chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; muscle pain; chills; joint pain; low grade fever; feeling unwell; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (lot: fb9810), via an unspecified route of administration in arm left on 13Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes, pacemaker, and high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was none. Concomitant medications included metformin, insulin glargine (LANTUS), insulin lispro (HUMALOG), and atorvastatin. The patient experienced headache, muscle pain, chills, joint pain, low grade fever, feeling unwell, and tiredness on 14Feb2021 08:00. Treatment was not received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved. This case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2012US012493 is an initial spontaneous report received from a medical assistant on 19 Jun 2012: This case refers to 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10130), intramuscularly, without being reconstituted with Men A component on 18 Jun 2012. No adverse reaction occurred following this administration error.
Baby was very fussy for two weeks, had lots of trouble sleeping, did not want to lay down horizontally, was very sensitive to light, and very sensitive to loud sounds. I suspect baby migraines.
This spontaneous report was received from a nurse and it concerns a potential product confusion. The reporter stated that she heard of many healthcare providers almost mistaking VAQTA pre-filled syringes with FLUZONE for patients 3 years of age and older as the products look very similar. The reporter was not aware of any instances in which product was administered to a patient as a result of this confusion. No adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.
feeling a lump in his armpit while taking a shower./ lump was in the arm where he received the vaccine.; He also stated feeling a sore muscle around the area of the lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Feb2022 (Lot number: FK9729) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose #1, Lot: EW0169, Unknown manufacturer), administration date: 30Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose #2, Lot: EW0186, Expiration: 31Aug2021, Unknown manufacturer), administration date: 21May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 06Feb2022, outcome "not recovered", described as "feeling a lump in his armpit while taking a shower./ lump was in the arm where he received the vaccine."; MYALGIA (non-serious) with onset Feb2022, outcome "not recovered", described as "He also stated feeling a sore muscle around the area of the lump". Additional information included: The next morning after vaccination on 06Feb2022, feeling a lump in his armpit while taking a shower. He also stated feeling a sore muscle around the area of the lump and that said lump was in the arm where he received the vaccine. He woke up with a lump in his armpit. He looked it up on internet and it said something about lymph nodes. He got a small lump in his armpit in the same arm he got the shot in. It is like a little ball. The patient still got it feels like a sore muscle. No follow-up attempts are possible. No further information is expected.
No additional adverse event; Expired vaccine administered; This spontaneous report was received from a clinical director referring to a 12-month-old female. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 27-JAN-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (valid lot #T002847, expiration date: 23-JAN-2022) (route of administration, vaccination scheme frequency, and anatomical location were not provided). No additional adverse event was reported.
Rash on face, chest, arms - resolved, joint pain in fingers and feet - resolved, neck pain - seeing massage therapists for muscle spasms - not parotid glands.
severe wheezing & SOB hospitalized ER 9PM 17NOV95 had EKG, blood work, 02, lung tx, shot cortizone-heart monitor; kept overnoc for observation & monitered overnoc;MD determined rxn to flu shot
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient. Current conditions of the patient included erythromycin allergy and sulfa allergy. The medical history of the patient included atopic dermatitis approximately on an unknown date in 2013 (unspecified if it was in September or October 2013) (reported as about a month ago), resolved on an unknown date in 2013 (reported as now, exact date unspecified). On 28-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date was reported as J006153 and 30-AUG-2014 respectively,  dose unspecified), subcutaneously in the right arm. Concomitant therapies included SIMVASTATIN TABLETS USP, WELLBUTRIN XL, topical estradiol cream and lorazepam. Approximately on an unknown date in October 2013 (reported as shortly after the administration of vaccine), the patient experienced red, itchy rash around the injection site. The patient sought medical attention (pharmacy call). The pharmacist reported that the rash appeared to be resolving with use of some hydrocortisone cream. ON 01-NOV-2013, the patient was presenting with a red, puffy spot on her right elbow that may or may not be related to the ZOSTAVAX. The relatedness for red, itchy rash around the injection site was unknown for ZOSTAVAX. Additional information has been requested.
2 days after my first shot I started to have left sided chest pain. The first few nights were so bad I couldn't sleep on my left side. With chest pain also came palpitations where it felt like my heart was skipping a beat. Palpitations were on and off until 4 days after where they were constant, one per minute, the whole day. Visited urgent care the next day for that reason, got an EKG, chest xray, everything looked normal. Was advised to rest on Monday (take off work) and see cardiologist ASAP. Saw doctor that Tuesday, EKG looked normal. Scheduled for echo and blood tests later. In the meantime I took magnesium which didn't seem to help, I did take 600MG of Advil one day for menstrual pain and my chest pain went away as did the palpitations. But following that I had horrible acid reflux where I felt food coming up in my mouth constantly for several days and gum inflammation. I have never had issues taking that much advil before. It is a month after my first dose and I still experience palpitations every day. At night they are the worst where I feel them once per minute, sometimes several following each other. With my 'attacks'  I still get chest pain, still left sided. Caffeine does not seem to affect my palpitations as I have cut back with no effects.
PATIENT ARTHRITIS FLARED UP IN BOTH KNEES LATER IN THE EVENING AFTER PATIENT TOOK HER FIRST DOSE OF COVID 19 VACCINE. PATIENT STATED SHE COULD NOT STAND UP BECAUSE PAIN WAS SO PAINFUL IN BOTH KNEES. PATIENT ICED AND TOOK NSAID FOR INFLAMMATION, BOTH WHICH PATIENT SAID HELPED THE PAIN. TODAY PATIENT SAYS KNEES STILL HURT BUT PAIN IS MORE MANAGABLE. PATIENT WILL CONTINUE TO ICE AND TAKE NSAID SINCE BOTH HELPS WITH PAIN.
Shortness of breath, tightness in chest, numbness in left side of body (arm, hand, below knee)
flu; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211019001069).  This case involves female patient (unknown age) who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Feeling hot; Grand Mal Seizure/ seizure w/ Injuries requiring stitcher; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher) (seriousness criterion medically significant) and URINARY TRACT INFECTION (Urinary Tract Infection). On an unknown date, the patient experienced FEELING HOT (Feeling hot). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher), URINARY TRACT INFECTION (Urinary Tract Infection) and FEELING HOT (Feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. The patient felt hot, and after that remembered being strapped to a stretcher and getting oxygen put in her nose. On 30-Aug-2021, she done with UTI test three times where result were unknown. On 20-Oct-2021, she had seizure with injuries requiring stitches.  Company Comment :  This case refers to a 43-year-old female patient with no relevant medical history who experienced the unexpected event of Generalized Tonic -Clonic Seizure approximately 25 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as the event occurred after the first dose. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received on 04-SEP-2021 contains No new information. However, updated reporter type to Non-Health Professional, missed in earlier step. On 22-Oct-2021: Follow-up received on 22-Oct-2021 included updated Adverse event.; Sender's Comments: This case refers to a 43-year-old female patient with no relevant medical history who experienced the unexpected event of Generalized Tonic -Clonic Seizure approximately 25 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as the event occurred after the first dose. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
large pink circle at the injection site; Discoloration at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Discoloration at the injection site) and INJECTION SITE DISCOLOURATION (large pink circle at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (Discoloration at the injection site). On 28-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (large pink circle at the injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Discoloration at the injection site) and INJECTION SITE DISCOLOURATION (large pink circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided.  Treatment Medications were not taken by the patient.
The vaccine was given at 2.30 pm on 7/12/2005.  The child experienced soareness in her arm during the evening and had trouble sleeping.  She woke up with fever increasing from 99.7 to 100.5.  15 mL of Children 's Tylenol was provided at 7 am.  The fever was slighltly reduced to 100.3 after 30 minutes.  It continue to be reduced to 99.2 after two hours.  However, it increased to 100.00 after a few minuted.  At 11.30 am we gave another does of Tylenol 15 ml.  She fell asleep.  She woke up at 1.30 pm and she is still hot, weak, lost appetite.  She is drinking now fluids and trying to stay cool.  We will recheck her temperature at 3.30 pm when it is time for her third doe of Tylenol.  Soareness continues to the touch.
Presented  with SOB and back pain, Covd +; Admit to Facility with Covid PNA; tx with Vit C, Vit D, steroids,  zinc, minimal O2 supplement Patient was in volume overload with acute diastolic congestive heart failure.  Patient attended 2 dialysis sessions with improvement of the symptoms.  She also had mild COVID pneumonia. Patient is fully vaccinated. On the day of discharge he was requiring 2 L oxygen and she has been discharged after the oxygen was arranged.
Sore arm at injection site; fatigue; Tachycardia; near syncope; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 15Apr2021 12:00 (at the age of 43-year-old) as 1st dose, single for COVID-19 immunisation . The patient's medical history was not reported. Patient was not pregnant. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (IBUPROFEN); both taken for an unspecified indication. The patient experienced sore arm at injection site, fatigue, tachycardia and near syncope on 22Apr2021 12:30. The events required emergency room and physician office visit. Patient received METOPROLOL as treatment for the reported events. Outcome of events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of Vaccination site pain, Fatigue, Tachycardia and Presyncope and 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.
Typical arm swelling; Headache; Tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 5th of the 17 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization at the village. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had typical arm swelling; headache; and tiredness. "Multiple friends" (unspecified number of patients) had the regular side effect of soreness in the arm. The outcome of the events, 'typical arm swelling', 'headache' and 'tiredness', was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/product/events, different patient
pt states had fever 102 & nausea the morning p/having 1st vax;
Pt was given a Pfizer covid vaccine that was drawn up the day before.  Vaccine was stored in refrigerator and was given approximately 12 hours after being drawn up.  Provider informed and then patient was informed no need for additional care, pt reports no symptoms.   No further care needed.
patient did not show up for her 2nd appointment; administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) and PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21A) 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 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) had resolved.        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.   Concomitant medications were not provided. Treatment details were not provided.  patient presented herself for covid vaccination after making an online appointment where she attested that she was 18 years old to make this appointment.  it was discovered that she was actually 17 years old when the informed consent form was scanned for billing purpose. at that point pharmacist called Moderna and spoke to an agent. it is my understanding that CDC did recomend use of moderna for 16-17 year old. and that second dose should be given as off label use. However patient did not show up for her 2nd appointment.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: As reported: patient did not show up for her 2nd appointment.
24DEC hrs p/inject pt became SOB, tightness in chest & throat; states that just does not feel good; no rash; pt took DPH-did not go to ER; pt has had rxn to different types of things;
I receved flu and pneumococcal vaccine on 11-08-05 were I work at 1:15 pm. The flu shot went in my right arm and pneumococcal in the left arm.  I felt some stinging after the pneunococcal shot was given in the left arm but didn't make anything of the situation.  By 5:00 PM I went to the office and told the first aid person to look at my left arm because it felt like it was on fire and I couldn't raise my arm.  She took one look at it and called the head person of first aid on my shift and decided to take me up to the hospital to have a doctor look at my left arm because of the red lump and burning pain I could not even raise my arm it hurt so bad.  At the hospital they took me to see the doctor that was on call.  The doctor told me that I develop a sit reaction to the pneumococcal shot and told me to home and put a warm compress on the site reaction.  I followed her instructions.  The next day Wed. 11/09/05 I went into work and by 7:00 PM I felt achy and feverish and finish my shift went home at 10:00 pm I took 3 Advil and went right to bed.  The next day Thurs 11/10/05 I  planned to go into work as I was undressing I looked in the mirror to examine my left arm to see if the site reaction was going away then I noticed red streaking on my left arm elbow up forward and back and under arm and into the chest area.  The time was about 12:15 pm I called work to let them know that I was going back to the hospital ER and was'nt planning on coming into work.  I arrived at the hospital and the doctor examined me and told me that I had infection and ordered an IV filled with strong antibotics along with a tetanus shot.  He also ask me if I had the lot number or the pneumococcal vaccine and I gave him the number which was "0876R exp 4Aug07 and called the hospital where the shot came from and to pull that lot number.  The next I went to see my family doctor and ask her if I had blood poisoning and she said yes and that I was grateful to notice the signs of the red streaking and went to the emergency clinic.  The reason why I get these vaccinations is to stay healthy because I have M.S. Information received from Medical records states cellulitis. msv
Bloody nose day after 1st vaccine Both legs Anterior shin pain felt like drop feet, hand and wrist pain Day 2nd vaccine Severe cramps in  both legs calves today. 6/17/21 Left calf continues to hurt
Admitted to Hospital on Date of Adverse Event [recorded in regulatory authority] for treatment of Covid-19 Positive following completion of Covid Vaccine Series
Shortness of breath, difficulty swallowing, coughing.   BP 230/98
Patient received tightness in chest. Thought to be allergic reaction. Pt took Benadryl and within min symptoms went away
(1) Excessive body aching - (2) Constant head pain - (3) Spots in the body that come and go.
Grandmother reports infant was being held by child care provider next day after imm. infant was asleep and stopped breathing. Rushed to hosp. turned blue, was breathing and OK again by the time they got to hosp. NO recommendations from DR. Grandmother states child felt hot-clammy the after of imm. but did not take temp. They gave Tylenol for that.
Information has been received from two nurses concerning a 20 year old female patient who was vaccinated with a first dose of Gardasil.  The patient experienced pain in the injection site right after receiving her injection.  The pain lasted approximately 1 hour following the injection.  No medical treatment was sought.  Additional information is not expected.