chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited literature report received from a healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090257, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Seven female patients, whose medical history and concomitant medications were not reported, had received a dose of H1N1 (batch number, route and site of administration were not reported) on an unspecified date. On unspecified date after vaccinations, patients experienced chorioamnionitis and patients were pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Pregnancy exposure timing was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
No additional AEs; vaccines administered after temperature excursion.; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On 17-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number U028164 has been verified to be valid, expiration date reported and established as 09-SEP-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration).   In addition, it was reported that the vaccine was improperly stored at 32.9 degrees Fahrenheit during a time frame of 28 hours and 39 minutes. Moreover, the vaccine was exposed to a previous temperature excursion of a maximum temperature of 20.7 degrees Fahrenheit for 32 hours and 10 minutes (product storage error).  No additional adverse events were reported (no adverse event). The patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) administered intramuscularly instead of subcutaneously (case # 2208USA010122).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA009718: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:
Lightheaded, dizzy, weak, lethargic, nauseated, immediately following vaccine-symptoms lasting-1 yr later diagnosed with POTS syndrome-still has symptoms.
I started experiencing cramping in both lower legs, feet, and hands. It was probably the next day that it started and it would happen intermittently. It started to taper off as time went by and I still get it on occasion, but it has gotten better. A naturopathic Doctor gave me topical cramping foam and it got to be difficult when it was happening in both feet and both legs. Mainly the lower legs would happen more often and it was my feet, side of calf, and calf itself. Sometimes it would happen in one leg, something both legs, and it was different and only thing that worked was this medicine I got from my homeopathic Doctor that helped it start to dissipate.
My period this month was April 15th-April 21st with no additional spotting/bleeding after the 21st. Within 24 hours after the first vaccine, I was bleeding enough to need a pad changed every few hours. I experienced all symptoms that I typically have during my period - uterine cramping, lower back pain, & a loss of appetite. After 48 hours, the bleeding has stopped and I?m no longer having symptoms similar to a period.   I?ve had an IUD for over a year & have never had break through bleeding or spotting. Additionally, this was heavier than slight spotting - it felt as if I had started a new period.
Rash, hives, stomach pains, drooling, loss of speech, tantrums.  03/07/2008 Vax record and OT (11/7/2007) report received from parent.  Report (+) for language delay, frequent night waking, and delayed social skills as well as temper tantrums, and separation anxiety. Pt receives OT to address these issues. 03/19/2008 Vax record with lot #s received from PCP and updated in database. MR received from PCP.  WCC dated 5/10/2006 with normal development and behavioral health noted. PE WNL except uneven circumcision. Frequent sick visits. 12mon WCC 11/06/06 with normal PE except foreskin adhesions. Development normal. Refered to audiology 2/28/07. Maculopapular rash noted 3/19/07. DX Eczema and diaper dermatitis 3/23/07
prengancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (prengancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (A glass of wine a night.) from 16-Oct-2009 to 12-Dec-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 06-Jan-2020 to an unknown date for Prenatal care.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 18-Nov-2020 and the estimated date of delivery was 25-Aug-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (prengancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (prengancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2020, Pregnancy test: positive (Positive) Positive. On 06-Jan-2021, Ultrasound foetal: normal (normal) normal single fetus, normal NT. On 03-Feb-2021, Ultrasound foetal: normal (normal) normal single fetus, normal NT. On 18-Feb-2021, Ultrasound foetal: normal (normal) normal single fetus, normal NT. On 07-Apr-2021, Ultrasound foetal: normal (normal) normal single fetus, normal anatomy scan. On 18-May-2021, Glucose tolerance test: normal (normal) normal.         No treatment information was provided. Estimated date of conception was 29 Nov 2020.    Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated pregnancy details LMP, PMH, Lab test. Added relevant information.
Miscarriage at week 11 and 6 days Due date 3/31/22
Child given MMR, VARIVAX, Flu and hepatitis A vaccines on 10/22. Soon after developed hives to both thighs which spread to face and trunk. No distress or anaphylaxis. Presented on 10/24 for evaluation - given BENADRYL for prn use. Has URI also.
he had tiredness and a little headache.; he had tiredness and a little headache.; This is a spontaneous report from a contactable consumer (patient's wife). A 65-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that she and her husband received the first dose of the vaccine on 08May2021. She mentioned her husband had a "small reaction" to the first dose and specified, he had tiredness and a little headache on an unknown date. She added their second dose was scheduled this coming Saturday and asked if their vaccination appointment could be changed to the previous day, Friday. No further details were provided due to disconnecting and the information documented was the only information that was provided by the medical information agent. Outcome of the events was unknown.  Information about lot/batch number is not available. Further information has been requested.
devel fine red rash on abdo which spread over face & body; fever not measured; seen by ER put on ATB taken to MD; dx viral rash & ATB stopped;
Day 11 post vaccine, fever (100 degrees), chills, muscle and joint aches. Ibuprofen decreased symptoms. This continued along with loss of appetite and fatigue for a total of 3-4 days. On day 5 appetite & energy improving and other symptoms gone aside from some neuropathy left side of left knee but this is tapering off.
Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards) in a 42-year-old male patient 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Johnson and Johnson vaccine initially/ Received moderna vaccine afterwards) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received Johnson and Johnson vaccine initially,went ahead and received a dose of Moderna vaccine as the patient did not feel that Johnson & Johnson was adequate vaccine. No concomitant medications were reported.  No treatment medications were reported.
PATIENT DEVELOPED LOWER EXTREMETY  SWELLING 3 DAYS POST VACCINATION, JOINT PAIN, MOSTLY IN RIGHT KNEE, GENERALIZED MYALGIAS, SHORTNESS OF BREATH, CALF PAIN RIGHT MORE THAN LEFT, LOW GRADE FEVER WHICH NOW RESOLVED, EXTREME GENERALIZED WEAKNESS AND FATIGUE.
Td given 12/5/05 approximately 9:15am.  Stated that "she didn't feel good" 12/6/05 AM, without fever. Reports severe pain, redness and "lump under L arm" on 12/7/05 AM, saw MD on 12/7/05 at 5 PM, MD dx "vaccine reaction" with Motrin 400mg, T = 100 degree.  Hot compresses.
States in mid December and same last year; began with macular scattered rash on entire arms, posterior popliteal to calves and lateral abdomen. Changes to papular; pruritic; open after scratched. No fever. Ruhuli gel decreases pruritus. On 2/1/01, saw MD and was put on prednisone.
Information was received on 14-JUL-2017 from a registered nurse regarding a 31 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was administered an expired dose of VARIVAX (lot # L025206, exp 07-JUL-2017) (dose, route, and site of administration not reported). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA002872: US-009507513-1707USA009936.
she was dying with the pain, it was severe cramping; severe stomach cramping; She's feeling a lot pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:20 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient had her 1st dose on 01Feb2021 at the age of 61 years old. Medical history included scoliosis, osteoporosis, major spine surgery from an unknown date. Concomitant medications included teriparatide (FORTEO) taken for osteoporosis from Jul2020 and ongoing. The patient received the 2nd dose of the Pfizer covid vaccine in the morning. By that evening, after eating, she had severe stomach cramping that has gone on for 2 months now. She has had everything looked at to see where the pain is coming from and is also now on antispasmatic drug. Feels like menstrual cramps. She is trying to eliminate all possible causes and is now down to the covid vaccine or a medication for her osteoarthritis. Additional Information for Concomitant Products forteo: It is daily injection. For her it is for bone growth because she had a major spine surgery. Had it 2.5 months before surgery it was a requirement from surgeon. She puts the pin needle on and inject. She has been having pain for the last 2 months. Every single stomach test and no one can find out the cause. They put her on Levsin, the generic for Levsin. It stops cramping. It is not all the way but it what GI doctors have given her. No further information provided. She asks if they have heard of severe stomach cramping from the vaccine. She's feeling a lot pain. She has dealt with so many doctors. She went through all the testing. Its either one of the injections she is taking or the vaccine. So we are ruling everything out to try to figure it out. She is recovering from a nine level spinal fusion, attempted to clarify what caller said. Caller stated she had a spinal fusion in October from scoliosis. She is having pain after meals. She has been having severe cramping. She was dying with the pain, it was severe cramping. She is on the medication Levsin. It doesn't work. The generic name is Hyoscyamine 0.125 mg sublingual. She clarifies when she said pain she meant the pain from the severe stomach cramping. She hasn't stopped the Forteo waiting for stomach cat scan results clarified as CT pelvis with contrast last test to see if something shows, to have an explanation to see if there is something like gastritis that is causing stomach cramping or vaccine. Only two things, it is either the vaccine or the Forteo injections she gets. Outcome of events was not recovered.   Information on lot/batch number has been requested.
Information has been received from a physician concerning a patient who on 06-MAY-2008 was vaccinated PO with the second dose of ROTATEQ. In May 2008, after vaccination the patient experienced "hematochezia." It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information was provided. Upon internal review, hematochezia was determined to be an other important medical event. Additional information has been requested.
Nausea, Headache, Chills, Cold Sweats,  body aches, weakness, tired.
Fatigue, headache, achy joints and muscle pain, upset stomach, chills and then sweats. All side effects ran a course of 24 hours and then nothing.
On Saturday he said his bones ached all over.  He had chills and was freezing.  He did not have a temperature.  On Sunday he tested positive for COVID-19 on July 2, 2022.  His doctor prescribed Paxlovid.  He also took a ZPack, Prednisone,  for his lungs.  Another symptom was that he was very tight chest and it was hard to get air out.  He felt about the same for a week.  He then took the second pack of Prednisone.  As of today he is still exhausted with fatigue.  We have a Pulse Ox machine and it was always normal and never ran a fever.  After 5 days of Paxlovid her still tested positive.  It took two weeks for him to test negative.
When receiving the vaccine the patient reports that ""it felt like fire was entering her arm." Patinet has been going to physical therapy once or twice a week since Nov. 2,2020, and has ad to perform the exercises at home ever since. Patient recieveed a corticosteroid shot in her bursa on Dec. 23, 2020.
Pt  was given Moderna COVID-19 vaccine EUA before vaccine administration. 10 Minutes after administration pt notified staff for adverse event.  Initially, Pt had redness of chest and neck. Pt stated she cannot take Benadryl. RPh monitored pt. When pt stated her hand and lips were tingling and going numb and began having "throat clicking" RPh administered Epinephrine Autoinjector 0.3mg at 12:08pm and called 9-1-1. EMS arrived on site at 12:25 and took over care of pt (pt was then transported to hospital).
tiredness and weakness; tiredness and weakness; back aches; side aches; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included very bad neck pain from an unknown date and doctor wanted him to take methylprednisolone for this. The patient's concomitant medications were not reported. The patient experienced tiredness and weakness on an unspecified date in Apr2021. Patient asked was tiredness and weakness a side effect of the vaccine? He was getting back aches and side aches in Apr2021, but that could be from laying down. He stated he just has so many things going on with him. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Headache, low grade fever, joint pain in his and shoulders, dry mouth, injection site soreness
Vaccine administered by intern pharmacist. Patient received PREVNAR concurrently on same arm, with no issues. Patient described pain, bruising that has persisted for 2 weeks. Normally gets shots every year with no issues. Claims to not be on blood-thinners. Pt went to see MD on 10/10/16, and MD suggested physical therapy.
stiff neck, cough, headache, abdominal cramping but no diarrhea, intermittent nausea, fever (100.8)
Client LOC x 5 sec became diaphoretic and pale. Pulse rapid, nauseated no vomiting for x 1 hr, taken to ER by ambulance. Client became less diaphoretic and less pale after approximately 20 minutes during event.
Patient received an incorrect 2nd dose manufacture vaccine.  Patient received 1st dose Pfizer covid vaccine on 4/22/21 and received the 2nd dose Moderna vaccine on 5/6/21.  No reported side effects from receiving the different manufacture per patient so far.
Gave .5ML instead of .25ML and 3 months after the 2nd dose instead of waiting 6 months.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Fever 103 - 104 for 12 hrs and leg pain, myalgia. Start ibuprofen 100 mg/5mL 10 mL Q6H x 2 days - return if worse. Also pharyngitis.
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 20 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "recovered", described as "Developed myocarditis after his second COVID vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event myocarditis and BNT162B2.  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 regulatory authorities,  as appropriate.
This case was reported by a physician via sales representative and described the occurrence of swelling in a 9-year-old male subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). In 2013 the subject received a dose of FLUARIX Quadrivalent (1 unknown prefilled syringe dose, unknown details). In 2013, within months of vaccination with FLUARIX Quadrivalent, the subject experienced swelling and erythema. The reporter was not specific as to whether the events were local or systemic. At the time of reporting the events were resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event.
Pericarditis which resulted in urgent care, ER, and cardiologist visits. Treating with NSAIDs. No change in outcome yet.
pt arm swelled up turned very hot & red;pt put ice on it;it took 4 days to go back to nl;3 by 4 in wide raised;reporter states pt has large arms there fore 5/8" needle provided on tubex did not go IM;
PATIENT WAS VACCINATED OUTSIDE OF GUIDELINES.  PATIENT IS 16 YEARS OLD.   MODERNA IS LICENSED FOR  AGES  18 YEARS AND OLDER.
Palpitation through out the body, increased heart beat, rash on her face  Given Diphenhydramine 25 mg.  Checked blood pressure and it was high 148, and 160 then went down to 128.  Patient said she did not feel palpitation anymore after 10-15 min.   Patient was told to monitor blood pressure at home and would feel drowsy due to allergy medication.  She was sent to home with her son.