chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness in area of injection; noted blotchy redness, no pain, extending  6 in below shot site; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL 9263) via an unspecified route of administration on 29Jan2021 at 19:30 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included HTN (hypertension), atherosclerosis, hip replacement, TIA (transient ischemic attack) and "INCR" lipids (increased lipids), all from unspecified dates and unspecified if ongoing. The patient had no known allergies to mediations, food or other products. Concomitant medications (received within 2 weeks of vaccination) included nebivolol hydrochloride (BYSTOLIC), lisinopril, calcium citrate (CITRACAL), ezetimibe (ZETIA) and pitavastatin calcium (LIVALO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site, both on 29Jan2021 at 23:00, both reported as non-serious. The events did not cause hospitalization. The clinical course was reported as follows: "tenderness in area of injection began hours after injection and increased over 24hrs and began to decease. 52hrs p shot noted blotchy redness, no pain, extending 6 in below shot site. Still there 18hrs later but fading in color." No treatment was received for the events. It was reported that it was unknown whether the patient was recovered. The clinical outcomes of the events tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site were both unknown.
tingling; swelling under the lymph nodes both arms; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) and LYMPHADENOPATHY (swelling under the lymph nodes both arms) in a 71-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 (No medical history reported.).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PARAESTHESIA (tingling) and LYMPHADENOPATHY (swelling under the lymph nodes both arms). At the time of the report, PARAESTHESIA (tingling) and LYMPHADENOPATHY (swelling under the lymph nodes both arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Mammogram: normal. On 18-Jan-2021, Ultrasound breast: normal.         This case was linked to MOD-2021-056421 (Patient Link).
This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 12 hrs after receiving SHINGRIX, the patient experienced fever, nausea, headache, influenza-like symptoms, fatigue and myalgia. On 3rd May 2018, the outcome of the fever, nausea, headache, influenza-like symptoms, fatigue and myalgia were recovered/resolved. The reporter considered the fever, nausea, headache, influenza-like symptoms, fatigue and myalgia to be almost certainly related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient experienced mild adverse reaction that was low grade fever, nausea, headache, flu like myalgia and fatigue. All the symptoms were resolved within 24 to 38 hours of injection. The reporter was uncertain of lot number and expiry date of the vaccine given.
I really felt good the whole time. I felt good beside for 3 hours that I tested positive for COVID, which was October 18, 2023. I barely had a fever. Other than that, I felt good. I also developed a frozen shoulder. I had that for three months. It has since gone away. I did go get x-ray on January 8th. January 18, 2023, I started having weird heart problems. I had irregular heartbeat. I have also had high blood pressure. My heart rate would spike and my blood pressure. I haven't had any of those symptoms for a few weeks now.
Acute GI bleeding. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient experienced more than localized discomfort. Complained of extreme pain in right arm following pneumovax vaccination. Also complained of swelling not around vaccine site but anterior aspect of upper arm with blotchy redness and itching.
Febrile seizure @ home 3.5 hrs p/DTP/HIB/OPV; also found to have acute rt serous otitis media;
ABOUT 5-8 MINUTES AFTER CASE RECEIVED TDaP VACCINE SHE FELT DIZZY, SAT DOWN BUT FAINTED AND FELL TO THE FLOOR ANYWAY. MOM DESCRIBES CASES EYES ROLLING IN THE BACK OF HER HEAD, HER BACK ARCHING AND SPASMODIC JERKS OF HER ARMS AND TO A LESSER EXTENT HER LEGS. EPISODE LASTED 5-10 SECONDS THEN SHE WOKE-UP WITH NO MEMORY OF PASSING OUT. AT THAT TIME BP 108/60, HR 72, AND RR 16,NO OTHER VITAL SIGNS WERE DONE. SHE WAS ABLE TO STAND WITHOUT DIZZINESS ABOUT 30 MINUTES LATER, WENT TO AN URGENT CARE CENTER WHERE THEY DID NOT SEE HER BUT REFERRED HER ON TO EMERGENCY ROOM. PT. AND MOM OPTED NOT TO GO TO ER, MOM SAYS SHE IS COMPLETELY RECOVERED NOW AND HAS FOLLOW-UP SCHEDULED WITH HER PEDIATRICIAN.
Since my second dose my mensuration cramps have become severely painful. Debilitating. Before I would have a little cramp, but now it is almost unbearable, I have to take medication every 4hrs at least. I wake up in the night with pain were it feels like my lower stomach is being ripped opened. I am a resident Of country and had to get vaccinated to go home. But since I've gotten my second dose it has sent my periods through the roof. They previously lasted for 3 days, and almost painless. Now I can't do anything for the 5 days my period is here. my back and my stomach are in so much pain. I honestly wouldn't have gotten the vaccine if I knew this was going to happen. It is horrible.
I got my initial shot of Moderna on 1/6/2021. One week later I had swelling and rash at the injection site and the Helix of my ear started to peel dry skin and to weep. Both gradually went away within that next 2 weeks. I received my 2nd dose on 2/2/2021 and experienced fever, chills, aches and pains with in the 8 hours after. Within 24 hours I developed my ear rash back and also had red, bumpy, itchy rash that encompassed my scalp, neck, shoulders, hands and chest. I contacted my primary care physician and he prescribed Methylprednisolone taper and cephalexin antibiotic. I finished my Methylprednisolone taper on a Friday and on that Sunday my rash had now spread to my stomach, underarms, breasts and back. At that point I went to the ER and the PA prescribed a higher dose Prednisone taper and some Triamcinolone cream. I finished my Prednisone on that Friday and it has seemed to tone down the inflammation rash but it is still present. I am still applying the Triamcinolone cream but now the rash is starting to appear on my buttocks and legs and keep on reoccurring in the previous areas.
First dose, given 12/13/18, Lot #K22Y4, same route and location, also caused shingles but in right eye. We thought it was pink eye. When second shot in series caused same reaction in left, I was referred to eye specialist, noted on this form. He confirmed shingles, prescribed Valacyclovir. Stated primary care doctors should be warned against giving vaccine to patients with prior shingles in eye, which I suffered in December of 2014, some years after having ZOSTAVAX vaccine.
Suspect pericarditis, elevated CRP, very very slight pericardial effusion, classic story, few EKG findings
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site,  & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days.  02/23/2021 itchinesss better.   Brown square area at site of injection. There is still a slight itch at times as if healing.
Information has been received from a physician concerning a child patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chickenpox. The reporter also mentioned two other patients that had adverse experiences following vaccinations with varicella virus vaccine live. Additional information has been requested.
had chilis,  headache, felt like I had a temp. but my battery was to low to take it. my arm hurt when I got the shot, put ice on it helped. slept most of the day under a heated blanket. later in the day I took 2 Ibuprofen. today I woke up with a back ache form being in bed all day took a pain pill and feel ok.
it knocked out; After the booster dose the side effects were worse; still sore/body aches were so bad, it seems to attack your weak points; tired; Mucousy in the lungs; body aches were so bad, hurting head to toe, achy; coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy) and COUGH (coughing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Asthma.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse) and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points). At the time of the report, LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired) outcome was unknown and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  After the booster dose, patient experienced the side effects and were worse, the body aches were so bad, it seemed to attack weak points. It was hurting head to toe, achy, coughing, tired, & mucousy in the lungs. Patient was still sore, out of it, said it knocked out the patient.   This case was linked to MOD-2021-405703 (Patient Link).
This spontaneous report was received from a physician assistant refers to a 5 year old patient of unknown gender. No medical history was reported. On 16-MAR-2013, the 5 year old patient was inadvertently vaccinated with a 0.5 milliliter (ml) dose of GARDASIL (lot #, expiry not reported), intramuscularly. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Approx 10 min after admin of HPV #2 & flu, she passed out at check out. She did not lose consciousness and B/P & O2 Sat were WNL. She was escorted to the car in approx 30 min.
Fever, muscle ache, headache, extreme fatigue, agitation nausea and lightheadedness
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022.; No adverse event; approximately 50 doses administered after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (approximately 50 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (approximately 50 doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (approximately 50 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (approximately 50 doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022.).    No concomitant medications were reported.   Number of doses or vials were reported as around 50 doses from 5 vials. Date the vial was initially stored in the refrigerator was reported as 08 Jul 2022. The vial did not undergo any temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  Treatment details were unknown.
Client was vaccinated for Covid with Pfizer vaccines on 7/16 and 8/6. Client developed symptoms of Covid on 9/2 (nasal congestion, sneezing, headache, loss of taste and smell) and tested positive PCR for Covid on 9/4.  Reported as a breakthrough Covid case in a fully vaccinated person.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-OCT-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
This spontaneous report as received from a Practice Manager via company representative referring a patient of unknown age who on 05-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J014401, exp date 26-NOV-2014 (dose and route not provided). On an unknown date the patient experienced a reaction. The outcome of reporting was unknown. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck).  Subsequently the patient developed transverse myelitis.  No further information was provided.  There was no product quality complaint involved.  Additional information was received on 29-OCT-2007.  The reporting physician did not have any further information as the patient belonged to another physician's practice.  Upon internal review the patient's transverse myelitis was determined to be an other important medical event.  No additional information is available.  This is one of several reports from the same source.
No additional adverse event or product quality concern; an expired dose of ROTATEQ was administered; This spontaneous report was received from a registered nurse refering to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 05-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, once, lot # 1660995, expiration date was 01-MAY-2021) orally for prophylaxis (expired product administered).  The vaccine was reported to have never undergone a temperature excursion. No additional adverse event or product quality was concerned.
Patient became dizzy and clammy but did not lose consciousness. He began throwing up. No sign of anaphylaxis. Remained pale, dizzy, for about 5-10 minutes. EMT called to scene but was doing a lot better by the time they arrived. Treated patient with cold compress face/neck. Dad stated he has anxiety and that this same thing happened previously after having blood drawn. He was able to walk out on his own with his father approximately 30 minutes later.
Patient had large amount of bleeding (soaking clothing) immediately following vaccine. Bleeding has now stopped.
Information has been received from a health professional concerning a 6 year old female who on 27 JAN 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot # unknown). Subsequently it was reported that on 14 MAY 2001 the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that the vaccine lot numbers were not similar in the other cases reported. Subsequently the patient recovered. No further information is available.
Patient is an 84-year-old male with history of hypertension, hyperlipidemia, type 2 diabetes, dementia and atrial fibrillation on Coumadin presenting to the emergency department via EMS for shortness of breath with Covid.  Patient was seen at our facility on 12/5 where he was diagnosed with Covid.  At that time he was 86% on room air and was sent home with home oxygen.  Family states patient has become more weak, and when they checked his oxygen they state it was very low, so they called 911 to bring him back to the ER.  Upon arrival to the ED, patient does not appear to be in respiratory distress, however he is hypoxic with oxygen in the 50s on room air. Associated Symptoms: cough, fatigue, fever, shortness of breath, weakness
This spontaneous report as received from a nurse refers to a unspecified amount of patients of unknown age and gender. On an unknown dates between 07-AUG-2017 and 19-SEP-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX (doses, route of administration and indication were not reported, lot# M035147 exp. 25-OCT-2017; M034765 exp. 25-OCT-2017). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Data logger involved (6°F to 14°F for 16 hours). Previous temperature excursion reported (6°F to 14°F for 16 hours). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1710USA009683.
Headache, pain in legs and abdomen, loss of appetite, moderate to high fever, severe tiredness/weakness, some dizziness
Moderate to severe Abdominal Pain. CT Abdomen completed with + mesenteric adenitis
This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A 65-year-old female patient of an unspecified race and ethnicity received, on 11Jan2018, pneumococcal 13-val conj vac (dipht crm197 protein) in left deltoid, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient developed a large round swollen area with rash 8 inches across following injection on 11Jan2018. Clinical outcome of the events was unknown at time of this report.
UNABLE TO SLEEP AT NIGHT; EXTREME TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced unable to sleep at night, extreme tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme tiredness, headache and unable to sleep at night was not reported. This report was non-serious.
Pt had a syncopal episode about 7-8 min after the vaccine was administered.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included ALBUTEROL SULFATE (ALBUTEROL SULFATE Inhalation  When needed) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT inhaler) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient has given Inhaler and Usenix
ADMINSITRATION ERROR:  The vaccine was not diluted.  They called the mother and she stated that she had no reaction.  They called the mother today and said that the child was very sleepy.  They tried to contact the doctor but they could not find her.  The mother reported that she did call the doctor.
Pt recvd 3 doses of Hep B vax on 20FEB91, 20MAR91, 22APR91 respectively; during the wk of 28JUN91 pt exp flu-like sx of weakness, nausea, swollen glands, sore throat, muscle aches; On 29JUN91 given ATB; pt still sick, sore muscles & joints;