chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Redness; Itching; Rash; Wondering if an allergic reaction; The vaccine injection site started to itch; hives all over the body; Hives appeared around the vaccine injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep7533), dose 1 via an unspecified route of administration, in right arm on 07Apr2021 12:00 (at 30-years age) as single dose for covid-19 immunisation. The patient relevant past drug history includes allergic to contrast IV Iodine and wheat. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. The vaccine injection site started to itch within 5 minutes after vaccination and hives all over the body on 07Apr2021 12:14. Hives appeared around the vaccine injection site within 10 minutes on 07Apr2021 12:10. Patient left the pharmacy without notification of reaction after 14 minutes. Continued to developed hives all over the body that came and went for approximately 2 weeks after receiving the vaccine. Patient was getting hives and redness around the itching rash; patient was asking if it was normal for all. Patient was wondering if it was an allergic reaction. Since the vaccination, the patient not tested for COVID-19. The outcome of the events was unknown.  Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: on the verge passing out/lightheaded/dizzy; nauseous; brain fog; This is a spontaneous report from a contactable consumer, patient. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 22Apr2021 (at the age of 32-years-old as a single dose for COVID-19 immunisation.; doxycycline monohydrate, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has not been tested for COVID-19 post vaccination. On an unspecified date, the patient experienced on the verge passing out/lightheaded/dizzy, nauseous, brain fog, and. The patient stated, I am having an adverse reaction to taking a prescribed antibiotic doxycycline after getting the COVID vaccine. When I take the antibiotic since having the vaccine. I feel lightheaded, nauseous, brain fog, dizzy and on the verge of passing out. I am no longer taking the antibiotic but wanted to bring this reaction to the attention of others. These reactions are not from the vaccine alone but specifically occur as a result of taking the antibiotic and exist in addition to the normal side effects of the vaccine.  The action taken in response to the events with doxycycline monohydrate was unknown. No treatment was provided for the events. The patient was recovering from the events, on the verge passing out/lightheaded/dizzy, nauseous, and brain fog.
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Rash
Clinical narrative: Daughter got rash from hottub on top of foot; had gotten a bacterial infection from a hot tub; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer reported for her daughter. A female patient of unspecified age received the first dose of BNT162B2 (Pfizer 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 was due for second dose on 21Apr2021. Patient got rash from hot tub on top of foot and would be taking antibiotics. Reporter was asking if rash/antibiotics would render second dose useless. Patient had gotten a bacterial infection from a hot tub. She was on antibiotics and wanted to know how long she had to wait to get the second dose. 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: Arthralgia, Dyspnoea, Pain
Clinical narrative: she has pain in her body/Her symptoms got worse; has shortness of breath still; joint pain; This is a spontaneous report from a non-contactable consumer (patient) reported for herself that an unknown age female patient received 1st dose of BNT162B2 (Pfizer COVID-19 Vaccine) on 08Apr2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. She has pain in her body. Her symptoms got worse. She has shortness of breath still and joint pain. She had to go to emergency room. She wants to know what issues will there be if she decides to not get second dose due to side effect she had with first dose. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vomiting
Clinical narrative: Ringing in the ears; dizziness; vomiting; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for four patients. This is one of four reports. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170) on 19Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ringing in the ears and dizziness a few minutes after the vaccine and vomiting on 19Apr2021. The reporter also stated that within 2 hours the patient had ringing in the ear, dizziness, and vomiting. The reporter considered the events related to BNT162b2. Reporter stated that seriousness was unknown and did not know if it was significant or not.  Stated the patient did not have any medical treatment, she was just given some water. The pharmacist reported same events for four different patients and stated that one person (unspecified which one) had to lay on the ground. The outcome of the events was unknown.   No follow up attempts are needed; no further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Vaccination site mass
Clinical narrative: Reddness occurred recently, both arms; hard lump at the injection site; Severe right shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in left arm on 18Mar2021 at 10:15 (at the age of 76 years) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included Amlodipine/Valsartan 5/160mg Tab, Finasteride 5mg. Patient was not aware of allergies. The patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number:EN6205) via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 as single dose for COVID-19 immunisation and experienced swelling, redness, hard lump and a small blister. Patient was not diagnosed with COVID-19 prior the vaccination. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, reddness occurred recently both arms, had a hard lump at the injection site and severe right shoulder joint pain. The patient did not receive treatment for events. Patient was not tested for COVID-19 since the vaccination. The outcome of the events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I got a very bad nose bleed that has been bleeding for about 30 minutes now; This is a spontaneous report from a contactable consumer, the patient. This 44-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route in the left arm on 22Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have any known allergies. The patient did not receive another vaccine within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via unspecified route in the left arm on 30Mar2021 as a single dose for COVID-19 immunization. Concomitant medication included fluticasone propionate (FLOVENT). On 24Apr2021 at 22:00, the patient experienced a very bad nose bleed that had been bleeding for about 30 minutes now. When he put gauze up his nose to try and stop it the blood clotted into a very thick globule but it was continuing to bleed. The patient was not treated for nose bleed. The clinical outcome of nose bleed was not recovered. The patient was not tested for COVID post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness
Clinical narrative: feeling light head; coughing; This is a spontaneous report from a contactable consumer (patient's father) reported for his son (patient) that a male patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. Patient experienced feeling light head and coughing on an unknown date. 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: Fatigue, Vaccination site swelling
Clinical narrative: The Injection site became red and swollen (half dollar size); the injection site became red and swollen (half dollar size); she is fatigued; This is a spontaneous report received from a contactable consumer (patient friend). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 21Apr2021 (reported as yesterday) as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021 (reported as this morning), the patient experienced injection site became red and swollen (half dollar size), and she is fatigued. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in the left arm on 26Mar2021 at the age of 49-years-old as single dose for COVID-19 immunization. The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and had no known allergies. The patient had no other vaccine in four weeks. Concomitant medication included ergocalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported (medication in 2 weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6202), administered in the left arm on 05Mar2021 at 10:00 AM at the age of 49-years-old for COVID-19 immunization. On 09Apr2021, the patient got her period 2 weeks early and she was bleeding very heavy and passing clots about 3 inches around in size. This has never happened to her in her life. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Caller states her client has broken out in hives and welts on her scalp and the only thng they have done different in 3 years is her client got her Pfizer Covid vaccine.; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 67-years-old) as single dose for covid-19 immunisation.Medical history included stroke and blood pressure. Concomitant medication included ongoing alendronate sodium at 70 mg for bone density and ongoing unspecified blood pressure medication and calcium for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6200) on 25Feb2021 for COVID-19 immunization. On 20Apr2021, the patient experienced dates for hives and welts on scalp during hair coloring. It was reported that caller wants to know if there have been any reports of after the vaccine of someone having an allergic reaction to hair color. It was stated that her client has broken out in hives and welts on her scalp and the only thing they have done different in 3 years is her client got her Pfizer Covid vaccine on 20Apr2021. It was stated that she tried to send an email, but it would not let her. It was stated that she was an EMT in her 20s. It was stated that the patient gets her hair colored every four weeks, has been doing this for 3 years and has not changed anything. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Lymphadenopathy, Nausea, Vomiting
Clinical narrative: Fatigue; Nausea; Vomiting; Diarrhea; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, in right arm on 22Apr2021 at 10:30 (at the age of 57-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced fatigue, nausea, vomiting, diarrhea and swollen glands on 23Apr2021 at 11:00. The events resulted in Emergency room visit and were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Rash
Clinical narrative: Rash all over the body; Extreme headache; Extreme weakness; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced rash all over the body, extreme headache and extreme weakness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Eczema, Pruritus, Pyrexia
Clinical narrative: had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination  of 103F; chills; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot/batch no: Unknown), dose 2 via an unspecified route of administration on 21Apr2021, as single dose for covid-19 immunisation.  Patient has a history of getting urticaria/hives from cold water. The patient concomitant medications were not reported.  On an unspecified date the patient experienced a wheel started on the injection site that was pinkish, red rash and circular. Its slightly raised and has uneven edges. She had a low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination of 103F and developed chills. She had no body malaise and no sore arms. Her fever lasted 2 whole days. It is unusual for her to get a high fever, and it did not resolve even with 1000 mg of tylenol. She took a sponge bath for 6 hours and she believes it helped bring down her fever.  Her "wheel" and itchiness were still occurring and getting bigger. She would be seeing her PCP tomorrow. Her lips/perioral area and eyes where one would usually apply eyeliner, though she did not apply makeup, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days but was still ongoing with the second dose.  She hypothesizes that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. She took an antiallergy medication before and at first the side effects were mild. Treatment included 1000 mg of Tylenol for fever. The events assessed as non-serious with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination  of 103F; chills; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot/batch no: Unknown), dose 2 via an unspecified route of administration on 21Apr2021, as single dose for covid-19 immunisation.  Patient has a history of getting urticaria/hives from cold water. The patient concomitant medications were not reported.  On an unspecified date the patient experienced a wheel started on the injection site that was pinkish, red rash and circular. Its slightly raised and has uneven edges. She had a low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination of 103F and developed chills. She had no body malaise and no sore arms. Her fever lasted 2 whole days. It is unusual for her to get a high fever, and it did not resolve even with 1000 mg of tylenol. She took a sponge bath for 6 hours and she believes it helped bring down her fever.  Her "wheel" and itchiness were still occurring and getting bigger. She would be seeing her PCP tomorrow. Her lips/perioral area and eyes where one would usually apply eyeliner, though she did not apply makeup, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days but was still ongoing with the second dose.  She hypothesizes that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. She took an antiallergy medication before and at first the side effects were mild. Treatment included 1000 mg of Tylenol for fever. The events assessed as non-serious with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: reaction/itchiness in her chest until it went to her neck; This is a spontaneous report from Pfizer-sponsored program COVAX US Support from a contactable consumer (patient's Husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient received second dose of bnt162b2 on 06Apr2021 for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient finished the 2 doses of vaccine. After she got the 1st dose 2 weeks after she started had this reaction/itchiness in her chest until it went to her neck, the patient was about to take diphenhydramine hydrochloride (BENADRYL) but they want to talk to someone first before anything else. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient medical history and concomitant medications were not provided. On an unknown date, during the night after the second dose of Covid-19 vaccine, the patient experienced fever and chills. The outcome of the events fever and chills was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug ineffective, Pain in extremity, SARS-CoV-2 test
Clinical narrative: xeljanz has been less effective; Reports More Pain In Her Legs And Hips Especially When sitting for more than 20 min; Reports More Pain In Her Legs And Hips Especially When sitting for more than 20 min; This is a spontaneous report from a contactable consumer (patient) and a nurse. A 55-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Jun2017 (Batch/Lot number was not reported; Expiration Date: 30Jan2023) to Oct2020, at 11 mg, daily for an unspecified indication. Medical history included headache unspecified, pyrexia from Oct2020 to an unknown date. Patient was COVID negative. Patient reported since taking her covid vaccine, tofacitinib citrate had been less effective and reported more pain in her legs and hips especially when sitting for more than 20 minutes. Patient was adherent with medication, though she was now taking out the count(OTC) pain relievers for the increase in pain levels. The action taken in response to the events for tofacitinib citrate was unknown. The 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: Asthenia, Dizziness postural, Hypersensitivity, Malaise
Clinical narrative: allergic reaction; dizziness/dizziness only occurs when she is walking and not sitting; weakness; overall not feeling well; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypersensitivity from an unknown date and unknown if ongoing COVID vaccine that she would have a reaction to any COVID vaccine due to her list of other allergies. The patient's concomitant medications were not reported.  The patient received the BNT162B2 at a pharmacy. The patient states she did not have the typical reactions but she had dizziness, weakness, and overall not feeling well on unknown date. The patient states she saw in the FactSheet that this was an allergic reaction to the vaccine. The patient reported her dizziness only occurs when she is walking and not sitting. The patient states she did not have a fever and she did not drive at first but she is driving now. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021462195 Same patient/ vaccine, different dose/AE
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Pain, Palpitations
Clinical narrative: rapid heartbeat; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; Body aches that night and next day; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (non-pregnant) female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration into the left arm on 31Mar2021 12:45 PM (at the age of 51-year-old) as single dose for COVID-19 immunisation. Vaccination facility was vaccine was administered: Pharmacy or Drug Store. The patient medical history included allergies to citrus, nut, broccoli, apricot, pear and iodine. Concomitant medications included Xyzal, multi vitamin, baby aspirin, herbal. On 31Mar2021, the patient reported that after the first shot, within five minutes she broke into a drenching sweat, heart racing/rapid heartbeat, dizziness/dizzy like going to pass out and body aches that night and next day. The device date was reported as 25Apr2021. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor has been tested since the vaccination. No treatment was taken for the events. Outcome was recovered for all the events.  Follow-up (25Apr2021): New information received from a same contactable consumer which includes: vaccine details, event details added.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: rapid heartbeat; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; Body aches that night and next day; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; 1st shot: within 5 minutes broke into a drenching sweat, heart racing, dizzy like going to pass out.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (non-pregnant) female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration into the left arm on 31Mar2021 12:45 PM (at the age of 51-year-old) as single dose for COVID-19 immunisation. Vaccination facility was vaccine was administered: Pharmacy or Drug Store. The patient medical history included allergies to citrus, nut, broccoli, apricot, pear and iodine. Concomitant medications included Xyzal, multi vitamin, baby aspirin, herbal. On 31Mar2021, the patient reported that after the first shot, within five minutes she broke into a drenching sweat, heart racing/rapid heartbeat, dizziness/dizzy like going to pass out and body aches that night and next day. The device date was reported as 25Apr2021. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor has been tested since the vaccination. No treatment was taken for the events. Outcome was recovered for all the events.  Follow-up (25Apr2021): New information received from a same contactable consumer which includes: vaccine details, event details added.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Decreased appetite, Feeling abnormal
Clinical narrative: reported having only pain in back and pain in joints; reported having only pain in back and pain in joints; fever; vomiting; no appetite; can't eat; strong cough or expectoration; started to feel bad also; she was too weak; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Patient asked if it would be okay to get the second dose, will it be worse on the 2nd dose, I had a side effect after the first dose of the vaccine. Should I get the second dose. Patient mentioned that she was okay after 7 days, reported having only pain in back and pain in joints. Patient mentioned her husband was not feeling well initially, and afterwards, patient started to feel bad also. After 10-11 days after the vaccine, patient reported to have a fever, vomiting, no appetite; can't eat, and a strong cough or expectoration. patient asked if these were possible side effects of this vaccine, offered to transfer to safety, but patient declined, mentioned she was too weak to do that right now. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Vomiting
Clinical narrative: reported having only pain in back and pain in joints; reported having only pain in back and pain in joints; fever; vomiting; no appetite; can't eat; strong cough or expectoration; started to feel bad also; she was too weak; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Patient asked if it would be okay to get the second dose, will it be worse on the 2nd dose, I had a side effect after the first dose of the vaccine. Should I get the second dose. Patient mentioned that she was okay after 7 days, reported having only pain in back and pain in joints. Patient mentioned her husband was not feeling well initially, and afterwards, patient started to feel bad also. After 10-11 days after the vaccine, patient reported to have a fever, vomiting, no appetite; can't eat, and a strong cough or expectoration. patient asked if these were possible side effects of this vaccine, offered to transfer to safety, but patient declined, mentioned she was too weak to do that right now. The 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: Reading disorder, Visual impairment
Clinical narrative: She couldn't see/read the card.; She couldn't see/read the card.; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (reported as "Covid-19 Vaccine"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is due to receive second dose of Covid Vaccine today (21Apr2021). Wanted to schedule a different day. Caller was encouraged to look at vaccination card to try to schedule an alternate time for today (21Apr2021) and she indicated that she couldn't see/read the card. Not clarified if caller had eyesight issues prior to first vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery stenosis, Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); This is the spontaneous report from a contactable consumer (patient). This 79-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 at a hospital facility, via an unspecified route of administration, administered in left arm on 10Feb2021 on 09:00 am (age at vaccination 79 years; batch/lot number: FL9267) as single dose for COVID-19 immunization. Medical history included borderline high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported however patient reported they had medication within 2 weeks of vaccination. The patient previously took penicillin on unspecified date, and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, administered in right arm on 18Jan2021 at 09:15 AM (age at vaccination 79 years; batch/lot number: EL9261) as single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination patient had been tested for COVID-19. Patient had a negative nasal swab on 22Feb2021. Patient experienced cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC; 163.511) on 02Mar2021 at 01:30 which resulted in emergency room/department or urgent care. It was also reported patient had a hospitalization for 2 days. Treatment received was reported as CT and MRI of head & neck, X-ray of chest, "echocar". Patient was recovering from CVA due to stenosis of right middle cerebral artery.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, SARS-CoV-2 test
Clinical narrative: Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); This is the spontaneous report from a contactable consumer (patient). This 79-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 at a hospital facility, via an unspecified route of administration, administered in left arm on 10Feb2021 on 09:00 am (age at vaccination 79 years; batch/lot number: FL9267) as single dose for COVID-19 immunization. Medical history included borderline high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported however patient reported they had medication within 2 weeks of vaccination. The patient previously took penicillin on unspecified date, and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, administered in right arm on 18Jan2021 at 09:15 AM (age at vaccination 79 years; batch/lot number: EL9261) as single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination patient had been tested for COVID-19. Patient had a negative nasal swab on 22Feb2021. Patient experienced cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC; 163.511) on 02Mar2021 at 01:30 which resulted in emergency room/department or urgent care. It was also reported patient had a hospitalization for 2 days. Treatment received was reported as CT and MRI of head & neck, X-ray of chest, "echocar". Patient was recovering from CVA due to stenosis of right middle cerebral artery.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: 1st dose 15Mar2021;  2nd dose 01Apr2021; diagnosed with Bells Palsy; On Wednesday, 14Apr I started experience numbness to the right side of my face; This is a spontaneous report from a contactable consumer (the patient).   A 62-year-old male patient received the second dose of bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP7534), via an unspecified route of administration, on 01Apr2021 at 16:30 (at the age of 62-years-old) as a single dose administered in the left arm for COVID-19 immunization.The patient's medical history was not reported. The patient has no known allergies.  Prior to vaccination,  the patient had not been diagnosed with COVID-19. Historical vaccinations included the first dose of  bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205) in the left arm on 15Mar2021 at 16:30 (at the age of 62-years-old) for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID vaccine. The patient stated that on Wednesday, 14Apr,  she started to experience numbness on the right side of her face. She went to the ER and was diagnosed with Bell's Palsy. The patient experienced diagnosed with Bell's Palsy on 14Apr2021 at 16:30 with outcome of recovering and "numbness to the right side of my face" on 14Apr2021 at 16:30 with outcome of recovering.  Therapeutic measures were taken as a result of  Bells Palsy and and hypoaesthesia and included the administration of prednisone (not further specified). It was also mentioned that since the vaccination,  the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fear, Speech disorder, Tremor
Clinical narrative: trembled like someone who had palsy and was real shaky; When she has to walk she feels weak; afraid of walking; cannot really say anything; This is a spontaneous report from a contactable consumer. A 67 year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, at the age of 68 years, on 25Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6198) on 02Mar2021 for COVID-19 immunization and experienced seizure, feel woozy, felt even weaker, jittery feeling, shaky, doesn't feel well and It has left her with a stutter. The patient stated when she took the second shot on the 25th, she trembled like someone who had palsy and was real shaky. Sometimes at night she has to get her husband. He has to wrap her close to him to keep her from doing that and she'll calm down. When she has to walk she feels weak. She's afraid of walking because she shakes so much and then it seems to be getting better. The first shot she got herself back then with the second shot it's hanging on a little more and its a scary experience. She cannot really say anything. Her daughter has gotten her a bell and a whistle. The outcome of the events was unknown.  Information about lot/batch number was available. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypertension, Rash, Skin lesion
Clinical narrative: High blood pressure 150/107  high consistent; Hand and arm rash with lesion; Hand and arm rash with lesion; Chest pain; Headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old patient of an unspecified gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ed7533) in the left arm, at single dose, on 24Apr2021, at 02:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Relevant medical history and concomitant medications were unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. On 24Apr2021, at 23:00, the patient experienced headache, chest pain, hand and arm rash and lesions and high blood pressure 150/107, high consistent. No treatment was received. The patient did not recover from the events at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Intermittent hives on palms/wrists starting day after first shot'; This is a spontaneous report received from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Lot Number: EN6208, Expiration date was not reported), via an unspecified route of administration, on 12Mar2021 15:45 on left arm as single dose for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Allergies to medications, food, or other product reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Allegra, Advair. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Intermittent hives on palms/wrists starting day after first shot on 03Apr2021 09:00. Patient did not receive treatment for the event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Intermittent hives on palms/wrists starting day after first shot, continuing through 2 weeks after second shot, in spite of continual use of antihistamines; persistent headache for 5+ days starting 1; headache; This is spontaneous report from Non-contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8732, Expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Apr2021 15 as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both are taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products reported as no. Historical vaccine included first dose of bnt162b2(Pfizer COVID-19 vaccine, Lot number: EN6208), on 12Mar2021 15:45 PM on left arm for COVID-19 immunization and experienced Intermittent hives on palms. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021 09:00 patient experienced Intermittent hives on palms/wrists starting day after first shot, continuing through 2 weeks after second shot, in spite of continual use of antihistamines; persistent headache for 5+ days starting 1 week after 2nd shot. Patient did not receive treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Eye pruritus, Lacrimation increased
Clinical narrative: eyes are dry and itchy, and also eyes are watering; eyes are dry and itchy, and also eyes are watering; eyes are dry and itchy, and also eyes are watering; eye pain; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Apr2021 (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 eyes are dry and itchy, and also eyes are watering in Apr2021. Caller stated caller googled it and read there is no treatment for eye pain in Apr2021, and also people got shingles after the covid shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.