chrisvoncsefalvay/vaers-outcomes huggingface dataset:
trouble breathing,can't take a full breathe of air; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing,can't take a full breathe of air) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing,can't take a full breathe of air). At the time of the report, DYSPNOEA (trouble breathing,can't take a full breathe of air) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  No Concomitant medication was reported.  No lab data was provided.
Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/22 to discontinue Monovalent COVID-19 Booster and to begin using BIVALENT COVID-19 Boosters.
This case was reported by a physician via sales representative and described the occurrence of black tongue in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced black tongue. It was reported that the subject ate mango in the morning and later received a dose of ROTARIX. After receiving ROTARIX, the subject's tongue turned black. The nurse was able to wipe the back substance off the subject's tongue. At the time of reporting the outcome of the black tongue was unspecified. Follow-up information was received via a nurse at the subject's physician's office on 23 November 2010. It was reported that the subject was a 7 month old female. The event of black tongue occurred on 05 November 2010 and resolved the same day. It was not considered to be serious. It was suggested that the event could have been associated with a reaction to mangos, but no further detail concerning this was provided. The dose of ROTARIX was reported to be the subject's 3rd dose and concurrent medications included PEDIARIX (GlaxoSmithKline, 21 May 2010), PREVNAR- 13 (unknown manufacturer, 08 June 2010) and unspecified dose flu vaccine all given intramuscularly (05 November 2010).
Hlth professional given 1st & 2nd dose of vax following 1st experienced pain @ inject site; p/2nd experienced prolonged pain & tenderness @ inject site;
nausea; tiredness; "no energy"; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy") in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030M21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided. ). Concomitant products included Montebello for Fibro, DULAGLUTIDE (TRULICITY), INSULIN ASPART (NOVOLOG), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy"). At the time of the report, NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy") outcome was unknown. Not Provided          Concomitant product code for fibro myology.
joint swelling, arthritis, joint pain, swelling w/fluid on knees;lymphadenopathy-axillary, cervical, groin;
Swelling of lymph nodes in right armpit (opposite side from injection site). Fatigue started the day after vaccination (18 hours after). Soreness in both sides of neck. Headache. Fever.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the medical clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Shingles (clinical) 2 days after shingles vaccine with typical rash R thorax.
Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated.         The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: Patient reported tiredness post second dose of covid vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt devel abd pain, flu-like sx, generalized achiness & arthralgia w/in 24 hrs p/recvd 1st dose of Hep B vax; sx resolved spontaneously over 3-4 day period; pt recvd 2nd dose of vax w/no rxn;
This spontaneous report as received from a pharmacist refers to about 8 or 9 unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX 19400 PFU (lot number, dose and indication were not reported). Concomitant therapies were not reported. The pharmacist stated that, on an unknown date, after reconstitution of ZOSTAVAX he was unable to obtain 0.65 ml from the vial; however he had administered ZOSTAVAX doses less than 0.65 ml to the patients(about 8 or 9). No adverse effects were reported. Additional information has been requested.
MA, administered the vaccine in error. The Pfizer vaccine that was administered is for 12 years and older; this patient is only 7 years old. No adverse reaction occurred.
diarrhea bout; This is a spontaneous report received from a contactable reporter, Consumer, from medical information team. The reporter is the patient.  An 85 year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea bout". Additional information: patient developed a "diarrhea bout" within several hours after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated feeling dizzy, then fainted 5-10 minutes after vaccinations were complete.  Doctor performed complete assessment on patient.  Condition stable.  Patient released to parents, advised to go to ER if any complications occur.
Elevated BP 176/108  , shakiness, didn?t ?feel right?, several episodes of vomiting.
HEART ATTACK; SEVERE LETHARGY; FEVER LIKE TEMPERATURE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug or non-drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808962, expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAY-2021, Patient experienced severe lethargy, fever-like temperature. On 23-MAY-2021 at about 09:40 pm, she began to severe chest pain from breast and upward. She was taken to emergency room with Electrocardiogram readings off the chart, that lead to a heart attack. She received double stent placement in her heart. Several weeks later, she was on several medications. Patient's coworker mentioned that it had to do with J&J/Janssen vaccine. Her lifestyle had detrimentally changed from healthy to living with a comorbid condition. She was treated by a cardiologist in hospital. On 27-May-2021, she was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever like temperature, recovered with sequelae from heart attack, and had not recovered from severe lethargy. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210738717 covid-19 vaccine ad26.cov2.s -Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
vaguely sore arm; This is a spontaneous report from a contactable consumer (patient) reported for self. A 76-year-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vaguely sore arm on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On May 17, 1999 the pt developed watery eyes which the pt mother attributed to cold sx. On the evening of May 19, 1999 the pt developed a fever, of 102.4F Within 24 hours the pt broke out with 2 pox which were not fluid filled. The pt also became nauseated. By May 24, 1999 the pt had broken out with pustules in the mouth and some of the lesions were noted to be in the ear canal and on the ear drum. The pt was treated with amoxicillin trihydrate. The reporter believed there was no association between the pt sx and the vax, however, the pt experience was considered an other medical event.
Patient reports pain around the injection site that started on the day of vaccination.  The pain seems to be getting worse and is spreading.  The painful area is approximately 4 inches in diameter centered around the deltoid muscle of the left arm.  There is no redness or swelling in the area.  The patient has tried to massage the area, but the pain has not resolved.  The patient no longer has a family doctor, so he is considering seeing a walk-in clinic for treatment.
Initial report received from a healthcare professional (Pharmacist) on 30 September 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number U5062BA, expiry date and dose in series not reported) on 27 October 2014. The patient had no illness at the time of vaccination and no known allergies. On 28 October 2014, one day after vaccination, the patient experienced blurry vision. Complementary investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 02-APR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additonal information has been requested.
This spontaneous report was received from a registered nurse refers to a 16 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were unknown. On 04-JAN-2019, the patient was vaccinated with an expired dose of M-M-R II (lot # M049212, expiration date: 16-DEC-2018) (anantomical location, route and dosing details not reported) for prophylaxis along with sterile diluent (concomitant medicaton). No adverse effects reported. Product quality complaint was not involved.
I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/30/2021 ACIDOSIS, UNSPECIFIED I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/30/2021 SECONDARY DM W NEPHROPATHY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/30/2021 SEIZURE, UNSPECIFIED I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/30/2021 THROMBOSIS OF UNSPECIFIED SITE OF AORTA
Received varicella vaccine 7/27/07. 7/31/07 developed 4 red lesions to legs - 8/1/07 had 25 lesions over legs, buttocks, trunk. Lesions red, papule/vesicles, 1mm diameter, some with surrounding erythema. + itchy. Also c/o nausea.
Severe arm soreness and pain  Approximately 20 hours after vaccine administration I had the absolute worst nausea and yellow bile come up from violently, super violently having thrown up multiple times.  I woke up with an empty stomach, since I'm 166 lbs and 5' 11 3/4" and I'm very healthy in terms of all my blood tests and levels.  This nausea and full body soreness today approximately 23 hours is so severe that I feel obligated to report these serious adverse effects.
Reportedly, the vaccinee had received "a complete Hep-B vaccination series years ago". The vaccinee had "recently" obtained "a Hep-B titer test" (NOS) and was found to have "no antibodies to Hep-B antigen".
22 y/o male who according to clinical entry dated 1/18/2011 reported "pressure to left pectoral muscle...radiates down left arm and left side of neck and jaw". Pain progressively worse over the course of four days and worst on 1/17/2011 when he was awakened at 0300 with "squeezing type pain that radiated down left arm and jaw and was associated with shortness of breath". VS and PE from 1/18 at presentation: 124/92, P 88, R 20, HT 71", WT 175, BMI 24.41, Lungs WNL. Per ED note on 1/18/2011 - onset of CP on early a.m. of 1/16/2011. Left arm felt kind of numb. Had tingling in the left side of his neck. Pain lasted 2-3 hours. He took some TYLENOL which helped and the pain went down from a 10 to a 6, and then later, he took some ibuprofen. Later that evening, the pain came back. He took more ADVIL, and then yesterday (1/17), the pain was up and down. Pain kind of worse if he was laying or leaning to the left. On a.m. of 1/18, pain was about 2-3/10, when he sought care at clinic where he was transferred to ER. He was given NTG enroute with eradication of pain. He also had been given four 81 mg ASA. PE: Heart sounded normal with no rub or murmur. Lungs clear. Chest wall was nontender. LUE) with SPV site not dramatically abnormal; axilla somewhat tender. Pt given LOVENOX 80 mg sub-q and nitro drip initially started, but dc'd in ED. Patient transferred and admitted to healthcare.
Started to break out in severe hives on head, torso, extremities, and bottom of feet.  Went to pediatrician started her on prednisone.  Did not help.  Took her to allergist, labs completed.  Does not seem to have food or environmental allergies.   Continued with hives.  Medication changed  to Hydroxyzine 25mg po 4 times a day, Famotidine 20 mg twice a day, and Zyrtec 10 mg QD.  Still no relief.  Ended up at  hospital due to difficulty breathing.  Epi pen and steroids given.  Observed for 8 hours.  Back to the allergist who sent us to the dematologist.  Biopsy of the hive was taken.  Nothing found.  Just stated it was a hive.   Received her first injection of Xolair (omalizumah) January 6,2022 which now shows some sign of relief.  At the time of vaccination  was taking Estarylla and spirtonolacton for PCOS and hyoscyamine 0.125mg for IBS.
Couldn't hear her/having heard time hearing her; incoherent; Change in seeing/couldn't see her/could see her when she moved close to her; Sick for a day; Unusual hoarseness; she will be there then doze off and it's like she is in a different zone; Appears confused at times; Few days after the booster injection,had strange looking things on her tongue/geographic tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent) and CONFUSIONAL STATE (Appears confused at times) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cataract (Cataract in one eye) and Diabetic.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced ILLNESS (Sick for a day). On 14-Dec-2021, the patient experienced HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent) and EYE DISORDER (Change in seeing/couldn't see her/could see her when she moved close to her). In December 2021, the patient experienced DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), CONFUSIONAL STATE (Appears confused at times) and TONGUE GEOGRAPHIC (Few days after the booster injection,had strange looking things on her tongue/geographic tongue). The patient was treated with Manual therapy (Cleaned ear out with an ear wax) for Hypoacusis. On 08-Dec-2021, ILLNESS (Sick for a day) had resolved. At the time of the report, DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent), CONFUSIONAL STATE (Appears confused at times) and EYE DISORDER (Change in seeing/couldn't see her/could see her when she moved close to her) outcome was unknown and TONGUE GEOGRAPHIC (Few days after the booster injection,had strange looking things on her tongue/geographic tongue) was resolving.            Concomitant information was not provided.  It was reported that the patient was unable to see her sister when sister visited her but eventually she could see when her sister moved closer to her.  Ear wax remover was used to clear the ear out but there was not wax. The patient was on P.D dialysis.   This case was linked to MOD-2021-415970, MOD-2021-416207 (Patient Link).
Patient came to pharmacy on 9/25/2018 in morning (around 955 am) and reported that her arm got sore on the day she has received vaccine which went away gradually. Even I have informed patient to use icepak and take ibuprofen upon swelling, patient has not used anything to recover. Today morning when she is arrived on day 3, at injection site redness started and slowly increasing towards downside of injection site. Informed patient to take ibuprofen. She took 2 tablet of 200 mg ibuprofen. We have informed MD office and MD office asked her to went in office. PT visited MD and MD informed that it will go away gradually. Pt denied prednisone therapy to MD as per patient and will take 2nd dose of ibuprofen soon when I spoke to patient at 749 pm.