chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 19 year old female patient with no drug reactions or allergies. On 07-AUG-2013, the pregnant patient was vaccinated with the first dose of VARIVAX (Merck) (lot # J003218 and expiry date 15-MAR-2013, dose and route unspecified) and first dose of M-M-R II (lot # H014646 and expiry date 03-AUG-2014, dose and route unspecified). There were no concomitant medications. Patient was 9 weeks gestation. Last menstrual period of the patient was estimated to be 28-JUN-2013 and estimated date of delivery (EDD) was found to be 04-APR-2014. The pregnancy outcome was pending. It was reported that the pregnancy was normal to date. The patient sought medical attention (seen in clinic). No treatment was given. Additional information has been requested.
The inside of my lips swelled up and there was tingling sensation. My tongue started to swell up and there were little bumps along the edges of my tongue. My throat was okay, and I didn't have any other reactions. I had an EpiPen with me, but I didn't need to use it. It began to gradually subside after four hours, and it last for eight hours. I had a decreased appetite.
There was not an adverse reaction to this vaccine but reporting that this dose was given from a vial beyond the recommended refrigeration limit of 31 days.  It was on the 32nd day
Case number PHEH2015US025416 is an initial spontaneous report received from a health care professional on 02 Dec 2015. This report refers to a 4 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number 173252) intramuscularly on an unknown date. On 24 Nov 2015, reported as within one week of receiving vaccine, the patient experienced fever and loss of appetite. The outcome of the events was not reported. Seriousness and causality of the events was not reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), administration date 2021 (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: HYPOAESTHESIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Arm has been going numb and stiff". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional information: "When probed for the concern, reporter (patient's husband) stated, "I am actually calling about my wife (consumer). I actually just had a question, my wife got her first (dose) vaccine and her arm has been going numb". 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer who provided the mailing address as withheld. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Neck, arm, back, buttocks soreness, heart palpitations, face breakouts, back stiffness and soreness/pain, constipation, chills, cold/flu symptoms.
About 45 minutes after the vaccination while the patient was walking in Grocery Store her husband noticed her Left eye had blood in the white part of her lower eye.  Pt had no discomforts or blurry vision.  Pt has no pain or complaints.  Left eye in the sclera has bright red blood lower aspects of eye below the retina area.
Headache; I feel like I am tired and want to sleep a lot.; I feel like I am tired and want to sleep a lot.; Have a pain in my arm; I do not feel good; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191, NDC number, UPC number, Expiry Date were unknown) via unspecified route on administration on 22Jul2021 at 13:16 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included vitamins nos (reported as patient receives sometime some vitamins) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: EW0191) as dose 1, single via unspecified route on administration on 01Jul2021 (at the age of 37-years-old) for COVID-19 immunization. The patient did not take any other vaccine during the COVID vaccine time period. On 23Jul2021, Patient had a headache, and was requesting the day off on work because, he did not feel good. Patient felt like tired and want to sleep a lot too and also feel like pain in arm, and on the right side of of head (headache). The patient did not undergo lab test. No investigation assessment. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a physician refers to a patient of unknown age. On unspecified dates in 2002, the patient received the first and second dose of RECOMBIVAX HB (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. In 2012 "recently", the patient received the third dose of RECOMBIVAX HB (dose, route and lot # not provided). No symptoms were reported. This is one of several reports from the same patient. Additional information has been requested.
p/3rd vax rxn seemed worse, kept pt awake @ noc d/t pain;hyper extending arms seemed to alleviate some pain;
This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with MENACTRA. The events for the other two patients were captured in case number 2011-00238 and case number 2011-00240. Initial report received from a health care professional on 14 January 2011. A male patient received on an unknown date an injection (route and site not reported) of MENACTRA, lot number U3710AA. The patient fainted about 10 minutes or so after receiving MENACTRA. No further information reported. The outcome was not reported. Documents held by sender: None.
1-inch welt at injection site;  2-inch diameter bruising around injection site; 3-inch red rash around injection site. Medium soreness around injection site for about 1 week. Bruising lasted 4 weeks.
She was weak, pale, and having excessive sweating,  O2SAT was 94% on RA, BS 159 mg/dl, temp 98.3 F. Patient stated that was short of breath.
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The CDC requested that a VAERS form be submitted for this patient.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE, ATORVASTATIN, GABAPENTIN, MELATONIN (TRANSZONE), LISINOPRIL and PIOGLITAZONE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand pain). At the time of the report, PAIN IN EXTREMITY (hand pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Patient given 0.5ml instead of correct dose of 0.3ml. Patient experienced no adverse events.
Tested positive 04May; Tested positive May 4.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Polycystic ovarian syndrome" (unspecified if ongoing); "Psoriatic arthritis" (unspecified if ongoing); "IGA" (unspecified if ongoing); "Depleted Blood" (unspecified if ongoing); "Known allergies: sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 31Jan2009; LEVOTHYROXINE SODIUM, start date: 17Aug2005; SPIRONOLACTONE, start date: 01Aug2017; LEXAPRO, start date: 22Aug2005; LORATADINE, start date: 04Feb2019; VITAMIN D3, start date: 09Aug2016; CIMZIA, start date: 05Jul2021; PREDNISONE, start date: 09Mar2022; AZATHIOPRINE, start date: 07Mar2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 04May2022, outcome "unknown", described as "Tested positive 04May"; COVID-19 (medically significant) with onset 04May2022, outcome "not recovered", described as "Tested positive May 4.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive; (10May2022) Negative; (13May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Tested positive 04May2022. Started Paxlovid 04May2022 in evening. Finished Monday morning 09May2022. Tested negative and only symptom left was exhaustion 10May2022. 13May2022 woke up with symptoms tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Double-vision due to misalignment of left eye. Examination resulted in a diagnosis of 6th nerve palsy. Symptoms remain after two weeks, with slight improvement.
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, Nausea Vomiting, Redness/Itching @ injection site
Syncope, patient fainted, had jerking movement, his jaw locked. MCV4.
Allergic cellulitis R outer thigh secondary to DTaP. Cellulitis began 1/14. Saw dr 1/16. No treatment given.
Guest was here for first dose of Pfizer COVID vaccine, reporting a hx of fainting after injection with a quick recovery. Vaccine was injected at 5:15pm by RN. The RN observed the guest losing consciousness briefly; she called for aid at 5:18pm. EMT arrived at 5:19pm. Guest was medically cleared after approximately 5 minutes of observation, stating that he felt recovered. Guest waited 15 minutes in observation area, stated that he felt well enough to walk home, and left on foot.
On her left arm patient states she had blistering/itching at the site of injection. That started a couple days after vaccine given. When she came to me the sores were resolving.
Dizzy; weak; Felt sick stomach; Dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaving), DIZZINESS (Dizzy), ASTHENIA (weak) and ABDOMINAL DISCOMFORT (Felt sick stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Hydroxyzine allergy).    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RETCHING (Dry heaving). On 12-Mar-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (weak) and ABDOMINAL DISCOMFORT (Felt sick stomach). On 10-Mar-2021, RETCHING (Dry heaving) had resolved. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (weak) and ABDOMINAL DISCOMFORT (Felt sick stomach) outcome was unknown. Not Provided
pt recv vax 1JUL98 & 1mo p/vax dose1 & 4-5 days p/dose 2 pt devel swelling of both hands;
By afternoon just feeling sluggish and tired. Did have chills and just slept alot. Didn't feel like eating. Drank water only, then decided to have chicken soup. Had one sip and started feeling faint. Went back to bed and then felt like vomiting and had diarrhea also. Just went to bed for the evening and only had that one instance. By morning felt much better, but still a little slow. So the vomiting and diarrhea was just like my 6th day experience with my first covid shot, now wondering if it was the vaccine too.
08-03-2021 / 0854 - Patient received Moderna vaccine 0.5 ml / lot 088D21A - Error because patient received Pfizer on 2/10/21 lot EL9261
Headache, body aches, join pain, fever, chills, nausea from 3 AM until 3 PM. Extremely fatigued for 24 hours.
07:35 Flu shot given (R) deltoid. 07:40 Report strange taste in mouth and upper lip tingling*. 07:45 Face reddened and generalized Facial itching. 07:50 taken to Emergency Dept. via wheelchair. *Reported No breathing difficulties at this time. Injection site WNL.
Booster; SIRVA; Pain; when she got her booster in the same arm it kind of got worse; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number Unknown), for COVID-19 immunization, reaction(s): "pain", "The vaccine was probably injected in the capsule of the joint", "SIRVA". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "not recovered", described as "SIRVA"; PAIN (non-serious), outcome "not recovered", described as "Pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "when she got her booster in the same arm it kind of got worse". The events "sirva" and "pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of shoulder injury related to vaccine administration, pain.  Additional Information: She has been in pain for 11 months. He said his wife is your typical SIRVA case. The vaccine was probably injected in the capsule of the joint. Over the next few days she started having the pain. It got better and when she got her booster in the same arm it kind of got worse. was there any information about decreasing the immune reaction in the tendons. Her pain went up then went down. When she got the booster it went back up significantly. She had 3 steroid shots and a Medrol dose pack. She was working with an orthopedic surgeon and therapy. She was just miserable. He states this was reported several to 6 months ago through the CDC but didn't get a report number. Stated there is no information regarding SIRVA in my resources or the PI. The caller is a pathologist and wants to know if there has been any reports about SIRVA.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Client called to report that tongue color is black on 2nd day post immunizations.  Denies pain and states no problem swallowing.  States she thinks that taste buds are swollen slightly at back of tongue.  Also c/o headache.  Talked to MD et was referred to PHD.
Systemic: Syncope -Severe, Systemic: Hypotension-Severe, Additional Details: Reported blood pressure after 911 paramedics arrived was 56/59. Patient was transported to facility. Called facility 3 times to follow up, but no response yet from facility director. Will follow up again on 2/23/21 in the AM.
I was extremely tired, I wasn't sick I was just exhausted and 36 hours later I woke up and I was groggy, it took about another day to feel. I back to normal. I wasn't hungry all I wanted to do was sleep. After that all of these kidney shut down after that, I spend 5 days in the hospital and then again it shut down again. I was on stage 5 on my kidney after the vaccination. Finally I came down to stage 3B. Local hospital. Right now my kidneys are no longer stage 5 so that is a good thing.
Information has been received from a registered nurse concerning a 68 year old male patient,who on Nov 18, 2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 643251/0445M). There was no concomitant vaccination. On Nov 19, 2002 the patient called the doctor's office reporting that his left arm was swollen 2 inches in diameter and that his whole arm was very sore. No systemic side effects were reported. The patient was advised to take ibuprofen (Advil) as needed and to apply ice. The patient did not wish to come to the doctor's office to be seen. Subsequently, the patient fully recovered. The reporter indicated that two other patients (WAES0211USA01991 and 0212USA01969) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions". The reporter also noted that"This office has given pneumococcal vaccine 23 polyvalent for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES0303USA00344). The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same lot". The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. Additional information is not expected.
Information has been received from a registered nurse concerning a female in 2007 who was vaccinated with a first dose of Gardasil (lot# unknown). On an unspecified date, the patient experienced a fainting episode. On 05-DEC-2007, the patient was vaccinated with a second dose of Gardasil. On an unspecified date the patient developed shingles like rash. The rash broke out on her face a few days later. Medical attention was sought. At the time of reporting the patient had not recovered. No further information is available.
headache; Shot site painfull; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headache) and VACCINATION SITE PAIN (Shot site painfull) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 017821A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Shot site painfull). On 01-Apr-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Mar-2021, VACCINATION SITE PAIN (Shot site painfull) had resolved. At the time of the report, FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.              The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Patient received Td vaccine on 7/30/07, along with MMR and PPD.  Later on 7/30/07, patient experienced a fever and at the injection site experienced warmth, swelling, tenderness and weakness.  The patient returned to the health care center on 8/1/07 and then again on 8/7/07 with all the reactions listed above except for the fever.  The fever subsided within 24 hours of vaccination. Follow up received on 05/08/08. Lot number of MMR vaccine - 0282U. Lot number of TB test - unknown.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:25 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.59.  Concomitant products were not provided.  On 11-Jan-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 98 and at 02:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Flu like symptoms and arm soreness started the next day. Never really subsided. Transitioned to headache, stronger body aches to the point of hurting when touched. Started a fever on 5/27. Today is 6/1 and she still has intermittent fever, aches, nausea, congestion. Started on Zithormycin by doctor. Now on day 3 with no alleviation of the symptoms. Lyme, mono, covid - negative. Bloodwork all normal except for C reactive protein which was elevated at 20.