chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Didn't feel well; Extreme sore throat; Chest discomfort; Joint hurt can't stand / My hip and back hurt so bad; Can't taste or smell; Can't taste or smell; Stuffy nose; Coughed my chest burns; Coughed my chest burns/chest burning; My hip and back hurt so bad; joint hurt can't stand; This is a spontaneous report. A contactable 59-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, she had an appointment on 19Jul2021 for her 2nd dose but due to her severe reaction she didn't get it. She wasn't feeling well to get the second dose. Patient stated, on an unspecified date in 2021 "She was feeling terrible: sore arm, didn't feel well, extreme sore throat, chest discomfort, joint hurt can't stand, can't taste or smell; stuffy nose and coughed my chest burns. Patient never had this chest burning before. It burns so bad. Patient coughed and coughed. And her hip and back hurt so bad. The patient was taking Aleve for the events and it wasn't helping, and once patient started taking Tylenol and Advil for the events it was better. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Day after shot pt was very tired. Pt states that adverse symptoms began with a severe headache (11/12/09) with neck pain and weakness that lead to tingling in feet body aches and then paralysis of lower extremities on 11/21/09.  She went to a Hospital mult. times for evaluation. She admitted to another hospital on 12/3/09.  12/7/2009 ED records for multiple visits from 11/16-11/30/2009,  patient with c/o's myalgias, headache, neck pain and weakness, LP, Tx IV ABX, Decadron Toradol 12/8/2009 MR for admission 12/3/2009, patient with c/o's paresthesias and weakness of extremities, neuro exam noted loss of sensation and areflexic globally, ICU, Tx: IVIG, suspect GBS
Per patients mother, patient awoke this AM with "orange sized" inflammation & "itching" at (L) delt region. Denied further c/o. Recommended Ibuprofen & cool compress, F/U with PCP if s/s persist or worsen.
started vomiting on 25APR96 x 5 days;27APR96 devel 3cm red rash on rt thigh w/fever & loose stools;also head & chest congestion, BOM & 19JUN96 cellulitis
As of 1 week ago penis has grown by approximately 3 inches.   Penile function remains intact.    No other symptoms.
tested positive for COVID-19; chest cough; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) for Sinus infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment using azithromycin(Z-Pak)  was reported.
4 hours after she had her flu vaccine last visit she started shaking uncontrollably and then by morning she felt so weak and miserable in her extremities that she actually had to crawl to the bathroom.  She states his lasted for several days.
Our MA accidentally gave patient an adult Pfizer booster dose instead of a pediatric dose. Pt is 5 years old. She notified me promptly of the mistake. I then immediately informed the mother of the patient of the mistake and how it will be handled and what side effects/reactions to watch for. I then informed Dr. of the mistake. Dr. then went out and spoke with mother of patient as well. I then called the local Health Department to report it and find out next steps. RN called Pfizer to report it as well and they both opened a case file. Local Health Department will email me with next steps. The first one was to report it to the mother of patient and let them no their are no adverse reactions/indications. Patient can go back to regular pediatric booster if a second one comes out in the future. I called mother of the patient and let her know what they said and informed her of what our current protocol is and how it will be changed moving forward so this does not happen again.
Became sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter who reported for an unspecified patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and became sick. No clarifying details were provided.  No additional information was provided. This case linked with US2020AMR145802 and US2020AMR145831, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145802:same reporter US-GLAXOSMITHKLINE-US2020AMR145831:same reporter
Severe pain in the arm; Felt trouble breathing; Swelling of the lymph nodes around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in the arm), DYSPNOEA (Felt trouble breathing) and LYMPHADENOPATHY (Swelling of the lymph nodes around injection site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe pain in the arm), DYSPNOEA (Felt trouble breathing) and LYMPHADENOPATHY (Swelling of the lymph nodes around injection site). At the time of the report, PAIN IN EXTREMITY (Severe pain in the arm), DYSPNOEA (Felt trouble breathing) and LYMPHADENOPATHY (Swelling of the lymph nodes around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia;  36 hours duration Ibuprofen; hydration; bed rest;  Work absenteeism x 3 days
This spontaneous report as received from a pharmacist refers to a 99 year old male patient. On 09-MAR-2015 the patient was vaccinated with expired dose of ZOSTAVAX lot # K003595, expiration date 07-FEB-2015 (dose and route of administration were not reported). No adverse events were reported. Additional information has been requested.
Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the pharmacy light headed, flushed, and claimed mouth, lips and tongue were tingling.  No signs of facial swelling. Nurse practitioner attached to the pharmacy examined the patient before sending her home in her husband's care.
Nausea and headache twenty minutes after 1st dose.  Proceeded to get 2nd dose on 1/21/15 without telling nurse about symptoms.  later developed diarrhea and back pain.
Headache, Myalgia, malaise, pain L arm, ha(frontal/side) Narrative:
baby diagnosed with cystic hygroma after the mother received both doses of COVID vaccine; Maternal drug exposure; This is a spontaneous report from a Contactable consumer who reported information for both mother and fetus case. This is the fetus report. The mother received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 08Apr2021 as single dose, second dose on unknown date at single dose for COVID-19 immunisation. The mother medical history and concomitant medications were not reported. Caller states that this is fetal case. He states that she is recently pregnant but doesn't know how far along she is. In the conversation the colleague informed him of a complication with the baby. They have indicated that the baby has Cystic Hygroma. Caller states that he thinks the baby is in the first trimester but he is not sure. Caller states that the patient has received both vaccines. Caller states that the diagnosis of cystic hygroma was made yesterday on 13May2021, and the patient informed the caller today and states that it is serious, very serious. He states that it is life threatening for the child, not likely life-threatening for the patient. The lab data included Ultrasound on 13May2021 included diagnosed with cystic hygroma. The outcome of Cystic hygroma was not recovered, of other event was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550420 mother case
Redness at injection site (large red circle) - measles- like bumps/rash on her body.
Information regarding PREVENAR was received from a healthcare professional regarding a 19-month-old male patient who experienced drug ineffective and meningitis. At 19 months of age, the patient received the fourth dose on an unspecified date. The patient received all four doses of PREVNAR therapy. On an unspecified date, the patient was admitted to the hospital and diagnosed with meningitis. Patient has since recovered. It was noted that titer levels were not done. No further information was provided.
History of hypertension and COPD presents to the ED 4/23/21 with complaints of fever, nausea, dizziness, muscle aches, diarrhea, urinary urgency, and shortness of breath that started 4/20/21. SARS-CoV-2 COVID-19 resulted positive 04/22/21 23:40 on PT admitted 4/23/21. PT received dose 1 Pfizer vaccines on 2/25/21 LOT EN6200. Pfizer dose 2 received 3/18/21 LOT EN6207. PT discharged 4/25/21.
Abdominal Pain started 8-22-19 Epigastric/periumbilacal Nexium/Hyoscyamine 8-29-2019 ED for abd pain  CBC, Amylase, CRP, CMP, sed rate, GGT,Lipase, U/A, UPT CT of Abdomen & Pelvis Trace free fluid thickened colon wall - colitis  Abd x-ray, abd. U/S 8-30-19 Back to ED CBC, CRP increased, CMP, ESR increased, U/A Lipase, Abd x-ray Hyoscyamine - Carafate, Tylenol  ED-> Hosp 9-1-19 Admitted to hospital intractable abd. 9-4-19 Narcotic pain control, Nexium  9-3 EGD & colonoscopy gastritis & duodenitis Acute colitis (ileocolitis) Minimal terminal ileol involvement  Patchy Colitis (Acute)  2 months of uceris (Budosemide) ulcers post hospital pentasu QID 1000 mg QID Nexium QAM
Patient was given COVID-19 mRNA Pfizer vaccine at 9:33 AM. At 9:38 AM patient notified nurse of itching at injection site on Left upper arm. Area was not raised but red. Patient also stated her throat was itchy and felt like it was swelling. Dr came in to see patient at 9:42 AM. Benadry 50mg given at 9:45 AM. Continued to monitor patient, at 9:55 AM patient stated she was feeling better. Patient was monitored until 10:10 AM. At that time patient was no longer itching or swelling in throat. Patient instructed to take Benadryl 50mg every 4 hours if needed for itching. Instructed to go to ER if any issues with breathing or swelling of throat Patient and mom verbalized understanding
Vaccine administered after the CDC recommended window of 2 hours after being removed from the refrigerator. Per manufacturer, the vaccine is not "expired" unless 12 hours up to 73 degrees, which the vaccine was and it was within this time limit. Explained to patient.
injection site pain; said had myalgia; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain) and myalgia (Verbatim: said had myalgia).The outcome of the injection site pain and myalgia were not reported.   It was unknown if the reporter considered the injection site pain and myalgia to be related to Arexvy.  It was unknown if the company considered the injection site pain and myalgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter mentioned that another healthcare professional (patient) got Arexvy shot and experienced myalgia and injection site pain. The reporter did not agree to follow up from GlaxoSmithKline.
flu; Initial information received on 15-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Hell No! Never would get one again! Last time I got one I was sick with the flu for 3 weeks."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Within 48 hours I begin to experience heart palpitations and drastic weight loss. Once seen by my doctor, it was determined I was having a hyperthyroid storm. Since this time I've been diagnosed with Grave's disease and Hashimoto's. My thyroid levels and autoimmune antibodies previously  normal; last checked March 2021.
Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retain even small amount of any fluid without vomiting; vomiting occurred one more time 30 hours after onset after eating small amount of chicken soup; night sweats, chills, and joint pain accompanied vomiting; night sweats and joint pain remain to date, approximately 4 days after onset of symptoms; no diarrhea. Vomiting was far worse than ever experienced in memory, except possibly when having a stomach bug as a child.
Pt states last year had a bad reaction to flu vaccine where her pulse went high and they made her lay down. Pre vaccine vitals, BP 120/84 R arm, P 76 R 20 at 1004. 1023 pt states she is feeling palpitations, P 116, R24 BP 143/99, R 26,  HA pain 7-8 out of 10, palms are red, pt is very anxious.  Denies itching, SOB. 1028 Benadryl 50 mg IM given in R arm (lot 6008296 exp 7/31/16), BP 150/106 P 126 R 22. 1033 - pt taken to ED and registered, reported off to Triage RN.  Will complete UAIR when pt done at the ED.
Fast heartbeat, dizziness, lightheadedness, diaphoretic and general weakness.
Rt thigh 5.5 x 3.5 cm erythema- mild tenderness increased warmer. Lt thigh -1 circle.
My son was walking prior to vaccination. About two weeks after he recieved his shots he woke up will limmit use of the left leg. He could not stand on it formore than a few seconds and every time he tried to step he would collaps. We took him to the doctor that evening and the doctor agnolaged this symptom and told us to ice it and wait and see. After a few days of its sevarity he slowly started to re use his leg. I THOUGHT IT IMPORTANT TO MENTION THAT HIS FATHER HAD A SEVER ALLERGIC REACTION TO THE STREPDICOCCAS VACCINE WHEN HE WAS A BABY. DOCTORS TOLD US THERE IS NO CONECTION WITH VACCINES AND FAMILY HISTORY.
Shingles Diagnosis, rash/bumps in ear and on neck. Treatment just begun. Viral medication
Pain, swelling, itching at injection site for 4 days and then resolved.  On Day 7 (today), severe itching, redness and swelling returned in left arm where injection was given.
within 13-14 minutes had my arm feel strange all the way to my finger tips. Then I started having fast heartbeat , heart pounding outside of chest. Also couldn't catch my breath. As of 6 hours later I still don't feel well
1/13/2022 Starting feeling tired tired at work and my lungs were feeling sluggish. By 1:30pm I had a CoVid test and was found positive and went home. I called my lung disease team and was advised to call 911 if my oxygen levels went below 80%. Three day days later it fell too low and called for an ambulance. And my state was awful, couldn't eat, sleep, or breathe very well. At the ER I was there for 7½ hrs. and had blood test done. Sent home with prescription paxlovid. 5 day issue and was in constant contact with my lung team. As of 2/21 still have reverberating issues and my taste and smell are still gone, headaches come and go. 2/24 Vid conf. Call appt. with advanced lung care team.
34 year old female, 34 weeks gestation here for 2nd Pfizer dose of Covid 19 vaccine. Vaccine administered at 1023. 15 minutes post administration, patient began to report a sensation of palpitations. VS checked and are as follow. BP 121/79 HR 87 RR 16 Saturation of 98% on RA. Patient reported sensation of "Braxton Hicks" contraction without and pain. MD STAT called for further evaluation. Per MD order, EKG and blood glucose checked. Disposition to OB clinic for further evaluation.
Felt like a bad wasp/hornet sting that burned.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: LOTER2613) via an unspecified route of administration in the arm right on 01Apr2021 at 12:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included diffuse cutaneous mastocytosis, osteoarthritis and attention deficit disorder (ADD). The patient received unspecified medications within two weeks of vaccination. The patient previously took codeine on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 12:15, the patient experienced vaccination site burning from the moment the injection started, the patient felt like she was being stung by a wasp or hornet. The patient never had that sensation with any other vaccine (or needle injection of any kind). For several hours after the injection it continued to felt like a bad wasp/hornet sting that burned. The patient iced it several times. The patient had cutaneous mastocytosis. The patient saw the release from) of a study to look at mast cells in adverse reactions to the vaccines, the patient thought perhaps mastocytosis might be linked to the immediate burning session that the patient experienced and then lasted for several hours. Therapeutic measures were not taken as a  result of the events. The events did not result in doctor or other healthcare professional  office/clinic visit, emergency room/department or  urgent care. The clinical outcome of the event injection felt like a bad wasp/hornet sting that burned (vaccination site burning) was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.; Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.) and PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range). On 19-Nov-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.). On 19-Nov-2021, PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range) had resolved. On 19-Nov-2021 at 10:15 AM, EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.
minutes after vaccine whilst patient was sitting down she lost consciousness and fell from her chair. her Bp was 74/40 and after minutes increased to normal.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M037248 or lot # M037248. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of six reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005170: US-009507513-1708USA001493: US-009507513-1708USA005169: US-009507513-1708USA005166: US-009507513-1708USA005167:
About 27 hours after vaccine about 3 inch diameter local redness. 28 hours after there was some scant serous discharge from the center of the redness.  By about 32 hours after vaccination there was redness and induration that had largely covered her anterior thigh. By 42 hours after vaccination there were a 4 inch diameter patch of vesicles (blisters) the redness and induration had somewhat improved. There were no fevers or systemic symptoms.
After immunizations given mom called nurse back to the room. Child's legs were bright pink/red; dark, non blanching spots on both lower legs; some swelling of feet noted; 1/4 tsp BENADRYL given and 6ml prednisolone as prescribed by NP. Before leaving office redness faded, purplish red spots on lower legs yet.