chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; tingling lips; headache; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A 7-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tingling lips, and headache. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry date was not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 21-AUG-2021, the patient experienced suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The patient experienced symptoms cough, sore throat, and runny nose on 21-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846436. This report was associated with product quality complaint:90000191006; Sender's Comments: V0: 20210847490-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Case number PHEH2012US013413 is an initial spontaneous report received from a medical assistant on 03 Jul 2012: This case refers to an 18-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11047), intramuscularly without being reconstituted with Men A component on 02 Jul 2012. No adverse reaction occurred following this administration error.
BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, with frequency time 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a blood clot and died from the blood clot. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from blood clot. This report was serious (Death).; Sender's Comments: V0: 20211009011-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
COVID arm/great big huge lump; COVID arm/ she had a circle rash; red rash on her arm; sleeping a lot; she was weak; Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration in the arm on 18Aug2021 in the late afternoon or early evening (at the age of 64-year-old), dose 1, single for COVID-19 immunisation. Medical history included aneurysm in 2015 (it has not changed, it was diagnosed 6 years ago), obesity (weighed the same for over 20 years) and COVID (Feb2021) and got an infusion. The patient did not have diabetes. The patent did not have family history. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. On 18Aug2021, the patient developed myocarditis right away after first shot. The patient did not know that was what it was. The patient thought it was normal and related to the shot. The patient had all symptoms of myocarditis. On 19Aug2021, the patient got COVID arm which started with a lump in her arm and then she had a circle rash from it at first. That was her biggest concern at first. She noticed it about 10:00 or 10:30. The patient got ready to take a shower and saw a red rash on her arm and she had great big huge lump. The was sleeping a lot and she was weak. The patient had to wait 90 days after to get her shot. The patient went to the doctor on 01Sep2021. The patient's doctor was referring the patient to a cardiologist and said for patient not to get second dose. The patient had an electrocardiogram (EKG) after COVID virus and her heart was fine. The EKG on 01Sep2021 showed irregular and she was going to the cardiologist. They did bloodwork and were sending her to a cardiologist because it was beyond what her primary care does. The patient could not have the second shot or a booster ever. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event myocarditis was not recovered. The outcome of the events sleeping a lot and 'she was weak' was unknown and outcome of other events was recovered.  Information on the lot/batch number has been requested.
Slept a lot; brain felt foggy; Maybe she doesn't have as much energy; Very bad headache; Churning in my stomach; tired/ fatigue/ Tiredness; extreme nausea; extreme vomiting/ Feeling like I might vomit; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept a lot), FEELING ABNORMAL (brain felt foggy), ABDOMINAL DISCOMFORT (Churning in my stomach), ASTHENIA (Maybe she doesn't have as much energy) and NAUSEA (extreme nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (extreme nausea) and VOMITING (extreme vomiting/ Feeling like I might vomit). On 27-Mar-2021, the patient experienced FATIGUE (tired/ fatigue/ Tiredness). On 25-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Churning in my stomach). On 27-May-2021, the patient experienced HEADACHE (Very bad headache). On an unknown date, the patient experienced SOMNOLENCE (Slept a lot), FEELING ABNORMAL (brain felt foggy) and ASTHENIA (Maybe she doesn't have as much energy). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH) at an unspecified dose and frequency and DOMPERIDONE (EMETROL [DOMPERIDONE]) for Adverse event, at an unspecified dose and frequency. On 27-May-2021, ABDOMINAL DISCOMFORT (Churning in my stomach), NAUSEA (extreme nausea), VOMITING (extreme vomiting/ Feeling like I might vomit), FATIGUE (tired/ fatigue/ Tiredness) and HEADACHE (Very bad headache) had resolved. At the time of the report, SOMNOLENCE (Slept a lot), FEELING ABNORMAL (brain felt foggy) and ASTHENIA (Maybe she doesn't have as much energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: excellent (normal) excellent.         No concomitant medication information were reported. The patient was still experiencing severe nausea and headaches. This same episode recurs about every 10 days to 2 weeks. The episode lasts for 3 days and the patient has been  through 10 cycles now. The patient had seen the doctor and her blood work and an abdominal CAT scan were all excellent.   On 25-May-2021, patient experienced another episode of nausea, vomiting and fatigue.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Another episode of events added. On 07-Jul-2021: Significant follow up as the same events with increased severity persists and concern about not received any additional information on side effects
Injection site below and above, raised, very hot, and itchy.  This lasted one and off for approx 10 days.
Patient's mother called because of fever 102.6, vomitting, light-headed/dizzy.  Had H1N1 flu shot earlier today.  Was on IV steroids in hospital recently . Mother advised to take patient to hospital for further evaluation and treatment.
fever to 102, persistent unconsolable crying for 4hrs;local rxn 10cm erythema
I had light diarrhea the day after the 1st pill. I had chills, nausea, stomach pain, and headaches the day after the 2nd pill. I had to sleep all of the day after the 2nd pill. I still had the symptoms of the day after the 2nd pill on later days, but lessened.
low grade fever/chills/weakness/body aches/extreme tiredness Treated with Ibuprofen 600mg once - relief from chills/fever/body aches
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 12-SEP-2014, the patient was administered an expired dose of ZOSTAVAX lot  number J004271, expiration date 12-JUL-2014, 0.65 ml, subcutaneously (dose number and anatomical location were not reported). No adverse events were reported. Concomitant medications were not specified. Additional information has been requested.
Red itchy bump appeared 7 days after vaccine was administered on lower back/upper buttocks. Blisters appeared 13 days after vaccine was administered. Groin pain accrued 13 days after vaccine was administered.  Dr. prescribed medicine on 4/29/2021
4/3/04 noted swelling, soreness at affected site by midday shooting pain into brachia plexus, as day went along became more difficult to move left arm, measured temperature at 99.5 degrees. 4/4/04 pain continued in brachial plexus noted. Golf ball size lump in the left deltoid, no fever. 4/5/04 and 4/6/04 taking tylenol 510mgm Bid which resulted in 50% less pain in brachial plexus.
I start to itch   on face an neck  on face day  after injection. Had a few hives on my face. today (2nd day),  I have itching  over whole  body
Medical Assistant self reported that she had just given a Covid Pfizer booster to a 15 year old.  Patient did not have any adverse reactions.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received, narrative updated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 at 14:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Aug2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 01Feb2023 to 05Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073973 same patient and drug; different dose and event;
APPROX 1-2 MINUTES PATIENT BECAME PALE, CONTINUED TO BECOME INCREASINGLY PALE EYES ROLLED BACK AND PATIENT STARTED TO HAVE GRAND MAL SEIZURE LASTING APPROX 5 SECONDS. CIRCUMORAL CYANOSIS NOTED.  PATIENT NEUROLOGICALLY APPROPRIATE POST SEIZURE.  BLOOD PRESSURE 102/40 IMMEDIATELY POST, 128/52 10 MINUTES POST.
I had my vaccine on the 3rd, I had took Tylenol shortly after taking the vaccine, just to be ready for side effects. Later that night my left arm was sore and I had a fever of 102.4 . The next day my arm is sore, and my temperature is 101.4. I took a bath and Tylenol my fever went back up to 102.3. I had a fever all day yesterday. I am taking Tylenol and Motrin every 6 hours. Last night around 2AM I got chills, and my temperature was 103.5. Today when I woke up my temperature was 100.2 and my arm is still sore. I am going to continue taking the Tylenol and Motrin every 6 hours. I am supposed to work tomorrow. I had call out yesterday.
So the day after my vaccine, in the morning, I was so exhausted and felt horrible I had a temperature of around 101. I was just like so tired and loss my sense of smell and taste. I had a little shortness of breath at first, headache, body aches and sore throat. I also experienced chest pain. This all slowly started and as the days went on I also experienced blurry vision and brain fog and swelling in my joints. For about the first three weeks after my injection I was literally in bed. I took unpaid leave because I just could not work and I maxed out my leave. I have a 2 and a 6 year old and it was just so painful that I could not move or get out of bed much. The pain in my body was horrible. After I lost my senses on that Monday, on May 3rd 2021 I went to get a Covid test and sure enough it came back positive on the rapid test. The fatigue is debilitating and I am still not working. On May 12 2021 I went to the ER for chest tightness, shortness of breath and fatigue, my oxygen levels were low. The ER DR took me off work for another week and then I ended up seeing my PCD on I think May 18th 2021, she ordered speech and physically therapy for me. PEM (protein-energy malnutrition) is what she diagnosed me with, specific to Covid-19. I am now on FMLA leave and that started on I think the 12th or the 18th of May 2021, this really messed me up with my memory and stuff so I am not sure. I have 8 weeks of physical therapy scheduled once per week. I was also referred to a Cardiologist. I saw a nutritionist on June 9th 2021 because I gained weight due to being in bed long term. They started me on an anti-inflammatory diet. On June 10 2021 I saw a speech therapist. I was supposed to return June 18th 2021 but I could not begin again. I am only allowed to worked one day per week right now and am supposed to start on Friday. On July 14th 2021 I also have another cardiologist appointment scheduled.
Pt reports feeling overly cold, even after a warm shower. Also reports a sore back. This started in the morning.
I hurt; felt horrible for a week; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week). At the time of the report, PAIN (I hurt) and FEELING ABNORMAL (felt horrible for a week) outcome 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 provided.
80x55mm area of induration noted @ 1300 4OCT92 w/tenderness to palpation; t36.4 cold compresses PRN & rest affected area;
Major muscle pain in LD, high fever 100.7 degrees - 102.2 degrees, chills, redness, swelling and warm vaccinated area (35 mm).
In less  than 2 hours, became very tired, could not stay awake.  was home within 30 minutes, had a temp of104.1, temp continued for 30-32 hours. Had a small wound on bottom of great toe, less than 1.5-2.0 mms, small but on 3rd toe, right foot.  Temp came down to 103.8 approx 32 hours after vaccine.  Was taking 1000mg Tylenol, alternating with 400mg Advil every 2 hours.  It is now Saturday late afternoon.  Noticed 3rd and 4th toe on right foot, bright red, looked like cellulitus was staring.  103.8 temp continued until Monday morning, them came down to 102.9.  Called local hospital about temps, right foot.  Informed that these were normal side effects.  Continued with Tylenol and Advil.  Had appointment with wound care for right foot great toe.  Cancelled d/t temps.  Rescheduled for 4/8/2021.  3rd ad 4th toes on right foot worsening, black tissue forming.  Appointment to see podiatry surgeon on 4/7/2021  Immediate referral to vascular surgeon.  04/08/201, angiogram performed d/t right leg blockage.
Patient's parent reported that patient started developing a bruise after her 2nd shot of the pfizer vaccine. Her arm was hurting more from the 2nd dose. After checking in with the parent 2 days after the vaccine, parent reported arm improving. Patient's parent denies use of NSAIDs prior to vaccination.
Fever 102degrees F, headache, intense body aches: joint pain (neck, hips, hands) and muscle aches, decreased grip strength, nausea, diarrhea, chills, dizziness
Woke up really warm, too temp and had low grade fever. About 20 hours after shot was administered I had nausea. About 22 hours after had small headache and chills. Fever grew around 24 hour timeframe. Took ibuprofen about 26 hours after vaccination. Fever was reduced, excessive sweating and tired. Started feeling better around 30 hours after vaccination. Fine for the rest of the evening. Sweated during sleep and  next morning with some hot flash episodes but no fever.
2-3 minutes after receiving inj Menactra, patient became diaphoretic pale, bradycardic, dizzy, hypotensive requiring prolonged assistance of approximately 45 minutes or so.  911 was called - transferred to ER.
At each injection site, the week of 06Jun22, I developed nodules that scabbed.; At each injection site, the week of 06Jun22, I developed nodules that scabbed.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FF2589, Location of injection: Arm Left), administration date: 28Sep2021, when the patient was 30-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FC3182, Location of injection: Arm Right), administration date: 07Sep2021, when the patient was 30-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 08Jun2022, outcome "recovered" (Jun2022), SCAB (non-serious) with onset Jun2022, outcome "unknown" and all described as "At each injection site, the week of 06Jun22, I developed nodules that scabbed.". Therapeutic measures were not taken as a result of vaccination site nodule.  Additional information: Patient did not receive any other vaccine in four weeks. COVID was not tested prior vaccination.
The day after my first and second vaccine, I sneezed uncontrollably for several hours each time.
Systemic: Fainting / Unresponsive-Medium, Additional Details: about 2 minutes after administration of vaccine, patient fell out of her chair.  quickly woke up, fully alert, able to speak, no pain, no anaphylaxis. fell on vaccine curtain but did not hit head, no injuries, bruises,or scratched noted or reported.  mom mentioned patient was fasting prior to administration. patient reported no pain, no confusion. abulance came and escorted patient out.  case number: 2021089124 sheriff's office
Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling  swelling of the  thong, itchy throat, head, neck, sob.  I immediately reported my symptoms to the MD  that was in  the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl,  20mg of Pepcid,  and salbutamol.  I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.
Patient was seen to establish care and for annual evaluation on 5/18/18. In that office visit note it states "Would like HPV vaccine series. Questions if okay to receive the vaccine if she is pregnant. She is not pregnant but would like to conceive. Just finished menstruation this past week.". Patient was given initial HPV vaccine at that time and scheduled for dose #2 on 7/13/18. Patient presented for dose number 2 on 7/13/18 and RN reviewed the notes from 5/18/18 office visit and asked the patient "Are you pregnant or is there a chance you could become pregnant during the next month?" Patient responded No, however OV on 5/18/18 notes patient would like to conceive. Patient affirms that she is not pregnant at this time. Due date 3/26/19, last menses 6/19/18.