chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Full blood count
Clinical narrative: Both knees started aching, they were painful at the same time and My knee still aches at times in the beginning it was very painful and it is less painful today; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection Batch/lot number: Unknown and expiry date was not provided), via an unspecified route of administration, in the left arm, on 05Apr2021 at 13:10 (at the age of 80-years-old) as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously taken first dose of vaccine on 14Mar2021 at 10:00. No other vaccine has been administered within 4 weeks prior to COVID shot. On 19Apr2021, patient had both knees started aching, they were painful at the same time and for his knee still aches at times in the beginning it was very painful and it was less painful today. They slowly started getting better but they aren't 100 percent yet patient was little concerned that will never get back to normal. Patient still experiencing less pain, both knees are the same slightly improved but not completely. On 18May2021, patient had complete blood count as routine lab tests and result was normal. Reporter seriousness for both knees started aching, they were painful at the same time and for my knee still aches at times in the beginning it was very painful and it was less painful today was unspecified. No treatment was received. The outcome of event was recovering.   Information about batch/lot number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Headache, Pruritus
Clinical narrative: headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE for Covid-19 immunization. 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. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE for Covid-19 immunization. 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. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity
Clinical narrative: breast are hurting; arm sore; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date (age at vaccination: 68-year-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Previously patient took first dose of bnt162b2 (Lot number EDOR76) via unspecified route for COVID-19 immunisation. The patient experienced breast was hurting and arm sore on 08Jun2021. Reporter states she took the shot yesterday and her breast are hurting. Would it make her breast hurt? she stated the second one. She had to look at the paper. It's got her arm sore and her pain in her breast. It was stated breast was hurting today, this morning it was hurting now the 8th. It keeps on hurting. she took two Tylenol as treatment for breast pain. The outcome of event was not resolved.  PSCC Communication: Provided caller with report reference. The caller was provided with phone number for safety if she would like to call back at a later time, option 3 for safety, and hours of operation.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose decreased, Hypoglycaemia, Therapeutic response unexpected
Clinical narrative: My sugar started running a little bit lower but not dangerous; I got the first shot it further gone down into the 110 which is where the warning and I kept going okay taking medicine working better; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 52 years) in Left Arm on 03Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included ongoing stage 4 non-alcoholic cirrhosis of the liver, the patient was diagnosed with a stage 4 non-alcoholic cirrhosis of the liver and they were just about they put me on a transplant now that all sudden was now the stage 2 and ongoing brittle diabetic, the patient had from a last 3 years I became very brittle diabetic they have been trying all the medication. Concomitant medications included dapagliflozin propanediol monohydrate 10mg (FARXIGA) and semaglutide 1 mg (OZEMPIC) taken for an unspecified indication. It was reported that prior to taking the first vaccine the patient had been stable and was on to medication. The patient knew their sugar started running a little bit lower but not dangerous, so something they don't know if anyone else have had experiences with blood sugars with taking this vaccine or not, you know sometimes they say unintended things affects you to medication, so they figured was this worth calling let me know about this in case is having in people and maybe whatever if getting again. Before the patient had the vaccine their sugars were very out of control, they were 200 and they had the patient on medications and was maintaining like 150 all the time. So, the patient got the first shot it further gone down into the 110 which is where the warning and they kept going okay taking medicine working better. The patient underwent lab tests and procedures which included blood glucose decreased: hypoglycemia on an unspecified date. The seriousness of the event was reported as non-serious. The outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Strange sensation in my mouth/It still kind of feels numb, a little bit.; This is a Spontaneous case report received from a Pfizer Sponsored Program. A 30-years-old contactable consumer (patient) of an unspecified gender reported that to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient took the Pfizer COVID vaccine number one shot and on an unspecified date experienced a strange sensation in mouth. She visits the dentist, and they give the shots to numb certain areas of the mouth when they go to work on the tooth or something like that. It felt just like that earlier. It still kind of feels numb, a little bit. But not as bad as 5 days earlier. The patient had this strange sensation. The events assessed as non-serious. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Feeding disorder, Headache, Insomnia
Clinical narrative: After the first dose I had nausea and headaches. Both worsened after 2nd dose; I can't eat a whole lot or sleep; I can't eat a whole lot or sleep; Everything has a funny taste to it/taste like pennies/it has a metallic taste/It's like when orange juice mixes with toothpaste/a nasty taste; My sinus is swollen too; After the first dose I had nausea and headaches. Both worsened after 2nd dose; My voice is raspy; had some diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 03Jun2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included, vomiting from. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 13-MAY-2021 and experienced nausea and headache. On an unspecified date in Jun2021, the patient experienced bad nausea, can't eat a whole lot or sleep, everything had a funny taste to it/taste like pennies/it had a metallic taste/it was like when orange juice mixes with toothpaste/a nasty taste, sinus was swollen too, headaches, voice was raspy and had some diarrhea. Patient had side effects that was not on the pamphlet she received. She received first dose on 13MAY and 2nd dose 3Jun2021. She had bad nausea, to top it off she could not eat a whole lot or sleep. Everything had a funny taste to it. taste like pennies. It did not matter what it was (it had a metallic taste; drink/liquids too). It was like when orange juice mixes with toothpaste. a nasty taste. she did have headaches when she got it initially. After the first dose she had nausea and headaches. Both worsened after 2nd dose (more with the nausea headaches was not too too bad). The nausea was unbearable. She had nausea after first shot; worsen with the 2nd one. Her voice was raspy. Her sinus was swollen too. She had vomiting before the covid vaccine when she gave blood. It had been over 3 weeks of being nauseous. She wanted to know if she should get a covid test done? She told that, she got a front and back information sheet. Not everyone was getting the same information; that needed to be corrected. Her cousin asked her about different things. Her paper was about wearing masks only have information on side effects: fever, diarrhea. She had no fever; had nausea (which wasn't mentioned on her information sheet). Even when she asked the nurse about it, she told her fever but not nausea. We all don't have the same reactions as others. She had some diarrhea. This nausea was annoying. The pamphlet they gave were different depending on clinic/site. She didn't get the same information sheet. The outcome of events was unknown.   Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sinusitis, Taste disorder
Clinical narrative: After the first dose I had nausea and headaches. Both worsened after 2nd dose; I can't eat a whole lot or sleep; I can't eat a whole lot or sleep; Everything has a funny taste to it/taste like pennies/it has a metallic taste/It's like when orange juice mixes with toothpaste/a nasty taste; My sinus is swollen too; After the first dose I had nausea and headaches. Both worsened after 2nd dose; My voice is raspy; had some diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration on 03Jun2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included, vomiting from. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 13-MAY-2021 and experienced nausea and headache. On an unspecified date in Jun2021, the patient experienced bad nausea, can't eat a whole lot or sleep, everything had a funny taste to it/taste like pennies/it had a metallic taste/it was like when orange juice mixes with toothpaste/a nasty taste, sinus was swollen too, headaches, voice was raspy and had some diarrhea. Patient had side effects that was not on the pamphlet she received. She received first dose on 13MAY and 2nd dose 3Jun2021. She had bad nausea, to top it off she could not eat a whole lot or sleep. Everything had a funny taste to it. taste like pennies. It did not matter what it was (it had a metallic taste; drink/liquids too). It was like when orange juice mixes with toothpaste. a nasty taste. she did have headaches when she got it initially. After the first dose she had nausea and headaches. Both worsened after 2nd dose (more with the nausea headaches was not too too bad). The nausea was unbearable. She had nausea after first shot; worsen with the 2nd one. Her voice was raspy. Her sinus was swollen too. She had vomiting before the covid vaccine when she gave blood. It had been over 3 weeks of being nauseous. She wanted to know if she should get a covid test done? She told that, she got a front and back information sheet. Not everyone was getting the same information; that needed to be corrected. Her cousin asked her about different things. Her paper was about wearing masks only have information on side effects: fever, diarrhea. She had no fever; had nausea (which wasn't mentioned on her information sheet). Even when she asked the nurse about it, she told her fever but not nausea. We all don't have the same reactions as others. She had some diarrhea. This nausea was annoying. The pamphlet they gave were different depending on clinic/site. She didn't get the same information sheet. The outcome of events was unknown.   Information about lot/batch number is requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Severe headache; sore arm.; This is a spontaneous report from a non contactable consumer (patient). A 31-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0165) via an unspecified route of administration, administered in Arm Left on 07May2021 at 17:30 (at the age of 31 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's past drug history included previously took Norco for allergy from an unknown date and concomitant medications were 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. The patient reported that after first dose, she had a severe headache the second day (08May2021) and a sore arm. The clinical outcome of the events was recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash; Had a reaction; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer reported for her daughter. A female patient with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, a week afternoon her arm and had a reaction. The patient didn't know what it was until her husband looked it up. It said that 7-10 days after the shot a rash can occur. No investigations were reported. Outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number are requested.
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Illness
Clinical narrative: very dejected; he's very, very sick; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. On an unspecified date, patient had no adverse effects to the COVID Vaccine after seven days that was patently false and knows a physician now after spending tens of thousands of dollars on a sick kid who was a star athlete in the state, who had not been able to find his butt with both hands after nine weeks after receiving the second COVID Vaccine and he was very, very sick and very dejected. Patient wanted to talk to a doctor who was studying the adverse effects report from the second virus from the second vaccine and wanted to talk to whoever was collecting information about the other people who had long term side effects from the COVID Vaccine. The outcome of both the events was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Chills; Fever; No appetite; Tired; This is a spontaneous report from a non-contactable consumer.  A 31-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0187) via an unspecified route of administration, administered in left arm on 28May2021 at 17:30 (at the age of 31-years-old) as a single dose for COVID-19 immunization.  dose 1 via an unspecified route of administration, administered in left arm on 07May2021 at 17:30 (Batch/Lot Number: EW0165) as 1st single dose for COVID-19 immunization. Patients past medical history included severe headache from 07May2021 after first dose and sore arm from 08May2021 (second day). The patient's concomitant medications were not reported. The patient previously took norco. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Facility where the most recent COVID-19 vaccine was administered was at the Pharmacy or Drug Store. On an unknown date, the patient experienced, headache the next day, chills, fever, no appetite for the entire day and tired. The clinical outcome for the events was recovered.   Follow-up attempts needed. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Seeing colors brilliantly.I wonder if it has somehow repaired my cones/rods. Also wondering if it has helped my blood pressure; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On an unspecified date, patient was seeing colors brilliantly. Patient knew that it was not something Pfizer has concerned with but was wondering if it has somehow repaired patient's cones/rods. Also wondering if it has helped blood pressure, of it was having started using progesterone. Prior to this, patient had very negative side effects from cardiac meds, so started progesterone and it seems to be helping. But was wondering if the shot was somehow fixing things. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Therapeutic response unexpected
Clinical narrative: Seeing colors brilliantly.I wonder if it has somehow repaired my cones/rods. Also wondering if it has helped my blood pressure; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On an unspecified date, patient was seeing colors brilliantly. Patient knew that it was not something Pfizer has concerned with but was wondering if it has somehow repaired patient's cones/rods. Also wondering if it has helped blood pressure, of it was having started using progesterone. Prior to this, patient had very negative side effects from cardiac meds, so started progesterone and it seems to be helping. But was wondering if the shot was somehow fixing things. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Rashes; Hives; Itching; Headache; Fever; This is a spontaneous report from a contactable consumer (mother) reported for her daughter. A female patient of an unspecified age 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 15Apr2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and reported that there is no reaction on previous exposure to vaccine. On 16May2021, the patient experienced rashes, hives, itching, headache, and fever (Reporter as the daughter's adverse events started on 16May2021). Caller wanted to know if these adverse events may be from the vaccine. She also wanted to know if other people have experienced their adverse events from the vaccine. The outcome of the events was reported as unknown. No PQC involved.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: she was very very tired; sleepy and weak; sleepy and weak; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (at the age of 40-years-old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received Tylenol for an unspecified indication and had allergy. On an unspecified date in 2021, after receiving first dose of vaccination, the patient was very very tired, sleepy and weak was hesitant about getting the second shot because of what happened the first time. Patient states that the only reason she got the shot was because her baby has asthma. Reportedly, the first shot patient got the day after her birthday and she was tired and weak and even the patient's baby noticed that the patient was sleepy and then she got scared. Patient reports that she just turned 40, and she was a medical assistant, so she knows her body and knows what she was talking about. The outcome of the she was very very tired, sleepy and weak were unknown.  Information on Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Headache, Hyperventilation, Malaise
Clinical narrative: Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow  pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow  pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Inflammatory marker decreased, Inflammatory marker test, Rheumatoid arthritis, Therapeutic response unexpected
Clinical narrative: her hands started sweating again; After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down; After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down; This is spontaneous report from contactable consumer. This contactable consumer (patient's husband) reported for 60-year-old Female (patient) that who received first dose 23-MAR-2021 14:40 BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number ER2613 expiry date was unknown) at arm, second dose on 29Apr2021 (Age at vaccination 60-year-old), at arm left (Lot number: ER8736 and expiry date was unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date in Jan2021 to an unknown date got the covid infection in Jan2020 and is a long hauler, hyperhidrosis from an unknown date and unknown if ongoing her hands would sweat, but after having covid they stopped sweating, arthritis from an unknown date and unknown if ongoing has a lot of inflammation of her joints. Concomitant medication(s) included prednisone (PREDNISONE) taken for rheumatoid arthritis from Jan2021 to an unspecified stop date. She was given prednisone 5 mg for the inflammation and was on it when she got her first Pfizer covid vaccine. After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down and her hands started sweating again. On an unspecified date in 2021 patient experienced after getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down (therapeutic response unexpected), after getting her second, some of her symptoms started to dissipate and on an unknown date in Apr2021 her inflammation markers are coming down and her hands started sweating again. The patient underwent lab tests and procedures which included inflammatory marker test: 2, inflammatory marker test: 8, rheumatoid arthritis: negative. Outcome of the events her hands started sweating again recovering, symptoms started to dissipate, and her inflammation markers are coming down (therapeutic response unexpected), after getting her second, some of her symptoms started to dissipate and on an unknown date in Apr2021 her inflammation markers are coming down was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Pyrexia
Clinical narrative: Stomach pain; fever for 101.5; Headache; 14 years patient received the BNT162B2 vaccine; This is a spontaneous report from a contactable consumer (patients Father). A 14-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Jun2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) on an unspecified date (3 weeks prior on Monday) for covid-19 immunisation. It was reported that his son who was 14 years old got the 2nd dose (Covid vaccine) of Pfizer yesterday around noon. So that was around something 17 hours ago, the reporter don't receive any information on how to handle any side effect. He apparently has headache and he has fever for 101.5 right now and he has stomach pain. But you said they were not open right now well that this was not very helpful at this point because its 5 eastern time right now. So where could get information on how to handle or what we should do with him to help him. If the reporter could go someplace for reference and couldnot contact at this point in time. Does not seem appropriate and especially giving that you know, you could do on a certain time. So pretty upset with that the reporter known it was recorded one. So, reporter hope someone on side does something about that because it was not very good practice he would try to find answers elsewhere. The outcome of the events were unknown.  Follow-up attempts are needed; information abut lot/batch number has been requested
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: I still have a very mild sort of ache or very mild cramp sort of feeling in my left shoulder; I still have a very mild sort of ache or very mild cramp sort of feeling in my left shoulder; This is a spontaneous report from a contactable consumer (Patient) reported herself. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 28May2021 09:45 (Batch/Lot Number: EW0183) as 2nd DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccine within prior 4 weeks of vaccination. After the administration of 2nd dose of vaccine on 28May2021 like 11 days ago and she still have a very mild sort of ache or very mild cramp sort of feeling in her left shoulder it was a lot more severe and worsened, improved and persisting.it was faded away about 3 days and when she didn't notice it for several days and she started noticing it again about 2 to 3 days ago which would have been 04Jun or 05Jun. No treatment was received. The event outcome is not recovered.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Pain
Clinical narrative: not feeling well; weak; in pain; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for a female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medication was not reported. When caller wanted to reschedule the 2nd dose of vaccine, the patient experienced not feeling well, weak and pain on unspecified date in May2021. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Illness, Lethargy, Nausea, Pyrexia
Clinical narrative: He kind of got sick; He felt lethargic; He felt feverish, he had a fever; He felt feverish, he had a fever; He felt clammy; He felt nauseated; This is a spontaneous report from a Pfizer sponsored program reported by consumer (patient mother). A 16-year-old male patient (reporter son) received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0182), via an unspecified route of administration on 02Jun2021 (at the age of 16-years-old) at 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that the patient experienced he kind of got sick, he felt lethargic, for he felt feverish, he had a fever, for he felt clammy and for he felt nauseated on an unspecified date in Jun2021. The reporter stated that it took him 3 days to get better and she is not sure what to do and she does not if she, if her son should get the second dose even after experiencing these symptoms. The outcome of all the events was reported as resolving.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a non-contactable consumer received from Pfizer sponsored program. A male patient (reporter's son) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness. The consumer wanted to know how long the vaccine was good in the fridge for. The consumer was told by Pharmacy Manager that it had changed to 30 days. The patient was taking a nap. The consumer reported possible side effect of tiredness. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Hypersensitivity, Rash
Clinical narrative: Marks on his body- rash or raised areas/patches; Allergic reaction; This is a spontaneous report from a non-contactable (Patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization.The patient experienced marks on his body- rash or raised areas/patches and allergic reaction on an unspecified date. It was reported that, patient had the first and second Pfizer vaccine and after the second shot, he developed what he thought to be an allergic reaction. He started getting marks on his body from all over and comes all by themselves and thought these were from the vaccine. Stated they were like a rash or raised areas/patches. He stated rashes or other incidents. Patient had a biopsy done and was waiting to see if this rash was drug related and stated he would call back when he gets his biopsy results if it was drug related. Patient underwent lab test which included biopsy on an unspecified date result unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This is a spontaneous report from a contactable consumer reported for her husband. This report re-ceived from a Pfizer Sponsored Program. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in right arm on 19Feb2021 (at the age of 65-year-old) at 16:00, as 1ST DOSE, SINGLE DOSE for covid-19 immunization. There were no addition-al vaccines administered on same date of the Pfizer vaccine. The patient did not receive any Prior vaccinations within four weeks. The patient did not have any medical history (including any illness at time of vaccination). Concomitant medication included Aspirin [ACETYLSALICYLIC ACID]), fish oil ,VITAMINS NOS taken for an unspecified indication. All the medications were taken by patient only sometimes. It was reported that the reporter was not certain whether he took medications within the two weeks before the vaccine. On an unspecified date in 2021, after the vaccination, the patient ex-perienced sore arm and felt tired. It was reported that the consumer was not able to remember whether the tiredness and sore arm was after the first or second dose of the vaccine. There were no relevant Tests performed. The patient did not have any adverse events following prior vaccinations. The patient did not have any family medical history relevant to adverse events. The events were re-ported as non-serious. On an unspecified date in 2021, Outcome of the events was resolved.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes all over the body; This is a spontaneous report from non-contactable consumer (reporter's husband) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rashes all over the body after first dose on an unspecified date in 2021. Reporter inquired how long will take to experience the reaction of the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: he noticed swelling on the upper L side of his body "underneath arm pit, by ribs"; he noticed pain on the L side of his body; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 27-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:00 (at the age of 27-years-old) as single dose for covid-19 immunisation. The patient did not receive additional vaccines on the same date of the Pfizer Suspect. The patient had no relevant medical history. The patient family medical history relevant to events was reported as her mother has high blood pressure. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in left arm on 14May2021 (at the age of 27-years-old) as single dose for covid-19 immunisation. On 05Jun2021, the patient experienced pain on the upper left side of his body and resolved the following day. On 08Jun2021, he noticed swelling on the upper left side of his body underneath arm pit, by ribs; on the left side of his body that has continued. After he woke today, he took pictures, and he saw the difference. He noticed the swelling after he got out of the shower and he felt it throughout the day. He is chubby but the other side of his body was not the same. It was like he had a roll with sweat underneath it. He was calling to see if this is a serious concern, and he will go to the doctor after work if he needs to. The outcome of event pain was resolved on 06Jun2021 and for another event it was not resolved.  Information on the batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: Itching all over body/lot of itching/itching felt like it was on the inside of her body, like a running itch, like ants running around constantly/itching was on the patient's back, scalp, feet, private area, arms, and legs; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration in right arm on 04Jun2021 15:50 as 0.3 mL single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient wanted to report that on Saturday and Sunday she had a lot of itching on 05Jun2021. The itching felt like it was on the inside of her body, like a running itch, like ants running around constantly. The itching was on the patient's back, scalp, feet, private area, arms, and legs. The patient would scratch her stomach and then it would go to her legs. Monday was when the patient wasn't itching near as bad as she was. The patient almost got some Benadryl but didn't know if she could take it. The itching got better. still the patient occasionally feels itching. This makes the patient nervous about getting the second dose. The patient was scheduled for her second dose of the vaccine on 25Jun2021. The patient gets a covid test about every 3 weeks to make sure she was safe. All of the patient's covid tests have been negative. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 26May2021. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.