chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE; Caller reports AE related to administration of expired PROQUAD.; Excursion occurred 11/17/2020; This spontaneous report was received from an office manager, referring to a 12-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 17-NOV-2020, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T016991, which has been verified to be valid, expiration date reported and validated as 11-NOV-2021) experienced temperature excursion (product storage error).  On 07-DEC-2020, the patient received the mentioned vaccine, which was expired (expired product administered ) at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided). No additional adverse events were reported.  This is one of several reports received from the same reporter.
twitch on the left-hand side of my face, ran from my left cheek bone to the left corner of my mouth.; This is a spontaneous report received from a contactable consumer, the patient. A 50-Year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via an unspecified route of administration in her left arm on 10Mar2021 at 12:30(at the age of 50-years-old), for COVID-19 immunisation. The patients medical history included high blood pressure and herpes. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks of vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient had reported no allergies to medications, food or other products. The patient had not diagnosed with COVID-19 prior to vaccination. The patient reported that she did not have any side effects immediately, but she woke up friday morning with a "twitch" on the left-hand side of her face, it ran from her left cheek bone to the left corner of her mouth on 12Mar2021at 07:00 hours. It was just an involuntary spasm on that side of her face, she did not have any drooping, it was just an annoyance, it persisted for about six days, she woke up on the 7th day, and the symptoms had almost completely subsided. The patient did not receive any treatment for the reported events. The clinical outcome of the event twitching was recovering at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
little bit of back pain right where her kidney is; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 ), via an unspecified route of administration on 05Jan2021 07:00 at single dose for covid-19 immunisation .  Medical history included 50 percent of her kidney function.  The patient's concomitant medications were not reported.  The patient experienced little bit of back pain right where her kidney is on 05Jan2021 13:00. The outcome of event was unknown.
Swollen, red, and hot at injection site. No treatment. Injection at 10:00 and had a reaction at 16:00 on the day of injection.
Reported red, swollen, hot, itchy at site 515p on 6/1/14.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 21-MAR-2012 and 15-MAY-2012 the patient was vaccinated with the first and second dose of GARDASIL (lot # 1560 AA, exp. date: 15-AUG-2014). On 11-JUL-2012, the patient was vaccinated with the third dose of GARDASIL (lot # 1860AA, exp. date: 30-SEP-2014) a few days earlier than recommended minimal dosing interval. If the patient sought medical attention was unknown. No adverse effects reported. Additional information has been requested.
vaccinated on 02/23/21: sore arm, swelling, redness at site lasting 3 days. symptoms returned 03/01/21: swollen Lymph node under left arm, soreness, swelling, itching, severe neck pain and headache
Subsequent to receiving vax pt developed a 3 X 3.25 inch area of redness, warmth and swelling at the injection site. Within 2 days post vax the swelling had doubled in size.
Face went numb and tingly approximately 2 hours after receiving second dose of Moderna vaccine. This effect lasted 1-2 hours.
Bell?s palsy on right side of face - taking an oral steroid  Swollen lymph node left armpit - nothing has changed not treating
This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAY-2015 ("VYC" stock), 0.5 ml once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lymph note swollen since first day of dose 1 moderna. Lymph node to left inner elbow swollen for a month without decrease in size.  Size is approx 1 inch in side, firm, not red.  PCP examed on 5/6/21 and recommended dose 2 in opposite arm.  Initially had stinging sensation as size increased per patient
area is throbbing - left arm; around the joint of the arm and shoulder coming together, it is swollen; pain sometimes goes down to elbow - left arm; where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty; can't straighten arm - left arm; vaccination area is very hot - left arm; injection site painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm) and MYALGIA (pain sometimes goes down to elbow - left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site painful to the touch). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (can't straighten arm - left arm) and VACCINATION SITE WARMTH (vaccination area is very hot - left arm). On an unknown date, the patient experienced PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), MYALGIA (pain sometimes goes down to elbow - left arm) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm), MYALGIA (pain sometimes goes down to elbow - left arm), INJECTION SITE PAIN (injection site painful to the touch) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty) outcome was unknown.            Patient reported that after three weeks her arm was better and she was able to use it with little or no problem.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-may-2021. Patient arm was better.
Sore throat and erythematous plaques on anterior aspect of bilateral legs erythematous macular papular rash upper aspect of bilateral arms.
patient symptoms start with arm soreness, fatigue, loss of appetite, and flu-like symptoms (headache, low grade fever, muscle/joint aches, night sweats); later developed swelling in the groin are and pain in the abdomen upper right area. Patient said that the adverse reaction was resolved/helped with Tylenol.
Case was hospitalized for and died of Covid 6 months after completing Covid vaccine series.  Patient is an 84 year old male, vaccinated against COVID-19, with a history of valvular and ischemic heart disease who was initially diagnosed with COVID-19 pneumonia on September 30. He presented to the hospital on October 13 with worsening shortness of breath. Initial workup was consistent with coronary ischemia and acute heart failure in addition to COVID-19 infection. He was admitted to the hospital and treated for heart failure, acute coronary syndrome, and COVID-19. Over the course of the first night of his hospitalization the patient developed rapidly worsening gas exchange and was transferred to the ICU. Point of care echocardiography revealed markedly abnormal LV systolic function consistent with an acute MI and systolic heart failure. Given the constellation of acute physiologic insults and his baseline poor health, goals of care discussions were conducted with the patient and his family regarding his very grim prognosis for survival from his critical illness. The patient was made DNR. On the morning of October 14 the patient developed worsening shock physiology, ultimately resulting in cardiac arrest. The patient expired at 09:45 on October 14 with family at the bedside.
anorexia/ unable to eat; upset stomach; sleep was interrupted; sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 02-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and RSV vaccine (intramuscular, left deltoid). On 02-NOV-2023, less than a day after receiving Shingrix and an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). On 03-NOV-2023, the patient experienced anorexia (Verbatim: anorexia/ unable to eat), upset stomach (Verbatim: upset stomach) and sleep disturbance (Verbatim: sleep was interrupted). The outcome of the pain in arm, anorexia, upset stomach and sleep disturbance were not resolved.   It was unknown if the reporter considered the pain in arm, anorexia, upset stomach and sleep disturbance to be related to Shingrix and RSV vaccine.     It was unknown if the company considered the pain in arm, anorexia, upset stomach and sleep disturbance to be related to Shingrix and RSV vaccine.   Additional Information: GSK receipt date: 03-NOV-2023 The patient reported that on (Yesterday afternoon) she received her 1st Shingrix dose along with an RSV vaccine.  The manufacturer of the RSV vaccine is unknown.  Today (on the day of reporting) she stated that she has a sore arm and an upset stomach, she was unable to eat, and that her sleep was interrupted a few times last night. The reporter did not consent to follow-up.
2 weeks later after receiving the vaccine I felt like I had a cold, but that went away after about a week. On August 15, 2021 I had tested positive for COVID, and after that I had went back to the doctor for an infusion.
To ED (hospital employee) 12/24/2007 reporting low grade fever at home. Temp 98.5, area swollen, red and hot. Diagnosis early sterile abscess. Tylenol and warm compresses recommended. Clindamycin/Lortab prescription given. 1/30/2008 referred to Occ Med due to complaints that Tdap caused anal irritation in patient with history of IBD, GAD. Recent colonoscopy shows anal irritation as source of bleeding. Occ med states undetermine if exacerbation of preexisting. Under care of GI physician.
Patient began with nausea and walked to the restroom because she felt she may throw up.  She returned to the post-vaccine administration monitoring area after about two minutes to sit down again.  At that time, I asked more questions about symptoms.  She was also feeling weak and like she may pass out.  I gave her a cold compress to place on her neck which improved her symptoms very rapidly.  She remained in the area with the cold compress for about 10 more minutes before she felt well and she then left with her husband.
This is a follow-up to a previously submitted VAERS report 503390-1. 35 y/o who received multiple vaccines (per VAERS report - AVA(3), DTAP, Hep B, IPV, Influenza, and Yellow Fever; per electronic Immunization Records - AVA(3) on 15 JAN 2011 per VAERS report/9 JAN 2011 per electronic Immunization records. Patient received Influenza and TWINRIX vaccines on 02 MAY 2011. He denies onset of any systemic symptoms within the first 48 hours following vaccine receipt, and denies any unusual or persistent reactions at or near the vaccination sites. Per patient report, he began experiencing lower back/"tail bone" and bilateral knee pain around JUN/JUL 2011. He underwent a number of clinical evaluations and treatments before he was eventually diagnosed with Ankylosing Spondylitis (AS), HLA B27 positive, around JUN 2012. Patient was followed by Rheumatologist between AUG 2012 and AUG 2013. Dr. has since retired and patient plans to follow up through the Medical System. He has been treating symptoms of AS with sulfasalazine 1000 mg twice daily, Prednisone 5 mg daily, Naproxen 1000 mg twice daily, and recently, monthly epidural corticosteroid injections. He is pending initiation of ENBREL. His knee pain has been evaluated by Orthopedics and was assessed to be Patellofemoral Syndrome, for which patient has undergone Physical Therapy. Patient has no evidence of URI or GI-related symptoms prior to vaccine receipt. He denies previous, persistent symptom of lower back and "tailbone" pain prior to JUN 2011. He did experience "jostling" causing soreness during training (simulates rollover accident in vehicle) in JUN/JUL 2011. PMHx at the time of vaccine receipt was noncontributory. Since Dx, patient has been diagnosed with HTN and Vit D deficiency for which medications have been initiated. No symptoms consistent with Inflammatory Bowel Disease or Iritis. Since the time of diagnosis, patient began experiencing bilateral hand pain and stiffness, but related diagnosis is not clear (Hand x-rays in 2012 were Normal). No history of previous vaccine adverse events. Patient received subsequent TWINRIX vaccine in DEC 2011 and Flu vaccine in OCT 2012 without experiencing symptom exacerbation or adverse event. Patient has no known allergies. Patient's medical board is pending.
3/14/03 Rash on upper left chest occurred w/swollen lymph nodes - left armpit. 3/15/03 Rash spread to stomach, back & left arm.
Beginning about 1:00 a.m., I had the expected flu like symptoms. But, then I started to experience a racing pulse and blood pressure that stayed around 190/120 off and on all night. My pulse stayed around 130 beats per minute. It would level out and be normal then it would go up again. It did this all night long.
red bumps started 3 days ago and spreading.  Complain of itchiness.
got only the diluent and not the full dose of Menveo; got only the diluent and not the full dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA758A) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: got only the diluent and not the full dose of Menveo) and inappropriate dose of vaccine administered (Verbatim: got only the diluent and not the full dose of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 01-AUG-2023 The nurse reported that in a box of 5 vials of Menveo, one powder was left behind and she believed that 1 out of the 5 patient probably got only the diluent and not the full dose of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
lost the energy; his exercise tolerance had dropped drastically; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "lost the energy"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown", described as "his exercise tolerance had dropped drastically".  Additional information: On 01Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for COVID-19 immunisation. It was reported that from the time he had the Pfizer shot, his exercise tolerance had dropped drastically. He lost the energy he had, and it was within a week of that shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Can't taste food very good; my tasting come sometimes and then goes away again; This is a spontaneous report from a contactable consumer (patient).   An 89-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered in right arm on 03Mar2021 (at the age of 89-year-old) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered in right arm on an unspecified date in 2021 as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced could not taste food very good, taste came sometimes and then went away again on an unspecified date in 2021. The patient did not receive any treatment for the event. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
next thing there was dairy cows flying over her bed; could hardly make it back to bed; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. Patient reported that she had the second shot at 11 AM in the morning, went to be and woke up at 8 AM. She could hardly make it back to bed and plopped back in bed the next thing there was dairy cows flying over her bed. By 11 AM she was feeling normal. Outcome of events was recovered.   Information on lot number/batch number has been requested.  Follow-up (08Mar2021): This case is being submitted to notify that the initial information for this case was first received by the Company on 08Mar2021 and not on 08Mar2020 as previously reported. Due to safety database technical limitations, the field "Initial Receipt Date" (i.e., Company first awareness date) can no longer be modified.
Guillain-Barre Syndrome onset progressive numbness/weakness about 2wks after influenza vacc. Characterized as mild/moderate by dr (neurologist). Currently resolving weakness with HTN & tachycardia.
Sharp pains in left armpit/upper breast and now sore and painful especially to the touch.
Vaccine administered Monday 12/12/2005 at 12:20pm.  Mild fever (101) on day 2 & 3.  Treated with acetaminophen 160mg every 4-6 hours.  On day 4, lethargic with loss of appetite, still feverish with medicine wears off.  Day 5, Friday, woke up feverish after a bad night's sleep.  Whiny and groaning.  Complained a little that tummy hurt.  Acetaminophen is reducing the fever, but appetite is still decreased and child appears to be miserable.
Clinic visit on 11/14/08 - Left sided chest pain since 11/11 with some radiation to left arm associated with diaphoresis and elevated BP, light headache and difficulty taking deep breath. Chest pain worse on morning of 11/13/08. Pain was worse when lying flat, cough, or deep breath. Not associated with exertion. Nonprandial. Given MOTRIN at local clinic with little relief. After enzymes (+) on 11/14/08, pt referred on 11/18/08 to hospital and admitted overnight. Discharged the following day. Since this episode, he has developed cold-like symptoms (runny nose, cough), but his chest pain has been absent. Performs ADLs w/o development of chest pain, sob, or tightness.  12/5/08 Reviewed hospital medical records of 11/18-11/19/2008. FINAL DX:noncardiac chest pain; asthma; tobacco use disorder. Records reveal patient experienced left side chest pain w/radiation down left arm x 1 week, constant x 3 days then intermittent.  Evaluated at outside clinic where troponin reported to be 0.97(H).  Cardiac w/u neg.  D/C to home w/PCP f/u.