chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin exfoliation, Weight
Clinical narrative: fire/ red sun burn rash; His skin is peeling from head to toe/He has a scaling skin; His skin is peeling from head to toe; This is a spontaneous report from a contactable consumer (patient's son) reported for a patient. A 80-years-old male patient 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 at an unspecified anatomical location on 21Jan2021 (age at vaccination was 80 years) as dose 1, single and second 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 at an unspecified anatomical location on 21Feb2021 (age at vaccination was 80 years) as dose 2, single for COVID-19 immunization. The patient's medical history included obese (he was already obese). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient developed a fire/red sun burn rash two days after his vaccine. He went to see a couple of specialists including an allergist who prescribed him prednisone. He had a scaling skin. The rash caused itchiness with prednisone it subsided. When he stops taking the prednisone it starts again. It was annoying to see him suffer like that. His skin was peeling from head to toe. The reporter didn't want the patient to take prednisone it made him hungry.On an unspecified date in 2021, he was gaining weight and he was already obese. The doctors said the rash should subside with time, but the reporter was worried and concerned. They were in May and they see no improvement. The reporter wanted to know more if anyone reported this kind of side effects and whether there was any medical treatment other than taking prednisone. The reporter received the response to discuss any alternative treatment plans with the patient's physician. The outcome of the events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever; nausea; chills; headache; achy; This is a spontaneous report from a contactable consumer (Certified Nursing Assistant) reported for a male patient. A male patient of unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, solution for injection, Lot number: unknown), via an unspecified route on an unknown date as a single dose for COVID-19 immunization. Medical history included COVID-19. The patient concomitant medications were not reported. On an unknown date, patient had a reaction after his first Covid-19 vaccine. Details of the event was not known. Patient had a fever and reporter was surprised at that because he had Covid prior to the vaccine as well. He had nausea and fever and similar symptoms (achey, chills, headache) she (reporter) was experiencing. The patient had not undergone relevant medical tests. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Excessive redness in the right eye; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced excessive redness in the right eye on an unspecified date. Event took place after use of product. Outcome of the event was unknown.   Reporter does not wish to be contacted for follow-up.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Rash pruritic
Clinical narrative: completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never goes away; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262, expiry date: unknown) via an unspecified route of administration, administered in left upper arm on 27Jan2021 11:00 AM as dose 2, single for COVID-19 immunization (at the age of 75-year-old) at hospital. The patient's medical history and concomitant medications were not reported. No family medical history relevant to AE(s). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, LOT: EL1284 expiry date: unknown) on 06Jan2021 11:00 AM via unspecific route of administration in left upper arm as dose 1, 0.3 mL single, for COVID-19 immunization (at the age of 75-year-old). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine, and no AE(s) following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. On an unspecified date in Feb2021, within a week or less of the injection the patient experienced completely round rash an inch wide on the opposite side of the injection spot that itches now and then but never went away in the inside of his arm versus the outside part of his arm where he got the injections and it might had been 3 days, it was came back from 27Jan2021 and he knew it was only there from the second injection. It was reported that, it was not rough, it was smooth, no bumps. It was started 3-4 days after the injection, it was grown in size, it was redder and more irritating. He did not pay much attention it, if it had appeared a couple days after, he expected it to fade and it never really faded. He was not wearing different shirts or anything, he had been wearing the same one. It looked like a cause and effect from the vaccination. Patient took Pfizer COVID Vaccine to protect himself from the virus. On an unspecific date, the patient underwent lab tests and procedures which included blood count: all came back fine. He had blood work every 3 months all came back fine, cholesterol blood pressure and things of that nature. It was nothing related to the COVID vaccine. The patient had not visited the emergency room for the event. The event resulted in doctor or other healthcare professional office/clinic visit which includes he had seen a dermatologist for the event about 3 weeks ago, approximately, and he saw it, and said it is not like rashes he has seen with the vaccine and thought it was an irritation of some short. The outcome of the event was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin disorder, Urticaria
Clinical narrative: I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; Rashes; Paintbrush stokes of redness on his skin; The initial case was missing the following minimum criteria [Unidentifiable reporter]. Upon receipt of follow-up information on [27Apr2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via Pfizer-sponsored program Corporate (Pfizer).  A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number-unknown (not specified clearly) via an unspecified route of administration in left arm on 08Feb2021 (at the age of 59 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient medical history was not reported. The patient had no known allergies. The concomitant medications included other medications taken within two weeks was simvastatin (ZOCOR) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no: not reported/Lot number- EL1283) via an unspecified route of administration in right arm (reported as right) on 11Jan2021 08:00 am (at the age of 59 years-old) as dose 1, single for COVID-19 immunization. No other vaccine taken within four weeks. Patient had not tested for covid prior vaccination and tested for covid post vaccination. It was reported that a week after his second dose on 17Feb2021, the patient had developed hives and rashes randomly on his body. Sometimes it looks like paintbrush strokes of redness on his skin, these hives/rashes are very itchy. Reported adverse events resulted in Doctor or other healthcare professional office/clinic visit. Both his allergist and dermatologist told him that it was his body reaction to the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test results negative for covid-19 on 13Feb2021 for type of other and on an unspecified date tested for Allergy test with normal results (everything was fine). No treatment received for adverse events. The outcome of all events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swelling in neck; He thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet; This is a spontaneous report received from a contactable consumer or other non-health professional (patient). A 49-year-old male consumer received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Unknown) dose 1, Via an unspecified route of administration, administered in left deltoid on 29MAR2021 at 12:00 as a single dose for (at the age of 49 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior Vaccinations were none.  On Apr2021 he has had swelling in his neck started late Tuesday and late Wednesday, and it comes and goes and he thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet. Treatment include he has been taking Advil and that seems to help. Outcome of the event were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Rash
Clinical narrative: rash; This is a spontaneous report from a contactable male consumer(patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced rash. The patient stated that he had what he suspect was rash from Pfizer Vaccine and his current dermatologist said only that it was unusual then left me hanging for the next month without any explanation for the numerous lab reports that were all inconclusive his lack of concern was unacceptable. Fortunately, the rash was finally went away, outcome appears resolved on its own. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait inability, Illness, Pyrexia
Clinical narrative: got sick; fever; chills; couldn't walk upstairs; This is a spontaneous report from a contactable other health professional received from a Pfizer COVID Vaccine Program. An adult male patient in his forties  received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got sick, fever and chills. It was reported that, the reporter has not seen anybody, they've, like, started to pull weird stuff that have happened three weeks later, there's like a, an, uh, obstetrician who had some blood platelet thing and they're trying to figure it out. But they're not really sure if it's related. They stated that, old people usually don't have a side effect. Stated that, [name other] got sick after the second one, too. Stated that, he got chills, fever and got sick after the second one. Stated that, dr had to send home the other day as the patient couldn't walk upstairs. The outcome of events was unknown. The causality was reported as related.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swole up; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 77-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sensitivity (not allergy) to iodine, penicillin which goes away by itself. The patient's concomitant medications were not reported. The patient previously took sulfur and experienced sensitivity which goes away by itself. On an unspecified date, the patient experienced swole up. When they went to see into her heart they gave her a lot of stuff, she swole up, they didn't tell her 100% that it was caused by the iodine. Also, an injection with painkillers made her swell up once. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Movement disorder, Pain, Pain in extremity
Clinical narrative: Painful burn / rash all over hands; Painful burn / rash all over hands; He has brown spots on the tops of his hands.; The burn are did go to his other pointer/index finger and across his other fingers; Everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands; he couldn't even lift his arm up; sleeps on his left side and he couldn't sleep the night he got the vaccine; his arm was super painful; He felt so mad; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 32-year-old) as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, he reports he sleeps on his left side, and he couldn't sleep the night he got the vaccine. On 15Apr2021 the patient experienced painful burn / rash all over hands, he has brown spots on the tops of his hands, the burn are did go to his other pointer/index finger and across his other fingers, everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands, he couldn't even lift his arm up, and on unknown date in Apr2021 his arm was super painful and he felt so mad. It was reported that, he's left-handed and the day he received the COVID 19 vaccine was the worst day, he couldn't even lift his arm up. His arm was super painful. He tried to sleep on his back, and he'd roll over onto his arm and wake up in pain. He took pictures of his hands every day. He has pictures to show. He took pictures of his hands to a friend of his who was an emergency room doctor and his doctor friend told him that he's definitely having a reaction to the COVID 19 vaccine. He went back to the facility that gave him the COVID 19 vaccine and the person at that facility told he should not get the second vaccine and that he should see his primary care doctor. He sent these pictures to his doctor friend. The clinical outcome of the event painful burn / rash all over hands, was not revered and while the outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Skin exfoliation, Thermal burn
Clinical narrative: Painful burn / rash all over hands; Painful burn / rash all over hands; He has brown spots on the tops of his hands.; The burn are did go to his other pointer/index finger and across his other fingers; Everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands; he couldn't even lift his arm up; sleeps on his left side and he couldn't sleep the night he got the vaccine; his arm was super painful; He felt so mad; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 32-year-old) as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, he reports he sleeps on his left side, and he couldn't sleep the night he got the vaccine. On 15Apr2021 the patient experienced painful burn / rash all over hands, he has brown spots on the tops of his hands, the burn are did go to his other pointer/index finger and across his other fingers, everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands, he couldn't even lift his arm up, and on unknown date in Apr2021 his arm was super painful and he felt so mad. It was reported that, he's left-handed and the day he received the COVID 19 vaccine was the worst day, he couldn't even lift his arm up. His arm was super painful. He tried to sleep on his back, and he'd roll over onto his arm and wake up in pain. He took pictures of his hands every day. He has pictures to show. He took pictures of his hands to a friend of his who was an emergency room doctor and his doctor friend told him that he's definitely having a reaction to the COVID 19 vaccine. He went back to the facility that gave him the COVID 19 vaccine and the person at that facility told he should not get the second vaccine and that he should see his primary care doctor. He sent these pictures to his doctor friend. The clinical outcome of the event painful burn / rash all over hands, was not revered and while the outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Temperature; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age 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 at an unspecified anatomical location on 14Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and temperature. The patient wanted to know if she has to get the second dose of vaccine as she experienced side effects of headache and temperature following the first dose on 14Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Polymerase chain reaction, Pyrexia, Respiration abnormal
Clinical narrative: fever; discomfort as well as breathing; discomfort as well as breathing; he experiences a shortness of breath; This is a spontaneous report from a Pfizer sponsored program. This contactable male consumer (Patient) reported for himself that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021 after the vaccination, the patient experienced a shortness of breath. On an unspecified date, the patient experienced fever and discomfort as well as breathing. On an unspecified date, the patient underwent lab tests and procedures which included PCR test: unknown result (he was waiting for the result). It was reported that, patient had his 1st shot this 22Apr2021. He did some workout in the gym after taking it, then after getting home, he experiences a shortness of breath that was about 45mins, the day after which was Friday, he felt fever and discomfort as well as breathing. On the same day, he actually did a PCR test, and he was still waiting for the result. Patient was concerned if those experiences was from COVID-19 or from the vaccine. Unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Disorientation, Dizziness, Fatigue
Clinical narrative: disoriented; dizzy; I felt drunk; Patient was also having paranoid thoughts; chills; nausea; forgetfulness; slightly depressed mood; fatigue; This is a spontaneous report from a contactable consumer(patient).    A 49-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Zn6208), via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. Medical history included OA HTN PMDD (premenstrual dysphoric disorder), food allergy, gluten sensitivity, dairy intolerance. The patient had COVID prior vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), lisinopril, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE], vitamin c [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL] (taken for an unspecified indication from an unspecified start date to an unspecified stop date). Patient was not pregnant at the time of vaccination. Patient reported after her first dose, later in the day, on 23Mar2021 at 20.00, the patient experienced disoriented, dizzy, felt drunk. It lasted for several hours. Patient was also having paranoid thoughts. Patient had to ask her husband to pick her up because she did not think she could drive. After that patient had the effects that most people report chills, nausea, forgetfulness, slightly depressed mood, fatigue, etc. The patient received Psych care treatment for the events. On 23Apr2021 patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative (nasal swab). The patient had COVID test post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Memory impairment, Nausea, Paranoia, SARS-CoV-2 antibody test
Clinical narrative: disoriented; dizzy; I felt drunk; Patient was also having paranoid thoughts; chills; nausea; forgetfulness; slightly depressed mood; fatigue; This is a spontaneous report from a contactable consumer(patient).    A 49-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Zn6208), via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. Medical history included OA HTN PMDD (premenstrual dysphoric disorder), food allergy, gluten sensitivity, dairy intolerance. The patient had COVID prior vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), lisinopril, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE], vitamin c [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL] (taken for an unspecified indication from an unspecified start date to an unspecified stop date). Patient was not pregnant at the time of vaccination. Patient reported after her first dose, later in the day, on 23Mar2021 at 20.00, the patient experienced disoriented, dizzy, felt drunk. It lasted for several hours. Patient was also having paranoid thoughts. Patient had to ask her husband to pick her up because she did not think she could drive. After that patient had the effects that most people report chills, nausea, forgetfulness, slightly depressed mood, fatigue, etc. The patient received Psych care treatment for the events. On 23Apr2021 patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative (nasal swab). The patient had COVID test post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Spinal pain
Clinical narrative: pain in joints; Pain in joints and spine; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 18Feb2021(at the age of 80-year-old), as Dose 2,Single for COVID-19 immunization at hospital. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Right on 28Jan2021 at 10:45 as Dose 1,Single for COVID-19 immunization. The patient medical history included hypersensitivity (allergies) since childhood and still ongoing, drug hypersensitivity (Allergy to IVP dye) from 1970 and ongoing since 1st administered, obesity from 1989 and ongoing, coronary artery disease from an unspecified date and still ongoing. Concomitant medications included valsartan from past 20 years and ongoing, atorvastatin from past 10 years and ongoing and metoprolol from past 20 years and ongoing, all taken for an unspecified indication. On an unspecified date, the patient experienced pain in joints and spine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling of face; Slight rash on face; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 01Apr2021 (age at vaccination was 21 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 22Apr2021 at 12:00 PM (age at vaccination was 21 years) as DOSE 2, SINGLE for covid-19 immunisation at other facility. The patient was not pregnant at the time of vaccination. Medical history was none. No known allergies reported. Concomitant medications were not reported. No other vaccines were received within four weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 22Apr2021 at 09:00 PM, the patient experienced swelling of face and slight rash on face. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures taken as a result of the events included treatment with Benadryl 25mg every 6 hours. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovering.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site haemorrhage
Clinical narrative: having some bleeding on the administration site of the vaccine; might have considered that they have hit a wrong vessel; This is a spontaneous report from a contactable Pharmacist reported for a consumer (patient). A 50-years-old female received second 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 at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously 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 at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had some bleeding on the administration site of the vaccine. The reporter wanted to get recommendations as to the administration of a possible third dose (it's safety and possible timing) to a patient who feared that they might not get the recommended dose to elicit full efficacy of the PFIZER-BIONTECH COVID-19 VACCINE following that her 2nd dose was administered on a manner where she bleed. Immunizing authority might have considered that they have hit a wrong vessel upon the administration of the vaccine, thus the bleeding on the patient's end. Now, patient was suggesting to have a 3rd dose as she was afraid that vaccine came out alongside with her blood. The reporter also gave an additional information that they would consider these events normal and not report this because on his own opinion, having some bleeding on the administration site of the vaccine didn't merely state that the vaccine/drug comes out of alongside with it. However, he only would like to be certain about this. The reporter wanted to know if patients receiving 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE who did not experienced any side effect should be concerned about vaccine efficacy. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue
Clinical narrative: bruisingon the neck; Experienced fatigue; This is a spontaneous report from a Pfizer sponsored program Support. A contactable female consumer (Patient) reported for herself:  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced bruising on the neck and fatigue (after getting second dose). The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Inflammation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 34-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0161), at the age of 34, via an unspecified route of administration, in left arm, on Apr 16, 2021, at 10:15, single dose, for COVID-19 immunisation. Medical history: none. The patient has no known allergies. The patient's concomitant medications not reported. The patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), on an unspecified date, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested for COVID-19 since the vaccination. On Apr 27, 2021, at 08:00, patient had a very big inflammation in her left armpit. It hurts and she was worried about it, since she will most likely need a mammogram to study the case. She read it might be linked to COVID-19 vaccine effects and wanted to report it in order to make the right diagnosis and treatment. No treatment received for adverse events. She was asked for further studies to identify the reason for the bump and if is a reaction from the vaccine or something else. Reportedly, the event took place after use of product. The outcome of events: not recovered. No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Red bumps to her legs and neck and they are itchy; red bumps to her legs and neck and they are itchy; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 23Apr2021 09:00 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 02Apr2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced red bumps to her legs and neck and they are itchy. Caller got the first dose of the vaccine on 02Apr2021 and the second was received yesterday 23Apr2021 at 9am (correct dosing schedule). Reporter said she woke up this morning with red bumps to her legs and neck and they are itchy. She wanted to know if it was okay to take Benadryl. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache; chills; fever; nausea; This is a spontaneous report from a Pfizer-sponsored program COVAX US support via a contactable consumer reported for a patient (reporter's granddaughter). A female patient of an unspecified age 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 at an unspecified anatomical location on 24Apr2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, chills, fever and nausea after the first dose of the COVID vaccine. The reporter was wondering what the patient could take to treat the symptoms. The outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Migraine, Polymerase chain reaction
Clinical narrative: Allergic reaction; Migraine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included mild case of covid infection (prior to first shot) and did not develop any antibodies as per a PCR test done 2 and 3 weeks after infection. The patient stated that she was at high risk for covid infections. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction, migraine for 14 days. On an unspecified date, the patient underwent lab tests and procedures which included polymerase chain reaction: did not develop any antibodies. The outcome of events unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Allergic reaction; Migraine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included mild case of covid infection (prior to first shot) and did not develop any antibodies as per a PCR test done 2 and 3 weeks after infection. The patient stated that she was at high risk for covid infections. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced allergic reaction, migraine for 14 days. On an unspecified date, the patient underwent lab tests and procedures which included polymerase chain reaction: did not develop any antibodies. The outcome of events unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Skin disorder
Clinical narrative: headache; fever; chills; very unusual markings on legs; This is a spontaneous report from non-contactable consumer (patient himself) via Pfizer sponsored program.  A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccine, the patient had experienced normal side effects such as headache, fever and chills. But the last week or so he had very unusual markings on legs. Lines on legs go up and down and they come and go. Never took any medication. Even HCP doesn't knew where marks came from but suggested covid vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arm sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an unspecified route of administration in Arm Left on 05Mar2021 (age at vaccination 64years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Taking metformin maintain normal range, obesity from an unknown date and unknown if ongoing 300 lbs, hypertension from an unknown date and unknown if ongoing maintain normal range with mild medication, arthritis from an unknown date and unknown if ongoing take anti-inflammatory drugs, pain medication as needed. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via an unspecified route of administration in Arm Left on 05Mar2021 14:00 (age at vaccination 64years old) as single dose for covid-19 immunisation. Concomitant medication(s) included paracetamol (TYLENOL); diphenhydramine hydrochloride (BENADRYL) all taken for an unspecified indication, start and stop date were not reported. The patient experienced arm sore on an unspecified date. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of arm sore.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site haemorrhage
Clinical narrative: she bled at injection site after administration and some vaccine; she bled at injection site after administration and some vaccine; This is a spontaneous report from a Pfizer sponsored program support. A contactable health care professional reported for the patient. A female patient of an unspecified age received 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 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had bled at injection site after administration and some vaccine might have come out. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia, Sinusitis
Clinical narrative: sinisistus; low grade fever; cough; body aches; chills; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 06Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinisistus, low grade fever, cough, body aches and chills. Patient and her husband were due for second dose of bnt162b2 vaccine Thursday, she had two questions, what was the reason for the time laps in reactions (14-15 days) and should they get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Fall, Fatigue
Clinical narrative: Arm swelling; Unable to stand without falling; Unable to stand without falling; Very dizzy; Severe fatigue; Migraine/sledgehammer feeling in my head and temp; Migraine/sledgehammer feeling in my head and temp; Chills; High fever; Vomited; Chest palpitations; A 43-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history was none. Patient had no known allergies. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, 7 hours after the vaccination, patient experienced arm swelling, unable to stand without falling, very dizzy, severe fatigue, migraine/sledgehammer feeling in my head and temp, chills, high fever, vomited 4 times and chest palpitations. Patent reported that she started recommended medication and will seek medical care. The outcome of all the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Palpitations, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling; Unable to stand without falling; Unable to stand without falling; Very dizzy; Severe fatigue; Migraine/sledgehammer feeling in my head and temp; Migraine/sledgehammer feeling in my head and temp; Chills; High fever; Vomited; Chest palpitations; A 43-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history was none. Patient had no known allergies. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, 7 hours after the vaccination, patient experienced arm swelling, unable to stand without falling, very dizzy, severe fatigue, migraine/sledgehammer feeling in my head and temp, chills, high fever, vomited 4 times and chest palpitations. Patent reported that she started recommended medication and will seek medical care. The outcome of all the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.