chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has headache again; went to sleep right after the shot; can't stop sneezing; has diarrhea; has had constipation for about a week; no strength; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week) and ASTHENIA (no strength   ) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea) and CONSTIPATION (has had constipation for about a week). 13-May-2021, the patient experienced ASTHENIA (no strength   ) and HEADACHE (Headache). On 29-May-2021, the patient experienced HEADACHE (has headache again). The patient was treated with PARACETAMOL (TYLENOL) on 13-May-2021 for Headache, at a dose of 1 dosage form and PSEUDOEPHEDRINE on 13-May-2021 for Allergy, at a dose of 1 dosage form. On 13-May-2021, SOMNOLENCE (went to sleep right after the shot) had resolved. On 14-May-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week), ASTHENIA (no strength   ) and HEADACHE (has headache again) outcome was unknown.            Concomitant medicine: Novolin, another insulin
Out of it; hiccups for 8 hours; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product AXITINIB (INLYTA) for Renal carcinoma.    The patient's past medical history included Disorientation, Dehydration, Fatigue, Diarrhea, Decreased appetite, Foggy feeling in head, Pain, Stomach cramps, Kidney transplant (Done 9 years ago), Nephrectomy (3 years ago), Surgery and Surgery. Previously administered products included for Cancer: cabozantinib and Cabometyx. Past adverse reactions to the above products included Pancreatitis with Cabometyx and cabozantinib. Concurrent medical conditions included Kidney carcinoma and DVT. Concomitant products included EVEROLIMUS for Immunosuppression, PREDNISONE, TORSEMIDE, APIXABAN (ELIQUIS), VITAMIN D [VITAMIN D NOS], LOSARTAN, CARVEDILOL and EZETIMIBE for an unknown indication.   In January 2020, the patient started AXITINIB (INLYTA) (unknown route) 5 milligram twice a day. In January 2020, AXITINIB (INLYTA) (unknown route) dosage was changed to 2 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours). At the time of the report, DISORIENTATION (Out of it) and HICCUPS (hiccups for 8 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Positron emission tomogram: Second PET scan showed slight decreased in cancer and Third PET scan showed cancer remained same.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient took Inlyta and symptoms got worsened and then took a break from medication and symptoms improved. Patient was not on Inlyta during the first PET scan on JAN 2021,which showed cancer metastasized  The concomitant medication was reported as Cabametics.
Pt has a history of CAD (status post multiple stents) and non-insulin dependent DM Type 2. Pt presented with 3 days of chest pain, shortness of breath, generalized malaise, and intermittent nausea. Pt states that she has had close contact with several family members with acute COVID infection. She was admitted due to acute hypoxic respiratory failure secondary to COVID-19 pneumonia.
Patient is a 94y.o. female with PMH significant for anemia, anxiety and dementia presents to ED as sent from ECF for c/o corona virus concern. Pt is reported to have tested positive for covid-19 at ECF and her ECF policy does not care for covid positive patients to pt was sent to ED for evaluation. History is limited as pt has hx dementia, A&Ox1. Pt currently denies SOB or chest pain. Pt states she does not feel well but cannot go into detail. Pt is grunting from her upper airway but when distracted with conversation patient stops grunting. Pulse ox stable on room air. Pt is not in respiratory distress.  In the ED, pt was afebrile and normotensive. Lab workup significant for K 3.0. Troponin 0.13. procalcitonin negative. Hgb 10.6. Covid-19 detected. Chest xray - Abnormal density in the right upper lobe which could relate to pneumonia in proper clinical setting. Progress exams recommended to ensure resolution. Prominence of the right hila which could relate to projection. Associated reactive adenopathy in the differential. Mass not excluded. This additionally can be reevaluated on progress exam. In the ED, pt was given 500cc saline bolus, duoneb NMT, albuterol NMT, mag IVPB and 20 meq KCL. Pt will be admit for further treatment with consult to cardiology.
1.  Diagnosed with petechiae 04/01/2021 - no treatment, lesions began to form on lower left and right legs 2.  Diagnosed with vasculitis and edema 04/23/2021, treated with antibiotics large lesions mainly on lower left leg, some on lower right, lower legs very swollen, lab results indicated staf infection 3. Diagnosed with high amount of protein in urine and swelling inlayer legs 05/28/2021, treated with furosemide for edema 4.  06/03/2021 - kidney biopsy to check for kidney disease 5.  06/11/2021 - Mild chronic (long term) kidney disease
eyes very reddened-blurred;lump in throat, sl difficulty breathing;recv flu vax 2:30 came back 810PM sx had progressed over 5hr;911 called;IV DPH & meds for nausea given;weakened & body ache;could hardly walk;migraine;felt like had flu;
Patient received pfizer vaccine on 1/26/21 and 2/19/21. Found to be COVID positive on 2/1/22. Presented to ER on 2/3/22. presented with fall in the bathroom at assisted living facility.  Time of fall unknown.              Soft tissue swelling left greater than right periorbital region and forehead. Suspected left-sided weakness- Neurology consulted . CT head negative for acute intracranial abnormalities. No focal deficit on exam. COVID-19 positive on 02/01/2022.  Vaccinated. Acute hypoxia requiring N/C oxygen on 2/6/22. No shortness of breath.  Ferritin 225, fibrinogen 396,  procalcitonin 0.05, CRP 37. Dexamethasone started.  Remdesivir deferred after discussing with family. Discharged on 2/21/22
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 21-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine Body aches, fatigue and slight headache. Fever ok 99.6
He said he did get Covid; He said he did get Covid; 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 male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He said he did get Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283516 same patient, different vaccine dose number, different event;
sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by the patient's friend via interactive digital media. Reporter asked dose anyone had side effects from new Shingles vaccine. Reporter stated that one of his friend that was patient was sick for a week after receiving the second dose. Additional supportive information:  Follow-up would not possible as no contact details were available.
dizzy spell; fever; chills; froggy and weak; soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 21-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizzy spell), ASTHENIA (froggy and weak), PYREXIA (fever) and CHILLS (chills) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (soreness) and ASTHENIA (froggy and weak). On 20-Jan-2021, the patient experienced DIZZINESS (dizzy spell), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (soreness), DIZZINESS (dizzy spell), ASTHENIA (froggy and weak), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-Jun-2021 has updated AE outcomes. AE outcome updated
Reaction started with minor itch.  Next day hives, welts, redness.  Moved from one part of body, left that area, and moved to another.  Controlled until Saturday with Benadryl; four tsp. every four hours.  Benadryl stopped working on Sunday.  Reaction spread to ears and swelling of nasal and throat passages making it difficult to breath.  Went to Hospital on Sunday around 2PM.  Was given a steroid shot, a pill, ranitidine, diphenhydramine and prednisone.  Still having symptoms the next day.
11/8/14 FLUZONE administered left deltoid. 11/9/14 Left deltoid with raised red welt. 11/10/14 Left deltoid reaction progressed during work day to pruritic erythematic raised 10 cm warm welt. Took BENADRYL PO, some improvement of swelling. 7:20 pm raised 10 cm red patch, warm. TX ice, BENADRYL, follow up PRN.
Pains; Blisters started forming; The area is still itchy; Breast pain; Back pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 24th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain, blister, pruritus, breast pain and back pain. On an unknown date, the outcome of the pain, blister, breast pain and back pain were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pain, blister, pruritus, breast pain and back pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age ta vaccination was not reported. The patient stated last year she/he got the flu shot in left arm that night she/he started getting pains and blisters started forming that night all on left side, all around under his/her left breast and across the middle of back. The patient also mentioned till today the area was still itchy, coincidence. The follow-up would not possible as no contact information was available.
Information has been received from a pharmacy technician/student referring to an adult patient of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On approximately 08-FEB-2019 (reported as about a week ago) the patient was inadvertently vaccinated with a dose of pediatric VAQTA 25/0.5 (unit not provided) (dose, lot # and expiration date were unknown, intramuscular) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported) , because a company representative mistakenly told that it was the Centers or Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
In late December I started wheezing and coughing, this is normal for me during an asthma attack. This time the asthma attack would not go away with any of my medication. I went to my pulmonologist; we discussed my symptoms. He prescribed a prednisone dose pack, once I completed the dose pack the wheezing, coughing came right back. I called his office to let him know that I was still having the same symptoms, he called in another round of the prednisone dose pack. This dose pack did not clear it up either. I made an appointment with my primary care physician; she ordered a prescription of prednisone dose pack but doubled it. I have since had a CT scan and chest x-ray. I saw a cardia thoracic surgeon today, he and the cardiologist are deciding the best way to proceed.
Mom contacted office after leaving appt, child with swollen eyes, was told to come back to office. Swelling of B/L eyes, could barely open eyes.  One hive noted at injection site of MMR.  Pt was given oral Benadryl and depo Medrol 40 mg IM.  Pt was monitored for 30 mins, with eye swelling reduced but not resolved when they left the office. No difficulty with breathing or tongue swelling.
Information has been received from Licensed Practical Nurse concerning a female who "at an unspecified time in the past" was vaccinated with PNEUMOVAX 23 (therapy route and lot # not reported). On 03-NOV-2010 the patient was vaccinated SQ with a dose of PNEUMOVAX 23, 0.5 ml (lot # 665924/0930Z, expired date 17-JUL-2011). The patient developed injection site reaction after receiving PNEUMOVAX 23. The same day she developed a red, hot, swollen area the "size of a baseball" on her arm at the injection site. The patient was treated with antibiotics. No lab diagnostics studies performed. Patient's present status was not specified by reporter. The Licensed Practical Nurse requested a lot check for PNEUMOVAX 23 lot # 665924/0930Z. The nurse requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. No further information is available.
Pt reports feeling dizzy and lightheaded. Vitals WNL. Water provided. Pt observed for 45 mins and reported improved symptoms. Pt discharged home, patient denies distress.
constant vascular leg pain, shooting pain pelvis, heart palpations, full feeling in head, headache, great fatigue
I started getting symptoms of sore throat and a cough. On 05/23/2022, I did an at home antigen COVID-19 test that was positive. I was traveling at that time so I contacted a doctor in a different area and was prescribed PAXLOVID. My symptoms progressed on 5/24/2022 to brain fog and fatigue. My symptoms did improve with PAXLOVID. I had to fly back home. And now I am getting my symptoms back with fatigue, brain fog, and cough. I did an at home COVID-19 test this morning that did show a faint positive line. It feels like my symptoms are rebounding. I did take all of my prescription for PAXLOVID.
PT called at 3:15 this AM concerned that she might be having an allergic reaction to the Pneumovax she received at her comp visit. She had a bad headache, and itching on her back and shoulders. She denied any rash or breathing difficulty. I advised her to take Tylenol 1000 mg Q 6 hours, and Benedryl 50 mg Q 6 hours, have someone drive her home, and if she did have problems breathing to call 911.
24 hours of fatigue; slight fever first night; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on Apr2021 as dose one, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecific date of Apr2021, the patient experienced 24 hours of fatigue, and slight fever first night. The outcome of the events was unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
While a nurse was preparing to reconstitute a COVID-19 vaccine, the vial was dropped and broken.  This error did not reach any patients and did not cause any adverse events.
Patient reported that 2 days after his vaccination he experience heart palpitations for 2 to 3  hours in the evening.  He felt this was caused by his vaccine because he doesn't frequently have heart palpitations.
Information has been received from a consumer concerning her 16 year old daughter with fruit allergy, penicillin and amoxicillin allergy and sulfonamide (BACTRIM) who in March 2007, was vaccinated with the first dose of GARDASIL (Lot # not provided). Concomitant therapy included hepatitis A virus vaccine inactivated (unspecified, manufacturer not provided) (received on same day, but not on the same arm as GARDASIL). It was reported that the patient developed a sore at injection site hours after taking the first dose of the vaccine. It was also reported that the patient developed a sore at injection site that lasted for one week after receiving the second dose of the vaccine in May 2007. The patient also developed bubbles in the injection site that looked like it contains a liquid inside the bubbles and it lasted for 2 months. Subsequently, the patient recovered from liquid filled bubbles in injection site and sore at injection site. The patient sought unspecified medical attention. Additional information has been requested.
Patient 44-year female comes to the emergency department today for upper respiratory symptoms.  She states for the past week she has had fevers, body aches, cough, shortness of breath, myalgias, vomiting, diarrhea, Patient was seen evaluated for multiple URI symptoms.  Vitals are significant for hypoxia requiring nasal cannula.
6:30pm 23rd Dec. Parents noticed rash, fever 102. 24th Dec. Dr tested for strep. Noted tachycardia. No results on blood test for strep. M.D. encouraged continued use of antipyretics. 25th Dec. 2-3am to emergency for copious, continues emesis. Anti-emetics administered and OTC Benadryl recommended prn. No conclusive diagnosis. Rash and itching continued 2-3 weeks. No residual problems noted.
pt recv vax 29MAR96 & 14MAR98 pt devel chickenpox that consisted of greater than 150 lesions;pt was treated w/colloidal oatmeal (aveeno), DPH & Motrin;pt recovered;
constant  headache, muscle aches, chills,  heavy fatigue,  this has been ongoing since injection.  After 1 week, systems appears to now be  slowly going away
This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 18Jan2021 14:00, at 78 years of age, (Batch/Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included chronotropic incompetence from an unknown date and unknown if ongoing, cardiac pacemaker insertion because of chronotropic incompetence on an unknown date. Concomitant medication included Vitamins and zolpidem tartrate (AMBIEN) taken for an unspecified indication since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19. On 21Jan2021 13:00 the patient experienced first shot sweating, chills and tiredness. No treatment was received. The events outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.
pt says he was nauseated, dizzy, and was restless so had trouble sleeping.  Today he has fatigue, some dizziness, still a little nauseated and has a red, sore arm.  Pt will contact his PCP if his symptoms get worse.
The shoulder that was injected has limited motion and extreme pain when the limit of the motion is reached.  The pain persists for up to a minute after the movement that caused the pain.  I can't sleep in certain positions due to the pain.  I search for positions to hold my arm that have no pain.  This has been going on for well over a month.
Per patient's mother: 6 days post vaccination with MENVEO vaccine patient had an episode of  syncope with seizure like movements while at school EMS was called and patient was transported to Hospital. 10/2/18 patient had two more episodes with same symptoms of syncope and seizure like movements while at school. 10/4/18 while in school patient began to have repeat of above symptoms of seizure like activity. Patient went to Clinic for further evaluation. Pt was hospitalized with 3 day EEG monitoring showed absence epilepsy. Patient was started on LAMICTAL and has not had further seizures.
42 yr old female patient complaining of sensation of  (L) inner ear swelling as with food and mold allergens. Area below (L) eye slightly itchy. No redness or swelling noted of ear or eye.
Patient received vaccination the morning of 11/11/2020, and the evening of the same day, patient stated he developed fever (101), upset stomach, muscle weakness, muscle aching, and fatigue.  No diarrhea, difficulty breathing or rash was reported.  Patient went to ER the next morning after vaccination due to his symptoms and possible concern about COVID.  COVID test came back negative.  Patient was in ER for about 8 hours and started feeling better and was completely symptom free by the evening of the same day.