chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Ear pain, Fatigue, Headache, Hyperacusis
Clinical narrative: Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Pain, Pain in extremity, Pyrexia
Clinical narrative: Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunisation. Medical history included Hypothyroidism controlled with meds. Concomitant medication included levothyroxine. On 14Jan2021 0130 (reported about 14 hours after injection), the patient experienced chills. The chills occurred about 2 in the morning and lasted only a short while. The patient had not tested for COVID post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered in Jan2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: muscle soreness; She had some arm soreness at the injection site/injection area hurt; This is a follow-up spontaneous report from Pfizer-sponsored program, from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), intramuscular on 30Dec2020 at a single dose for COVID-19 vaccination. Medical history included pains in her arm (so any injection would hurt). There were no concomitant medications. Physician had muscle soreness after getting the 1st dose of the COVID 19 vaccine last 30Dec2020. Took ibuprofen (ADVIL) for pain management and wondering if this will affect the antibody response. Requesting for data regarding people that took pain medications during the clinical trials and asking for antibodies titer after taking pain medications. She will have the 2nd dose on 20Jan2021 and wants to know the options. On 14Jan2021, it was reported that right after the patient took the vaccine, she took some ADVIL because the injection area hurt. She is now seeing she was not supposed to take ADVIL, acetaminophen (TYLENOL), ibuprofen. She also wanted to know during the clinical trials, did they notice a decrease in antibodies after taking ADVIL or TYLENOL. Confirms she took ADVIL right after the injection. She already had pains in her arm so any injection would hurt. She was explaining she is now seeing on Medical (Social site name), a study in mice shows with COVID infections, NSAIDS were given, clarified as meloxicam, and it reduces the neutralizing antibody response. Now, all over Medical (Social site name), physicians are saying you shouldn't take ibuprofen, Naproxen, or Tylenol after receiving a dose. Wanted to know what was seen in the clinical trial data. Mice are mice. It's now all over Medical (Social site name). She has her second dose coming on Wednesday. She also wants to know what is she going to tell her patients? They are not going to want to know what happened in mice, they are going to want to know what happened in Phase 3 of Clinical trials. She had some arm soreness at the injection site. She confirms the arm soreness was gone in less than 48 hours, but she took ADVIL every 8 hours. Once the soreness was gone, she didn't take it. But now she is freaking out, wondering if she didn't get an antibody response? She received the standard dose, which she believes is 3mL of the solution, but she isn't sure. Therapeutic measures were taken as a result of muscle soreness and 'she had some arm soreness at the injection site'. The outcome of the event muscle soreness was unknown, while of 'She had some arm soreness at the injection site/injection area hurt' was recovered on Jan2021.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; headache; muscle pain; fever; nausea; running nose; This is a spontaneous report from a contactable other hcp. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:El3246, expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE then (lot: El3246) via an unspecified route of administration on 13Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient experienced chills, headache, muscle pain, fever, nausea and running nose on 14Jan2021. Treatment was not received for all events. The outcome of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Chills; headache; muscle pain; fever; nausea; running nose; This is a spontaneous report from a contactable other hcp. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:El3246, expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE then (lot: El3246) via an unspecified route of administration on 13Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient experienced chills, headache, muscle pain, fever, nausea and running nose on 14Jan2021. Treatment was not received for all events. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; Localized redness and swelling (hard knot like) approximately the size of a half dollar; pain the arm and shoulder; pain the arm and shoulder; This is a spontaneous report received from a contactable nurse (who is also the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the right arm, on 11Jan2021 07:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 prior to vaccination. The patient has no known drug allergies and is not pregnant. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), omeprazole (PRILOSEC) and biotin. The patient did not receive other vaccine in four weeks. The patient experienced localized redness and swelling (hard knot like) approximately the size of a half dollar with continued pain the arm and shoulder on 12Jan2021. The patient was not tested for COVID-19 post vaccination. Treatment was reported as unknown. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing
Clinical narrative: 1st shot- flushed/hot feeling a couple minutes after, only lasting minutes; 1st shot- flushed/hot feeling a couple minutes after, only lasting minutes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 18Dec2020 12:00 PM at single dose on the right arm  for COVID-19 immunization. The patient is not pregnant. Medical history included Bell's palsy in 2017.  No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No COVID prior vaccination. The patient reported that on the first shot on 18Dec2020, she experienced flushed/hot feeling a couple minutes after, only lasting minutes. Outcome of the events was recovered on 18Dec2020. Patient was not tested for COVID post vaccination.  Information about batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Gastrooesophageal reflux disease, Headache, Malaise
Clinical narrative: acid reflux flare; acid reflux flare; nausea; mild headache; feeling unwell; severe fatigue; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 32-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL8982, expiry date: 31May2021), via an unspecified route of administration, on 13Jan2021 03:00 PM, at a single dose on the left arm for COVID-19 immunization. Medical history included acid reflux. The patient was not pregnant and had no known allergies. The patient received the vaccine at a country vaccination drive through. Facility type vaccine was other. The patient had not received any other vaccine in four weeks prior to vaccination. Concomitant medications (other medications in two weeks) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), ubidecarenone (COQ10), zinc, and magnesium. On 13Jan2021 03:30 PM, half an hour after the vaccination, the patient experienced an acid reflux flare, nausea, mild headache, feeling unwell, and severe fatigue. The symptoms lasted for about 4 hours. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on 13Jan2021 07:30 PM.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: acid reflux flare; acid reflux flare; nausea; mild headache; feeling unwell; severe fatigue; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 32-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL8982, expiry date: 31May2021), via an unspecified route of administration, on 13Jan2021 03:00 PM, at a single dose on the left arm for COVID-19 immunization. Medical history included acid reflux. The patient was not pregnant and had no known allergies. The patient received the vaccine at a country vaccination drive through. Facility type vaccine was other. The patient had not received any other vaccine in four weeks prior to vaccination. Concomitant medications (other medications in two weeks) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), ubidecarenone (COQ10), zinc, and magnesium. On 13Jan2021 03:30 PM, half an hour after the vaccination, the patient experienced an acid reflux flare, nausea, mild headache, feeling unwell, and severe fatigue. The symptoms lasted for about 4 hours. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on 13Jan2021 07:30 PM.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: losing taste and smell for two days; losing taste and smell for two days; This is a spontaneous report from a contactable pharmacist. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on her left arm on 19Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The reaction with the first dose was losing taste and smell for two days (unknown date). 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. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: slight metallic taste" on the back and sides of her tongue; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 15 minutes after the patient received her first dose of the Pfizer-BioNTech Covid-19 Vaccine in Jan2021, she noticed a "slight metallic taste" on the back and sides of her tongue. She wanted to know if this was a common side effect and if there have been reports regarding it. Outcome of the event was unknown.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Erythema, Fatigue
Clinical narrative: slightly light headed; rt hand got red & hot; rt hand got red & hot; numb,  heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Lymphadenopathy, Stomatitis
Clinical narrative: slightly light headed; rt hand got red & hot; rt hand got red & hot; numb,  heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, SARS-CoV-2 test, Skin disorder
Clinical narrative: small bump under left arm (not near injection site); rash appeared on both legs on upper thighs, slight itch, blotchy, red; rash appeared on both legs on upper thighs, slight itch, blotchy, red; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 23Dec2020 16:00 at a single dose at left arm for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) and fish oil. The patient previously took aspirin (E.C.) for gastro upset and experienced allergies. It was reported that rash appeared on both legs on upper thighs, slight itch, blotchy, red, no leg swelling or pain; no pus or discharge. On 11Jan2021, the patient had a small bump under left arm (not near injection site). The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab) on 14Jan2021 which showed negative. The patient received hydrocortisone cream as treatment medication. The outcome of the event was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizzy; Vertigo/room spins; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 15:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no other vaccine in four weeks. Medical history included anxiety, depression, high cholesterol, tinnitus, GERD and seasonal allergies. Concomitant medications in two weeks included valaciclovir hydrochloride (VALTREX), omeprazole (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin, "BCP, and daily vitamin." The patient had no COVID prior to vaccination and was not pregnant. The patient experienced vertigo/ dizzy/ room spins starting in Jan2021 (reported as 08Jan2021/09Jan2021), 1-2 days prior to 2nd vaccine (10Jan2021). The patient did not receive treatment for the events and was not COVID tested post vaccination. The outcome of events was not recovered.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Feeling hot, Heart rate
Clinical narrative: fast heart rate (167 bpm); anxious; had a warm feeling; BP was 154/100 mmHg and her baseline is 100/70 mmHg; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiry unknown), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced an AE 5 minsutes after the dose on 29Dec2020, patient had a fast heart rate (167 bpm), was anxious, had a warm feeling, BP was 154/100 mmHg and her baseline was 100/70 mmHg. The patient would like to know if she should proceed with the second dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart rate (167 bpm); anxious; had a warm feeling; BP was 154/100 mmHg and her baseline is 100/70 mmHg; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiry unknown), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient experienced an AE 5 minsutes after the dose on 29Dec2020, patient had a fast heart rate (167 bpm), was anxious, had a warm feeling, BP was 154/100 mmHg and her baseline was 100/70 mmHg. The patient would like to know if she should proceed with the second dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Limb discomfort
Clinical narrative: half of my legs feel uneasy; had bad taste like metal; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8482, expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 12:00 at a single dose for COVID-19 immunization. Medical history included history (Hx) of blood clots. The patient has no known allergies. The patient is not pregnant. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medication in two weeks. The patient had no COVID prior vaccination and had not tested post vaccination. On 14Jan2021 at 1315, the patient experienced half of her legs felt uneasy, no pain, just like she worked out. The patient also reported that after the vaccine, she had a bad taste, like metal. No treatment was administered for the events. The events had not resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: chills; muscle aches; headache; fatigue; nausea; didn't feel well; This is a spontaneous report from a contactable consumer. A 36-year-old female patient (pregnant: unknown) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, muscle aches, headache, fatigue, nausea in Jan2021 as a result of her second vaccination. The patient didn't feel well in Jan2021 after her second vaccination on 13Jan2021. It was unknown if treatment for the adverse events. No Covid prior vaccination. It was unknown if Covid tested post vaccination. The outcome of the event didn't feel well was unknown, of the other events was recovering.  Information on the lot/ batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chills; muscle aches; headache; fatigue; nausea; didn't feel well; This is a spontaneous report from a contactable consumer. A 36-year-old female patient (pregnant: unknown) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, muscle aches, headache, fatigue, nausea in Jan2021 as a result of her second vaccination. The patient didn't feel well in Jan2021 after her second vaccination on 13Jan2021. It was unknown if treatment for the adverse events. No Covid prior vaccination. It was unknown if Covid tested post vaccination. The outcome of the event didn't feel well was unknown, of the other events was recovering.  Information on the lot/ batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mass, Tenderness
Clinical narrative: left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid filled to her; There was a pear size lump that is very tender there. It feels fluid filled to her; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3302,via an unspecified route of administration in the left arm, on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization. Medical history sleep apnea, GERD, TMJ and depression. Historical vaccine included first dose of  BNT162B2 on 22Dec2020 for COVID-19 immunization. Concomitant medication included cefixime (FLEXERIL), fluoxetine hydrochloride (PROZAC), omeprazole (PRILOSEC) and trazodone. on 13Jan2021 12:00, 24 hrs post vaccination, patient noticed that her left underarm was hurting, and she touched it. There was a pear size lump that is very tender there. It feels fluid filled to her. Therapeutic measures were taken as a result of events included an unspecified treatment and will be receiving an ultrasound. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Visual impairment
Clinical narrative: she couldn't get the words out properly when speaking with a client; she was looking at her husband and she couldn't see about a quarter of his face; This is a spontaneous report from a contactable consumer.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the upper left arm, on 05Jan2021 08:45 at a SINGLE DOSE for covid-19 immunization. Patient had no other relevant medical history. There were no concomitant medications used. Historical vaccine included Flu vaccine. On 10Jan2021 11:51, the patient experienced that when she was looking at her husband and she couldn't see about a quarter of his face.  About 10 minutes later (12:01), she couldn't get the words out properly when speaking with a client. Within five minutes or so, everything was back to normal. Outcome of events was recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Headache; Fatigue; swollen lymph nodes; arm soreness; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscular in the left arm on 08Jan2021 08:15 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). The patient previously took tamiflu and experienced allergies. On 08Jan2021 10:00, the patient experienced headache, fatigue, swollen lymph nodes and arm soreness. The patient has not tested positive for COVID post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Nausea, SARS-CoV-2 test, Vision blurred
Clinical narrative: Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Urticaria
Clinical narrative: Itchy; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; Patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. Rash started 2 days after the initial vaccine.; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 11Jan2021 09:00 at a SINGLE DOSE for covid-19 immunisation.  Medical history was reported as none. Concomitant medication included magnesium citrate (MAGNESIUM CITRATE), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) and Organic multi vitamin. On 13Jan2021 16:30, the patient experienced itchy, patchy rash with pin point spot and hives with blisters all over my right lower flank and bilateral posterior proximal leg. It was noted that the rash started 2 days after the initial vaccine. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Tendon pain, Vaccination site bruising
Clinical narrative: Big bruise on right arm; Shoulder and tendons very sore; Shoulder and tendons very sore; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 05Jan2021 at 01:30 AM at a single dose for COVID-19 immunization.  The patient's medical history included allergies and patient had no COVID prior to vaccination.  Patient is not pregnant. The patient's concomitant medications were not reported. The patiently previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient has not had any other vaccine in four weeks and no other medications in two weeks. On 06Jan2021, the patient experienced big bruise on right arm. It was also reported that shoulder and tendons were very sore. The patient reported that it has been 10 days and it was not getting better. The patient had not been tested for COVID post vaccination. The outcome of the events was not recovered at the time of the report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: high itching over her whole body, itching all over even her head and hair, up and down her spine, everything; This is a spontaneous report from a contactable consumer (patient's husband). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on 13Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced high itching over her whole body, itching all over even her head and hair, up and down her spine, everything in Jan2021. Outcome of the event was unknown.   Information about Lot/Batch has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node above left collar bone; This is a spontaneous report from a contactable nurse (patient herself). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 at single dose for COVID-19 immunisation. Medical history was not reported. 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 vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included insulin aspart (NOVOLOG). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The patient had enlarged lymph node above left collar bone on 14Jan2021. Clinical outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle twitching, Myalgia, Oropharyngeal pain
Clinical narrative: rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Hyperhidrosis
Clinical narrative: fever (up to 101.8); mild nausea; slight fatigue; aching joints; runny nose; slight headache; breaking into sweats; injection site pain; This is a spontaneous report received from a non-contactable other healthcare professional. A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in the right arm, on 13Jan2021 15:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730), via an unspecified route of administration in the right arm, on 23Dec2020 at 16:00, for COVID-19 immunization. On 13Jan2021 at 18:00, the patient experienced fever (up to 101.8), mild nausea, slight fatigue, aching joints, runny nose, slight headache, breaking into sweats and injection site pain. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: fever (up to 101.8); mild nausea; slight fatigue; aching joints; runny nose; slight headache; breaking into sweats; injection site pain; This is a spontaneous report received from a non-contactable other healthcare professional. A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in the right arm, on 13Jan2021 15:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730), via an unspecified route of administration in the right arm, on 23Dec2020 at 16:00, for COVID-19 immunization. On 13Jan2021 at 18:00, the patient experienced fever (up to 101.8), mild nausea, slight fatigue, aching joints, runny nose, slight headache, breaking into sweats and injection site pain. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; Injection site pain; Feeling a little unwell; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 1284, expiry date not reported), via an unspecified route of administration on the left arm on 13Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior to vaccination). There were no concomitant medications.  The patient experienced mild fever on second day, injection site pain, feeling a little unwell; all unspecified dates. The outcome of the events was unknown. The patient was not covid tested post vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: at injection site redness; at injection site: redness, swelling; at injection site: redness, swelling, itchiness; at injection site: redness, swelling, itchiness, and warmth; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included allergies to oranges and pineapples and many food sensitivities and latex sensitivity from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN), ergocalciferol (VIT D), zinc, vitamin C and vitamin B complex. The patient previously took flexeril [cyclobenzaprine hydrochloride], naproxen and Z-pak and experienced allergies. The patient previously had first dose of BNT162b2 in left arm on 23Dec2020 for COVID-19 immunization. The patient was not pregnant. 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. On 13Jan2021, the patient experienced at injection site: redness, swelling, itchiness, and warmth that continues to increase. The diameter of redness and swelling is approximately 2 inches. Half of my surrounding arm area is warm to the touch and the redness is very itchy. Other side effects have greatly diminished. The outcome of the events was not recovered. No treatment was given to the patient for the events.   Information on the lot/ batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Heart rate
Clinical narrative: chills; severe shortness of breath; rapid heartbeat; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) via intramuscular at right arm on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced sinus infection from 24Dec2020 and recovered on 31Dec2020, he went through antibiotics for a week for the sinus infection which was completed by the second dose. Patient works in a hospital laboratory. He wanted to report a reaction/side effect for Pfizer COVID 19 vaccine. Stated this was his second dose. The reaction started 12 hours post vaccination of chills that went overnight (12Jan2021). Stated that it was followed by severe shortness of breath at about 4 to 5 AM and rapid heartbeat. He was advised to get tested and was negative (undated). He also had headache and fatigue, all on 12Jan2021. Stated that he had gotten his second dose at 14:00 on 11Jan2021.  Stated that he never experienced anything like on 12Jan2021 that he was literally frantic. Outcome of fatigue was recovered on 13Jan2021, outcome of other events recovered on 12Jan2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test
Clinical narrative: chills; severe shortness of breath; rapid heartbeat; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) via intramuscular at right arm on 11Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced sinus infection from 24Dec2020 and recovered on 31Dec2020, he went through antibiotics for a week for the sinus infection which was completed by the second dose. Patient works in a hospital laboratory. He wanted to report a reaction/side effect for Pfizer COVID 19 vaccine. Stated this was his second dose. The reaction started 12 hours post vaccination of chills that went overnight (12Jan2021). Stated that it was followed by severe shortness of breath at about 4 to 5 AM and rapid heartbeat. He was advised to get tested and was negative (undated). He also had headache and fatigue, all on 12Jan2021. Stated that he had gotten his second dose at 14:00 on 11Jan2021.  Stated that he never experienced anything like on 12Jan2021 that he was literally frantic. Outcome of fatigue was recovered on 13Jan2021, outcome of other events recovered on 12Jan2021.