chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt very sick; face was red; lethargic; felt like she got hit by a train; very tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train) and FATIGUE (very tired) 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 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever). At the time of the report, MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided .  No treatment medications are provided
Fever 101.4, bodyaches, insomnia, sore throat, dizziness, headache. Treating with TYLENOL and drinking alot of fluids.
Pt c/o redness to face and chest and lightheadedness.  Rash noted on checks, neck, and upper chest noted.  Pt denied SOB, difficulty breathing, or chest heaviness.  C/O mild itching.  Pt declined referral to ER.  Given 50 mg of oral Benadryl per protocol.  Husband to drive home.  Encouraged pt to call PMD and alert to reaction.  Instructed to go to ER or call 911 if difficulty breathing develops or s/s worsen.
Day after received 1st booster dose, at 12:17 pm  resident was found with head slumped to the side and no response from resident, no pulse or respirations noted.  12:18 pm CPR was initiated, 911 called, AED and code cart grabbed.  12:20 pm AED applied shock advised no response, CPR continued.  Two other shocks advised and no response, CPR continues.  12:33 pm Medics arrived and took over CPR.  12:48 Time of death called by medics.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug and allergy history were not reported.  On an unknown date, the patient was vaccinated in the physician office with GARDASIL 9 on her arm (dose route, lot #, and expiration date were not provided) for prophylaxis. The patient's concomitant therapy was not reported. On an unspecified date, 2 weeks after vaccination, the patient came back to the office because the arm in which she received GARDASIL 9 was "very swollen, very sore, and very sensitive." Patient was told to return to the office in 2 to 3 days if the symptoms did not resolve and patient never returned to the office, so the registered nurse assumed the patient had recovered. At the reporting time the final outcome of the events was unknown. The causality assessment between GARDASIL 9 and the adverse events was unknown. Additional information has been requested.
Staring spells 56 hours after shot. Vomiting - 62 1/2 hrs after shot. Crying 3 hrs straight 62 1/2 hrs after shot. Fussiness loss of appetite 62 hrs after shot. Seizure 70 hrs after shot. Fever 69 hrs after shot.
Pt verbalized being nervous and having history of "passing out" stating he doesn't like needles. After vaccine was administered, Pt stopped talking, became pale and closed eyes, this lasted a few seconds, pt opened eyes and skin color became very pink, pt began to speak again, then color turned pale, pt stated he felt nausea, dry heaved twice, after approx 10 min pt color had returned to natural color and nausea had past.
13JAN92 pt exp low grade fever & parents gave APAP; On 15JAN92 parents did not give APAP & fever went to 106 ax; pt was hyporesponsive, very pale; pt taken to ER by parents; no local rxn @ inject site noted; dx rxn to DTP;
One day before the vaccine, my daughter come home with a runny nose and watery eyes; the next day, I had a vaccine appointment, and a few hours later vaccinated; my body feels chills and got a runny nose and nasty sore throat. My throat was hurting so bad, and my body feels so weak and chills. I was unable to sleep until 6 am and took Nyquil. After drinking Nyquil, I feel better, but the next day, my body feel weak, chilling, and unable to leave the bed. I took the second round of Nyquil, and on the third day, I feel normal and recovered. My armed got mark on vaccinated area and it pain so much.
AFTER PRELIMARY QUESTIONS, PATIENT RECEIVED MODERNA BIVALENT BOOSTER AND FLUARIX. UPON STANDING , HE FELT DIZZY. WAS TOLD TO SIT. FACE COLOR TURN PALE & HAND FELT COLD WHEN TOUCH. HE WAS SWEATING PROFUSELY AND HANDS WERE TINGLING/NUMB. CALL 911 & CALL IN-HOUSE MDs/RNs FOR HELP. RNS APPLIED ICE PACK ON NECK & GAVE WATER. HE FELT FINE. COLOR SLOWLY COME BACK. EMT ARRIVED & ACCESS PATIENT. OXY LEVEL WAS NORMAL. EMT SAYS IT'S VASOVAGAL SYNCOPE. AFTERWARD, PATIENT TOLD EMT THAT HE HASN'T EAT OT DRINK THAT MORNING AND ONLY ATE SOME CHIPS PRIOR TO COMING IN TO GET VACCINES. AFTER DRINKING 2 BOTTLES OF WATER HE FELT BETTER. HE REFUSE ER SERVICE OR MEDICAL ATTN. HE CONTINUES TO SIT IN PHARMACY FOR ABOUT 1HR AND WAS BACK TO NORMAL SELF. HE WANT TO LEAVE AND SAYS HE'LL TAKE A TAXI INSTEAD.
patient received 1st dose 10/10/2024 and 2nd dose 10/24/2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number D99N7, expiry date 29-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 24-OCT-2023, the patient received the 2nd dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received 1st dose 10/10/2024 and 2nd dose 10/24/2024.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The health care professional (HCP) reported that the patient received 1st dose and 2nd dose with in a month, which led to shortening of the vaccination schedule .  No reactions reported. The reporter consented to follow up via email
I am age 50 and have an IUD /  I began having periods again.; The first time, it started within a couple of weeks (late April) and stopped again in late July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 11:00 (Lot number: EW0158) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IUD" (ongoing), notes: I am age 50 and have an IUD. Concomitant medication(s) included: METOPROLOL; BUSPAR; VITAMIN D; CALCIUM. Vaccination history included: Bnt162b2 (1st dose, lot number: EN6204,  administration time: 11:00 AM, vaccine location: Left arm), administration date: 17Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 19Apr2021 12:00, outcome "recovered" (Jul2021), described as "I am age 50 and have an IUD /  I began having periods again."; MENSTRUATION IRREGULAR (non-serious) with onset 19Apr2021 12:00, outcome "recovered" (Jul2021), described as "The first time, it started within a couple of weeks (late April) and stopped again in late July". The events were evaluated at the physician office visit. Therapeutic measures were taken as a result of postmenopausal haemorrhage, menstruation irregular. No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 2 vaccines Pfizer 2/1/21 lot# EL9265;  Pfizer 2/22/21 lot# EM9810
Fever 104, vomiting, not playful. ER visits on 2/6/98 & 2/7/98, dx w/ rare blood disorder - cyclic neutropenia. Treated with Rocephin IM. Hospitalized. 60 day follow-up dated 9/26/00 provided no additional data.  CBS's, bone marrow aspiration.
Patients wife called to inform pharmacy that husbands arm was very painful after receiving SHINGRIX vaccination in the morning. Stated that husband had to put arm in a sling to help alleviate pain. Patient was instructed to call physician to discuss reaction to vaccine.
Have some kind of bleeding issue I am on warfarin; Hard of hearing; leg started swelling a week; Eye pain, they hurt; Low grade fever with a 100; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: EW0161) as 2nd dose, single for COVID-19 immunization; warfarin, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose for bleeding issue. Concomitant medication included simvastatin; and furosemide (LASIX) taken for an unspecified indication from 26Apr2021 to an unspecified stop date. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose on 25Mar2021 (lot number: EN6199) for COVID-19 immunization and experienced leg swelling and hard of hearing. The patient mentioned she was hard of hearing. The patient had a reaction to both of the Pfizer shots. Her second one was on the 26Apr2021, her first one was on 25Mar2021. Her leg started swelling a week after and on 26Apr2021, she had her second and the same evening she started having eye pain, it's just they hurt, there was no redness, no swelling, no visual problems, they just hurt and they still hurt. And that night, she had low grade fever with a 100, chills and that lasted about, the fever and chills lasted about 10 hours but the eye pain was still there, it's just eye pain, no vision changes, no redness nothing it's just eye pain. She mentioned she was not tired or stressed, it was just there. The patient also reported that she had some kind of bleeding issue and she was on warfarin. The outcome of the event eye pain was not recovered, fever and chills was recovered while other events was unknown. The event bleeding issue was assessed as serious- medically significant.
have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster; have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cirrhosis" (unspecified if ongoing). Concomitant medication included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have a break through Covid infection after having both dosage of the Pfizer vaccine plus the booster". The patient underwent the following laboratory tests and procedures: Covid-test: unknown result.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient hospitalized with COVID-19 pneumonia on day 15 of symptoms. He is requiring supplemental oxygen but is overall stable
15-20 minutes, post vax, baby turned bright red. Mom called doctor and child was taken immediately, to ER where airway was obstructed and hives were developing. Epinephrine and Benadryl was given. Baby recovered and was allowed to go home.
Pt RECEIVED 6 IMMUNIZATIONS ON MON 8/24/09 including VARICELLA vaccine. Child woke up with Little Red bumps all over his body. Father instructed to send child to ER. Child diagnosed with mild case of Chicken Pox (At Urgent Care R.P.) 8/28/09 Child is doing fine.
Pt received 1st dose of Gardasil 5/21/07. Within 9 days she developed severe bilateral joint pain and stiffness with bilateral elbow effusion. Her ANA was 1:2560. Normal sed rate, RF, CBC, Mild elevation of liver function tests.
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (once or twice a week before pregnancy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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 on 22-Dec-2020 and the estimated date of delivery was 26-Sep-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test was 16-Jan-2021. The patient has an established prenatal care. No treatment information provided.
Walk in child's mother said pt received 4 vaccines Friday 5/16/03 and later in the evening she had an episode of 101 temp, complained of sore right deltoid and neck area, nausea, vomiting 2-3 times during the night, was lethargic Saturday.  She's been fine since.
Employee complained of shoulder discomfort in vaccinated arm, which began radiating to her other arm.  She reports being unable to lift any item.  She is seeing her primary physician later today.
Fever; Feeling bad; Feeling achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad"; PAIN (non-serious), outcome "unknown", described as "Feeling achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. Swollen hot arm after 2 hours of injection 2. Swollen lymph nodes on the left side of the neck (underneath the chin) the next day 3. Lymph nodes left armpit at day 3. Persistent Headaches for the next 4 weeks. Also feeling very weak 4. More lymph nodes in the left groin area. Starting to become very debilitating  5. After three weeks of injection nearly impossible to move my head. Experiencing severe pain. 6. Visiting clinic twice. "Doctor" is completely clueless. Two REAL  doctor friend from out of state, one (Infectologist) recommended a short course of Prednisone, 5-10mg over 3-5 days. Incompetent "doctor" at clinic could not even find lymph nodes.
On 03/03/2021, 7 days post vaccine, my baby was 12 months old and I had confirmation that I had Lactate Amenorrhea. I was tracking everything quite carefully. I had breakthrough menstrual bleeding. l was bleeding without ovulating.  I don't ovulate so I should not be bleeding. I use a wearable device to track body temperature. I have the data from the sensor telling me I did not ovulate.  I should not have had any sort of bleeding. I did not notice the infection till 03/04/2021. It happened concurrent with the breakthrough bleeding.  I incurred an infection called Mastitis and I treated with Antibiotics for it. On 03/05/2021 I had a telehealth appointment. The breakthrough bleeding stopped after 3 days.
Vaccine was administered post use date. Patient's provider Dr. contacted parents or guardian on 02/22/23 stating manufacturer's vaccine activity at the time of administration.   Manufacturer's Statement: We do not have stability data to support your excursion from prescribed storage conditions.  Stability data supports the storage of unpunctured vials between 2-8°C for up to 75 days.
patient has Covid after receiving the vaccine; patient has Covid after receiving the vaccine; This is a spontaneous report from a contactable physician reporting for a patient via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine and now has Covid. They want to give the patient a treatment of antibodies. The patient underwent lab tests and procedures which included sars-cov-2 test: now has COVID on an unspecified date. Reporter has questions on how that would affect the vaccine. Outcome of the event was unknown.  Information about lot/batch has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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 agencies as appropriate.
Headache within 30 minutes, body aches, fever, confusion within 12 hours.
Patient given 0.5ml instead of correct dose of 0.3ml.  Patient experienced slight fatigue and chills.
pt developed hoarseness in throat just after she left the parking area outside the clinic.  she returned to the clinic and received benadryl.  she felt better and went home.
24 hours after vaccination child had a red, hot inflammation at IM site, increased in size to 3 cm x 7 cm. Began using hot compresses and Benadryl. Resolved without ABX.
sickly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A male patient received BNT162b2 (BNT162B2 NOS), 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: ILLNESS (non-serious), outcome "unknown", described as "sickly".  Additional Information: Reporter questioned why was Pfizer COVID-19 vaccine  being recommended while people are dying and what was the content of the vaccine and her husband became sickly when he took the vaccine too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141645 same reporter, different patient/ event.;US-PFIZER INC-PV202300061028 same reporter, different patient/ event.;
Information has been received from a registered nurse concerning a 62 year old white female with glaucoma and no allergies who on 24-SEP-2007 was vaccinated on left arm with a first dose of Zostavax (Oka/Merck) (Lot #658212/0887U).  Concomitant therapy included esomeprazole magnesium (Nexium), latanoprost (Xalatan), cetirizine hydrochloride (Zyrtec), omega-3 marine triglycerides, HCTZ/triamteren (Triamteren Comp), diclofenac Na (Diclofenac DR) and ethinyl estradiol/norethindrone acetate (Femhrt).  There was no illness at the time of vaccination.  On 27-SEP-2007 (previously reported as 26-SEP-2007), the patient developed soreness, warmness and itchiness at injection site on her arm.  It was reported that there was firm mass under skin that was the size of a golf ball.  The site was slightly red raised lesion with 3x3 cm.  The lesion had slight fluid clustering under the skin.  The patient was prescribed local warm compresses, acetaminophen (Tylenol) or ibuprofen (Advil) and itch cream.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been received from the registered nurse who stated that on 27-SEP-2007 the patient developed a golf ball sized lump at injection site, redness, itchy, painful to touch for 3 days.  The patient was treated with warm compress, acetaminophen (Tylenol) or ibuprofen for pain relief.  The patient recovered on an unspecified date.  No further information is expected.
Took the vaccine at 930 am   On the 1/18/2121 side effects started around 230 pm  head ache, body and joint pain ,  woke up with fever chills, nausea,   Diarrhea,  pain at the injection site all day on the 1/19/2121  alleve   and dayquil  today no fever some nausea pain under the left hand armpit  still there.
This spontaneous report was received from a healthcare worker refers to a 60 year old female patient. The patient's pertinent medical history was not reported and was allergic to Penicillin. It was reported the patient does not know if she had received the MMR II in the past but that it was a possibility that she had received it. On an unknown date as the patient aged, she developed osteoporosis, anxiety, Achilles bursitis and vitamin D deficiency. On 28-JUL-2015, the patient had a blood test and results showed she had no immunity to rubella and mumps. On 06-AUG-2015, the patient was vaccinated with MMR II (lot # K011189 and expiration date 12-AUG-2016) (dose and route were not reported). Concomitant therapies included XANAX, LEXAPRO, EPIPEN and hydrocortisone suppositories. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Information has been received from an office manager concerning a patient who on 01-OCT-2010, was vaccinated with VARIVAX (Merck) (Lot # not reported) instead of MMR II. No adverse effects were known. Additional information has been requested.