chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; had a COVID exposure on 23Dec2020; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medication included chemotherapy. It was reported that patient got the first dose of the COVID vaccine on 18Dec2020 and then had a COVID exposure on 23Dec2020 and was positive via COVID PCR test on 26Dec2020. It was mentioned that patient is a chemotherapy patient. The patient was given the antibodies for COVID on 28Dec2020 and the patient is currently doing well. Reporter's question was that the patient was scheduled to get the second dose of the vaccine on 08Jan2021 and the reporter is wondering if given this patient's situation, is it safe for the patient to receive the second dose or if there are any recommendations on when the patient should receive the second dose. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and SARS-CoV-2 test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Conjunctivitis allergic, Disease recurrence, Feeling abnormal, Fungal infection
Clinical narrative: Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, she was off; grumpy; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730 and expiry date: Mar2021), via an unspecified route of administration in arm on 22Dec2020 at single dose for Covid-19 Immunization. Medical history included yeast infection 20 years ago (in 2000). There were no concomitant medications. The patient received her first dose on 22Dec2020. She is due for the second dose on 12Jan2021. She got allergic conjunctivitis on 23Dec2020, yeast infection on unspecified date in Dec2020, and seasonal allergies that were very bad, which doesn't typically happen to her this time of year on 26Dec2020. She had a Covid test that was negative. She wants to know if she should get the second dose. The conjunctivitis was not bad, it stopped after she took out her contacts, used allergy drops and it cleared it up. The last one she had yeast infection was like was 20 years ago, but she treated it herself and it is gone now. She got the conjunctivitis within 24 hours of receiving the first dose, she got the yeast infection 2-3 days after the first dose, and the allergies began about 4 days after the first dose. The conjunctivitis and the yeast infection have both resolved but the allergies are still ongoing, they come and go, the intensity comes and goes, she even checked the pollen count and it was non-existent. She had a Negative Covid Test on 28Dec2020. She had a Negative Antibody Test back in Jun2020. She has had no positive test for Covid prior to getting the vaccine. She has had No issues with vaccines in the past. She stated that she's read all the stuff on the website, and is has the usual stuff, yes her injection site was a little... not bad, she did not feel great, she was off, and grumpy on unspecified date in Dec2020. The events conjunctivitis and the yeast infection resolved on unspecified date; the event seasonal allergy was not recovered; and the remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability postvaccinal, SARS-CoV-2 test, Seasonal allergy, Skin test
Clinical narrative: Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, she was off; grumpy; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730 and expiry date: Mar2021), via an unspecified route of administration in arm on 22Dec2020 at single dose for Covid-19 Immunization. Medical history included yeast infection 20 years ago (in 2000). There were no concomitant medications. The patient received her first dose on 22Dec2020. She is due for the second dose on 12Jan2021. She got allergic conjunctivitis on 23Dec2020, yeast infection on unspecified date in Dec2020, and seasonal allergies that were very bad, which doesn't typically happen to her this time of year on 26Dec2020. She had a Covid test that was negative. She wants to know if she should get the second dose. The conjunctivitis was not bad, it stopped after she took out her contacts, used allergy drops and it cleared it up. The last one she had yeast infection was like was 20 years ago, but she treated it herself and it is gone now. She got the conjunctivitis within 24 hours of receiving the first dose, she got the yeast infection 2-3 days after the first dose, and the allergies began about 4 days after the first dose. The conjunctivitis and the yeast infection have both resolved but the allergies are still ongoing, they come and go, the intensity comes and goes, she even checked the pollen count and it was non-existent. She had a Negative Covid Test on 28Dec2020. She had a Negative Antibody Test back in Jun2020. She has had no positive test for Covid prior to getting the vaccine. She has had No issues with vaccines in the past. She stated that she's read all the stuff on the website, and is has the usual stuff, yes her injection site was a little... not bad, she did not feel great, she was off, and grumpy on unspecified date in Dec2020. The events conjunctivitis and the yeast infection resolved on unspecified date; the event seasonal allergy was not recovered; and the remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis allergic, Fungal infection, Hypersensitivity, Respiratory tract infection
Clinical narrative: Seasonal allergy; allergic conjunctivitis; yeast infection; yeast infection; she didnt feel great, she was off; grumpy; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK5730 and expiry date: Mar2021), via an unspecified route of administration in arm on 22Dec2020 at single dose for Covid-19 Immunization. Medical history included yeast infection 20 years ago (in 2000). There were no concomitant medications. The patient received her first dose on 22Dec2020. She is due for the second dose on 12Jan2021. She got allergic conjunctivitis on 23Dec2020, yeast infection on unspecified date in Dec2020, and seasonal allergies that were very bad, which doesn't typically happen to her this time of year on 26Dec2020. She had a Covid test that was negative. She wants to know if she should get the second dose. The conjunctivitis was not bad, it stopped after she took out her contacts, used allergy drops and it cleared it up. The last one she had yeast infection was like was 20 years ago, but she treated it herself and it is gone now. She got the conjunctivitis within 24 hours of receiving the first dose, she got the yeast infection 2-3 days after the first dose, and the allergies began about 4 days after the first dose. The conjunctivitis and the yeast infection have both resolved but the allergies are still ongoing, they come and go, the intensity comes and goes, she even checked the pollen count and it was non-existent. She had a Negative Covid Test on 28Dec2020. She had a Negative Antibody Test back in Jun2020. She has had no positive test for Covid prior to getting the vaccine. She has had No issues with vaccines in the past. She stated that she's read all the stuff on the website, and is has the usual stuff, yes her injection site was a little... not bad, she did not feel great, she was off, and grumpy on unspecified date in Dec2020. The events conjunctivitis and the yeast infection resolved on unspecified date; the event seasonal allergy was not recovered; and the remaining events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Lip swelling
Clinical narrative: her lips and gums were mildly swollen; her lips and gums were mildly swollen; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included latex allergy with only swelling. The patient's concomitant medications were not reported. On Dec2020, the patient reported has mild latex allergy with only swelling and after receiving the vaccine, she noticed her lips and gums were mildly swollen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Neck pain
Clinical narrative: Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left upper arm on 18Dec2020 15:30 at a single dose for COVID-19 immunisation.  Medical history included high blood pressure and had electrocardiogram (EKG) unknown result a week before vaccination in Dec2020.  Concomitant medication included acetylsalicylic acid (ASPIRIN), lisinopril, and guaifenesin (MUCINEX).  It was reported that patient tested positive for COVID on 31Dec2020. She has not gotten her second dose but it was scheduled for 08Jan2021 for which will still be in quarantine then and requested guidance on when/if she should get the second dose. Patient explained her parents have COVID and that the rapid test for the COVID test was how she found out she had COVID. The patient has not recovered from the events.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration, Paraesthesia, Pruritus
Clinical narrative: Right leg paresthesia and slight left leg paresthesia; tingling mainly in the right foot and calf; Itching mainly in the right foot and calf; Slight burning sensation mainly in the right foot and calf; Most recent COVID-19 vaccine was administered 17 days after first dose of COVID-19 vaccine; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history included gastritis. There were no concomitant medications. The patient previously took the first dose of BNT162B2 on 18Dec2020 at 2:30 PM for COVID-19 immunization (intramuscular in left arm; Lot Number: EL0140). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 at 3 PM, the most recent COVID-19 vaccine was administered in a hospital, 17 days after first dose of COVID-19 vaccine. On 04Jan2021 at 10 PM, the patient experienced right leg paresthesia and slight left leg paresthesia; and tingling, itching, and slight burning sensation mainly in the right foot and calf. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain in extremity, Sinus congestion
Clinical narrative: Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supraclavicular lymph node (injection side); general fatigue; sinus congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), with the first dose on 15Dec2020 and second dose on 05Jan2021; both intramuscular in the left arm at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and lactose allergy. Concomitant medications were not reported. 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 and had not been tested for COVID-19 since the vaccination. On 05Jan2021, the patient experienced arm pain, swollen and tender supraclavicular lymph node (injection side), general fatigue, and sinus congestion. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: sick; fever; chills; body aches; This is a spontaneous report from a contactable healthcare professional.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for Covid-19 immunization. The patient is a healthcare worker and she had the corona virus on 23Nov2020. The patient's concomitant medications were not reported. The patient received the Covid vaccine on 18Dec2020. On an unspecified date, the patient got really sick after the first vaccine with fever, chills, body aches, etc. The patient was scheduled to receive the second dose on Friday, 08Jan2020, the patient asked if the patient should still take the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site pain
Clinical narrative: swollen lymph node a couple of days later/swollen lymph node a couple of days later. Which is still a little swollen but improving; pain at injection site/painfulness at the injection site; shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included immunosuppression. Concomitant medication included ongoing vedolizumab (ENTYVIO) for immunosuppresion. The patient got a couple of the side effects listed. She developed painfulness at the injection site, and it was red a couple of days. She is wondering if she needs to be worried about getting the second one. It was pretty painful that night. It was pretty painful for the next day. If someone barely brushed up against it, it was very painful. Two days later, her husband noticed her shoulder was very red. And then she realized there was a defined red mark where the injections was. The pain is fine now. She didn't get a rash or have trouble breathing. She did have a swollen lymph node a couple of days later. Which is still a little swollen but improving. She does take an immunosuppressant. The outcome of the events pain at injection site and shoulder became very red/painfulness at injection site and redness/ was a defined red mark where the injections was recovered, while recovering for the event swollen lymph node a couple of days later was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Illness, Pain
Clinical narrative: left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vaccination site pain
Clinical narrative: left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Inappropriate schedule of product administration, Pain
Clinical narrative: Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Feeling abnormal, Hypoaesthesia, Neck pain
Clinical narrative: I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Toothache
Clinical narrative: I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: developing symptoms of COVID; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse asked if the patient can continue with the 2nd dose of COVID 19 vaccine after developing symptoms of COVID on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test
Clinical narrative: Developing symptoms of covid/ symptoms of Covid after having the vaccine; Developing symptoms of covid/ symptoms of Covid after having the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1688, via an unspecified route of administration in the left arm, on 21Dec2020 at a single dose for covid-19 immunisation as she works with disabled people and for general community health. Patient's medical history was none. Family history included her kids/children had covid (unknown if ongoing). There were no concomitant medications. It was reported that the patient had symptoms of covid after having the vaccine with outcome of recovering. The patient received the first dose of covid vaccine on 21Dec2020 and on the 02Jan2021 she started developing symptoms of covid. She mentioned that her children have virus and she had the covid test done. She wanted to know if she can get the second dose of the vaccine. She queried for her co-worker who has the Covid and was told to not take the vaccine yet and how long they need to wait. She was tested this morning. She has not gotten the results. Her kids had Covid and she felt certain she had it because she has symptoms. It comes and goes. It was better during the day and worse at night. She received the vaccine because she works with disabled people where there are extremely high numbers of the virus. She also got it for general community health. The Covid test was done on 06Jan2021 with unknown result.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Tinnitus
Clinical narrative: Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as "for work." The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like "when you have water in your ear." It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like "if you have water in your ear." It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event "developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now." Outcome of the events "headache" and "fatigue and feeling run down" was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: 100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization.  Medical history included high cholesterol.  The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash, Vaccination site erythema, Vaccination site mass
Clinical narrative: Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK 9231, via an unspecified route of administration in the right arm on 31Dec2020 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism, hypertension, high cholesterol, penicillin allergy; all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan, levothyroxine/liothyronine (NP THYROID), simvastatin, vitamin B, vitamin c [ascorbic acid], colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 01Jan2021 at 12:00, the patient experienced a sore right arm. Treatment was not received for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the sore right arm was resolved on Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She states that she is experiencing body aches; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a 55-year-old female patient assistant who received the COVID-19 vaccine yesterday, on 05Jan2021. She stated that she was experiencing body aches with outcome of unknown in Jan2021. She would like to know if taking TYLENOL is permitted after receiving the vaccine.  Information about lot/batch number has been requested.