chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; This is a spontaneous report from a contactable nurse reported for herself. This 33-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Es1686), via intramuscular at left arm on 11Jan2021 08:00 am at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 21Dec2020 10:15 AM for COVID-19 immunisation. The patient had no known allergies. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient was pregnant. Last menstrual date was 14Dec2020. Delivery due date was 16Sep2021. Gestation period was 3 weeks. The patient experienced miscarriage on 16Jan2021 after 2nd vaccine. AE resulted in congenital anomaly or birth defect. The patient had no COVID prior vaccination. The patient had COVID tested/nasal swab post vaccination with negative results on 11Jan2021 and 13Jan2021. Outcome of the events was unknown.; Sender's Comments: Based on the available information, a causal relationship between event  miscarriage after the second COVID-19 vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt started with mild cold sxs the day after the vaccine.  Then 2 days after the vaccine in the evening developed chest pain - mid sternal - when going to bad.  Vomited x1 and pain resolved and fell asleep.  Next day also with an episode of chest pain in the pm but more severe and also with n/v; took to ER but left before evaluation done bc pain resolved.  The following day 2 more episodes of chest pain less severe. 5 days later sought care for follow up- EKG and labs abnormal so sent to ER for further evaluation.
Information has been received from a licensed nurse concerning a 12 month old male patient with no known pertinent medical history, and no known drug reactions, who on 08-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot # 661980/1145X), 0.5 ml, subcutaneously.  That same day, the patient was also vaccinated with MMR II, PREVNAR, DTAP - IPV, and ACTHIB.  there was no other concomitant therapy.  The licensed nurse reported that on 17-OCT-2008, the patient's mother called the office to report the child had a rash.  On 22-OCT-2008, the patient was seen in the office for chicken pox.  The spots were healing when seen.  The licensed nurse reported that no treatment was required.  This is one of two reports from the same source.  Further information has been requested.
I'm trying to fall asleep; Hot flashes in hands and feet.; My hands and feet will start to feel really hot; My skin feels feverish to other people.; This is a spontaneous report from a contactable consumer (patient herself). A 18 years (non-pregnant) female received BNT162B2 (Pfizer BioNTech COVID 19 Batch/lot number: ER8733) via intramuscular route of administration in Left arm on 08Apr2021 at 12:15 PM as dose 1, single (age at time of vaccination 18 years) for covid 19 vaccination and received dose 2 of BNT162B2 (Pfizer BioNTech COVID 19 Batch/lot number: EW0161) via intramuscular route of administration in Left arm on 30Apr2021 at 16:45 PM as dose 2, single (age at time of vaccination 18 years) for covid 19 vaccination. The patient had allergies with sulfa drugs, amoxicillin. The medical history include endometriosis from unknown date if ongoing unknown. Patient received drug at Pharmacy or Drug Store. The patient had not diagnosed with covid prior to vaccination and had not tested post vaccination. The patient had not received any other vaccine in four weeks. Patient received Junel Fe Birth control pill, Ibuprofen in two weeks. On 13Apr2021 patient experienced Hot flashes in hands and feet. Several times a day, my hands and feet will start to feel really hot. No sweating. My skin feels feverish to other people. Sometimes it lasts hours, sometimes it lasts minutes. Patient experienced fall asleep. Hands and feet get miserably hot at random times during the day and night and vary greatly in duration over time. The hot flash will spread to the rest of me unless stopped by applying cold to wrists/ankles. More common when patient was trying to fall asleep, makes it difficult to stay outside in the heat for long periods. The patient received no treatment. The outcome of hot flashes in hands and feet, feels feverish, hands and feet will start to feel really hot were recovering while rest event was not recovered.  Follow-up attempts are completed. No further information is expected. This is case closure.
diarrhea, vomiting, headache, chills, sweating profusely, hot flashes, and lack of appetite - started on Saturday and continues to have the same symptoms today (05/10/2021).  Pt was given number to contact to receive authorization code to be seen at her nearest Urgent Care facility.
pt recvd vax; eczema type raised rash the size of quarter at inject site;
same reaction patient had to this when first shot was given 7/11/16.  Arm got swollen by bicep and swelled to size of a baseball.  Was warm to touch and painful.  Muscle aches in arm that shot was given in.  24 hours and swelling has gone down some but not all.  the last vaccine in 2016, swelling was there for 3 days before gone.
Hospitalization for shortness of breath related to COVID-19 on dates 8/15/2022-8/28/2022.  Treated with dexamethasone, baricitinib,  zinc 50 mg PO daily.
This is an serious observational study case, initially received on 31-Oct-2018, concerning a 22-year-old, pregnant female, subject of Body mass index:  40.8, weight: 216 lbs and height: 61 inch, enrolled in a study. This was the subject's first pregnancy. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 01-Feb-2018. The gestational age of the subject was 37 weeks. The subject's current condition included hypothyroidism. The subject's concomitant medication included LEVOXYL [start date: 10-Apr-2018, dose:  200 mcg, frequency: four times a day (qid), route: oral] for hypothyroidism. On 10-Apr-2018, the subject underwent ultrasound test and no major congenital malformation was noted. On 08-May-2018, the subject underwent nuchal translucency test and no major congenital malformation was noted. On 08-May-2018, the subject underwent first trimester screening test and no major congenital malformation was noted.  On 05-Jun-2018, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP)/serum markers test and no major congenital malformation was noted. On 23-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, and left pelviectasis was noted. The subject's estimated date of delivery was reported as 14-Nov-2018. At the time of this report, the outcome of the events left pelviectasis was not reported. This case was linked to the original case: 201805222.
Light Headed, Nausea, Watery Diarrhea, Chills, Severe Joint Pain, Swollen Arm (unable to lift) Fatigue
Severe Chills-constant for about 6 hours,  Fever of 102 degrees or higher-Took Tylenol, fever broke around 6:30am next morning  Vomiting - lasted a couple hours  Headache- mild, Took Excedrin , stayed constant for about 24 hours   Lightheaded - mild, stayed constant for about 24 hours    Exhaustion- lasted about 48 hours
Half hour after injection on 1/12, severe back ache lasting 1 hour. 2 pm same day, severe pins and needles followed by pain in fingers of both hands. 5 pm that day, chills lasting about an hour. 7 pm that evening, tight "headband " feeling across top of skull. I had not felt this since surgery 5 years ago. (Lasted about 15 minutes). 1/13/21 went to work, a little extra tired, went to bed early. Woke up in the night with severe pain in hands, had hard time sleeping. I called off work and slept most of the day 1/14/21. When I woke up 1/15/21 I could not put my full weight on my left leg without pain running from behind my knee up my outer thigh. I called my Dr and took Tylenol and worked a mostly sedentary job.
Narrative: Patient presented to ED triage 12 days after receipt of vaccine. States he was having severe headache and double vision. CT head demonstrated supraseller mass possible bleed. MRI demonstrates large enhancing sellar and supraseller mass extending into the left sphenoid sinus and causing mass effect on the optic chiasm and inferior left hypothalamus likely representing a microadenoma, no hemorrhage. Patient was transferred to a facility with neurosurgical expertise. Platelets are normal, PT/INR are normal.
Sx of confusion/clumsiness began on 1/25. Fever (max 101), chills, fatigue, body aches, and severe sweating occurred 1/26 and resolved 1/27. TM stated he lost 12 lbs from the vaccine
Very Itchy about 13 minutes after the first dose. Given 1 Benadryl 25 mg capsule. No relief after about 10 minutes, and given another Benadryl 25 mg capsule, to which she had some relief. No hives, no shortness of breath, no throat/chest tightness.
Arm sore,  swollen, pink blotches, eventually one large swollen pink blotch by site of injection, painful, yet somewhat  itchy. Used cold compresses to sooth.
fever, swelling @ site of inject; swelling lt neck & shoulder; pain w/neck movement; nausea, vomited x 2; seen by MD blood drawn;
Approx 17 hours after shot began to experience severe uncontrollable shivering and headache. No fever, sweating, other symptoms, just uncontrolled whole body shivering to the point of waking partner in bed. Shivering lasted for 30-45 minutes then subsided. Began to notice headache approximately 15 minutes into shivering episode. Headache has persisted throughout the night and began subsiding after about 8 hours.
About 2 weeks after vaccine I began having  coughing and coughing up mucus.  Until past couple of weeks, I thought it wasn't anything  too unusual.  But it isn't going away, and coughing a few days ago was so severe that I got dizzy and had dizzy spells for about 20 hours. I have to keep a box of tissues nearby around the house.  Once I am up-and-about for a few hours, I can go out shopping for an hour or so an hold-back coughing episodes.  I have started taking a minimal dose of cough medicine and aspirin in the last 3 or 4 days and that helps a little.  I haven't been to see a doctor as I had just seen my cardiologist about a month prior to vaccine, and have seen other doctors for various reasons and tests in last several months -- and have had my flll of them.
Symptoms: Dizziness/vertigo, accelerated heart rate (120), lower end of O2 (94%) Every time I got up and did regular daily tasks, my heart rate spiked and O2 dropped  I contacted my doctor via email to relay my symptoms. I did take a Hydroxyzine and rested for the rest of the day as well as the day after
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient presented at the pharmacy asking to receive his Moderna Covid-19 immunization.  Patient stated it was his first shot.  Moderna vaccine administration was billed through Medicare.  Vaccine was administered to patient.  Patient was monitored for 15 minutes with no apparent reaction.  When pharmacy technician attempted to add the vaccination information, it was discovered that patient had 2 previous Moderna Covid-19 vaccines reported on 2/11/2021 and 3/11/2021.   Dr. was notified of the 3rd dose administered.  Nurse stated she would report it.  Called and left a message with the patient to call.  No return call has been received at this time.
Severe stabbing pain in shoulder 11 days following injection.  I use my arms all the time while riding my horse, but now I can't raise the arm very far from my body.
just a few days later she hurt her back/sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "just a few days later she hurt her back/sore back". Therapeutic measures were taken as a result of back pain. Additional information: Patient stated that everything went great after the vaccination and then she threw her back out and took anti-inflammatories over the weekend. It was reported that just a few days later after the vaccination, the patient hurt her back and went in to see her HCP who gave her a steroid injection for her sore back. Caller stated she was now worried that she did something wrong and wanted to know if steroid injections affect the efficacy of the vaccine. Patient would also like to know if she should wait a certain amount of time to receive the second dose since receiving the steroid injection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aching, neck pain, headache treated with Motrin. I believe vaccinated in 1979-1980.
Experienced extreme joint pain in my knees, hips, lower back, elbows and shoulders for about a week or so. Pain was intense and super painful, extremely at night. Since then my right shoulder would get a tight tenses feeling while working (I landscape). After working and lifting I now have inflamed tendons in my right shoulder that I'm trying to get back under control before tearing happens. Occasionally my left shoulder will get a tight and uncomfortable feeling as well. Tendons occasionally inflaming in the left shoulder with normal small things that shouldn't cause any problems. Carrying one grocery bag, lifting arm above head to grab a glass of shelf, etc. Both shoulders where vaccine shots were given still have a bruise like feeling to them and are very tender to the touch.
Client received MMR, Td, HepB and PPD on 8/19/03.  On 8/21/03 returned to Health Department for PPD reading and reported to staff that she had "hemoplegic migraine" shortly after receiving vaccines on 8/19/03.  Client reports history of "hemoplegic migraine " after previous MMR approximately 3 years ago.  On 8/26/03 client reported that she had not informed nurse of hx of hemplegic migrains on 8/19/03 prior to receiving vaccines and only recalled the episode with the previous MMR when she had the "migraine" on 8/19/03.  Client reports does not have family MD.  She plans appointment with neurologist and awaiting client to notify Health Department with MD name so consent can be obtained to receive medical information if applicable in regards to vaccination.  Client reported signs and symptoms subsided gradually without medical attention on 8/19/03. Follow up on 12/10/03: "No action required for follow up."
Severe pain in arm that received injection and pain throughout entire body. Increase in involuntary muscle spasms and twitches. Pain was at an 8 on 0-10 scale. Whole body aches, exhaustion.
I developed red, itchy blotches on the right side of my stomach approximately 1.5 weeks after my first Moderna dose. I did not take any medications to treat these symptoms and they have faded away for the most part. There is significantly less redness and no longer an urge to scratch.  I have not experienced any other serious adverse reactions. I was advised to see an allergist, however, my insurance requires that I see my PCP to get a prior auth/referral for an allergy specialist. The allergist that is contracted with the Super POD has a 50+ person waitlist and I will be going to my local urgent care to see a provider.
Patient was given undiluted dose of vaccine. Patient was very lethargic the next day and had redness, warmth, swelling and blisters to injection site. Symptoms continue to resolve.
patient experienced some lightheadedness and sensation of warm flushing sensation radiating up from her lower chest.  Sensation would come and go.  Symptoms lasted about 30 minutes.
Delayed reaction; Itching around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), VACCINATION SITE PRURITUS (Itching around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), VACCINATION SITE PRURITUS (Itching around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), VACCINATION SITE PRURITUS (Itching around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 15-JAN-2015 was inadvertently vaccinated with an expired dose of M-M-R II (lot # H018949, expiration date 18-OCT-2014) (dose and route were not reported). No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
AFTER INJECTING PATIENT WITH NEEDLE AND TRYING TO PUSH VACCINE INTO PATIENT'S ARM, THEN VACCINE LEAKED OUT BETWEEN THE SYRINGE AND NEEDLE AND DRIPPED DOWN PATIENT'S ARM.
Case number PHEH2016US029307 is an initial spontaneous report received from pharmacist on 04 Nov 2016. This report refers to 08 year old male patient (off label use). Medical history and concomitant medication was not reported. The patient was vaccinate with single dose of FLUAD (batch number: 165703) at a dose of 0.5 ml intramuscular on 29 Oct 2016. No adverse event was reported following this medication error.
No adverse effects Covid 19 vaccine given > 12 hours from drawing. Vaccine was drawn, stored in refrigerator overnight. given to patient the following afternoon. Manufacturer notified. Awaiting guidance re. patient.
Red, hot, pear sized inflammation at L deltoid injection site.  Pt given Benadryl and ice used.  Arm eventually twice the size of the unaffected arm from elbow to shoulder.
Broke out in rash/hives all over body. Swelling of the face/eyes and hands, sore throat and difficulty breathing.
Experience chest pain on right side of chest near armpit which spread across chest one week after the first vaccine shot given on January 25, 2021.  Pain was going away before the second shot. Received second shot on February 22, 2021 and had the chest pain return, extreme fatigue, headaches, rash at injection site and all over back, achy muscles mainly in upper body, dizzy spells, nausea, and abdominal pain. All these symptoms (minus nausea) continued for three weeks and some are still present (fatigue, chest pain and periodic headaches) after six weeks.   I was tested for antibodies and the results came back greater than 400, which is the max limit for the test.  The doctor has never seen results that high and we have no idea how high my antibodies actually are.   Since my symptoms seem to be slightly improving, the doctor did not recommend further treatment.  However, I am concerned as to any possible danger of antibody levels this high.
Later in the evening, around 10pm, symptoms got worse including: body aches, headache, fever, fatigue--like if someone hit with with bat.   Patient thought initially symptoms were related to food poisoning. Today, patient had soreness on muscles and joints sore, a little fever, and a  headache.  Patient was trying to eat and took naps which were helpful. Patient has not taken any medicine and will follow-up with provider.  Per patient, worse of it was last night since he couldn't even sleep. Vaccine area feels sore but not as much anymore.
Member complains of extreme swelling of the immune sight.  Described as the size of small baseball.  Excessive redness, and headache experienced.