chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 year old female patient with unspecified food allergies. The patient had no medical history. On 26-JAN-2011, the patient was vaccinated with her first dose of GARDASIL (0.5 ml, once, intramuscular). On 12-APR-2013 and 30-APR-205, the patient was vaccinated with her second and third dose of GARDASIL respectively (inappropriate schedule of vaccine administered). No concomitant therapy was reported. On 01-MAY-2015, the patient developed pain in her tailbone when rising from a lying position to a sitting position. The patient did not experience the pain on ambulation. The physician would be scheduling an office evaluation in her near future. No treatment was given for the event. No lab diagnostics studies were performed. The physician had sought medical attention by contacting the physician via phone. The tailbone pain was not recovered at the time of reporting. Additional information has been requested.
Information has been received from a health professional concerning a 78 year old male with allergies to horse serum and NSAID and no drug reaction who on 11/05/2004 was vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  On 11/09/2004 the patient broke out with swelling and redness of the arms.  Unspecified medical attention was sought.  The patient had not yet recovered.  No product quality complaint was involved.  Additional information has been requested.  It was also reported that a female patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES 0501USA00113).
Increase heart rate, BP increased, heart urn, indigestion. Left arm tingling numb.
SORE ARM; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and sore arm was not reported. This report was non-serious.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2012, at approximately age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Very fatigued the following day. Unable to perform daily activities. Just wanted to sleep all afternoon.
Dry constant Barky cough; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 as a single dose (at the age of 38-year-old) for COVID-19 immunisation. The medical history of the patient included liver disease, barrettes oesophagus, diabetic and tachycardia. The patient had known allergies to morphine, dilatid and nubane. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), flonase (MANUFACTURER UNKNOWN), BENADRYL, aspirin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not tested for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 13:30, the patient experienced dry constant barky cough. Patient was treated with ALBUTEROL inhaler for the event dry constant barky cough. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dry constant barky cough was not recovered at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained
Vomiting and a fever of 102, myalgias, injection site soreness, redness and swelling for three days.
Pt received Pfizer x1 on 4/27/21. Pt was COVID positive on  5/5/21. Pt admitted to hospital on 5/5/21 .
chills; joint pain/Joint achiness/she fell off of her roof; hives/she broke out in hives; severely itchy; This is a spontaneous report from a contactable consumer reported that a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) intramuscularly in left shoulder as single dose on 04Feb2021 at 12 for COVID-19 vaccination. Medical history reported was ongoing asthma diagnosed at about age 21. Stated that it is under control and she gets her allergy shots. She stated that it was environmental, ongoing bee allergy and severe allergy. She carries an epipen. Concomitant medications were not reported. Caller received the first shot of the Pfizer covid vaccine yesterday at 12 and after staying for 45 mins did not experience any issue. Later on, she started developing hives all over her body (itchy palms, neck, scalp, stomach) which she took 2 Benadryl for. Her hives have gotten 90% better, but she was experiencing some chills and joint pain. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she went yesterday, 04Feb2021, for her first shot at 12:00 and stayed there for 45 minutes because she was allergic to certain things. She said that she had no issues when she left at 12:45. Caller said that at about 16:45, she started to get severely itchy, and she broke out in hives. Caller said that it was on her scalp, her lips, her neck, her stomach, her arms, the palms of her hands, and the pads of her feet. The caller stated that there was nothing on her legs. She said that she woke up with more symptoms today 05Feb2021, and said that she woke up with chills and like every joint in her body feels like she fell off of her roof. Caller said that she took 2 Benadryl, and the hives are better. She stated that it totally knocked her out and she passed out on the sofa. Caller stated that the hives and the itching are about 90 percent better. Caller estimated her weight at about 160lbs. Caller stated that she took Tylenol for the chills and stated that it did not help the achiness in her joints at all. Caller stated that her chills and her joint achiness are the same. She said that she is allergic to Tetracycline, Penicillin, and sulfa drugs. Caller does not have the NDC, Lot, or expiration date for the medications. She stated that it was a long time ago. She has not followed up with her physician. They told her at the facility that for a reaction she needed to call Pfizer. Caller stated that she has a EpiPen, nebulizer and a rescue inhaler at home with her if needed. There was no previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations was reported as non (within 4 weeks). Just takes her allergy shots, but that was 3 weeks prior, and it was cleared with the physician. Outcome of the events hives/she broke out in hives and severely itchy was recovering, chills and joint pain/Joint achiness/she fell off of her roof was not recovered.  Follow-up attempts are completed. No further information is expected.
Seizure around 10:30, Started experience left eye twitching, along with absence seizure, followed with her mouth going unintentionally to the right. Glaze eyes and after getting conscious she didn?t have any recollection of what had happened. Follows with a very sever headache and vomiting.
REDNESS AND SWELLING UNDER THE RIGHT ARM. ABOUT A DOLLARBILL SIZE RAISED AREA. PT PURCHASED BENADRYL ON 11/09/18. PT STATED THAT THE REDNESS HAD GONE DOWN SINCE 11/07/18.
About 5 days after 2nd vaccine I started getting severe cramps in both of my legs, and on left side of body. These were not caused by electrolyte deficiency as that blood work was checked at the end of June. Cramps are made worse by inactivity. Think worst charlie horse ever up and down legs, buttocks, and ribs.
severe headaches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headaches) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headaches) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (severe headaches) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Didn't feel good about 1 hrs p/immun 8 hrs later t102 & swelling of face; 18 hrs later eyelids & bridge of nose swollen; Seen by MD & referred to allergist;
Fever, body aches, chills started 7pm Saturday evening.  I was still aching and chilling when I went to bed at 10pm.  Seemed fine in the following morning.
Painful, swollen arm w/some numbness in right arm down to hand; no fever. Limited range of motion & abduction for a brief period after shot.
stomach issues, went to dr due to stomach issues was told she has colitis, after she went on a diet prescribed by her dr her stomach issues went away
2 days after receiving first Rotavirus vaccine, baby had projectile emesis (with no prior history of emesis) and diarrhea (no prior history of diarrhea on formula). Patient also became extremely gassy and would show signs of abdominal pain evidenced by crying after eating and drawing legs up to guard abdomen. Patient not eating well. Patient continued to have symptoms for a few days, at which time he went to see his PCP. Patient went to Emergency Department for symptoms 8 days after receiving vaccination on 11/02/17. Patient had to change formula to Gerber Soothe, the most broken down form of dairy, for alleviation of symptoms.
74y.o. male patient with PMH of COPD/asthma, A. fib not on AC, and possible CHF who presented with SOB and A. fib with RVR with rates to 180 and SBP in 70s. In the ED the patient received IV fluids with a recovery of his blood pressure.  5 mg IV metoprolol was given for rate control in addition to home metoprolol.  The patient quickly became bradycardic and went into PEA.  CPR was started and ROSC was achieved after 3 rounds of epi. The patient was intubated and sedated and started on 4 pressors, broad-spectrum antibiotics.  Echo revealed EF 15%, pan scan demonstrating findings concerning for pneumonia, cholecystitis, shock bowel, small punctate hemorrhage versus calcification in the periventricular white matter. General surgery, cardiology, neurosurgery were consulted.  The patient had anisocoria on 8/10 prompting stat neurosurgery consult.  A CT scan was ordered but given the patient's hemodynamic instability, the patient was not transferred for completion of the scan.  Family was called and the situation was explained.  Family expressed that patient would not have wanted to be on life support and changed the patient's CODE STATUS to DNR/DNI.  The family then came to the hospital for compassionate extubation, which was performed on 8/10 at 1400.  The patient expired with family at the bedside.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6199), on 08Apr2021 as dose 2, single (Lot number: ER8730) and on 30Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure but blood pressure has been under control for several months. Concomitant medication(s) included: LISINOPRIL; METFORMIN; ATORVASTATIN. Past drug history included: Sulfa antibiotics, reaction(s): "known allergies: Sulfa antibiotics". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results; Negative; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 07Jul2022 to 12Jul2022, Lot number: GC4035.  Clinical course: Adverse event: Even though starting testing negative for COVID 5 days after initial start of symptoms and continued to test negative up to around day 15 following onset of symptoms, symptoms have lingered. Symptoms began to worsen 17 days following initial symptom onset and when tested, test was positive. Other medical history: type 2 diabetes, high blood pressure but blood pressure has been under control for several months.
pt recv vax; persistent, inconsolable crying > 3 hrs p/ vax;
Patient arrived back to clinic about an hour and half (1600) after vaccine administration c/o itching, redness/flush on face, itchy/scratchy throat, redness and swelling at YF injection site, and difficulty swallowing. Administered 50mg IM Benadryl on right arm at 1604. Called husband to come pick her up.  Client waited in our office for symptoms to subside.  Client still had some symptoms upon leaving our office at 1700 but symptoms have not worsened. Informed her to call 911 if she were to develop difficulty breathing. Instructed to take another dose of po Benadryl in 4-6 hours.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old male patient who received PEDIARIX (batch number KG34F, expiry date 21st January 2017). Co-suspect products included GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On 26th February 2015, the patient received the first dose of PEDIARIX (intramuscular) .5 ml, GARDASIL, Hepatitis B vaccine, MMR and Meningococcal Group C Conjugate vaccine. On an unknown date, an unknown time after receiving PEDIARIX and Hepatitis B vaccine, the patient experienced inappropriate age at vaccine administration, injection site pain, neck pain and fever. On an unknown date, the outcome of the inappropriate age at vaccine administration, injection site pain, neck pain and fever were recovered/resolved. The reporter considered the injection site pain, neck pain and fever to be possibly related to PEDIARIX. It was unknown if the reporter considered the neck pain and fever to be related to Hepatitis B vaccine. Additional information was provided: Reporter called to state that PEDIARIX given to adult patient on 26 February 2015. Also, she mentioned that when she followed up with patient after misadministration, patient said that she was having neck pain, some pain at injection site, and fever. She feels as though these issues have resolved at this time.
BODY ACHE; RASH ON FOREARM; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and rash on forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on forearm and body ache was not reported. This report was non-serious.
Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue
Pt called to say arm felt sore after injection yesterday-overnight developed temp max to 101 with headache, sweats, body aches, back pain & nausea. Today at 730am temp 100.2 & at 11am temp to 99.5-Wondering if reaction-no other focal symptoms. Rx-Rest, ADVIL & monitor.
Developed Varicella Disease on 10/27/04 had varicella vaccine on 03/09/1998
Fever/ throat infection began on 1/25/07.  Fever lasted for more than 5 days.  Rash developed on 1/27, lips were cracked and ulcers appeared inside and on mouth.  Blood tests ran on 1/29/07.  Sed rate above normal (30 on 1/29; increased to 81 by hospital admission).  Diagnosed with Kawasaki Disease and admitted to hospital on 1/30/07.  IVIG was given that night, baby released on 1/31/07.  07/30/2007 MR received for hospital DOS 1/30-31/2007.  Child initially presented to PCP 1/25/07 with fever and pharyngitis.  Conjunctivae were noted to be slightly red at that time. Cheilosis, mouth ulcers, rash and persistant fever were noted several days later and child was refered to ER with possible DX of Kawasaki's Disease. PMH: none.  Admitting DX:  Atypical Kawasaki. Addendum: Cardiology consult and echocardiogram mentioned in H&P, however TC to MR dept says there is no record of either.  TC to PCP office and request sent for any cardiology consults. 07/31/2007 cardiac consult received for OV and echocardiogram on 4/9/07 in F/U for Kawasaki disease.  Post treatment child had normal R & L coronary arteries. PE WNL.  EKG normal for age. Echo with normal intracardiac relationship, normal L & R coronary arteries, normal biventricular systolic function
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
This spontaneous report was received from a female patient of unknown age who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On 08-JAN-2015 the patient was vaccinated with 1 single shot of ZOSTAVAX (vial, route of administration, lot number and expiration date were not reported). On 08-JAN-2015, after receiving ZOSTAVAX the patient experienced a burning, stinging sensation and redness near the injection site. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected because there is no patient's and physician's contact information.
11/21/08-"Pain began evening of 11/21/08 (several hours after receiving injection).  Swelling, reddness warmth began 11/22/08 above & below elbow on right arm.  Saw primary MD 11/24/08.  Symptoms subsided that evening.  No antibiotics needed".
a little redness; a little hard induration; a little eruption; itchy; a little pain; it burned a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it burned a little bit), VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (it burned a little bit). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (a little pain). On 29-Jan-2021, VACCINATION SITE PAIN (it burned a little bit) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (a little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Presented to the emergency department with shortness of breath and lethargy from skilled nursing for surgery.  She is found to be COVID-19 positive.  Tx w/ abx, remdesivir, O2, steroids. Weaned down to 2 L of nasal cannula.  Dc'd to SNF
Around 4-5pm I did not feel well. About 6-7pm I started shivering and a fever of 102. I had muscle pain, just pain all over, I continued with a fever for two day. I took Tylenol for two days and called out of work. I had a migraine as well, I was hot/cold and sweating through my clothes.  I seen my  doctor, and she ran a Covid and flu test both came back negative.
Patient states injection site was red morning of 02/27/12 and became very itchy as time passed. As of 02/28/12 is still red/itchy no better/no worse. She will contact her MD 2/29/12 if not better.