chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Pain in extremity
Clinical narrative: headache; tenderness (sore) in the arm that received the injection; feeling achy in my back; feeling achy in my back and large joints (knees and elbows); This is a spontaneous report from a contactable consumer. A male patient (Age: 46; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced headache, tenderness (sore) in the arm that received the injection and feeling achy in my back and large joints (knees and elbows). Patient took an ibuprofen and the headache and soreness started to go away after a couple of hours. Event took place after use of product. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising at the site; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were 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 received the 1st dose of the Pfizer Covid-19 Vaccine and had bruising at the site. She was on a blood thinner and we did not mention that before the shot. When she goes for the 2nd shot, I would like to know if she should stop taking Zoral Blood thinner before the shot. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Headache; feeling tired; little bit of chills; joint pain; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 24Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on unspecified date for covid-19 immunization. The patient experienced headache, feeling tired, little bit of chills, joint pain on an unspecified date. Would like to take Aspirin or Tylenol. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: experiencing swelling; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for male patient (husband) that:  A male patient of unspecified age had received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, on 29JAN2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. (Reporter name) called on behalf of her husband (Name) who got his 1st dose last 29Jan2021. 2nd dose was cancelled due to the snowstorm. New appointment for the 2nd dose will be 27Feb2021. On an unspecified date, patient had experienced swelling. The took patient to the Emergency room and took 40 shots of Kenalog. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus allergic
Clinical narrative: Allergic reaction - pruritis over entire body; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 39-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 04Mar2021 15:30 (at the age of 39-years-old) as DOSE 1, SINGLE for covid-19 immunization. (Vaccination facility: other). Medical history included hypertension, Hashimoto, depression all from an unknown date and unknown if ongoing. Concomitant medication (other medications in two weeks) included lisinopril (LISINOPRIL), fluoxetine hydrochloride (PROZAC), levothyroxine (LEVOTHYROXINE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug hypersensitivity (known allergies to doxycycline). Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. It was reported that on 04Mar2021 15:30 patient experienced Allergic reaction Pruritus over entire body. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result event with Self medicated Benadryl. The outcome for the event was reported as unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.  .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: chills; headache; body aches; Malaise; This is a spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter sent in across referenced case which included that. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231; Expiration Date: Apr2021), dose 2 intramuscular, administered in Deltoid Left on 11Jan2021 17:30 (at the age of 65-year-old), as dose 2, single for COVID-19 immunization in hospital. Medical history included Crohn's disease from 2011 to an unknown date. The patient's concomitant medications were not reported. On 11Jan2021 the patient received Tylenol per oral prior to vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK5730; Expiration Date: Mar2021), dose 1 intramuscular, administered in Deltoid Left on 21Dec2021 (at the age of 65-year-old), as dose 1, single for COVID-19 immunization. No pneumococcal vaccine was vaccinated within four weeks before BioNTech Vaccine and was not Pfizer vaccine. On 11Jan2021 08:00, the patient experienced chills, headache, body aches, malaise. The patient did not receive any treatment for the events. Emergency Room and  Physician Office visit was not required for events. No primary infection site applicable. No predisposing factors were there. No culture performed. No seriousness criteria provided. The clinical outcome of the events was recovered in 2021.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: arm soreness, body ache, fatigue 24hour later; arm soreness, body ache, fatigue 24hour later; arm soreness, body ache, fatigue 24hour later; This is a spontaneous report from a contactable other HCP (patient). This other HCP reported in response to the HCP letter sent in cross reference case that, A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 2 intramuscularly administered in Deltoid Left on 13Jan2021 at 18:00 (at the age of 26-years-old) as SINGLE DOSE for covid-19 immunisation at Hospital. The patient medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 2008 to an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) Synthroid 62.5 mg PO (oral) daily taken for hypothyroidism from 2008 and ongoing. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), dose 1 intramuscularly administered in Deltoid Left on 23Dec2020 at 18:00 (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Prior Vaccinations (within 4 weeks) and events following Prior Vaccinations were none. The patient experienced arm soreness, body ache and fatigue 24hour later on 13Jan2021 at 18:00. The patient provided information regarding the reported adverse events with the use of the product. Patient considered the Pfizer product had a causal effect to the adverse event. After dose one, patient had arm soreness & headache 24 hour later. After second dose had arm soreness, body ache, fatigue 24 hour later. Event did not require emergency room or physician office.The patient was not deceased, and treatment was not required. Family Medical History Relevant to events were none. Relevant Tests done were none. The patient was not admitted to hospital. There was causal relationship reported as reasonable possibility that the event is related to suspect products. Outcome of all the events were recovered.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL3147) via an unspecified route of administration (age at vaccination 41-year) on 21Jan2021 as dose 2, single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen; paracetamol (TYLENOL); ipratropium bromide, salbutamol sulfate (COMBIVENT); salbutamol (VENTOLINE [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 for COVID-19 immunization. On an unspecified date the patient experienced chest pain. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Echocardiogram, Gait disturbance
Clinical narrative: her blood pressure was 88 over something/her pressure was very low; started having some difficulties, then Friday was the worst, she couldn't hardly walk no appetite; started having some difficulties, then Friday was the worst, she couldn't hardly walk no appetite; weak; diarrhea; listless; This is a spontaneous report from a contactable consumer or other non hcp. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6203), intramuscular, administered in Arm Left on 24Feb2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Caller reported that he and his wife got their first Pfizer covid vaccine dose on 24Feb and his wife started having some difficulties, then Friday (unspecified date) was the worst, she could not hardly walk, she became weak, has had no appetite, they called the doctor, the doctor they said they had to get checked out for covid first. They went to get checked out and were reported negative for covid. The doctor seems to think that the vaccination caused the problem. The doctor suggested for them to call Pfizer and advise them on what to do. He wanted to know if he and his wife can go for second shot scheduled on 17Mar2021 or not. Upon follow-up patient herself explained every day after she received the shot, she got weaker and weaker. Patient clarified events began on Thursday, 25Feb2021. She got the shakes sometimes it was uncontrollable. She also had diarrhea. At one point, it got so bad she could not walk. She mentioned she had no appetite, she was listless. She could not think of all the different things that went wrong. Every day was a slight improvement. She was doing physical therapy, she clarified as of today (unspecified date), she had it. She states her doctor took a cardiogram and her blood pressure was 88 over something, her pressure was very low. She stated the doctor also took a couple of vials of blood. She does not have the results yet. The patient underwent lab tests and procedures which included echocardiogram: blood pressure was 88 on cardiogram and her blood pressure was 88 over something, her pressure was very low, sars-cov-2 test: negative on an unspecified date. Patient visited physician office for adverse events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Listless, SARS-CoV-2 test
Clinical narrative: her blood pressure was 88 over something/her pressure was very low; started having some difficulties, then Friday was the worst, she couldn't hardly walk no appetite; started having some difficulties, then Friday was the worst, she couldn't hardly walk no appetite; weak; diarrhea; listless; This is a spontaneous report from a contactable consumer or other non hcp. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6203), intramuscular, administered in Arm Left on 24Feb2021 (at the age of 80-year-old) as dose 1, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Caller reported that he and his wife got their first Pfizer covid vaccine dose on 24Feb and his wife started having some difficulties, then Friday (unspecified date) was the worst, she could not hardly walk, she became weak, has had no appetite, they called the doctor, the doctor they said they had to get checked out for covid first. They went to get checked out and were reported negative for covid. The doctor seems to think that the vaccination caused the problem. The doctor suggested for them to call Pfizer and advise them on what to do. He wanted to know if he and his wife can go for second shot scheduled on 17Mar2021 or not. Upon follow-up patient herself explained every day after she received the shot, she got weaker and weaker. Patient clarified events began on Thursday, 25Feb2021. She got the shakes sometimes it was uncontrollable. She also had diarrhea. At one point, it got so bad she could not walk. She mentioned she had no appetite, she was listless. She could not think of all the different things that went wrong. Every day was a slight improvement. She was doing physical therapy, she clarified as of today (unspecified date), she had it. She states her doctor took a cardiogram and her blood pressure was 88 over something, her pressure was very low. She stated the doctor also took a couple of vials of blood. She does not have the results yet. The patient underwent lab tests and procedures which included echocardiogram: blood pressure was 88 on cardiogram and her blood pressure was 88 over something, her pressure was very low, sars-cov-2 test: negative on an unspecified date. Patient visited physician office for adverse events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine, Blood urine present, Ear haemorrhage
Clinical narrative: blood in urine; blood on my ear; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 72-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Age at vaccination: 72-years-old) as single dose for covid-19 immunization. Medical history included atrial fibrillation and Blood pressure both from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol (BISOPROLOL) taken for an unspecified indication start and stop date were not reported, rivaroxaban (XARELTO) taken for Heart murmur and atrial fibrillation start and stop date were not reported. It was reported that patient had the shot and he on blood thinner and four days after the shot he got little blood in his urine. So, he was wondering, was that any effect of the shot. Upon date 16Mar2021 it was reported that had a problem after had his second shot within 3 days he went to the bathroom and he had blood on his ear and for about 3 times he went to the bathroom. he want to know is that from the shot or should he go see a doctor. Upon date 16Mar2021 it was reported that. he was wondering, he had his shot, two shots, the second shot he got about three days ago and then after the shot, he had blood in my urine. Three days after his second shot, he had blood in my urine for about two to three times. Patient further stated, all he want to know is if other people has had that or is it common or should he go to another doctor or what is going on. Patient was not received any treatment for the events. The patient underwent lab tests and procedures which included blood urine: blood in urine. The outcome for the evens was reported as unknown at the time this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: hive near my hair line; felt lousy / was kind of in a fog and didn't feel great.; This is a spontaneous report received from a non-contactable consumer reported for 74-Year-old female patient that:  A 74 years female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, on 01MAR2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states she received the Pfizer Covid vaccine first dose on the 01Mar2021, and experienced "I got a hive near my hair line, 4 or 5 days after I got my vaccine, I felt lousy for 2 weeks after the shot. but I always have bad reactions to everything. I didn't have SOB or fever, but I took Tylenol after the vaccine. I took Benadryl, I took 2 on Saturday night and 1 on Sunday and one on Monday. I went back to normal on Friday, I was kind of in a fog and didn't feel great. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis
Clinical narrative: been overcoming a cold. She's starting to feel better but still has cough and congestion; Cough; congestion; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old female patient received BNT162B2 (PFIZE-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, 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 had been overcoming a cold. She was starting to feel better but still has cough and congestion. The outcome of event cold was recovering, and outcome of all other event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Rash
Clinical narrative: Rash on the chest; itchy feel, rash inside of the thigh, itching; Sore throat; This is a spontaneous report from a contactable consumer, reported for herself. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 18Mar2021 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 on the chest warm to the touch, bunch of bumps, itchy feel, rash inside of the thigh, itching, sore throat. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bite, Inappropriate schedule of product administration, Rash
Clinical narrative: developed a rash on his left leg; the rash became more itchy and they look like little bites; The first was on 26Feb2021 while the second one was on 09Mar2021.; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on 09Mar2021, dose 2, single and first dose at an unknown route on 26Feb2021 as dose 1, single for COVID-19 immunization. The patient was allergy to sulfa. The patient medical history and concomitant medications were not reported. The patient had the first was on 26Feb2021 while the second one was on 09Mar2021, developed a rash on his left leg and the rash became more itchy and they look like little bites. The patient had gotten both doses of the Pfizer COVID-19 vaccine. The first was on 26Feb2021 while the second one was on 09Mar2021. After getting both doses, he developed a rash on his left leg. At first he was not worried about it but as days went by, the rash became more itchy and they look like little bites. He had applied topical steroid ointment and he was expecting it to subside but the rash got worse. It only occured in one leg. The patient said he did not go to the woods and he can only attribute the rash to the vaccine. The patient received treatment for rash became more itchy and they look like little bites. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bite, Condition aggravated, Rash, Rash pruritic, Skin depigmentation
Clinical narrative: developed a rash on his left leg; the rash became more itchy and they look like little bites; The first was on 26Feb2021 while the second one was on 09Mar2021.; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on 09Mar2021, dose 2, single and first dose at an unknown route on 26Feb2021 as dose 1, single for COVID-19 immunization. The patient was allergy to sulfa. The patient medical history and concomitant medications were not reported. The patient had the first was on 26Feb2021 while the second one was on 09Mar2021, developed a rash on his left leg and the rash became more itchy and they look like little bites. The patient had gotten both doses of the Pfizer COVID-19 vaccine. The first was on 26Feb2021 while the second one was on 09Mar2021. After getting both doses, he developed a rash on his left leg. At first he was not worried about it but as days went by, the rash became more itchy and they look like little bites. He had applied topical steroid ointment and he was expecting it to subside but the rash got worse. It only occured in one leg. The patient said he did not go to the woods and he can only attribute the rash to the vaccine. The patient received treatment for rash became more itchy and they look like little bites. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Haematospermia
Clinical narrative: Blood in semen; Caller was experiencing burn when he use the bathroom; This is a spontaneous report from a contactable consumer or other non hcp (patient) from Pfizer  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. On unknown date in Mar2021, caller was experiencing burn when he use the bathroom and blood in semen. The outcome of all the events was unknown.  Follow-up attempts is completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Myalgia
Clinical narrative: skin painful to touch even the slightest touch hurt; Chills; temperature spiked 102 degree; muscles and joint hurts; muscles and joint hurts; Cold; felt fatigued and slept most of the day; slight body aches; Swelling and redness at injection site; Swelling and redness at injection site; felt fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number EN6203) via intramuscular on 25Feb2021 12:30 PM (age at vaccination was 41 years) as DOSE 2, SINGLE for COVID-19 Immunisation at hospital. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number Ek4176) via intramuscular in right bicep on 03Feb2021 12:30 PM as DOSE 1, SINGLE for COVID-19 immunisation at hospital and nine days after my first dose I experienced redness and swelling at injection site. I treated it with over the counter Benadryl cream the first day. I also took Benadryl over the counter medicine that night. The redness and swelling was still there on day 10. I treated it with over the counter cortisone cream. The redness and swelling had cleared up by day 11. The patient experienced few hours after receiving the vaccine, cold on 25Feb2021, on the next day she woke up feeling fine but with slight body aches, around 10:45 am she started to experience chills and then her muscles and joint hurts, she also experienced her skin painful to touch even the slightest touch hurt, her temperature spiked 102 degree on 26Feb2021. She also felt fatigued and slept most of the day. She had redness and swelling at the injection site. Patient underwent lab tests and procedure of body temperature and resulted into 102 degree on 26Feb2021 and 99.6 on 27Feb2021. She took children's liquid Tylenol throughout the day and evening for fever. The next day the fever broke bout her temperature remained around 99.6 degree throughout the day. By Sunday 28Feb2021 her temperature was back to normal. She did not have any covid like symptoms and felt completely fine. She treated redness and swelling at the injection site with cortisone 5(over the counter cream). The redness and swelling was gone by Monday (01Mar2021) afternoon. If this information help with future vaccine development please feel free to contact. The outcome of events cold, chills, muscles and joint hurts, skin painful to touch even the slightest touch hurt, fever, fatigue and slept most of the day was recovered on 28Feb2021 and outcome of redness and swelling at the injection site was recovered on 01Mar2021.  Follow-up attempts were completed. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pyrexia, Sensitive skin, Somnolence
Clinical narrative: skin painful to touch even the slightest touch hurt; Chills; temperature spiked 102 degree; muscles and joint hurts; muscles and joint hurts; Cold; felt fatigued and slept most of the day; slight body aches; Swelling and redness at injection site; Swelling and redness at injection site; felt fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number EN6203) via intramuscular on 25Feb2021 12:30 PM (age at vaccination was 41 years) as DOSE 2, SINGLE for COVID-19 Immunisation at hospital. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number Ek4176) via intramuscular in right bicep on 03Feb2021 12:30 PM as DOSE 1, SINGLE for COVID-19 immunisation at hospital and nine days after my first dose I experienced redness and swelling at injection site. I treated it with over the counter Benadryl cream the first day. I also took Benadryl over the counter medicine that night. The redness and swelling was still there on day 10. I treated it with over the counter cortisone cream. The redness and swelling had cleared up by day 11. The patient experienced few hours after receiving the vaccine, cold on 25Feb2021, on the next day she woke up feeling fine but with slight body aches, around 10:45 am she started to experience chills and then her muscles and joint hurts, she also experienced her skin painful to touch even the slightest touch hurt, her temperature spiked 102 degree on 26Feb2021. She also felt fatigued and slept most of the day. She had redness and swelling at the injection site. Patient underwent lab tests and procedure of body temperature and resulted into 102 degree on 26Feb2021 and 99.6 on 27Feb2021. She took children's liquid Tylenol throughout the day and evening for fever. The next day the fever broke bout her temperature remained around 99.6 degree throughout the day. By Sunday 28Feb2021 her temperature was back to normal. She did not have any covid like symptoms and felt completely fine. She treated redness and swelling at the injection site with cortisone 5(over the counter cream). The redness and swelling was gone by Monday (01Mar2021) afternoon. If this information help with future vaccine development please feel free to contact. The outcome of events cold, chills, muscles and joint hurts, skin painful to touch even the slightest touch hurt, fever, fatigue and slept most of the day was recovered on 28Feb2021 and outcome of redness and swelling at the injection site was recovered on 01Mar2021.  Follow-up attempts were completed. No further information was expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: skin painful to touch even the slightest touch hurt; Chills; temperature spiked 102 degree; muscles and joint hurts; muscles and joint hurts; Cold; felt fatigued and slept most of the day; slight body aches; Swelling and redness at injection site; Swelling and redness at injection site; felt fatigued and slept most of the day; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number EN6203) via intramuscular on 25Feb2021 12:30 PM (age at vaccination was 41 years) as DOSE 2, SINGLE for COVID-19 Immunisation at hospital. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number Ek4176) via intramuscular in right bicep on 03Feb2021 12:30 PM as DOSE 1, SINGLE for COVID-19 immunisation at hospital and nine days after my first dose I experienced redness and swelling at injection site. I treated it with over the counter Benadryl cream the first day. I also took Benadryl over the counter medicine that night. The redness and swelling was still there on day 10. I treated it with over the counter cortisone cream. The redness and swelling had cleared up by day 11. The patient experienced few hours after receiving the vaccine, cold on 25Feb2021, on the next day she woke up feeling fine but with slight body aches, around 10:45 am she started to experience chills and then her muscles and joint hurts, she also experienced her skin painful to touch even the slightest touch hurt, her temperature spiked 102 degree on 26Feb2021. She also felt fatigued and slept most of the day. She had redness and swelling at the injection site. Patient underwent lab tests and procedure of body temperature and resulted into 102 degree on 26Feb2021 and 99.6 on 27Feb2021. She took children's liquid Tylenol throughout the day and evening for fever. The next day the fever broke bout her temperature remained around 99.6 degree throughout the day. By Sunday 28Feb2021 her temperature was back to normal. She did not have any covid like symptoms and felt completely fine. She treated redness and swelling at the injection site with cortisone 5(over the counter cream). The redness and swelling was gone by Monday (01Mar2021) afternoon. If this information help with future vaccine development please feel free to contact. The outcome of events cold, chills, muscles and joint hurts, skin painful to touch even the slightest touch hurt, fever, fatigue and slept most of the day was recovered on 28Feb2021 and outcome of redness and swelling at the injection site was recovered on 01Mar2021.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; low grade fever; Achy; This is a spontaneous report received from a contactable consumer herself (Patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received first doe of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on 17Mar2021 (Batch/Lot number: Not provided) as single dose for COVID-19 immunisation. The patient medical history included COVID-19 on 30Jan2021 and concomitant medications were not reported. It was mentioned that patient had her first dose of the vaccine yesterday 17Mar2021. She tested positive for Covid-19 last 30Jan2021. She did a test on 10Feb2021 and results came out negative for Covid. She read from some resources that you should wait 60 to 90 days before taking the vaccine. She was worried if she took the vaccine too soon. She mentioned that she experienced flu like symptoms like low grade fever, achy on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included covid-19: positive on 30Jan2021, covid-19: negative on 10Feb2021. She also mentioned that she took 2 tablets of Tylenol. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had rashes on the neck and chest in between the 2 doses; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient herself). An 89-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021 patient had rashes on the neck and chest in between the 2 doses (first dose 02Feb2021, 2nd dose is 23Feb2021). Outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Loss of personal independence in daily activities, Neck pain, Pain
Clinical narrative: significant pain in the upper back/ pain in upper back; significant pain in the should/started to pain in the shoulder; significant pain in neck/started to pain in neck; significant pain gradually worked its way down the arm to the head and fingers/ on the right side it started to pain in the wrist in right arm; on a scale of 1-10 she would rate the pain as an 8; She had a low grade fever as well; She was kind of temporarily incapacitated like couldn't grasp things with right hand, couldn't write and things like that; This is a spontaneous report from a Consumer or other non-health professional (patient's husband). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Left arm on 04Mar2021 (at the age of 72-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, atrial fibrillation and She had quite a lot of blood loss from a cut and she was anemic at that time and she has recovered from that. No longer present but should be noted and that was about just about a year ago. Concomitant medications included METOPROLOL taken for primarily to control the heart rhythm and apixaban (ELIQUIS) an anticoagulant taken as a precautionary measure for atrial fibrillation both are from unknown start and stop date. Reporter stated he was calling about his wife. After the first shot taken by patient on left arm, on 05Mar2021, on the right side the patient experienced significant pain in the upper back, shoulder, neck and gradually worked its way down the arm to the hand and fingers, became quite painful. It started about the day after the shot. It was pretty severe, even with Tylenol and ice packs was still very painful. She had a low grade fever as well. On a scale of 1-10 she would rate the pain as an 8. Had some slight fever even after taking Tylenol and lying down with icepacks. For about ten days it went on fairly severe, bad enough. She spent a lot of time in bed for a couple of days. on an unspecified date in Mar2021, She was kind of temporarily incapacitated like couldn't grasp things with right hand, couldn't write and things like that. Treatment for events given with Tylenol, nothing else. It was reported events outcome was improved. Reporter wants to know the reaction to the vaccine that probably comes before that was whether unknown effect of vaccine or whether it was quite possibly something could be coincidental or could have a different cause. Her second dose is scheduled for the 25th and she was wondering that a reaction like this after the first one that the second one might be particularly severe, or she should either delay it or go for it. Seriousness was reported as no. Reporter was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information department. Outcome of the events were resolving.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: significant pain in the upper back/ pain in upper back; significant pain in the should/started to pain in the shoulder; significant pain in neck/started to pain in neck; significant pain gradually worked its way down the arm to the head and fingers/ on the right side it started to pain in the wrist in right arm; on a scale of 1-10 she would rate the pain as an 8; She had a low grade fever as well; She was kind of temporarily incapacitated like couldn't grasp things with right hand, couldn't write and things like that; This is a spontaneous report from a Consumer or other non-health professional (patient's husband). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Left arm on 04Mar2021 (at the age of 72-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, atrial fibrillation and She had quite a lot of blood loss from a cut and she was anemic at that time and she has recovered from that. No longer present but should be noted and that was about just about a year ago. Concomitant medications included METOPROLOL taken for primarily to control the heart rhythm and apixaban (ELIQUIS) an anticoagulant taken as a precautionary measure for atrial fibrillation both are from unknown start and stop date. Reporter stated he was calling about his wife. After the first shot taken by patient on left arm, on 05Mar2021, on the right side the patient experienced significant pain in the upper back, shoulder, neck and gradually worked its way down the arm to the hand and fingers, became quite painful. It started about the day after the shot. It was pretty severe, even with Tylenol and ice packs was still very painful. She had a low grade fever as well. On a scale of 1-10 she would rate the pain as an 8. Had some slight fever even after taking Tylenol and lying down with icepacks. For about ten days it went on fairly severe, bad enough. She spent a lot of time in bed for a couple of days. on an unspecified date in Mar2021, She was kind of temporarily incapacitated like couldn't grasp things with right hand, couldn't write and things like that. Treatment for events given with Tylenol, nothing else. It was reported events outcome was improved. Reporter wants to know the reaction to the vaccine that probably comes before that was whether unknown effect of vaccine or whether it was quite possibly something could be coincidental or could have a different cause. Her second dose is scheduled for the 25th and she was wondering that a reaction like this after the first one that the second one might be particularly severe, or she should either delay it or go for it. Seriousness was reported as no. Reporter was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information department. Outcome of the events were resolving.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Cough, Diarrhoea, Dizziness
Clinical narrative: Glands swollen; Coughing; Abdominal discomfort; Diarrhea; Weak; Dizzy; Headache; This is a spontaneous report received from a contactable consumer patient (daughter) that. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient past Medical history included clostridium difficile colitis from an unknown date and unknown if ongoing five years ago and she knows that is involved with the bowel.  The patient's concomitant medications were not reported. Caller states that her daughter just called her. States that her whole family has gotten the Pfizer vaccine, but the women are having abdominal pain, and her daughter also has diarrhea. States that her daughter just had the vaccine 3 days ago. States that her daughter asked her to do some research to see if this is a normal side effect of the vaccine. Caller states that she is two weeks past her vaccine, and she has her next dose after that, but she is having a lot of problems now. States that she is wondering if this is something that people are having? States that she is not seeing it listed as one of side effects. States she looked online as well, and it doesn't seem to be popping up. States that she is wondering if she [her daughter] should go for second since she feels so sick? States the day of shot, her daughter felt weak and dizzy and had a headache later that evening on 20Mar2021. She had abdominal discomfort and diarrhea starting 21Mar2021and this is her third day into it. She states her glands are swollen starting today. States that her daughter is not long weak and dizzy. States the rest of the symptoms are ongoing. States that she also started coughing two days ago. Treatment: States she doesn't think there was any treatment. Caller states her daughter isn't a person that resorts to treatments. No medications, medical conditions, or tests that are relevant. The event outcome Not recovered for Headache, Abdominal discomfort, Diarrhea, Glands swollen and cough and recovered for weak and dizziness on an unspecified date in 2021.  Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Glands swollen; Coughing; Abdominal discomfort; Diarrhea; Weak; Dizzy; Headache; This is a spontaneous report received from a contactable consumer patient (daughter) that. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient past Medical history included clostridium difficile colitis from an unknown date and unknown if ongoing five years ago and she knows that is involved with the bowel.  The patient's concomitant medications were not reported. Caller states that her daughter just called her. States that her whole family has gotten the Pfizer vaccine, but the women are having abdominal pain, and her daughter also has diarrhea. States that her daughter just had the vaccine 3 days ago. States that her daughter asked her to do some research to see if this is a normal side effect of the vaccine. Caller states that she is two weeks past her vaccine, and she has her next dose after that, but she is having a lot of problems now. States that she is wondering if this is something that people are having? States that she is not seeing it listed as one of side effects. States she looked online as well, and it doesn't seem to be popping up. States that she is wondering if she [her daughter] should go for second since she feels so sick? States the day of shot, her daughter felt weak and dizzy and had a headache later that evening on 20Mar2021. She had abdominal discomfort and diarrhea starting 21Mar2021and this is her third day into it. She states her glands are swollen starting today. States that her daughter is not long weak and dizzy. States the rest of the symptoms are ongoing. States that she also started coughing two days ago. Treatment: States she doesn't think there was any treatment. Caller states her daughter isn't a person that resorts to treatments. No medications, medical conditions, or tests that are relevant. The event outcome Not recovered for Headache, Abdominal discomfort, Diarrhea, Glands swollen and cough and recovered for weak and dizziness on an unspecified date in 2021.  Information on lot/batch number has been requested.