chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Vaccination site pain
Clinical narrative: left arm getting hot and numbing sensation; left arm getting hot and numbing sensation; tenderness where the  injection was; Tingling; This is a spontaneous report received from a contactable consumer. This 48-year-old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8734) on 07Apr2021 on her left arm for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient began to feel the following while walking to her car afterward: left arm getting hot and numbing sensation.  It is not as severe as of 08Apr2021.  She can feel numbness in her fingertips and tenderness where the injection was. The patient was wondering if she should get the second dose of it based off of her symptoms from the first dose. The patient stated her numbness, tingling, and tenderness in the injection was not preventing her from typing or working. She stated it was just something she felt. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia, Vaccination site pain
Clinical narrative: tenderness of arm; numbness in fingertips; arm felt hot; numbness in whole arm; This is a spontaneous report from a contactable consumer reported for herself. A 48-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Her appointment was at 13:08 and she might have got the vaccine a couple of minutes earlier than her appointment. Medical history included hypothyroidism from 2007 and ongoing. Concomitant medication included levothyroxine taken for hypothyroidism from 2007 and ongoing. Caller stated she is calling about the first dose of the COVID 19 vaccine. Caller stated she is not sure if this is normal but she just received the first dose yesterday and she did not feel the injection but later she was walking to the car and her arm felt hot and numbness but she just shook it off. Caller stated today, the next day, she felt tenderness of arm, stated this is around the injection, stated just last night she took 2 Advil, and fingertips if she presses them it does not feel the same as the other hand but not fully numb but feels like a numbness sensation. Tenderness of arm was reported as worsened. Outcome of event arm felt hot and numbness was recovered on 07Apr2021, of vaccination site tenderness was not recovered, of numbness in fingertips was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Vaccination site pain
Clinical narrative: tenderness of arm; numbness in fingertips; arm felt hot; numbness in whole arm; This is a spontaneous report from a contactable consumer reported for herself. A 48-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Her appointment was at 13:08 and she might have got the vaccine a couple of minutes earlier than her appointment. Medical history included hypothyroidism from 2007 and ongoing. Concomitant medication included levothyroxine taken for hypothyroidism from 2007 and ongoing. Caller stated she is calling about the first dose of the COVID 19 vaccine. Caller stated she is not sure if this is normal but she just received the first dose yesterday and she did not feel the injection but later she was walking to the car and her arm felt hot and numbness but she just shook it off. Caller stated today, the next day, she felt tenderness of arm, stated this is around the injection, stated just last night she took 2 Advil, and fingertips if she presses them it does not feel the same as the other hand but not fully numb but feels like a numbness sensation. Tenderness of arm was reported as worsened. Outcome of event arm felt hot and numbness was recovered on 07Apr2021, of vaccination site tenderness was not recovered, of numbness in fingertips was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Joint range of motion decreased
Clinical narrative: Limited arm movement; chills; achy joints; This is a spontaneous report from contactable consumer (patient) and consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced limited arm movement, chills and achy joints on 03Apr2021.  Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pain, Pyrexia
Clinical narrative: his is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 (Lot Number: EN6207) as SINGLE DOSE for COVID-19 immunization. Medical history included back pain from an unknown date and unknown if ongoing , COVID-19 from Nov2020 to an unknown date and family history of Amyotrophic lateral sclerosis (ALS) from an unknown date and unknown if ongoing. The patient previously had dose 1 of BNT162B2 (lot number: EN6198) on 17Mar2021 in left arm as single dose for COVID-19 immunization. Concomitant medications included ibuprofen taken for back pain, start and stop date were not reported and probiotics twice a day. The patient had fever that reached 101.5°F on 07Apr2021 and last night when he laid down in his stomach he got nosebleeds on 08Apr2021 until this morning. The patient was given Tylenol and the fever has receded and the nosebleeds have stopped and he can get upward. She is just concerned about the nosebleeds of the patient and she would like to know if this has been reported as a side effect since she was not able to find anything about this. The patient has been having a pretty rough fever of 102 today, which was higher than last time. States that the patient did get a little fever last time but was still able to work. If the patient lays on his stomach, it just drains out and if he lays on his back, he is basically swallowing it.  The patient has been having other symptoms, like aches, pains and 102 fever but is most concerned about the nosebleeds. The patient was feeling feverish last night. States that temperature was 101 or something two hours ago and went checked 15 minutes ago, was 102. States that it has raised in the last couple of hours. The patient just took Tylenol when temperature was 102 as treatment. The nosebleeds started this morning and is still going on now. Drainage is not as much but still has drainage and is now sitting upright. States that when he lays on his stomach, it starts flowing. States that when he came to bed this morning, he suddenly felt like his nose was draining. Explains that he just took another nap on his stomach and found a little blood on the sheets. The patient had no emergency room visit or visit to physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fever was not recovered and outcome of the rest of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: he had a low grade fever and headache after receiving both injections; he had a low grade fever and headache after receiving both injections; This is a spontaneous report from a non-contactable consumer (patient) reported that a 70-year-old male patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included having low grade fever and headache "all the time". Concomitant medications were not reported. Patient previously took acetylsalicylic acid/caffeine/salicylamide (BC Powder) for low grade fever and headache routinely. Patient stated that he had a low-grade fever and headache after receiving both injections and wanted to take some BC Powder, but heard that he should not do so with the vaccine.  Patient stated that he has low grade fever and headache "all the time" and routinely uses BC Powder to treat. He would like to know if it's okay for him to take it after receiving his Pfizer covid vaccine the other day. Patient also wondered how long it takes after receiving the second vaccine to be fully vaccinated and whether there is any information on protection against the new variant strains. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: tired; weak; This is a spontaneous report from a contactable consumer who reported for his wife (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unwon route for Covid-19 immunization. Medical history included autoimmune condition, Type 1 Diabetes Mellitus, Graves Disease (hyperthyroidism), some eczema.  Patient got the diabetes later in life like 6 years ago from having her immune system compromised.  Patient was perfectly healthy. Concomitant drugs included levothyroxine sodium (SYNTHROID) and insulin.  Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. After the shot, patient was tired and weak for a couple of days.  Outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Positive COVID-19 test with symptoms on an unspecified date with clinical course of post-nasal drip and started to have a fever prior to the second dose on an unknown date. The patient underwent lab tests and procedures which included body temperature: 99.7, 99.2 and 99.3 on unknown dates and she tested positive for COVID on an unknown date. The clinical outcome of the event COVID-19 was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: soreness on the arm which is on the injection site; soreness on the arm which is underneath the arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose of vaccine on 07Mar2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness on the arm which is on the injection site and underneath the arm after the second dose on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Feeling abnormal
Clinical narrative: tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and Cold; nauseated/Nausea; fever; chills; headache; tired; feeling bad; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EP6955), on an unspecified route of administration on Arm Left on 19Mar2021 at 11:00 as single dose for COVID-19 immunisation. No additional vaccines were administered on the same date. The patient had a medical history included ongoing asthma (last time she had asthma was one month ago. Caller doesn't remember when she was first diagnosed by a doctor). The patient's concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both are at three times a day (takes it every 8 hours). The patient was not received any vaccinations within 4 weeks. It was reported that, Patient felts tired after the vaccine. Caller states her first dose was 19Mar2021 and the next day 20Mar2021, she was tired and had a headache. Caller states she has chills on 27Mar2021 for two days only. Caller verifies it was chills she was experiencing, states she was hot and cold on 27Mar2021, unsure of what the word is in English for that. Tired and headache no more after the vaccine. Caller states nausea stopped around 03Apr2021 or 04Apr2021. Caller states she waited for her test to come back, her symptoms were bad on 27Mar2021, so she waited and stayed in her house. Caller states she tested positive for COVID, last Sunday, she waited for a long time for the test to come back. Caller verifies the date she was tested for COVID was 04Apr2021 and she found out the same day she was positive. Patent second dose will be scheduled tomorrow (09Apr2021). Caller states she would like to know if she can take the vaccine tomorrow or if she needs to wait. The patient was not visited to emergency room. Caller states she went to her physician's office after her first dose of the vaccine. Caller states she visited her family doctor because she was feeling bad by a telephone appointment yesterday with her. Caller states her doctor said she needed her weight, and she can take Tylenol. The outcome of the event tested positive for Covid last Sunday was reported as recovering, fever, chills, Hot and Cold was recovered on 28Mar2021, headache was recovered on 04Apr2021, tired was recovered on 05Apr2021, nausea was recovered on Apr2021, whereas outcome for feeling bad was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and Cold; nauseated/Nausea; fever; chills; headache; tired; feeling bad; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EP6955), on an unspecified route of administration on Arm Left on 19Mar2021 at 11:00 as single dose for COVID-19 immunisation. No additional vaccines were administered on the same date. The patient had a medical history included ongoing asthma (last time she had asthma was one month ago. Caller doesn't remember when she was first diagnosed by a doctor). The patient's concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both are at three times a day (takes it every 8 hours). The patient was not received any vaccinations within 4 weeks. It was reported that, Patient felts tired after the vaccine. Caller states her first dose was 19Mar2021 and the next day 20Mar2021, she was tired and had a headache. Caller states she has chills on 27Mar2021 for two days only. Caller verifies it was chills she was experiencing, states she was hot and cold on 27Mar2021, unsure of what the word is in English for that. Tired and headache no more after the vaccine. Caller states nausea stopped around 03Apr2021 or 04Apr2021. Caller states she waited for her test to come back, her symptoms were bad on 27Mar2021, so she waited and stayed in her house. Caller states she tested positive for COVID, last Sunday, she waited for a long time for the test to come back. Caller verifies the date she was tested for COVID was 04Apr2021 and she found out the same day she was positive. Patent second dose will be scheduled tomorrow (09Apr2021). Caller states she would like to know if she can take the vaccine tomorrow or if she needs to wait. The patient was not visited to emergency room. Caller states she went to her physician's office after her first dose of the vaccine. Caller states she visited her family doctor because she was feeling bad by a telephone appointment yesterday with her. Caller states her doctor said she needed her weight, and she can take Tylenol. The outcome of the event tested positive for Covid last Sunday was reported as recovering, fever, chills, Hot and Cold was recovered on 28Mar2021, headache was recovered on 04Apr2021, tired was recovered on 05Apr2021, nausea was recovered on Apr2021, whereas outcome for feeling bad was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and Cold; nauseated/Nausea; fever; chills; headache; tired; feeling bad; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EP6955), on an unspecified route of administration on Arm Left on 19Mar2021 at 11:00 as single dose for COVID-19 immunisation. No additional vaccines were administered on the same date. The patient had a medical history included ongoing asthma (last time she had asthma was one month ago. Caller doesn't remember when she was first diagnosed by a doctor). The patient's concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both are at three times a day (takes it every 8 hours). The patient was not received any vaccinations within 4 weeks. It was reported that, Patient felts tired after the vaccine. Caller states her first dose was 19Mar2021 and the next day 20Mar2021, she was tired and had a headache. Caller states she has chills on 27Mar2021 for two days only. Caller verifies it was chills she was experiencing, states she was hot and cold on 27Mar2021, unsure of what the word is in English for that. Tired and headache no more after the vaccine. Caller states nausea stopped around 03Apr2021 or 04Apr2021. Caller states she waited for her test to come back, her symptoms were bad on 27Mar2021, so she waited and stayed in her house. Caller states she tested positive for COVID, last Sunday, she waited for a long time for the test to come back. Caller verifies the date she was tested for COVID was 04Apr2021 and she found out the same day she was positive. Patent second dose will be scheduled tomorrow (09Apr2021). Caller states she would like to know if she can take the vaccine tomorrow or if she needs to wait. The patient was not visited to emergency room. Caller states she went to her physician's office after her first dose of the vaccine. Caller states she visited her family doctor because she was feeling bad by a telephone appointment yesterday with her. Caller states her doctor said she needed her weight, and she can take Tylenol. The outcome of the event tested positive for Covid last Sunday was reported as recovering, fever, chills, Hot and Cold was recovered on 28Mar2021, headache was recovered on 04Apr2021, tired was recovered on 05Apr2021, nausea was recovered on Apr2021, whereas outcome for feeling bad was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Head discomfort, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: cold like symptoms; sore throat; constantly blowing her nose; her head is so stopped up; trouble breathing, like catching her breath; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine) via unspecified route of administration in arm left on 03Apr2021 (Lot EP7533, unknown expiration date) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as no. The patient experienced trouble breathing from 05Apr2021, cold symptoms from 07Apr2021. On 05Apr2021, the patient started having trouble breathing, like catching her breath. On 07Apr2021, the patient came down with like a cold. She felt cold like symptoms, a sore throat. She was constantly blowing her nose, her head was so stopped up, the symptoms came on all of the sudden, she felt very unlucky. The patient would like to know whether their side effects; problems breathing, trying to catch her breath, cold-like symptoms and a sore throat, were related to the COVID vaccine. The patient also asked if please get COVID from the covid vaccine, if she had COVID, what should the patient need to do. Investigation assessment was reported as no. Her second dose is scheduled on 24Apr2021. The outcome of the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Swelling of eyelid
Clinical narrative: Left eye lower lid was very swollen, it got worse; It is not like a small growing, it is really big and all the way to the cheek bone; high fever; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that a 67 years old female patient received 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 on 05Apr2021 at single dose on left arm for covid-19 immunization. Medical history and concomitant drug were not reported. Caller states the thing is, on Monday 05Apr2021 she had her second Pfizer Covid vaccine and Monday afternoon she was okay, states from Monday night up until yesterday she had a very high fever, states right now it is reduced, she knows that is sort of normal, but states on Tuesday afternoon on left side of her eyelid is swollen very badly, it got worse. She got this Less than 24 hours of having the vaccine it has to be related to the vaccine, she never had this before. It is not like a small growing, it is really big and all the way to the cheek bone. Outcome of the event fever was recovering, for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: many welts on his body; This is a spontaneous report from a contactable consumer (patient's wife). A 59-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 21Mar2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. The vaccine caused him many welts on his body, although they disappeared with diphenhydramine hydrochloride (BENADRYL). He had the second dose scheduled for 21Apr2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received her 1st dose/then tested positive for Covid; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that Patient received her 1st dose on 18Mar2021 then tested positive for Covid on 23Mar2021. The 2nd dose is scheduled on 09APR2021 (more than 21 days). She was told to wait 90 days to take the 2nd dose because of the said situation. The patient underwent lab tests and procedures which included covid-19: positive on 23Mar2021 Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Facial pain, Pain in jaw, Swelling face
Clinical narrative: cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; cheeks, chin and marionette lines/ pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at single dose for COVID-19 immunization, started to receive hyaluronic acid, lidocaine (RESTYLANE L) from 23Mar2021 for unspecified indication. Medical history was not provided. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Patient injected to cheeks, chin and marionette lines with hyaluronic acid, lidocaine on 23Mar2021 and experienced swelling, bruising, and pain in Mar2021. Patient took Arnica, ibuprofen and applied ice; bruising resolved, other events were ongoing. Action taken with hyaluronic acid, lidocaine was unknown. Outcome of the event bruising was recovered while other events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive last week.; I tested positive last week.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Apr2021, the patient's husband got COVID. In Apr2021, the patient tested positive last week. The patient had very mild symptoms, no fever. She have to delay her second shot by 3 weeks. She know the fist vaccine helped her out so much. In Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got infected with Covid-19 virus 2 weeks ago; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number unknown), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Mar2021, patient got infected with COVID-19 virus. The patient wants to reschedule the second dose as a result of the event. The outcome of the event COVID-19 was unknown. The patient underwent lab test which included SARS-CoV-2 Test: Positive on 24Mar2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Rash, Swelling face, Vaccination site streaking
Clinical narrative: rashes; swelling on the mouth; swelling on the lips; swelling on the face; Streaks on arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 01Apr2021 at single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure; both diagnosed long before, probably 20 years before. Concomitant medications were not reported. Patient said that after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed rashes, and swelling on the mouth, lips and face on 01Apr2021. She was told not to receive the second dose but called to confirm if it was true. Patient waited the 15 minutes she was told to after the vaccine. Then an hour after the vaccine her face swelled, mouth swelled, lips swelled up over her nose, she had a rash, and streaks down her arms. She went to the emergency room on 01Apr2021 and was given a steroid and was told to take diphenhydramine hydrochloride (BENADRYL) every 6 hours.  She was not admitted to the hospital. She recovered completely as of 03Apr2021. Patient read the papers that she was given and they said if you had reactions like this you should not get the second shot. She went to the doctor and they told her it was up to her whether or not she got the second shot. She wanted to know whether or not she should get it. She was leaning towards not getting it because it was the same recipe as the first shot and she felt she would have the same reaction. Outcome of the events was resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Balance disorder, Blood cholesterol, Blood cholesterol abnormal, Flushing
Clinical narrative: Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Oropharyngeal discomfort, Pain, Throat tightness
Clinical narrative: Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test, Thyroid function test abnormal
Clinical narrative: Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Balance disorder, Blood cholesterol, Blood cholesterol abnormal, Flushing
Clinical narrative: Pt. Complaint of throat tightness after receiving vaccine. Benadryl administered and symptoms relieved after 35 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Oropharyngeal discomfort, Pain, Throat tightness
Clinical narrative: Pt. Complaint of throat tightness after receiving vaccine. Benadryl administered and symptoms relieved after 35 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test, Thyroid function test abnormal
Clinical narrative: Pt. Complaint of throat tightness after receiving vaccine. Benadryl administered and symptoms relieved after 35 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Pt. Complaint of throat tightness after receiving vaccine. Benadryl administered and symptoms relieved after 35 minutes.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Vaccination site haemorrhage
Clinical narrative: At the time of injection, the nurse said she had bled a little; a "quarter size of bruise on her arm a couple of days later"; lump under the arm; This is a spontaneous report received from a contactable consumer (patient herself) of an unspecified age received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 01-APR-2021 as single dose for COVID-19 immunization and first dose on an unspecified date via unspecified route of administration. At the time of injection, the nurse said she had bled a little and caller stated that she developed a "quarter size of bruise on her arm a couple of days later" and a "lump under the arm" and said the bruise was going away now. Caller had a concern was the vaccine still effective asked was the vaccine was given possibly in a vein or capillary. No info found regarding bruising after the injection or inadvertent administration in a capillary/vein. Referred to her HCP. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: soreness on the injection site on the left arm; she couldn't sleep; could barely move; body aches; sweats; chills; diarrhea; stomach doesn't feel great; headache; muscle aches; This is a Spontaneous report from Pfizer program. A contactable 59-years old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number ER8737) as SINGLE DOSE for covid-19 immunisation.  Medical history included torn rotator cuff, tendonitis. The patient's concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday, 06Apr2021. Then she started feeling some side effects yesterday 07Apr2021 like, soreness on the injection site on the left arm, she couldn't sleep and could barely move, she had body aches, sweat and chills, diarrhoea, stomach didn't feel great, headache and muscle aches. She stated her arm was feeling a lot better than last night. Outcome of events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Myalgia, Pain, Vaccination site pain
Clinical narrative: soreness on the injection site on the left arm; she couldn't sleep; could barely move; body aches; sweats; chills; diarrhea; stomach doesn't feel great; headache; muscle aches; This is a Spontaneous report from Pfizer program. A contactable 59-years old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number ER8737) as SINGLE DOSE for covid-19 immunisation.  Medical history included torn rotator cuff, tendonitis. The patient's concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday, 06Apr2021. Then she started feeling some side effects yesterday 07Apr2021 like, soreness on the injection site on the left arm, she couldn't sleep and could barely move, she had body aches, sweat and chills, diarrhoea, stomach didn't feel great, headache and muscle aches. She stated her arm was feeling a lot better than last night. Outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Pain
Clinical narrative: fatigue; really bad body aches; Brain fog; had 1st dose of covid-19 vaccine last 01APR2021 but not scheduled for the 2nd dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of COVID-19 vaccine last 01Apr2021 but not scheduled for the 2nd dose. After her 1st dose of the vaccine, she experienced being on the couch for 2 days because of fatigue, really bad body aches, and brain fog. She would like to know if it is safe to get the 2nd dose of the vaccine. Th outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes all over his body from his trunk down to his belly; This is a spontaneous report received from a contactable pharmacist. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced rashes all over his body from his trunk down to his belly on an unspecified date. Pharmacist was asking about administration of the second vaccine dose to a patient who reported having a reaction to the first dose. Patient reported that a few hours after having his first vaccine dose he experienced rashes all over his body from his trunk down to his belly. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.