chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: Testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient didn't receive any other medication in 2weeks. Patient received Paxlovid for COVID 19 Treatment. Treatment start date was 8Sep2022 and stop date was 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
some aches [after first shot]; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (some aches [after first shot]) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MYALGIA (some aches [after first shot]). At the time of the report, MYALGIA (some aches [after first shot]) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-311030 (Patient Link).
Shingles on left trunk along T8-T9 confirmed V2V vax.
Pt started feeling lightheaded, dizzy & nauseated 2 mins after vaccine admin. He ran to the bathroom & vomited undigested oatmeal. His hands were cool to touch. RN stayed with pt in bathroom. He sat on the floor for 15 mins after applying cool H2O to face. He was off balance & holding to wall, assisted him back to chair in the room. BP was 128/88, HR 8, w/c was higher than his usual. He sat for another ten minutes and stated he felt better. He walked out of the room with steady gait. RN reminded him to call back or report back if symptoms persisted. No reply after 2 attempts (calls) by person in office.
Initial injection site pain and almost passed out but did not. All body chills and shaking at 11, followed by fever, all over aching through 8Apr with focus on lower back.  Injection site soreness through 8 Apr.
Patient's arm was red area slightly larger than golf  ball, tender to touch and warm to touch. Patient also had slight fever 2 days after injection and aches which resolved after 1 day. Checked with patient four days after vaccine today she said swelling, soreness, and heat to touch was resolved and only thing remaining was red itchy spot. Used ice, BENADRYL and ibuprofen for symptoms.
Patient started to fill dizzy immediately after the shot was given. Patient stated that she didn't eat all day.
Patient states that she felt chilled and feverish the evening of the imm.with a sore arm. The next day 3-13 chills were gone but arm still sore and her boss noted her arm was swollen and red. She came to the clinic and we measured the indurated, red area to be about 4mm by 4mm. Advised antihistamine during the day and BENADRYL at night and circumscribed the area. She returns the following day (today on 3-14-18 with an enlarged area of redness (5mm x 6mm) some swelling and soreness. She denies itching or any swelling or tingling of oral mucosa. She is continuing to take BENADRYL, ZYRTEC and apply topical BENADRYL cream.
pt recv vax 1DEC97 & c/o 9DEC97 of redness & soreness @ site of inj;seen by PMD;10DEC97 dx cellulitis lt arm tx augmentin & DPH;f/u as 15DEC97 PMD & mom requests not recv #2 & #3 vax of hep b;
We received the following information from the literature article on 02 SEP 2009: A female adult patient had suffered from exacerbation of ulcerative colitis following an influenza vaccination (manufacturer, batch no. or vaccination date not reported). The woman had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months when she was vaccinated with another influenza vaccine. The night after that vaccination she developed abdominal pain and bloody diarrhea (please refer to case MA2009-2379). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)
vomiting ,diarrhea, headache, muscle weakness, chills, fever, loss of conscious, fatigue. Loss of conscious resulted in hitting my as I hit the floor.  Sustained a sore spot and bruise. More severe effects lasted for about 24 hrs, fatigue about 1 week or so.
This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender,. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ orally, lot # L035511, expiration date on 21-MAY-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Redness to site, swelling site, vomiting 6 hours later and every 4-6 hours for 24 hours. Return to urgent care for treatment of reactions.
09/03/2021, I went to a 1 day funeral out of town, and 5 of us got COVID-19. I came home 09/02/2021 and found out I had COVID-19. I found out a friend at the funeral was at the hospital with COVID-19. The following Wednesday, 09/08/2021 my legs gave out and I could not get up, and that was my only symptom. The EMT came and took me to the hospital in my town. My heart rate was fine the whole time I was in the hospital. A couple of days when I got home my heart meter showed I was 120. It is usually 70. I called my doctor, upped my beta blockers, and that did not help. I went to the hospital Wednesday and I was there until Monday. They did a Catheterization on my heart and 2 other tests, and prescribed Eliquis. On Monday I came home. On Wednesday I went back to the hospital and came home on Thursday afternoon. They put me on an IV drug that brought my heart down to 70. They diagnosed me with A-flutter. The next morning they electrical shocked me and my heart went back to 70. I came home 10/19/2021 and my heart has been normal. I was in the hospital for 12 days for COVID-19, and 7 days with heart problems. The doctor told me that he is sure I had an effect with COVID-19 with my heart. The vaccine did help me from having a serious case.
I?ve been experiencing inflammation at areas of direct contact. It started about 20 days after the second dose of moderna vaccine. Symptoms started in my feet.  About one week later it transitioned to my arm. Then to my face. Then to my buttocks. Then to my testicles. These symptoms happen after direct pressure is applied to an area for an extended period of time and last about 1-3 days.  I?m am a resident doctor and needed to go to the ER when my face had angioedema. I?ve gone to my primary care physician as well, who agrees that these symptoms could be vaccine related. I have photos and time stamps of all the above mentioned symptoms and episodes
1/30/22 pt had a positive COVID test; was hospitalized for SOB, dyspnea at rest, COVID pneumonia and hypoxia; O2 via NC; transferred to Medical Center on 1/31/22; DNR/DNI; given Remdesivir and Dexamethasone; hypotensive; AKI; increased O2 needs; Vapotherm then BiPAP; given Baricitinib; pt had worsening lethargy; possible aspiration; given ABX; pt's condition worsened and she expired in the hospital
Right side of tongue is numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Right side of tongue is numb) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Right side of tongue is numb). At the time of the report, HYPOAESTHESIA ORAL (Right side of tongue is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
Woke up on 01/12 with abdominal pain and moderate headache. Took 800mg OTC ibuprofen for headache, helped pain, headache kept returning throughout day. Abdominal pain lessened through out the day 1/12 dissipated by 9pm. 1/13 woke up with headache again,  no abdominal pain.
Patient given Varivax second dose 51 days after first dose of Varivax.  According to package insert patient should have been given this dose spaced 90 days from first dose due to her being under 13 years old.  If she had been 13 years old only 28 days spacing would have been required.
This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). The healthcare worker reported that on an unknown date, the patient experienced unspecified type of reaction after receiving M-M-R II. The patient's mother did not want to give M-M-R II to her younger child because her older child (patient for this AE) experienced some type of adverse effects after receiving M-M-R II. The outcome of unspecified type of reaction was unknown. Additional information has been requested.
2nd day after my first dose, I was experiencing eye twitching and face spasms. After my 2nd dose, my mouth was twisted, right side of face not able to move, can't hold air bubble in my mouth. right upper and bottom lip have no muscle control, can't raise my right eyebrow and dry right eyes.   Was prescribe prednisone 10 mg tablet, acyclovir 800 mg tablet and eye gel
The Patient is a 35 year old male.  Pt c/o Nausea and vomiting x24 hours in association to a vaccination for smallpox he received 9 days ago.  Pt states he has felt chills and fever.  Pt states the smallpox is spreading.  8/10 pain scale from his L arm where he received the vaccine.  Feeling terrible.  Fever.  Chills.  Headache.  Nausea.  Vomiting.  Normal appetite.  No diarrhea.
Headache, Myalgia & Arthralgia Narrative:  Developed headache shortly after vaccination, dose 1. Over time also experienced muscle and joint aches. Missed one day of work. Used ibuprofen. Feeling better now.
At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs).  Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m.  After waking up at 8:00 a.m. noticed pronounced ringing in my right ear.  Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling.  The ringing in my right ear has been nonstop since it started.  The other symptoms have come and gone intermittently but are still present.
Felt like they had slight fatigue; A low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever). At the time of the report, FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment medications were reported.  Patient did not experience events after second dose.   This case was linked to MOD-2021-406549 (Patient Link).   Reporter did not allow further contact
Guest  had two failed vaccination attempts with the vaccine running down his left arm and the third vaccination was successful.  No indicated treatments for this event at this time. Guest with active ROM. Education on signs and symptoms of infection at the injection sites. No untoward outcomes known at this time.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 30th May 2018, the patient received the 2nd dose of SHINGRIX. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, general body pain and influenza like illness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, headache, general body pain and influenza like illness were unknown. It was unknown if the reporter considered the injection site pain, headache, general body pain and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: On 27th March 2018, the patient received 1st dose of SHINGRIX. The patient experienced very painful at injection site, severe headache and body ache. The patient also felt like flu. The reporter did not agree to follow up.
Patient initionally had Myalgias but presented to ED with Rhabdomyolysis w CPK  38,906
Pt received his 8th anthrax vaccine; day after receiving it developed erythematous rash around injection site and swelling with taught skin. Pt reports this is typically how he reacts to vaccine - sought medical care at request of co-worker.
Stayed under observation at Clinic for 15 minutes.  Upon leaving  started to feel dizzy but assumed it was just my nerves.  Upon 20 minutes after shot my top lip started to tingle and  went numb.  Within 30 minutes extreme weakness and dizziness.  Brain fog started within one hour.  Fever, aches, and pain in arm within 24 hours.  Covid arm and red neck within 36 hours. Stayed home for 3 days with  gradual improvement each day.   Fourth day fatigue and vertigo.  Fifth day fatigue. Fatigue continued for one week
patient was given expired diluent; Initial information received on 19-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old male patient who was administered a 0.5 mL dose with an expired vaccine of HIB (PRP/T) VACCINE [ACT-HIB] (powder lot number- UI964AA and expiry date 28-Jun-2020 and diluent lot number- U6178AA and expiry date 13-Mar-2020) via intramuscular route in left thigh on 19-Mar-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Mar-2020, the concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) (not produced by Sanofi Pasteur, lot number unknown) via unknown route in unknown administration site.  It was an actual medication error case due to expired vaccine used.   No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
redness swelling @ site;t99.7 R, inconsolable crying since vaccine given 11:30; time of report 420PM;
The Moderna Covid-19 vaccine was given today to an adolescent 15yrs old at 3:30pm on 5/14/2021. At 10pm on the same day I called the grandmother and she stated that there were no adverse symptoms thus far.
I had my vaccination on 10/07/2022. On the same date I started to experience swelling in lymph nodes in my armpits on my left side. I also had fever, malaise, headache, joint pain and nausea. The lymph node swelling lasted for 3+ weeks. On 03/03/2023 I tested COVID-19 and was positive. I started to have COVID-19 symptoms the evening of 03/03/2023 to include vomiting for 4 days fever headache extreme fatigue joint pain sinus pain throat pain coughing and sneezing. I was unable to get out of bed for 10 days and unable to eat for 7 days. I contacted my physician and I was denied PAXLOVID. I was instructed to quarantine and over the counter medication. I presently feel ok but I am still coughing on 04/12/2023.
by 5PM that noc pt arm was red-swollen & warm;took 2 days to feel better;on 20OCT97 arm had few hard areas but redness was gone;
Pt went to the ER on 11 Apr 2018 for pain in the lt arm. Pt was diagnosed with cellulitis on the lt arm. Pt given Keflex for tx.
(+) mild case of chicken pox-few vesicle with erythematous base on her lower extremities.
Lump on arm for approximately 9 days. Red raised squared on injection area for 14 days with minor rash containing small bumps. Minimal itching, mainly after shower. I failed to report in the survey as I wasn't confident that the reaction was resulted from the vaccine
Rashes on arms, legs and groin area appeared a few days after the vaccination. On 5/22, the pharmacist recommended to use some antifungal cream to help relieve the itchiness of the rashes. Patient  applied antifungal cream to his rashes and it seemed to have recovered mostly.
Developed shingles rash 1 month after vaccine on lower back. Rash and pain were mild and easily improved with prescribed antiviral medication.
fever; head pulses; muscle aches; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication on an unknown date. The patient previously took Aspirin and experienced allergy to the medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 06:00, about 12 hours after the injection (next morning), the patient experienced fever, head pulses and muscle aches. Therapeutic measures were taken as a result of adverse events and included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on 22Apr2021 while that of head pulses and muscle aches was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Rash - erythematous, diffuse, macular popular rash on all body surfaces (except palms & soles); Re-emergence of rash on subsequent day; Pt evaluated in ER - flu vaccine suspected by ER physician.
I received a Moderna dose to augment a Johnson & Johnson dose I received in April 2021.About 10 hours after receiving the vaccine I felt fatigue and headache. A few hours later I was in bed with chills, tremors, body ache, etc, which were quite uncomfortable. In the morning I took tylenol and ibuprofen which managed most of this. I continued to feel fatigued and some generalized body ache for the next few days. As of 11/8 AM I am fine.
Restless night couldn't sleep or find comfortable position. Fatigue. Third day now getting better i think.