chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills for 48 hours; Injection site pain; tiredness; headache; dizziness; muscle aches; pain; needed to sleep for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 31Mar2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN; PEPCID.  The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills for 48 hours"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle aches"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "needed to sleep for 24 hours".  Additional information: Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
6 hours post vax, mom noted several episodes of rhythmic rocking. Occurred few times a day for 5 days then stopped.
Information has been received from a physician concerning a patient who on an unknown date, was vaccinated with a second dose of ROTATEQ (dose, route and lot# not reported) about 3-4 weeks after the 1st dose and no adverse effect reported. Additional information has been requested.
When I had a massive pulmonary embolism, my heartrate went up extremely due to trouble breathing. The doctor stated I was having the issues due to not having enough air in my lungs. They diagnosed me with Atrial Tachycardia, and prescribed me with blood thinners to take for treatment.
Information has been received from the CDC (reporter unknown) concerning a 5 year old patient who on unspecified dates was vaccinated with full doses of PEDVAXHIB (manufacturer unknown).  Subsequently, on an unspecified date the patient developed HIB pericarditis.  This case was reported by the CDC.  It was unknown if the patient sought medical attention.  The outcome of the event was unknown.  Additional information is not expected.
Rotator cuff tear, rotator tendinopathy, shoulder impingement, biceps tendinopathy (unlikely), labral tear, AC and SC joint problems, chronic tears (no other hx although has repetitive use), something caused by the hep b injections (seems chronologically related). Chronologically related to hep b injections: No further hep B injections (#3).
I had used a Cologuard test for colorectal cancer. I had received an email to check on my test results last week. My results came back positive for showing that they found something. I called my doctor's office to let them know what my test results had come back telling me. I have a follow up colonoscopy scheduled in June to rule out that the positive test result is a false positive.
pt recvd vax & had local allergic reaction involving erythema & swelling of lt arm assoc w/lt hand, wrist, elbow & shoulder burning;
The wrong medication was given to patient. They were to receive a DTaP and IPV vaccine. The label was not fully read;  instead of just DTaP the patient received the combination vaccine that has DTaP,/IPV/HIB/Hep B.  Pt was also due & given IPV along with combo vaccine; therefore, they received double dose of IPV. Mother notified and watched for any adverse reactions. We have not been notified there have been any.
Patient presented to Urgent Care today with swollen 4x4 cm area on his left thigh were the Hep A vaccine was given. No central or punctum discharge Line drawn to monitor swollen area. Instructed parents to use warm compresses on area to help with swelling and to moitor line for continued swelling and any other symptoms.  Patient was crying and reaching for swollen area.   Patient was in to Urgent Care on 5/13/23 with ear/eye infection. Given Amoxil for 10 days. No sign of infection (eye or ear) at well child visit on 5/23/23
Started with sore throat Sun. night, Nov. 6, 2022. Progressed to 100.3 fever, dry cough, congestion over next three days.
diagnosed with covid-19; Was refused 2nd dose due to infusion and told to wait 60-90 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) and PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days). On 27-Apr-2021, the patient experienced COVID-19 (diagnosed with covid-19). At the time of the report, COVID-19 (diagnosed with covid-19) and PRODUCT DOSE OMISSION ISSUE (Was refused 2nd dose due to infusion and told to wait 60-90 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included antibody infusion.
Patient began to experience heavy sweats and fevers for almost 10 days following the vaccination.  For the next 3 weeks, patient reports chills, intermittent fevers, cough, general weakness and an unsteady gait.  Patient is also newly anemic.
6" rash and pain around injection site 4-5 days after administration. Site is hot to touch.
Immediate dizziness/ light headed. Mild headache within 4 hours. Moderate headache within 8 hours. Sore at injection site begins within 8 hours. Fatigue sets in almost immediately after injection. Next morning, less than 24 hrs later, nausea and vomiting. Extreme Fatigue and major head pain. Tylenol not working. Headache and Fatigue last two weeks. Unknown rash on left arm.
Information has been received from a physician via a company rep concerning an 83 yr old male a history of previous vaccination with a first dose of pneumococcal 23v polysaccharide vaccine who three weeks ago, on approx 21Oct05 was vaccinated with a dose of pneumococcal 23 polysaccharide vaccine (lot not provided). Three weeks ago, on approx 21Oct05 the pt developed a local injection site cellulitis reaction. The pt was treated with antibiotics for 10 days. In Nov 2005, the pt developed bronchitis. The pt was reported as recovered in late Oct 05. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Erythema, swelling left upper arm (whole area). Rx Prednisone for 5 days.
Information has been received from a 79 year old female patient with rapid heart beat, cholesterol and diabetes and no drug allergies or reactions, who on 26-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not specified). Concomitant therapy included Atenolol, ATIVAN, TYLENOL WITH CODEINE #3, simvastatin (manufacturer unknown), glipizide and aspirin. The patient reported that "the next day" (on 27-JAN-2011), she had the break out of shingles. The patient said she did not remember the medication given to her by her health care professional. Information received on 16-MAR-2011 contained the following adverse experiences: the patient was prescribed with capsaicin for the nerve pain from shingles and shingles rash and immediately (also reported as "last week" (on approximately 07-MAR-2011)), she started to feel a burning and redness where the cream was applied; the patient stated "she washed it off and had not reintroduced the cream". At the time of the report patient's outcome was not reported. The patient sought medical attention. Additional information is not expected.
Shortly after her shot she experienced a flushed feeling and some L arm tingling.   She also felt lightheaded and dizzy. She had no new rashes or hives.   She recently returned from 1 week in Florida and had some sun burn on her forehead and arms, that was unchanged by her own mirror inspection and husband's evaluation.   She had no SOB or wheezing on multiple exams. No throat tightness, tongue swelling, or palate tingling.     Symptoms resolved slowly over a 1 hour observation period. BP, pulse, and O2 sats were all stable through her stay.    Initial BP = 148/63, Pulse = 78%, 100% sat.    No orthostasis at discharge. No adverse Rxn to 1st Covid shot. She has a Hx of bee sting allergy and carries an Epi pen usually.   She did not have it with her today. My impression was a mild focal allergic reaction without progression. Advised patient & husband to go to ED if symptoms return.
Approximately 15 minutes after receiving vaccination, patient complained of tingling in her lips and throat with mild difficulty swallowing. BP 143/101, HR 80. Denies SOB or difficulty breathing. Given 50 mg benadryl IM. Patient monitored for approximately 45 minutes. Campus police and EMS arrived to scene. Patient felt better and police escorted her back to her dorm.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current conditions was reported. No historical drug was reported. On 12-AUG-2014 the patient was vaccinated with M-M-R II (SDV, MDV or addictive) lot # H012142, expiration date 29-JUN-2014, Albumin Status for H012142 was HSA, subcutaneous (dose  strength was not reported). No concomitant medication was reported. On 12-AUG-2014, the patient received an expired dose of M-M-R II. No known adverse effect was reported. No product quality complaint was reported. Additional information has been requested.
Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So tired could hardly stay awake.
Felt like I had the flu. All I wonted to do was sleep  For 3 days. The first day I felt a little sick , then mostly  Felt real bad.
My husband tested positive for COVID-19 earlier in May but felt fine and tested negative several times. I felt bad on 05/15/2022 but still tested negative. I had cough, fatigue, headache, and low-grade fever. I tested myself again on 05/16/2022 and tested positive. I called my doctor on 05/16/2022 and asked him to prescribe PAXLOVID. He prescribed it and advised that I stop taking some of my other meds while taking it. I am still testing positive and still have mild symptoms but I am feeling better.
Swollen lymph node; experiencing throat pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration, administered in arm left on 20Jan2021 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hodgkin's disease from 1985 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced swollen lymph node and that she was experiencing throat pain. She was done with both doses of the vaccine. The patient wants to know if this has been reported as a side effect of the covid vaccine. The patient was taking COVID Vaccine as she was extremely vulnerable. She was missing part of a lung and had Hodgkin's lymphoma. She has been having pain in her throat. It was not like a sore throat. It was like there was a painful obstruction. She thinks it might be a swollen lymph node. The patient inquired if there been reports of swollen lymph nodes after receiving the COVID vaccines and if any others reporting this. It was reported that the patient received the second dose on 16Feb2021. The patient had blood work a week ago on an unspecified date in Feb2021. The doctor has the results. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Injection site red and tender immediately following injection, 2 x 3 cm at widest. No warmth.
Body aches.; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737), via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and COVID-19. The patient receives unspecified medications in two weeks of vaccination. Prior to the vaccination, the patient was 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 08Apr2021 at 00:00, during 12 to 24 hours after injection, the patient experienced body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches and fatigue were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was asked to provide information for the report questions, but she stated that she did not have all the details. All that was documented was what she said. The reporter did not consent to follow up.
Waking up at 3:30am  Friday the 5th it was difficult to open my eyes, like my eyes were glued shut. When I finally opened them everything looked crystallized, I couldn?t see the tv which was on but it was brighter in that area, I couldn?t make out anything. I closed my eyes for a few minutes and opened them with the same results. I closed my eyes about 4 times and then finally I could make out everything .  The only thing different that I took was the vaccine and a packet of Thera Flu.    Nothing else has happened since except a sore arm which lasted 4 days
27MAR95 tc fr mom reporting to NP pt recv vax & w/in 3hr of vax pt t103; still has fever & is vomiting; pt referred to PMD by nurse
Started to feel cold; Shaking uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunoglobulin g decreased. Concomitant products included immunoglobulin human normal (Gammagard).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling cold and tremor. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the feeling cold and tremor were recovered/resolved.   It was unknown if the reporter considered the feeling cold and tremor to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 76 or 77 years old. The patient had an IgG deficiency and received an infusion of Gammaguard every six to eight weeks. The patient received the second dose of the Shingrix vaccine and she believed it was the next day that she had her Gammaguard infusion. Approximately 1.5 hours into the infusion she started to feel cold and stopped the infusion to go to the restroom. When the patient returned to continue the infusion, she started shaking uncontrollably and was given steroids and other medications (she did not know what they were) to stop the shaking.  She was told it was a reaction to the infusion but she said that she had received the infusion for five years and never had a reaction. The shaking ultimately stopped and she was able to complete the infusion.  When asked if she thought it was shivering she replied that it was not and it was uncontrollable shaking. The reporter gave permission for her physician to be contacted.
My sugar level shot up to 300 on and off all day. I walked around. All day. Day 2  I developed a headache. Day 3 I developed a rash all over my body.
Admitted to ICU on 4/29/21 with shortness of breath, requiring bipap. Tested + for covid on 4/10/2021. Last vaccine dose given 2/10/2021. Discharged home on 5/3/2021 and doing well currently.
1945 pt began crying and seizing in crib. Seized  2-3 min. Mom called 911, pt transported to ER via ambulance. ER administered TYLENOL and amoxicillin (suspected ear infection). D/C from ER approximately 2200 same night. Temperature on arrival to ER: 103.7 degrees F.
My menstrual cycle was affected.  My period was extremely heavy for 3 extra days with excessive bleeding,.  This has never happened.  Then I got a bladder infection which was documented by my primary physician.  Waiting to see what it does to my next cycle.
15 cm x 12 cm erythematous swollen area Rt deltoid, emesis x 3, no diarrhea, SOB, coughing, swelling of mucous membranes.
A mother reported that her 15 month old son with a history of "reflux" received Prevnar and Hib vaccines on 12/18/00 and subsequently, vomited in the physician's office. Later that day, he vomited and slept for an unusually long time. He developed a low-grade fever, rapid breathing and he was fussy. On 12/19/00, the fever resolved. He then developed an injection site reaction characterized by redness and swelling at the site of the Prevnar injection. He was treated with diphenhydramine. On 12/20/00, his breathing was improved.
Lethargy, irritability, loss of words, withdrawal, became more aggressive and sensitive to sounds and people, congestion, etc. Knot at the sit of vaccine.
76 yo female with PMH significant for aortic/mitral mechanical valves, permanent pacemaker, subdural hematoma, NSTEMI, severe PAD, critical R limb ishcmiea, L BKA, R AKA, phantom limb pain, NYHA stage 4 CHFrEF (50-55%, 9/2021) presenting to the ED for evaluation of chest pain and elevated troponin value of 3.45. Was complaining of chest pain and shortness of breath last night. This morning troponin was measured and came back at 3.45. Currently denying shortness of breath and chest pain. Does have pain in right leg at the AKA site, consistent with her hx of phantom limb pain, currently described as a 8/10, non radiating. Otherwise denies headache, dizziness, nausea, vomiting, dysuria. Fully vaccinated for COVID. .
73 y/o male with hx hypertension, hypothyroidism, history of CVA without any residual deficits, morbid   obesity, on chronic systemic steroids/hydrocortisone due to unknown reason probably history of adrenal insufficiency, COPD, rectal adenocarcinoma status post port placement with neoadjuvant radio/chemotherapy for T3 N1 disease. Came to ER with severe weakness and fall. Was not able to walk. ER W/U showed Hypokalemia. Admitted for replacement of K and PT to ambulate. Tested positive on 9/23/2021. 73 year old male with hx hypertension, hypothyroidism, history of CVA without any residual deficits, morbid   obesity, on chronic systemic steroids/hydrocortisone due to unknown reason probably history of adrenal insufficiency, COPD, rectal adenocarcinoma status post port placement with neoadjuvant radio/chemotherapy for T3 N1 disease. Came to ER with severe weakness and fall. Was not able to walk. ER W/U showed Hypokalemia. Admitted for replacement of K and PT to ambulate. Routine Corona virus test + however he is asymptomatic.
Itching, discomfort, burning, swelling, red area. Erythema 10cm x 15cm diameter.
pt reports bad bruising and feeling bad that night.  whole body heaviness and fatigue.  100 % in 2 days
Information has been received from a pharmacist referring to 4 patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (rHA,, lot # L040414 with expired date 13-APR-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This was one of several reports from the same source. Additional information is not expected since the reporter refused further contact.
CLIENT WAS GIVEN THE WRONG FORMULATION OF INFLUENZA VACCINE.  CLIENT WAS GIVEN THE FLUZONE HIGH-DOSE QUADRIVALENT AND SHOULD HAVE BEEN GIVEN THE FLULAVAL QUADRIVALENT.
Expired Havrixa dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 14th July 2022, the patient received Havrix. On 14th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Jul-2022 Reporter's Comments: On 14th July 2022, the patient received a dose of Havrix that had expired on 18th June 2022. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix that had already expired on 18th June 2022, which led to expired vaccine used.
I felt a little achy after receiving the vaccine for a couple of days. On 11/07/2022, I work up with severe gastric pain, vomiting, nausea and the smell was terrible. I was vomiting feces.  I went to the emergency room and then they transferred me to a hospital. I stayed for three days. I was diagnosed colitis with a blockage. I am scheduled for surgery soon.
Alopecia areata noted on top of scalp starting shortly after first dose and seemed to worsen after 2nd