chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pyrexia, Vaccination site pain
Clinical narrative: Felt tired; developed a low grade fever and just felt crummy; developed a low grade fever and just felt crummy; My arm got sore at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration in the arm right on 26Mar2021 at 13:00 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medication. The patient had no known allergies. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 26Mar2021 at 20:00 (later that Friday evening), the patient experienced arm sore at the injection site. On 27Mar2021 (the next day Saturday), the patient felt tired and developed a low-grade fever and just felt crummy.  On 28Mar2021 (Sunday), she felt better but on 29Mar2021 (Monday) the patient felt like old self again. Arm soreness lasted till 31Mar2021 (Wednesday). The patient did not receive any treatment for these events. The outcome of the events tiredness and fever was resolved on 29Mar2021 and for sore arm was resolved on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electromyogram, Joint stiffness, Joint swelling, Pain in extremity
Clinical narrative: Extreme pain in both wrists and pain in elbows bilaterally; Pain in 4th and 5th fingers; bilateral knee swelling as well as left ankle swelling; Knee stiffness and Left ankle stffness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283 and expiry date not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 39-year-old) as dose 2, single, for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lamotrigine (manufacturer unknown) and levothyroxine sodium (SYNTHROID) all for unknown indication from an unknown date. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number EJ1685 and expiry date not reported) via an unspecified route of administration, administered in left arm, on 22Dec2020 (at the age of 39-year-old) as dose 1, single, for COVID-19 immunisation and experienced tingling down the arm in the 4th and 5th fingers, aching in the left wrists more than the right. 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. On 13Jan2021, the morning after receiving second dose, patient woke up in the early morning hours with extreme pain in both wrists. This progressed to include 4th and 5th fingers and elbows bilaterally. The patient was seen by the doctor a week later and scheduled for EMG due to concern over ulnar neuropathy. EMG/NCS were completely normal. In between that time on an unknown date in Jan2021, the patient developed bilateral knee swelling and stiffness, as well as left ankle swelling and stiffness. The patient finally saw a rheumatologist who is working up the patient for inflammatory arthritis. The adverse events were reported retrospectively as, the patient didn't make the connection of the timing of symptoms corresponding with dates of vaccination until consulted the rheumatologist. The patient received prednisone (manufacturer unknown) as a therapeutic measure for the joint inflammation. The patient underwent lab tests and procedures, which included EMG/NCS: completely normal; COVID-19 virus test (nasal swab) on 02Feb2021 and the result was negative. The outcome of the events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme pain in both wrists and pain in elbows bilaterally; Pain in 4th and 5th fingers; bilateral knee swelling as well as left ankle swelling; Knee stiffness and Left ankle stffness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283 and expiry date not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 39-year-old) as dose 2, single, for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lamotrigine (manufacturer unknown) and levothyroxine sodium (SYNTHROID) all for unknown indication from an unknown date. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number EJ1685 and expiry date not reported) via an unspecified route of administration, administered in left arm, on 22Dec2020 (at the age of 39-year-old) as dose 1, single, for COVID-19 immunisation and experienced tingling down the arm in the 4th and 5th fingers, aching in the left wrists more than the right. 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. On 13Jan2021, the morning after receiving second dose, patient woke up in the early morning hours with extreme pain in both wrists. This progressed to include 4th and 5th fingers and elbows bilaterally. The patient was seen by the doctor a week later and scheduled for EMG due to concern over ulnar neuropathy. EMG/NCS were completely normal. In between that time on an unknown date in Jan2021, the patient developed bilateral knee swelling and stiffness, as well as left ankle swelling and stiffness. The patient finally saw a rheumatologist who is working up the patient for inflammatory arthritis. The adverse events were reported retrospectively as, the patient didn't make the connection of the timing of symptoms corresponding with dates of vaccination until consulted the rheumatologist. The patient received prednisone (manufacturer unknown) as a therapeutic measure for the joint inflammation. The patient underwent lab tests and procedures, which included EMG/NCS: completely normal; COVID-19 virus test (nasal swab) on 02Feb2021 and the result was negative. The outcome of the events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Not feeling very good; Diarrhea; Sore throat; Nausea; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apremilast (OTEZLA) taken for psoriatic arthritis, start and stop date were not reported. On 31Mar2021, the patient developed diarrhea, sore throat, nausea, headache and fever. The patient stated that she went to her HCP and had tests done on Friday 02Apr2021. The patient was not feeling very well on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Not feeling very good; Diarrhea; Sore throat; Nausea; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apremilast (OTEZLA) taken for psoriatic arthritis, start and stop date were not reported. On 31Mar2021, the patient developed diarrhea, sore throat, nausea, headache and fever. The patient stated that she went to her HCP and had tests done on Friday 02Apr2021. The patient was not feeling very well on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: the fever at the first vaccine was very livable, was not uncomfortable, and did not last long; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 09Mar2021 (Lot Number: EN6199, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, allergic to penicillin, since around 1996, corrected to 1995, she has been diagnosed with this, nodule from 2020 to an unknown date, nodules in throat, diagnosed early last year, diverticulitis from an unknown date and unknown if ongoing caller had three episodes three different times, one way back in May2010 that was the first time, then Apr2016 and the 3rd time was Sep2019, osteoporosis from an unknown date and unknown if ongoing, diagnosed when she was at 35. The patient previously received Flu vaccine and she states in 2012 the flu vaccine really hurt pain in her arm, it had not been like the other times. Concomitant medication included raloxifene hydrochloride (EVISTA) taken for osteoporosis, start and stop date were not reported, has been on for 2 or 3 years or 3.5 or longer maybe and regular vitamins but she did not take yesterday. On an unspecified date in Mar2021, the patient experienced the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. Caller adds fever with first vaccine was very low grade at night in bed, she started perspiring and that woke her up and she knows that mean by then the fever was going down. Caller adds that at the first vaccine, she may have also had this fever a couple of hours. She took notice of it because she thought it was interesting that she was not expecting any reactions. Caller adds that the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. The outcome of the event was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Hyperhidrosis, Hypersensitivity, Peripheral swelling
Clinical narrative: Allergic reaction; everything was swelling up, my feet, my toes, my hands, my stomach everything; profuse sweating; everything was swelling up, my feet, my toes, my hands; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration in the upper right arm on 06Apr2021 as dose 1, single for COVID-19 immunization (at the age of 57-years-old). Medical history included cholesterol problem from an unknown date and unknown if ongoing. Concomitant medication(s) included simvastatin and omeprazole, it was a 20mg tablet but she always took half of it so it was 10mg, taken for an unspecified indication, start and stop date were not reported. Patient initially stated she was wondering if she had an allergic reaction. She was much better that day (07Apr2021) than she was yesterday (06Apr2021). She was on Simvastatin and omeprazole and took them the night before she got her shot. Later she clarified that she had an allergic reaction to her first vaccine shot. Well, it was an allergic reaction it started out within 20 minutes (on 06Apr2021, date of vaccination) profuse sweating and she kind of brushed that off because it lasted for about she did not know off and on about an hour. And then she noticed everything was swelling up, her feet her toes her hands her stomach everything and that was when she realized she was having an allergic reaction. So, she went ahead and chewed up some Benadryl lied down took a nap slept most of the night. She was seeing signs of relief then, she meant her feet had gone down her hands had gone down her stomach had gone down. So, but she thought it was just an allergic reaction. Patient also stated that she tended to be sensitive to drugs (unspecified medications) anyway so she did not think that was anything unusual for her body because it just hated anything, it just does not like to take drugs. Patient further added that she had just a little bit of a cholesterol problem that she was on medication for. And she also wanted to ask, she was not told, not to take her usual meds the day before so she went ahead and took that statin the night before like she always did. And she wondered if that (Simvastatin) did not have something to do with it too and she also had acid reducers (Unspecified Medications, patient might be referring to Omeprazole) so she took that yesterday morning as well. Treatment was that she took Benadryl once she realized what she was going through, she went ahead and took some Benadryl. She believed it was 24 mg because she just chewed up a kitty sized one. The clinical outcome for the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Quarter size bruise that's swollen on right leg; Quarter size bruise that's swollen on right leg; This is a spontaneous report from a contactable consumer (patient's husband) or other non-health care professional. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on 05Apr2021 at 10:05 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced quarter size bruise that was swollen on the right leg. Reporter reported that they both had the vaccine yesterday, but he was concerned because it was swollen. He stated it had been a full 24 hours since the vaccine. Reporter reported that the vaccine was given yesterday, but the bruise appeared today. They have only noticed it within the last hour. Reporter mentioned that the second vaccine is scheduled on 26Apr2021. Reporter was unsure if the symptom was improved, persisting, or worsening. Outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Gingival disorder, Headache, Lymphadenopathy
Clinical narrative: entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places; lymph nodes in my throat are swollen; pain; gums all cracked open; feeling like everything was going black; chest pains; pounding headache; intense pain in my right arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 17:00 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 at 14:00 (Batch/Lot number was not reported) both as single dose (at the age of 63-year-old) for covid-19 immunisation. Patient was non pregnant at the time of vaccination. Medical history included allergies to codeine, adhesive glues/chemicals. Concomitant medications were not reported. 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 prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 01Apr2021 21:00, the patient experienced chest pains, pounding headache, intense pain in my right arm, nausea, entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places, lymph nodes in my throat are swollen, pain, feeling like everything was going black and gums all cracked open. It was reported that, patient initially had chest pains and a pounding headache within about five minutes after receiving the vaccine, along with feeling like everything was going black. After being stabilized, she went home and was okay for about 4-5 hours. When she went to bed, she became incapacitated for the next 40 hours with intense pain in her right arm and nausea. The following day, her entire mouth swelled up to the point where her gums all cracked open, along with the roof of my mouth splitting open in several places. The lymph nodes in her throat were swollen as well. It had now been 6 days and she was still in pain. No treatment was received to treat adverse events. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Nausea, Pain, Pain in extremity
Clinical narrative: entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places; lymph nodes in my throat are swollen; pain; gums all cracked open; feeling like everything was going black; chest pains; pounding headache; intense pain in my right arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 17:00 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 at 14:00 (Batch/Lot number was not reported) both as single dose (at the age of 63-year-old) for covid-19 immunisation. Patient was non pregnant at the time of vaccination. Medical history included allergies to codeine, adhesive glues/chemicals. Concomitant medications were not reported. 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 prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 01Apr2021 21:00, the patient experienced chest pains, pounding headache, intense pain in my right arm, nausea, entire mouth swelled up to the point where my gums all cracked open, along with the roof of my mouth splitting open in several places, lymph nodes in my throat are swollen, pain, feeling like everything was going black and gums all cracked open. It was reported that, patient initially had chest pains and a pounding headache within about five minutes after receiving the vaccine, along with feeling like everything was going black. After being stabilized, she went home and was okay for about 4-5 hours. When she went to bed, she became incapacitated for the next 40 hours with intense pain in her right arm and nausea. The following day, her entire mouth swelled up to the point where her gums all cracked open, along with the roof of my mouth splitting open in several places. The lymph nodes in her throat were swollen as well. It had now been 6 days and she was still in pain. No treatment was received to treat adverse events. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: lips tingling; fingertips/fingers tingling; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: EP7534, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in upper left arm on 20Mar2021 at 10:00 hours as dose 1, single (at the age of 58-years) for COVID-19 immunisation. The patient had no relevant medical history or family history, and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and did not received any additional vaccine. On 21Mar2021 around 08:00 hours, the day after he got the shot, patient had lips tingling, fingertips/fingers tingling, and events lasted for about 30 minutes. Reporter asked were these an allergic reaction to the shot, side effects of the vaccine. Patient did not treat any symptoms or received any treatment for the events. Patient had no physician office or emergency room visits. No relevant tests were performed. Patient was scheduled for tomorrow (10Apr2021) for the second dose. The outcome of all the events was recovered on 21Mar2021 at 08:30 hours.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Hands became swollen; Precursor to hives; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that 5hours after taking the Pfizer covid 19 vaccine her hands became swollen which she recognize as the precursor to hives (on an unspecified date), she took some Zyrtec (treatment) and when she woke up this morning (on an unspecified date) the swelling was gone. The patient asked was it okay for to take the second dose to which she was replied yes, the Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart, if she receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, she should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series, these may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects might occur. Pfizer-BioNTech COVID-19, Vaccine was still being studied in clinical trials. The patient further stated that her doctor told to take Tylenol and Benadryl before the second dose will that be okay, in the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take fever-reducing medications and pain relievers. The patient considered that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. But, ACIP also states that these medications should not be routinely given before the vaccine to prevent these symptoms because the effects of the medications on mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) were not available at that time. Outcome of events was recovered on an unspecified date.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Hypersensitivity, Investigation, Oropharyngeal pain
Clinical narrative: sore throat; allergic symptoms; headache; sneezing; sore throat that's burning; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Medical history included bit by a tick (but did not realize she had a tick until a few days after and it was attached for a few days and then she had the vaccine and stated that she realized it the same day or the day before and was fine and got the vaccine and was fine for several days) from 2021 to an unknown date.  The patient's concomitant medications were not reported. Patient never was sick and never got COVID. On Apr2021, (symptoms did not appear right away, started earlier this week), had sore throat and allergic symptoms and she never had allergies to spring or anything at all before and stated that she had a headache and sneezing and no fever. Patient does have a sore throat that was burning. Patient was surprised and asked was it the vaccine or not. Patient is getting worse. Patient talked to her doctor and he doesn't know and did some tests just in case. Patient wanted to know if symptoms she was having could be from the vaccine even 4-5 days after the vaccine and with symptoms or if have a reaction or symptoms was it that same day or 2 days later or can it be later. Patient was also wondering if the tick like gave problems would that interact with the vaccine, was there consequences with that if it was only the tick or only the vaccine. Patient stated it was a mess. Patient does not know what to do and patient had no fever, and the doctor won't give her antibiotics. Patient stated that a few days after the vaccine she feels like this and was testing it is a little ridiculous and also concerning. On 09Apr2021, patient was tested for Covid and waiting for the results. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Throat irritation
Clinical narrative: sore throat; allergic symptoms; headache; sneezing; sore throat that's burning; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Medical history included bit by a tick (but did not realize she had a tick until a few days after and it was attached for a few days and then she had the vaccine and stated that she realized it the same day or the day before and was fine and got the vaccine and was fine for several days) from 2021 to an unknown date.  The patient's concomitant medications were not reported. Patient never was sick and never got COVID. On Apr2021, (symptoms did not appear right away, started earlier this week), had sore throat and allergic symptoms and she never had allergies to spring or anything at all before and stated that she had a headache and sneezing and no fever. Patient does have a sore throat that was burning. Patient was surprised and asked was it the vaccine or not. Patient is getting worse. Patient talked to her doctor and he doesn't know and did some tests just in case. Patient wanted to know if symptoms she was having could be from the vaccine even 4-5 days after the vaccine and with symptoms or if have a reaction or symptoms was it that same day or 2 days later or can it be later. Patient was also wondering if the tick like gave problems would that interact with the vaccine, was there consequences with that if it was only the tick or only the vaccine. Patient stated it was a mess. Patient does not know what to do and patient had no fever, and the doctor won't give her antibiotics. Patient stated that a few days after the vaccine she feels like this and was testing it is a little ridiculous and also concerning. On 09Apr2021, patient was tested for Covid and waiting for the results. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Rash
Clinical narrative: Left arm very swollen; Very hot to touch; Red and rashy on entire upper arm; This is a spontaneous report from a non- contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8733) (age at the time of vaccination was 29 years) via an UNKNOWN route of administration on 02Apr2021 in left arm as dose 1, single for COVID-19 immunisation. The patient's medical history included drug hypersensitivity, allergies to Sulfa. Concomitant medications included Junel (ETHINYLESTRADIOL, NORETHISTERONE ACETATE). There were no other vaccine in four weeks. There was no Covid tested prior to vaccination and not tested for COVID post vaccination. Patient most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 03Apr2021, the patient experienced left arm very swollen, very hot to touch and red and rashy on entire upper arm. No treatment was received for the events. It was reported that the events were started day after vaccination and lasted about 5 days. The clinical outcome of the event left arm very swollen was recovered in 2021. The clinical outcome of the events very hot to touch and red and rashy on entire upper arm was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling cold, Hyperhidrosis, Illness
Clinical narrative: Sick; High fever as high as 101.9 degree; Vomiting; Diarrhea; Sweating and feels very cold and it has been four days; Sweating and feels very cold and it has been four days; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 51-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 31Mar2021 (Lot Number: ER8733, Expiry date: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included COVID-19 from Feb2021 to an unknown date, patient had COVID before in February. The patient's concomitant medications were none.  On an unspecified date, the patient experienced sick, high fever as high as 101.9 degree, vomiting, diarrhea, sweating and feels very cold and it has been four days. The patient had the Pfizer vaccine (COVID Vaccine) on Wednesday and patient had been sick ever since. The patient underwent lab tests and procedures which included body temperature: high fever as high as 101.9 degree on an unspecified date and sars-cov-2 antibody test: 39.10 on an unspecified date in Feb2021. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: Sick; High fever as high as 101.9 degree; Vomiting; Diarrhea; Sweating and feels very cold and it has been four days; Sweating and feels very cold and it has been four days; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 51-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 31Mar2021 (Lot Number: ER8733, Expiry date: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included COVID-19 from Feb2021 to an unknown date, patient had COVID before in February. The patient's concomitant medications were none.  On an unspecified date, the patient experienced sick, high fever as high as 101.9 degree, vomiting, diarrhea, sweating and feels very cold and it has been four days. The patient had the Pfizer vaccine (COVID Vaccine) on Wednesday and patient had been sick ever since. The patient underwent lab tests and procedures which included body temperature: high fever as high as 101.9 degree on an unspecified date and sars-cov-2 antibody test: 39.10 on an unspecified date in Feb2021. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site mass
Clinical narrative: bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; bruise the size of a quarter with lump underneath on arm at injection site/the bruise has started to turn colors so she would say, yes, it is improving; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8733) via an unspecified route of administration, administered in arm right on 01Apr2021 at 14:00 as dose 2, single (at the age of 48-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6204) via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 1, single for covid-19 immunization at the age of 48-years-old). It was reported that after receiving the second dose of vaccine on 02Apr2021 in the afternoon the patient experienced the bruise the size of a quarter with lump underneath on arm at injection site. She reported that the bruise has started to turn colors so she would say, yes, it was improving. After the patient first dose she had no side effects, it was fantastic. The patient had not underlain health conditions. The patient did not visit emergency room and physician office for the adverse events. The outcome of the events was recovering at the time of report.  No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Malaise, Respiratory disorder
Clinical narrative: little flare up of her asthma; get sicker; respiratory illness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little flare up of her asthma, get sicker and respiratory illness. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient/himself). A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201, expiration date: unknown), at the age of 72, via unspecified route, left arm, on Apr 10, 2021, at 12:50, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Apr 10, 2021 (after the vaccination), patient experienced a little swelling of his bottom lip. He took 2 Benadryl but didn't think it helped any. He also wanted to know if he should get the second dose in 3 weeks. No vaccines taken 4 weeks prior vaccinations, The outcome of the events: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (reporter's son and grandson). This is the first of two reports. A male patient (grandson) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The grandson was healthy and fine. The consumer stated that his grandson had the PFIZER Covid vaccine and had joint pain. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402538 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: significant swelling without pain; This is a spontaneous report from a non-contactable other-HCP. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunization and received lidocaine HCL strength 180 mg via an unspecified route of administration for an unknown indication. Patient medical history and concomitant medications were not reported. Patient was injected with Juvéderm VOLIFT Lidocaine in the lips a few months ago. Patient received the second Pfizer vaccine in Jan. 3 days after the vaccination, patient presented significant swelling without pain on an unspecified date in 2021. Treatment included hydrochloride 180 mg for one day without improvement, therefore the day after patient started steroids as Prednisone 20mg BID. The patient was getting better and continued with the medications. The outcome of the event was unknown.   No Follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: major swelling of all cheeks and lips area; major swelling of all cheeks and lips area; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had 1ml of VOLUMA T1. 4 months later patient had COVID-19 2nd vaccination. 2 days later the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. Patient symptoms have improved. Update that HCP feels event was not device related. Symptoms on going. Outcome of event was not recovered.  No follow-up attempts are possible. No further information was expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Contusion, Swelling
Clinical narrative: abnormal bruising; swelling started at night; This is a spontaneous report from a non-contactable other health care professional. An unspecified age and gender patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and received hyaluronic acid, lidocaine hydrochloride (Juvederm Volbella with lidocaine injection, Batch/Lot number and Expiration date was not reported), via unspecified route of administration, on an unspecified date for an unspecified indication. Patient took COVID-19 vaccine 3 weeks before the Juvederm Volbella with lidocaine injection. The patient's medical history was not reported. Patient received pre-treatment of numbing cream as concomitant medication. On an unspecified date, patient was injected with Juvederm Volbella with lidocaine injection under eye and voluma in checks jawline temples nasolabial and patient had abnormal bruising immediately after injection and swelling started at night. On an unspecified date, after 10 days, patient developed product aggregation in jaw angle and cheeks and under eye. Therapeutic measures were taken as a result of abnormal bruising and swelling started at night and treatment included post treatment of vitamin K. Record related to Juvederm Volbella with lidocaine injection. The outcome of both the events was not recovered.  No follow-up attempts were possible, information about lot/batch number could not be obtained
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Migraine, Musculoskeletal chest pain, Nausea
Clinical narrative: Severe migraines for weeks; Fatigue; Nausea; Rash on both sides of my neck; strange dreams; Night sweats; Extreme sore arm; Burning in the back of my head; Muscles soar in the back and lower rib cage; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 09:45 (Lot Number: ER8734, Expiration date was not reported) (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient received other medications in 2 weeks (details were not reported). The patient had known allergies (details were not reported). The patient had covid prior to vaccination and was tested for covid post vaccination (blood test and nasal swab). Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 09:30 (Lot Number and Expiration date was not reported) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid vaccine. On 10Apr2021 19:00, the patient experienced patient experienced severe migraines for weeks, fatigue, nausea, rash on both sides of my neck, strange dreams, night sweats, extreme sore arm, burning in the back of my head and muscles soar in the back and lower rib cage. Laboratory tests on an unspecified date included sars-cov-2 test (blood test) unknown result and sars-cov-2 test (nasal swab) unknown result. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Shot of Zofran and tramadol, Benadryl & Cortizone. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Nightmare, Pain in extremity, Rash, SARS-CoV-2 test
Clinical narrative: Severe migraines for weeks; Fatigue; Nausea; Rash on both sides of my neck; strange dreams; Night sweats; Extreme sore arm; Burning in the back of my head; Muscles soar in the back and lower rib cage; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 09:45 (Lot Number: ER8734, Expiration date was not reported) (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient received other medications in 2 weeks (details were not reported). The patient had known allergies (details were not reported). The patient had covid prior to vaccination and was tested for covid post vaccination (blood test and nasal swab). Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 09:30 (Lot Number and Expiration date was not reported) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid vaccine. On 10Apr2021 19:00, the patient experienced patient experienced severe migraines for weeks, fatigue, nausea, rash on both sides of my neck, strange dreams, night sweats, extreme sore arm, burning in the back of my head and muscles soar in the back and lower rib cage. Laboratory tests on an unspecified date included sars-cov-2 test (blood test) unknown result and sars-cov-2 test (nasal swab) unknown result. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Shot of Zofran and tramadol, Benadryl & Cortizone. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash
Clinical narrative: Had gotten rash and sore body; Had gotten rash and sore body; This is a spontaneous report from a Pfizer-sponsored program via non-contactable consumer (son) for a male patient (father). A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 01Apr2021 as dose 1, single for COVID-19 immunisation; infliximab (REMICADE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included  Still disease. The patient's concomitant medications were not reported. The patient had infusion close to vaccine. On an unknown date, the patient had gotten rash and sore body. The patient's healthcare professional (HCP) kept patient back on Prednisone 06Apr2021. The patient had not taken Remicade in 4 or 5 months. The patient's son was wondering when the patient can get 2nd dose of covid vaccine. It was not clarified if after 1st dose of vaccine, patient had to get treatment of Remicade. Therapeutic measures were taken for the events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.