chrisvoncsefalvay/vaers-outcomes huggingface dataset:
encephalopathy; seizures; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALOPATHY (encephalopathy) and SEIZURE (seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C01A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Systemic lupus erythematosus since an unknown date.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced SEIZURE (seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ENCEPHALOPATHY (encephalopathy) (seriousness criteria hospitalization and medically significant). At the time of the report, ENCEPHALOPATHY (encephalopathy) and SEIZURE (seizures) outcome was unknown.            Treatment information not provided. Concomitant medications were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 28-AUG-2014, the patient was vaccinated with ZOSTAVAX (lot # K000996, expiration date: 13-MAR-2015), 0.65 ml, subcutaneous in deltoid region of the upper arm. Concomitant therapy included Temazepam. On 29-AUG-2014, patient developed swelling and a "hot lump" at the injection site. The patient sought medical attention by visiting pharmacy and was advised by the pharmacist to ice the affected area. No lab diagnostics studies were performed. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Dizzy; Arm pain; Weakness in legs; Problem with memory; Sickly feely; Itchy all over; A bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory) and ILLNESS (Sickly feely) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm pain), MUSCULAR WEAKNESS (Weakness in legs), MEMORY IMPAIRMENT (Problem with memory), ILLNESS (Sickly feely), PRURITUS (Itchy all over) and NAUSEA (A bit of nausea) outcome was unknown.            Concomitant medications were not reported.
Patient received her 2nd dose of Moderna despite being 15 years old. This is because for her 1st shot (RX 7614085) she received Moderna erroneously. To maintain continuation of care the CDC recommends she receive another dose of Moderna.
Arm swelled, itched, became red, hot -- scratched so much it made places.  This persisted fir about a week.
Tongue and throat swelled up; Tongue and throat swelled up; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 16:30 (at the age of 74-year-old) as DOSE 1, SINGLE for covid-19 immunisation (Persuasion of Family). Medical history included Severe Acid Reflux (Probably diagnosed with about 30 years ago), allergic to Penicillin, sulfa, and all kinds of food. The patient concomitant products included takes Allergy shots from 2016 to Ongoing) for allergies. The patient previously took Myocins [methocarbamol] and aspirin [acetylsalicylic acid] and experienced allergy. On 08Apr2021, the patient experienced tongue and throat swelled up. Reported that events lasted for about 30 minutes with no lasting effects. She said that it was a kind of delayed reaction. States it didn't happen until after caller left the facility that administered the vaccine. Caller didn't' require any hospitalization or anything. It was reported that patient contacted her doctor via phone the day after receiving the first dose Pfizer Covid Vaccine and the Doctor doesn't think the first dose Pfizer Covid Vaccine had anything to do with it. The Doctor thinks the severe acid reflux comes up into the esophageal tubes real bad and the doctor thinks this was what happened. Patient have the second dose scheduled for 05May2021 and don't know if its safe to go ahead and take the second dose Pfizer Covid Vaccine. Want to know if she can take Allegra or Benadryl before receiving her second dose Pfizer Covid Vaccine. The outcomes of events were recovered on 08Apr2021.  No follow-up attempts are needed. No further information is expected.
Swelling and redness down to the elbow. Patient went to the ER and was given Cephalexin 500mg.
pt recvd vax 315PM & 325 PM cheeks sl flushed, rt arm @ inj site was reddened w/4-5 whelps w/some itching reported;ice was applied to area pt hear rate & resp regular & even;pt alert & responsive;observed for 30mins;
Fever, headache, chills, joint pain, gas, diareah, loss of appetite, anger
On day 8 post vaccination, patient reports her left arm is "hard, red, warm and swollen" near site of injection.  She took 2 Benadryl (50mg dose) around 9 AM and does not have any other symptoms.  She says her arm feels "painful".  Advised patient to take Ibuprofen (Advil 200mg) per package instructions, apply ice compress (10 min on, 10 min off) to area and to continue Benadryl as needed.  Counseled her to contact Primary care physician to monitor her and to take a picture of the arm to document.  Advised patient to call 911 or go to urgent care if symptoms worsen or if experience hives/difficulty breathing.  Patient stated she understood and would seek follow-up with a provider.
sore injection site; muscle fatigue/side effects; tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle fatigue and tiredness. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, muscle fatigue and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, muscle fatigue and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 08th July 2020 at evening, the patient received 2nd dose of Shingrix. On 9th July 2020 at morning, the patient woke up with very sore injection site and tired. The patient also experienced have General muscle fatigue. These were common side effects. The patient asked to have Motrin for them.
expired Tenivac given to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient and it was reported expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-JUN-2023, an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] Suspension for injection (batch/lot number, expiry date, strength, route: not reported) given to a patient in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.   Action taken: Not applicable.  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 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.
Patient stated that he experienced a fever, swollen lip, and difficulty breathing the night after receiving the vaccine.
No adverse reaction to immunizations.  Unknown states "as far as we know, pt did not have reaction (fever etc). Infant given a bottle and put down for nap. Later the babysitter found the baby unresponsive. Autospy states cause of death as pneumonia. Autopsy also shows pulmonary edema and congestion.
I have been anxious my whole life but never had a panic attack..30 minutes after my first dose I had a panic attack that lasted 2 hours..thought I was just overwhelmed but they have persisted every single day for the last 3 weeks all day everyday feeling anxious overwhelmed and scared
Heart Complications; dealing with some adverse symptoms; a rapid heartbeat out of proportion to age and level of exertion; fever; Went for their flu shot but instead got the Pfizer Covid vaccine; Went for their flu shot but instead got the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer (parent) and a Pfizer-sponsored program. A 5-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Lot number: Unknown), via an unspecified route of administration as DOSE 1, SINGLE on 04Oct2021 at afternoon time (at the age of 5-year-old) for COVID-19 immunisation at pharmacy. Patient's medical History (including any illness at time of vaccination) included had patient tachycardia. There were no concomitant medications. No history of all previous immunization with the Pfizer vaccine considered as suspect. Caller was a 35-year-old male and wife (29 years old) with 2 children (4 years old male and 5 years old). Caller called because him, his wife, his 4-year-old, and his 5-year-old child all went to get the flu vaccine but were given doses of the Pfizer COVID-19 Vaccine instead on 04Oct2021. Their two children were mistakenly given the COVID-19 vaccine instead of a flu shot a week ago at their local pharmacy and they are now dealing with some adverse symptoms. a rapid heartbeat out of proportion to age and level of exertion. The children have been taken to a paediatric cardiologist, and the family was told both are showing signs of heart issues, since last week, the family now says the patient had developed a fever. Seriousness criteria was assessed as hospitalization for Heart Complications. The caller and his wife had already received both doses last Apr2021 of the Pfizer COVID-19 Vaccine before. Both children, were given full adult doses of the Pfizer COVID-19 Vaccine. Caller declined to provide initials, date of birth, sex, height, weight, or ethnicity of the patient and HCP information. Caller states his wife was better at keeping up with that information than he was. Stated that he just wanted to provide information on the other child due to the other child's symptoms. Caller stated that he has been trying to get the Lot number from the pharmacy. The patient underwent lab tests and procedures which included Heart rate increased as rapid heartbeat out of proportion to age and level of exertion. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to report for this child. The outcome of events was reported as unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.  Follow-up (12Oct2021, 14Oct2021,18Oct2021): New information received from a contactable consumer. This consumer (Father) reported for a 5-year-old male patient that: Clinical course updated. New event fever was added. Medical history updated (tachycardia). lab tests added.
1250PM approx 1/2 hrs p/vax pt came back to provider c/o swelling & redness of site, watery, swollen  itchy eyes, watery, swollen nose, redness & itching of lt chest w/rapid progression 1254PM Epi; c/o frequent h/a;
Pt seen at her PCP office on 12/21. She reported received COVID booster Moderna on 12/14 L arm. Noted soreness over L arm , chills, pain.  However, on 12/17, she noted a "red blotch" in L axillary region which appeared as ecchymosis. This seemed to progress following day with appearance of ecchymosis over L lateral breast and L side of chest as well as towards abd.
Information has been received from a 67 year old male consumer with no pertinent medical history and drug reactions/allergies to sulfur, penicillin and strawberries, who on 19-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included morphine, FAMVIR and topical lidocaine. On 16-JAN-2011 the patient was diagnosed with aphthous stomatitis and was hospitalized from 17-JAN-2011 to 22-JAN-2011. Blood tests were performed daily (results not provided). On an unspecified date the patient recovered. No further information is available.
Started period  much earlier after the shot. Then, same thing happened after the second shot. Two cycles were shortened and the third men?s track cycle was delayed for a month (skipped one menstral cycle after two short cycles).
Initial report received from a health care professional on 20 Aug 2010: This patient was vaccinated MENVEO (batch number unknown), on an unspecified date. Following administration with the vaccine, the patient developed hives on an unspecified date. The outcome of the event, seriousness and causality was not reported.
After injection I skipped my period which was regularly every month. I got the injection in April 2021 and did not have period in April or May. Then I had "period" in June and I have been continued to bleed since June 2021. I have sought medical care and they are trying to figure out what is causing the bleeding. I have been told it could be an adverse effect from the COVID vaccine.
Weakness, cough, tightness in chest, shortness of breath, glassy eyes, red eyes, chills/sweats.
5/7/23  I was really congested, upper respiratory and nasal.  I started coughing a few days later, which really hurt because of a fall I had several days before. On 5/11/23, I went to a walk-in clinic and had a COVID test, results pending.  I was prescribed a Z-Pack and a steroid thinking it was a virus. After being prescribed these medications, my COVID results came back positive. I called my PCP and was prescribed Molnupiravir and a nebulizer. I took the Molnupiravir for five days.   I am now dealing with significant fluid retention and have a call into my doctor.
a little soreness at the injection site that day; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient) via social media. This case was linked to case 2020SA304070.  This case involves a patient (unknown age and gender) who experienced a little soreness at the injection site that day (injection site pain), while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.   On an unknown date of September-2020 (reported as last month) , the patient received a dose of suspect Influenza Vaccine injection produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date of September -2020 (reported as that day), same day after starting the suspect vaccine therapy, the patient experienced a little soreness at the injection site (injection site pain) and  no ill effects afterward.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
This spontaneous report as received from a pharmacist refers to a 36 year old female patient with allergy to sulfa. The patient had anxiety IBS (Irritable bowel syndrome), acne, sexually transmitted disease and obesity. The patient was not pregnant. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as H015749) (0.5 ml, intramuscular in the right arm). Concomitant medications included INSALENZA (manufacturer unknown) and a TDAP vaccine. The PNEUMOVAX23 was the only vaccine administered in the right arm. On 06-MAR-2013 the patient visited an Urgent Care Facility. She was treated by a physician. The right arm site of injection was red and inflamed on an unknown date in March 2013. It was a 29cm by 16 cm reddened patch on her right arm which was hot to touch. Patient also complained of fatigue and chills on an unknown date in March 2013. Physician prescribed cephalexin. The pharmacist stated that the patient was fully recovered at the time of report. There was no laboratory diagnostics study performed. Action taken and causality were not provided. This is one of several reports received from the same source. Additional information has been requested.
Next day after the shot, underarm pain that was unbearable.  Then two days later, the lymph nodes in my breast were enlarged and my breast swelled to twice its size.  I had redness and swollen glands that kept spreading until I was given antihistamines.  Had to go to the ER twice and my primary doctor once.  I am getting better after 8 days.
pain at injection site; pain in sternum; fever of 103; vomitting; diarrhea; headache; body pain; difficulty taking deep breath; dizziness; WBC in urine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in February 2019, for tolerance, refer case US2019GSK097510).   On 20th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive. The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), analgesic, nos (Pain Medicine (Medication Unknown)) and intravenous fluid (nos) (Intravenous Fluid). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive were unknown.   It was unknown if the reporter considered the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for himself. After receiving Shingrix, the patient experienced pain at injection site, and then at 2 AM woke up with fever of 103, vomiting, diarrhea, headache, body pain, pain in sternum, difficulty taking deep breath and dizziness. The patient was taken to emergency room (ER) for evaluation and found white blood cells (WBC) in urinalysis and she was prescribed Bactrim. Also the patient was given pain medicines and intravenous (IV) fluids and was sent home by 12 noon the next day. Emergency room visit required. The patient was not admitted to the hospital and did not consent to follow-up until she has a chance to be seen by her physician.
Patient said she experienced a rash one week later. It lasted about a couple of days, but she didn't even notice it. Her husband pointed it out.
Received TDAP 11/11/10 R deltoid area. Developed local reaction (skin redness/heat) on 11/18/10.
Exacerbation of MS Symptoms.  Including nerve pain and Cognitive difficulties along with heavy fatigue.
Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Ongoing sleep problems. Taking Zyrtec and is helping a tiny bit. Melatonin is not working. Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Day 2 5/4/2021 slight fever 99.8 took a tylenol. Day 4 slight swelling and red oblong circle at and around the injection site.  Hot to the touch.  Day 5 bad itching started tried not to rub or scratch applied ice and cortizone 10 .  Day 6 today still red and itching hot to the touch.  Read that it was not a serious reaction will continue to treat at home
Client complained of itchy throat.  seen and assessed by EMS.  Vitals are as follows:  B/P 107/72, HR-109, O2-99.  Client denies any other symptoms and verbalized decrease is sensation.  Client cleared by EMS to go home.  Client advised to seek MD if symptoms worsen.