chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning lips; Body aches; Fever; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), vitamin d nos (MANUFACTURER UNKNOWN) and multivitamin; all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 16:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced burning lips, body aches, fever, headache and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events burning lips, body aches, fever, headache and chills were resolved on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected
Severe headaches for 3 days.  Burning and achiness at and around injection site.  Measured at 2 1/2 inches in diameter.  Redness, hot, and inflammed at site.  Like a welt.
Patient received Tdap, became immediately dizzy, diaphoretic had syncopal episode. Vitals taken, patient placed in supine position w/legs elevated. She developed emesis, abd camping, urge to defecate. Pt declined EMS transport, she was watched in the clinic for an hour, returned to baseline and picked up by a friend who stayed with her overnight.
Fever 100.1-100.6*F Body chills Body aches, severe lower back ache. Joint aches Headache, severe Painful breathing
Over six days later, fever over 101 for three days. Severe body aches, fever, lethargy
Rash/breaking out with a rash on the inside of her left arm; itching/itching all over; stinging/ skin started stinging on the outside like she was being stung by an ant; If she tried to rub or touch it, it would sting and burn/felt like she was sunburned; feeling like her lips were tingling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3180), via an unspecified route of administration in the left arm on 06Aug2021 at 10:0 (at the age of 72-year-old), dose 1, single for COVID-19 immunisation. Medical history included open heart surgery (2013), she was fairly health. The patient had no family history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was asked to take the shingles vaccine and she declined it. It was reported that the patient was fine the first day and did not really feel any strange side effect. On 07Aug2021, the patient's skin started stinging on the outside like she was being stung by an ant but there was nothing there. The patient started itching all over on the same day, then she started breaking out with a rash on the inside of her left arm and it itched a lot. If she tried to rub or touch it, it would sting and burn. This went on all day long. The patient's daughter was a registered nurse and her daughter told her to take Benadryl. The patient took a child's dose of Benadryl since Benadryl makes her go to bed. On 08Aug2021, the patient woke up feeling like her lips were tingling and the itching continued, and she felt like she was sunburned. It was further reported that the ash still itches in the area once in a while but it was not visible. The patient was still getting the stinging itching feeling that goes all over, it is intermittent, it stings on her leg then on her back, then on her arm, and it was all over, it was just the weirdest thing. The patient's lips were not tingling after she took the Benadryl. The patient reported that she locked herself in the house and was not going anywhere. Something tells her it had to do with the sun. The patient also mentioned that she got the first dose against her will. The patient did not undergo lab tests and procedures. The event did not result in physician office visit or emergency room visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the event 'rash/breaking out with a rash on the inside of her left arm' was recovering. The outcome of the event 'feeling like her lips were tingling' was recovered and outcome of 'itching/itching all over' and 'stinging/ skin started stinging on the outside like she was being stung by an ant' was not recovered. Outcome of the event 'If she tried to rub or touch it, it would sting and burn/felt like she was sunburned' was unknown.  No follow-up attempts are possible; No further information is expected.
Immz 10/6/05 Thurs, Fri small red spot, chills, vomited all night, sweats began Sat T 102.3, achy all over. Sun arm turned, hot, swollen pain entire arm except small area in upper arm. Mon gave keflex 500 TID and Benadryl.
Fussiness Diarrhea (ongoing) Mother became ill with vomiting and diarrhea after vaccine; possible shedding from fecal route as no one else became ill
Numb on entire right side; chest tightness; checked at ER for heart and brain scans; referred to neurologist for further evaluation.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY HYPOTENSION 4/27/2022 -- RECURRENCE OF SAME SYMPTOMS
Swelling; Redness in front of left armpit; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 15:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included raynaud's phenomenon, osteopenia, hyperlipidaemia, covid-19 from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing reaction 20+ years ago. Concomitant medication included nifedipine (NIFEDIPINE), dhea (DHEA), calcium (CALCIUM), magnesium (MAGNESIUM), raloxifene (RALOXIFENE). The patient experienced swelling, redness in front of left armpit on 17Feb2021 18:00. The outcome of the events was recovering.
Very dizzy (seasick nauseous), flu like, chills, body aches, hive like very itchy rashes on lower back. Symptoms began within an hour of vaccine, lasted 3 days and then just stopped. Rash is still visible but not itchy.  Treated rash with cortisone cream to relieve the itchiness.
W/in 1 hrs of 2nd vax pt developed muscle aches in arm of inject & numbness of hand; Pt rec'd 1st dose of vaxw/o adverse experience;
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 21.5 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Started to get nausea and headache around 1 and then began vomiting.  Treamtent with fluid and rest so far.
pt recv vax 11JAN95; 13MAR95 arthralgias, lower extremity swelling that gradually progressed to include the hands;
Acute stiffness of neck 18 hours after shot admin.  COMPREHENSIVE REPORT SENT BY MAIL
swollen lt ax lymph node the size of egg;feeling tired & has some nausea;
Patient was given incorrect vaccine. She was due for PEDIARIX and was given KINRIX instead. KINRIX is a vaccine intended for 4 - 6 years olds. There were no adverse effects just wrong dosing given. Pt was also due for ROTARIX, which is a 2 part vaccine given orally. You should mix the diluent with the powder in the vial. So the child only got the diluent. That makes this baby behind on her Rota immunizations.
Patient completed the 2 dose Pfizer COVID-19 vaccine series on 2/18/21. Patient presented to clinic on 10/9/21 with cough with wheezing, shortness of breath and some diarrhea. Patient was admitted to reporting hospital on 10/12/21 when 02 stats were unable to be maintained above 90% on room air. He did receive monoclonal antibody treatment prior to being hospitalized. He received casirivimab and imdevimab. Patient was discharged 2 days after admit.
?Fullness in ears specifically right ear feels blocked ?Tinnitus in right ear (loud water rushing sound) ?Mild Vertigo
Pt had abdominal pain and went to ED for treatment one day following HPV vaccination. Pt is pregnant.
hives; large red itchy patches all over the body; getting sick; large red itchy patches all over the body; large red itchy patches all over the body; allergic reactions; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body) and RASH (large red itchy patches all over the body) in a female patient of an unknown age 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 information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired). At the time of the report, URTICARIA (hives), RASH PRURITIC (large red itchy patches all over the body), ILLNESS (getting sick), RASH ERYTHEMATOUS (large red itchy patches all over the body), RASH (large red itchy patches all over the body), HYPERSENSITIVITY (allergic reactions) and FATIGUE (Very tired) outcome was unknown.            Patient had allergic reaction to the vaccine. No concomitant medications and no treatment medications were reported..   This case was linked to MOD-2021-094421 (Patient Link).
She is fine with the rash; She is breastfeeding; She is breastfeeding; She is breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Lot number: FD8448) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), MATERNAL EXPOSURE DURING BREAST FEEDING (non-serious) all with onset 24Aug2021, outcome "unknown" and all described as "She is breastfeeding"; RASH (non-serious), outcome "recovered" (2021), described as "She is fine with the rash".  Additional information: Patient was breastfeeding and her 17 months old son, has developed a rash a week after her vaccination and the rash was worsening. Caller would like to know if she gives him Benadryl, would that affect his antibodies. No investigation assessment. She had talked to her pharmacist who had given her the vaccine about her son who was breast fed. He had gotten sick in Jan2021 and everyone around him tested positive for COVID. At the time they were not testing children in her area and he was not tested. He had a rash from head to toe at that time. Caller just got her vaccination on 24Aug2021. After a week, her son started developing a rash. Caller has called her pharmacist and her sons pediatrician. The doctor said it could be related. The pharmacist said it sounds like COVID rash and that caller should call and report it because there is not much research on how it reacts in breast fed patients. She was not too concerned about it, but she does not want another mom to get vaccinated and freak out thinking it is the Measles. Age adverse event started: 27 years or she might be 28 years old. Caller states that she doesn't take any medications and she has no underlying health conditions. No prior vaccinations (within 4 weeks). Could she give him Benadryl or will that effect the vaccine. Clearly he was getting the antibodies if he was getting a rash. She was fine with the rash. Would it be ok or would it interfere with it because it has been 2 weeks.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101176985 child case
Pt recvd HIBTITER FEB91; On 09APR91 @ 4mos pt was given HIB (MSD); @ time of report there were no noted problems;
Hypertension since 2016. Diagnosed with Type 2 Diabetes May 2020 & was put on Metformin ER 2000mg daily. Improved Hgb A1C 3 months after being on Metformin from 6.8 down to 6.4. Hgb A1C increased to 6.9 after 2 doses of Pfizer mRNA Covid vaccine & even went up to 7.9 at 2 months after the booster shot. This was with diet, exercise & losing almost 50lbs. Metformin was ineffective. Insulin Autoantibodies, GAD & C-peptide tests were consistent with Latent Autoimmune Diabetes of the Adults(LADA or Type 1.5 DM). I found a scholarly article that links Covid mRNA vaccine to this autoimmune diabetes. I now have to be dependent on Insulin. I found 2 other colleagues who share the same fate as I do.
sweating episodes started a couple hours after the shot, shaky feelings started that night, headache began late that first night and continued the following day through the overnight hours, nausea and vomiting started the next morning.  Things got better after a solid 48 - 50 hours post shot
pt devel severe rash-redness of face approx 4-6 hrs p/vax; rash generalized over body; assoc itching redness of eyes;
Received Pfizer COVID-19 Vaccine as 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number MY2B2, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, chills and nausea. On an unknown date, the outcome of the injection site pain, chills and nausea were unknown. It was unknown if the reporter considered the injection site pain, chills and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
After injection, upon standing up, patient became light headed. Assisted to chair. Patient immediately went limp, clammy, and unresponsive. 911 called. Assisted to floor. Legs raised. Became active at about 15 seconds, speaking to nurses. Began recovering. Pulse 96 BP 98/56 Pulse 52 Repeated vital signs when standing up, 72/47 Pulse 51 became slightly lightheaded again. Returned to laying position on floor, continued to talk to nurses. EMS arrived and took over assessment. Declined to go to hospital. Return to chair with no issues. Stood with no issues. To recovering area for further observation before leaving.  In recovery area Participant lying on monitor cot post EMS departure. 1619 BP 88/56, P 65, O2 Sat 99%. Voiced lighted headedness better and mother at side. 1622 Assisted to sitting position BP 84/62. Encouraged to sit and continue hydration. 1625 Participant and mother voiced readiness to leave. Educated to monitor closely for p.m. and call 911 for s/s return and or resp. distress. Both voiced will return to urgent care / hospital if any issues. 1625 Participant stood with minimal assist. BP 90/47, P 57. Ambulating without c/o. At time participant departed Howard vaccine site via private car.
MMRV given in (L) leg. Pt noted scratch leg after bandaid applied. Paper work completed. Checked leg prior to leaving. Pt states no linger itching, area red in arm swelling, ice pack applied. Swelling decreased. Pt denied any other itching.
Nauseousness and vomiting (dry heaves mostly and constant every 15-30 minutes) 7 PM 10/16 through 4 AM 10/19; chills on day 1; headaches, lethargic (exhausted after walking the dog....and I am a marathon runner ...very active); sleopt for first day after Monday 10/17 then could not sleep much after for daysbut also could not get up energy to get out of bed; vivid dreams or mind drifting awake or asleep (very intense); could not keep a drop of water down or food therfeore went almost 40 hours with nothing
acute left arm pain and decreased mobility status post PPSV23 immunization 4 days ago.  He got the immunization in his left deltoid muscle.  Per discussion with the CMA who administered it, he had a nicotine patch placed superiorly to the site of the injection.  He states that later that day he had onset of pain in his left arm with difficulty raising it beyond 90 degrees.  Today he denies pain, weakness or numbness in his fingers, hands, wrists, or elbow on his left side.
7 hours after injection noticed itching on back of left thigh - found rash from hip to knee, progressing down the leg. Spread to (R) leg same evening & 2 days later, welt type rash on both upper arms, symptoms also of anxious, rapid breathing, took ZYRTEC, helped w/breathing/Monday started pred 20mg qd x 5d.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 16-MAY-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE ( expiry date, dose units, route and anatomical location were not specified), on 05-JUN-2013, patient  received improperly stored VARIVAX dose 2, from batch/lot # 0610AE. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Swollen (R) upper arm - painful warm, pink area 10 cm diameter surrounding vaccine site fever, fatigue.
Information has been received from a health professional concerning an 84 year old female with an allergy to sulfa medications who on 05-JAN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Three days after vaccination, on 08-JAN-2007, the patient developed herpes zoster. Unspecified medical attention was sought. At the time of the report, the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Received booster (3rd dose) on Friday Nov. 19th 2021 When waking up on Saturday Nov. 20th 2021 I immediately noticed neurological symptoms Stinging/Tingling/Burning/Itching "pins and needles" all over my body especially in my hands and feet  These symptoms lasted for ~24 hours and then slowly tapered off. I have largely recovered although I still notice very slight tingling occasionally in my extremities.
Got Results yesterday "Positive"; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Results yesterday "Positive") in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (Got Results yesterday "Positive"). At the time of the report, COVID-19 (Got Results yesterday "Positive") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported No treatment information was provided.
NauseaVomiting fatigue, increased HR and BP,chills, sore arm Narrative:  Employee states: experiencing severe nausea, fatigue, at rest HR of 122, and BP of 133/92, experiencing chills )(has not taken temp), arm is sore and swollen and overall feel miserable. Patient did have COVID a month ago.
post vaccine client fainted did not hit head, skin pale (history of fainting), light headed. Client awake and talking  lay down with feet elevated, water and OJ given. No improvement  offer to call 911 sent to ER
Erythema of 4-5 cm surrounding injection site. Pt also fussy with low grade fever. Started 2D after injection and lasted 72 hours. Better with Benadryl given. Right thigh only.
RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 224M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME). At the time of the report, FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.