chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt dizziness and passed out after moving to the post-immunization waiting area.  Pharmacist lowered patient to ground and layed her on her back and monitored pulse and respirations.  Patient became responsive to voice commands after about 30 to 60 seconds.  Remainded laying down alert for a few minutes and still felt dizziness.  After a few more minutes felt comfortable to sit up and move back to sitting in a chair.  Patient waiting sitting for a while longer and drank some water.  Eventually patient left under her own power with no other known issues.
Patient complained about getting sick with fever, fatigue, no energy to move, severe headache, redness, swelling and painful arm (injection arm) and she had the symptoms for about 5-7 days.
Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 03:45 PM (at the age of 55-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient no allergies. Prior to the 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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. It was reported that the patient expereinced right arm pain next morning on 04Feb2021. Unable to lift arm above shoulder height without sharp pain on 04Feb2021. No treatment was given to the events. Outcome of the events were recovered on 05Feb2021.  Information about batch/lot number has been requested.
After the 2nd dose vaccine,] within 30 minutes I started to notice tingling in both arms and both legs and the tingling was traveling upwards.  I did take a dose of Claritin (not effective) and Benadryl and fell asleep. I woke up and did not have any more tingling. I had some residual tingling in my arms and legs but it was not traveling up. The tingling did resolve after 24 hours.
IN NOVEMBER 2020, PATIENT WAS IN THE HOSPITAL  DOUBLE BLIND CLINICAL TRIAL OF THE JOHNSON AND JOHNSON COVID-19 VACCINE AND WAS TOLD THAT SHE RECEIVED THE ACTUAL VACCINE AFTER THE TRIAL. DR    WHO WAS RESPONSIBLE FOR THE TRIAL TOLD THE PATIENT THAT SHE COULD GET THE  MODERNA VACCINE IF SHE WISHES SINCE THE  JOHNSON AND JOHNSON VACCINE IS ABOUT 75% EFFECTIVE.  THE PATIENT FELT STRONGLY ABOUT GETTING THE MODERNA VACCINE BECAUSE SHE HAS DIABETES AND OVERWEIGHT AND WANTED THE MOST PROTECTION.  BASED ON THE INFORMATION GIVEN, I DECIDED TO VACCINATE THE PATIENT. SHE DID NOT EXPERIENCE ANY SIDE EFFECTS AT THE TIME OF VACCINATION
Day after pain, "couldn't bend elbow because it hurt:. Day after that red, warm splotchy rash from elbow to shoulder.
1 1/2 hours after administration patient experienced chills and spiked > 102 degree fever. Patient went to hospital due to extensive health conditions to be cautious. Numerous tests ran on the patient. Per pt. CDC MD stated must have had reaction to egg protein in the vaccine despite having previous flu vaccinations.
Information has been received from a medical assistant concerning a 10 yr old male who on 23Aug04 at 15:30 was vaccinated SC in the left arm with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). There was no illness at the time of vaccination. On 26Aug04, 3 days post vaccination, the pt developed a fever, headache, nausea, neck pain, malaise, a sore arm and redness and pain at the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested. It was also reported that several other pt's at this office that received pneumococcal 23v polysaccharide vaccine have had AE's (WAES0409USA01310).
Shingles even after the shot/ suspected Vaccination failure; Shingles 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 3 times even after getting the shot. The reporter said that beware one can get shingles again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt developed reels and red areas around neck and chest area, no c/o difficulty breathing or SOB. Pt given 200mg Benadryl PO and observed in exam room for one hr.
lethargic, t103.7 for 36+ hr w/fever reducing medicine given q 4hr;paralysis of inj leg, pale white, measles-like rash over entire body, screamed when injected let was touched;
I was fine up until the 2/3/2021. About 7PM I started getting the chills, I covered with a blanket, and I was still shaking. So I turned the heater on and became hot. Yesterday I got the chills again about 1pm. Then when I got inside my car and it was hot in there, I started getting an headache. I it felt like my face was getting warm so I stopped by Walgreens and brought a thermometer. My temperature was 101.2. I took one Ibuprofen and 2 Tylenol and an hour later my temperature was 101.2. It took another hour to go down to 98. I continue to drink water, 7-up and some soup. I got up at 2AM this morning because I had a slight headache, so I took 2 more Tylenol and when I woke up this morning the headache was still there so at 8AM I took 2 more Tylenol. Right now I feel good. I started taking Vitamin D3 and Zinc and Aspirin Turmeric today.
pt recv vax 3MAY95 & 4MAY95 pt exp dizziness, tiredness; that evening, pt awoke & stated that felt bad & exp nausea; pt got into bed w/mom & began shaking which was felt to be a poss sz; pt taken to ER & was found to be in cardiac arrest
Pt inadvertently received the first dose of Havrix for prophylaxis of hepatitis A.  Subsequently she experienced injection site tenderness. Pt is currently nursing a 4.5 month old baby who is a little fussy at night for a couple of nights.
Late period, expected 3/18, now 12 days late. Negative pregnancy test. Never been this late.
On 12-24-2020 I started to have a metallic taste in my mouth and at 2:35pm I experienced rapid  heart beat with chest tightness. On the next day I  felt two places in body begin with hives and it grew with itchiness till the third day.  I had under-skin itchiness which grew  into hives. I did a telemedicine consult with a doctor who started me on Benadryl, for me to take it 3 times a day for Monday and Tuesday after Christmas (12-28-2020 and 12-29-2020).
area now itches; certain parts of the area are hard; red area was the size of a fifty cent piece; (left)arm itches; (left)arm is red, at first was the size of a quarter; (left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard) and VACCINATION SITE PRURITUS ((left)arm itches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL and ATORVASTATIN for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter). On 28-Mar-2021, the patient experienced ERYTHEMA (red area was the size of a fifty cent piece) and VACCINATION SITE INDURATION (certain parts of the area are hard). On an unknown date, the patient experienced PRURITUS (area now itches). At the time of the report, ERYTHEMA (red area was the size of a fifty cent piece), PRURITUS (area now itches), VACCINATION SITE WARMTH ((left)arm is warm, at first was the size of a quarter, warm area was the size of a fifty cent piece), VACCINATION SITE INDURATION (certain parts of the area are hard), VACCINATION SITE PRURITUS ((left)arm itches) and VACCINATION SITE ERYTHEMA ((left)arm is red, at first was the size of a quarter) had resolved.            Other concomitant medication included stomach medicine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Outcome of the events updated
Large red reaction at injection site 1/2 dollar size. TX: Antihistamine and cool compresses.
05JAN21 shot #1, 08JAN21, Migraines start 08FEB21, Onset of severe abdominal pain 15FEB21, ER Visit admitted due to CT scan finding hepatic portal vein thrombosis 16-18FEB21, treated with heparin, while doing dozens of blood tests 18FEB21, discharged with Eliquis 5mg twice daily for 90 days    05MAR21, persistent migraines end Currently awaiting follow-up with heptologist and hematologist
Hives over 90% of body; swollen face; difficulty breathing; This is a spontaneous report from a contactable consumer (reported for herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 29 years, on 21May2021 18:00 (Batch/Lot Number: EW0186) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol;norethisterone acetate taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically took first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EW0179) at age 29 years on 30Apr2021 05:00 PM on the left arm for COVID-19 immunisation. On 21May2021 at 21:00, the patient experienced hives over 90% of body, swollen face and difficulty breathing. Patient was hospitalized in May2021 for 1 day. Patient was treated with dexamethasone 12mg for the events. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was recovering.
Pt called clinic and reported red, warm, swollen area around injection site of varicella ((R) arm outer). Pt reports no other S/S.
This case was reported by a physician and described the occurrence of erythema in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced erythema, tenderness, swelling and pharmaceutical product complaint. The subject's top part of thighs was red, tender and swollen for approximately three or four days. At the time of the report, no other details were provided. At the time of reporting the erythema, tenderness, and swelling were resolved. This is the first of three subjects the physician reported who experienced adverse events with INFANRIX within two to three weeks; see cases A0851210A and A0851211A. Follow-up information was received on 05 April 2010, via physician. The 5-year-old female subject who was vaccinated with 5th dose of INFANRIX (.5 ml, intramuscular, left thigh) on 12 March 2010; lot number reported as "B091AA". Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 March 2010; poliomyelitis vaccine inactivated IPOL, (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 12 March 2010. The subject received four previous DTaPs. No adverse events were reported with previous vaccinations. On 13 March 2010, 1 day after vaccination with INFANRIX, the subject was diagnosed with a "large local reaction" and experienced erythema, tenderness, swelling and pharmaceutical product complaint. The physician stated the subject was a "healthy child". The physician did not consider the events serious and were not associated with medical history/ concurrent illness, lack of efficacy, erroneous administration, or suspected transmission. On 17 March 2010, the local reaction, erythema, tenderness, and swelling were resolved.
AFTER RECEIVED THE VACCINE DO NOT KNOW EXACTLY WHAT WAS IN FOOD; BREAK OUT IN HIVES (ZIP LIKE KIND OF PINS AND NEEDLES IN THE BACK OF TRUCK AND THEN GOING DOWN TOWARD ENTIRE BODY); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced after received the vaccine do not know exactly what was in food, and break out in hives (zip like kind of pins and needles in the back of truck and then going down toward entire body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the after received the vaccine do not know exactly what was in food and break out in hives (zip like kind of pins and needles in the back of truck and then going down toward entire body) was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: El9265), in left arm, on 20Feb2021 as dose 2, single (Lot number: En6200), in right arm and on 26Sep2021 as dose 3 (booster), single (Lot number: En6200) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 066k21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There was no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "recovering"; OFF LABEL USE (medically significant) with onset 03Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) positive, notes: Rebound symptoms and positive test 9 days after negative tests and no symptoms; (Sep2022) negative, notes: Rebound symptoms and positive test 9 days after negative tests and no symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Inject was given in left arm. Approximately 6 hours after receiving, patient started to have swelling in opposite arm, swelling of the hand and fingers specifically between the middle and 2nd finger. Patient is experiencing a lot of pain along with swelling and stiffness of fingers to the point where she cannot complete daily functions like openning doors or lighting a glass with affected hand. Patient did apply ice to the affected area, as well as took bendryl. Pharmacist also recommended patient contact primary care regarding reaction. Primary care told patient to continue benadryl and ice. At last time of speaking with patient, patient symptoms had not resolved, but have not heard back from patient this evening.
hard itchy lump at the vaccination; Serious pain in the vaccination site for both first and second dose; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 41-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: er8733), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 as (At the age of 41-years) dose 1, single for covid-19 immunisation. Medical history included Known allergies Sulfa, shellfish.  Concomitant medication included amoxicillin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient experienced Serious pain in the vaccination site for both first dose on Mar2021 and second dose. The second dose was worse and now the pain has abated somewhat I can feel a hard itchy lump at the vaccination site. Patient did not receive any treatment for events. The outcome of event serious pain in the vaccination site for both first and second dose was not recovered and outcome of event hard itchy lump at the vaccination was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372659 similar report from same reporter
On 04/14/2021, the patient was given a dose of Pfizer Covid-19  vaccine that was drawn the previous day(04/13/2021) and kept in the refrigerator over the Manufacturer's  recommended  6 hours after reconstitution. In fact , the syringe was in the refrigerator for about 22 hours after reconstitution. The patient was notified and appeared in stable conditions. CDC was contacted and recommended that the dose to be repeated.
51/2 x 5 1/2 cm area of erythema and induration around injection site.
Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour after vaccination and lasted 3 days.  Sore arm for 3 days.  Fatigue starting 1 day after vaccination and ended 4 days later Body aches and pains for 6 days after vaccination Rash on head,  shoulders,  and neck that started on day 3 after vaccination and lasted 5 days.
Pt received vax developed headaches & chills also soreness of neck fatigue, sore throat. Recovered
Had 6-10 loose stools per day from giving the Rotateq. Lasted 3 wks.
Two days after receiving the Covid-19 vaccine, I began to have tinnitus, a constant ringing in both of my ears.  I saw my personal physician on 5/4/2021 who recommended continuing Allergy medication (Claritin) and prescribed a nasal spray (Flonase) to take over the next few days and said if still no change to go to ENT she referred me to.
Fever that lasted from evening on 06/17/15 until the morning on 6/19/15.  We let it run it's course on it's on without any fever reducers.
A report was received from a health care professional on 10/17/2003 concerning a 3 year old vaccinee of unknown sex, who received Fluvirin on 10/17/2003. No Adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: I had given 4 people in a family group the pfizer bivalent booster.  patient fainted shortly after he recieved the vaccine. as i was trying to attend to the brother, i looked at patient and his face was white. i asked if he was ok and he mumbled no. i got his mom to help me get him on ground and put his feet up and i gave him some cold water... he was pretty much unresponsive for  a few minutes, but came around very quickly.
Roughly 4 days after getting the shot, I started getting slight body aches. The next day, it got worse all throughout the day. I had to go rest in the middle of the day. Got the chills and then sweats.  This continued for 6 more days slowly getting better.  Also developed a major sinus infection that just showed shortly after the shot. Zero symptoms prior.  In fact, had not been sick at all for the last 13 months.  I mostly slept for 6 days with chills and sweats.  Did not once have a registered fever of any degree.
vertigo; room started spinning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and VERTIGO (room started spinning) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vertigo (had it 20 years ago). Concomitant products included DENOSUMAB (PROLIA), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), PRAVASTATIN and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VERTIGO (vertigo) and VERTIGO (room started spinning). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) and VERTIGO (room started spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K00120, expiration date 22-JAN-2016, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started to get uncontrollable shakes the night of my vaccine for 10-15 minutes. I had chills for about an hour afterwards and a sleepless night. The next morning I woke up with a headache and was achy/sore throughout my body. While I was eating I passed out without any signs. I was unconscious and do not remember the episode. Once I was alert, I felt nauseas and was heading to the restroom when I passed out again and was unconscious. I do not remember the episodes. There were no signs of passing out before I did either time.