chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like she was having a "heart attack"; extremely nauseous and dizzy; extremely nauseous and dizzy; reported stiffness in both legs and could not walk; reported stiffness in both legs and could not walk; This is a spontaneous report from a contactable pharmacist. An elderly (65+ Years) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 23Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Public Health Clinic/Administration facility. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 intramuscular on unknown date at SINGLE DOSE for covid-19 immunisation. After 2nd dose on 23Feb2021, the patient felt extremely nauseous and dizzy, felt like she was having a "heart attack" though no reported difficulty breathing or anaphylaxis. The patient also reported stiffness in both legs and could not walk and do could not reach phone to call anyone. No treatment received. The outcome was unknown. No covid prior vaccination.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relationship, the causal association between BNT162B2 and the reported "felt like having a heart attack" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
22Jan91-swollen glands neck-bilat., 26Jan91-edema in ankles & red eyes, 30Jan91-edema in fingers-bilat., 31Jan91-hands & fingers tingling(asleep), 31Jan91-to MD,Dx: Rxn to MR vax,Rx Ibuprofen &Lasix prn.Remains bilat edema in hands/tingling
about 7 hours after receiving the vaccine I had horrible body aches, chills, and a fever. these persisted overnight and into the nest day. i continued to have body aches and chills for three days. I then developed a horrible headache two days after receiving the vaccine that lasted for 4 days. once the headache was gone, I continued to be fatigued and have body aches for two more days. overall, I had awful side effects for 7 full days post vaccine.
had gotten sick; Positive COVID-19 test; Coughing; Temperature of 100 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (had gotten sick), SARS-COV-2 TEST POSITIVE (Positive COVID-19 test), COUGH (Coughing) and PYREXIA (Temperature of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree fahrenheit. On an unknown date, SARS-CoV-2 test: Positive and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also include Z-pack The patient was scheduled for his second dose of the vaccine on 23MAR2021-24MAR2021.
THE JANSSEN COVID 19 VACCINE THAT WAS ADMINISTERED TO THIS PATIENT EXPIRED 2DAYS AFTER THE ADMINISTRATION DATE.  THE BEYOND USE DATE WAS OMMITED ON THE LAST BOX CONTAINING THE VACCINE VIAL. I ASSUMED IT WAS STILL IN DATE WHEN I PULLED THE PRODUCT.  EXPIRED VACCINE WAS USUALLY NOT STORED IN THAT SPECIFIC REFRIDGERATOR. I WAS THE ONLY PHARMACIST AND THIS WAS IN MIDDLE OF A BUSY DAY AND  THAT WAS TYPICAL LOCATION WHERE IN DATE CURRENT VACCINES WERE STORED.
Woke up with headache and allergic symptoms on throat and nose.  After a few minutes of being woke nausea and vomiting started.
Severe chills, cold extremities, body aches, muscle aches, stomach pain, low appetite, diarrhea, severe headache (third day after shot)
pruritic, non tender, induration noted @ site of inj 2 wk p/vas;1mo p/vax has sl redness & induration;
Since the vaccination, I experience very frequent headaches that often do not respond to the usual headache medication (Tylenol, ibuprofen).
2/16/05 office visit, rash x5 days, treated with Benadryl every 4 to 6 hrs as needed. Varicella in previous vaccine.
my mom who has every shot and booster got covid; my mom who has every shot and booster got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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 "my mom who has every shot and booster got covid".  Clinical course: Everyone reporter knew who had the vaccine has gotten very sick, not just a little sick. In fact, the reporter's mom, who had every shot and booster, got covid, reporter couldn't help but be around her. And yet reporter didn't got sick, neither did reporter girlfriend. reporter mom, who was supposed to be the most protected, got very sick, VERY. And yet we experienced nothing. NOTHING. This had happened to numerous other people reporter personally knew. Every person who got the vaccine got sick and then said that "it would have been so much worse if hadn't had the vaccine," but study psychology, this was justification, this was not reality. IF they knew anything about evolution and adaptation, they would recognize that the shots were of very fleeting interest as far as protection goes because the virus mutates with each body it enters."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nearly passed out; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm at the age of 42-year-old on 03Jun2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included None. There were no concomitant medications.  The patient experienced nearly passed out on 03Jun2021.  As reported as follows: Transferring agent stated, "I have the caller on the line. The reason for this transfer is because he nearly passed out after receiving the first Covid vaccine about 2 hours ago and he wants to know if he should take the second vaccination and if this vaccination card that he received from his first vaccination will be valid for him to get the second one." When paraphrased the concern, consumer stated, "Yes that was half of my question. I wanted to consult with my physician but it is a little late in the day today, so I couldn't get a hold of him after I received it. But I am pretty sure that the second dose probably will not necessarily have this circumstances now, am I correct?" The patient underwent lab tests and procedures which included laboratory test: unknown results in May2021 (3 weeks ago). Not received treatment for the event. The outcome of event was unknown.
Flu like symptoms,  muscle aches. Joint pain and stiffness,  severe headaches and dizziness.  Lack of energy,  chills and severe pain and burning sensation at the injection sight.
Administration error. 15y/o patient received Pfizer vaccine on 1/20/21 and 2/10/21. Parents claimed child was 16 years old. Actual age discovered later on chart review. Patient tolerated both doses of vaccine well without significant side effects.
Evening of injection noticed large lump under skin. Next morning large red, warm circle around injection site. Later that evening the spot became very itchy.
sick; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a (unknown demographic) patient who experienced sick (illness) when received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Nope not for me every time I did take it i got really sick all year and that goes for they're b.s. Vaccine too I'll take my chances"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Headache ringing ears, body aches 6 days current. Elevated temp z3 days    Loss of energy
12/18/2020 Covid vaccine #1 Pfizer Lot EJ1685  11am Left arm 1/8/2021  Covid vaccine #2 Pfizer Lot EK9231 11am Left arm 4/8/2021 Exposure to husband 4/11/2021 became ill 4/12/2021 tested positive for covid - PCR test
PERIPHERAL NEUROPATHY HYPOTENSION  05/30/22  - patient had same adverse effects again
Within 5 minutes after the vaccine administration, the patient fell dizzy and slipped from the exam table to the floor, landed on her bottom and her head hit the floor.  Her dad was the only one in the room other than the patient.  I went in immediately,  and saw the patient lying on the floor. She was able to open her eyes.  Her radial pulse was well felt.  BP 100/70 mm Hg.  Oxygen saturation was 99%.  She was responding well to questions.  She was observed for 2 hours and sent home.  Her exam was normal.
pregnant;received both doses of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Delivery (Live, full-term birth) on 19-Dec-2012 and Alcohol use (Ocassionally). Concurrent medical conditions included Anxiety. Concomitant products included PARACETAMOL (TYLENOL) for Ache, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MAGNESIUM for Headache, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROBIOTICS NOS for Upset stomach and Bloating.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 10-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive Positive.         The date of positive pregnancy test was Oct-2020 and estimated date of conception was Sept-2020. The patient has an established prenatal care. On an unknown date, ultrasound, blood work, and urine sample test was performed which was reported to be normal. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: Internal review conducted on 21-JUL-2021, resulted in updates to the pregnancy details, vaccine information, relevant history, lab data, concomitant medications, action taken, event onset/stop dates, event outcome, and iNarrative supplement.
COVID 19 Treatment; COVID 19 Treatment; 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 36-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2022 at 13:00 as dose 3 (booster), single (Lot number: 33025BD) at the age of 36 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 had no relevant medical history. There were no concomitant medications. The patient had not received any other medication within 2 weeks of vaccination. The following information was reported: COVID-19 (medically significant) with onset 24Aug2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (30Aug2022) Negative, notes: Tested Negative on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received Paxlovid from 24Aug2022 to 29Aug2022.
SEVERE HEADACHE, CHILLS, FEVER 101.5 BEGINNING APPROXIMATELY 12 HOURS AFTER ADMINISTRATION AND LASTING FOR 18 HOURS.
Starting at 2:00am on the day after the injection, fever of 102F, chills, no appetite, fatigue. Symptoms lasted for 6 days but able get fever down to 99.2F with Ibuprofen. Fever tended to spike in the afternoon ans evenings. Diarrhea on the 5th day, for only one day.  On 7th day felt better, but still not 100%. Now normal.
Redness at injection site; Skin induration at injection site; Bubble / blister at injection site; Intended to administer tuberculin; On 30Nov2021, Nurse Practitioner called and reported that three patients, (Female age 56), (Female age 25), and (Female age 55) were incorrectly administered TDVAX (lot# A132A). A 0.72mL dose of TDVAX was administered to each patient via intradermal injection whereas the labeled dose of TDVAX is 0.5mL administered IM. The stated intent was to administer tuberculin testing. The errors were discovered approximately 5 minutes after the administration of TDVAX to the third patient who noted that the injection did not feel like TB test. Each patient was alerted to the error on the same day.   The next day, 30Nov2021, each patient reported injection site reactions. One patient noted redness at the injection site and the other two had slightly larger red areas with induration at the injection site. One developed a blister. Did not specify which adverse reaction belonged to which patient.     Upon being asked about the site of administration, stated that it involved both left and right arms, without providing further details.  Requested to provide with the name of the facility where these events took place. Refused to disclose additional information and stated that she needed to talk with her lawyer.    Note: Three separate ICSRs have been submitted to VAERS for all three patients mentioned in this case.   1. ICSR Submission Name "US-MassBiologics-AE21-06" 2. ICSR Submission Name "US-MassBiologics-AE21-07" 3. ICSR Submission Name "US-MassBiologics-AE21-08"; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
Within a couple of days of vaccination, I developed diarrhea. I felt like my stomach was a little upset and I didn?t have much appetite. My doctor advised I take over the counter stomach medication. I took some Mylanta and that helped. I can?t take Miralax because it upsets my stomach, and I heard the vaccine also has Polyethylene Glycol and I thought that may have been why I reacted with that. The diarrhea lasted ten days.
320PM patient complained of thick, fuzzy tongue, speech clear, no shortness of breath, no cough. Patient complained of feeling "weird", shakiness and heart racing. Adult epipen 0.3mg injected into right thigh, 911 called. Patient remained alert, oriented x3, and speaking clearly. Patient departed via ambulance to ER at 3:40PM.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 14 months old patient who was vaccinated with a diluent of the vaccine PENTACEL lot number C5572AA (Expiry date 13-Oct-2019) via unknown route in the left thigh on 23-Jan-2019. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccination involved Hepatitis A Vaccine, Hepatitis B Vaccine and PREVNAR 13. It is a actual medication case error due wrong injection technique. It was reported that PENTACEL was reconstituted left out for 60-90 minutes but the injection was given. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Difficulty breathing due to heart pounding and could not walk more than 50 feet. Had ECHO yesterday 4/26/21, which revealed inflammation. Provider recommended waiting to do second dose for now.
pt recvd call on 26AUG92 from pt's cousin; stated starting fever not long p/leaving clinic then was up all noc w/vomiting & fever of 102; took pt to MD who prescribed an antispasmmodic & told them pt reacted to vax; pt rt arm was also sore;
onset <24 hrs post inject; site inc itching & erythemia; erythemia 5" x 4"
PAIN IN LEFT LEG AND NOW THE PAIN WAS AFFECTING HIS RIGHT LEG; This spontaneous report received from a patient concerned an 89 year old male. 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: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain in left leg and now the pain was affecting his right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left leg and now the pain was affecting his right leg. This report was non-serious.
constant crying for 5 hrs but able to feed a little & nap slightly; no fever-had lump on leg for 2 wks;
1st Moderna vaccine--7/22/21:  had migraine headache, very sore and red arm at injection site.  2nd Moderna vaccine--8/25/21; had migraine headache over 5 days, took 4 doses of Imitrex (very unusual); 8/27-9/1 developed bright red rash over all of torso, front and back, including even brighter red rash at injection site, took Benadryl, slight itching when resolving.  No shortness of breath.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 76-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 7th November 2018, the patient received the 2nd dose of SHINGRIX. On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, the patient received SHINGRIX on left deltoid. Later on the day of vaccination, the patient had experienced a baseball sized rash below the injection site between the shoulder and the elbow. There was consented to follow up.
I also have headache; I've been feeling dizzy; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced headache and dizziness. On an unknown date, the outcome of the headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had feeling dizzy and still went to work and had been here all day. The patient also had headache. The reporter just wanted to make sure that the he/she did not had to run the emergency room or something. The reporter wanted to make sure that what he/she feeling was basically normal.