chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncopal episode; Urticaria from neck to feet; This is a spontaneous report from a contactable nurse. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3184) via an unspecified route of administration, administered in Arm Left on 31Aug2021 at 09:00 as DOSE 2, SINGLE (at the age of 45-year-old) for covid-19 immunisation. The patient received first dose on 10Aug2021 at 9:00 AM on left arm (lot number: EW0181) for covid-19 immunisation. Medical history included migraine, hypertension. Concomitant medications included topiramate; lisinopril; hydrochlorothiazide (HCT); metoprolol succinate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Sep2021 the patient experienced urticaria from neck to feet starting day 4 post injection lasting till present time. Syncopal episode on day 5 (05Sep2021) post injection, resolving once patient hit the floor. It was unknown if patient received the treatment or not. The outcome of the events was not resolved.; Sender's Comments: Based on the temporal relation, the association between the event of syncope and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented to pharmacy on 11/08/17 (19 days after receiving the shot) complaining that her whole arm hurts especially when she moves it and the pain is still there since day of the shot. It was not clear whether the arm was swollen or not. Pharmacist advised patient to see a physician and get it checked.
While showering patient felt bumps all over his upper back.  Red spots were present on the lower back and upper front chest. The bumps or hives are mostly raised.  They do not itch or cause irritation.
Pain and swelling in arm. Pain steadily increasing in strength and in length of arm - from shoulder to above wrist.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date multiple unspecified patients were vaccinated with improperly stored VAQTA lot# K012457 and expiry date 04-JUN-2017 and Lot# L002717, with an expiry date of 02-JUN-2017. No adverse events were reported. The outcome of events were unknown. No product quality complaint reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient presented and was admitted through the ED for with altered mental status and respiratory distress. COVID positive today. On arrival to ED patient was obtunded, nonverbal and was orally intubated. Patient has history of chronic atrial fibrillation and on arrival to ED patient was significantly tachycardia.   Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Fever 101.9, myalgias, lethargy, headache, dry cough, dour stomach, abdominal cramping, loose stool
Patient called as part of booster follow up and declined vaccine, shared he was in rehab due to stroke. No other details shared
Dizzy/ dizziness; Site pain; Tiredness; Chills; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 16:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) taken for unknown indication from unknown dates and unknown if ongoing. On 26Feb2021 at 06:30, the next day after the vaccine the patient felt very dizzy, it was reported that dizziness was not described on the side effects. Also, the patient had other effects which included site pain, tiredness, chills, and feeling unwell. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy/dizziness, site pain, tiredness, chills, and feeling unwell was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist via a company representative refers to a 75 year old male patient. The patient's medical history included double bypass surgery prior to vaccination and removal of impacted tooth. No allergies were reported. In summer 2007 the patient was vaccinated with a single dose of live ZOSTAVAX, 0.65 ml, subcutaneously (dose # and lot # not reported). No laboratory diagnostic studies were performed. In 2008 the patient had a shingles outbreak. On an unspecified date the patient recovered from shingles outbreak. The patient sought medical attention. No other adverse event information was reported. Additional information is not expected.
Patient developed a rash 7 days after administration.  Patient was given steroids to treat.
Five days post vaccination the child broke out in an erythematous, macular rash.  The Doctor does believe the rash was a reaction to the ProQuad.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: MOUTH AND FACIAL AREA
urticaria ge w/in 2 to 4hr pt recd epi & DPH;transferred to ER;recd solumedrol & DPH;admitted 23 hours observation -IV meds and nebulizer tx
Itching over most of body/Barely noticeable at first but by Apr it was driving me nuts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 (Lot number: EK9231) at the age of 80 years as dose 1, single and intramuscular, administered in arm left, administration date 09Feb2021 (Lot number: EL8982) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 18Jan2021, outcome "not recovered", described as "Itching over most of body/Barely noticeable at first but by Apr it was driving me nuts". The event "itching over most of body/barely noticeable at first but by apr it was driving me nuts" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: Itching over most of body. Barely noticeable at first but by Apr it was driving me nuts. The patient was being treated with Gabapentin but so far it was not working. As on 11Feb2021 (Approx Feb2021), the patient still experiencing symptoms. The patient was treated with Pregabalin. The most recent COVID-19 vaccine was administered at other facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Vaccine was not administered at facility.  No follow-up attempts are possible. No further information is expected.
Starting about 8 hours after receiving the injection I experienced: High fever (>103F) Vomiting (several times) Severe headache Sweats and Chills  12 hours after the injection the fever came down to 101 with Tylenol and Ibuprofen.  Vomiting still occurred when I attempted to eat toast or sip water. These continued for about 18 hours, into the evening following receiving the injection. Late in the evening the fever broke,  I was able to eat and drink without vomiting.  I additionally had moderate pain (more than the minor pain from other vaccines and most blood tests) at the injection site.  I had to call out of work on this day (3/24/21) and I also missed out on 2 hours of per-hour employment at my second job, which cost me $90.
Immediately broke out in hives around both injection sites right administering vaccines. Gave patient 5ml Benadryl and 5ml of Acetaminophen given before vaccines.
missed 4 doses due to a severe sinus infection; This is a spontaneous report from a contactable other HCP. A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. Medical history included ongoing osteoporosis, anxiety disorder, ongoing chronic pain, ongoing essential hypertension, ongoing allergy to antibiotic. Patient previously took vancomycin and experienced allergy to vancomycin. Relevant surgical, social, or substance-usage history was not provided. Co-suspect medication included abaloparatide (TYMLOS) at 80 ug, 4x/day via subcutaneous route of administration from 13Apr2021 to unknown date for osteoporosis. Concomitant medications included albuterol [salbutamol], amlodipine, duloxetine, gabapentin, hydrochlorothiazide, montelukast, pantoprazole, rizatriptan, prednisone, potassium chloride, tizanidine, rosuvastatin, trazodone, venlafaxine, salbutamol sulfate (VENTOLINE [SALBUTAMOL SULFATE]). On an unspecified date in 2021, patient missed 4 doses due to a severe sinus infection. It was reported that the patient experienced sinusitis (sinus infection, start date the past 28 days), product dose omission issue. Per the physician the patient did not experience any adverse events from missing four doses of Tymlos. Information on treatment for the events was not provided, the physician could not determine what treatment was given for the sinusitis. No relevant lab or diagnostic tests were reported. The action taken with Tymlos treatment was does not changed. The relationship between Tymlos and the events of sinusitis and product omission issue was assessed as not related by the reporting physician. Per the physician, the patient reported the sinusitis was a symptom related to the Covid-19 vaccine. Additional information was received from physician on 15Jun2021. Casuality co-suspect medication and no adverse event from missed doses were reported. Additional case number for this patient included 2021 US000624 (alopecia). The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives post flu vaccine, pain in leg - Received benadryl and ibuprofen
I have had my menstrual cycle 3 times since getting both doses. I have not had a period since October prior to this. They are heavy, painful and long lasting.
Since about an hour after the first shot, I have been having horrible migraine headaches that have affected my daily life. I have blurred vision and light sensitivity with them. Nausea and vomiting have happened. I also had a hard time getting out of bed the next day. And the same thing happened after the second shot as well. I am still having the headaches in different severities every day.
COVID arm upper arm; very large rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced RASH (very large rash). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm upper arm). At the time of the report, VACCINATION SITE REACTION (COVID arm upper arm) and RASH (very large rash) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
pt recvd vax;2 days later, exp a pruritic rash over entire body sparing face,hands,& feet;tx over the counter dph; sxs still persisting as of 24apr94;
had two occurrences that were only the familiar tingle on my lip; tingling on lip; This case was reported by a consumer and described the occurrence of herpes on lip in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of oral herpes (received 1st dose in December 2019, refer case US2020AMR070644).   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, immediately after receiving Shingrix, the patient experienced herpes on lip and tingling lips. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the herpes on lip and tingling lips were recovered/resolved.   It was unknown if the reporter considered the herpes on lip and tingling lips to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and since had two occurrences that were only the familiar tingle on lip but no blister, and the tingle lasted about 24 hours. The reporter thought that the Shingrix vaccination has boosted immunity to herples simplex.
Fever, chills, fatigue, body aches, headache, pain in right arm, fingertips numb/tingling on right arm. Also abdominal pain.
Very very bad pain in her injection arm and it was hard to move; Pain in the arm of the injection was getting better and then it has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse) and INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 immunisation.  Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.  On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse). The patient was treated with IBUPROFEN for Adverse event NOS, at an unspecified dose and frequency. On 20-Feb-2021, INJECTION SITE PAIN (Very very bad pain in her injection arm and it was hard to move) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in the arm of the injection was getting better and then it has gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included: cold and hot packs.
Received Pfizer for patients 12 and older. Patient 11 years old at time of vaccination.
Pt recvd 2nd DTP on 6MAR92 & on 9MAR exp a sz which lasted approx 40-45mins; seen in ER; hospitalized 4 days; tx w/Cephalosporin; 12MAR neurologist dx developmentally delayed; questionable if pt was developmentally delayed a/vax;
Pt. given Tdap in left upper arm-IM 12/15/08. Pt called Tues - achiness Monday night-on AM Tues-L arm red, warm, rash, swelling took BENADRYL Tues night & Wed to Tx Sx- and to sleep. Had red cuff like around upper L arm 20 cm X 10 cm pat seen in office 12/19 prescribed ALEVE -states sx decreased denies SOB-pt was eval by PA, called on 12/31 to confirm next app- stated rash, better, slight elevation. Evaluation by MD/ cont. Tx Sx go to ER if Sx increase.
Dizziness the next day and soreness. The following day dizziness resolved but pt noted tender red streaks.
Child developed fever on Friday 1 week after receiving the vaccines, then had rash on Monday morning. Rash mostly on trunk, with ABD the worst. Extremities and head with a few raised red areas. No pustules noted at this time.
Swelling, redness, tenderness of injection site 9 days after vaccine of chicken pox.
prolonged soreness at injection site.  Entire body muscle ache within one week, lasting one week.  Both upper arms remained painful.  Treated with MOTRIN, with no effect.  Cortisone injections had no effect.  Condition subsequently diognosed as  Bi-Lateral rotator cuff tendonitis.  Currently undergoing PT.
This spontaneous report was received from a 76 year old male patient concerning himself. Patient's current condition with high blood pressure and cholesterol. Drug reactions or allergies was reported as none. Approximately on an unknown date in 2007 (also reported as 7 years ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). The consumer also stated that he uses other medications (unspecified names, dose/frequency and manufacturer) as concomitant medications. On 25-SEP-2014 the patient was diagnosed with the shingles, after receiving ZOSTAVAX about seven years ago. Unspecified labs/diagnostics were performed. Treatment included Valacyclovir (manufacturer unspecified) (unspecified dose/frequency) and Prednisone (manufacturer). The outcome of shingles was reported as not recovered/not resolved. There was no product quality complaint (PQC) involved. Patient sought medical attention and had an office visit on an unspecified date. Causality assessment was not provided. Additional information has been requested.
EMPLOYEE REPORTS TINGLING IN LIPS AND FACIAL AREA RADIATING DOWN BOTH ARMS Narrative:
Local reaction to PQ of L thigh: about 2 cm in diameter. Viral exanthem of the trunk.
Nickel size area of erythema with "small bumps" per mother. Area is warm to the touch. Referred to primary care provider for assessment.
Patient said she fell asleep and woke up between 8 and 9 pm 11/8/19 and had dizziness, weakness, headache, fever of 102, runny nose, sore throat and pain in left breast/chest area, joint aches.  She said at around 3-4 am on 11/9/19 she had trouble breathing going down stairs.  She called her MD office 11/9/19  with symptoms still and and they wanted her to come in or go to ER/urgent care.  She said no she wouldn't and would treat the symptoms with zicam and aspirin, vitamin c, proair, tylenol.  She mentioned that the office told her to come in if things continued. She said that she got a call from the office for 3 days in a row to check in on her.  By Monday 11/11/19 she said she felt better and temp was down to 100 11/9 Saturday her temp  was 101.  Tuesday am 11/12/19 she was feeling back to normal.  Patient never went in to be seen regarding these symptoms at this time.
After second shot head ache for 2 days and menstruations for 41 days following.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt anxious after recieving pfizer vaccine booster, paramedics were called, paramedics siad patient was not having an allergic reaction, patient decided to go home
Breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir.; This is a spontaneous report from a contactable nurse. A 59-year-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK4176, intramuscular in the left arm, on 22Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Medical history included depression, SEM, Herpes Simplex 3 and BET.  Concomitant medications included sertraline, clonazepam and propranolol. The patient also had thiomersal allergy. 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 hasn't been tested for COVID-19. On 25Jan2021, the patient experienced breakout of 4 cold sores lower left lip despite 400mg daily prophylactic acyclovir. The outcome of event was recovered.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Chills; Tired; Light headed; General not feeling well; This is a spontaneous report from a contactable consumer (patient).  A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 23Jan2021 at 09:50 (Batch/Lot Number: EL9263) as 1st dose, single for covid-19 immunization. Patient's medical history included, light-headed, hormone therapy, goiter, blood pressure and water pill (water retention), all were ongoing. It was mentioned that she was lightheaded before the vaccination and light-headedness was still ongoing. Patient's family history was reported as none. The vaccine was not administered in military facility. Concomitant medication(s) included amlodipine (AMLODIPINE) (ongoing since several years) at 5mg (one and one-half) daily orally for blood pressure, lisinopril (LISINOPRIL) (ongoing since several years) at 20mg take once daily orally for blood pressure, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) (ongoing since 8 months or a year) at 25mg (one and one-half) daily orally as water pill, levothyroxine (LEVOTHYROXINE) (ongoing since few years) at 25mcg (one-half) once daily orally for goitre, estrogens conjugated (PREMARIN) (ongoing since long time) at 0.03 mg five times a week orally for hormone therapy and also Vitamins since an unspecified date. The patient previously took clindamycin and experienced allergic reaction to an antibiotic. It was some years ago that a doctor gave her clindamycin and she had a reaction. Had no product or information to provide NDC, lot or expiration date for the clindamycin she took. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced Light headed and not feeling well and on 25Jan2021, the patient experienced chills and tired. It was reported that patient had a vaccine shot on 23Jan2021 and she had chills and a general not feeling well and she was tired. The patient noticed about 24 hours later, she felt the chills really bad on 25Jan2021 monday morning. She had chills all day monday (25Jan2021) and Tuesday(26Jan2021). She also started to feel tired on Monday also mentioned she told the pharmacist and he suggested she got up too quickly. She was scheduled to take the second dose of the vaccine 13Feb2021.The outcome of the event chills was recovered on 28Jan2021 and outcome for the event tired was recovering, outcome for all other events was unknown.    Follow-up attempts are completed. No further information is expected.