chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 10-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
This spontaneous report refers to a 67 year old male patient. Concurrent conditions included high blood pressure, diabetes, high cholesterol, phlegm in throat and a cough for about a year (approximately since 2013) and recently place stent. On 11-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX single shot in the back of the right arm for shingles prevention, (route, dose, lot, batch # and expiration date not reported). Concomitant therapies included lisinopril (manufacturer unknown), carvedilol, amlodipine, NOVOLOG, atorvastatin, aspirin and omega-3 fish oil and PLAVIX for recently placed stent. On 19-DEC-2014 the patient began to itch all over, both legs were itchy, and there were welts on the backs of both legs. He tried to call his Primary Care Physician (PCP), but there was no answer on the phone. He would try again to reach his PCP. There was no relevant laboratory data. As of 20-DEC-2014, he no longer took ZOSTAVAX and experienced worsening of itching all over, both legs itching, and having welts on the backs of both legs (outcome not recovered). Additional information has been requested.
Patient came to the pharmacy 3 days letter after vaccination with a swollen, red, painful and limited mobility in the arm. She was referred to her PCP.On May 17,2019 she went to the clinic and was prescribed naproxen for pain and inflammation, physician inject a dose of toradol and told the patient to apply warm compresses. On May 20,2019 patient refers that she feels better and is gaining back mobility in the arm.
Date of injection 9-22-20 Left shoulder pain began on 9-24-20. Decreased shoulder ROM, pain with lifting noted on 10-2-20 Evaluated at Employee Health on 10-6-20. Referred for physical therapy, given Naproxen, home exercises also given, assigned light duty. Follow-up appointment on 10-14-20: improved ROM.  PT approved, first appointment pending. Continue med, home exercises, LD. Next follow-up scheduled for 10-28-20.
Came in 4/16/2012 stating that he had Tdap vaccine on 1/19/2012 (R) arm has been sore since vaccine & has not gone away. No hard lump or anything visible. No numbness/tingling.
CLIENT GOT HER VACCINES ON A FRIDAY. ON SUNDAY,HER LEFT ARM   WAS VERY SWOLLEN, RED, HOT AND  HARD TO TOUCH. SHE WENT TO THE ER AND THEY GAVE HER AN ANTIBIOTIC AND MARKED THE AREA WITH A PEN. TOLD CLIENT  THAT IF IT GETS BIGGER TO COME BACK. SHE  WENT TO HD TO GET WRM READ FROM PPD ON MONDAY.   SAW CLIENT TODAY ON 10/22/19, SHE SAID SHE WAS GOING OK AND SHE DID PUT COOL COMPRESSES ON IT ON SUNDAY. BUT DIDN'T TAKE ANYTHING FOR PAIN.
Vomiting; Fatigue; Tested COVID19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested COVID19 positive), VOMITING (Vomiting) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested COVID19 positive). On an unknown date, the patient experienced VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested COVID19 positive), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This is a case of a 72-year-old who tested positive for SARS-CoV2 after receiving 1st dose of vaccine. The event is considered unlikely related to the vaccine. Additionally, based on the current available information and temporal association between the use of the product and the start date of the events of vomiting and fatigue, a causal relationship cannot be excluded. Further information has been requested.
red, swollen, painful rt arm @ site of inject; felt very weak; unable to get back into bed; went to hosp 1030-11 Thurs AM; admitted; poss also had UTI;
He reports a rash after the first dose that has not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "He reports a rash after the first dose that has not gone away". The event "he reports a rash after the first dose that has not gone away" was evaluated at the physician office visit.  Additional Information: No RA Present. Reason for no lot number of covid vaccine was complainant does not have the product with them at the time of call. The reason patient took covid vaccine (Verbatim) was the thing to do and apparently not. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Patient had a rash since he got the shot. Patient states that he had his second one on the last week of Apr2021. He reports a rash after the first dose that has not gone away. He has had it for ten months and has seen 2 dermatologists and one allergist. Asks how long will it take for the rash to go away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slight fever, soreness of arm, slivering, chills, headache, aches, stomach pain
This is a spontaneous report received from a contactable other-HCP (patient). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single  dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient reported increased blood cholesterol (her cholesterol has elevated by 80 right after she received product), with outcome of unknown. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated she received the vaccine, including booster. Patient stated her cholesterol was elevated by 80 right after she received product. Patient indicated it has been steady for years and since May has elevated. Patient was asking for information on this topic. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient is a 10 year old boy brought for his Pfizer Pediatric booster. He receiver 0.2ml dose, but vaccine was not diluted.
Information has been received from a nurse practitioner concerning a 16 year old female patient with seasonal allergies who on 28-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (Lot #660387/1967U). On 28-APR-2008, the patient experienced hives all over. On 30-APR-2008, the patient recovered. Hives were considered to be an other important medical event. No further information is available.
Patient reports a week after dose she experienced on opposite side of where dose was administered, scalp itchy, her face broke out (hives).  If she doesn't take Benadryl her face itches and hives.  Patient says she developed allergies after HepB shot and influenza vaccine caused he to have vertigo.
Within 40 minutes my arm started to ache badly.  About 15 minutes after that while I was driving my head started to feel strange - almost lightheaded.  Within a couple of minutes my eyes involuntarily went to the left and the right and then my vision went black (this all happened in a matter of seconds).  I stopped at a store and felt light headed and confused/brain fog.  That continued at home for around 2 hours.  The pain in my arm continued to get worse.   I woke up several times throughout the night with pain in specific sites.  Today I was unable to go to work because of the full body muscular and joint pain, muscular weakness, headache, pain behind the eyes, and feel like I have fluid in my head (kind of like when you have a cold).   I had a significant reaction after the first dose as well (1/5/21 Moderna Lot 026L20A) but it was completely different - mainly arm pain, fever, chills, extreme fatigue, and what feels like fluid retention.  I gained 9 pounds without changing anything diet/exercise following the injection. On day 10 a large red welt appeared on my arm at the site of the injection.  On 2/1 my Endocrinologist sent me for lab work and urinalysis.  Those results are not back.   I likely would not have reported any of this if it wasn?t for the visual occurrence with the mental confusion and lightheadedness. I have never experienced anything like that in my life.
It started out with a scratchy throat and a slight headache and that started Monday. I took a test, and it was positive. That evening I started with chills I took the Tylenol. I made contact doctor. I had a stuffy head stuffy nose, chills and bad fatigue. My temperature is down, and it had been up to 100.6. Today it is at 99.1. I am having a progressive cough and coughing out something with a yellowish tint.
History of prematurity, caffeine was given by mouth in ICN. Discharged one week prior to hospital discharge. No apnea at home prior to immunization. Had apneic spells at home following immunization.  Follow up on 12/12/03: "Vaccine recipient has recovered from the adverse events that were reported for this vaccination.  Has received his 4 month immunizations without difficulty."
Double Vision began 2 weeks after 1st injection.  However I had a 2nd Shigrex shot 17 days prior to the first Covid shot.  I believe the vaccines so close  together has caused 6th nerve palsy and that is the reason for my double vision.
Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
Patient was vaccinated on 12/28/20 and 1/16/21, so was fully vaccinated when testing positive for COVID-19 on 10/6/21.
Swollen left arm red and warm to touch 8/11/2004 applied ice to site fever 99.6 ice and tylenol used.
Patient felt clammy, sweaty, dizzy and nauseous post vaccination. Patient was laid down, given water and verbal support. Symptoms resolved with no issues. Patient was released @1030 after 30 minutes of observation.
Twelve hours after vaccination, I started running fever up to 102.0, body aches, hot/cold flashes, restless legs and nausea for 6-8 hours. I felt like I had the flu really bad. The following day, I felt very run down/fatigued and I could not go to work. I did not go to see a doctor. I have fully recovered.
She got the vaccine and claims the next day she felt "sick". Symptoms were described as nausea, shortness of breath, increase in blood pressure, increase in pulse. Doctor says her increase in INR was also from her immunization.
Patient called at 6:45 to inform me she had just gotten home and her arm was very sore. She says arm is red and swollen. She also say it's itchy. We discussed taking BENADRYL and Ibuprofen and I will follow up tomorrow.
This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 28-NOV-2017, the patient was vaccinated with the first dose of VAQTA lot # N019924 with an expiration date of 02-SEP-2018, intramuscular for prophylaxis (dose, and anatomical location were not reported). No adverse effects were reported.
Hot prickly feeling accompanied with dizziness. (initially) Experienced difficulty breathing while driving and went to ER.
c/o bumps between toes on rt foot, arms, face & torso;low grade temp;p
Nausea on an off for 1 week. Patient is stable and fine. No vomiting only has nausea for 1 week on an off.
PMD-reported child admitted to hospital with T 103.4 (Tylenol given by mom). Status epilepticus.
8cm X 5cm area of swelling noted to left thigh with some central induration.
She claims to have severe nausea, dizziness, and diarrhea.  She also said her arm was very sore and she developed a rash from shoulder to elbow.  Symptoms resolved by 10/30/2015.
Patient fainted few minutes after receiving the vaccine. EMS was called and patient was treated on site. Patient was not transported to the hospital.
Woke up 10/24/06 with fever 101F and feeling sick 10/26/06 developed rash left wrist area size of fist 11/03/06 had seizure was hospitalized for 3 days 11/09/06 continues to have left arm weakness, hands and feet drawing up to have MRI 11/10/06.  MR received revealing an ER admission for c/o sharp, mid-sternal chest pain, teeth chattering and body aches.  Pain was intermittant and occasionally radiated into her left arm.  Admitted to r/o MI. PE essentially negative with the exception of significant anxiety and depression. Discharged home in stable condition. Discharge DX:  1) Non-cardiac chest pain 2) Hypertension 3) Hyperlipidemia 3) Anxiety
Lymph gland on left side under armpit swelled up for four days then returned to normal size. No other symptoms or effects noticed.
pronounced erythema around site, radiating into shoulder & neck;itching of throat & neck;tx w/DPH rxn resolved w/in 60min;
Fever  Chills Body aches (esp bottom of feet and butt cheeks) Headache
Immediately begin to feel a little off. In the middle of the night I woke up with chills, possibly a slight fever, body aches, headache. Slept in late. Feeling a little better now as of time of submission.
About 20 minutes after receiving vaccine, burning arm and neck, hurting; head starting hurting, became very tired and dizzy; feeling weak and cold; temperature was normal throughout this time; side effects are not worse at this time (about 2 hours after vaccination), but about the same
13th of April. I had a blood clot in my hand. My index finger on  my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.
I felt fine after getting my first dose of vaccine. I notice a few hours later that I had a small red bump (about the size of a silver dollar) at the injection site. It did not go away. After about 3 days the bump was less hard/raised but roughly 3-4 times the size. This hive lasted until 1/20/2021 which was a week and a half after the injection. There were no other side effects, just the hive and some itchiness at the site. It has now been a week since the hive went away but there is still some slight bruising about the size of 2-3 silver dollars.
Started with a fever, turned into achy ness, then chills,  nausea when I went to bed. Woke up twice and threw up both times. Fighting constant fever of 100.7, constant nausea, can?t keep any food down
Headache followed by migraine. Severe chills that night.  Headache again Sunday with upset stomach Monday swelling of right sinus and pain until 5:30 am Tuesday when sinus drained down throat. Very tired and right side of face sensitive.
HEADACHES WITH THE WORST ONSET BEING THIS MORNING AS SHE HAD TO LAY DOWN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clotting disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced headaches with the worst onset being this morning as she had to lay down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches with the worst onset being this morning as she had to lay down was not reported. This report was non-serious.
Wheezing a little bit; Coughing all the time with Asthma; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, expiration date: not reported via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 07:00 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing Asthma causes patient to have wheezing a little bit, which she has all the time and she also has coughing all the time with Asthma, ongoing diabetes mellitus (Onset date unknown other than more than 15 years ago and is ongoing). There were no concomitant medications reported. The patient experienced tested positive for covid-19 on 14Mar2021, wheezing a little bit and coughing all the time with asthma on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Mar2021 COVID-19 test. The outcome of event tested positive for covid-19 was not recovered and wheezing a little bit and coughing all the time with asthma was unknown.  Follow-up activities have been completed and information on the lot/batch number has been requested.
It was reported that a  pt rec'd a TD adult vaccination 4/18/2001. Reportedly on 4/19/01 the pt developed redness, swelling and itchiness. The pt told her son that her entire upper arm looks like it was scalded down to her elbow. The pt was prescribed an antihistamine and antibiotic.
Tdap (Boostrix)  vaccine was administered by staff, who was still in training with the immunization program, to an 45 year old male who presented to the clinic with  an injury, requesting a tetanus booster. The vaccine was, in error, pulled from the VFC stock instead of the county purchased stock. The patient did not report any adverse reaction from the vaccine. The simple error being the wrong stock was used in this case.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) No. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had no Known Allergy. No concomitant medication were reported. No treatment drug were reported. The vial  was not underwent any temperature excursions. Vial was transferred from another store. The vaccine had an expiration date 18-Mar-2022 and a stability study has been initiated with Moderna. The patient reported that no adverse event from the vaccine. This case was linked to MOD-2022-544296 (Patient Link).
My throat and face were swelling up, I couldn't breath, my heart was racing, I felt dizzy and confused and weak and extremely nauseaous. My son called my dad to drive me to the Emergency Room. I was immediately admitted. They asked if I could still swallow, or they would begin IV. I was still barely able to swallow. They gave me a cup with numerous pills (steroids, anti-nausea, anti-histamines and others). I was put in bed in a room and stayed for observation all night. The next day I  felt better and was released.
Severe back pain and spasms in lower back that were not present before. Treated with electrical stimulation and chiropractic care to reduce the pain until it subsides.