chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant medicine were reported. No treatment medicine were reported.
I started with sneezing; I started with a runny nose - on the right side; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (I started with sneezing) and RHINORRHOEA (I started with a runny nose - on the right side) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced SNEEZING (I started with sneezing) and RHINORRHOEA (I started with a runny nose - on the right side). At the time of the report, SNEEZING (I started with sneezing) and RHINORRHOEA (I started with a runny nose - on the right side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication given no treatment provided
Patient did not know at the time of vaccination that she was pregnant nor was she trying to get pregnant. Patient did sign a consent form for the vaccines and it did ask if she was pregnant or intended on becoming pregnant in the next few months, and she answered no since she had no idea that she was pregnant. She missed her period the following week and took an at home pregnancy test 10/14/17 which came back positive. She went to her first OB appointment 10/31/2017 and had an ultrasound. Fetus was measuring 6 weeks and 3 days with a due date of 6/23/2018.
I have had numerous GI issues, constant daily headaches and had a absent seizure last Friday for the first time in my life.  I have also had hormonal issues including inflammed ovaries and cycle changes.
Patient is a 25-year-old male with past medical history of depression with anxiety, esophagitis and hemorrhoids.  Patient presented with petechial rashes all throughout his body  started on Friday 4/9 after getting a tattoo the day prior and his first moderna covid vaccine 3/28.  On admission patient was found to have a platelet count of 1. Heme/ onc was consulted and thrombocytopenia was deemed secondary to ITP.  Hepatitis B panel, showed previous hepatitis B infection, although results may be inaccurate due to patient receiving IVIG prior to hepatitis panel being done.  Patient also had an equivocal syphilis result, which also could be a false positive due to immune response.  Patient received 2 IVIG, 4 days of Decadron, and 1 dose of Nplate.  Patient did not receive rituximab, due to stable increasing platelet count.  Patient received hepatitis-B prophylaxis for 2 days in case he were to receive rituximab.  Platelet count now stable at 25, to follow-up with hematology in 1 week outpatient for repeat CBC.  Patient also to follow-up with his Primary Care Physician in 1 week.
Returned to clinic 10/18 c/o fever 99 degrees F - seen by med provider L shoulder to elbow red, swollen - warm to touch and tender without erythema and edema. Dx as arthus reaction. Rx - tylenol and cool pack to area 10/99 referred to clinic - swelling resolved - given Benadryl for itching
4/22/21 Patient admitted to hospital for COVID D/C summary: Clinical Summary a 70 y.o. male with a history of HTN, prostate cancer, chronic pain, T2DM, OSA noncompliant with CPAP who presented to ED 4/22/2021 with scant hemoptysis. Found to be COVID+ and hypoxic requiring 2L NC. Cr. 1.4. He was transferred for further evaluation and management. Improved with Remdesivir and steroid therapy. Patient completed 3 doses of remdesivir, recommended completion of steroid therapy (5/2) and repeat outpt CT Chest.     1. Acute Hypoxic Respiratory Failure: requiring 2-3L NC on admission in setting of COVID-19 pneumonia. CTPA with no PE, patchy multifocal ground glass opacities, mildly enlarged mediastinal and hilar LAD, likely reactive. Pulmonary hygiene. Weaned off of O2 4/24/21. Home o2 evaluation with patient desaturating to 91% with exertion. 2. COVID-19 Pneumonia: symptoms began 4/20/2021 with headache, fever, chills and diarrhea. Presented with scant hemoptysis. COVID + 4/22/21. Febrile to 101 on admission. CTPA as described.  Hypoxia as described. Started decadron (stop date 5/2), scheduled albuterol, mucinex. Monitor respiratory status. Pulmonary followed, initiated Remdesivir 4/23 following improvement in renal function. Recommended completion of 10 days of steroid therapy. Recommend repeat CT chest in 4-6 weeks for resolution.
fever / went as high as 102; shivers; headaches; body pain; pain level was / 5 out of 10 and was in "all my joints" /  knees, hips, neck, and bottom of her feet; pain level was about a 5 out of 10 / was in / neck; pain level was about a 5 out of 10 / was in / bottom of her feet; could not stand; had to lay down for 2 days (due to the pain).; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreaks on 2 occasions). Previously administered products included Zostavax (prior vaccination with the other shingles vaccine).   On 5th March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, shivers, headache, general body pain, joint pain, neck pain, foot pain, difficulty in standing and activities of daily living impaired were recovered/resolved.   The reporter considered the fever, shivers, headache, general body pain and joint pain to be related to Shingrix. It was unknown if the reporter considered the neck pain, foot pain, difficulty in standing and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose in her left deltoid. The patient did not have the lot number and expiration date but did provide the contact information of her doctor's office where she received the shot. The patient experienced severe side effects of all the symptoms. The patient experienced fever, shivers and headaches and she said they all resolved after 2 days and she was fine now.  The reporter mentioned that her fever went as high as 102 degree C and she thought that it perhaps would have gone higher but she took Advil and that brought it down. The patient also had body pain and pain level was about a 5 out of 10 and was in all her joints including her knees, hips, neck, and bottom of her feet.  The patient could not stand and had to lay down for 2 days due to the pain. The reporter consented to follow-up.
Hospitalization due to shortness of breath and difficulty breathing. Other symptoms include fever, chills, myalgia, new loss of taste and smell.
Patient called and complained of flu like symptoms. Had injection site pain and knot at injection site. Also complained of fever, chills, rigors and malaise.
I had stem cell injections Stepember 2020 on my right knee. And yesterday I was walking out in front of may house about 3pm and my knee started to hurting so bad it like the vaccine wipe out my Stem Cell injections. And I ice it down and it was better...And today I tried walking again it 3pm and I had the same problem..
4 inch welt at injection site on left arm. Area inflamed and itchy. Treated with Benadryl po and warm compresses. Recovering
Patient reported that  immediately after receiving the vaccine, she felt a tickle in her nose, but noticed nothing else out of the ordinary. About 2 1/2 hrs later, she started having a nosebleed. Nosebleed persisted and after 2 hours, she presented to ED for treatment which included cautery. Reported BP of 150/94 and slight fever. Fever of 101 persisted the following day, accompanied by chills. As of 2/12/21, feels some fatigue, but otherwise back to normal.
From superior imm in left ant thigh sig inflamnation spread //// all the way to his knee. Rash overlying. Limp. Did not treat for bacterial infection. Probably DPT.
Urgent Care and was diagnosed with chickenpox; Information  has been received from a physician via a company representative reporting on a female married patient in her fifties. The patient's pertinent medical history included thyroid cancer. The patient's concomitant medication and drug reactions/ allergies were unknown by the reporter. The patient reported that her husband developed shingles. The patient never had had chicken pox or had an unknown varicella vaccination history.  On an unspecified date in August 2019 (reported as "in last 10 days"), the patient received an unspecified dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous for prophylaxis (lot number and expiration date were not reported) which was diluted with sterile diluent.  On an unspecified day recently (also reported as on "12-AUG-2019"), the patient reported to Urgent Care and was diagnosed with chickenpox. It was unknown if lab diagnostics/studies were performed. The patient was prescribed valacyclovir hydrochloride (VALTREX) and at the time of the report was doing fine (recovering).  The causal relationship between the event varicella and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX) or sterile diluent was not provided.
Pt was given varicella inj. on 4/30/13 in (L) arm SQ. Pt RTC on 5/1/13 c/o pain, redness at inj. site - lemon size red area noted with warm to touch at inj. site. Instructed to apply ice to area, use TYLENOL/MOTRIN PRN. Report to ER/MD with further concerns or if worsens at all.
Lumps on front and back of neck. Dx: Lymphadenopathy. Amoxicillin 40 mg/5 ml take 10 ml BID. *Pt was seen at express care.
I notice some swelling during the day, when I looked at it around 6:00 PM It had swollen up the size of a baseball and there was a red 1/2 inch line under the swelling.
17 year old who was vaccinated and scheduled for the 2nd dose; A spontaneous report was received from a Health care professional concerning a 17 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) at 17 years of age (17 year old who was vaccinated and scheduled for the 2nd dose).  The patient's medical history was not provided by the reporter. No concomitant medications was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient was vaccinated at 17 years of age (17 year old who was vaccinated and scheduled for the 2nd dose) and scheduled for a second dose on 27-FEB- 2021.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of 17 year old who was vaccinated and scheduled for the 2nd dose was unknown.; Reporter's Comments: This report refers to a case of 17 year old who was vaccinated and scheduled for the 2nd dose for mRNA-1273 (lot # unknown) with no associated adverse events.
Patient came in for second covid shot. She was alert as time of administration. During administration, Rph recalls that the needle punctured the patient's skin, but then slid out before the plunger could be activated. Rph apologized to patient and continued to administer the vaccine without further incident. patient left the vaccination room, and within 5 minutes was complaining of feeling dizzy. A family member alerted the pharmacist, who went out to examine the patient. she was sliding down in her chair and began to turn pale. after a few more moments of observation, the pharmacist called 911 and EMS was dispatched to the scene within 5 minutes. With their evaluation, the patient was taken to the hospital by EMS for further evaluation and treatment.
Pain at the injection site from as soon as the needle went in to now, almost 2 months later. I can't lift items outside of a certain range. Sometimes the pain stops me from being able to close my car door with that arm.
Pain in front of left leg, to the right of shin area.  No treatment.  Jaw pain when making side to side movement
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (strength, dose, frequency and route were not reported) lot # K022446 and lot # K020751 expiry dates not reported. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of two reports from the same reporter. Additional information has been requested.
sore arm; Diarrhea since day got 2nd shot; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 (Lot number: EWOISO) at the age of 57 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; FARXIGA; SIMVASTATIN; UBRELVY. Vaccination history included: Bnt162b2 (DOSE 1; lot number: ENG207; administration time: 02:30 PM; anatomical location: Arm left), administration date: 09Mar2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 17:00, outcome "unknown", described as "sore arm"; DIARRHOEA (non-serious) with onset 31Mar2021 17:00, outcome "unknown", described as "Diarrhea since day got 2nd shot". Therapeutic measures were not taken as a result of pain in extremity, diarrhoea. Additional Information: There are no other vaccine administered within 4 weeks. Patient has not tested positive for Covid prior/post vaccination. Patient was taking unspecified vitamin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361153 same drug/reporter, different dose and events
Within 6 hours of getting my shot, I went into A-Fib; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 63-years, at single dose in right arm on 17Mar2021 at 09:30 (Lot Number: ER2613) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, within 6 hours of getting his shot, he went into A-Fib (on 17Mar2021). He was in it for 18 hours before going back into the clinic. They took him to ER where he was electro-cardioverted. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". And the patient received treatment of electro-cardioverted for the event. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was recovered.
requested  medical records, records never received; pt had a positive COVID test on 9/18/21; per death certificate, pt died in the nursing home with a condition contributing to death being recent COVID 19 infection
Feeling bad; Feels a little bit with a cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Feels a little bit with a cough), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced COUGH (Feels a little bit with a cough) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad). The patient was treated with CAMPHOR, EUCALYPTUS GLOBULUS OIL, MENTHOL (VICK VAPORUB [CAMPHOR;EUCALYPTUS GLOBULUS OIL;MENTHOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Feels a little bit with a cough), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling bad) had not resolved.    No concomitant medications were provided.  The patient got the first two shots of Moderna and now wanted to get the third one. The patient was feeling a little bit with a cough. The patient mentioned that it had been three days since the patient started to experience cough and a runny nose. The patient was feeling bad.  Other treatment information provided included Tea and water.
Per Allergy note 9/23/09: Received the Influenza intramuscular injection in the left arm as well as pneumococcal intramuscular injection in the right arm on Wed, Sept 16th.  She states that during her waiting period of 15 minutes, she did not have any sxns.  However about 45 minutes post vaccination, she developed a sense of flushing and redness over her upper body, starting at her chest and rostrally to her head. She also had a sensation of mild pruritis initially.  She states that her sxns got progressively worse over the next 24-36 hrs.  48 hrs post vaccination, her sxns had progressed to facial erythema pruritis, and swelling.  She also felt she was having some tightness in her throat, and throat pain.  In addition, she began developing some SOB.  She saw her case manager, who recommended that patient go to the ER.  She did not initially go, but that afternoon around 1400 her sxns were to the point that she was seen in the ER (worsening SOB and throat tightness).  She was given BENADRYL and ZANTAC IV, as well as IV steroids.  She was noted to be wheezing per patient report and received ALBUTEROL x2.  She was observed for a few hours and discharged with PO BENADRYL 50mg q6hrs, po ZANTAC 150mg po bid, and PREDISONE 7 day taper.  That evening, she had a recurrence of SOB sxns, and was seen in the ER and received another dose of BENADRYL, steroids, and ALBUTEROL nebs x 3.  She did not receive Epinephrine.  She was discharged and instructed to continue her medications.  She states that her sxns did not progress from there, but gradually improved over the next 2 days, completely resolved 2 days ago.  She was seen yesterday by her PCM for continued throat pain and given TESSALON pearles.  Her air movement has improved, but she continues to use ALBUTEROL 2 x/day, previously not requiring any.  She describes slight heaviness of her chest.  She did not develop any abdominal sxns, dizziness, or neurologic sxns.  Her vaccine sites had mild erythema and tenderness, larger on the area of her pneumococcal vaccine. No hx of reactions to previous FLUMIST vaccines or previous IM flu vaccines.  No history of egg or gelatin allergies.  Symptoms: Pruritus, wheezing swelling (facial), dyspnea (shortness of breath), Odynophagia (burning pain w/swallowing, tightness in throat).
Severe bone pain, feet, ankles, risk, hands , and especially legs pain hands everything resolve within a week with exception being hand  and fingers. Hand and fingers  severe pain for a 3 weeks got better for a week and came back more severe and the sought treatment form doctor . NPN sent for blood test for inflammation and arthritis.   Rheumatologist arthritis negative and  inflammation  factors was high.  Referred Rheumatologist.
HEADACHES IN THE BACK OF HEAD; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches in the back of head, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site, and the outcome of headaches in the back of head was not reported. This report was non-serious.
He developed redness, pain in left arm following vaccine, developed some streaking of arm towards his neck and chest. He was treated with oral KEFLEX. After 1-2 days it seemed to worsen, and he was taken to ER. He was admitted to hospital 1/29/21-2/2/21. He received IV antibiotics and continued with significant pain. He had ultrasound of arm and MRI of arm and shoulder that were wnl. He was diagnosed with neuralgic pain by neurology. Pain management team has started him on Neurontin. He is still experiencing pain especially with moving his arm above his shoulder.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/24/20 2nd dose01/14/21 Diagnosed covid positive:09/08/21 Symptom onset:09/08/21 Exposure:community Symptoms:fever, cough,fatigue,muscle aches,sore thraot,chills,runny nose,HA
Within 24 hours of receiving the flu shot, patient's left arm became red, hot and very swollen.  Went to emergency room.  Patient was treated with augmentin.  Cellulitis resolved.