chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Urine analysis
Clinical narrative: pt started having abdominal pains a day or two after vax. Pt visited his PCP on 1/12/201 which ordered X-ray and Cat scan, blood work which came back normal.  On 1/16/2021 pt was having more abdominal pain so went to the ER where they did another Cat scan which was also normal so he was given a pain pill and sent home.  When pt got home from ER a rash had developed on right side of torso.  Pt saw his PCP on 1/18/2021 for the rash and was diagnosed w/ Shingles.  Rash is still visible but fading.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: I received the second dose around 1:39-1:40pm and II didn't feel anything until 2-3am the next day. I felt chills, shivers, headache, body aches, I felt slow. I would feel cold and then warm and then cold again. I was sweating a lot and I currently still have a dull headache 2 days later.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sluggishness
Clinical narrative: I received the second dose around 1:39-1:40pm and II didn't feel anything until 2-3am the next day. I felt chills, shivers, headache, body aches, I felt slow. I would feel cold and then warm and then cold again. I was sweating a lot and I currently still have a dull headache 2 days later.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pruritus, Rash
Clinical narrative: Shingles- developed on 1/2/2021.  I did not know that I had the shingles when I took the vaccine on 1/5/2021.  I have never had the shingles, I thought it was a rash. I have allergies, have been known to develop dermatitis occasionally. Diagnosed with shingles by my primary care provider on 1/6/2021.  Also went to Ophthalmologist as a precaution since the  area around my left eye was affected.  Primary care doc prescribed Valtrex (7 day regimen).  As of today 1/29, I have residual nerve itching, skin is healed. Some nerve pain.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Injection site swelling
Clinical narrative: Red, swollen injection site Welt two-three inches below site; not connected directly to site Fever of 101 Aches Chills Difficulty breathing- needed rescue inhaler Fatigue
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Red, swollen injection site Welt two-three inches below site; not connected directly to site Fever of 101 Aches Chills Difficulty breathing- needed rescue inhaler Fatigue
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: Pink itchy rash on torso, arms , elbow and knee creases consistent with a drug rash.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: fever. called in sick to work.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: First Tingling in lips. Then entire face started to tingle. This has not subsided.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Neuralgia, Pain
Clinical narrative: First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination.  Trunk rash developed 48 hours after vaccine and resolved within hours.  Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F.  After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination.  Symptoms resolved within 24 hours.  Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Skin burning sensation
Clinical narrative: First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination.  Trunk rash developed 48 hours after vaccine and resolved within hours.  Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F.  After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination.  Symptoms resolved within 24 hours.  Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Headache, Hypertension, Impaired work ability
Clinical narrative: Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine.  I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine.  I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Paient was treated by healthcare providers for shingles, and other zoster-related conditions.; Patient was treated by healthcare providers for shingles, and other zoster-related conditions; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a helthcare professional for the long term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, ptwas treated by healthcare for shingles, and other zoster-related conditions. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large 3 inch circle around injection site, swollen, warm, itchy and lasted 3 days after injection then returned on day 7 after injection and was 4 inches wide on arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff was treated by healthcare providers for shingles, and other zoster-related conditions.; Plaintiff was treated by healthcare providers for shingles, and other zoster-related conditions.; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a helthcare professional for the long term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by healthcare for shingles, and other zoster-related conditions. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Son who is 16 received the Moderna vaccine by mistake; A spontaneous report was received from a HCP concerning his 16-year old, son who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, my son who is 16 received the Moderna vaccine by mistake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the 16-year old received the mRNA-1273 vaccine. No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 16-year old received vaccine was considered Resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old was given the moderna vaccine; A spontaneous report was received from a physician concerning a 17-year-old patient who received Moderna's Covid-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknown date, 17-year-old was given the Moderna COVID-19 vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, a 17-year-old was given the Moderna vaccine, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old patient who received the first of two planned doses of mRNA-1273 (Lot unknown), reporting product administered to patient of inappropriate age and at this time no adverse events were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Heart rate decreased, Hyperhidrosis, Hypotension
Clinical narrative: Patient felt light headed within 5 minutes of having Modera Covid-19 vaccination.  Consumer then became unresponsive after receiving vaccination.  He was breathing and had a pulse. .  It looked like he was having a seizure; his eyes rolled upward, his left arm shook and he did not respond to touch or voice.  .  911 was immediately called and responded within a couple minutes. After a minute he came to and still felt very lightheaded Upon arrival of 911 his BP and heart rate were extremely low and he was profusely sweating.  He was then taken to the emergency department.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient felt light headed within 5 minutes of having Modera Covid-19 vaccination.  Consumer then became unresponsive after receiving vaccination.  He was breathing and had a pulse. .  It looked like he was having a seizure; his eyes rolled upward, his left arm shook and he did not respond to touch or voice.  .  911 was immediately called and responded within a couple minutes. After a minute he came to and still felt very lightheaded Upon arrival of 911 his BP and heart rate were extremely low and he was profusely sweating.  He was then taken to the emergency department.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague.  A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced sore injection site on an unspecified date. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Injection site pain, Nausea
Clinical narrative: 12/24  felt horrible, experienced body aches, chills, dizziness, nausea, night sweats , possible fever , did not check, soreness at injection site. 12/25 felt the same until 12/27
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain
Clinical narrative: 12/24  felt horrible, experienced body aches, chills, dizziness, nausea, night sweats , possible fever , did not check, soreness at injection site. 12/25 felt the same until 12/27
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: This is a spontaneous report from a contactable nurse, reporting for herself. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 23Dec2020 11:45 (lot number: EL0140) and second dose on 10Jan2021 10:15 (lot number and expiry date were not reported), both intramuscularly in the left arm at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included occasional gastrooesophageal reflux disease (GERD), osteoarthritis, penicillin allergy and sulfa allergy, all from an unknown date and unknown if ongoing; and shingles from Mar2018 to an unknown date. Concomitant medication included paracetamol (TYLENOL), famotidine (PEPCID), melatonin and colecalciferol (VITAMIN D). The patient previously took vicodin and experienced allergies. It was reported that after both injections, the patient had a headache in the same area where shingles had started in Mar2018 throbbing above left eye radiating to top of head on 23Dec2020 14:30. No treatment was given. There was no other vaccine in four weeks. There was no Covid prior vaccination. No Covid tested post vaccination. The patient was not pregnant. The patient recovered with lasting effects.  Information on the batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received second single dose of BNT162B2 (Pfizer, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 12Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included allergies to penicillin. There were no other medical history. The patient was not pregnant. The patient did not have COVID prior vaccination. Other medications in two weeks include escitalopram oxalate (LEXAPRO) and meloxicam. There were no other vaccines in four weeks. The patient was previously given first single dose of BNT162B2 on 24Dec2020 10:30, Intramuscular (Right arm) for COVID-19 immunization. The patient previously took tetracycline and experienced allergies. The patient experienced severe joint pain in bilateral knees on 12Jan2021 22:00, and was still present 3 days post 2nd injection. No treatment was given for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered. Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching.
Sex: M
Vaccine: COVID19
Symptoms: Eye contusion, Eye swelling
Clinical narrative: all around his eye- swollen puffy and corner is very red ("like a bruise"); all around his eye- swollen puffy and corner is very red ("like a bruise"); This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age (reported as "85", unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration from 12Jan2021 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient experienced all around his eye- swollen puffy and corner is very red ("like a bruise") on an unspecified date in Jan2021. Outcome of the events was unknown. Patient was taking a blood-thinner and reporter was asking if it was causing the event.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: her throat would be sore; tongue started tingling; stinging in her tongue, like she had burned it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age 75; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3248), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on Monday 11Jan2021, and her tongue started tingling the next day (12Jan2021) and was continuing at the time of report. On Tuesday (12Jan2021), she started stinging in her tongue, like she had burned it. She can eat and swallow, it's just that her tongue was stinging. And sometimes her throat would be sore but it's still here. The patient was wondering if the side effect last that long or there may be some more concern. Outcome of the events was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Pain, X-ray
Clinical narrative: Chest Pain - All across the upper chest - pain scale 5/10; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 14Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 in Feb to Mar2020 (patient could have had COVID-19, No COVID tests were available). The patient's concomitant medications were not reported. The patient experienced chest pain - all across the upper chest - pain scale 5/10 - no other symptoms on 15Jan2021 11:15. The event resulted in emergency room/department or urgent care. The patient was given aspirin 325 mg as treatment. The patient also underwent lab test which includes EKG, XR Chest, two blood samples on an unspecified date. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence
Clinical narrative: I had terrible bloating and gas January 22, all day diarrhea  January 25 and gas all this week which is only helped by heating pad on stomach and when ready to exit standing to release gas from bowels, plus have had to take the simethicone 6 to 7 times per day.
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient reported he takes a blood thinner. Received 1st dose of vaccine and "look like blood when I was spitting/hacking up last night, this morning no blood." The outcome of the event was unknown.   No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable physician. A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient is not pregnant. There were no concomitant medications. The patient received first dose of BNT162B2 on 18Dec2020 08:00 AM at left arm lot number= EJ1685. On 09Jan2021 11:00, the patient experienced right tinnitus. The patient did not receive treatment for the event. The outcome of the event was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Sleep disorder
Clinical narrative: 51 yo female with no significant headache history presented with new onset left sided parietal headache, severe 9/10 pain several days after receiving vaccine.  Headache lasted for over 2 weeks, was treated with Motrin and Tylenol around the clock and eventually subsided on it's own.  Headache intensity was significant enough and different enough to include awaking the patient at night, that an MRI was undertaken to rule out intracranial pathology.  No other neurological deficits, aura, or symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Fatigue, Gingival bleeding, Joint swelling
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Multiple dizzy spells while sitting; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2 (lot number: EL3248) via an unspecified route of administration in Left arm on 15Jan2021 08:45 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included bupropion, clarithromycin (CLARITIN). The patient previously took cefalexin monohydrate [KEFLEX] and experienced drug hypersensitivity. The patient experienced multiple dizzy spells while sitting on 15Jan2021 14:30 with outcome of unknown. No treatment received for event. The patient was not pregnant.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: ; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: El1823, expiration date was unknown), via an unspecified route of administration on the right arm on 14Jan2021 at 11:00 at a single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 26Dec2020. Both doses were administered at the hospital. The patient had no medical history; she had no known allergies. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 15Jan2021 at 12:00, the patient experienced nausea, vomiting, and fever greater than (>) 103 (units unspecified). The patient did not receive any treatment for the events. The patient was not recovered from the events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Started evening of  01/027/2021Body Aches , fever chills , headache, on01/28/2021 2and 01/27/2021  nausea and  diarrhea, arm soreness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Started evening of  01/027/2021Body Aches , fever chills , headache, on01/28/2021 2and 01/27/2021  nausea and  diarrhea, arm soreness
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Insomnia
Clinical narrative: This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 16:15 at a single dose on left arm for COVID-19 immunization. Medical history included GERD, sciatica, allergies, asthma, allergies to some foods (non anaphylactic). Concomitant medication included curcuma longa (TURMERIC [CURCUMA LONGA]), metaxalone, mometasone furoate (NASONEX), famotidine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 26Dec2020 01:00 PM at a single dose on left arm for COVID-19 immunization. About 8 hours after the shot, on 15Jan2021 01:30 AM, patient woke up very cold, checked temp it was 95.9. Remained that way though the night (96F), could not sleep much b/c of chills. In the AM, temp gradually increased back to baseline 97.9. She doesn't think it was thermometer malfunction bc sx (symptoms) correlated with the temperature and she took the value repeated times. No treatment received for the events. The outcome of the events was recovered on 15Jan2021. The patient was not pregnant. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications.  The patient experienced a sore arm (added that she cannot move it from the pain) for 24 hours on an unspecified date. The patient did not receive any treatment of the event. The outcome of the event was recovered on an unspecified date.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Started to have vertigo, vertigo has not stopped and has continued for one day so far; nausea; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El3246), via an unspecified route of administration at site of right arm on 11Jan2021 at single dose for COVID-19 immunization. The patient previously received first of dose BNT162B2 with lot number: Ek5730, on 22Dec2020 at site of left arm for COVID-19 immunization when he was 39-year-old. Other medical history reported as none. The patient's concomitant medications were not reported. The patient started to have vertigo and nausea on 15Jan2021, no history of vertigo in the past. Vertigo has not stopped and had continued for one day so far. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. The outcome of events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Throat tightness
Clinical narrative: MODERNA COVID- 19 Vaccine EUA Shortly after receiving the second, scheduled dose of COVID-19 vaccine, patient experienced shortness of breath, weakness, and sensation of throat tightening. Was administered an Epi-pen and presented to ED for follow-up care. In emergency department patient received diphenhydramine orally. Patient was discharged with resolution of all symptoms after 5 hours of observation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) at left arm on 11Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history included high blood pressure. Patient is not pregnant. Other medications in two weeks included Amlodipine besylate and lisinopril and "altor". No other vaccine in four weeks. Patient used had known allergies to tetracycline. Patient experienced diarrhea on day 2, 3, 4 start on 12Jan2021. No treatment received for the events. Outcome of the event was unknown. No covid prior vaccination. No covid tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization.  Medical history included asthma.  Concomitant medication included salbutamol (ALBUTEROL) for asthma.  The patient experienced left side of his face went numb, his eye became swollen on 09Jan2021 with outcome of recovered. Caller stated this lasted 8 hours and then went away. Caller stated he used an ice pack during the reaction. The outcome of the events was recovered on 09Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Pain, Pyrexia
Clinical narrative: fever, chills, body aches. called in sick to work.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable nurse. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), intramuscular the first dose on arm left on 23Dec2020 09:00 am, the second dose on right arm on 14Jan2021 09:00 am, both at single dose for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included ibuprofen (MOTRIN [IBUPROFEN]). The patient experienced pain injection site, fever of 102.2, malaise, all on an unspecified date with outcome recovered. Therapeutic measures were taken as a result of pain at injection site. The patient underwent lab tests and procedures which included Covid test with nasal swab: negative on 16Jan2021. The patient is not pregnant. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 13Jan2021 17:00 at a single dose (first dose) on left arm for covid-19 immunization.  The patient medical history was not reported.  There were no concomitant medications reported as well.  Patient has not received other vaccine in four weeks. Patient has no COVID prior vaccination.   Patient stated:"I received the shot (13Jan2021) at 5 pm and I could not sleep that night. I felt fine, but was awake until 9 pm the next day". The outcome of the event recovered on unspecified date. The patient has not tested COVID positive since vaccination. Information on the Batch/Lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chills, Computerised tomogram head, Electrocardiogram
Clinical narrative: At 6pm on 1/25/21, 10 hours after dose 2 of the Covid vaccine she began to shake, have chills . She did not take her temperature but felt she had a fever. She went to sleep and woke at 4am and had wet the bed. The next day, 1/26/21 she had a headache, tremors and chills. She stayed home from work. On 1/27/21 she went to work, felt better except for a headache.  On 1/28/21 she went to work but felt "weird". At 12:30 that day her head was pounding, glassy eyed, felt chest pressure and was "foggy". She went to eat lunch but on the way back to the elevator her legs buckled and she could not walk. She was escorted by wheelchair to her desk . Her Manager stated she did not look well and 911 was called. She was taken to an adult ED. She was thoroughly evaluated ( Head CT, blood work, EKG ) give IV fluids. She was found to have a UTI and was placed on Keflex. Given RX for nausea and vomiting. She was discharged home to follow up with PCP. 1/29/21, she is feeling better except for some fatigue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Enuresis, Fatigue, Feeling abnormal, Glassy eyes, Headache
Clinical narrative: At 6pm on 1/25/21, 10 hours after dose 2 of the Covid vaccine she began to shake, have chills . She did not take her temperature but felt she had a fever. She went to sleep and woke at 4am and had wet the bed. The next day, 1/26/21 she had a headache, tremors and chills. She stayed home from work. On 1/27/21 she went to work, felt better except for a headache.  On 1/28/21 she went to work but felt "weird". At 12:30 that day her head was pounding, glassy eyed, felt chest pressure and was "foggy". She went to eat lunch but on the way back to the elevator her legs buckled and she could not walk. She was escorted by wheelchair to her desk . Her Manager stated she did not look well and 911 was called. She was taken to an adult ED. She was thoroughly evaluated ( Head CT, blood work, EKG ) give IV fluids. She was found to have a UTI and was placed on Keflex. Given RX for nausea and vomiting. She was discharged home to follow up with PCP. 1/29/21, she is feeling better except for some fatigue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nausea, Pyrexia, Tremor
Clinical narrative: At 6pm on 1/25/21, 10 hours after dose 2 of the Covid vaccine she began to shake, have chills . She did not take her temperature but felt she had a fever. She went to sleep and woke at 4am and had wet the bed. The next day, 1/26/21 she had a headache, tremors and chills. She stayed home from work. On 1/27/21 she went to work, felt better except for a headache.  On 1/28/21 she went to work but felt "weird". At 12:30 that day her head was pounding, glassy eyed, felt chest pressure and was "foggy". She went to eat lunch but on the way back to the elevator her legs buckled and she could not walk. She was escorted by wheelchair to her desk . Her Manager stated she did not look well and 911 was called. She was taken to an adult ED. She was thoroughly evaluated ( Head CT, blood work, EKG ) give IV fluids. She was found to have a UTI and was placed on Keflex. Given RX for nausea and vomiting. She was discharged home to follow up with PCP. 1/29/21, she is feeling better except for some fatigue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: At 6pm on 1/25/21, 10 hours after dose 2 of the Covid vaccine she began to shake, have chills . She did not take her temperature but felt she had a fever. She went to sleep and woke at 4am and had wet the bed. The next day, 1/26/21 she had a headache, tremors and chills. She stayed home from work. On 1/27/21 she went to work, felt better except for a headache.  On 1/28/21 she went to work but felt "weird". At 12:30 that day her head was pounding, glassy eyed, felt chest pressure and was "foggy". She went to eat lunch but on the way back to the elevator her legs buckled and she could not walk. She was escorted by wheelchair to her desk . Her Manager stated she did not look well and 911 was called. She was taken to an adult ED. She was thoroughly evaluated ( Head CT, blood work, EKG ) give IV fluids. She was found to have a UTI and was placed on Keflex. Given RX for nausea and vomiting. She was discharged home to follow up with PCP. 1/29/21, she is feeling better except for some fatigue.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Fever of 100. Headache, Chills, Head Fog, Slight Body aches
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Fever (100.9 F) from 3:30 PM - 9:30 PM, treated with ibuprofen and acetaminophen.  Chills that coincided with the fever.  Body aches and joint pain, starting at 8 AM and increased in intensity throughout the day, lasted until awakening the next day, ibuprofen and acetaminophen did not help.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Dysphonia, Fatigue
Clinical narrative: 15-20 minutes after vaccine, pain in chest with deep breath, no trouble breathing, O2 sat 99%,  felt need to cough, hoarseness. Felt better but then  about 45 minutes began to feel worse  Followed up with family MD prescribed albuterol inhaler.  1/29/21 seen in  ER for nausea, fatigue, body aches and weakness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: 15-20 minutes after vaccine, pain in chest with deep breath, no trouble breathing, O2 sat 99%,  felt need to cough, hoarseness. Felt better but then  about 45 minutes began to feel worse  Followed up with family MD prescribed albuterol inhaler.  1/29/21 seen in  ER for nausea, fatigue, body aches and weakness
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Flushing, Headache
Clinical narrative: 1/17/21 L/Arm sore at injection site.  1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps.  Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed.  Woke up my spouse to get me something to take for headache, etc.  Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS.  After that the injection site started itching, with redness.  Lump finally getting smaller.  I took a photo of the injection site which has a red circle the size of my hand.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 1/17/21 L/Arm sore at injection site.  1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps.  Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed.  Woke up my spouse to get me something to take for headache, etc.  Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS.  After that the injection site started itching, with redness.  Lump finally getting smaller.  I took a photo of the injection site which has a red circle the size of my hand.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Mobility decreased, Multiple sclerosis relapse, Pain
Clinical narrative: 1/17/21 L/Arm sore at injection site.  1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps.  Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed.  Woke up my spouse to get me something to take for headache, etc.  Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS.  After that the injection site started itching, with redness.  Lump finally getting smaller.  I took a photo of the injection site which has a red circle the size of my hand.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: 1/17/21 L/Arm sore at injection site.  1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps.  Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed.  Woke up my spouse to get me something to take for headache, etc.  Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS.  After that the injection site started itching, with redness.  Lump finally getting smaller.  I took a photo of the injection site which has a red circle the size of my hand.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient reported for 2nd vaccination of the Moderna vaccine. He did not present a card but was scheduled for vaccination. He reported having had the first vaccine on Dec. 28 2020. This was verified after receiving second dose and having left the site. However, the first vaccination was given on Jan 5, 2021 and not Dec. 28 2020 as reported by the patient.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: 11 days after the vaccine a red dot appeared at the injection site.  It itches and burns severely.  That was yesterday.  Today, the red is bigger and there is a lump forming under the skin.  Itch and burn is worse.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Flank pain
Clinical narrative: Bilateral flank pain for 18 hours, then blood in urine for 2 hours.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ?Moderna COVID?19 Vaccine EUA approximately 4-1/2 X 3 inch swollen, hot, red, itchy achy local reaction at site of shot
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Dysphagia, Pruritus
Clinical narrative: Dermatitis, itching, about 40 min later had diffulty swallowing
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Hypothermia, Pyrexia, Rash
Clinical narrative: Hypothermia - chills and shivering - temperature 91.8 and lasted for at least one hour.  Next morning fever 100.3 lasted for several hours - Rash appeared on abdomen and flanks on 12-19-2020.  Rash has disappeared however is till faint at this time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Pain, Vomiting
Clinical narrative: vomiting, body aches, chills. called in sick to work.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: had dizziness 15 minutes after vaccine.  orthostatic BP taken and were negative
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Lethargy, Pain
Clinical narrative: 12 hrs after shot began to get chills, then developed a temp Of 103, lasting for 2 days, aches, pains and extreme lethargy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: The headaches are getting strong.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash
Clinical narrative: Red rash at injection site. 4 inch by 6 inches
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint swelling, Myalgia, Pain in extremity
Clinical narrative: Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Nervousness
Clinical narrative: 9:40am:Client first reported dizziness, light-headedness, nausea and shaky , 12 minutes after administration, Vital signs taken.  9:43am client felt "tight in chest", 911 called,  and client used her Ventolin inhaler. 9:45am  0.5ml of 1:1000Aq Epinephrine administered at 9:45am in left thigh. 9:55am 0xygen 6 lpm per nasal cannula started. 10:05am paramedic arrived, administered IV Benadryl and transported to hospital at 10:20am.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Impaired work ability
Clinical narrative: headache, dizziness, chills. called in sick to work.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Rash, Throat irritation, Urticaria
Clinical narrative: 1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Erythema, Gastrooesophageal reflux disease, Inflammation
Clinical narrative: This person began developing side effects later in the evening on the day of the vaccination.  She developed low grade fever, red inflamed arm, intense nausea and reflux, and weakness.  She went to the ER and was treated for her symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This person began developing side effects later in the evening on the day of the vaccination.  She developed low grade fever, red inflamed arm, intense nausea and reflux, and weakness.  She went to the ER and was treated for her symptoms.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Left sided Bell's palsy.