chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3-4 Months after 3rd dose of GARDASIL, Pt developed, headaches, dizziness, abdominal discomfort, various aches / pain, dairy sensitivity, elevated discomfort with menstruation, elevated susceptibility to infections, headaches are daily + progressively worse.  5/20/09 medical records (consultation) received DOS 9/9/08 FINAL DIAGNOSIS: gastritis and irritable bowel. Presents with abdominal pain and back pain. Nausea, sore throat and cough.   5/21/09 medical records received DOS 8/6/08. FINAL DIAGNOSIS: Cephalgia etiology unknown, neck pain musculoskeletal. Presents with abdominal, flank, and back pain. Diarrhea. Sinusitis with headache. Fuzzy vision, difficulty focusing. Generalized joint pain.
She got her vaccine, had a headache, low temperature, body aches.  She felt like she had COVID.  Her arm was not too bad.  She took extra strength Tylenol and Ibuprofen.  Her temp got up to 100, but was kept down due to taking the Tylenol and Ibuprofen.  Tuesday she wasn't as achy but still had a headache and a low temp.  Today she is still feeling fine.  She did not call her doctor.
covid 19 Pfizer biontech chills/ fever/ aches/ exhaustion mar 24 exhaustion mar 25
09/15/2017 The patient's mother called the office few hours after the shots with complaints of abdominal pain. On 9/18/17 the nurse documented Rt deltoid swell up erythema and pain on the weekend size 15 cm.
Fever; Pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     Patient had never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Arthritis (on her left wrist), Raynaud's syndrome and Drug allergy (Sulfa Allergy). Concomitant products included TRAZODONE for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site) outcome was unknown.            Treatment details were not reported.    This case was linked to MOD-2022-550368, MOD-2022-550270, MOD-2022-550322 (Patient Link).
had both doses of the Pfizer vaccine and now has Covid; Had both doses of the Pfizer vaccine and now has Covid; This is a spontaneous report from a contactable consumer (patient's mother) or other non-healthcare professional. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had both doses of the Pfizer vaccine and now has covid. The reporter stated that her son is healthy, and he had both of the Covid vaccines, Pfizer, and he got Covid. The patient underwent lab tests and procedures which included Sars-cov-2 test: got positive on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Rapid heart rate, shortness of breath, flushing face, the day after the injection.  The next day I got a huge rash on my arm at the injection site.
8 days p/vax pt devel fever to 102 ax; 9 days p/vax devel maculopapular rash eves face, scalp which spread to trunk; fever resolved 10d p/vax, rash began to resolve @ 12d
pt recv vax DEC97 & pt exp a sterile abscess @ inj site which was like a marble under the skin;
Patient started to complain of tightening and palpitations in her abdominal area.  She also started to perspire.  This occurred about 10 minutes after she received her Fluvirin Prefilled Syringe Influenza Vaccine.  I had one of the pharmacy technicians call 911.  Then, I took her pulse and blood pressure (see below).  The ambulance arrived shortly thereafter and she decided to go into the ER to get checked out due to her previous stroke history.  She was discharged from the ER later that evening.
Patient called pharmacy on 10/7/17 said that her arm was extremely red, swollen, and hot, she was advised if it didn't get better after a cool compress to see a Dr, patient called back on 10/8/2017 and said that she had went to an urgent care and they told her she had cellulitis and prescribed her doxycycline. I called patient on 10/9/7 to check on her and she stated I had not worn gloves during administration of  vaccinations, I explained to her that I had wore gloves, and they were more for my protecion. I also used inject safe bandaids for the injections, she got upset and hung up on me and I have not been able to contact her to get more information. She said that the arm started swelling and hurting about 4 hours after it was given. I did ask her if it was worse on the front or back side of her arm and she stated it was worse towards the back and there was a knot she could feel under the skin, I gave the PNEUMOVAX 23 towards the back of the arm and the FLUARIX QUAD towards the front. She did say that it was getting better after starting the antiobiotics. I do not have the information for the Dr. she saw.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia", start date: Aug2020 (unspecified if ongoing), notes: Pneumonia Aug2020, 2015; "COVID19", start date: Aug2020 (unspecified if ongoing); "Tinnitus", start date: Aug2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
18JAN93 petechiae on arms & up to mid thigh on legs; rash is very itchy; 20JAN93 devel edema of face & extremities; also SOB; seen in hosp ER given Pred;
Sluggish, cough, sneezing, head stuffy, joints ache. Symptoms lasted 2 days.
He was a diabetic /sugar was 120/this morning about 8:30ish it was 99.3 now 98.3; diarrhea; discomfort in his body; aching; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Feb2021 (at the age of 72-year-old) at single dose for covid-19 immunisation. Medical history included ongoing diabetic (his sugar was 120) and urinating. The patient's concomitant medications were not reported. The patient was referred here by a nurse practitioner in their other department. The patient would like to know if any of these particular symptoms experienced are related to the Covid vaccine. When the patient first got it on 23Feb2021 the patient had some soreness in arm and discomfort in his body, aching. It lasted until the next day on 24Feb2021 and then went away. He didn't have any problems until 11pm last night on 25Feb2021. He was a diabetic and he was urinating every hour on the hour sometimes twice an hour. His sugar was 120 on an unspecified date. This morning (on 26Feb2021) the patient had diarrhea. Also this morning (on 26Feb2021) about 8:30ish it was 99.3 now 98.3. The outcome of the events some soreness in arm and discomfort in his body, aching was recovered on 24Feb2021 and of the other events was unknown.  Information on the lot/batch number has been requested.
Aching joints, runny nose, rash all over, temp 103. Started approx 13 days after MMR.  Dr. saw child according to mother & felt this was an abnormal reaction.
Had severe stomach pain for 30 hours #10 pain and flu like symptoms went to ER
Second shot at gap of 35 days; Left arm sore; Bodyache; This spontaneous report was received from consumer on 05-feb-2021, concerning a 75 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). and she had experienced sore arm, body ache and Inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant  medication also not provided.   The patient received suspect product  mRNA-1273 on 05/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:025L20A) intramuscularly on the left arm  for prophylaxis of COVID-19 infection  On 05 Jan 2021, the patient received her first shot in her left arm. She experienced a sore arm for 2 days and body ache for a couple of hours following the vaccination. On 25 Jan 2021, at surgical center she received steroid epidural injection in her back for pain, her Moderna Vaccine is scheduled 2 days after the steroid shot. But, she was able to reschedule her second dose 5 weeks from 1st shot that is on coming Tuesday 09Feb2021. Caller enquired having second shot at gap of 35 days is fine.  Having a steroid injection prior to Moderna COVID Vaccine is safe and will it have any effect on the vaccine effectiveness.  Action taken with the second dose of mRNA-1273  in response to the event was not reported; Reporter's Comments: This case concerns a 75-year-old female who had NS expected adverse events of Vaccination site pain and Myalgia occurring 1 day after the first dose of mRNA-1273. She had a NS unexpected event of Inappropriate schedule of vaccine administered without associated AEs after a delay in the second dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the adverse events, a causal relationship cannot be excluded.
Hospitalization for dyspnea due to COVID-19  on dates 8/5/2022- 8/14/2022.  Treated with no COVID medications.
Abnormal jerky movement, followed by convulsion for which he was admitted and received Phenobarbital 9/10/08-records received for DOS 6/13/08-presented to ED with C/O legs twitching intermittently since vaccines. Myoclonic jerks noted mainly upon waking. Assessment: Myoclonic jerks. Heat rash. Discharged home.
08:37 Vaccine administered. Observation time increased to 30 minutes related to history of anaphylaxis. 08:50 Patient shaking and stating she needs O2. Pt placed on monitor. O2 sat 99% on room air. Patient and daughter requesting O2. Patient placed on O2 at 2L via nasal cannula. 09:05 Pt registered as ED patient. Care assumed by doctor and registered nurse. Patient monitored as ED patient and released home in stable condition.
The report had been received from a health professional. The report concern a patient of unknown age and gender. Concomitant medications, concurrent diseases and medical history were not reported. The patient was receiving FLUMIST (intranasal). The patient experienced severe headaches and sinus symptoms. The outcomes of the events of severe headaches and sinus symptoms were unknown. The events were considered to be non-serious by the company physician.
Day of vaccination - afternoon hours: child had loss of balance sporadically through out day. Would loose balance while standing or walking. Balance issues continued over a 20 + day period. The symptoms gradually decreased and when away after 30 days or so. Developed fever on 8/18/2016 and rash on 8/21/2016. rash cleared in about 48 hours of being present. Fever came back on 8/24/2016 and rash two days later on 8/26.
No adverse event; Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Patient had no allergies . Patient had no medical history relating to adverse events and both Acute and Chronic illnesses at the time of vaccination.  On 17-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine ages 6-11 administered instead of Bivalent Booster vaccine). Concomitant medications details were not reported by the reporter. Patient ever had COVID positive test or diagnosis was reported as unknown. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.
administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter.
sz-(afeb, tonic clonic) 3 occurred on the day following the immunization
Information has been received from a physician concerning a 68 year old male patient with no history of gastrointestinal problems, no ulcers, no drinking, who on 27-JAN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). According to the physician, on 30-JAN-2010 the patient was hospitalized with the diagnosis of pancreatitis. The infectious disease doctors at the hospital told the patient that it was due to the ZOSTAVAX (Merck). At the time of the report the patient's status was not specified. Additional information has been requested.
2/1 midnight woke up with fever, chills 2/1 No reaction to vaccine but sore arm. 3/3 went to orthopedic dr for shoulder, put on meloxicam began noticing that I couldn't hear well, keep saying excuse me, trouble hearing tv, tinnitus began (Never had this problem before.  Husband could hear better than me without his hearing aids.) 3/18 went to doctor.  He thought I had fluid in my ears.  Put me on fluticasonne Propionate Nasal spray, stopped meloxicam Called Dr. and he put me on antibiotic (10 days) thinking I had ear infection. Still couldn't hear well. on 3/1 at 11:45 am had 2nd moderna vaccine shot. By midnight I had fever, chills 3/2 fever, chills am, very tired.
I experienced migraine headaches after my vaccine. I went to the ER got a lab work, EKG test, CT scan of the head on 07-0-2021. On 07-05-2021 I went to urgent care I got IV because I was vomiting a lot.  My symptoms of vomiting and migraines stopped around 07-17-2021. I also had extreme fatigue that kicked in after that and that fully subsided on 07-31-2021.   I have no symptoms today.
developed shingles on the left side of torso; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles on the left side of torso) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (developed shingles on the left side of torso). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (developed shingles on the left side of torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up was received on 21 May 2021 included reporter contact details were updated. On 29-Jun-2021: Follow-up information received on 29-Jun-2021 contains non-significant information.
Pt came back and showed the arm she received the shot. Large area was bruised. Same area showed color changed to yellow.
some of the vaccine leaked out of the injection site; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unknown date. On an unknown date, the patient experienced some of the vaccine leaked out of the injection site during the administration. She was following with the CDC recommendations and wanted to see if we have recommendations on our side with regards to revaccination or getting more than the intended dose of the vaccine. The outcome of the event was unknown.  Information on Lot /Batch Number has been requested.
Stopped breathing in a sleep apnea type of scenario from approx 5:30a - 11a on May 2nd. Extreme body aches and headache for two days. Fever and way overheated for three days. Sweating profusely from 5:30a and still occuring today three days after shot. Intense chest pain 1:50a  Tuesday morning 5/4 along with acid reflux and body aches continuing. Insomnia started  30 hrs after injection and has lasted two days. Loss of appetite started 5/3 all day.
Pericarditis diagnosis:  This is a 21 year old male who presented to the emergency department on 4/27/21 with a two-day history of chest pain.  He was seen in a  emergency department on 4/26 and reported a normal EKG, blood work, and x-ray.  He was discharged home.  His was worsened so he reported to an urgent care in .  That team had a concern for pericarditis, so referred the patient to the  emergency room.  He had a reproducible pain over the costal margin but did describe a positional component.  Provider felt they still had to consider pericarditis as well as costochondritis.  The suspicion for pulmonary embolism or acute coronary syndrome or very low.  The suspicion also for myocarditis was low.  His EKG did show some J-point elevation versus ST elevation in the anterior and lateral leads.  There was no evidence of reciprocal depression.  His troponin test was normal.  His CBC and metabolic panel were normal.  He had had CRP which was mildly elevated at 4.6. A bedside point-of-care ultrasound showed no evidence of a pericardial effusion.  Provider felt it was reasonable to treat him for pericarditis although his EKG is not classic for this.  It was recommended he use his scheduled ibuprofen 600 mg 3 times a day.  He was also given a 1 month course of daily colchicine 0.6 mg. It was recommend he follow closely with his PCP to see if he needs to have this colchicine course extended.  He will follow-up with his primary doctor in 1 week for repeat check.
Patient reports that about 11 hours after receiving a Afluria Quadrivalent Flu Vaccine IM he experienced shaking chills that latest for several hours which culminated with diaphoresis. Additionally noted he had a headache.
covid vaccine breakthrough case  dose 1 moderna 5/2/21  003C21A dose 2 moderna 5/30/21  011D21A
Heavy Menstrual bleeding after both Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines) outcome was unknown.            no concomitant was provided no treatment medication was provided   This case was linked to MOD-2021-245555 (Patient Link).