chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient report numbness and tingling along right jaw and drooping of corner of mouth (slight), initially. After several minutes patient said she had numbness and tingling from shot and up her arm. Note: Hospital called asking if vaccine contained Thimerosal because they thought patient was having a reaction to it.
Developed chest pain, fever, chills, dyspnea, and diarrhea beginning a most immediately after the vaccination
Allergic reactions to air borne substances. Symptoms: runny nose, hay-fever. Increasing over the years... controlled with Benadryl... which ended up causing high blood pressure and prostate problems... which required blood pressure medication and prostate medication.
Muscle spasms in her back; A spontaneous report was received from a consumer, concerning an 86-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle spam in her back and went to the hospital for muscle spam.  The patient's medical history was not reported. Products known to have been used by patient, within two weeks prior to the event, included baclofen and regular pain pill.   On 22-Jan-2021,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm . On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021, experienced muscle spams in her back. On 3-Mar-2021 went to the hospital for muscle spam.. Treatment for the events included was unknown.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events, muscle spams in her back and went to the hospital for muscle spasms were considered resolved on 4-Mar-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a certified medical assistant refers to a 1-year-old male patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 16-MAR-2016, the patient was vaccinated with the first dose of PROQUAD human serum albumin (HSA) lot # L004007, expiration date: 05-AUG-2016 (dose and route of administration were not reported). The patient had no concomitant medications. On 26-MAR-2016 (reported as exactly 10 days after vaccination), the patient stopped babbling, smiling and making eye contact. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The causality assessment between the event and (Oka-Merck) PROQUAD was not provided. Additional information has been requested.
Bruising,  pain at injection site for 9 days . Raised red itchy spot size of silver dollar appeared below injection site after 6 days. Aches, pain, nausea 2nd 3rd, 4th day after injection.
RECEIVED FLUZONE HD ON 9/25/19. PATIENT FELT ARM SORENESS FOR 2-3 DAYS AFTER IMMUNIZATION. AROUND 2 & 1/2 WEEKS LATER FELT "WOBBLY" AND WENT TO ER NEXT DAY. PARALYSIS ORIGINATING AT FEET AND PROGRESSED TO RESPIRATORY ISSUES. DIAGNOSED WITH GUILLAN-BARRE SECONDARY TO FLU SHOT. PATIENT RECEIVED IVIG, IN ICU FOR 2 WEEKS, ACUTE NURSING FOR 4 WEEKS, CURRENT UNDER CARE TO GET OFF TRACHEA ASSISTANCE AND TO WALK UNASSISTED. VAR FORM CORRECTLY FILLED OUT AND THE VIS SHEET WAS DOCUMENTED AS GIVEN TO PATIENT. HUSBAND REPORTED ADVERSE EVENT TO PHARMACY FOR THE 1ST TIME ON 12/07/19.
9 hours, post vax, temperature rose to 104F, had heavy breathing and a rash all over her body by the 2nd day.
pt recv vax & 4months p/vax lab eval by VZV screen & ACIF test revealed a lack of seroconversion;
The Moderna vial expired on 11/3 and I wasn't aware of this expiration date until after the vaccines were given.
After the first dose of Moderna's COVID-19 vaccine, my period came with a severe headache and throughout my period I had bleeding with clots. This had never happened to me.
After 1st shot, progressivly worse: Severe headache, fatigue, speech and hearing problems, personality changes, muscle weakness, impaired judgement, memory loss.  After 4th shot, hallucinations, seizure.  Doctor is saying encephalitis. Follow up 6/30/05: Residual symptoms include short and long term memory loss, cognitive problems, balance/coordination difficulties, smell and taste loss, anxiety, anger, depression developments. The final outcome or recovering is still unknown at this time. Currently, these symptoms have disrupted my life completely and I hope I will eventually make a full recovery. (This form took me two weeks to fill out.) 12/30/2009 "Encephalopathy." Cognitive dysfunction and poor memory. Referred to hospital for consultation after one year of recovery, First appt. 5/12/06. Patient unable to return to work due to memory problems. Neurology expects another 6 months to one year for recovery.
Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  On 24-Sep-2021, the patient received the booster dose of the vaccine.   This case was linked to MOD-2022-531880 (Patient Link).
Large red area below injection site. Showed up approximately 4 days after receiving immunization. Seems to be getting larger. Painful to the touch. Counseled pt. to call Primary MD.
Patient received Pfizer Monovalent vaccine instead of Bivalent. No adverse effects have been reported at this time.
Patient presented red spots and pain in the back and knee area. She went to her PCP and was diagnosed with ringworm. This ocurred three days after having the first dose of the COVID 19 vaccine.
Approximately 9-10 hours from the vaccine, patient had a 102 temperature and this 102/103 temperature lasted for 24 hours. Tylenol only brought fever down a little; fever spiked every 5 hours. Day 2, fever stayed 100.4F for 18-24 hours. On 10/10/02 patient seen by family pediatrician who confirmed this was a shot reaction. Fever continued for the next 4 days.
Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unspecified lot number, reported as EH9899 or TH9899), intramuscularly at site of right arm at 10:00 on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN, lot number: 300045; Expiration date: May2022) from Jan2021. The patient previously took cetirizine hydrochloride (ZYRTEC) daily for allergies forever. Clinical course: Patient received the first dose of the BNT162B2 on 20Dec2020, and was tired afterwards, she didn't feel tired continually. She began to feel tired on 21Dec2020, she was just exhausted, she was so tired and she just slept, she couldn't get out of her own way. On 22Dec2020, she was fine, but on 23Dec2020, she began to feel tired and exhausted again. By 24Dec2020, her symptoms were over. She also experienced injection site pain in her right arm that started on 21Dec2020 and resolved by the evening of the same day. No treatment received for this event. Vaccination Facility Type was in hospital. No vaccine administered at Military Facility. No emergency room visit needed. It was unknown that physician office visit needed. No prior vaccinations within 4 weeks. Adverse event(s) following prior vaccinations was N/A. Family medical history relevant to adverse event(s) was not provided. Relevant tests were none. The outcome of event 'tiredness/exhausted' was recovered on 24Jan2021; of event 'injection site pain in her right arm' was recovered on 21Dec2020.  Information on the Lot/Batch number has been requested.
Pt vaxed w/ 1st & 2nd dose;of DTP/OPV on 29JUN90 &20AUG90 respectively & exp viral myocarditis 14JAN91 admitted to Hosp; Culture biopsy reveals polio type 2, now has flaccid paralysis & graft versus host disease; Dx w/hypogammaglobulinemia;
MOM & PATIENT CAME IN FOR  A SCHEDULED COVID VACCINATION.  PHARMACY WAS GIVING BOTH PFIZER (2ND DOSES) & MODERNA 04/30/2021.  PATIENT GIVEN MODERNA. REALIZED AGE AFTER VACCINE GIVEN.  PATIENT 16 YO.  MODERNA INDICATED FOR 18 YOU & UP. BOTH PATIENT AND MOM AWARE OF THE SITUATION.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored oral ROTATEQ lot # L013192, expiration date- 19-JAN-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 1.0 C, Time frame was 20 minutes. There was a previous temperature excursion- 1.2 C for 20 minutes and call was because of data logger. MMR II was in the product tab did not experience a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
We were very tired; We had very hot sweaty night; I felt cold; she was chillier than I was during Friday; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. Medical history included believed they had a mild case of COVID in Jul (unspecified year; it was prior to COVID Vaccine, in Sep (unspecified year), both him and his wife tested positive for the antibodies for COVID). The patient's concomitant medications were not reported. The patient reported that had a couple of side effects that the paper they were given asked them to report it. The patient reported the vaccination was on 04Feb2021. On 05Feb2021 morning, his wife had chills most out of that day. The patient felt cold but not uncomfortable (in Feb2021). That night (in Feb2021), they were very tired and then they went to bed at that night they had very hot sweaty night and they assumed that was the reaction to the vaccination. The patient confirmed that they both had reaction and stated, "Yes, she was chillier than I was during Friday" (in Feb2021). They were wondering if the reaction to the vaccination was because they had antibodies in their system already. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Bedridden with severe URI from 5/12/23 to currently.  Covid vaccination was 5/10/23
Started working at 07:00 with my patients in the hospital, I became very diaphoretic, and my pulse rate  as 110 - 160's, became short of breath, and dizzy., I went to the emergency room where they did STAT EKG, CT of head, echocardiogram, and bloodwork. the radiology tests were negative. My blood work was unremarkable except for an elevated D-dimer. Because of a previously reported DVT last March (by the way was 2 months after my 2nd COVID vaccine) the ER docs ordered a CT of chest with angiography. That result was a pulmonary embolism in the right lower lobe. I am currently on ELIQUIS.
improperly stored vaccine was administered; Information has been received from a registered nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant medication were not provided.      On 25-JAN-2021, the patient was administered an improperly stored dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) (1 injection, lot # T004378 has been verified to be a valid lot number for hepatitis b vaccine (recombinant), expiration date reported as 31-OCT-2022, but upon internal validation established as 01-NOV-2022; strength and route were unknown) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 injection, oral, lot # 1688504 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021; strength was unknown) for prophylaxis. The vaccines underwent temperature excursions prior to being administered at above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes (incorrect product storage). There was no previous temperature excursion. The data logger was involved.
Within one to two hours post vax, the pt developed an injection site reaction characterized by severe swelling, redness, and warmth extending from her elbow to her shoulder. The symptoms lasted 4 to 5 days and resolved without treatment.
Diffuse targetoid rash (erythema multiforme minor) with 102 degrees fever.
This is a spontaneous report from a contactable pharmacist.   A 45-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on 29Jan2021 at 08:00 (at the age of 45-year-old), as single dose, for COVID-19 immunization. The patient's medical history included the IDA (Iron deficiency anemia), anxiety, MDD (Major depression), migraine with aura, vitamin d deficiency and known allergies to metoclopramide. Concomitant medications in two weeks included citalopram (10mg qday), vitamin c (500mg qday), vitamin d3 (50,000 international units qweek), ferrous sulfate (325mg qday), fluticasone propionate (FLONASE ALLERGY RELIEF), folic acid (1mg qday), norethindrone (0.35mg qday) and olopatadine (0.2 percentage ophthalmic solution). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 08Jan2021 at 08:00, as single dose, for COVID-19 immunization and did not develop any side effects after her first dose. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient completed 2 doses of COVID 19 vaccine. Patient did not develop any side effects after her first dose, but developed acute on chronic migraine HA, nausea, low grade fever and back pain after her 2nd shot on 30Jan2021 at 08:00. On the day of the 2nd shot (29Jan2021), patient did not have any symptoms, but woke up the next day (30Jan2021) with symptoms. Her symptoms persisted after more than one week. Events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for events. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
I went into Atrial Fibrillation, I started after getting my vaccine. I could feel the irregular heard, it was rapid and I was short of breath. I went to my PCP and they found out I was Afib which they started me on medication. I also had cardioversion and that lasted 6 days, in about 6 weeks I'm going back to the hospital for a cardiac ablation.
Patient experienced severe arm pain in his shoulder at 8:00am. Blood pressure at 8:00am was 151/80 (normal for patient) and heart rate was 79 beats per minute. At 8:15am pain was radiating down the patient's arm. At 8:40am the patient was feeling better and felt comfortable leaving with his wife because she is a nurse
This report from study was reported via Pregnancy Registry (initial receipt 25-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included lavender oil, prenatal vitamins, doxylamine, wine, docosahexaenoic acid, folic acid, zinc, magnesium, ubidecarenone, copper, selenium, zingiber officinale rhizome, green or black tea, unspecified antibiotics, OXYCOCET, ondansetron, progesterone, magnesium hydroxide, paracetamol, docusate sodium, calcium carbonate, hydrocortisone, oenothera biennis oil and miconazole nitrate. The 34-year-old mother had medical history of BRCA1 gene mutation, chronic fatigue syndrome (in 2007), was suspected to have Raynaud's and also had history of uterine cysts (in 2007) (refer to the mother case 2015052718). On 17-Oct-2014, the patient received AFLURIA vaccine (batch number not reported) at 1 shot 1x QD, in-utero via the mother. On 04-Nov-2014, the patient's mother underwent ultrasound scan which was normal. On 02-Dec-2014, the patient's mother underwent first trimester serum screen, the result of which was normal. On 12-Dec-2014, the patient's mother underwent an ultrasound scan and on 01-Jan-2015, she underwent alpha fetoprotein test, both of which were normal. On the 02-Feb-2015, the patient's mother underwent an ultrasound scan which was normal. On 21-Mar-2015, she underwent glucose tolerance test which was normal. On the 17-Apr-2015, the patient also received TDAP vaccine (batch number not reported) at 1 shot per day, in-utero via the mother. On the 28-Apr-2015 and 01-May-2015, the patient's mother underwent a non-stress/stress test. On the 01-May-2015, she also underwent an ultrasound which was normal. On the 19-May-2015, the patient's mother underwent a non-stress/stress test and on the 29-May-2015, the patient's mother underwent an ultrasound which was normal. The patient was born (gestational age of delivery 40.3), and was diagnosed with aplasia cutis congenita at delivery. The patient's birth weight was 3093 grams and Apgars at 1 min was 8 and Apgars at 5 mins was 9. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
HIVES ON BOTH ARMS UP TO ELBOWS AND BOTH LEGS UP TO HIPS, PROFOUND ITCHING; GIVEN A MEDROL DOSEPAK, TOLD BY PCP NOT TO GET THE SECOND DOSE
Starting day of first shot on March 6 (and in the three weeks between first and second shot on March 27), I began having atrial fibrillation/flutter episodes twice a week for about four hours per episode. After second shot, episodes averaged four per week for six weeks. I went to the ER April 4 and was referred to electrophysiologist. I saw electrophysiologist on April 15, he immediately scheduled me for double cardiac ablation. I had this procedure on May 7, whereupon my episodes ceased.
Got tired with the first dose; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Got tired with the first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cough (when she gets sick(non COVID)) and Bronchitis (when working in an office). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (ZICAM [OXYMETAZOLINE HYDROCHLORIDE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (Got tired with the first dose). In 2021, FATIGUE (Got tired with the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment  medications were reported.   This case was linked to MOD-2022-606222 (Patient Link).
Rash spreading started at the neck slowly progress to the entire neck, then the scalp, torso, legs and arms. Started within 4 hours over night then at 0830 am started getting worse.; This is a spontaneous report from a contactable nurse reporting for herself.  A 40-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included hyperlipidaemia, antiphospholipid syndrome and migraine. Concomitant medication included metronidazole benzoate (FLAGYL), butalbital, caffeine, paracetamol (FIORICET), iron (IRON) and multivitamin. The patient experienced rash spreading started at the neck slowly progress to the entire neck, then the scalp, torso, legs and arms on 20Dec2020 21:30 with outcome of not recovered.  On21Dec2020 at 08:30 am it started getting worse. The outcome of the events was not recovered. The patient took Benadryl as treatment for the events. The patient did not undergo COVID test and did not have COVID prior to vaccination.    Information on the lot/batch number has been requested.
ran fever 14MAY93 & 18MAY93 (101 or less); 18MAY93 rash started on legs spread to arms, chest, face; lace like rash macular cheeks very red 19MAY93 early AM had fever 105.3 in noc; seen by MD 19MAY 2PM who thinks its a viral rash;
patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine; patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine".  Clinical Course: Reporter was calling on behalf of one of his female patients for information about the timing of the 4th dose of the Pfizer Covid19 vaccine. Caller states that his patient had COVID and got monoclonal antibodies and was asking when should she have her Pfizer Covid19 booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Experienced blurred vision and dizziness. Refused medical care. Medical Device recommended patient go to clinic. Symptoms resolved.