chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On 19-AUG-2015, the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneous (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On 24-AUG-2015, the patient developed an itchy, bumpy rash on her back and abdomen. The patient was advised to use hydrocortisone cream as treatment, but at the time of this report no treatment was used for the event. The outcome of rash was reported as recovering. The reporter did not provide a causality relationship assessment between the event and therapy with M-M-R II. Additional information has been requested.
sore throat; weakness; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (received all COVID-19 Pfizer shots .). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient experienced a strong reaction and had been kind of sick for 3 days. Patent was unsure whether sore throat was related to the vaccine. Treatment information was not provided.   Reporter did not allow further contact
Received MMR and VARIVAX on 6/9/08. Seen on our office 6/24/08 with fever x 1wk-14 days after immunes. Temp 101 with mild rash (not Varicella) on face. No evidence of OM, PREVNAR, meningitis. VA; UC done (has Grade 2 urinary reflex)
For the first 2 days she had the normal reaction. After that she stated she became stuff with a lot of mucus. She had a lot of burping way more than usual. She also had a bad case of diarrhea and nausea vomitting.
Friday I felt flush within 5-10 mins after vaccine. Within a few hours the vaccine site had a knot the size of a baseball with redness, soreness and hot to the touch. Saturday about 11:30 I started running a fever of 101.8, had severe bone pain and headache. I felt overall bad. These symptoms lasted 3 days. By Sunday the knot on my arm was improving to golf ball size and continued to improve each day. I developed a rash on my face and chest on Tuesday or Wednesday. Still having headaches on and off through Friday. Friday I had stomach upset. It took me a full week to feel pretty good again. Saturday through Monday was the worst with fever., headache and bone pain.
Patient started having a tight throat immediately upon receiving the vaccine.  She thought it could have been attributed to anxiety, so we waited together.  Her throat started to get more tight after a few minutes but started to return to normal after 15 seconds of deep breathing.  I waited a few more minutes to determine if it was from anxiety or an actual allergic reaction.  When her throat started tightening up again and her tongue started feeling weird I decided to act and give a dose from an EpiPen.   Upon administering the EpiPen the patient immediately went to urgent care with her husband to receive further treatment / observation.
Fever, runny nose, cough, body aches and very, very red, watery eyes.
12:14pm - Patient was walking through store and collapsed. Was brought to a seated position in a chair. Felt dizzy, lightheaded.
Fever 102.8, chills, uncontrollably shaking, loss of appetite,  nausea, vomiting,  loss of bladder and bowel I.V. fluid given at hospital
Sore arm; Red arm; Itching at the injection site; A spontaneous report was received from a type consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm(Vaccination site pain), red arm(Vaccination site erythema), itching at the injection site(Injection site pruritus).  The patient's medical history was provided as arthritis,have an artificial shoulder in my left due to an infection she had some years ago . Concomitant medications reported were Tylenol .  On 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 016M20A) in the right arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) arm was pretty sore and red and it was already 5 days since she gotten the shot.    Treatment details included Ice packs 3 times a day and cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, red arm,itching at the injection site was unknown.
Patient got 1 injection more than a week ago with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who got 1 injection more than a week ago with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date of July 2022, the patient received a  dose of suspect RABIES VACCINE (lot number not reported) at an unknown dose via unknown route at an unknown administration site as immunization.  On an unknown date of 2022,  the patient states that he/she got 1 injection more than a week ago with no reported adverse event (incorrect product administration duration) (unknown latency) and wanted to confirm how to proceed with the other 3 injections.  Action taken :not applicable  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   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 the guidelines. 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.
Meningitis/ The patient was currently hospitalized with "VZV meningitis"; pleocytosis; This spontaneous report has been received from a physician, referring a 13-year-old female patient. The patient's medical history included asthma, allergies were reported as none. The patient's concurrent conditions and concomitant medications were not provided.  On 06-AUG-2010, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 0224Zhas been verified to be a valid lot number, expiry date 28-JAN-2012) (strength, dose, and frequency were not reported) On 05-AUG-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 5002316 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)) (strength, dose, frequency, lot number, and expiry date were not reported) both vaccines were indicated as prophylaxis.  On 09-JAN-2023, the patient experienced arm pain; on 16-JAN-2023, the patient experienced herpes zoster skin rash, and was admitted to the hospital on 19-JAN-2023 for VZV meningitis (herpes zoster meningitis) and pleocytosis. The patient was described as "healthy and not immunocompromised". On the same date, diagnostical testing were performed: cerebral spinal fluid (CSF) was available for testing with protein 74 mg/dL red blood cells (RBC) <1000 (units not provided), glucose 56 mg/dL, and white blood cells (WBC) 269 (units not provided) (16% neutrophils, 70% lymphocytes, and 14% monocytes) with the results of meningitis panel and encephalitis PCR panel: with VZV PCR positive, and a sample from a skin lesion.  The outcome of the events herpes zoster meningitis and pleocytosis was not provided. It was stated that the patient is still hospitalized.  The causality assessment was not provided.  Upon internal review, the event herpes zoster meningitis was determined to be medically significant, and reported as life-threatening by the reporter.
This case was reported by a other health professional via call center representative and described the occurrence of blistery rash in a 60-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2022) for prophylaxis. On 12th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown. It was unknown if the reporter considered the blistery rash to be related to SHINGRIX. Additional details were provided as follows: The batch number of SHINGRIX was reported as D249J, which was corrected to D294J as per sales data sheet. The patient experienced shingles like blisters. The healthcare professional (HCP) did not have too much details as the patient had not been seen by the HCP till the time of reporting, per HCP patient would be seen later. The healthcare professional consented to follow up.
Patient up to date on COVID vaccinations who admitted with hypoxia and COVID.  Provider d/c note:  "84 YO female with h/o obesity, CKD3b, ANCA vasculitis, DVT/PE on Xarelto, hypertension, GERD, anxiety/depression, resident of Assisted Living Facility presenting for generalized weakness, acute hypoxia in setting of recent COVID diagnosis.  Patient with initial symptoms on 8/21 and tested positive for COVID at facility on 08/22 and was brought in for worsening shortness of breath to the ER where she was found to be hypoxic down to 88% when trying to sit her up although otherwise was saturating well on room air at rest.  Patient x-ray showing mild interstitial opacities bilaterally.  Inflammatory studies relatively unremarkable with CRP only 0.8 and D-dimer 190.  Patient started on remdesivir and dexamethasone although by 8/24 patient was able to be taken off of oxygen and even with activity able to ambulate around the room without desaturating below 94%.  Patient also eating much better and PT and OT recommended the patient can be discharge back to her assisted living facility.  Daughter was able to provide transportation back to facility this evening.  On discharge sent patient home with 8 more days of dexamethasone 6 mg daily to complete 10 day course.  Otherwise no changes to her home medications."
Wife called in to report that Husband received booster shot on 08/23/2021, and had a stroke in his right eye on 09/15/2021.  Also stated that husband has lost vision in his right eye.
Shorten menstraul  cycle. Started bleeding 10 days early. Headache, fatigue, muscle ache, sore throat, back pain, nausea, chills
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with incorrectly stored dose of VAQTA (route of administration, dose and frequency were not reported, lot #L009445 with expiration date: 01-JUN-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in 2014 (also reported as about two years ago), the patient was vaccinated with the first dose of ZOSTAVAX (route, dose and lot # not reported). On 09-MAY-2016, the patient was administered a second dose of ZOSTAVAX (route and dose not reported, lot # L034724, expiry date: 09-DEC-2016). No adverse effect was reported. Additional information has been requested.
Pfizer given on Friday evening 6.30pm waited for 12 mins as requested before leaving. Felt fine and well. Early saturday morning 1am woke up with acheing bruise sensation at injection site.  Woken up twice during the night Saturday (1am-6am) feeling cold and covered in sweat. Saturday morning around 10am, bruised feeling and tender at the back of the injected arm. Sore to touch that area and also sore to touch injection site.  Saturday Evening around 6pm pins and needles tingling sensation in both feet and also sharp stabbing pain on and off in left calf muscle.  Saturday night waking from sleep sweaty and disoriented. Sunday morning 10am light foggy feeling headache. Taken paracetamol with no change. Same symptoms continued on and off but were manageable at home. Monday evening dizziness during the day time and fstigue. Feeling of being drunk, everything in slow motion. Chest tightness began monday evening 8pm aprox (like my asthma symptoms) tickle in throat but no cough.  Woken up feeling cold but sweating. Tuesday morning mild headache again front of head. Chest tightness persisting but taken usual asthma medications. Tuesday evening 6pm Palpitations began. More of a hiding feeling than heart racing. Stronger than I have ever felt before and more frequent (6-8 times in 30 mins) Felt light headed again, hands and feet freezing cold and blue colour, body trembling, called NHS 111 advised A&E. Had blood tests, ECG and BP monitoring. ECG normal at the time but heart shows working harder than it should. Still waiting on blood results Weds (3/3/21)
The patient developed hives and swelling all over her body that began on 3-24-19. The patient went to Hospital ER on Sunday, 3-24-19. The patient was administered IV SOLU-MEDROL and diphenhydramine during the ER visit. The patient was given a prescription for prednisone 10 mg tablets for a 10 day taper prescribed by the ER physician. The patient picked up the prednisone prescription on 3-25-19.
Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT WAS SITTING WAITING HER 15 MINUTES AFTER GETTING INJECTION. HER MOM CALLED FOR HELP AND ANOTHER PERSON AND I RAN OVER AND ASSISTED HER AS HER DAUGHTER WAS UNRESPONSIVE. TOGETHER AS WE WENT TO PUT HER ON HER SIDE SHE CAME BACK AND ALL WAS OK. WHOLE EPISODE WAS ABOUT 10-15 SECONDS.
pt recv vax 14APR97 230PM & 430Pm t102, chills, loss of balance, generalized aches;went to MD 15APR97 w/cont sx;130/80, t101 orally;16APR97 leaves work because of fever again;
Pt C/O blurry vision, palpitations and sweating for 3 seconds. this occurred 10 minutes after receiving vaccine.
I have chronic lymphocytic leukemia, so I am immunocompromised. I have received 3 full doses of the Moderna vaccine against COVID-19. On 11/18/2021, I underwent a SARS-COV-2 spike AB test at the local clinic. It was determined that I had no immunity (-0.40 value). On 12/3/2021, I received monoclonal Regeneron, which I think may have enabled me to go on a cruise later that month and not get infected. On 2/4/2022, my husband and I attended an indoor function, where I suspect we both contracted COVID-19. On 2/9/2022, I began to have dizziness and fever. On 2/10/2022, I took an at-home test for COVID-19, and the result was positive. Also on 2/10/2022, I received monoclonal antibodies. I had a fever of 102.5, which I treated with Motrin and Tylenol. By the evening of 2/12/2022, my fever finally broke, though I still had swollen lymph nodes, some dizziness, and a feeling of tightness when breathing afterwards. I went to the doctor on 2/17/2022, and I was given an albuterol inhaler and told to rest. The doctor also told me that my lungs sounded clear after she listened to my breathing. I think that the tightness I feel when I breathe may be due to the swollen lymph nodes.
Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu; Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu; metallic taste; Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu; Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis throughout her body and everything esle is good; 10 years ago; "Anxiety" (unspecified if ongoing), notes: Caller states she started taking Prozac brand 22 years ago. Concomitant medication(s) included: PROZAC taken for anxiety; NAPROXEN taken for arthritis. Past drug history included: Flu shot, notes: Flu Shot many years ago; unknown name. The following information was reported: DYSGEUSIA (non-serious) with onset 03Feb2021, outcome "recovered", described as "metallic taste"; ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu"; CHILLS (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "Caller states she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She states she slept for 3 days but didn't have a cough just felt like the flu". The events "caller states she was quite sick after her first covid-19 vaccine for 3 days with chills and tired. she states she slept for 3 days but didn't have a cough just felt like the flu" and "metallic taste" required physician office visit.  Additional information: The patient stated she has had 2 of Pfizer COVID-19 vaccines and the COVID-19 booster and she is 74 years old. The patient stated she wants to mention that after her first Pfizer COVID-19 vaccine exactly 1 hour after she got a metallic taste in her mouth for about 3 days. The patient stated she wakes up in the middle of the night and the taste is there. The patient stated she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She stated she slept for 3 days but didn't have a cough just felt like the flu. She stated she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine and felt a little sick but not as much and she was fine after her booster dose of the COVID-19 vaccine.
Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events "Tested positive for Covid/had the (Covid) infection" (coded to Drug ineffective / COVID-19) and  swollen lymph nodes and BNT162B2 vaccine 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.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 17-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L017140, expiration date 13-NOV-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot number unknown) and fainted. No additional information was available. Additional information has been requested.
Tested positive for Covid-19 10/11/2021.  Admitted to hospital form cough and dyspnea
This spontaneous report as received from a 61 year old female consumer concerning herself. There was no pertinent medical history and no drug reactions/allergies. On 08-OCT-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date unknown), one time vaccine, dose and route unspecified in the left arm. There were no concomitant medications reported. On 12-OCT-2013, the patient broke out in shingles on her left arm which traveled down to her lymph node by her breast. The patient sought medical attention on 14-OCT-2013 and acyclovir 800mg was prescribed as antiviral medication. No labs diagnostic tests were performed. The outcome of broke out in shingles on her left arm which traveled to her lymph node by her breast was reported as recovering/resolving (also reported as the event did not improved). Additional information has been requested.
4/26/2022-Covid + on 4/14 treated with Decadron, presents with AMS and increased confusion. CT head- no acute intracranial abnormality. CXR: small to moderate left pleural effusion with left lower airspace disease. Admit Covid-19 pneumonia with possible concomitant steroid confusion. Start ceftriaxone and azithromycin.  4/30/2022- Improvement in AMS since d/c decadron and continues on RA, VSS.  5/2/2022-Improved, D/C to home.