chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse affects after 2nd shot , 3/9/21 - ongoing undulating headaches at back of skull/ears.  Headache pain 3 to 5 out of 10. Tightness in upper neck.  Occasional nausea.   Headache usually stronger early waking hours and late afternoon.    Scheduled Doctor appointment Tues 3/16/21 with health care provider.  Taking 325 mg aspirin to help manage pain -  only slightly effective.  Side effects have gone well past average 72 hrs reported as normal.
Pt. states that after receiving the 2nd dose of Shingrix 01/13/2022, started to experience symptoms that evening of chills, teeth pain, headache, fever (100.4), and fatigue. No noted Primary visit/communications. Pt. still experiencing symptoms.
Cough, tightness in chest, headache, fever, itchy, profused generalized rash. (Took TYLENOL, BENADRYL, albuterol Inh). Was given flu shot at 10/08/2015 5:00 PM. On 10/9/15 I had a cough, headache and started to feel achy, tired around 5:00 PM. I noticed the area of IM site was swollen, sore with red area where Band Aid was. I took a shower for aches and noticed the back of my arms were bright red and faint rash on abd, back. I felt hot, itching. My cough became tight/hacking and I felt tightness in my chest. I took TYLENOL, BENADRYL, albuterol Inh and felt better by 1:00 AM. Woke at 4:15 with fever, itchy prickly rash and swollen joints (wrist). Took another TYLENOL, BENADRYL and woke at 10:00 AM better.
fever, body aches, chills, gastro discomfort, mild diarrhea.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted), URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria) and ERYTHEMA (Redness/ erythema) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 007C21A) for COVID-19 vaccination. No medical history was provided. Concurrent medical conditions included Food allergy (rawpumpkin, Straw berrie, carrots and peaches.), Gluten sensitivity (Which manifeste GI tract issues, not itches or hives) and Food allergy (Indian foods/Tamarind- Head to toe hives, itching with in 8 hours of meal.) since 2015.Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) from 09-Sep-2005 to an unknown date for Birth control. On 18-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted) and URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria). On 13-Nov-2021 at 9:00 AM, the patient experienced ERYTHEMA (Redness/ erythema). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 15-Nov-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) ongoing from 15-Nov-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy head then spreading down neck and further down my back/ itchiness persisted), URTICARIA (with bumps appearing where I scratched / Hives/ Urticaria) and ERYTHEMA (Redness/ erythema) had not resolved. On 04 Nov morning, patient had event itching. Patient took shower to relieve the symptoms but persisted. The next morning, symptoms including bumps persisted. There had been no changes to his food, cosmetics or laundry products. No environmental changes either. Patient continued treatment medications. This case was linked to MOD-2021-404961, MOD-2021-404946 (Patient Link).
Narrative: Patient reported injection site pain following administration of 1st dose of pfizer covid vaccine. Patient was released without any intervention.
I got the first COVID (Pfizer) shot on 8/16/21 and my arm not only stayed red, swollen (hardness knot under the skin), warm to the touch, and hurting for about a week, but my ankle starting getting  sore, tight, and swelling on 8/19/21.  It feels like fluid pools in the lymph nodes after I have stood on it during the day. My ankle would swell to the point I couldn't even see my ankle and nothing like this has happened to me before. I am in very good health. I would send pictures if you had that option.  I consulted my doctor and started icing it, using Ibprofin or Tylenol, and wearing compression socks. It got a little better, but then I got my second COVID (Pfizer) shot on 9/6/21 and all the soreness, tightness, and swelling got worse again. Here we are on 10/9/21, and I am still having these issues with my ankle. It is not as severe as it was, but it is still a problem and I still take Ibprofin and wear compression socks when I can. I sure hope this isn't permanent damage!
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
fever 105 x 24 hrs, first 24 hrs, dec to 103 x 3 days; vomited x 2 w/in 24 hrs of vax; dec activity w/in 5 days of vax;
Positive Rapid Covid Test On 13Jan2023; Positive Rapid Covid Test On 13Jan2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2,,  BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 45 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 18Mar2021 as dose 2, single (Lot number: EL3247), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FH8020), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "TYPE 2 diabetes mellitus" (unspecified if ongoing); "Hypertension (HTN)" (unspecified if ongoing); "High Cholesterol/Triglycerides" (unspecified if ongoing); "CAD (3 Cardiac Stents)" (unspecified if ongoing), notes: CAD (3 Cardiac Stents). Concomitant medication(s) included: NORVASC; ASPIRIN 81; METOPROLOL SUCCINATE; RANEXA [RANOLAZINE]; BRILINTA; LOSARTAN; JANUMET XR; VASCEPA; ATORVASTATIN; TERAZOSIN; FENOFIBRIC ACID; FEXOFENADINE. Past drug history included: Enalapril, reaction(s): "Allergy"; Cephalexin, reaction(s): "Allergy". There was no other vaccine in four weeks and there was no covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2023, outcome "not recovered" and all described as "Positive Rapid Covid Test On 13Jan2023". The event "positive rapid covid test on 13jan2023" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jan2023) Positive, notes: positive rapid covid test on 13Jan2023; (10Jan2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: positive rapid covid test on 13Jan2023 from urgent care after teledoc visit. Symptoms of cough and chest congestion appeared evening of 12Jan2023. Paxlovid prescribed 13Jan2023, not yet picked up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 , BNT162b2 omi ba.4-5 to the Vaccination  failure (LOE) and Covid -19 cannot be ruled out.
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #K021444, expiration date: 17-SEP-2016 (dose, route and anatomical location were not reported) or RECOMBIVAX HB lot # L006231, expiration date: 06-OCT-2016 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
1st dose- one hour after dose, felt woozy, laid down in bed on back, awoke several hours later to violent vomiting and severe migraine. took aspirin returned to bed. awoke next morning to family standing over me trying to wake me, I was so sleepy,  I could see them, I could hear them but I could not move. I refused medical treatment and struggled with severe migraine. I soiled the bed. I awoke Approximately 48 hours later I was able to move, still sleepy but migraine moved to bad headache and paralysis was gone. Just severe body aches. Returned to light duty .  2nd dose- no effect at first, 12 hours after 2nd injection began  severe headache, no temperature but face and head swollen. Very sleepy and dizzy. Contacted Hospital was informed normal reaction. Severe headache and body ache continued. Remained on bed rest. No Paralysis,  Returned to normal duty after 72 hours. Will never ever get another vaccination of any kind!
Severe pain in the arm; Swollen arm, shoulder and breastbone; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), SWELLING (Swollen arm, shoulder and breastbone) and PAIN IN EXTREMITY (Severe pain in the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Lisinopril                                                     High blood pressure medication for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Muscle pain). On 22-Mar-2021, the patient experienced SWELLING (Swollen arm, shoulder and breastbone) and PAIN IN EXTREMITY (Severe pain in the arm). At the time of the report, MYALGIA (Muscle pain) and PAIN IN EXTREMITY (Severe pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
pt devel fever 103-ear @ approx 530PM on 13SEP93 & shortly thereafter had febrile sz; MD feels may be related to fever; mom states pt had sz in JUL94 which father did not report to clinic;
Tingling, pins and needles in hands and legs; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Apr2021, the patient experienced tingling, pins and needles in hands and legs and was happening all the time. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling, pins and needles in hands and legs was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Accidental overdose; 17 year old got an adult dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received HBV (Engerix B adult) (batch number C44K4, expiry date 07-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B 10).   On 17-MAR-2023, the patient received the 2nd dose of Engerix B adult. On 17-MAR-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: Accidental overdose ) and inappropriate age at vaccine administration (Verbatim: 17 year old got an adult dose). The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-Mar-2023 The pharmacist reported that 17 year old patient received first dose of Engerix-B vaccine on 19 February 2023. The patient came back for second dose, and was inadvertently administered an adult dose.  The reporter consented to follow up.  The patient inadvertently administered an adult dose, which led to accidental overdose and inappropriate age at vaccine administration.
Expired Bexsero administered; 60YO was administered Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment:  Reporter stated that 60 year old patient administered expired dose. Reporter asked how to proceed with patient vaccination.  Additional supportive information: As patient received expired dose and taken vaccine at inappropriate age which led to expired vaccine used and inappropriate age at vaccination. Reporter consented to follow up.
extremely dizzy; chills; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous). At the time of the report, DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.            Other concomitant medications include blood pressure medications and water pills.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received on 3-JUN-2021 contains significant information- update dosage information
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL. Pertinent medical history and concomitant medications were not reported. The reporter stated that on an unknown date the patient experienced syncope and atrial fibrillation after receiving a dose of GARDASIL. The outcome of the events was unknown. The causality was unknown. No further information was available. Additional information has been requested.
Patient received Flu vaccine in AM and developed temp 101.6, body aches, runny nose and fatigue in PM.
At approximately 12:30 PM patient started inconsolably crying. He cried until approximately 3:30 PM. At that time he became lethargic, less responsive, and pale. We called the Dr's office and by the time we had them on the phone he was opening his eyes and more responsive, but still lethargic. They told us to keep an eye on him, and that he had probably worn himself out crying. He recovered after about 1 hour. At the time we weren't that concerned. We are reporting this because a more severe but similar episode occurred at the 4 month vaccination.
Welts about 2x6 inches on the back of my left calf.  Later when welts went down there wer red marks all over my leg that mimiced the shape of the corona virus
I had cold symptoms when coming home from a cruise trip. I tested for COVID-19 I had very mild symptoms I called my doctor who prescribed PAXLOVID, I took it for the course, I tested negative for COVID-19 and then had rebound case and tested positive again. I also had two eye strokes on 31MAR2023. I lost vision in my left eye.
Fever 101.4 on and off for over 24 hours.  Nausea, body aches, headache, chills, malaise, fatigue, loss of appetite.  Fever treated with Tylenol every 6-7 hours after fever started until it broke.  Sweatiness continued for another day. Took Zofran for nausea.  Fatigue and loss of appetite have continued 4 days after the injection
7 days after the vaccine I received a very large red, warm circle, that has grown a little every day. Day 8, day 9 .  Painful, and itching
Child was given DTAP, Comvax and Prevnar on 3/8/01 and within hours, child became febrile and irritable. Fever continued and was admitted for rule out of sepsis; LP; Blood cultures; and IV antibiotics X 3 days. All cultures were negative. Child recovered.
Itching; Joint pain; One left eye is watery/eyes is still watery; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EN6204), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Blood pressure high. Concomitant medication(s) included Amlodipine taken for an unspecified indication, start and stop date were not reported and Lisinopril taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced Itching, Joint pain and one left eye is watery/eyes is still watery. Consumer stated Since she got the shot on an unspecified date Wednesday night, but she thought it was going to go away by maybe Thursday or Friday. She was talking to you, and she was still getting itchy its very itchy and eyes is still watery. Consumer asked what could do, just leave it or just, do you have anything to put on it, you say anything or what and not want itching, she meant she did not know about her eyes, they were watery. She stated she was still getting itchy. Consumer stated, she just dropped alcohol on the top of her hand. For her eye she did not put anything she just rubbed the alcohol and put it last night. The consumer stated that the events were still consistent. Consumer stated, she was caregiver. She take care of disability people. (Further not clarified, hence captured as consumer or non-health professional). (Not alpha spelled, hence not captured in tab). There was no Investigation Assessment provided. No treatment was received to treat the events. The patient outcome of the events was Not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, she experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment: Time of assessment 1915. Alert and oriented. Actions taken: placed in wheelchair,  given water and crackers, VS BP-102/61, P-69, O2-100%, VS BP-124/89, P=87, O2=100. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for minutes. Discharged home. Immunizations Administered: Name, Date, Dose, VIS Date, Route - Pfizer COVID-19 Vaccine 3/22/2021, 7:07 PM, 0.3 mL, 12/11/2020, Intramuscular, Manufacturer: Pfizer, Inc.
From the 3/23 onwards heart palitations.  The doctor From the 5/20  to 5/30 i was unable to sleep due to the heart palpitations.  The doctor at urgent care said it was mycoclonus and prescribed clonazepam and referred me to a cardiologist.
elevated temp w/in 4hr of giving vax;peak temp 104.7R;
Rt arm swollen red, warm. Tx Keflex, Benadryl, cool compress.
Child was irritable afternoon of shots, then about 6:20PM had staring/limp episode for few seconds. Then was tired for 2 hours. Child evaluated in ER with NL CBC/BC/VA/UC NL, VSS. Child admitted for 24 hours without further episodes.
covid vaccine breakthrough event  dose 1 2/25/21  Moderna  010A21A dose 2 3/25/21 Moderna  018B21A
Sore arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with HYDROCODONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Early the next morning around 6 am started feeling unwell with chills, headache took Tylenol but did not help symptoms increased. Took migraine meds.  March 28-30th severe chills and headaches, chest pain on left side with tight chest increase cough along  with increased joint pain. April 1st appointment with Dr.  for my Xolair injection, discussed symptoms seemed to be resolving some and lung function test normal.  Took xolair.   April 2-5 th increased tight chest headaches, low body temp, arm and leg numbness, right side, later very sore.  April 7 -15th right side leg pain comes and goes increase hip pain, chest tightness, extremely tired, lack of concentration with continues headaches.  On April 15th went to ED after Dr contacted me to go there after information had been released about other cases of reactions similar.