chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Nausea, Oropharyngeal pain, Pruritus
Clinical narrative: tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made.  Information on the Lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Swelling face
Clinical narrative: right side of her face swollen; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246, expiration date not reported), intramuscular on the upper left arm, on 12Jan2021 at a single dose to develop immunity for Covid 19 virus. The patient has no medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID). The patient stated she got Pfizer Covid 19 vaccine two days ago at a hospital in the city and right side of her face was swollen and had extreme fatigue on 14Jan2021. Stated she is resting now and is feeling fine. She stated that it happened this morning. Stated that she waited for 15 minutes after the vaccine and had no side effects. She stated that her next dosage is 02Feb2021. There was no treatment received for right side of face swelling. Outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Right arm killing her through the night; Little Achy; Headache; This is a spontaneous report from a contactable consumer (patient herself).  A 71-year-old female patient received bnt162b2 (BNT162B2 also reported as Pfizer COVID Vaccine, lot EL3247), intramuscular in the right arm on 13Jan2021 18:00 at SINGLE DOSE for Covid-19 immunisation (reported as prevention for age group). She received the vaccine in a hospital. Medical history included a Covid-19 patient on Mar2020, hypothyroidism and normally had headaches. No other vaccines taken prior to vaccination. There were no concomitant medications.  On 13Jan2021 03:00, she had arm pain that was killing her through the night. She was a little achy, had a headache, but no fever. The outcome of events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: really tired; This is a spontaneous report from a contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included parkinsons. Concomitant medications were not reported. The patient was having a hard time right now. He was really tired on Jan2021 and does not know if he has any other symptoms. Outcome of the event was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Bruise where he got the shot; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 07Jan2021 at single dose (left arm) for COVID-19 immunization (Over 65 years old; 2nd group to receive in state). The patient medical history was not reported. There were no concomitant medications. Patient got the COVID Vaccine last Thursday (07Jan2021). He had soreness in his arm, which is fine, but when he took the Band-Aid off he had a bruise where he got the shot (13Jan2021). His wife told him he should call and report this. About the arm soreness, it was really sore the first couple of days. The nurse said if he moves his arm and works it, it would help. It was sore for about 2-3 days. Sore to the touch, but not painful. There were no treatment given. They were asking if they should contact his physician, if this is normal. He has had vaccines before, but never had a bruise. The outcome of the event Bruise where he got the shot was not recovered, while for other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer reporting on herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On the same date that evening, the patient experienced headache. The patient received treatment for the event which included 2 aceteminophen (TYLENOL). The outcome of the event headache was unknown.   Information on the Lot/Batch number has been requested
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Sinus disorder
Clinical narrative: migraine from sinuses; migraine from sinuses; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 39-year-old female patient received BNT162B2, via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that the patient got the vaccine on 16Jan2021, and she experienced migraine from sinuses. She asked if it is okay to take Migraine medicine while she had her vaccine. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rhinorrhoea, Sneezing
Clinical narrative: runny nose; sneezing; don't feel right; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced side effects after receiving the COVID-19 vaccine on 14Jan2021. The patient experienced runny nose, sneezing and he don't feel right in Jan2021. He is also concerned about his wife if there is a possibility of infecting her since she doesn't have received the COVID-19 vaccine yet. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Extreme fatigue; This is a spontaneous report from a contactable physician (sister in law). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received 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 and did not experienced adverse side effects. On 11Jan2021, the patient experienced chills and extreme fatigue (developed 12 hours after injection). The patient outcome of the events was recovered on 12Jan2021 (after a night of rest).  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vaccination site reaction
Clinical narrative: fever; injection site reaction; flulike symptoms; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative. A 32-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16Jan2021, the patient developed injection site reaction, fever, and flulike symptoms after being administered the second dose of the Pfizer/BioNTec COVID-19 vaccine. The patient's symptoms have since resolved on Jan2021.  No follow-up attempts are Possible; Information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: lips, mouth and tongue were numb; This is a spontaneous report from a contactable nurse (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Medical history included diagnosed with COVID on 03Nov2020. Ever since the patient had had COVID. The patient had a terrible burning sensation in mouth and tongue.  The patient's concomitant medications were not reported. Immediately after the vaccine, the pateint's lips, mouth and tongue were numb and felt full, lasted for approx 2 hours. Later that evening the burning the patient had since recovering from covid had stopped. The outcome of the event was unknown.   Information on the lot/batch number had been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as the second single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fever and chills on an unspecified date.  The outcome of fever and chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: It's really itchy on my back; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient)   A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Dec2020 at single dose via an unspecified route of administration  for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. Patient informed that since an unspecified date it was really itchy on my back, it was no terrible hype but really for the last 3 days (as reported). Patient also mentioned that she should get her booster this coming week (as such). At the time of the reporting event outcome was unknown.   The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Enlarged lymph nodes surrounding the area where it was injected, one of the lymph nodes is right on my clavicle bone in close proximity; I am also feeling swelling under my armpit and up my neck; This is a spontaneous report from a contactable consumer reported for self. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. Medical history included asthma. Concomitant product included vortioxetine hydrobromide (TRINTELLIX).  The patient previously the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient got the COVID Vaccine second booster on Sunday and was having enlarged lymph nodes surrounding the area where it was injected. The patient stated, "No, it's not at the site of injection, I have one so it's on, I got the shot in my left shoulder and one of the lymph nodes is right on my clavicle bone in close proximity and I am also feeling swelling under my armpit and up my neck."  Treatments included Tylenol and Advil. Outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 23Dec2020 12:30 at a single dose for COVID prevention. Medical history included diabetic (On insulin only. Diabetic for six to seven years and have had no hypoglycemic events). There were no concomitant medications. It was reported that the patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy  was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Panic reaction
Clinical narrative: three nights of very vivid nightmares; waking up with Panics with worm head; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 11Jan2021 at 13:15 at a single dose in the hospital for COVID-19 immunization. The first dose was received on 19Dec2020 at 13:15 on the left arm for COVID-19 immunization. The reaction with the first dose was losing taste and smell for two days. Medical history included sulfa allergies. Patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering.  Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Pain in jaw, Pyrexia, Vaccination site pain
Clinical narrative: chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering.  Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tachyphrenia, Vertigo
Clinical narrative: Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 1st of 2 reports reported for the reporter. A female patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient and her husband both had vaccine on Friday and they discovered that they both were Covid positive on Monday. Patient did not have symptoms but her husband did, the question was whether they should still get the second shot. Events outcome was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049698 Same reporter, same drug, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Continuous headache since first dose .; This is a spontaneous report from a contactable nurse (patient). A 53-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 22Dec2020 13:30 in right arm (at the age of 53-years-old) at SINGLE DOSE ,  second dose via an unspecified route of administration on 12Jan2021 16:30 in right arm (at the age of 53-years-old) at SINGLE DOSE for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing.  The patient did not have any allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a hospital. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Dec2020, the patient experienced continuous headache since first dose. The patient did not receive treatment for the continuous headache since first dose. Outcome of the event continuous headache since first dose was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare professional (patient).  A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021, at 18:30 as single dose for COVID-19 immunization.  Medical history included hyperthyroidism and known allergy to latex.  Concomitant medication included St. John's wort (MANUFACTURER UNKNOWN), elderberry (SAMBUCUS NIGRA), cetirizine hydrochloride (ZYRTEC).  The patient experienced fever, headache, body aches and sore arm on 15Jan2021, at 04:30.  No Covid prior vaccination was noted; the patient has not been tested  for COVID post vaccination.  No treatment was  given for the events. The outcome of events was recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling
Clinical narrative: bilateral eye irritation; edematous right eyelid since day of 2nd vaccine; This is a spontaneous report from a contactable nurse reported for herself.  This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 12Jan2021 10:15 for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), paracetamol (TYLENOL). Previously the patient received the first dose of BNT162B2, intramuscular in the left arm on 24Dec2020 02:00 PM for Covid-19 immunisation. On 12Jan2021 12:00 PM, the patient experienced bilateral eye irritation, edematous right eyelid since day of 2nd vaccine. No treatment was performed. The outcome of the events was not recovered.    The vaccine was administered at Hospital Facility. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post the vaccination.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgias; dizziness; headache; fever; chills; This is a spontaneous report from a contactable Physician reporting for herself.  A 50-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), intramuscular in the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot SK5730) on 23Dec2020 at 09:30 AM intramuscular in left arm. The patient experienced myalgias, dizziness, headache, fever and chills on 16Jan2021 12:00 with outcome of recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Dizziness, Fatigue
Clinical narrative: weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient).  This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Lethargy, Nausea, Pain
Clinical narrative: weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient).  This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vomiting
Clinical narrative: weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient).  This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Injection site swelling, Pain, Pyrexia
Clinical narrative: swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse.  A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse.  A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; headache; chills; Extreme fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 25-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 19Dec2020 at 12:00, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications included cannabidiol (CBD OIL) and unspecified birth control. The patient experienced diarrhea, headache, chills and extreme fatigue all on 09Jan2021 at 16:00 with outcome of recovered in Jan2021. Extreme fatigue recovered after 36 hours. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient, who worked in a hospital laboratory, stated that after the first dose, he got a sinus infection on 24Dec2020. He went through antibiotics for a week for the sinus infection which was completed by the second dose. The outcome of the event was recovered on 31Dec2020.  Information about lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Headache, Laboratory test
Clinical narrative: site was sore; Brain fog; Fatigue; rash on his hand; Extreme anxiety; Headache; This is a spontaneous report from a contactable consumer (patient). An adult male patient with age at vaccination of 33-years-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), via an unspecified route of administration, on 30Dec2020, at single dose for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated he got the shot on 30Dec2020. There was no allergic reaction however, the site was sore, sore for a couple of days from an unspecified date. The patient added that from an unspecified date, he did have kind of brain fog, fatigue, and headache for 3 days. Those symptoms subsided after 3 days. Additionally, 2 or 3 days ago in Jan2021, he started getting a rash on his hand and have also now been suffering from extreme anxiety, fatigue and brain fog. He informed that he went to the emergency room yesterday and he was prescribed some Xanax for the anxiety and a steroid for the rash. The patient was currently taking those now. He also did some basic lab testing yesterday, 13Jan2021, and all his labs were pretty much okay. The outcome of the events site was sore, and headache was recovered on an unspecified date; the outcome of event rash on his hand was unknown; while the outcome of the other remaining events was not recovered.