chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of fever, body ache, chills, and sore throat has been received from a nurse concerning a 14-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Aug-2009. On 30-Aug-2009, the patient developed fever of 102, body ache, chills, and sore throat. The outcome of fever, body ache, chills, and sore throat was not reported.
Information has been received from a physician concerning a 26 year old female patient with no relevant medical  history, no relevant past drug history and no known drug allergies who on 21-SEP-2009 was vaccinated with once unknown dose of GARDASIL (route and lot# not reported). There was no relevant concomitant medication. On 28-SEP-2009 the patient developed a generalized rash which was raised. The rash did not itch. It was unknown if there was any relevant laboratory data. As of 03-OCT-2009, it was unknown if there was any relevant laboratory data. As of 03-OCT-2009, it was unknown if the patient would continue to take GARDASIL and she continued to experience generalized rash. Additional information has been requested.
excruciating pain from 2nd dose; Still sick; Anxiety; freezing, teeth chattering; panic attacks; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering) and PANIC ATTACK (panic attacks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Rash: dexamethasone (Dexamethasone 4mg for 6 days). Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second 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 (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills). At the time of the report, PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills) outcome was unknown. Not Provided          Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.  Treatment medication includes STEROIDS.  Patient stated after 2nd dose of vaccine that he had typical symptoms from the vaccine chills (patient did not check his temperature) freezing, teeth chattering, felt a little off the next day symptoms lasted a couple of days, he had severe anxiety and panic attacks.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-081819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up received on 03-jun-2021, patient past medication and concomitant medications were updated
The evening after administration of Tdap pt got a headache and upper arm became red, warm to touch and swollen. Pt observed (temp, not taken). Pt continued to attend school but still c/o pain in entire upper arm. Still swollen, but improved et sl. Red 3 days later.
9:00 pt received H1N1 vaccine - approx 5 min later felt "tightness in chest" Hx asthma - used inhaler then developed H/A which worsened - At about 2:00pm presented to nurse c/o increased H/A. Shortness of breath O2 sat 80 - HR 140 Sent to PMD - tx with IM steroid and steroid dose pack and inhaler - H/A persisted x 3 days.
Red circle at site of injection about 3 inches in diameter.  First noticed 10 days after shot but might have been there earlier. Itchy and swollen for a few days. Lasted about a week and then faded to a light pink.
Beginning 4 days after 2nd vaccine dose: muscle pain in rt. arm, left and right legs, lower back getting progressively more severe each day.  Appointment with NP at medical facility 03/30/2021. 5 day course of prednisone therapy pack. Symptoms improved. 4 days later symptoms returned. Friday, 04/16/2021 began NP advised me to take 600 mg ibuprofen every 6 hours for 1 week. If not better make appointment to be seen again.
Swollen upper arm; Warm upper arm; Itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm). At the time of the report, PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm) outcome was unknown.
Trouble breathing; Pneumonia; A spontaneous report was received from a consumer, concerning patient (unknown age and gender) who received Moderna's COVID-19 (mRNA-1273) and experienced pneumonia and trouble breathing/dyspnea.   The patient's medical history included chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the events were not reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection on an unknown date.   On 04 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, the patient had trouble breathing and was diagnosed with pneumonia. The event pneumonia was considered as serious (medically significant).   Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event pneumonia and trouble breathing was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 24 year old male . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1808609 and expiry: 06-DEC-2021) dose was not reported, 01 total was administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with the Regulatory Authority: 90000222232.; Sender's Comments: V0: 20220334117-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
arm sore, itchy, swollen (baseball size), body aches, weakness, n/v, diarrhea, chest pain, SOB; took DPH helped SOB, itching; cont sl weak;
SWELLING AT SITE OF INJECTION WITH SECONDARY INFECTION 2 DAYS LATER.  3/16/07 Received medical records from PCP/hospital clinic which reveal patient hospitalized x 3 days for swelling, infuration & erythema of right arm where received DTaP & Hep A as catch up vax due to loss of vax records.  Dx w/cellulitis/abscess formation.  Tx w/IV antibiotics then d/c to home on oral antibiotics for 7 more days. When seen 10/16, was asymtomatic. PMH: intermittent asthma since age 6 mos; eczema; obesity; speech & developmental delays at age 2 yrs; dx w/autism at age 2.5 yrs. Plumbism (lead poisoning) dx 8/05. Birth HX: 41 wks, 7 lbs 8 oz.  Uncomplicated. Family Hx: cousins w/sickle cell; autistic aunt & uncle. LABS: high lead level of 14 8/05. FINAL DX: Cellulitis/abscess formation. 4/6/07 Received medical records from hospital which reveal patient experienced swelling & redness of RUE.  Admitted 10/5/06-10/7/06 following vax on 10/3/06.  Also had diarrhea w/abdominal cramping on day of admission.  Temp in ER was 100.  Tx w/IV antibiotics.  Patient progressed well & was d/c home on continued oral antibiotics & to f/u in clinic. FINAL DX: Right upper extremity cellulitis, resolving.
Patient became pale limp and  fainted had jerking episode recovered in observation for 30 min post vaccines
Patient admitted and treated for stroke. Patient hospitalized for 17 days (10/17-11/3/2021) and discharged to facility.
Patient had a tingling arm and fast heart rate. The symptoms started within 5 minutes of receiving the COVID vaccine and it started with a tingling sensation on the back of her hand.
Started with muscle aches and weakness  in the right arm on Jan 7th,  this afternoon I have a red lacy rash all down my arm a little itchy.  Headache and lips tingle .
A report received from a health professional on 15Oct02, concerning a 72 year old female vaccinee who was inadvertently administered partially frozen Fluvirin on 14Oct02. On 14Oct02, the vaccinee was inadvertently administered partially frozen Fluvirin into the left deltoid. The vaccinee has not displayed any signs of symptoms of an adverse reaction. No treatment was administered to the vaccinee. The physician plans to revaccinate the vaccinee in three weeks and will monitor the pt closely for adverse reactions. There is insufficient information to determine the reporters causality assessment.
sick; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.    This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.    On an unknown date, the patient developed non-serious had the flu (influenza intensity-mild) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of report, the outcome was unknown for the event. There will be no information available on the batch number for this case.
Ringing in my ears since a day after I got the shot , Have had the condition previously but this has been exacerbated  significantly since the vaccine. Sensation in tip of my tongue. Left eye feels like it is a bit burry . Hands and feet very cold . Has gotten better after the 5th day.  Was tired for 5 days after vaccine.
Attempted ID administration of vaccine, did not achieve wheal on left arm.  Tried again with fresh dose and needle, achieved wheal on right forearm.  No injury to patient.
This spontaneous report was received from a certified medical assistant concerning a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On 18-SEP-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23, which had expired on 16-AUG-2015 (administration route, dose and anatomical location and lot number were not provided). No concomitant therapies were reported. No adverse effects were noted and no product quality complaint was reported. Additional information has been requested.
pt fell to floor trembling w/ a fixed stare; put on exam table w/legs elevated, BP 110/90 & given water;
Severe non stop headache for the last 3 days. Periodic headaches since 10/10/12. Eye pressure with eye movements. stiff neck. Feel side to side head movements increases headache.
Chronology of Events: March 19th 2021-One day post vaccine, severe headache developed along with flu like symptoms and pronounced malaise March 20th 2021-Continued symptoms from previous day and additionally bleeding vaginally (had cycle end over a week prior to vaccine dose 1) March 21st 2021-Severe hemorrhaging vaginally with large amounts of clots developed.  Completely saturated overnight pads at a rate of about 1 per hour.  Began at 7pm.  Had never had bleeding like this before with other cycles.  Unable to control so went to local Emergency Department in the where we are stationed.  Unable to determine a cause for the bleeding, was put on TXA to help control.  Discharged at 0400 March 22nd.   March 22nd 2021-Continued to have excessive bleeding, and continued TXA treatment during day at home with Rx.  Follow up made with GYN doctor for Wednesday March 24th.  Headache has continued this entire time.
Information has been received from a registered nurse concerning a 27 year old female with sulfonamide allergy and nickel sensitivity who on 20-DEC-2007 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) 0.5 ml SQ. Concomitant therapy included hormonal contraceptives (unspecified). On 21-DEC-2007 or 22-DEC-2007, the patient experienced injection site reaction. The area of the arm had erythema 6 inches in diameter and darker red are of induration that was three inches in diameter. The patient was seen in the doctor's office. The patient was treated with diphenhydramine hydrochloride (BENADRYL). No lab or diagnostic studies were performed. The reaction lasted for two days. This is one or two reports from the same source. Additional information has been requested. Folow up: There were no adverse events following prior vaccination. There was no illness at time of vaccination. The outcome was reported as recovered.
Headache, Fever, NauseaVomiting,  low grade fever, site soreness Narrative:
Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
Patient complained of headache dizziness, chest pain, and weakness, symptoms were gone by next day.
This is a spontaneous report from a contactable physician. An 18-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration on 12Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced facial swelling, itchiness/generalized itching and a sensation that throat was closing up on an unspecified date. The patient went to the emergency room (ER) and received treatment for more than 24 hours with steroids and BENADRYL. The reporter wanted to know if they can administer the 2nd dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events facial swelling, itching and throat closing up.
Subacute Thyroiditis  Began with neck pain several days after vaccination; developed severe neck pain, then insomnia, night sweats, fever, myalgias, anxiety (symptoms actually worsened after influenza vaccine on 10/22/21)
9 days after the shot my upper left arm is hot and swollen and red it is now on day 10 starting to bruise.
This case was reported by a medical assistant and described the occurrence of an injection site reaction in a 5 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 06/30/2004, the patient received the fifth dose of Infanrix (lot DTPA614A9) in the left arm.  Approximately one day following the administration of Infanrix, on 07/01/2004, the patient developed an area of deep redness and pain the size of a quarter at the injection site; there was no swelling.  The patient was seen at a physician's office and was treated with Duricef.  The event resolved on an unspecified date.  The medical assistant initially considered the injection site cellulitis to probably be related to vaccination with Infanrix and a problem with specific lot number of Infanrix.  Subsequently she stated that the injection site cellulitis was possibly related to vaccination with Infanrix.
Patient was given dose mixed with sterile diluent vs the diluent provided. Patients mother denies adverse outcomes at time of reporting
Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet.  Went to ED, per patient did not receive any medications, just had an EKG.
Swelling in left arm occurred later that evening, followed by migraine that started that evening and lasted 2 full days and continued to reoccur regularly. I also have had muscle spasms in my arms legs and hands ever since receiving COVID vaccine
My injection site sore started to go away on the forth day (12/19/21)...then, all of a sudden I woke up in the morning  (12/19/21) with the whole body being sore, my lower back and my neck are especially painful.  I can't bend forward to pick up things from the floor.  For the whole day, I was very nervous about it since I have had continual herniated discs problem with my lower back ad my neck.  Then, the pain is getting unbearable, I had to take tylenol  to relief my pain.  I had to take it for a few days.  Then, slowly the pain died down which took another 3 to 4 days by the end of the week on 12/24/21.  However, the remnant of the pain persist for a few days longer.
FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient refused to give details regarding allergies, drug abuse or illicit drug usage, alcohol consumption, smoking and lab details. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Moderna COVID-19 Vaccine EUA  Weakness in knees which lasted approximately 2 to 3 seconds.  Almost feel before sitting down
About 12 hours after I received the booster shot, I woke up and began to feel nauseous. I began to walk to the bathroom, started to get tunnel vison and passed out in the hallway. I woke up a minute later and was helped to the bathroom and passed out a second time shortly after (again for about 1 minute). I have no memory of losing consciousness - only waking up on the floor and unsure of how I got there.
Patient fainted in passenger seat of car within seconds of vaccine. She recovered to baseline slowly over 30 minutes and improved markedly with snacks. She reports not having eaten lunch.
A non-serious spontaneous report of two children were inadvertently given the field corrected expired H1N1 was received from a nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 19-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Moderna vaccine in L Deltoid. Unable to move L arm past 90 degrees fwd flexion x abduction. Symptoms started in evening post shot. Given Rx for Prednisone
Eight days post injection, lump developed at injection site which continued to increase in size to about 4" in diameter, become inflamed, hot to the touch and very itchy.  Skin on hands and feet was ultra sensitive to environment, especially wind and cold.  Swelling in arm went away in 4 or so days.  Skin is still sensitive to the elements on 4/10, but sensitivity seems to be decreasing.
Patient was inadvertently administered the bivalent version of the vaccine as the first dose on November 23rd . Patient was immediately contacted and instructed to return immediately to receive the monovalent dose and reported no adverse symptoms. The patient said they would come in the next business  day Friday Nov 24th but never followed up. We spoke to the patient again Friday, they still felt fine with no side affects. Still awaiting the patient to come in for the monovalent vaccine, Tuesday Nov 29th the pharmacy contacted the patient again and the patient insists they will be coming in but feeling fine.
syncope after immunization, waited 30 minutes, syncope resolved.  Patient called 2 hours later to report that syncope had come back and patient was referred to urgent care.
pt recv vax 26OCT97 & noticed a large knot, arm inflamed & red, extremely hot;no tx provided resided in 3-4 days;
Information has been received from a physician via a company representative concerning a male patient of unknown age. On unspecified date in 2014 (reported as "about one year ago"), the patient was vaccinated with his second dose of GARDASIL (dose, strength and route were not reported). On an unknown date the patient developed dizziness and sweating. The patient had sought unspecified medical attention. The outcome of the events was reported as recovered on unspecified date. Additional information is not expected because the physician did not want to be contacted.
My stomach has been bothering me from this morning; my stomach is doing couple of flips and stuff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "My stomach has been bothering me from this morning; my stomach is doing couple of flips and stuff".  Additional information: Consumer stated, took shot, Pfizer shot yesterday. So, patient was wondering, patient take these nauseous pills. So, patient stomach in the morning. So, patient was calling to see if still be able to take the nauseous pill (Unspecified medication) because patient stomach was doing couple of flips and stuff. So, patient want to know if patient can still take the nauseous pill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up attempts completed.
SMALL PATCH OF REDNESS 2 INCHES FROM INJECTION SITE APPEARED ONE DAY AFTER, CURRENTLY RED PATCH HAS EXPANDED TO 6X3 INCHES, ITCHING PRESENT.