chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Wheezing
Clinical narrative: I feel sick; Still lousy; My arm swelled and felt like it going to fall off; Asthma attack; I could not breathe, that was wheezing; Asthma attack; I could not breathe, that was wheezing; Asthma attack; I could not breathe, that was wheezing; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 72-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 22May2021 at 12:30 (Lot Number: EW0176, Expiration date: Unknown) as 2nd dose, single dose for COVID-19 immunization. The patient past Medical history included high blood pressure and irritable bowel syndrome not bothering her either. The patient previously received first dose of BNT162B2. The patient's concomitant medications included, yes lots of it, it will be on patient's record, because patient was on her medicines. On 23May2021, the patient experienced asthma attack, could not breathe, that was wheezing, on an unspecified date, experienced arm swelled and felt like it going to fall off, feel sick and still lousy. The first time all she had was 2nd day was her arm swelled and felt like it going to fall off, but patient got this 2nd injection yesterday and it really started bothering her but she woke up 4 this morning with an asthma attack and she have been using a nebulizer today, feel sick, really sick. The patient never had an asthma attack. Patient was breathing better but still lousy. The patient's lab data procedures included thyroids are little high, that was last month. Therapeutic measures were taken with nebulizer Ipratropium Bromide and Albuterol sulfate inhalation solution for asthma attack, could not breathe, that was wheezing. The outcome of the events asthma attack, could not breathe, that was wheezing was recovering, still lousy was not recovered and arm swelled and felt like it going to fall off, feel sick was unknown.  NDC number and UPC number, consumer stated, "All she had was the product number, the date of injection." )."
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she is having the horrible headache; This is a spontaneous report from a contactable consumer received from Pfizer sponsor program. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178, NDC number, UPC number and Expiration date are unknown) via an unspecified route of administration on 22May2021 as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient had already taken the Pfizer BioNTech Covid 19 vaccine that was yesterday 22May2021, now the patient have already taken 2 Advil (Further not clarified hence captured as event conservatively) because she experienced a horrible headache on an unspecified date in May2021. The caller asked about if it was okay to take, she had already taken 2 Advil on an unspecified date (NDC number, UPC number and Expiration date are unknown) as per her first dose. Reporter seriousness for horrible headache was unspecified. The outcome of the event was unknown.  Information on the lot/batch number is present; further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches after the first dose for a couple of days; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 (at the age of 42-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event and relevant tests was none. The patient did not receive any other additional vaccines on 20Apr2021 other than the suspect product. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination no adverse event was there for the patient. The patient did not emergency room and physician office. The patient reported that "headaches after the first dose for a couple of days" on an unknown date in Apr2021. The outcome of the event was resolved on an unknown date in 2021.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: felt tired / "worn out" (he could not describe the feeling more accurately); fever; chills; Nausea; This is a spontaneous report from a non-contactable consumer. A male patient in his mid-30  received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on 11May2021, as 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unknown date, as single dose for COVID-19 Immunization. On Wednesday, 12May2021, around 3-4 AM, the patient began to feel like he had fever and chills. He also felt some nausea and worn out (he could not describe the feeling more accurately). On Thursday, 13May2021, the patient felt tired but had no nausea and by Friday, 14May2021, the patient felt better. The outcome of the event nausea was resolved whereas the outcome of the events fever, chills, worn out and fatigue was unknown.  Follow up (24May2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of the query. This reported included reporter country.  Follow up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Neck pain
Clinical narrative: Aching going from my neck to the back of my head; It's not really bad, but it's like aching; Aching going from my neck to the back of my head; It's not really bad, but it's like aching; This is a spontaneous report received from a contactable consumer (patient).   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185, NDC Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 22May2021 as 1ST dose single, for COVID-19 immunization. The patient has medical history with Allergy and Heartburn from an unspecified date. Concomitant medications included Omeprazole for Heartburn and Cetirizine HCL for Allergy form an unspecified date and unknown if ongoing. Patient reported that, got the first dose of the Pfizer Covid-19 vaccine yesterday, 22May2021. This morning she got a dull ache from the neck to the back of the head on the left side, the same side that the vaccine was administered. she stated that, aching going from my neck to the back of my head; It's not really bad, but it's like aching. Patient reported that, she has bloodwork couple of months ago on an unknown date (Vitamin D deficiency). Everything was okay except for Vitamin D, so she was taking Vitamin D supplements. Patient did not receive any treatment for the event she reported that, she hasn't. she was trying not to, to see what the side effects are though. Outcome of the events were unknown.  Follow up attempts are needed. Further information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal pain, Rash, SARS-CoV-2 test
Clinical narrative: lethargic; sore throat; radh; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer reported for a 15-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation .  The patient's medical history was none.  Patient's concomitant medications were not reported. Patient had no known allergies. On17May2021, 3 days after vaccine, she had a very sore throat, radh and was lethargic. Patient treatment was unknown. It was reported that most recent COVID-19 vaccine was administered at Public Health Clinic. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test and strep: negative  on 19May2021. The outcome of all event was recovering.  Information on the batch/lot number has been requested.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Rash all over my legs.; It Didn't itch but it was red spots all over my legs; This is a spontaneous report from a contactable consumer. A 30-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/lot number: ER8736), dose 1 via an unspecified route of administration at left arm on 01May2021 (age at the time of vaccination 30-year-old) as first dose, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. consumer stated, "It happened a week after my vaccination I had rash all over my legs, It Didn't itch but it was red spots all over my legs. I did go to the minute clinic and they prescribed me a steroidal cream (further clarification unknown, captured as unspecified medication) and that I used on my legs, It seemed to go away but then kind a came back, then it went away and came back again, so it's been on and off for 3 weeks now." consumer stated, about 2nd shot of Vaccine scheduled " I was actually scheduled for yesterday, 22May2021." The outcome of the event rash was not recovered and for red spots all over legs was unknown.  Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Asthenia, Diplopia, Headache, Inflammation
Clinical narrative: Inflammation of entire body/ specifically lower body; Headaches; double vision; Low energy; Low sensation; Neck pain; Extreme foot pain; Nervousness; anger; This is a spontaneous report from a contactable consumer (patient, self-reported). A 33-year-pld male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 2 via an unspecified route of administration in the right arm, on 06May2021 at 17:00, as single for COVID-19 immunization in the pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 1 via an unspecified route of administration in the right arm, on 24Apr2021 at 11:00, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On 17May2021 at 01:00, the patient had inflammation of entire body/ specifically lower body, headaches, double vision, low energy, low sensation, neck pain, extreme foot pain, nervousness, and anger. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Nervousness, Pain in extremity, Sensory disturbance
Clinical narrative: Inflammation of entire body/ specifically lower body; Headaches; double vision; Low energy; Low sensation; Neck pain; Extreme foot pain; Nervousness; anger; This is a spontaneous report from a contactable consumer (patient, self-reported). A 33-year-pld male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 2 via an unspecified route of administration in the right arm, on 06May2021 at 17:00, as single for COVID-19 immunization in the pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 1 via an unspecified route of administration in the right arm, on 24Apr2021 at 11:00, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On 17May2021 at 01:00, the patient had inflammation of entire body/ specifically lower body, headaches, double vision, low energy, low sensation, neck pain, extreme foot pain, nervousness, and anger. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: That evening when she laid down she had some neck soreness; she woke up she saw the swollen lymph nodes.; She also experienced fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care profession. A 61-years-old female patient received second dose of BNT162b2 (solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 61-year-old) as a single dose for covid-19 immunisation. Medical history included ongoing lymphadenopathy three narrowing's in her neck and needs to get surgery on it. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162b2, via unspecified route of administration on unspecified date (at the age of 61-year-old) at a single dose for COVID-19 immunisation. On 21Apr2021, on evening of same day of vaccination, the when the patient laid down, she had some neck soreness, and the next morning when she woke up she saw the swollen lymph nodes. She still has swollen lymph nodes now. She also experienced fatigue and arm soreness and she just put some alcohol on that and it resolved. Therapeutic measures were taken as a result of arm soreness. The patient was called to see if this is a side effect/ how long it lasts and She cannot get her neck injections or surgery until it resolves. The outcome of some neck soreness and fatigue were unknown, swollen lymph nodes was not recovered, , arm soreness was recovered.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy
Clinical narrative: her daughter experienced a swollen lymph node under the left armpit; bruising on the left breast.; she got lymph nodes left side, got it on left hand and lymph node is swollen under armpit; This is a spontaneous report from a contactable consumer (patient's mother) or other non HCP. reported for a 20-year-old female patient (reporter's daughter). A 20-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 19apr2021 as 2nd dose, single for COVID-19 immunization. The patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: unknown), via unspecified route of administration, on 29Mar2021, at first dose single for COVID-19 immunization. The patient medical history includes acne (from an unknown date). concomitant medications were not reported. On 19Apr2021, 1 to 2 days after the vaccination, the patient experienced a swollen lymph node left side, got it on left hand and lymph node is swollen under armpit, and she got bruises on her breast. The swollen lymph node under the left armpit and bruising on the left breast. symptom resolved in about 3 days, but then recurred about a month later. it was reported that symptom again appeared for the second time, the swollen lymph node under the left armpit and bruising on the left breast are much improved but have not gone away completely. patient did not received any treatment for events. Reporter enquired about the need of a third injection/booster of the Pfizer covid-19 vaccine due to the variants. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of arm after injection; Redness and swelling of arm after injection; This is a spontaneous report from a non-contactable consumer. A 13-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced redness and swelling of arm after injection on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: Sudden chest pain radiating toward armpit; Dizzy; Sweaty; Rapid pulse rate; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 13-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administered in left arm on 21May2021 13:30 as single dose for COVID-19 immunisation at School or Student Health Clinic. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Patient had no allergies. On 21May2021 22:30, the patient experienced Sudden chest pain radiating toward armpit, dizzy, sweaty, rapid pulse rate, nausea. The symptoms resolved after about 10-15 minutes. This repeated a second time on Saturday 22May around 4 pm. Repeated a third time on Sunday 23May around 3 pm but was less in severity. Lot number on card not clear but appears to be EN0185 or EW0185. The events assessed as non-serious. No treatment was received for the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Sudden chest pain radiating toward armpit; Dizzy; Sweaty; Rapid pulse rate; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 13-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administered in left arm on 21May2021 13:30 as single dose for COVID-19 immunisation at School or Student Health Clinic. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Patient had no allergies. On 21May2021 22:30, the patient experienced Sudden chest pain radiating toward armpit, dizzy, sweaty, rapid pulse rate, nausea. The symptoms resolved after about 10-15 minutes. This repeated a second time on Saturday 22May around 4 pm. Repeated a third time on Sunday 23May around 3 pm but was less in severity. Lot number on card not clear but appears to be EN0185 or EW0185. The events assessed as non-serious. No treatment was received for the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Blood potassium, Blood test, Lymphadenopathy, Peripheral swelling
Clinical narrative: blood vessels are not reacting properly; Swollen lymph nodes; Legs keep swelling; Oozing fluid out of legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 83-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 01Apr2021 at the age of 83-years-old (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization. Medical history included hip arthroplasty from Jan2021 to an unknown date.Provide other relevant medical history including but not limited to these conditions were diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine. Patient took first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot number was EN6206) on 11Mar2021for COVID-19 immunization. Family Medical History Relevant to AE was not reported .The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Unspecified May2021, (these symptoms began about 3 weeks ago) between 1pm to 2pm after vaccination the patient experienced swollen lymph nodes, legs keep swelling, oozing fluid out of legs, on an unspecified date blood vessel are not reacting properly. The patient underwent lab tests and procedures which included blood potassium: normal on May2021, blood test: normal on May2021.Therapeutic measures were taken as a result of swollen lymph nodes, legs keep swelling, oozing fluid out of legs treatment included "10 water pills."which have all been taken, last water pill was on 18May2021. Other Conditions includes still recovering states that she had a messed up physical therapist. The outcome of events swollen lymph nodes, Legs keep swelling was not recovered, oozing fluid out of legs was recovered on 21May2021, blood vessels are not reacting properly was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Skin weeping
Clinical narrative: blood vessels are not reacting properly; Swollen lymph nodes; Legs keep swelling; Oozing fluid out of legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 83-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 01Apr2021 at the age of 83-years-old (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization. Medical history included hip arthroplasty from Jan2021 to an unknown date.Provide other relevant medical history including but not limited to these conditions were diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine. Patient took first dose of BNT162B2(COMIRNATY, Solution for injection, Batch/Lot number was EN6206) on 11Mar2021for COVID-19 immunization. Family Medical History Relevant to AE was not reported .The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Unspecified May2021, (these symptoms began about 3 weeks ago) between 1pm to 2pm after vaccination the patient experienced swollen lymph nodes, legs keep swelling, oozing fluid out of legs, on an unspecified date blood vessel are not reacting properly. The patient underwent lab tests and procedures which included blood potassium: normal on May2021, blood test: normal on May2021.Therapeutic measures were taken as a result of swollen lymph nodes, legs keep swelling, oozing fluid out of legs treatment included "10 water pills."which have all been taken, last water pill was on 18May2021. Other Conditions includes still recovering states that she had a messed up physical therapist. The outcome of events swollen lymph nodes, Legs keep swelling was not recovered, oozing fluid out of legs was recovered on 21May2021, blood vessels are not reacting properly was unknown.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On May2021, the patient experienced headache, fatigue, muscle aches. Patient reported could someone get side effects after single dose of Pfizer vaccine 2 weeks later. Meaning delayed side effects, having headache, fatigue and muscle aches and got first dose on 05May2021 second dose scheduled for 26May2021. The event reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypersomnia, Lymphadenopathy, Mass
Clinical narrative: 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain assessment, Pain in extremity, Rash, Retching
Clinical narrative: 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; This is a spontaneous report from a contactable consumer or other non hcp and from Pfizer-sponsored program. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 21May2021 09:00 (Batch/Lot Number: EW0169) as 1st dose, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a sore left arm after her first Covid-19 vaccine dose, but other than that felt fine on 22May2021. Patient asked if it would be ok for her to take a herbal cleanse after receiving the first COVID-19 Vaccine, stating she wanted to make sure there wouldn't be any problem doing so. Patient also wants to know if the following ingredients would effect the vaccine: Magnesium Citrate, vitamin B6 (pyridoxine HCI) vitamin B12 (cyanocobalamin), sodium, potassium citrate, potassium sorbate, hexametaphosphate, sodium benzoate. Patient said she didn't notice the left arm soreness until upon waking on Saturday morning, 22May2021. She said her left arm was still tender, but the left arm soreness had improved. It was reported patient took TYLENOL (clarified as generic Acetaminophen 500mg), and (generic) Ibuprofen 200mg to treat her left arm soreness. She said she did not have the generic Acetaminophen 500mg and generic Ibuprofen 200mg NDC Numbers, Lot Numbers, and Expiration Dates to provide because she had transferred the generic Acetaminophen 500mg and generic Ibuprofen from their original product bottles to a smaller bottle that she kept in her purse. It was reported patient found a Manufacturer's Date (Oct2020), but did not see a Expiration date on the product's outer packaging or product bottle. She stated she purchased the Herbal Cleanse liquid directly from the manufacturer (It Works), and only had the Herbal Cleanse liquid for about 5 weeks or so. She said she did not see a UPC Number listed on the product packaging. She said she was using the Herbal Cleanse liquid as a kick start to weight loss. She said she had planned to take the Herbal Cleanse liquid over a 2-day period, taking one-4 oz. bottle before breakfast, and one-4 oz. bottle before dinner over two days. The outcome for event sore arm (pain in extremity) was unknown and outcome for limb discomfort was recovering.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart beat; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 19May2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The next day vaccination on 20May2021 at 12:45, patient had a fast heart beat. No serious reported. Caller states she received the first does of the Pfizer COVID-19 vaccine on 19May2021 and the next day had a fast heart beat, per Safety occurred at 12:45, she would like to know this is a common side effect. She was asking what is Polyethylene glycol. She was asking what is the efficacy after the first dose. she was told the second dose is stronger than the first. Is this true. she was trying to figure out if she should get the second dose of the vaccine. she had a side effect after the first dose of the vaccine.  Should  get the second dose. The outcome of fast heart beat was unknown.  Follow-up attempts are needed. Information about lot/batch number is requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; I have both my eyes swollen; This is a spontaneous report received from a contactable consumer (reporting on himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Left on 20May2021 11:45, as 2nd dose, single dose for COVID-19 immunization. The patient medical history nad concomitant medications were not reported. Patient previously took first dose of BNT162B2 29Apr2021 11:45. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. He had his second shot on 20May2021 11:45 and he went to fever, chills and headache until Saturday morning. 23May2021 late in the evening he noticed his eyes started swelling up a little bit; they went down a little bit and he went to bed; 24May2021 he woke up with swollen eyes again. He clarified that he already reported this information; but he was unable to obtain reference number from that report. He had questions regarding these side effects after the Pfizer Covid Vaccine and wanted to know about recommendation on taking histamines like Zyrtec Benadryl after the vaccine Response. Since the vaccination, the patient has tested for COVID-19. The outcome of the event i have both my eyes swollen was not recovered and for rest events was unknown.  Information about lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: Insomnia for about 36 hours; fever (101.5 @ highest); body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 19May2021 at 13:30 at the age of 17 years (Batch/Lot Number: EW0173) as 2nd dose, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. The patient did not diagnose with COVID-19, prior to vaccination. Medical history included allergies bee Stings. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 28Apr2021 at 12:30 PM at the age of 17 years (Batch/Lot Number: ER8736) for covid-19 immunisation. On 19May2021 at 11:00 PM, the patient experienced insomnia for about 36 hours, fever (101.5 at highest), body aches and headache. The patient has not been tested for COVID-19 since the vaccination. No treatment was given for the events. The outcome of the events was reported as recovered on an unspecified date.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anxiety, Depressed mood
Clinical narrative: his wife started loosing her hair 4 days after the administration of the vaccine; as a consequence she is anxious and depressed.; as a consequence she is anxious and depressed.; This is a spontaneous report from a contactable consumer (patient's husband). A 27-years-old female patient (reporter's husband) received first 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 05May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient experienced his wife started loosing her hair 4 days after the administration of the vaccine and as a consequence she is anxious and depressed. It was reported that a reporter called on behalf of his wife for information about if losing hair is a side effect for the administration of the Pfizer's COVID-19 vaccine and information about if it would be safe to be administered with the second dose of the Pfizer's COVID-19 vaccine after loosing her hair possibly as a side effect for the administration of the vaccine. The reporter was going to speak with his Physician for more information and management. Reporter called on behalf of his wife for information about the maximum timeframe for the administration of the second dose of the Pfizer's COVID-19 vaccine. There was no PQC (product quality complaint) present. The outcome of both event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Joint pain in the elbow was reported as worsened.; have been experiencing joint pains to our elbows for 5 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 06May2021 15:30 as 2nd dose, single dose for COVID-19 immunisation. The patient previously received first dose of Pfizer vaccine on 15Apr2021; Lot number: EW0150 and the expiration date on 31Jul2021 via an unspecified route of administration in left arm. Medical history included ongoing diabetes mellitus diagnosed a little over a month ago. The patient's 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. No other vaccines within four weeks prior to first administration. On 08May2021, two days after receiving vaccination, the patient experienced joint pains to elbows for 5 weeks and on an unspecified date, experienced joint pain in the elbow was worsened. The caller reports her joint pain was in one elbow. This began probably two days after the caller received the second dose Pfizer Covid Vaccine. The caller reports the pain was not constant, it was just like if the caller moves. The caller states the joint pain in the elbow has worsened. The patient did not visit emergency Room or physician office, but the caller thinks she is going to go within the next week if her pain doesn't get better. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021594113 Same reporter/drug/AE, different patient
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes (mild swelling) in left armpit; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left in May2021 at 10:45 AM (Batch/Lot Number: ER8736) (at age of the 14-year-old) as 1st dose, SINGLE for covid-19 immunisation. Medical history included precocious puberty, attention deficit hyperactivity disorder, anxiety and the patient had known allergy to animal: Pet dander. The patient received methylphenidate hydrochloride (CONCERTA), guanfacine (GUANFACINE), vitamin c [ascorbic acid], melatonin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  In May2021, the patient experienced swollen lymph nodes (mild swelling) in left armpit. The patient did not receive any treatment of the event. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: She seems to not have the feeling of intimacy since receiving the vaccine.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine, Solution for Injection, Lot/Batch Number: Unknown), dose 1 via an unspecified route of administration on 30Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included cortisone (CORTISONE) taken for an unspecified indication on 14May2021. The patient seems to not have the feeling of intimacy since receiving the vaccine. Patient has read information that the Pfizer Covid 19 Vaccine changes the genes in the body and ask if there's any reports on the Pfizer Covid 19 Vaccine effecting the ability to have kids. The outcome of the event was reported as unknown.  Information on Batch/lot number has been requested
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nasal congestion, Rhinorrhoea, Throat irritation
Clinical narrative: patient has stuffy nose; scratchy throat; not able to go to school; runny nose; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 21May2021 15:00 (Batch/Lot Number: EW0191) as 1st dose, single dose for covid-19 immunisation. Patient's relevant medical history included none. The patient's concomitant medications were not reported. The patient experienced stuffy nose, scratchy throat, not able to go to school and runny nose on 24May2021 06:00. Patient was asking she was expecting that Pfizer can give recommendations if her son needs to have COVID testing due to his symptoms after receiving the vaccine. The Caller was calling about the Pfizer Covid-19 Vaccine. Her son got his vaccine on Friday, he was 15 and the next day he experienced nothing. He did not feel anything but he was having a stuffy nose and then he had some scratchy throat. Caller wants to know if a stuffy nose and scratchy throat are a side effect or if she should get her son checked for Covid. Caller adds that really all side effects will happen in 24 hours, but this is more than 24 hours, it is like, 48 or 50 hours later. Caller wants to know if the stuffy nose and scratchy throat are side effects. The caller clarifies that she means will he test positive for Covid -19 after getting the vaccine. The caller states she did not want to provide name or date of birth information and Pfizer can call her instead if they want. Stuffy maybe a little bit runny nose, scratchy throat, both of these occurred today morning around 6 o'clock. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The outcome for the event not able to go to school was unknown while rest of all was not recovered.   Follow-up attempts are needed; Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in his left shoulder; This is a spontaneous report from a contactable consumer. A 66-years old elderly male patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL3302), via an unspecified route of administration in left arm on 01Mar2021 as FIRST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccination, the patient experienced pain in his shoulder for a couple of days and then the pain subsided. Caller states that he has consulted with his HCP in which they advised him to perform stretching exercises and states that the exercises have not helped. The Outcome for the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.