chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in left hand, especially thumb; This is a spontaneous report from a non-contactable consumer or other non hcp (patient reported for self). A 35-years-old (non pregnant) female patient received first dose of BNT162bB (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration, administered in Left arm on 10Mar2021 16:45 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. (Lot unknown reason: Unable to locate or read the details). Medical history included known allergies to Penicillin. There were no concomitant medications, no other medications in two weeks. No other vaccines were received in four weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. On 11Mar2021 08:00, the patient experienced numbness in left hand, especially thumb. Patient has not been tested for COVID-19 since the vaccination. No treatment was received for the adverse event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
itching of the right arm; headache; hot to touch injection site right arm; hard injection site right arm; swelling of the injection site was a little bigger than a silver dollar; A little nausea; Tired & fatigue; red injection site right arm; sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue) and VACCINATION SITE ERYTHEMA (red injection site right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm) and NAUSEA (A little nausea). On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm) and VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar). On 06-Jan-2021, the patient experienced HEADACHE (headache). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching of the right arm). At the time of the report, VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm), VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar), NAUSEA (A little nausea) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Treatment information was not provided.   Reporter did not allow further contact; Sender'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.
High fever, ear infection, bowel problems, loss of speech, loss of appetite, learning disability PDD/Autism all with 6 months of MMR/Hib shot at 18months
Rash,head pain, chest pain, shortness of breath, legs swollen, numbness, glands swollen,tongue swollen, face,throat closing, chills,fever.
Pt had localized reaction(hives, edema, erythema, warm to touch) starting day of vaccination 9/11/13 which resolved 1-2 days ago. However 4 days ago developed scattered pruritic vesicles on red base consistent with mild case of varicella.
17JUL96 per mom: pt looked shaky, lips swollen, extremities were bluish-colored;17JUL96 @ ER no s/s of anaphyl shock, only sx was t102;18JUL96 no problems just fever of 102 per MD;
first 24 hrs ? 1) numbness and tingling in fingers and arm of vaccinated arm 24-56 hrs ? 1) slight facial paralysis on left side of face causing muscle twitching when I tried to smile 2) pain, inflammation and redness at the exact site of a scar from a childhood vaccine approx 2-3 inches from Pfizer injection 3) fatique
Extreme body aches that lasted 20 hours and did not respond to Ibuprofen. Chills. Low-grade fever.
Received DTaP 8/14/07 right thigh. 8/16/07 c/o of 1/2 dollar size red and swollen thigh. 8/17/07 went to Ed - cellulitis given Keflex 550mg PO right thigh red 4 1/2 x 4" in size.
Initial and follow up information has been received from a pharmacist, concerning a 66 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions and concurrent conditions were not reported. On 24-APR-2015, the patient was vaccinated with a first dose of ZOSTAVAX (strength, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. Then, on 03-OCT-2017, the patient stated that he had not received ZOSTAVAX, therefore the patient requested to get immunization and on the same day, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX lot number N013274 with expiration date in 04-JUL-2018 (strength, anatomical location and route of administration were not provided) that was reconstituted with one dose of sterile diluent (MRK), for prophylaxis. Upon notified the patient's primary care physician (PCP), the PCP confirmed that the patient was already vaccinated. On the same day, the patient was also vaccinated with FLUAD and his/her concomitant medications included simvastatin (manufacturer unknown) and levocetirizine. No adverse effect was reported.
This spontaneous report as received from a nurse (Licensed Vocational Nurse) refers to a patient of unknown age and gender reported as child. On an unknown date the patient was inadvertently, instead of VARIVAX (Merck), vaccinated with PROQUAD (Merck), injection (dose and route not provided). No adverse effect was reported. The outcome of events was not reported. This is one of 2 reports from the same source. Additional information has been requested.
arm discomfort; This is a spontaneous report received from a contactable consumer (patients' wife). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151; Expiration Date: 01Jan1900), via an intramuscular route of administration, administered in Arm Left (non-dominant, upper arm, closer to shoulder) on 09Apr2021 (at the age of 61-year-old), as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (onset of symptom occurring after the first dose), the patient experienced arm discomfort and the reporter stated that the symptom seemed to have gone away 24 hours after the first dose and her husband did not take any medication to treat this symptom. There is no product complaint associated with this case. The outcome of the event arm discomfort was resolved on 10Apr2021.
Cough that doesn´t go away; Feeling tired; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired). The patient was treated with BENZONATATE at an unspecified dose and frequency. At the time of the report, COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Vaccine adminstered on 10-Dec-2021 placed in refrigerator on 18-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine adminstered on 10-Dec-2021 placed in refrigerator on 18-Oct-2021) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine adminstered on 10-Dec-2021 placed in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine adminstered on 10-Dec-2021 placed in refrigerator on 18-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  HCP reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. No temperature excursions was noted. No adverse events were noted.  The vaccine was placed in refrigerator on 18-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Shot given 06/29/06, after which her arm became sore and then became swollen. On 06/30/06, the patient vomited twice, had body aches, chills, and a temperature of 101.3 degrees. By 07/01/06, she had a headache and sore arm. She was better by 07/02/06. Had adacel 6/29/06; 6/30/06 had sore arm, swollen , fever of 101.3 degrees, body aches, dull, recovered by 7-2-06.
Lymph Nodes in neck, clavicle and underarm swollen; Lymph Nodes in neck, clavicle and underarm swollen; Lymph Nodes in neck, clavicle and underarm swollen; Frozen shoulder in both arms; inflammation in both shoulder joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa drugs" (unspecified if ongoing); "Alllergies: penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 31Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 10Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PERIARTHRITIS (non-serious) with onset 10Mar2022, outcome "recovering", described as "Frozen shoulder in both arms"; LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious) all with onset 10Mar2022, outcome "recovering" and all described as "Lymph Nodes in neck, clavicle and underarm swollen"; ARTHRITIS (non-serious) with onset 10Mar2022, outcome "recovering", described as "inflammation in both shoulder joints". The events "lymph nodes in neck, clavicle and underarm swollen", "frozen shoulder in both arms" and "inflammation in both shoulder joints" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymphadenopathy, lymphadenopathy, periarthritis, arthritis.  Additional Information: No the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Reported Events Lymph Nodes in neck, clavicle and underarm swollen for 4 months, frozen shoulder in both arms inflammation in both shoulder joints. What treatment received for the adverse event. Physical Therapy for Frozen Shoulders. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, yes the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
recived pediarix,prevnar, and hib afternoon of 10/11/2007. Broke out in hives at 730 pm.Also had swelling with extreme redness in lt leg. Dr was called and they were instructed to give benadryl and bring daughter in 10/12/ was seen 10/12/07 by pac. was instucted that baby waas fine and to give benadryl prior to next immun.
THE NEEDLE FALL OFF THE SYRINGE AS MODERNA BOOSTER WAS ADMINISTERED- THERE WAS NO ADVERSE RXN - PATIENT WAS FINE- (MORE THAN HALF OF THE MODERNA DOSE WAS ADMINISTERED)
Patient given expired dose. Patient called, returned to clinic, and immunized with non expired vaccine. Age of patient at time of event: 5 years 5 months 29 days.
Patient's wife reported physical illness (fever, nausea, diarrha) which she believes was due to the flu shot.
Swollen lymph nodes in armpits, breast, torso, groin over 15 in total appearing over 10 days. Fatigue lasting a few days. Chills for one night on the 4th day.  Rash that was a cluster of red marks on lower back about half dollar size lasted for a few days. Most lymph nodes have gone down but some still noticeable.
Arm aching took acetaminophen.  Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.
Symptoms lasted for a couple of weeks after the second dose of the Pfizer COVID19 vaccine.  Symptoms included: Full body aches, joint pain, hot and cold flashes, headache, soreness at injection site, heart palpitations (thought to be from myocarditis after Drs visit), slight chest pain/tightness when breathing deeply, fatigue, neck pain, dizziness, light headed, fever, light sensitivity.
Covid19 breakthrough.  Pt vaccinated on 04/02/2021.  62y/o PMH of HTN presented to ED on 1/10/22 with c/o multiple Covid symptoms and +test 8 days ago.  Pt c/o 1 week history of productive cough, scalp sensitivity, tmax-105 and worsening cough/SOB.  CXR- mod multifocal flocculent airspace opacities right lung.  Room air sat 96%.  Pt discharged home with doxycycline abx.  Pt returned 1/11/22 with concern for worsening symptoms.  CXR-multifocal PNA, febrile, productive cough.  Admitted and started on IV ABX/steroids.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patient were vaccinated with oral, ROTATEQ lot # K023534 with expiration date of 22-MAY-2016 and K011948 with expiration date of 07-JUN-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range(incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received the shot at a drive-thru event and then was directed to park in a lot with an EMT squad on standby to wait in my car case of adverse reaction. Due to a prior reaction to vicodin I was asked to wait 30 minutes. I began reading on my phone, and after 10 minutes passed I noticed I was becoming very short of breath and was having difficulty mentally focusing on what I was reading. As this was not an expected reaction, I decided to wait a bit before honking my horn to request assistance. After 5-7 minutes, the feeling went away and my breathing and concentration returned to normal. I waited an additional 30 minutes just in case, but have been fine for the past 6 hours without even a sore arm. Had anything been in bloom in the surrounding area, I would have presumed rolling down my window allowed me to breathe pollen that triggered my allergies, but it is still too early in the spring for that. Weather was 53 F, sunny and dry.
pneumonia; very ill; vomitted; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reported as 60, unit unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got very ill, vomitted  and ended up with pneumonia after getting the vaccine. The outcome of the events was unknown.  Information about lot/batch number is requested.
Arm hurt and was painful to touch.  After 7 hours I started with a headache followed by stomach ache.  Then diarrhea and severe chills that would not stop until I got into a hot shower and then used heating pad and got under blankets.  Then the body aches all night long.  The next day I could not go to work.  Then 3 days later I came down with fever, aches, and coughing and have been sick on a off since, which has been 3 weeks. I fell the reaction to this vaccine wiped out my immune system.
I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT). In February 2021, PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not reported.
No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving.  Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Funny feeling/sensation on both sides of jaw, dizzy and heaviness of both eyes.  BP 192/109, 182/115 O2 sat - 100%
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 16th July 2018, the patient received SHINGRIX (intramuscular). On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, chills and tremor. On an unknown date, the outcome of the injection site pain, fever, chills and tremor were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills and tremor to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported the patient had a fever of 103 degree F with shakes and chills for a day after getting SHINGRIX. Less than a day after vaccination, the patient also had pain in her arm at the injection site.
On 10/16/01, the pt's parent reported a severe cellulitis on their son's arm, located below the deltoid and above the elbow, at the site of the injection. The pt was seen by a physician on 10/17/01 when the cellulitis area was determined to be approx. 11.5cm by 12.5cm in size. The event was considered to be "Medically Significant". The physician prescribed oral onphalexin antibiotic to treat the cellulitis. The event was still ongoing at the time of reporting. The reporter has assessed the relationship of study medication to the event as probable.