chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles infection; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HERPES ZOSTER (Shingles infection). At the time of the report, HERPES ZOSTER (Shingles infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR followup. No newinformation received.
Atrial fib. 08/28/2008 MR received for DOS 7/29-31/2008 with D/C DX:  New onset atrial fibrillation.  Benign hypertension. Pt presented with onset of palpitations with a fast, irregular heartbeat associated with some mild SOB.  PE(+) for irregularly irregular heart rhythm. Unable to revert with meds so was cardioverted sucessfully and started on anti-coagulants.
PERIPHERAL NEUROPATHY 8/11/2022 &  8/17/2022 -- RECURRENCE OF SAME SYMPTOMS
Sycopal episode approximately 5 minutes after receiving vaccines. Pt fell backwards landing on floor, hit back of his head. Regained consciousness after approx 30 seconds, no apparent injury. Ice applied to back of head and legs elevated. Provide juice. Pt. complained of headache.Mother planned to take pt into the after hours clinic or call the emergency department if any further care should be given.
This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
(2ND SHINGLES VACCINE SHOT) ON 2/7/21 I STARTED WITH FEELING VERY COLD AROUND 5PM.  AROUND 6:30PM BECAME EXTREMELY COLD TO THE BONE.  7:30ISH STARTED EXPERIENCING WEAKNESS, BODY ACHE &  HEADACHE, CHILLS,  NAUSIA AND UNCLEAR THOUGHTS.  I VOMITED ONCE AROUND 1:30AM. MY  SLEEP WAS RESTLESS WITH VIVID DREAMS THAT WERE DELUSIONAL AND SCATTERED. ALL OTHER SYMPTOMS CONTINUED THROUGHOUT THE FOLLOWING DAY 2/8/21 BUT NOT AS INTENSE AS THE FIRST 10-12 HOURS.  MOST OF THE DAY WAS SPENT SLEEPING AND RESTING. 2/9/21 ALL SYMPTOMS WERE GONE.
HA approx 6 hrs post , profound muscle pain, fatigue & nausea 8hrs post.  Next day, severe (pain level 8-9 muscle, fatigue, HA, nausea T-99.9 for 36hrs.
Patient called on 11/4/2020 to report that after receiving the vaccine, she had fever for 2 days, arm was swollen down to the wrist, and that she felt pain in her arm; she said the pain was going away but arm was still swollen.
Pfizer covid (5-11y) vac (eua), moderna covid (12y up)vac(eua); she got sick from the covid vaccine; congestive heart failure; Atrial fibrillation; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (Unknown).  An 86-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "wild-type transthyretin-relat attr amyloidosis" (unspecified if ongoing), notes: wild-type transthyretin-relat attr amyloidosis; "Allergy to wasp venom" (unspecified if ongoing), notes: Allergy to wasp venom treatment kit; "Allergy to wasp venom" (unspecified if ongoing), notes: Allergy to wasp venom treatment kit. Concomitant medication(s) included: ELIQUIS; FUROSEMIDE; ZOLPIDEM TARTRATE; HYDROXYZINE HYDROCHLORIDE; LATANOPROST; OMEPRAZOLE; METOPROLOL TARTRATE. The following information was reported: ILLNESS (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "she got sick from the covid vaccine"; CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "congestive heart failure"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), outcome "unknown", described as "Pfizer covid (5-11y) vac (eua), moderna covid (12y up)vac(eua)"; ATRIAL FIBRILLATION (medically significant), outcome "unknown"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath". Therapeutic measures were taken as a result of atrial fibrillation. The patient received unspecified treatment on 12Jul2021 for atrial fibrillation  Clinical course: It was stated she could only go a block then gets short of breath. She had heart failure with preserved ejection fraction. In Mar2021 she got sick from the covid vaccine and ended up in the hospital for congestive heart failure. In Aug2021 she got the covid booster and went to the hospital for 5 days and had a partial collapsed lung. Vyndamax start date was unknown, reported as 1.5 years ago. No additional information available. Reporter did not consider event (Shortness of breath) caused by suspect product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely 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.
Covid arm.  Hockey puck sized swelling, redness with itching.  Slightly tender.
left axillary lymph node pain; Lymph node pain in her neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (left axillary lymph node pain) and LYMPH NODE PAIN (Lymph node pain in her neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain in her neck). On 10-Jan-2021, the patient experienced LYMPH NODE PAIN (left axillary lymph node pain). On 06-Jan-2021, LYMPH NODE PAIN (Lymph node pain in her neck) outcome was unknown. On 12-Jan-2021, LYMPH NODE PAIN (left axillary lymph node pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was included. Treatment included unknown.   Reporter did not allow further contact; Sender's Comments: This case concerns a 42-year-old female with a nonserious unexpected event of Lymph node pain.  Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I had fever, chills and body aches beginning the morning after my booster shot and continuing for two full days.  On the third day I felt better but was still weak and running a slight fever.  Today is the fourth day but I am not yet 100%.
Headache, Myalgia & Fever Narrative:  Employee reports body aches, fever, and headache. Temp was up to 103. 1/11 - Employee reports resolution of her symptoms as of 1/9 in  the afternoon. Sunday she felt normal.
Patient saw her primary care practitioner the day after receiving Prevnar 13 complaining of swelling/edema to joints, puffy hands, mild pain, mild limitation to range of motion, timing of 4-6 hours after vaccine administration. The nurse practitioner recommended the patient not get Pneumovax 23 in the future due to the joint swelling experienced after Prevnar 13. Patient was also prescribed a prednisone taper and chart notes the clinic would continue to monitor her closely.
Acute on chronic congestive heart failure. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
4/2/2021 approx. couple minutes after rcvding the 1st dose. Patient reported after rcvding his first dose he felt super hot in his face and all over his body ("felt like my blood was getting hot"), these symptoms went away approx. 8 hours later. Next day (4/3/2021) patient reported pens and needles sensations on his arms, legs and tongue but when he woke up the next morning on 4/4/2021 these sensations went away. That same evening (4/4/2021) the pens and needles sensations returned, and approx. 1 hour later pt experienced shortness of breath (patient reported using his Albulterol inhaler to help with the SOB). On (4/3/2021), also reported had random chills for approx. 10 minutes which than disappeared. Today (4/5/2021), patient reported he felt a little better after taking Prednisolone 4mg, but still continue to have shortness of breath and develop sweaty palms while on the phone. Reported that his resting heart is ranging between 100-105 bpm. Patient reported taking his rescue inhaler Albuterol when he started to experienced the shortness of breath on 4/3/2021, which he stated it only helped for a couple of hours. He took a 4mg Prednisolone dose today 4/5/2021, and felt a little better. Patient also reported he called and got an appt with his PCP to be seen in a few days.  Recommend patient to contact the urgent care facility or hospital since his shortness of breath has not gotten better per based on the information he reports, the medical personnel may ask him to seek medical attention right away. Patient called back 4/6/2021 at 9:49am: Patient stated he felt better today, and the pens and needles sensations has reduced some. Also reported that he tried reaching out to his PCP office but was not able to speak with his doctor. He called the ER yesterday and was advised by the ER nurse to continue to take his Prednisolone, and to go to ER for further evaluation since a diagnose cannot be provided over the phone. Patient reported that he was taking 4mg of Prednisolone in intervals and it that seems to help with the symptoms for approx. 30-45 minutes, but after 4 hours of taking the Prednisolone the symptoms comes back. Patient have an appointment with his PCP on 4/8/2021, advised will follow up with him again on Friday.
Exactly 7 days after the vaccine,  I developed a severe rash all over my body.  Itchy, red and hot
03/23/2005- Right arm itchy, red, and swollen. Treatment with Benadryl- good results
Nausea, unable to vomit due to previous esophagus procedure.  Fever: 101.3
This medically confirmed spontaneous report (initial receipt 06-MAR-2012) concerns a female patient with a medical history of high cholesterol. The patient reported that they have had severe reactions to flu vaccines. Vaccine name and manufacturer was unknown. The patient had a reaction to flu vaccine in 1990 and several other times. One time she developed dry eyes and the flu. Of note, in 2009, the patient's throat swelled and she went to an unspecified emergency room (ER) after receiving a flu vaccine (manufacturer unspecified) (WAVES 2012032146). The event resolved on an unknown date. No other information was provided.
Breakthrough COVID-19 infection. Presented to ED for shortness of breath 08/17/2022. Tested positive for COVID-19 in the ED.
I took the flu vaccine from pharmacy, on 21st October 2020. On 25th October I woke up with high fever and headache and rashes on the left side of my body! I initially tested for covid and the test came out negative. On 29th October my physician diagnosed me with Shingles! I am 33 year old healthy male with no comorbidities or preexisting conditions. I am highly suspicious that the chickenpox virus which was dormant in my brain was reactivated as a result of the flu vaccine. The vaccine was Fluclvx 20-21 Quad 0.5 ml Seq. I am currently experiencing excruciating pain due to shingles and being treated with antiviral drugs.
Immediately after receiving IM AFLURIA pt experienced arm and neck pain; then headache, increased blood pressure, rash, hives and SOB. IM epinephrine administered, then IM BENADRYL. Pt was transported to ER via ambulance.
Patient presented to hospital with SOB. Patient was vomiting at home and his oxygen dropped to low 50s so she called EMS.  Patient was placed on BiPAP and brought to ED for further evaluation. Currently  on 3 L, saturating 100%.  Afebrile
rapid heart beat / heart beat had a fluttering quality; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality). At the time of the report, HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Bodyache; Aches and cramps; chills; headache; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyache), MUSCLE SPASMS (Aches and cramps), CHILLS (chills), HEADACHE (headache) and MYALGIA (Sore muscles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Bodyache), MUSCLE SPASMS (Aches and cramps), CHILLS (chills), HEADACHE (headache) and MYALGIA (Sore muscles). At the time of the report, PAIN (Bodyache), MUSCLE SPASMS (Aches and cramps), CHILLS (chills), HEADACHE (headache) and MYALGIA (Sore muscles) outcome was unknown. Not Provided          No concomitant medications were reported. No corrective treatment was reported.
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days.  No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
No reaction at time or day of injection. Patient called the pharmacy on 1/7 to discuss that starting on 1/5 he was breaking out in hives. So significant that he did present to Urgent Care for it. Started on one shoulder, then spread to the other, then trunk of body, down the legs. Hives and itching were his chief complaints. Denies other systemic involvement. As of 1/7 afternoon when I talked to him there had  NOT been improvement yet with his systems but denied worsening. He was advised by urgent card MD to take OTC benadryl to help with the reaction. He was advised to follow-up with primary care MD and allergist or to return if worsening occurs. On 1/7 when I talked with the patient he as taking the benadryl only about once daily - mainly because of the drowsiness potential was making him nervous. We discussed using OTC once daily antihistamines that aren't as sedating . Could also use benadryl at bedtime if itching was bothersome. Advised he could use cold compress or washcloth on areas that are bothering him as a comfort measure. I did discuss that taking hot showers or baths could make the skin look more red or the hives look worse. Also discussed about what to do if worsening, if new symptoms started and then the importance of following up with MD/allergist.
Myalgia for 3 days after first dose.  Pain in all joints, muscles, bones.  Also experienced minor flu-like symptoms for 3-4 days.
At 24 minutes after vaccination, pt experienced chest tightness, shortness of breath, cough, flushing, and rash on chest and neck.
8 pm chills and tremors started. Alternated throughout the night with chills/ fever and sweating. Severe muscle ache and headache. Lasted about 12 hours.
Nausea for a day followed by stomach pain and vomiting for approximately 24 hours, the nausea continued for about 6 more days. No one else in my household became ill and I was the only one that had recently received a vaccine.
Pain in lungs; Pain at top of breath; Felt pain in back; Joint pain in right ankle; Joint pain in right wrist; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath), BACK PAIN (Felt pain in back), ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021 at 2:00 AM, the patient experienced PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath), BACK PAIN (Felt pain in back), ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist). The patient was treated with IBUPROFEN for Adverse event, at a dose of 800 milligram. On 08-Feb-2021, ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist) had resolved. At the time of the report, PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath) and BACK PAIN (Felt pain in back) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.
Symptoms include headache, sore throat, fever and decreased appetite.  Fever was up to 102.5.
Patient is currently pregnant received Influenza (Flulaval) vaccine on 10/31/23, at 10 weeks 3 days gestation, due date is on 5/25/24, post administration she started having itch & generalized rash on body. Denies airway issues & facial swelling. Patient called our clinic on 11/3/23 stating her allergic reaction, & continues with a rash with itch, she was triage one of our nurse and recommend to take Zyrtec & to follow label instructions & ED precautions were reviewed.
48 hours after vaccine developed erythema sl swelling and itching - improved with compress and antihistamine
pain in arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain in arm) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
generalized hypoesthesia, extreme for 36 hours, fading but still present 7 days out fatigue, nausea, lack of coordination
Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022; 25 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Initially the vial was stored on the refrigerator on 17-Feb-2022. The vial did not undergo any temperature excursion. It was reported by the reporter that the vials likely did not maintain the activity necessary to fully protect against the SARSCoV-2 (COVID-19) virus at time of administration. No adverse events were reported by the patient.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: No new information added