chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Paraesthesia, Skin disorder
Clinical narrative: all over her body in random places she feels pricks on her skin; on one side of her abdomen that she started to get a sensitive area; sensitive spot on her abdomen, felt like it was sticking to her skin, and then felt like she had pricks all over her skin; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 24Feb2021, in evening, she developed a sensitive spot on her abdomen, felt like it was sticking to her skin, and then felt like she had pricks all over her skin, on 25Feb2021 all over her body in random places she feels pricks on her skin, on 24Feb2021 she noticed last night on one side of her abdomen that she started to get a sensitive area. She did not have a rash. 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: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Really, really sore, swollen arm and headache; Really, really sore, swollen arm and headache; Really, really sore, swollen arm and headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown (Consumer stated, "cannot even read this, Is it GN6202. do not know if it is an E or G, GN6202)), via an unspecified route of administration on 24Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced really, really sore, swollen arm and headache on an unspecified date. Are these normal? Can she take Tylenol to treat? Second dose scheduled for the next shot for 24Mar2021 and now that was 4 weeks away and she know that the second dose was supposed to be 3 weeks apart. She wanted to know why that was? The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Tinnitus
Clinical narrative: ringing in left ear; she got extremely dizzy for 2 days; sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269, Expiration date: May2021), via an unspecified route on 18Feb2021 at 08:15 (at the age of 73-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included hyperthyroidism, low vitamin D. The patient concomitant medications included vitamin D 2400mg daily by mouth (Taken about 3 years, 2000mg tablet 400mg was gel cap, she takes 2 separate pills) for low vitamin D, methimazole 10mg one day tablet by mouth for hyperthyroid (Has taken for years). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation and experienced soreness in her arm. The patient experienced sore arm so she put a cold pack on it on 18Feb2021. After 3 days of getting the second shot of the covid vaccine she got extremely dizzy she could barely move for 2 days on 21Feb2021 and on the next day, the dizziness got better but she started getting had ringing in the ears on 22Feb2021. On the fifth day, the dizziness was there but she thought she could get up and try to walk. She reports she would not drive though, she was still dizzy. The dizziness drives her nuts. She doesn't feel sick to her stomach. Patient states she goes to an endocrinologist once a year for her blood work. She has hyperthyroidism. The outcome of the events sore arm was recovered on 19Feb2021, she got extremely dizzy for 2 days was recovering and ringing in left ear was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was extremely tired; This is a spontaneous report from a contactable consumer (patient). An 87-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in arm left on an unspecified date as DOSE 1, SINGLE for covid-19 immunization at physician office (doctor's office/urgent care). The patient was not pregnant at time of vaccination. Patient medical history included diabetes from an unknown date and unknown if ongoing. The patient had known allergies. The patient did not receive any other vaccines within 4 weeks. It was reported that patient took other medications in two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 12:00, the patient reported to be extremely tried to do anything. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the injection site; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in the injection site on an unspecified date. It was reported that on an unspecified date (reported as Saturday), he felt pain in the injection site that apparently was gone for one day, and then on Sunday it came back and continued to be felt with growing in intensity through Monday and Tuesday. Patient was also asking if NSAID medications could reduce the efficacy of the Pfizer's COVID-19 vaccine building up antibodies. The outcome event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache
Clinical narrative: usual headache; This is a spontaneous report from a contactable female consumer (patient) reported for herself. An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9810), via an unspecified route of administration on 16Feb2021 (age at vaccination: 82-year-old) as a single dose for covid-19 immunization. Medical history included High blood pressure, patient do take medicine and was under control. Concomitant medication included ramipril in the morning and 10 at night. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at the age of 82-year-old as a single dose for covid-19 immunization. On 16Feb2021 the patient experienced no immediate side effects other than a small headache the first couple of days. Starting on Friday (19Feb2021), she's been having headaches ever since. Patient wanted to know if it was normal for these headaches to last for this long. The headaches were not as bad now as they were and not a usual headache, as its more of a sharp pain. Therapeutic measures taken as a result of the events included Tylenol. The patient underwent lab test and procedure which included blood test past Monday and the result was unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.  Follow up (25Feb2021): New information received from a contactable consumer included medical history added, concomitant medication added, treatment drug added, and lab data added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Extrasystoles, Visual impairment, Vitreous floaters, Weight increased
Clinical narrative: had vision issues; seeing dots; burning sensation around/near sternum; my heart skipped; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN9581, expiration date: May2021), via an unspecified route of administration on arm left on 23FEB2021 17:45 age at vaccination: 57 years as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included SVT heart condition tachycardia and not had any other recent vaccinations or started any new medications. The patient Concomitant medications she takes VITAMIN D pills and hormone therapy progesterone and estrogen, but she has for a while. No further details provided about these. On 25Feb2021, the patient experienced seeing dots and had vision issues. It was reported that she received the first dose of the Pfizer vaccine 2 days ago and had vision issues, when she saw white surface and bright light she saw dime sized blue dot changed to pink which wouldn't go away for a minute. She reported While she was closing the garage door, when you go into the sun flare of vision and it goes away as she was going to the bathroom, everywhere that was white. She saw blue dots and there was a continuous pattern to it blue changed to pink and remained pink. Same color as in the bathroom, for a minute up to longer than a minute that concerned me. I have no medical conditions. If I see pink dots it that retina detachment. Wondering if it's causing any damage. I have SVT heart condition tachycardia. I was concerned about it because the night I took it I had a circular burning sensation around/near sternum and my heart skipped, and it scared me, just the first night. I got the vaccine at 5:45pm this happened about 11pm. I don't know if it was gas or anxiousness. When I was signing up they asked if I had/was COPD, smoker, and clicked yes, since I have a heart issue but no one was concerned about it. I heard about a new strain which is more deadlier than the others. What I'm concerned about is the 2nd dose and needing the another variant dose. She was concerned about if there could be damage to the retina in her eye, whether she should seek treatment, and what if she decides not to take the second dose and goes with another vaccine, what are her options about what she can do. The lab test included Weight increased 15lbs (Weight: Caller says after a year being inactive after COVID, clarified that she did not have COVID-19, she was inactive in her home and has gained 15lbs it's terrible) on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I experienced extremely mild soreness at site of injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EL3247) via an unspecified route of administration, administered in right arm on 24Feb2021 10:30 AM (at the age of 46 years) as DOSE 1, SINGLE for covid-19 immunization. The patient was non pregnant at the time of vaccination. Prior to vaccination patient was not diagnosed with covid 19. The patient's medical history included known allergies to medications, food, or other products: sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. On 24Feb2021 18:30, the patient experienced felt extremely mild soreness at site of injection approximately 8 hours following vaccination. Soreness was gone by the time she woke up the next morning. Patient not been tested for covid 19 since vaccination. Reporter assessed case as non-serious. No treatment received for the events. The outcome of the events was recovered on 25Feb2021.    No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: mild headache; Soreness of right arm,; This is a spontaneous report from a contactable pharmacist.   A 36-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 24Feb2021 14:30 (at the age of 36 years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021 12:00, the patient experienced mild headache, soreness of right arm. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any treatment for the events. The outcome of soreness of right arm, mild headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: lump appeared; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, She got vaccinated on Monday Feb 22nd with the first dose and the next day a lump appeared a little below the injection site in her arm, like the vaccine infiltrated however it does not hurt on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Vaccination site erythema, Vaccination site swelling
Clinical narrative: were the shot is, but it's still red; were the shot is, but it's still red and swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 21Feb2021 (age at the time of the vaccination 71-year-old) as dose 2, single for COVID-19 immunization. Medical history included allergy to penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration on 30Jan2021 (age at the time of the vaccination 71-year-old) as dose 1, single for COVID-19 immunization had little reaction to the first shot but her heart doctor changed her cholesterol levels. On an unspecified date in 2021, the patient had to take Benadryl all three days after the second vaccination. The patient placed a sore bean junior were the shot was but it was still red and swollen. The outcome of all events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 76-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date after receiving the second dose of the Pfizer COVID-19 vaccine, patient experienced pain at injection site. It was very bad. She couldn't raise her arm until today. She also had fatigue, muscle pain, chills and swollen lymph nodes in her neck. Last night it was pretty bad. It took her until midday to feel a little bit better. Patient stated she did not receive any paperwork including the recipient fact sheet, so she did not know what to expect. Patient wanted to know if these symptoms were common after receiving the second dose of the Pfizer COVID-19 vaccine and how long these symptoms would last. Patient also mentioned when she was speaking to the agent prior to disconnection, she was told more people have reported side effects after the second dose than the first dose. She wanted to know if that information was true. Investigation assessment: no. Therapeutic measures: not taken. The outcome of events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 76-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date after receiving the second dose of the Pfizer COVID-19 vaccine, patient experienced pain at injection site. It was very bad. She couldn't raise her arm until today. She also had fatigue, muscle pain, chills and swollen lymph nodes in her neck. Last night it was pretty bad. It took her until midday to feel a little bit better. Patient stated she did not receive any paperwork including the recipient fact sheet, so she did not know what to expect. Patient wanted to know if these symptoms were common after receiving the second dose of the Pfizer COVID-19 vaccine and how long these symptoms would last. Patient also mentioned when she was speaking to the agent prior to disconnection, she was told more people have reported side effects after the second dose than the first dose. She wanted to know if that information was true. Investigation assessment: no. Therapeutic measures: not taken. The outcome of events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: not been feeling well; very tired; body hurts; This is a spontaneous report from a contactable consumer (patient). A 74 (unit unknown) female patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, after receiving the vaccine, patient has not been feeling well, has been feeling very tired, and her body hurts. Outcome of the events was not recovered. Patient was scheduled for the second dose on 12Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: not been feeling well; very tired; body hurts; This is a spontaneous report from a contactable consumer (patient). A 74 (unit unknown) female patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, after receiving the vaccine, patient has not been feeling well, has been feeling very tired, and her body hurts. Outcome of the events was not recovered. Patient was scheduled for the second dose on 12Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Taste disorder
Clinical narrative: hint of a taste in my mouth; peckish; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 22Feb2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included cancer, fatigue, peckish (low appetite) and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included rituximab (RITUXAN) for cancer on an unspecified date. The patient got first dose of vaccine on 22Feb2021 and takes Rituxin and was told by her pharmacist to wait 20days after Rituxin dose to get the vaccine. The patient says the vaccine enhanced symptoms she already has. The patient stated that immediately after first dose, she had a hint of a taste in her mouth during the 15 minutes waiting after dose and she felt peckish immediately after the dose on an unspecified date in 2021. The patient asked that, since she had effects after first dose, how will it be after second dose. The patient wants to report something probably not made clear to people getting the shot that are on immunosuppressive drugs and gave person example: patient get cancer medication every 2 months, Rituxin. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Extreme nausea; chills; headache; exhaustion; This is a spontaneous report from a contactable Consumer. This 65-year-old non-pregnant female Consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 at 09:45 on left arm (at 65-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included coeliac disease from an unknown date and unknown if ongoing, lung issues from an unknown date and unknown if ongoing and hysterectomy from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported and cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported. The patient did not take other vaccine was in four weeks. The patient did not have Covid prior vaccination and was not tested for covid post vaccination. On 19Feb2021, the patient experienced extreme nausea, chills, headache and exhaustion. No treatment was received for the events. On an unknown date in 2021 the patient recovered.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ENS318; Expiration Date: 30May2021), via an unspecified route of administration in right arm on 29Jan2021 (at the age of 50 years old) as dose 1, single for covid-19 immunisation. Medical history included she has allergies and asthma, she has had it since when she was 5 years old, COVID-19 virus test positive from Nov2020 to an unknown date. There were no concomitant medications. She stated she received her 1st dose at the end of Jan2021 and has been having difficulty obtaining appointment for 2nd dose and was worried about that. She has not received her second dose yet. Also the patient has been experienced headaches on an unspecified date and patient said she "does not typically get headaches wanting to know if there was any relation with the vaccine. She stated she has been having a slight headache that she doesn't know if that was from the shot, she has it every other day. Therapeutic measures were taken as a result of headache with tylenol, no further details provided about this product. Reporter considered events as non-serious. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue, Feeling hot, Myalgia
Clinical narrative: noticed where the injection was it  is red, welt, seems to be going away and feels hot.; hurting a little; Fatigue; Her temp was 99 or 98; muscle was hurting; felt hot right there; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunization and experienced pain. On an unspecified date after second dose of vaccination, patient noticed that where the injection was given it was reddish and kind of like a welt. It seems to be going away. It had been hurting a little. It felt hot right there. Patient asked if it was a side effect and if she need to go doctor. On the paperwork it said redness at the injection site. It was on the bottom like a circle where she got injected. She still has the Band-Aid on there. There was some soreness. Yesterday there was fatigue. Her temp was 99 or 98 yesterday. She took Tylenol and by this morning or by 10PM last night she was feeling well. She thinks she would be able to see if it was a welt. The circle looks like it is going away. She doesn't know to put ice on it. Patient felt more of a pain from the 2nd shot than the first shot, the muscle was hurting. Redness was going away, it's like a circle. Patient massaged it out and now it was not as dark. Outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: noticed where the injection was it  is red, welt, seems to be going away and feels hot.; hurting a little; Fatigue; Her temp was 99 or 98; muscle was hurting; felt hot right there; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 64-year-old) as single dose for COVID-19 immunization and experienced pain. On an unspecified date after second dose of vaccination, patient noticed that where the injection was given it was reddish and kind of like a welt. It seems to be going away. It had been hurting a little. It felt hot right there. Patient asked if it was a side effect and if she need to go doctor. On the paperwork it said redness at the injection site. It was on the bottom like a circle where she got injected. She still has the Band-Aid on there. There was some soreness. Yesterday there was fatigue. Her temp was 99 or 98 yesterday. She took Tylenol and by this morning or by 10PM last night she was feeling well. She thinks she would be able to see if it was a welt. The circle looks like it is going away. She doesn't know to put ice on it. Patient felt more of a pain from the 2nd shot than the first shot, the muscle was hurting. Redness was going away, it's like a circle. Patient massaged it out and now it was not as dark. Outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue, Feeling hot, Myalgia
Clinical narrative: felt more of a pain from the 2nd shot then the first shot/ muscle is hurting; noticed where the injection was it  is red, welt, seems to be going away and feels hot.; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had noticed where the injection was it is red, welt, seems to be going away and feels hot and felt more of a pain from the 2nd shot then the first shot/ muscle is hurting on an unspecified date. Redness is going away, it's like a circle and now it is not as dark. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: felt more of a pain from the 2nd shot then the first shot/ muscle is hurting; noticed where the injection was it  is red, welt, seems to be going away and feels hot.; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient had noticed where the injection was it is red, welt, seems to be going away and feels hot and felt more of a pain from the 2nd shot then the first shot/ muscle is hurting on an unspecified date. Redness is going away, it's like a circle and now it is not as dark. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Headache, Lymphadenopathy
Clinical narrative: swollen lymph nodes in the arm of the injection; Chills; Aches/body ache; headache; Body temperature/Fever; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a male patient. 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on 03Feb2021 (at the age of 49 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on unknown date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter husband received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks ago. On an unspecified date in Feb2021, he had pretty much all of the symptoms-swollen lymph nodes in the arm of the injection, fever, chills, body ache, headache and those started about 12 hours after the vaccine and they lasted about 36 hours. The patient was a little achy and felt fine to do day to day stuff. However 3 weeks later, her husband had chills and aches again but no fever, at 97. It was also reported that she wants to know if this was normal. The lab data included body temperature was 97 on an unspecified date in Feb2021. The outcome of the events chills and aches were not recovered and other events were recovered on an unspecified date in Feb2021.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: swollen lymph nodes in the arm of the injection; Chills; Aches/body ache; headache; Body temperature/Fever; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a male patient. 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on 03Feb2021 (at the age of 49 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on unknown date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter husband received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks ago. On an unspecified date in Feb2021, he had pretty much all of the symptoms-swollen lymph nodes in the arm of the injection, fever, chills, body ache, headache and those started about 12 hours after the vaccine and they lasted about 36 hours. The patient was a little achy and felt fine to do day to day stuff. However 3 weeks later, her husband had chills and aches again but no fever, at 97. It was also reported that she wants to know if this was normal. The lab data included body temperature was 97 on an unspecified date in Feb2021. The outcome of the events chills and aches were not recovered and other events were recovered on an unspecified date in Feb2021.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: injection site redness; injection site was a bit warm; swollen arm; felt like it had a hard lump; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced injection site redness, injection site was a bit warm, swollen arm and felt like it had a hard lump. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: bad taste in mouth/ bad after taste that she described as a metal taste; dizzy; Tired; arm hurts; tingling in right hand; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6198), via an unspecified route of administration, administered in right arm on 19Feb2021 (at the age at vaccination of 71-year-old) as dose 1, single for covid-19 immunization. The patients medical history included fibromyalgia diagnosed as a child. The patient's concomitant medications were not reported. On 19Feb2021 the patient mentioned she was dizzy, tired, arm hurts a little and tingling in right hand, they had her move it around and it went away. On 20Feb2021, the patient stated she had a bad taste in mouth/ bad after taste that she described as a metal taste. The patient stated when she brushes her teeth or uses mouthwash the taste goes away but if she drinks water, it comes back. The patient stated the people at the medical college told her to call Pfizer. The patient wanted to know if her symptoms were normal after receiving the vaccine. The outcome of event tingling in right hand was recovered on 19Feb2021 and for the rest of the event the outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain in extremity
Clinical narrative: soreness in the arm; headache just for a little while; little unsettling in the stomach; tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 at 14:30 (at the age of 63-years) as dose 1, single for covid-19 immunization at other facility. The patient medical history was not reported. The patient had known allergies to antibiotics. The patient's concomitant medications received in two weeks included amlodipine besilate (NORVASC) for unknown indication, start and stop date was not reported. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 25Feb2021 at 21:00, the patient experienced soreness in the arm, headache just for a little while, little unsettling in the stomach and tiredness. The patient reported that, soreness in the arm, after I got home had a headache just for a little while, little unsettling in the stomach and tiredness. The patient had not received any treatment for the events. The outcome of all the events were unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity, Palpitations
Clinical narrative: had slight pain in her arm; [her] heart was racing; [she] felt her heartbeat was faster; This is a spontaneous report from a Pfizer-sponsored program. A consumer reported for herself.  A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included asthma, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing for which patient takes steroid medications, heart rate increased from an unknown date and unknown if ongoing patient explained she does have this problem, heart raises easily with different things. On an unspecified date after receiving first dose of the Pfizer-BioNTech COVID-19 vaccine. Patient explained she had slight pain in her arm, heart was racing, and felt her heartbeat was faster. Patient described this experience as nothing out of control. Patient stated her second dose was scheduled on 03Mar2021. Patient explained she had appointment with her doctor in a few minutes. Patient also explained that she heard polyethylene glycol could be an allergens and doubts that her daughter's reaction was due to the mRNA. Patient was asking if her condition will inhibit the efficacy of the vaccine (Asthma, COPD), she took steroids as well after the first dose. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity
Clinical narrative: arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness; her arm is still kind of sore and she thinks it is in the muscle area going to her neck; her arm is still kind of sore and she thinks it is in the muscle area going to her neck; This is a spontaneous report from a Pfizer-sponsored program regulatory authority. A contactable 85-year-old female consumer (patient) reported to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (on Thursday, at the age of 85-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications was reported as no. On 19Feb2021 (next day), the patient experienced arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness, her arm is still kind of sore and she thinks it is in the muscle area going to her neck. Reported that event experienced for a week after the first dose. Patient wanted to know the duration of this adverse event. The outcome of event (arm pain/her arm is still kind of sore and she thinks it is in the muscle area going to her neck/was not really hurting but it was kind of sore/soreness) was not recovered and the outcomes of events (her arm is still kind of sore and she thinks it is in the muscle area going to her neck) were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Exposure to toxic agent, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: exposed to a chemical; his hand started hurting, swelling, and became red; his hand started hurting, swelling, and became red; his hand started hurting, swelling, and became red; allergic reaction; This is a spontaneous report from a contactable consumer or other non-HCP (reporter's husband) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9264), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient exposed to a chemical, his hand started hurting, swelling, and became red, allergic reaction. Reporter calling for 69-year-old husband who received his first Pfizer COVID vaccine on 29Jan2021. Patient will receive his second Pfizer COVID vaccine on 27Feb2021. Patient works as a janitor and was exposed to a chemical (unsure of name) while cleaning. His hands became painful, swollen & red. Pt received one Kenalog 40 mxl injections in his hip when seen by his provider. Wife asking if it's okay to take the COVID vaccine after have the Kenalog injection. Reporter is a consumer that was calling about6 the covid-19 Vaccine. The reporter reported that her husband, (Name), had the first vaccine on 29Jan2021 and did wonderful. Patient was scheduled for his second shot, but because of snow and the vaccine getting there it was rescheduled for this Saturday, 27Feb2021. Reporter said that he is a janitor for a park and was cleaning up and he got into some chemicals and his hand started hurting, swelling, and became red. They do not know exactly what caused it and she said that he is assuming that he came into contact with some chemicals. She said that he typically wears gloves when he is cleaning, but for this particular job he did not wear any gloves. The reporter said that the doctor told him it was an allergic reaction and treated him with Kenalog 40MXL and told him to take Tylenol and Ibuprofen. Can he still take his Covid vaccine in Saturday without a problem or is it contraindicated because he had the Kenalog 40MXL. The patient received Kenalog 40MXL injection as treatment for all the events. Outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body pains; mild head ache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 01:00 PM (age at vaccination: 48 years), as Dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Feb2021 at 01:00 PM (age at vaccination: 48 years), as Dose 1, single dose for COVID-19 immunization. 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 was not tested for COVID-19. On 26Feb2021 morning, since she woke up i.e. 6 AM, she had the symptoms. The patient experienced body pains, mild head ache and tiredness and took advil at 9:30 AM. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.