chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; tongue swelling; Initial information was received on 02-Feb-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 33-year-old male patient who experienced shortness of breath (dyspnoea) and tongue swelling (swollen tongue), after vaccination with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 13-Jan-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot (C4712AA, expiry date- 27-Mar-2017) via intramuscular route in left deltoid for prophylactic vaccination.  On 13-Jan-2015, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in an unknown administration site for prophylactic vaccination.  On 13-Jan-2015, the patient developed non-serious shortness of breath (dyspnoea) and tongue swelling (swollen tongue) about 2 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that, the patient was asking for ingredients for Fluzone Quadrivalent and Adacel.  The patient was scheduled to have the COVID-19 vaccine tomorrow and was hoping to get an answer to question before then.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown. for both the events.  There will be no information available on the lot number of Fluzone Quadrivalent for this case.
p/vax pt woke up Thursday Am w/cough & s/s of asthma exacerbation;10/23 went to MD;required 2 doses of adrenalin in MD office & long term therapy w/pred & inhalers & prescription cough med;
Severe migranes, development delay, joint pain, weakness in around and legs, insomnia, was A-B student, now F student, decrease I.Q. scroing. Per 60 day follow up: it is unknown if pt recovered. Father called, pt has multiple behavioral and physical problems which father states are vaccine related. This is all I know-I've never seen either father nor son. We are not the primary health care provoder. The 60 day follow up received on 5/29/03 states chronic fatigue, headache, unequal coordination, irritability, dizziness diagnosed with PDD arthritis-joint pain, lump on neck lasted over one year. Requires 24/7 supervision. Home schooling now since 2-03.  Arthritis.  Annual follow up on 04/21/04: "Pt has not recovered from adverse events.  Still suffers from PDD, back at 2nd and 3rd grade work despite being in 10th grade.  Headaches continue without treatment."
Client received her second dose of Moderna vaccine and was sitting in her car for the 15 minutes post-vaccination period. Ten minutes into the wait time, she started experiencing difficulty breathing and stated: ?I felt like something was going through my body.? She also stated that she felt ?shaky.? Her first dose of the vaccine was uneventful and she has no history of anaphylaxis. She denied any itching or rash. Her vital signs were as follows: BP=136/83; Pulse=80; Respiration=18. 911 was called and the Medical staff arrived and evaluated her. They decided, with the client, that she did not need to be transported to the hospital.
This spontaneous report was received from a medical assistant referring to multiple unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patient's were vaccinated with improperly stored doses of RECOMBIVAX HB), (strength: 5/0.5 mcg/ml which has a lot # L016427, expiry date: 12-APR-2017)(route and dose not reported). The vaccines were exposed to temperature of 9 degree Celsius for 3 hours (also reported as 50 degree Fahrenheit for 4 hours). No previous temperature excursion was reported. The temperature excursion was detected by a data logger. Additionally , no adverse effects were reported and no quality complaint was involved. Additional information has been requested.
Became tachycardic on Saturday, January 1, 2022. This has lasted over a week. With the racing heart (highest BPM of 145), I?ve had extreme nausea, dizziness, headaches, sweating, feeling like I am going to pass out, and stomach pain.
LEFT HAND BECAME WEAK. HARD   TO GR1P OR HOLD THINGS. A BIT  NUMB.  COULDN'T SENSE BEING HIT.  OTHER WISE,, JUST THE NORMAL ACHES AND PAINS IN THE NECK AND SHOULDERS AS  NOTNONED IN FACT SHEET
Breakthrough Case of COVID-19: Started out with a tickle in the back of my throat, then went to muscle aches and pains and then a fever which I treated with Tyelnol, I had some coughing as well.  The symptoms lasted for about three days. Started Paxlovid  3days later.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted after 15-20 minutes of getting vaccination. He said he felt overheated and exhausted before passing out. Gave him ice pack and water and had him lie down for several minutes. His bloodpressure was low then rose after a few minutes. Patient declined to be checked out by EMTs and stated was fine to go home and lay down. Figured he was probably anxious about getting the shot
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury based preservative thimerosal. The alleged result of these vaccinations is that the patient suffered from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization records were received as follow up which stated that on 7/11/96, the patient was vaccinated in the left leg with a second dose of hepatitis B vaccine recombinant 9 (yeast)(lot# 619088/0135D). The first and third doses of hepatitis B vaccine recombinant (Engerix-B) were given in the left leg on 4/4/96 (lot# 1967A2) and on 2/13/97 in the left thigh (lot # 2196A2). Concomitant therapy included MMR (lot # 1248D reported, invalid for the product) given on 3/10/97, SC, in the left thigh, diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid (ACTHIB/DTP)(lot# 5L6174 given in the left leg on 5/7/96; lot # 5F71109 given in the left leg on 7/11/96; lot # 6H71044 given in the left leg on 3/9/96; and a dose of haemophilus B conjugate vaccine (lot # 7J81539) given in the left thigh on 7/16/97, oral poliovirus vaccine (ORIMUNE) (lot# 738M2 given on 5/7/96; lot #742P0 given on 7/11/96; lot #440072 given on 8/10/97), and tuberculin purified protein derivative (PPD TINE TEST)(lot # 2431-12 given on 3/10/97 in the left forearm. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events. No further information is available. A follow up report received 05/20/2003 adds: Follow up info received on 05/01/2003 indicated that the pt received injections of vaccines allegedly containig thimerosal on the following dates: 04/04/1996, 05/07/1996, 07/11/1996, 09/03/1996, 02/13/1997, 03/10/1997 and 07/16/1997. Upon internal review, mercury poisoning and neurological disorders were considered to be other important medical events. No further info is available.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.  Company comment  This is a spontaneous case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious of Covid 19, unknown days after receiving the 3 dose of m RNA1273 vaccine in the covid 19 vaccination series, Patient had previously received the 2 primary doses with Moderna vaccines at an interval of about 28 days, with the 2 dose taken about 8 months prior to the 3 dose of Moderna vaccine. Details of co morbidities, labs and diagnostic tests, concomitant medications and treatment details was not provided. It was reported that the patient was taking Adalimumab (Humira) for Rheumatoid arthritis, which could be considered as a confounder. The event had resolved. The benefit-risk relationship of the vaccine is not affected by this report. Events' seriousness assessed as per medical judgement; Sender's Comments: This is a spontaneous case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious  of Covid 19, unknown days after receiving the 3 dose of m RNA1273 vaccine in the covid 19 vaccination series, Patient had previously received the 2 primary doses with Moderna vaccines at an interval of about 28 days, with the 2 dose taken about 8 months prior to the 3 dose of Moderna vaccine. Details of co morbidities, labs and diagnostic tests, concomitant medications and treatment details was not provided. It was reported that the patient was taking Adalimumab (Humira) for Rheumatoid arthritis, which could be considered as a confounder. The event had resolved. The benefit-risk relationship of the vaccine is not affected by this report. Events' seriousness assessed as per medical judgement
At 2 PM on the date of injection (1/24/19) the mother returned with her child stating that her legs were twitching uncontrollably even while the child slept. The child was evaluated and no loss of motor function or muscle spasms were observed so the mother was asked to return home and continue to monitor. On Monday 1/28/2019 the child returned to the office with a blistery rash on her leg at the injection site.
headache, nonproductive cough, chills, loss of taste, loss of smell, diarrhea, sinus congestion, nasal congestion, post nasal drainage, sneezing, itchy eyes, ear fullness   also c/o dysphagia--starting 12/1/21
Initial literature received on 22 Mar 2010: This literature deals with vaccination against classic influenza in medical personnel: self-protection and patient protection. This patient was vaccinated with Influenza virus vaccine (manufature unk, batch no. unk) for immunisation on unspecified date. On an unspecified date, four weeks after the vaccination, the patient had presented with the vitilligo on both hands and the arms. The causality assessment was unknown. The outcome of the event was not reported.
Since then she's been feeling drained, tired and queasy; Since then she's been feeling drained, tired and queasy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (on Tuesday) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that patient was feeling drained, tired and queasy on unspecified date and patient reported her friend has also received the vaccine and has been feeling tired over a week. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored GARDASIL 9 (lot # reported as M026306, expiration date 30-APR-2018, lot # M041212, expiration date 21-JUN-2019, lot # M040412, expiration date 30-JUN-2019) for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012808: US-009507513-1708USA001216.
102.7 -102.4 temperature until roughly 24 hours after shot.  Aches, headeache, shaking, cold then hot.  Finally fever went down to 99 degrees around 26 hours after shot.  No fever after 42 hours after shot.  Continued hot/cold chills and headache.
She denied further AE.; a patient was administered VARlVAX that expired on 20MAY2021; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.     On 07-JUL-2021, the patient was vaccinated an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # S015463 and expiration date of 20-MAY-2021, 0.5 milliliter (route of administration was unknown) for prophylaxis. There was no adverse event reported. The vaccine had no any temperature excursions.
Per patient: By evening of 10/23/18 extreme soreness at injection site, by morning of 10/24/18 extreme pain at injection site, shoulder, underarm, pain radiating through left breast and chest area, injection site red, hot area size about 4 inches in diameter, reaction lasted 4 days.
21 y/o AD female presents for walk-in appt, with "itchy, little red bumps that look like mosquito bites" on arms, chest, abdomen and back 10-days s/p receipt SPV right deltoid (3/10/09). Noticed first itchy red papule behind right elbow on 3/16/09, then one on same forearm. No accompanying fever or malaise. Pruritic red papules spread to chest, abdomen and today has several discrete pustular papules on her back, which do not resemble a primary jennerian pustule. She has been performing careful daily dressing changes and wound care-covering jennerian Pustule with band aid till scab forms and falls off, wearing long sleeves, changing band aid daily, disposing dressing in sealed plastic bag and washing hands to avoid auto - inoculation. I reviewed principles of preventing transmission to others in close contact, as SM's female partner accompanied SM to visit. Both patient an partner deny hx of eczema or psoriasis. No children present in household. No showering together, etc.
Swelling & redness to site L deltoid no pain - felt hot to touch - no SOB. ZYRTEC 3/4 tsp po given in office & will con't daily x 3 days.
This spontaneous report as received from a nurse refers to patients of unknown age. The patients medical history was not reported. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored. No adverse effect was reported. The outcome of improperly stored (Oka/Merck) VARIVAX administered was unknown. This case if linked to case # 1406USA009790 (same reporter link). Additional information has been requested.
Fever, headache, muscle aches, tired started morning of 4/15 and lasted till 2AM in 4/16
Patient stated she has had a hard lump at the injection site that has not resolved since her vaccination on 10/11/18. The lump is hard and painful and has only slightly resolved. Pt has tried applying heat, applying BIOFREEZE, and massage the lump. There has been only a slight improvement at the injection site.
Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil.  Subsequently the patient passed out after receiving the vaccine.  Therapy with Gardasil was discontinued.  Additional information has been requested.
very sick as described by pt;not seen;pt claimed to have B12 shot mixed w/vax,but no record of vitamin administered;@ time of inj,c/o nausea & was given dramamine & observed for 2hrs then discharged to home;pt called stating almost died;
This spontaneous report as received from a pharmacist refers to a female patient in her 20's. The patient had an increased risk of pneumococcal disease due to smoking. In October 2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular (lot #, expiration date, dose and site of administration were not reported) and an unspecified flu vaccine for prophylaxis. On an unknown date, the patient experienced redness, swelling, and soreness from the shoulder to the elbow and soreness in the breast on an unspecified side. The outcome of events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006102: US-009507513-1702USA006265: US-009507513-1702USA006019.
Right side of mouth to chin became red and numb.  Over the next 10 minutes or so whole face, from eyes down became numb.  No breathing problems.  Numbness/redness lasted 4 hours then slowly subsided.
Received vaccine while breastfeeding; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding). On 06-Jan-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided  This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
swollen lymph node under chin  in throat; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (swollen lymph node under chin  in throat) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node under chin  in throat). At the time of the report, LYMPHADENOPATHY (swollen lymph node under chin  in throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment medication was reported.
DOS 12/19 Skin rash in site of injection, itching, arm swelling, color change TX: KEFLEX/BACTROBAN.
THE PATIENT RECEIVED 1ST  DOSE OF THE PFIZER  SERIES ON 7/9/21. THE SECOND DOSE WAS GIVEN ON  7/20/21,  11 DAYS APART FROM THE FIRST DOSE.  THE PATIENT CHECKED IN FOR THE  SECOND DOSE EARLIER THAN THE APPOINTED TIME AND DATE SCHEDULED.  THE PATIENT WAS STABLE, ALERT, ORIENTED, AND  AMBULATORY BEFORE  LEAVING THE VACCINATION SITE. THE PATIENT REPORTED NO SIGNS ,SYMPTOMS, OR ADVERSE REACTIONS.
After 1st vaccine my arm was sore and tingling within two hours. The next day I couldn't move my arm at all and had an overall sick feeling. I called in sick to work. After 2nd vaccine my arm was not so sore but two days later I had (still have) hives on the same arm as the vaccine was injected into. I have no other hives but again this time, feel ill. I also have lightheadedness this time.
2/4/2019 slight redness and swelling at injection site of Left arm and fever of 100.3 that evening, treatment with TYLENOL, local reaction and fever resolved in less than 24hrs. 2/5/2019 stomach ache and decreased appetite lasted 2 days. 2/7/2019 rash on both legs and abdomen which cleared within hours, no treatment.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, concentration, route and lot number not specified) (reported as "patient was a candidate"). On an unknown date (reported as 6 months after receiving ZOSTAVAX) the patient developed a mild case of shingles. The outcome of developed a mild case of shingles was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
NONE Report received 02/21/2005: Mouth itchy, flushed skin, later had prolonged allergic reaction; symptoms persisted till 11/02/2004.  Treated wtih Benadryl, Tagamet.
pt woke upt w/t102 during the noc temp went as high as 105.6; rash appeared on chest & back 2MAY;
Nausea; Stomach pain; Fever; Headache; This case was reported by a consumer and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2021, 1 days after receiving Shingrix, the patient experienced nausea, stomach pain, fever and headache. On 3rd September 2021, the outcome of the nausea, stomach pain and fever were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the nausea, stomach pain, fever and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received the vaccine in the left arm and experienced nausea, stomach pain, and fever that began in the morning of the next day after vaccination and resolved in the morning of the reporting date. The patient had also experienced a headache that started on next day after vaccination and had gotten better, but it had not totally resolved till the time of reporting. The reporter did not consent to follow-up and did not give permission to contact health care professional.
I developed hives on approximately 50% of my body.  Symptoms subsided after 2 Benadryl but have re-occurred on 3/26, around my ankles and on the tops of my feet.
24 hours post injection child experienced swelling of the deltoid and injection area was warm to touch.
Pt received FLUVIRIN vaccination around 4:20pm on 9/17, at around 4:40pm patient returned to pharmacy reporting left side facial numbness, swelling in mouth, metallic taste in mouth and itching on neck and left face - pt given liq Diphenhydramine 50mg at 4:45pm - BP at 4:47pm was 127/104 pulse 70, BP at 4:53pm 138/111 and pt reports itching as resolving and swelling going down (still tingling and metallic taste). BP at 5:07pm 127/104 pulse 70. Pt declined 911 and left at 5:17pm. Advised to take more BENADRYL around 10pm.
Sore throat; slight headache; congestion; upper respiratory congestion; cough; and feeling lousy; diarrhea, too. I have been taking like a dayquil gel pill. It usually gives me some relief.