chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brain is still in a fog; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; received the first dose of the Pfizer COVID Vaccine and then 2 weeks later got COVID again; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for Covid-19 immunization and tetanus vaccine (manufacturer unknown) via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included COVID diagnosed in Mar2020. Concomitant medication was not reported. The patient received the first dose of the Pfizer COVID Vaccine and then 2 weeks later on 05Jan2021 got COVID again. He wanted guidance as to when he can get the second dose of the vaccine. His vaccination provider refused his second dose and the 21-day interval has passed. He was tested for COVID on 05Jan2021 and was positive. The patient said that his brain is still in a fog on unspecified date. He is normally not this cloudy. It was also reported that around the same time he got a Tetanus shot, and he can not remember which one was given in which side. The outcome of the events was unknown.
Patient passed out for a few moments after receiving the shot. Was extremely light-headed and dehydrated
Itchy rash on the left arm, legs, ankles, stomach, left breast; Red rash on the left arm, legs, ankles, stomach, left breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). In April 2021, the patient experienced RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast). At the time of the report, RASH PRURITIC (Itchy rash on the left arm, legs, ankles, stomach, left breast) and RASH ERYTHEMATOUS (Red rash on the left arm, legs, ankles, stomach, left breast) outcome was unknown. Not Provided          The biggest patch remained on her left breast and they were small red itchy patches. The patient was told by her doctor on 12-Apr-2021 to take Benadryl at bedtime, Triamcinolone acetonide 0.025% cream two times a day. The patient started the medications on 13-Apr-2021.
Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness, chest pressure, shortness of breath, extreme tiredness. Everyday passing I was feeling worse, adding radical mood swings. Today March the 25/2021 I am still with taste loss, with chills, with the mood swings (the ones that had me partially hospitalized), the skin pigmentation changes is not the same, and tiredness.
Developed Covid 19 7 days after receiving 1st vaccine.  Sore throat, chills, fever, body aches, headaches.
HORRIBLE INTESTINAL DISTRESS; DIARRHEA; COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 36 year old white female. The patient's weight, height, and medical history were not reported. Patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered on unspecified date for COVID-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 01-MAR-2021 for COVID-19 prophylaxis. Age at time of vaccination 35 years old. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included escitalopram oxalate.  In JUN-2022, the patient experienced COVID-19 infection (Dose number in series 2) (latency 15 months) and received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 28-JUN-2022 till 29-JUN-2022 for covid-19 treatment. On 29-JUN-2022, the patient experienced horrible intestinal distress with paxlovid and bad diarrhea (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and paxlovid was drug discontinued. The outcome of the horrible intestinal distress, diarrhea and covid-19 infection was not reported. This report was non-serious.
Patient sat in chair, stated chest hurt. Patient stood suddenly, eyes rolled back in his head, and he grabbed the privacy screen.  He fell, striking his head on the ground, and appears to  seize for approximately a minute.  Patient regained consciousness, sweated profusely, stated he was thirsty, complained of his head hurting. Patient was very pale.  Paramedics arrived and patient/his mother refused to go to the hospital despite repeated offers from paramedics.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was taking covid-19 treatment from 01Jun2022 to 04Ju2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
wrist started feelingtired and numb; stiffness; Wrist Hurting; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 21Mar2021 at 18:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021, the patient's wrist was hurting. Th arm soreness/stiffness had subsided, but wrist started feeling tried and numb, then started to hurt. The patient never had this issue before the vaccine. The patient had not gone to doctor yet, but it had been a problem. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events wrist hurting, arm soreness, stiffness and wrist started feeling tried and numb. The clinical outcomes of the events arm soreness and stiffness were recovered on an unknown date in Mar2021 while that of wrist hurting and wrist started feeling tried and numb were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd pneumococcal vax in NOV91 & devel a large local reaction @ the inject site w/induration & local cellulitis; There was no systemic reaction;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 31-AUG-2014, the patient was vaccinated with PNEUMOVAX 23, injection, 1 standard package syringe of 1, (lot # J004747; Exp. Date: 20-JUL-2014), 0.5 ml, intramuscular (strength and route not provided). Co-suspect or concomitant therapies were not provided. The dose of PNEUMOVAX 23 that the patient received on 31-AUG-2014 expired on 20-JUL-2014. No adverse effects were reported. Additional information has been requested.
knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: she knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300085 similar report from same reporter;US-PFIZER INC-202201300194 similar report from same reporter;
Case number PHEH2015US022677 is an initial spontaneous report received from a pharmacist on 28 Oct 2015. This report refers to a 55 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MDV) on 28 Oct 2015. It was reported that the vaccine administered was pre-drawn into a syringe from multi dose vial for 10 days and held at proper temperature. No adverse events were reported following this maladministration.
On 2/252021 at 9:30 am  I experienced a very strange sensation spreading across my chest, left to right, my right be partially numb. I checked my blood pressure & it was 199/105,   10 minutes later 197/101. I went to ER arriving at 10 am.  Had EKG, blood work, chest xray, covid quick test.  All ok. BP stayed very high until 12:30 pm then started to go down.  After about an hour bp went back up to 188/99.  I was given a pill to lower pressure but it didn't  lower.  Finally given a dose of metroprolol & pressure went down. Was released from ER at 3:45 pm.   Today, 3/1/2021 BP is still high,  166/87.   Went to cardiologist 3/1/2021, was told they were having these type issues lately.  No problem with EKG, blood work.  Gave me another BP pill to try for 2 weeks to try lower BP.
Taste changes - Onions and ginger beer so far. Used to love both. Onions: now taste and smell extremely rotten. Every color/type of onion, cooked or raw,  even dried minced & onion powder. The smell of onions smells rotten, or like porta potties/sewage.  Ginger beer: I have tried it twice now, and it tastes "old" to me. Like expired, almost having a dusty taste to it. Also similar rotten taste to it as well.   Period changes - I have had random menstrual bleeding. As of a few days ago (during one of these times of bleeding - while in the middle of a birth control cycle), I had a piece of mucous/membrane/blood clots/tissue come out of my vagina, which has never happened before.   I was positive with COVID around March 3-13th was my 10-day quarantine. The vaccine became available to me during my quarantine,the vaccine right after that. So I am not sure if these side effects are from COVID, or the COVID vaccine. I have found research stating both.
Itching on most of her body; Mild Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on most of her body) and VACCINATION SITE PAIN (Mild Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient is a 81 y.o. male patient of Private MD with a history of Covid 19   Discharge Diagnoses:   Assessment/Plan: Patient is a 81 y.o. male who presented to local General Hospital 2/9/2023 with shortness of breath      1. Acute respiratory failure Most likely 2/2 covid and bibasilar consolidation Procalcitonin neg. ATBs stopped Add decadron 6mg daily Patient tested positive for COVID-19 on 2/9.  Patient was seen by pulmonology.  -Patient does qualify for home oxygen   2. Covid-19 Virus Infection Date of onset of symptoms:  unknown Symptoms present on admission: Hypoxemia Date of covid positive test:  2/9/23 Vaccination status:  vaccinated. Imaging:   bibasilar consolidation on CXR Oxygen requirements on admission:   3L Current oxygen requirements:  2L Medical therapy: azithro, rocephin, decadron Consultants following:  Pulmonary Anticipated special isolation end date  TBD   3. Hypotension -Hold home BP medications for now.   4. Supratherapeutic INR -No active bleeding. Will not reverse as level under 6 and patient has a valve.  Now 4.5 5. Bradycardia -Heart rate dropped and cardiology was consulted.  Noted episodes of bradycardia while sleeping.  Echocardiogram was performed
Pt. called health dept. on 5/11/2017 reported breaking out in head/toe rash night after receiving Td Imm; severe itching. Took BENADRYL 50 mg, slept all night and all the day after. Rash now resolved.
Severe headache, responsive to acetaminophen but persistent over 18 hours requiring repeat doses of acetaminophen
I felt most of the symptoms i had when i had covid in april. My legs were sore and when i stretched it felt so tight. my head hurt so bad the day after the shot pounding headache and sensitivity to light. the first feeling i had was at like 2am i woke up with a very sore throat felt like i had strep to the point where i went to the mirror with a flashlight to see if i had spots on my throat. I took tylenol to help with the pain. by tuesday i still felt very weak and was sleeping alot like when i had been sick. I took off thursday from work because i still felt weak and hopeless. when i was sick with covid i was very depressed as i got better. I started feeling more like my self today, friday.
SHORTNESS OF BREATH, SEVERE FATIGUE, ENDED UP IN HOSPITAL DIAGNOSED WITH CHF
-Redness and swelling  (entire upper arm swollen and red) and pain (stated evening of vaccination) - Pt advised to use Benadryl and ice and to follow up with MD if no change in sx's. - Rxn reported on Right arm.
pt recvd vax; swelling of arm & axillary lymph nodes; pain & weakness which has cont; had a "bad sunburn" at same time;
Patient reported having a brief wave of nausea after waiting 10 minutes in observation.  When she got up to leave when her observation period was over, she reported tinging in her lips.   13:18  138/80, pulse 70, resp 20...tingling in lips 13:50  Pulse 72, Resp 12.  Feeling better.  Drank some water.  Lip tingling present but faint.  Reports she has to "focus to know it is there".  Pulse reg,  lungs clear, mentation clear, no stridor, no rash, no lip or tongue swelling.  Call placed/Voice message left for follow up on 3/26.  No return call received.
cried since shots & wouldn't walk;APAP/codeine 1 tsp;motrin 1tsp;
rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious.  Information on the lot/batch number has been requested
Patient given Varicella 0.5 cc sq left arm and within 10 minutes returned to office with redness around site and one hive at injection site.  Doctor saw patient immediately.  No wheezing.  Benadryl liquid given and ice pack and within 20 minutes, all symptoms gone.
Feeling Tired; Having Chills; Nausea; Feeling achy; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form and DIMENHYDRINATE (DRAMAMINE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FATIGUE (Feeling Tired), CHILLS (Having Chills), NAUSEA (Nausea), PAIN (Feeling achy) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
MA did not see BUD date of 3/14/23 upon check and not with double check with second MA. Lot was not entered into our system according to workflow protocols prior to vaccination. Therefore patient was given vaccination 13 days past BUD date.
PATIENT EXPERIENCED PAIN IN INJECTION SITE THAT HAS NOT IMPROVED IN PAST WEEKS, SHE NOW STATES SHE HAS NUMBNESS IN UPPER ARM AND THERE IS SWELLING AND HEAT JUST ABOVE THE ELBOW.  SHE HAS NOT SOUGHT TREATMENT, BUT WAS REFERRED BY RPH TO PCP FOR FOLLOW UP, DIAGNOSIS, AND TREATMENT.
This spontaneous report as received from a Licensed Practical Nurse refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JAN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose and route of administration were unknown) with lot # N020620 and expiration date of 22-JAN-2019 and sterile diluent (manufacturer unknown) (strength, dose, frequency, route of administration, lot number and expiration date were unknown) both for prophylaxis; which was reported as "49 days early". No adverse effects reported.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had some side effects from the vaccine and went to hospital. The hospitalization days was unspecified The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211124761-COVID-19 VACCINE AD26.COV2.S-Side effects. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
AFTER THE INJECTION THE PATIENT HAD ITCHINESS AT THE INJECTION SITE.  WE PROVIDED THE PATIENT WITH BENADRYL 25MG AND MONITORED HER FOR 45 MINUTES.
Nausea and severe stomach cramps 10 hours post vaccine, continuing on two hours later with chills, headache and intense fatigue. Could not get out of bed all day. Used 600 mg Ibuprofen to take the edge off the pain. Next day still had weakness and fatigue.