chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Fatigue, Movement disorder, Pain, Vaccination site pain
Clinical narrative: Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; Severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away.   Injection site pain has rendered my left arm unable to lift.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 39-year-old female patient received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 26Jul2021 at 01:00 PM (age at vaccination: 39 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included seizure and allergic to Bactrim. Concomitant medication included levetiracetam (KEPPRA). The patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not received any other vaccine in four weeks. On 26Jul2021, the patient experienced severe body aches and fatigue as of 72 hours post injection. Having to continually take ibuprofen and It does not take all the ache away. Injection site pain has rendered my left arm unable to lift. The patient underwent lab test and procedure included covid-19 with positive result on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling, Pruritus
Clinical narrative: my right hand begin to swell out and itch/hand swelling/it is in the arm pit; my right hand begin to swell out and itch; my right hand begin to swell out and itch/hand swelling/it is in the arm pit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 14Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Jul2021, patient experienced my right hand begin to swell out and itch/hand swelling/ and it is in the arm pit on an unspecified date in Jul2021. Patient reported that I had the vaccine on my right arm and just this afternoon vaccination, my right hand begin to swell out and itch and wanted to know it was possible side effect of could come that late. It just started this afternoon and begin to swell you know my hand swelling. Patient stated, I was sorry can you speak slow for me please. No, it was not the written on its says, it was said something right possible to had swelling and joint pains and a muscle pains and itching but it was in the arm pit but I was just trying to know if this could be possible that it could be bad and it said to side effect to get something know only about can had rash, itches, hives so was it possible it could be this late from start, of course because I had you know few days ago possibly this could be late before I had my concern side effect. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Bradyphrenia, Fatigue
Clinical narrative: I am extremely fatigue thinking slower moving slower not getting any better; I am extremely fatigue thinking slower moving slower not getting any better; I am extremely fatigue thinking slower moving slower not getting any better; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 13Jul2021 at 15:45 pm (age at vaccination was 44 years) as dose 1, single for COVID-19 immunization. The patient's medical history included hypothyroidism, high blood pressure, diabetes and lumbar spine surgery (just had lumbar spine surgery). The patient received concomitant medications or other medications in two weeks. The patient previously took morphine and experienced known allergy to it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if post the vaccination, the patient has been tested for COVID-19. On 13Jul2021 at 15:45 pm, the patient was extremely fatigue thinking slower moving slower not getting any better. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if any treatment was received for the adverse events. The outcome of the events was not resolved.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling drunk, Laboratory test
Clinical narrative: brain fog; feeling to being slightly drunk; This is a spontaneous report received from a contactable consumer.   A 28-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, UNKNOWN), via intramuscular route, administered at arm left on 14Apr2021 (age at vaccination was 28-year-old) as DOSE 2, SINGLE and first dose BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number, UNKNOWN), via an intramuscular route, administered at arm right on an unknown date (age at vaccination was 28-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history of the patient was included COVID back in Nov2020. Patient stated, that he had an allergy to milk (Lactose intolerant). Concomitant medications of the patient included Tylenol, Whenever something hurts. Regarding others vaccination (prior 4 weeks), patient stated, No. The first vaccine so the first Pfizer vaccine and then the second Pfizer so he did take another vaccine but that was the original first dose but other then he haven't had the flu or any of the other vaccine before. On 30Apr2021, the patient was getting brain fog again, like he had when he had COVID. Patient had it when he had COVID and then after his vaccine until now so about 3 or 4 months he had like brain fog all day. Patient didn't know if it may be just COVID because they didn't know everything about it yet. He didn't know if this, what so ever. He didn't know if this was just lingering effect or maybe you guys . He had 'no complaints' about the vaccine, That's what he was curious about. He was not saying Pfizer did anything wrong or anything like that. Patient stated regarding adverse event treatment as no, he was talked to his doctor about it, other than that no. He was wondering was long term brain fog after the COVID-19 Vaccine a side effect. When again probed for the concern, consumer stated, "patient stated, "Like a brain fog more of a fatigue but it was constant like brain fog, almost the feeling to being slightly drunk. When paraphrased the above concern, patient stated, "That's something which you guys are hearing about, that's what he was curious?. At the time of this report event outcome was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: battling bi-lateral wrist pain; swelling since her 2nd shot; This is a spontaneous report from a contactable consumer (reporter's niece).   A 50-years-old not-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), unspecified route of administration as dose 2, single covid-19 immunisation. Patient had no known allergies. The patient medical history included ongoing systemic lupus erythematosus, sjogren's syndrome from 2017 and ongoing and autoimmune syndromes ongoing. The patient family history Auto immune disorders ongoing (My family relations, who also suffer with auto immune disorders). The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, single for covid-19 immunization. The patient had been battling bi-lateral wrist pain and swelling since her 2nd shot. She spoke with her the other day and learned she had similar symptoms. She suffers from sjogren's and lupus. The outcome of events was not recovered.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was really sick,; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 58-Years-Old female patient that:  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced was really sick. She also said she received both COVID vaccines not long after starting xeljanz and had bad side effects from it, said she was really sick, no other details reported. start of therapy was reported. Mar2021 per initial call but today she said she may have started a bit earlier than that with samples from her doctor. she has not spoken to her doctor but said she plans to call since she feels xeljanz is not helping and she is also due for follow up labs soon. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: my entire sense of taste and smell has completely changed and I can no longer enjoy having the food that I love; my entire sense of taste and smell has completely changed and I can no longer enjoy having the food that I love; This is a spontaneous report from a Pfizer a contactable consumer (Patient himself). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced with No reaction on previous exposure to vaccine. On an unspecified date patient stated that "her entire sense of taste and smell has completely changed and she can no longer enjoy having the food that she love, there is nothing else that could have caused that and she haven't got sick. She hasn't done anything except taking the vaccine and it's ruining my life." Outcome of events was unknown.  The lot number for the vaccine, [Pfizer/BioNTech COVID-19 Vaccine], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug hypersensitivity, Dysphonia, Hypoaesthesia, Paraesthesia
Clinical narrative: slight allergic reaction including hives; slight allergic reaction including hives; her face was swollen; face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling; Felt like it was burning and chills; within 15 minutes injection felt like it was burning; have slight hives on arms/ hives on both arm including around injection site; slight swelling; numbness in face; nasal voice; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in Arm Right on 01Aug2021 11:30 (age at vaccination: 36 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Famotidine, Levothyroxine, Zyrtec-D within 2 weeks of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing 5 to 10 years ago, polycystic ovaries from an unknown date and unknown if ongoing 5 years ago, seasonal allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity from an unspecified start date and ongoing; famotidine (FAMOTIDINE) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine (LEVOTHYROXINE) taken for biopsy thyroid gland abnormal, start and stop date were not reported. Patient didn't had COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. The patient experienced within 15 minutes injection felt like it was burning on 01Aug2021 12:00, have slight hives on arms/ hives on both arm including around injection site on 01Aug2021 12:00, slight swelling on 01Aug2021 12:00 ,numbness in face on 01Aug2021 12:00, slight allergic reaction including hives on an unspecified date, slight allergic reaction including hives on an unspecified date, her face was swollen on an unspecified date, nasal voice on 01Aug2021 , face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling on an unspecified date, felt like it was burning and chills on an unspecified date. No therapeutic measures were taken for the events. The outcome of the events vaccination site pain, urticaria, swelling, hypoaesthesia, dysphonia was recovering, the outcome of the events drug hypersensitivity, urticaria, swelling face, paraesthesia, chills was unknown.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Urticaria, Vaccination site pain
Clinical narrative: slight allergic reaction including hives; slight allergic reaction including hives; her face was swollen; face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling; Felt like it was burning and chills; within 15 minutes injection felt like it was burning; have slight hives on arms/ hives on both arm including around injection site; slight swelling; numbness in face; nasal voice; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in Arm Right on 01Aug2021 11:30 (age at vaccination: 36 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Famotidine, Levothyroxine, Zyrtec-D within 2 weeks of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing 5 to 10 years ago, polycystic ovaries from an unknown date and unknown if ongoing 5 years ago, seasonal allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity from an unspecified start date and ongoing; famotidine (FAMOTIDINE) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine (LEVOTHYROXINE) taken for biopsy thyroid gland abnormal, start and stop date were not reported. Patient didn't had COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. The patient experienced within 15 minutes injection felt like it was burning on 01Aug2021 12:00, have slight hives on arms/ hives on both arm including around injection site on 01Aug2021 12:00, slight swelling on 01Aug2021 12:00 ,numbness in face on 01Aug2021 12:00, slight allergic reaction including hives on an unspecified date, slight allergic reaction including hives on an unspecified date, her face was swollen on an unspecified date, nasal voice on 01Aug2021 , face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling on an unspecified date, felt like it was burning and chills on an unspecified date. No therapeutic measures were taken for the events. The outcome of the events vaccination site pain, urticaria, swelling, hypoaesthesia, dysphonia was recovering, the outcome of the events drug hypersensitivity, urticaria, swelling face, paraesthesia, chills was unknown.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a contactable consumer. This 35-year-old non-pregnant female consumer (patient) had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EWO191) via an unspecified route of administration on 14Jun2021 into right arm; 12:15 PM as DOSE 1, SINGLE for covid-19 immunization (at the age of 35 years) at Pharmacy or Drug Store. The patient medical history included allergic to avocado. The patients concomitant medications were not reported. It was reported that patient did not take any vaccination in four weeks and did not take other medications in two weeks. The patient was not diagnosed with COVID-19 prior to the vaccine. It was also reported that since the vaccination the patient had not been tested for COVID-19. On 18Jun2021 at 12:00 AM the patient had experienced tachycardia. Therapeutic measures were taken as a result of tachycardia and included treatment with Beta blocker. The patient had visited Emergency room/physician office/department or urgent care. The outcome of the event was recovering  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity, Peripheral swelling, Quality of life decreased
Clinical narrative: my arm got very swollen and was extremely painful; my arm got very swollen and was extremely painful; I had a lot of severe pain and I could not drive; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 25Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced my arm got very swollen and was extremely painful, i had a lot of severe pain and i could not drive on 03May2021. It was reported that as per patient, she received her 1st dose on 25Apr2021 and 8 days later her arm got very swollen and was extremely painful. She went to urgent care and they gave her pain pills but it did not work. It was only in Jul2021 that the pain stopped completely. She was told she had no scar tissue. Patient want to ask if it would be ok to get the second dose now. She received the first dose on 25Apr (clarified as 25Apr2021) and experienced swelling on arm after taking the first dose. She missed the second dose and she was asking when should she taking it again. Patient also reported that well it was not just the swelling. She had a lot of severe pain and she could not drive. So, that was the reason she could not have the second one. she only had that arm and if she got the injection on the other arm and that one swells with pain and then she would not have any arm to drive. So, then she went to the doctor and the doctor checked her arm for any scarred tissues, she did not see any scar tissues. She said it was not an allergic reaction but it was more of a rare reaction and she did not seem to know when she said when do she take the next one. She said when do she take or if she should take it. When asked for permission for further probing, patient stated that well, she does have some people here and she does not feel well to leave her information. The patient underwent lab tests and procedures which included laboratory test: had no scar tissue on 2021. Therapeutic measures were taken as a result of events with pain pills. The outcome of the events was recovered on unspecified date of 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Malaise
Clinical narrative: Very fatigued; Feeling sick; Has no energy whatsoever; was in bed all the time; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very fatigued, feeling sick, has no energy whatsoever, and was in bed all the time on an unspecified date. It was reported that, reporter friend got vaccinated in March, and it sounded like she was dying, went to 4 or 5 doctors and didn't do anything. She (the friend) was ready to go see a different doctor somewhere there. 3 people she knows that have this, and she thinks that maybe people are getting worse effects. Asked if we knew anything about that. She replied, stating that 3 of us (her and some friends) have this, and her one friend saw 4 or 5 different doctors and it didn't seem to help, which was why she decided to call us for information. Then said she would reach out to her doctor. The outcome of the events was unknown.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101007383 same reporter, same drug/event, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Headache, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: She just has a feeling of not feeling too well; fever; sore throat; her ears and face feels like a sinus issue; feeling of ear and face having a "sinus issue"; headache; This is a spontaneous report from a contactable consumer.     A 40 years old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FA7484; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 09:30 (at the age of 40 years) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccination 4 weeks prior to COVID-19 vaccination. On 30Jul2021 10:00, the patient experienced headache; 03Aug2021, the patient experienced sore throat, her ears and face feel like a sinus issue (at 07:00), fever (at 14:00), feeling of ear and face having a "sinus issue"; on an unspecified date, the patient experienced she just has a feeling of not feeling too well. The clinical outcome of the events headache, feeling of ear and face having a "sinus issue", her ears and face feels like a sinus issue was not resolved; sore throat was resolving; fever, was resolved on 04Aug2021; She just has a feeling of not feeling too well was unknown.  No follow-up attempts are possible. No information is required.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: She just has a feeling of not feeling too well; fever; sore throat; her ears and face feels like a sinus issue; feeling of ear and face having a "sinus issue"; headache; This is a spontaneous report from a contactable consumer.     A 40 years old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FA7484; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 09:30 (at the age of 40 years) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccination 4 weeks prior to COVID-19 vaccination. On 30Jul2021 10:00, the patient experienced headache; 03Aug2021, the patient experienced sore throat, her ears and face feel like a sinus issue (at 07:00), fever (at 14:00), feeling of ear and face having a "sinus issue"; on an unspecified date, the patient experienced she just has a feeling of not feeling too well. The clinical outcome of the events headache, feeling of ear and face having a "sinus issue", her ears and face feels like a sinus issue was not resolved; sore throat was resolving; fever, was resolved on 04Aug2021; She just has a feeling of not feeling too well was unknown.  No follow-up attempts are possible. No information is required.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pain
Clinical narrative: Headache; Dizziness; injection site pain and redness; injection site pain and redness; Dose 1 start date: 15Jun2021/ Dose 2 start date: 08Aug2021.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 08Aug2021 at 16:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and ethinylestradiol; norethisterone acetate (JUNEL), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 15Jun2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 08Aug2021 at 17:15, the patient experienced headache, dizziness, injection site pain and redness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, dizziness, injection site pain and redness was not recovered at the time of this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: 16 days (so far) of weakness; 10 days of fever of max 102.7F; 16 days of major rash; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 23Jul2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 21Jun2021 at 09:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 23Jul2021 at 18:00, the patient experienced 10 days of fever of max 102.7 degrees Fahrenheit; 16 days of weakness; and 16 days of major rash, now 50 percent of body. The adverse events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. On 06Aug2021, the patient had an "ID Now COVID-19 test" (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, weakness, and major rash were recovering at the time of this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Nasal congestion, Oropharyngeal pain, Toothache
Clinical narrative: Sore throat; Unexplained gum and tooth pain on right side of upper and lower jaw; Unexplained gum and tooth pain on right side of upper and lower jaw; Congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 00:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 07Aug2021 at 13:00, the patient experienced Sore throat, congestion, unexplained gum and tooth pain on right side of my upper and lower jaw. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not not taken as a result of reported events. The clinical outcome of the events sore throat, unexplained gum and tooth pain on right side of upper and lower jaw and congestion were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus off and on in left ear; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) 15 mg and levothyroxine (MANUFACTURER UNKNOWN) 150 mcg; both from an unknown date for an unspecified indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced tinnitus off and on in left ear. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus off and on in left ear was unknown at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Injection site pain; Injection site -Discomfort when the patient moved her left arm; Range of motion majorly effected; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9962) via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and asthma. The patient took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valaciclovir hydrochloride (VALTREX) and spironolactone (MANUFACTURER UNKNOWN); both taken for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 14Jan2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 08Feb2021 the patient experienced injection site pain and discomfort when she moved her left arm, and range of motion was majorly effected. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with exercise and stretching. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and discomfort, and range of motion majorly effected was not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Pleuritic pain
Clinical narrative: My last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath; My last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath; On Aug, 8th, when to the ER at (Hospital name) Hospital. The diagnosis was Pleuritic Chest; This is a spontaneous report from a contactable consumer or other non hcp.     A 68-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Right on 04Aug2021 21:00 as dose number unknown, single for covid-19 immunisation. Medical history included and concomitant was not Reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID It was Reported that, my last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath. On Aug 8th, when to the diagnosis was Pleuritic Chest Pain. Never had this before. I wanted to report this because I felt it may be related to the vaccine. on 07Aug2021 10:00 with outcome of unknown. The patient underwent lab tests and procedures which included computerised tomogram: unknown on Ae treatment. Therapeutic measures were taken as a result of my last injection was aug 4th on aug 7th, started having chest pains and hard to breath (chest pain), my last injection was Aug. 4th. on Aug. 7th, started having chest pains and hard to breath (dyspnoea), on aug, 8th, when to the er at (hospital name) hospital. the diagnosis was pleuritic chest (pleuritic pain).  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Very large swollen lymph nodes near clavicles on both sides (left and right); This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On an unknown date in Jul2021, the patient experienced swollen lymph nodes near clavicles on both sides (left and right). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes near clavicles on both sides (left and right) was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited profusely; This is a spontaneous report from a non-contactable consumer. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Aug2021 (at the age of 12-years-old), as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Jul2021, as a single dose for COVID-19 immunization. On 08Aug2021, the patient vomited profusely within 3 hours of receiving the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included rest and treatment with unspecified fluids. The clinical outcome of the event vomited profusely was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 09Aug2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications was not reported. On 09Aug2021 at 11:15, the patient experienced dizziness within 5 minutes and lasting. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event dizziness was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Begin to break out with Eczema after first dose on my back and my arms; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient began to break out with eczema after first dose on her back and her arms. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of eczema after first dose on her back and her arms and included treatment with steroids - prednisone. The clinical outcome of the event began to break out with eczema after first dose on her back and her arms was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Gastrointestinal distress; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: FC3180) via an unspecified route of administration in the right arm on 09Aug2021 at 14:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications and did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021, the patient experienced sore arm, fatigue and gastrointestinal distress. The patient did not receive any treatment for the reported events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, fatigue and gastrointestinal distress was recovered with sequelae on 09Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, SARS-CoV-2 test, Visual impairment
Clinical narrative: A week after  first dose, started experiencing about 100(+) per day eye flashes in my left eye; odd visual images; This is a spontaneous report from a contactable healthcare professional. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021(at the age of 25-year-old) as a single dose for COVID-19immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021(at the age of 25-year-old) as a single dose for COVID-19immunisation. Medical history included asthma and small fiber neuropathy. Concomitant medications included ascorbic acid (VITAMIN C) for unknown indication on an unknown date and vitamin d nos (VITAMIN D)  for unknown indication on an unknown date, multivitamins (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. The patient previously took metronidazole (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced eye flashes, it was reported that about 100(+) per day eye flashes in left eye, gone to both an ophthalmologist, who stated eyes were fine, and a neurologist who ran brain tests and did not find anything. The neurologist also theorized that this could be related to the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. . On an unknown date, the patient underwent COVID-19 virus test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event eye flashes  left eye was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Neuralgia, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Swelling of the feet, ankles, legs and hands; Neuropathy like pain; Swelling of the feet, ankles, legs and hands; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, prediabetic, asthma, high blood pressure, high cholesterol, anxiety and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously received ampicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. On 03May2021 the patient experienced swelling of the feet, ankles, legs and hands. Also neuropathy like pain in all of the above increasing with time that worsened at night. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Aug2021, the patient underwent covid rapid test and the result was Negative. Therapeutic measures were taken as a result of the reported events and included low dose diuretic. The clinical outcome of the events swelling of the feet, ankles, legs and hands and neuropathy like pain were not recovered at the time of this report.