chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included pneumonia, penicillin allergy, diabetec and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included potassium citrate, tamsulosin, glipizide, magnesium sulfate, (6s)-5-methyltetrahydrofolate glucosamine, mecobalamin, pyridoxal phosphate, thioctic acid (PODIAPN), dulaglutide (TRULICITY), carvedilol, rosuvastatin, furosemide, acetylsalicylic acid (BAYER ASPIRIN) , valsartan, ubidecarenone (COQ-10), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA), salbutamol sulfate (PROAIR HFA) and apixaban (ELIQUIS). The patient previously took amoxicillin at 1 DF, 2x/day (one tablet by mouth every 12 hours), azithromycin at 250 mg (250mg, take two tablets by mouth and then one tablet by mouth for four days) and prednisone at 20 mg (20mg, three pills daily for three days then two pills daily for four days). It was reported that the patient had rash toes up to neck. The patient's wife was wondering if it was normal for his husband to experience rashing after getting the vaccine. The patient had a rash that started from his feet. It looks like sunburn. It is going up his legs, body, and chest. It started the day after the vaccine. Two weeks ago he went to his pulmonary doctor and he had pneumonia. They gave him prednisone, Amoxicillin, and Azithromycin and both are forms of penicillin which he is allergic to. He hasn't taken it in years. The doctor knew that. She is not sure if the rash if from that. He ended those medications the Friday before the vaccine, 08Jan2021. She is confused. Everyone she calls says they are not sure if it was the medications or the shot. She is trying to get a dermatologist to see the patient. The rash started on 16Jan2021. It has progressively gotten worse. She is wondering if the patient should go back on the fifth for the second vaccine. She is assuming it is the medication. The nurses and doctor don't know. They said take him to the ER. He is not having trouble breathing. If he was having trouble breathing she would take him to the ER. She can't get anyone to look at the rash. She didn't do anything. He is supposed to get the second dose on 05Feb2021. The outcome of the event was not recovered.
I have been post menopausal for about seven years.  Two months after my vaccine, I began spotting again.  An endometrial biopsy showed a lot of tissue.
severe migraine, body aches, fever, arm so sore I could barely move it, lack of appetite all started about 15 hours after the shot, tylenol helped with fever, but not with the headache,
HCP reports no further AE's; A 12 year old inadvertently received a 3rd dose of Hepatitis A vaccine; This spontaneous report has been received from a medical assistant, regarding a 12-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was unknown.  On 22-MAR-2011, the patient was vaccinated with the first one dose of hepatitis A vaccine (manufacturer unknown) and on 16-FEB-2012 with the second dose of hepatitis A vaccine (manufacturer unknown) (formulation, strength, exact dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided).    Moreover, on 17-MAR-2022, the patient was vaccinated inadvertently with a third dose of hepatitis A vaccine (VAQTA) syringe, at a dose of 0.5 milliliters (mL) one time as prophylaxis (lot number U004366 was verified as valid, expiration date reported and established as 01-OCT-2022) (route of administration and anatomical location date were not provided) (extra dose administered); on that same day the patient was also vaccinated with human papilloma virus (HPV) vaccine (manufacturer unknown) and with meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). No adverse events reported (no adverse event).
Body aches; Nausea; This spontaneous case was received on 23-Sep-2020 from other health professional via agency (reference number: SEQW20-02108) and concerned a 27-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed nausea and body aches. No corrective treatment was given for the event.   On the same day, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked with the cases 202004663, 202004664, 202004666, 202004667 and 202004610 (the same reporter).  Company comment: The patient developed pain and nausea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain and nausea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Patient suffers shoulder pain and limited movement after getting 2nd Covid shot on 04/27/2021. Any NSAID does not help reducing her pain nor her shoulder movement. She also got steroid shot and waits for MRI.
This spontaneous report was received from a consumer referring to her husband, a 72 year old male patient. The patient had no relevant medical history, drug reactions/allergies or concomitant medications. On 28-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot number: N019983 (expiration date: 03-MAR-2019), for prophylaxis (strength, route and dosage schedule were not reported). On 29-JAN-2018, the patient's arm was swollen to the extent that the bicep was below the elbow. The patient also had some light pain but no fever. The patient did not seek medical attention but was advised to take BENADRYL. No studies or diagnostic tests were carried out. The outcome of swollen arm and pain was reported as not recovered. Causality assessment was not provided.
3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago; Patient received vaccine from vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J121A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2022 at 10:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received first two Moderna COVID-19 vaccines at a different vaccination site. Date the vial initially stored in the refrigerator  was 07-Feb-2022, date and time the vial first punctured was16-Feb-2022 at 10 am. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was 27 hours. The reporter was not aware of any adverse event complaints.  No treatment information was reported.   This case was linked to MOD-2022-487921, MOD-2022-487948 (Patient Link).
Following the shot I had a little bit of ache and arm soreness and tiredness and when the reaction hit, I laid down for a short nap woke up walked to kitchen and couldn't catch my breath. I called my an ambulance and went to hospital the doctor said I had blood clots in both lungs and an enlarged heart.
side effect; 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 VACCINATION COMPLICATION (side effect) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.            no concomitants and treatments drugs was reported.
My normally regular period (28/29 day cycle, regular for many years), was over two weeks late. Menstruation was due 2/1-2/2 and did not begin until 2/18. Both the duration and flow were normal for me.
He only had the flu shot. He started bruising and having blood spots under the skin. Went to pediatrician and sent for labs. Bloodwork showed platelet count of 5. Sent to ER. Bloodwork confirmed low count. Sent to hematologist and diagnosed with ITP on 12/11/2018. Went to clinic for second opinion on 12/13/18 and diagnosis was agreed.
vaccines were administered to an unspecified number of unspecified patients after being out of proper temperature range on unspecified dates; No adverse effects; This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age and gender.      On unknown dates, these patients were vaccinated with an unspecified number of doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis after being out of proper temperature range (product storage error). The stored highest temperature reached 52.7 Fahrenheit (F) for 1 hour and 50 minutes and the data logger was involved. Vaccines had previously been exposed to out of range temperatures however this information was not available at the time of the report. No adverse effects reported.  This is a non-valid case due to no patient identifier.
The 1st and 2nd day the pt reports tightness in the chest and difficulty breathing. The 3rd day the pt reports burning and red blotches and sores on both hands, arms, and face. The pt went to the dr office on 6/12/19 and was sent to the emergency room. she was given benadryl for the reaction. 6/14/19 she was seen again by her primary care dr and was told to continue the benadryl and to cover the sores with vasoline. 6/14/19 her face arms and hands are beat red with open sores.
Got a rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Got a rash) 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 event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Got a rash). At the time of the report, RASH (Got a rash) outcome was unknown.        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.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021.
unable to eat; weakness; Weight loss; chills; fever of 102 degrees F; nausea; tiredness; pain in arm; red ring around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) in a 77-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.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site). On 22-Mar-2021, the patient experienced FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness). On 25-Mar-2021, FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 (Inconclusive) 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided. The patient was due for  second dose on 14Apr2021, but had concerns about getting the second dose due to the side effects patient was experienced after the first vaccine.; 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.
Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temperature/redness  extending from axilla into Right pectoral region with pain/discomfort also. Performed gentle lymph drainage massage to Right trunk/shoulder regions and added Lymph Tone II homeopathic drops 3 times daily, with resulting dissipation of  fluid in the pec region and decreased soreness.
General body pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second 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) 40 milligram every two weeks. On 21-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN (General body pain). On 21-May-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN (General body pain) had not resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
My 12 yo daughter became extremely hot, brain fog and dizzy abt 5 min after shot.  Facility put her in a plastic chair in middle of the decongestant isle after shot, with customers shopping amongst her.  She was wearing her mask and fainted, and fell off the chair into the decongestion rack.  Scratching side of face / deck with cut lip and bump on lip.  They pharmacy intern who administered the shot did ask if we wanted emt and I said no.  Drove her home, ministered her and called her primary doc,.
Patient received Moderna COVID vaccine on 3/5/21 (lot # 029A21A), 4/5/21 (lot # 026B21A), 11/17/21 (lot # 066F21A), and 4/27/22 (lot # 065K21A). On 10/29/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 pneumonia and generalized weakness. On 11/3/22, patient discharged back to ALF.
Swelling at Immunization site since given 4/4/11. Sometimes as large as an egg. Swelling typically goes down inthe pm and recurrs during the daytime. Inability to lift arm above 45 degree angle. These signs and symptoms reported to provider by patient.
Received DAPTACEL (DTaP) Right thigh IM on 6-3-2011. Experienced swelling of Rt thigh from hip to knee over the weekend. X-ray neg (to R/O fx). Pt presents not walks without limping, no pain, no erythema. Still has non tender nodule at upper Rt thigh. May use TYLENOL/ADVIL PRN.
Complete paralysis of arms, hands and face for more than 1 hour.  Tingling and some numbness in legs and feet.  Extreme pain in the arms.  Rapid heart rate and sweating accompanied the paralysis.
COLITIS ULCERATIVE AGGRAVATED; This spontaneous report received from a patient via other company concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported.  On an unspecified date, the patient experienced colitis ulcerative aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from colitis ulcerative aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220863481- covid-19 vaccine ad26.cov2.s - colitis ulcerative aggravated. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Legs hurt below knee during sleep; Itching injection site; Rednss of Left arm, Injection site around 2 inch; Swelling , Injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.
24hrs after the vaccine was administered, I experienced the usual mild body weakness and perhaps a slight temperature.  It was not concerning to me and I rested that evening early,  However, after a few days, I noticed an increase in my tinnitus.  I initially thought it was due to the cold weather and perhaps some underlying cold developing.  But this was not the case and the tinnitus has persisted ever since to become a hissing sound in both ears, put perhaps more so in my left ear.  The original underlying tinnitus hum has increased in volume but it is the new hissing sound that particularly disturbs me to the point that I have found sleep very difficult.  The tinnitus has varied in type and volume, but hardly ever ceased at all.  I have never experienced it for this length of time at this volume.  Sometimes the noise has been steady, at other times pulsating.
Muscular paralysis, does not allow movement for several hours. The second dose had completely paralyzed me for 14 hours in a row and in this third dose, although I had some limited movement in my hands and legs, the effect lasted for a day and a half. The first were around for 20 hours I could hardly move, then with a lot of pain and difficulty I could stand, today on the third day I still had some pain in my legs and imbalance when walking. At the moment I have no movement control.