed with everything - a headache and all the symptoms. On the second vaccine, patient stated only one day in bed but still all the symptoms. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: spent one day in bed with still all the symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and experienced spent two days in bed with everything - a headache and all the symptoms. On an unspecified date, the patient experienced spent one day in bed with still all the symptoms. It was reported that the patient had the vaccine in April and she will  be travelling so the airlines wanted proof of her vaccination which has to be official and they have to be able to scan it, and they cannot use the card. The patient stated that she received the vaccine at the parking lot and that nurses gave the vaccine. She also stated that she had two vaccines and needed proof. The patient reported that on the first vaccine she had spent two days in bed with everything - a headache and all the symptoms. On the second vaccine, patient stated only one day in bed but still all the symptoms. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Left arm began to swell from 4 to 5 inches from the shoulder to 2 inches from the crease of her elbow, in the front, after second vaccine; her arm was swollen and red and the shape of an eggplant, it was that large; Itching on left arm, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EWD175, Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 07May2021 at 15:55 (at the age of 82 years old) as second dose, single for COVID-19 immunisation. The patient has no medical history (including any illness at time of vaccination) and no family medical history relevant to adverse effect. The patient previously received the first dose of BNT162B2 (lot number: EWD162, expiration date:01Jul2021), via an unspecified route of administration administered on left shoulder (as reported) on 16Apr2021 at 1:45pm (at the age of 82 years old) as single dose for COVID-19 immunisation. There were no concomitant medications. On 11May2021, the patient experienced that her left arm began to swell from 4 to 5 inches from the shoulder to 2 inches from the crease of her elbow, in the front, after second vaccine. It was further reported that redness and swelling of left arm are the size of an eggplant, 2.5 inches on the top part of the arm and 4.5 inches at the base of the swelling, a total of about 6 inches from top to bottom in length. There was also itching on left arm. Events did not result in Emergency Room nor Physician Office Visit. The patient stated that the for the redness, it has improved by a small amount, and was ongoing, she can still see the redness; for the swelling, it was still there, but was not as swollen as it was before and for the itching of left arm it was still ongoing a little and it was described as a minor itching. Patient was recovering from left arm swelling and redness of left arm but was not recovered from itching in arm.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Fever 101.4; Fatigue; Chills; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on 13May2021 04:45 (at the age of 75-years-old), as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR [ATORVASTATIN]); unspecified multivitamin; and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101.4, fatigue, chills, nausea, vomiting, and feeling unwell on 14May2021 12:30. The patient underwent lab tests and procedures which included body temperature: 101.4 (fever) on 14May2021. It was unknown if treatment was given as a result of the events. Patient seek consult with her physician. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 101.4; Fatigue; Chills; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on 13May2021 04:45 (at the age of 75-years-old), as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR [ATORVASTATIN]); unspecified multivitamin; and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101.4, fatigue, chills, nausea, vomiting, and feeling unwell on 14May2021 12:30. The patient underwent lab tests and procedures which included body temperature: 101.4 (fever) on 14May2021. It was unknown if treatment was given as a result of the events. Patient seek consult with her physician. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Vomiting
Clinical narrative: feel severely weak; Sever headache; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 13May2021 13:15 (at the age of 31-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included multivitamins taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced sever headache, nausea and vomiting all on 14May2021 16:00; feel severely weak on 15May2021 08:26. It was reported that the patient took 500 mg of Acetomophine for the event sever headache while no treatment was received for the other events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervousness, Paraesthesia, Presyncope
Clinical narrative: I started to get a weird quick sensation that started in my chest and moved down my body(kind of like when you go over a hill really fast but intensified)/felt like something inhabiting my body; really freaked me out; wasn't sure if I was going to pass out or not; my arm felt tingly, like when you hit your funny bone; This is a spontaneous report from a contactable consumer(patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 14May2021 04:45 PM (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization at a Pharmacy/ drug store. The patient's medical history was not reported. Concomitant medications included progesterone and estradiol; both taken for an unspecified indication, start and stop date were not reported. Patient was also reported to be on hormone replacement therapy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 14May2021, right away after the shot, the patient experienced or felt tingly arm, like when you hit your funny bone (reported to have waited for 15 mins and felt fine) and on the way home about 25-30 mins after the shot, at 05:30PM, the patient experienced a weird quick sensation that started in her chest and moved down her body (reported as kind of like when you go over a hill really fast but intensified) and felt like something inhabiting her body (which was reported to have lasted probably less then a minute), that really freaked her out and wasn't sure if she was going to pass out or not. Luckily she was close to home. No treatment was given for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 10:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced slightly sore arm after first dose on an unspecified date. Treatment was not given as a result of the event. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: doesn't have a thyroid; This is a spontaneous report from a non-contactable consumer (patient's mother). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the ER doctor told the reporter to call Pfizer Medical Information to find out if her daughter should get the second shot due to adverse reactions to the first shot. The reporter stated that her daughter doesn't have a thyroid (as reported) and her body went nuts after she received the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: headache; sore arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8735, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 21Apr2021 10:30 (at the age of 49-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included sulfa drugs and avocado allergy both from an unknown date. Concomitant medication included multivitamin taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced headache, sore arm, and dizziness. It was reported that the patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8734, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 31Mar2021 10:00 (at the age of 49-years-old) for COVID-19 immunisation and experienced severely dizzy, continued for 2.50 weeks 24/7. The only time she felt ok was laying down.  It started to get better in time for her second dose.  After second dose it didn't get worse.  Only a headache in the middle of the night and a sore arm for about a week.  The dizziness has not gone away completely. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events included meclizine. The outcome of the events was recovered with sequels.    No follow-up attempts are possible. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0170, (Reporter stated that they could be 0's or O's, she did not know) Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 14:00 (at the age of 17 years old) as first dose, single for COVID-19 immunisation. The patient has no medical history and no family medical history relevant to adverse effect. No prior vaccinations was received within 4 weeks. The patient's concomitant medications were not reported. On 13May2021 at 23:00, the patient experienced that on the side where the patient received the injection, which was his left side, the area right by his arm pit, right by the front of his body was swollen and hurt like crazy. The events did not require visit to Emergency Room or Physician Office. Outcome of all events was unknown. The reporter was asking if this is normal and if she should be concerned.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: swelling on her right eye; This is a spontaneous report from a contactable consumer(spouse). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0173; Expiration date was not reported), via unspecified route of administration in the left arm on 11May2021 17:30 (at the age of 38-years-old) as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0162; Expiration date was not reported), via unspecified route of administration in the left arm on 20Apr2021 05:00PM (at the age of 38-years-old) as first dose, single dose for COVID-19 immunisation. On 13May2021 at night, the patient experienced the swelling on the right eye. The outcome of the event was not recovered. The reporter wanted to understand if any action needs to be taken and asked if this was normal and expected and how to go about it.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb mass, Pain, Upper respiratory tract infection
Clinical narrative: I have a lump, it's like a size of a golf ball on my arm; I did get a tiny little lump smaller than the marble. But it's worst today.; it's red; it's warm to touch/ like hot to touch; Achiness; Upper respiratory infection/ kind of had a runny nose; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735; Expiration date: Jul2021), via unspecified route of administration in the left deltoid on 13May2021 (at the age of 41-years-old) as second dose, single dose for COVID-19 immunisation. The patient has no relevant medical history. Concomitant medications were not reported. The patient was preciously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number:  ER8735; Expiration date: 31Jul2021), via unspecified route of administration in the left arm, left deltoid on 22Apr2021 (at the age of 41-years-old) as first dose, single dose for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced a tiny little lump smaller than the marble which became worst (reported as today) like a size of a golf ball on her arm and it was red and warm or like hot to touch, just kind of had a runny nose, achiness all day (reported as today) and upper respiratory infection that was not still bad. Treatment with Dayquil (2 tablets), Ibuprofen (800mg) and ice were taken as a result of the events.  The outcome of the events was unknown. The relatedness of events lump, like a size of a golf ball on her arm and it's red and warm to touch and achiness was reported to be related and causality of all the events was reported as yes by the reporter. There was no investigation assessment.  No follow-up attempts are needed. No further information is expected.