chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Neoplasm
Clinical narrative: big tumor on the side of his neck; He says last night his neck was tight because it stretches so much; This is a spontaneous report from a contactable consumer.   A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 12Mar2021 (Batch/Lot Number: EN6208) at single dose (at the age of 91 years old) for COVID-19 immunisation. Medical history included emphysema from smoking, which was diagnosed about 11-12 years ago. He says he doesn't know if he has got it, his doctor had took some test that come back then he said you have emphysema. He says that it never bothers him, and he doesn't take oxygen at all. He says he take 8 medicines that he has been taking since he had a heart attack in 1996, they are not new medications. He says he had heart surgery then too.  The patient's concomitant medications were unspecified. The patient previously took BNT162B2 on 16Feb2021, dose, 1 (lot number: EN6200) for COVID-19 immunisation; the patient also had flu shot (INFLUENZA VACCINE) for immunisation. On Mar2021, the patient said he has got a big tumor on the side of his neck from it, and he wondered if there is anyone there that can tell him something to put on his neck to make it softer or go down, he has had it 4 weeks since that Friday. He said it was after the second shot that the tumor started, about the second day after it.  He said last night his neck was tight because it stretches so much. He says he has done no treatment. The events were reported as medically significant. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: rash; pain is coming; diagnosed with shingles; This is a spontaneous report received from a contactable consumer (patient's wife). A 78-years-old male patient received second Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration at a right arm on 12Feb202 at a single dose for covid-19 immunisation. The patient medical history included cancer, asthma. Caller states against his better judgement, has had cancer and has a tendency towards asthma, so he felt that he was at risk. Historic vaccine included first dose Pfizer Covid Vaccine, (BNT162B2, lot no: EL3246) at left arm, on 22 Jan 2021. Caller states he doesn't remember exactly, the first maybe the left arm and second in the right arm. Concomitant Products: Caller states nothing out of the ordinary, has had his routine medications. The patient's prior vaccinations were reported as none. On 22Mar2021, patient was diagnosed with shingles. On an unspecified date, Patient has rash and pain is coming. The report received as, caller states she is calling to report that after her husband got his second Covid shot on 12 FEB 2021, two weeks ago, he was diagnosed with shingles. Caller states she actually read an article online this morning with news that said some of the side effects are shingles. Caller states when he first got them, she jokingly said oh it's from the Covid. Caller states now after reading more and more, it could possibly be a side effect. Caller states they are drying up because the patient went to the clinic the same day that they noticed the rash and he got Valtrex. the rash on the right side from the middle of his belly around the side and have stopped at the spine and Caller states that stopped the progression of them. Caller states they are on the right side from the middle of his belly around the side and have stopped at the spine. Caller states there is no more breaking out now. Caller states the rash is better, but now the pain is coming. Caller states the clothing touching it is painful. Caller states the pharmacist suggested Asper cream with lidocaine because it calms the nerve pain. Caller states that helps for a while. Outcome of events was not recovered (reported as ongoing).   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Weight bearing difficulty
Clinical narrative: all of a sudden a pain shot through knee; he can't put any weight on it; This is a spontaneous report from a contactable consumer. A 64-year-old male patient (reporter's boyfriend) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunization. Medical history included his weight is too much, maybe 210 pounds or something around there. The patient's concomitant medications were not reported. The patient experienced all of a sudden a pain shot through knee in Mar2021, he can't put any weight on it in Mar2021. Clinical course as reported: Reporter is a consumer reporting her boyfriend received the first dose on 24Mar2021 and is reporting pain in his knee. Reporter said the boyfriend's knee pain 'comes and goes really quickly'. Her boyfriend went golfing and he was getting ready to swing and getting set and all of a sudden, a pain shot through his knee and he couldn't put any weight on it. Patient said this knee pain was happening every one in a while but not often. Patient is running around like crazy person, he never sits still. Reporter stated she would have to check with her boyfriend to say when the pain began, she thought boyfriend stated it was the same day he received the first dose of Pfizer Covid 19 Vaccine on 24Mar2021. Also said it was the same day boyfriend received first dose of Pfizer Covid 19 Vaccine or the next day, within a couple days. Happened again the other day and it seemed to be sporadic and not as intense. Reporter reported her boyfriend received his vaccine at the same place as the reporter. He got his vaccine at the same place as reporter at a different time of the day around noon. Reporter said boyfriend was supposed to go back for the second dose of Pfizer Covid Vaccine the same day the reporter was scheduled to do so. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Chills, Discomfort, Hyperhidrosis
Clinical narrative: she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfortable; armpit swelling and soreness; armpit swelling and soreness; arm being sore; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, near the top of her shoulder) on 06Apr2021 14:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her arm started to feel sore immediately after getting the vaccine on 06Apr2021. It stated that as the day went on, the soreness was getting more pronounced. When the syringe went in, she felt it, like it had crossed the cartilage or something. A few hours after that, the soreness was settling in and it was getting more sore. By the end of the day, it was more sore. Her arm was sore most of the day yesterday (07Apr2021) and was uncomfortable. Her arm is still sore today (08Apr2021) but not as bad as it was. Wednesday morning, yesterday, she woke up feeling like she was getting a cold, she was shivering. Yesterday, she spent the whole day in bed, shivering, and sweating, and running a fever. By the time she got to bed, she was feeling a little better so she thought she would be feeling better this morning. Her fever started yesterday mid-morning around 9:30 or 10:00 am. The fever lasted the whole day and subsided in the evening. She clarifies she may have a little bit of a fever now but she has not taken her temperature yet. If she does have one, it is very mild. In the middle of the night, she started to feel uncomfortable, like right under her armpit, it was sore. She woke up this morning and stated it was pretty noticeable, there was swelling kind of like under her armpit, but its more towards her chest a little. The area was very uncomfortable and very sore. She confirmed she started feeling the armpit swelling and soreness overnight last night. It's still very uncomfortable and sore. Treatment included she took 2 Acetaminophen pills, 500mg each, yesterday around 2pm and took 2 pills before going to bed last night around 8:00pm. The adverse events didn't require a visit to emergency room or physician's office. Patient had blood work in Mar2021 that showed that she had antibodies in her system. In Dec2020, patient's husband was positive for Covid and she was negative. The outcome of event feel uncomfortable unknown, armpit swelling and soreness was not recovered, the other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test, Swelling
Clinical narrative: she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfortable; armpit swelling and soreness; armpit swelling and soreness; arm being sore; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, near the top of her shoulder) on 06Apr2021 14:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her arm started to feel sore immediately after getting the vaccine on 06Apr2021. It stated that as the day went on, the soreness was getting more pronounced. When the syringe went in, she felt it, like it had crossed the cartilage or something. A few hours after that, the soreness was settling in and it was getting more sore. By the end of the day, it was more sore. Her arm was sore most of the day yesterday (07Apr2021) and was uncomfortable. Her arm is still sore today (08Apr2021) but not as bad as it was. Wednesday morning, yesterday, she woke up feeling like she was getting a cold, she was shivering. Yesterday, she spent the whole day in bed, shivering, and sweating, and running a fever. By the time she got to bed, she was feeling a little better so she thought she would be feeling better this morning. Her fever started yesterday mid-morning around 9:30 or 10:00 am. The fever lasted the whole day and subsided in the evening. She clarifies she may have a little bit of a fever now but she has not taken her temperature yet. If she does have one, it is very mild. In the middle of the night, she started to feel uncomfortable, like right under her armpit, it was sore. She woke up this morning and stated it was pretty noticeable, there was swelling kind of like under her armpit, but its more towards her chest a little. The area was very uncomfortable and very sore. She confirmed she started feeling the armpit swelling and soreness overnight last night. It's still very uncomfortable and sore. Treatment included she took 2 Acetaminophen pills, 500mg each, yesterday around 2pm and took 2 pills before going to bed last night around 8:00pm. The adverse events didn't require a visit to emergency room or physician's office. Patient had blood work in Mar2021 that showed that she had antibodies in her system. In Dec2020, patient's husband was positive for Covid and she was negative. The outcome of event feel uncomfortable unknown, armpit swelling and soreness was not recovered, the other events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Some pollen allergies like 10 days ago that caused sinus headaches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hay fever and pollen allergies and every spring she got that. Concomitant medications were not reported. The patient reported that she got the first shot on of the Pfizer COVID vaccine on 22Mar2021 and the second shot was scheduled for 16Apr2021. She stated that she had some pollen allergies like 10 days ago (On 30Mar2021) that caused sinus headaches. And 10 days ago (On 30Mar2021), she had to take antibiotics for 5 days, which ended 04Apr2021.  She wanted to know if it was okay to get the second shot. The patient stated that this was not a reaction to the vaccine, that she had been having hay fever and pollen allergies, every spring she got that. She did not think it was because of the vaccine. Event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Her fever is 103; Vomiting; Nauseated; This is a spontaneous report recieved from a contactable consumer (husband) reported for a 38-year-old female wife(patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 07Apr2021 10:30 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 15:30, the patient experienced her fever is 103, nauseated and vomiting. Caller was reporting on behalf of his wife. They both just got the Covid-19 Vaccine earlier today at around 10:30. Right now it was 16:00. It seems like his wife was experiencing some side effects, and he wanted to call to confirm and report it. She was nauseated and unwell. She has a fever, and he took her temperature several times just now. She vomited as well. She became nauseated about one hour ago. It got worse and is causing her to throw up. She threw up 3 different times in the last 30 to 40 minutes. Her fever was 103. He asks if that temperature was considered an emergency. It seemed fever as a common thing on the list about the risks, but he doesn't know about 103. Referred caller to his wife's physician for medical advice. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 after receiving the Covid 19 vaccine; Tested positive for Covid 19 after receiving the Covid 19 vaccine; This is a spontaneous report from a non-contactable pharmacist (reported for his wife). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19 after receiving the COVID-19 vaccine. She was supposed to receive her second COVID-19 vaccine on 30Mar2021 but could not because she acquired the COVID-19 virus after the first dose. The caller wants to know when his wife can receive her second COVID-19 vaccine. The patient got cleared 2 days ago. The pharmacist was getting different information on the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This is a Spontaneous report received from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Mar2021 as single dose for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  They scheduled it at 17 days to get the second dose, which is 4 days before the recommended 21 days. The patient experienced pain at the injection site. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021387360 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Influenza like illness
Clinical narrative: Chills; Flu like symptoms; Might have had diarrhea; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient friend's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus. The patient's concomitant medications were not reported. Patient was sick for a few hours after the second dose. He got it at the same time same place. He had chills, flu like symptoms, and he might have had diarrhea. He got flu like symptoms, reporter was not sure exactly what they were. Patient had chills and some more symptoms. He had the shot in the afternoon and his symptoms were over with by 23:00 or 00:00 that evening. Those symptoms are gone. The outcome of events was recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Chills; Body ache; Throat swelling; Sore throat; Fatigue; No appetite; Headache; Cough; Nausea; Cold; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; congestion; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration at the 73-year-old on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were none. The patient stated, "she had her vaccine on the 19th and she developed very strong symptoms, chills, body aches, throat swelling, sore throat, fatigue, no appetite, headaches, cough, congestion, nausea in 2021. So, last Sunday her son took she to the walk in clinic and they put she on Azithromycin pack, the Z-Pak. She was still not a 100 percent and she was scheduled to get the second vaccine next Friday which was the April 9th. So, she understand the Azithromycin, the Z-Pak, she finish on Friday. But it will cover her for the next week. So, will it be advisable for her to get the second vaccine under the effect of the Azithromycin?" The patient further stated, "she waited for so long today and I had cold previously in 2021. But she just didn't wanted to keep postponing it." Patient stated, "she was 120 before she got sick. At this report, she thought that she had lost about 5 Pounds in 2021. she was not able to eat from her throat in 2021." Patient stated, "After she took the vaccine. After the vaccine, she got sick in 2021." Patient stated, "the treatment was when she went to the she gave Azithromycin, the Z-Pak. She just said that her throat was red in 2021."Patient  stated, "She had another question for the second vaccine. Did you think she would have lighter symptoms or the same". The outcome of events was unknown.  Information about Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasal congestion, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: Chills; Body ache; Throat swelling; Sore throat; Fatigue; No appetite; Headache; Cough; Nausea; Cold; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; congestion; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration at the 73-year-old on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were none. The patient stated, "she had her vaccine on the 19th and she developed very strong symptoms, chills, body aches, throat swelling, sore throat, fatigue, no appetite, headaches, cough, congestion, nausea in 2021. So, last Sunday her son took she to the walk in clinic and they put she on Azithromycin pack, the Z-Pak. She was still not a 100 percent and she was scheduled to get the second vaccine next Friday which was the April 9th. So, she understand the Azithromycin, the Z-Pak, she finish on Friday. But it will cover her for the next week. So, will it be advisable for her to get the second vaccine under the effect of the Azithromycin?" The patient further stated, "she waited for so long today and I had cold previously in 2021. But she just didn't wanted to keep postponing it." Patient stated, "she was 120 before she got sick. At this report, she thought that she had lost about 5 Pounds in 2021. she was not able to eat from her throat in 2021." Patient stated, "After she took the vaccine. After the vaccine, she got sick in 2021." Patient stated, "the treatment was when she went to the she gave Azithromycin, the Z-Pak. She just said that her throat was red in 2021."Patient  stated, "She had another question for the second vaccine. Did you think she would have lighter symptoms or the same". The outcome of events was unknown.  Information about Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal erythema, Pharyngeal swelling, Weight decreased
Clinical narrative: Chills; Body ache; Throat swelling; Sore throat; Fatigue; No appetite; Headache; Cough; Nausea; Cold; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; I got sick, I have lost about 5 Pounds, as not able to eat from my throat; throat was red; congestion; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration at the 73-year-old on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were none. The patient stated, "she had her vaccine on the 19th and she developed very strong symptoms, chills, body aches, throat swelling, sore throat, fatigue, no appetite, headaches, cough, congestion, nausea in 2021. So, last Sunday her son took she to the walk in clinic and they put she on Azithromycin pack, the Z-Pak. She was still not a 100 percent and she was scheduled to get the second vaccine next Friday which was the April 9th. So, she understand the Azithromycin, the Z-Pak, she finish on Friday. But it will cover her for the next week. So, will it be advisable for her to get the second vaccine under the effect of the Azithromycin?" The patient further stated, "she waited for so long today and I had cold previously in 2021. But she just didn't wanted to keep postponing it." Patient stated, "she was 120 before she got sick. At this report, she thought that she had lost about 5 Pounds in 2021. she was not able to eat from her throat in 2021." Patient stated, "After she took the vaccine. After the vaccine, she got sick in 2021." Patient stated, "the treatment was when she went to the she gave Azithromycin, the Z-Pak. She just said that her throat was red in 2021."Patient  stated, "She had another question for the second vaccine. Did you think she would have lighter symptoms or the same". The outcome of events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Contraindication to vaccination, Off label use, Product use issue
Clinical narrative: Patient received first dose vaccine and has a blood clotting condition; as a blood clotting condition,She is asking if she is still advisable to get the 2nd dose; has a blood clotting condition ,She is asking if she is still advisable to get the 2nd dose; She is asking if she is still advisable to get the 2nd dose; This is a spontaneous report received from Covax US Support. This is a spontaneous report from a contactable consumer (patient). 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 30Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Ongoing medical history included antiphospholipid syndrome. The patient's concomitant medications included aspirin.   The patient stated she received first dose vaccine and has a blood clotting condition on an unspecified date. It was reported that she is scheduled for the 2nd dose on 20April2021 (exactly 21 days apart). However, she has a blood clotting disorder. She was asking if she is still advisable to get the 2nd dose. The event blood clotting condition was considered as serious (medical significant). It was reported that patient does not have the vaccine card information with her and was unable to provide the lot number. Expiry date of pfizer covid vaccine was unknown. She was given a piece of paper with all the facts on it and it said that there is concern about people with blood clotting or taking products. She has a condition called antiphospholipid Syndrome, a blood clotting disorder. (APS is the abbreviation for caller's blood clot disorder, its an autoimmune disorder, called Antiphospholipid Syndrome). She was asking if AstraZeneca Vaccine had this issue, perhaps a little bit of an issue with other vaccines as well. She made this call to find out what information can be given before receiving her second dose Pfizer Covid Vaccine. She wanted to make sure the benefit is greater than the detriment. She was asking if she is still advisable to get the 2nd dose. Therapeutic measures were taken as a result of patient received first dose vaccine and has a blood clotting condition. The outcome of events were unknown. She wants to know if she can take the second dose and she is taking aspirin for her APS.  No follow-up attempts are needed. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP7533, via an unspecified route of administration, administered in left arm on 07Apr2021 13:00 as single dose for Covid-19 immunisation. Medical history included Crohn's disease, penicillin allergy. The patient was not pregnant at the time of vaccination. On 09Apr2021, the patient experienced feeling faint and lightheadedness/dizziness. No treatment information was provided. The outcome of the event was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Influenza like illness, Myalgia
Clinical narrative: headache; muscle pain; diziness; flu simptoms; Runny nose; pain in shoulder; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported) in pharmacy or drug store, via an unspecified route administered at an anatomical site of right arm on 04Apr2021 at 12:00 (at the age of 48 years) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient stated that she only felt pain in shoulder on the second and third day of getting the first dose while also reported like the first and second day and it went away but today she was having a lot of symptoms. She read that getting the symptoms at the beginning of vaccination is normal but she had it after six days of vaccination. The patient experienced headache, dizziness, muscle pain and flu symptoms on 10Apr2021. The patient also experienced runny nose on an unspecified date in Apr2021. No treatment was received by the patient for headache, dizziness, muscle pain and flu symptoms. She wanted to know if it is normal to get the symptoms after 6 days and was informed about Pfizer medical information department. The outcome of headache, dizziness, muscle pain and flu symptoms was not recovered at the reporting time. The outcome of runny nose was unknown at reporting time. The outcome of pain in shoulder was recovered in Apr2021.   No Follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headache; muscle pain; diziness; flu simptoms; Runny nose; pain in shoulder; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported) in pharmacy or drug store, via an unspecified route administered at an anatomical site of right arm on 04Apr2021 at 12:00 (at the age of 48 years) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient stated that she only felt pain in shoulder on the second and third day of getting the first dose while also reported like the first and second day and it went away but today she was having a lot of symptoms. She read that getting the symptoms at the beginning of vaccination is normal but she had it after six days of vaccination. The patient experienced headache, dizziness, muscle pain and flu symptoms on 10Apr2021. The patient also experienced runny nose on an unspecified date in Apr2021. No treatment was received by the patient for headache, dizziness, muscle pain and flu symptoms. She wanted to know if it is normal to get the symptoms after 6 days and was informed about Pfizer medical information department. The outcome of headache, dizziness, muscle pain and flu symptoms was not recovered at the reporting time. The outcome of runny nose was unknown at reporting time. The outcome of pain in shoulder was recovered in Apr2021.   No Follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Hypotension, Loss of consciousness, Oxygen saturation
Clinical narrative: passed out/continued to drift in and out of conscientiousness; BP was very low; chest tightness; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via intramuscular route of administration on 09Apr2021 at 17:45 (at the age of 54 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stroke/heart attack from 2014 to an unknown date. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); citalopram; and clopidogrel. The patient previously took the first dose of BNT162B2 (lot number: EP6955) on 19Mar2021 (age: 54 years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient had no known allergies. On 09Apr2021 at 18:00, after second vaccine was given, patient passed out. His wife was with him. He came to but continued to drift in and out of conscientiousness. His BP was very low, pulse ox 99. He also had chest tightness. Ambulance was called. He was stable till ambulance came and took him to hospital. The events resulted in emergency room/department or urgent care and hospitalization. Therapeutic measures were taken as a result of the events which included IV fluids, Tylenol and something was placed under his tongue for chest tightness. The patient had COVID test on an unspecified date with unknown results. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: passed out/continued to drift in and out of conscientiousness; BP was very low; chest tightness; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via intramuscular route of administration on 09Apr2021 at 17:45 (at the age of 54 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stroke/heart attack from 2014 to an unknown date. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]); amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); citalopram; and clopidogrel. The patient previously took the first dose of BNT162B2 (lot number: EP6955) on 19Mar2021 (age: 54 years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient had no known allergies. On 09Apr2021 at 18:00, after second vaccine was given, patient passed out. His wife was with him. He came to but continued to drift in and out of conscientiousness. His BP was very low, pulse ox 99. He also had chest tightness. Ambulance was called. He was stable till ambulance came and took him to hospital. The events resulted in emergency room/department or urgent care and hospitalization. Therapeutic measures were taken as a result of the events which included IV fluids, Tylenol and something was placed under his tongue for chest tightness. The patient had COVID test on an unspecified date with unknown results. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Late-term miscarriage; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization in a hospital. The patient's medical history was not reported. There were no concomitant medications. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient has not had COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced late-term miscarriage on 22Mar2021 that required physician clinic visit and hospitalization for 1 day. The mother was 15 weeks pregnant at the onset of the event. Gestation period at exposure was not reported. Pregnancy due date was reported to be scheduled on 07Sep2021. The pregnancy resulted in spontaneous abortion. Fetal outcome was not reported. Therapeutic measures were taken as a result of late-term miscarriage which includes dilation and evacuation (D&E). The outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Loss of consciousness, Nausea, Pain
Clinical narrative: stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Blood test, Bone pain
Clinical narrative: BP 190/110; fainted; shortness of breath; severe pain to upper back; severe pain to upper back and shoulder; chest pain; Pain to sternum; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had pain began on 28Mar2021. This is severe pain to upper back and shoulder and chest pain causing shortness of breath and the patient fainted went to the emergency department and was ruled out stroke. 2 weeks later, the patient was still taking Ibuprofen for pain. The patient had pain to sternum on 28Mar2021. The patient has a history of hypertension and had BP 190/110 resolved only after taking Ibuprofen 800mg 3 times a day, otherwise the pain prolongs. The patient underwent laboratory tests and procedures which includes CT, blood work, EKG, Chest X-ray of chest of lung; all negative on unspecified date. The patient was reported to be hospitalized due to the events. The events were treated with Ibuprofen. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: BP 190/110; fainted; shortness of breath; severe pain to upper back; severe pain to upper back and shoulder; chest pain; Pain to sternum; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had pain began on 28Mar2021. This is severe pain to upper back and shoulder and chest pain causing shortness of breath and the patient fainted went to the emergency department and was ruled out stroke. 2 weeks later, the patient was still taking Ibuprofen for pain. The patient had pain to sternum on 28Mar2021. The patient has a history of hypertension and had BP 190/110 resolved only after taking Ibuprofen 800mg 3 times a day, otherwise the pain prolongs. The patient underwent laboratory tests and procedures which includes CT, blood work, EKG, Chest X-ray of chest of lung; all negative on unspecified date. The patient was reported to be hospitalized due to the events. The events were treated with Ibuprofen. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Syncope
Clinical narrative: BP 190/110; fainted; shortness of breath; severe pain to upper back; severe pain to upper back and shoulder; chest pain; Pain to sternum; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had pain began on 28Mar2021. This is severe pain to upper back and shoulder and chest pain causing shortness of breath and the patient fainted went to the emergency department and was ruled out stroke. 2 weeks later, the patient was still taking Ibuprofen for pain. The patient had pain to sternum on 28Mar2021. The patient has a history of hypertension and had BP 190/110 resolved only after taking Ibuprofen 800mg 3 times a day, otherwise the pain prolongs. The patient underwent laboratory tests and procedures which includes CT, blood work, EKG, Chest X-ray of chest of lung; all negative on unspecified date. The patient was reported to be hospitalized due to the events. The events were treated with Ibuprofen. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, SARS-CoV-2 test, Sensory loss
Clinical narrative: Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; some loss of sensation is also present in the index finger of the left arm; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54 years, via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EL9265; Expiration Date: May2021) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia like symptoms localized just to the right side of  body. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for an unspecified indication, start and stop date were not reported.  The patient has no known allergies. The patient experienced diagnosed radial nerve inflammation in the left arm, radiating pain throughout the lower left arm, some loss of sensation is also present in the index finger of the left arm on 01Mar2021. It was further reported that the patient was diagnosed with radial nerve inflammation in the left arm. Pain occurred two weeks after vaccination and continues up to today despite multiple medications (steroids and anti-inflammatory) tried over the last two months. In addition to radiating pain throughout the lower left arm, some loss of sensation was also present in the index finger of the left arm. The patient underwent lab tests and procedures which included nasal Swab on 24Mar2021 and 06Apr2021 which were both negative. Therapeutic measures were taken as a result of the events included Prednisone, Zorvolex and Tizanidine and Dexamethason. The outcome of the event was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Electromyogram abnormal, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; some loss of sensation is also present in the index finger of the left arm; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54 years, via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EL9265; Expiration Date: May2021) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia like symptoms localized just to the right side of  body. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for an unspecified indication, start and stop date were not reported.  The patient has no known allergies. The patient experienced diagnosed radial nerve inflammation in the left arm, radiating pain throughout the lower left arm, some loss of sensation is also present in the index finger of the left arm on 01Mar2021. It was further reported that the patient was diagnosed with radial nerve inflammation in the left arm. Pain occurred two weeks after vaccination and continues up to today despite multiple medications (steroids and anti-inflammatory) tried over the last two months. In addition to radiating pain throughout the lower left arm, some loss of sensation was also present in the index finger of the left arm. The patient underwent lab tests and procedures which included nasal Swab on 24Mar2021 and 06Apr2021 which were both negative. Therapeutic measures were taken as a result of the events included Prednisone, Zorvolex and Tizanidine and Dexamethason. The outcome of the event was not recovered.