chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delusional and confrontational; Unable to take meds or eat; Seemed to be having a mental breakdown; Constantly obsessing over minutia that was not pertinent to what she is being asked to do; She gets very upset and anxious and angry; This is a spontaneous report from a contactable nurse. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular (left arm) on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included depression, cerebrovascular accident (CVA), chronic heart failure (CHF), emphysema, and angina, all from unknown dates and unknown if ongoing. Concomitant medication included furosemide (LASIX), amlodipine, losartan, sertraline, nortriptyline, methazolamide, quetiapine fumarate (SEROQUEL), dorzolamide, tiotropium bromide (SPIRIVA), ciclesonide (ALVESCO), albuterol (ALBUTEROL [SALBUTAMOL]), carvedilol, calcium magnesium, iron, curcuma longa (TURMERIC), clarithromycin (CLARITIN), magnesium citrate, cyanocobalamin (B 12), paracetamol (TYLENOL), estradiol (ESTRACE) , d-mannose, vitamin D3. Concomitant medication also includes multivitamin, and stool softeners. It was reported that on 15Jan2021 at 15:30 the patient became delusional and confrontational and unable to take meds or eat. The patient seemed to be having a mental breakdown. No physician (MD) in ER would address the issue. It happened approximately two hours after the vaccine. She will not eat or take meds; she is constantly obsessing over minutia that was not pertinent to what she is being asked to do. For example, she comes up with steps she needs to take before she can eat, but she doesn't know them, so she gets very upset and anxious and angry. The events were assessed as life-threatening. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. However high age of the patient and underlying medical conditions cannot be ruled out a contributory factors 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.
Patient admitted in mid October 2012 for GBS, paralysis involved LEs and distal UEs. Treated with 5 days of IVIG.
3/14/08 received Tdap, IM, left deltoid. 3/17/08 presented with cyst and enlarged lymph  nodes Left axilla approx 70 mm x 40 mm. Soft with slight tenderness. No erythema, drainage.
Heart palpitations, increased pulse rate at rest up to 104 bpm, vertigo, ringing in right ear starting around March 10 or about 2 weeks after 2nd Moderna shot.
she heard that 2 other people were sick after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she heard that 2 other people were sick after the vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she heard that 2 other people were sick after the vaccine). At the time of the report, ILLNESS (she heard that 2 other people were sick after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: TCR received on 06-JUL-2021 to contact through mail ID provided, On 28-Jul-2021: Followup received included pt gender,age group and intials were updated.
Pt devel Bell's Palsy w/in 2 days of receiving Influenza vax; sx included lt sided facial weakness & aching, & dull h/a; Pt was treated w/pred 2 days later; Pt had URI 1 wk prior to receiving the vax;
1/12-day after injection, PT started getting red swollen sore arm. Also had headache that wasn't relieved by excedrin. 1/13/- progressing redness and warmth to arm, outlined, fatigued, felt warm and sweaty, 99.9 tympanic temperature, sought medical care at local Urgent Care. Diagnosed as post injection irritation.  1/14, fatigue increased, directed by employer to get covid test
This case was reported by a physician via call center representative and described the occurrence of chills in a unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and gastrointestinal disorder. On an unknown date, the outcome of the chills and gastrointestinal disorder were unknown. It was unknown if the reporter considered the chills and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The health care professional reported that a number of patients had reported reactions after the first dose of SHINGRIX, from chills to GI stuff (gastrointestinal disorder) all the stuff that was in the label. The health care professional did not have any details about specific lots, patient identifiers, or the number of patients involved.
PATIENT WAS SITTING IN CHAIR AND EYES ROLLED, WENT LIMP AND FELL TO THE GROUND. A FEW SECONDS LATER HE REGAINED CONSCIOUSNESS BUT FELT "SLOW" LIKE HE JUST WOKE UP. AFTER 20 MINUTES OBSERVATION HE WAS ABLE TO GO BACK TO WORK.
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-AUG-2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2014, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 39 year old female patient. The patient's medical history and concurrent conditions were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of MMR II (0.5 ml, once, lot# L002242, expiration date: 21-JAN-2017) intramuscularly instead of the recommended subcutaneous route. Concurrent conditions were not reported. On the same day, the patient experienced burning and pain at the injection site following the vaccination. No treatment was given for the events and no lab diagnostics studies were performed. The patient did not seek any medical attention. The outcome of the events was unknown. The causal relationship between the events and MMR II was not reported. No further information was provided. Additional information has been requested.
no additional AE; temperature excursion of 47.9 F for 47 min; This spontaneous report was received from an other health professional and referred to a 16-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), intramuscularly at left thigh for prophylaxis (lot #W006596 has been verified to be a valid lot number, expiration date was 11-OCT-2024; dose and strength were not provided). It was reported that the vaccine the patient administered was stored in clinical practice and had a temperature excursion at 47.9 Fahrenheit for 47 minutes which was read from a digital data logger (product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
breast milk; sore arms; fatigue; sore back; headache; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.   On 21-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 19-Apr-2021, the patient was diagnosed with PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back) and HEADACHE (headache). On 20-Apr-2021, the patient was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk) and NO ADVERSE EVENT (son has not has side effects.). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING ( breast milk), PAIN IN EXTREMITY (sore arms), FATIGUE (fatigue), BACK PAIN (sore back), HEADACHE (headache) and NO ADVERSE EVENT (son has not has side effects.) outcome was unknown.
I woke up with difficulty breathing and hoarseness; spat out clumps of dark flesh, sinus membranes and blood from behind uvula, then bright red blood. I immediately requested to see health care, by the time I did an hour later, the symptoms subsided. I still went over to health care to report this but was subverted by being differentially diagnosed with acid reflux, a condition I hadn't had since my cholecystectomy in 2006. All was clear by the time I was seen by health care.
reported high fever  104.6 approx 48hrs p/vax;temp in ER p/APAP was 101.9;sepsis work-up neg;
Case number PHEH2013US001091 is an initial spontaneous report received from a physician on 10 Jan 2013: This report refers to an adult female patient. She had no reported medical history and concurrent conditions. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date a year ago. The physician reported that after vaccination, she was diagnosed with transverse myelitis on an unspecified date. No further information about seriousness, outcome and causality was reported.
Within hours of vaccination my injection site and then later my entire arm became extremely sore.   I had a hard time moving my arm.  After a few days this went away.   Now, 8 days later,  the soreness at the injection site is back again.  However, so far not as bad as when I first got the vaccination.
Deviation from dosing schedule(he did not want second dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule(he did not want second dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment medication information was not reported   Reporter did not allow further contact
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 102 doses/vials were given for LOT  026C21A.  Date the vial was initially stored in the refrigerator was reported as unknown.~  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document contain non-significant information was updated.
7-28-07 C/O headache, photophobia, feverish. 7-30-07 con't c/o headaches, photophobia, chills; took ibuprofen 600mg - symptoms resolved. 8-1-07 States sore throat and rash on her back - better today. 8-2-07 totally resolved. Pt states "feeling great".
Terrible headache lasting almost 3 days, slight fever the first day, extreme tiredness lasting 3 days- 4 days. After about 5 days noticed an itchy rash of small dots on my stomach.   Not all over just random areas.
First Vaccine Pfizer EN6206 Wednesday Night 3/17/21 Bumps on Throat, hard to swallow, tongue felt swollen and warm, Took Tylenol PM (has Benadryl  in Tylenol)  Thursday 3/18/21 Bumps on Throat, tongue felt swollen and warm, NO TASTE, Headache, Queasy Stomach, Lightheaded. Friday 3/19/21 Bumps on Throat, No Taste, Headache.  Taste Returned Friday Night Saturday 3/20/21 Bumps on Throat, mild headache.
Initial raised and inflamed at site of injection.  By evening, low grade fever, sore throat, sore glands in throat, headache. Returned to Doctor on 06/23/2011.  Throat was swabbed for Strep (neg) and issued prescription for cephalexin 500mg.  Fever and throat swelling persisted until Sunday, 06/26/2011, when I couldn't swallow at all, 103 degree fever, swollen throat, and vomiting, pain in shoulder and chest.  Went to ER.  Cat Scan showed bacterial infection.  Given IVs of steroids and antibiotics.  Admitted to hospital Sunday 06/26/11, continued antibiotics and steroids.  Released Monday evening 06/27/2011 with prescription for Dexamethasone 4mg and Clindamycin HCL 150.  Throat seemed better. Low grade fever continued and by Thursday 06/30/2011 was back up to 102 degree.  Follow-up on Friday with Dr.  Told was getting better.  Fever and pain in shoulder and chest continues thru 07/05/2011, always around 102 degree.  Another Dr. Appointment.  Blood work taken and was told I had a viral infection of lymph nodes.  Treat fever.  Fever continues through Sat. 07/09/2011. Pain in shoulder and chest continues through 07/11/2011
My son's left arms swelled up to the size of his bicep. It was red and hot and painful. Swelling went down and was almost gone by 5:30 pm. He got the shot before lunch. The school nurse applied ice and gave him TYLENOL then monitored him.
mixed series administered- second dose administered 3/4/21  Pfizer, first dose received Moderna 4 weeks ago.  Administration nurse stated they did not confirm manufacturer of first dose prior to administration of second dose, assumed it was asked earlier in the process.  Pt. did not have vaccination card at time of second appt to confirm manufacturer, caregiver stated "it was too big to fit in his wallet so we didn't bring it."   Site manager called Regional Medical Consultation Coordinator, to verify next steps.  Advised per CDC not to re-vaccinate.
felt flush; dizzy; nauseous; a pounding in her head; She wants to know if the vaccine would cause any side effects with her glatopa medication.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, age at vaccination 49 years), dose 2 via an unspecified route of administration on 25May2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included glatiramer acetate (GLATOPA). The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization.The patient experienced felt flush, dizzy, nauseous, a pounding in her head, she wants to know if the vaccine would cause any side effects with her glatopa medication on 26May2021. Reported as, she got the second Pfizer COVID-19 Vaccine yesterday and when she took her glatopa today she felt flush, dizzy, nauseous, and a pounding in her head. She wants to know if the vaccine would cause any side effects with her glatopa medication. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Ringing in the ears /there is a another male patient (age not provided) who experianced it as well; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is one of two reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated there was another male patient (age not provided) who experienced it as well. The patient experienced ringing in the ears on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021783245 Same reporter/product/event, different patient
Tightness of chest, trouble breathing, fever, weakness, dark orange urine, headache.
SWOLLEN EYES LIDS AND EYE AREA ALONG WITH ITCHNESS
MALAISE; ACHES; This case was reported by a nurse via other manufacturer and described the occurrence of malaise in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise and pain. On an unknown date, the outcome of the malaise and pain were recovered/resolved.   It was unknown if the reporter considered the malaise and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, for about 5 days after administration, the patient had malaise and had ache. The patient did not have nausea, stomach ache, and headache. The reporter stated, the symptoms were lasted for about 5 days. This case was linked with case US2021AMR007364, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007364:same patient
VasoVagal response. Drop in BP. Paramendics evaluated and transported due to low BP
large amount of swelling at the side, redness, and heat; large amount of swelling at the side, redness, and heat; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (reported as 1) who experienced large amount of swelling at the side, redness, and heat (Inflammation  and vaccination site reaction), while he/she received vaccine INFLUENZA VACCINE  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (09/17), the patient received a dose of suspect INFLUENZA VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had experienced large amount of swelling at the side, redness, and heat (Inflammation and vaccination site reaction) (Unknown latency) following the administration of INFLUENZA VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site inflammation, vaccination site swelling, vaccination site erythema and vaccination site warmth.   Office recommended ice to site of injection, motrin, and benedryl. Seen in office 9/19 (flu shot administered 9/17), oral steroids if not improved with OTC recommendations  The patient outcome was reported as unknown for experienced large amount of swelling at the side, redness, and heat (Inflammation  and vaccination site reaction).  Information on batch number was requested.  List of document held by sender: none.
Testing for antibodies done @ 3 & 4 wks p/last dose indicated non-response;
Extreme fatigue, skin painful to touch, extreme body and bone pain, excessive sweating, rapid heart rate
NO adverse event. Patient has not had any side effects. Patient was due for Tdap (BOOSTRIX by GSK); nurse accidentally gave a DTaP (INFANRIX by GSK). Called GSK and states not to administer a Tdap but consider this 6th dose of DTaP as Patient's Tdap booster. Re-dose a Td in 10 years from 10/16/18.
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot #, expiration date, dose and route unspecified) that were stored improperly. No adverse effects reported. This is one of several reports received from same source. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received from an other health professional. It was reported that 4-year-old male patient was vaccinated with a dose of PROQUAD (Merck) on 14-FEB-2014. Additional information is not expected as no further information is available.