chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/5 around 1130AM I received my annual flu shot in my left arm and my prescription for Vitamin D 50000 UNIT Oral Capsule to Take 1 Capsule Weekly for my deficiency. The only reaction I seemed to have from the flu shot was a slight headache that afternoon and evening (no medication taken). Around 2pm I ate lunch (mixed greens/vegs, grilled chicken). Around 9pm I took one capsule of the VitD, with calcium lactate and magnesium oxide tablets (normal daily supplements), while eating a snack mix of baked fruit and nuts & yogurt pieces. Within one hour my throat swelled up--swollen lymph gland on left side, under jaw. Painful to eat/swallow/touch. Still swollen and tender 2 days later.  I've never had a reaction to the yearly flu shots I get; nor did I react to the same VitD regimen I had previously in May 2008. I don't have any allergies; have never had a swollen gland before.  My doctor prescribed Methylprednisolone 4MG DOSTRI for 6 days.  I began the medication on 10/07/2009 and have experienced significant reduction in the swelling and tenderness.
fever; arm sweeled up; arm became red; arm hot to touch; felt dizzy; disoriented; does not feel right; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2019, 1 days after receiving Shingrix, the patient experienced fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell. On an unknown date, the outcome of the fever, swelling arm, dizziness, disorientation and feeling unwell were unknown and the outcome of the erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the fever, swelling arm, erythema of extremities, skin warm, dizziness, disorientation and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The caller reported that she received Shingrix and felt fine for about 24 hours, then she got a fever and her arm swelled up and became red and hot to the touch. She felt dizzy and disoriented. This lasted for over 2 days before she started feeling better. At the time of reporting she still did not feel right and her arm was less swollen, but still red and hot to the touch.  The reporter consented to follow up.
vascular issues; limited circulation on her lower extremities on her feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "She was told by her allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOPATHY (non-serious), outcome "unknown", described as "vascular issues"; POOR PERIPHERAL CIRCULATION (non-serious), outcome "unknown", described as "limited circulation on her lower extremities on her feet".  Additional information: Reporter also mentioned that she had called in before for herself to inquire about the Pfizer BioNtech covid-19 Vaccine because she had some vascular issues however it was not mentioned if this brought about an AE after getting the dose/doses. She was told by her allergies, cardiologist and vascular doctor to kind of wait because she had limited circulation on her lower extremities on her feet and she had blown all the vessels on her feet.   Follow-up (08Nov2021): The initial case was missing the following minimum criteria: Adverse events. Upon receipt of follow-up information on (08Nov2021), this case now contains all required information to be considered valid. Added AEs, RMH information.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
At first my arm was sore like it typically is after my flu shot. I noticed that it was still really sore a week later and I had associated weakness and increased pain in my right shoulder.  I have pain with range of motion and when I first wake up I can barely use my right arm.
Mild fever, nausea, vomiting, fatigue. Also redness, pain and itching around the injection site.
pt recv vax 29MAR96 & 16MAR98 pt devel varicella;pt was prescribed med;
Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days). On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter.  On 12-Jul-2021, the patient got the first dose of the Moderna vaccine at reporter's facility and then received a second dose after 9 days at another facility on 21-Jul-2021.  Patient now returned to get a third dose. HCP wanted some guidance on whether they should administer this second dose or not.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received contains no new information
felt some of the vaccine run down his arm; got about 90% of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine). At the time of the report, VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) 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.   Concomitant medication was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Correspondence email attached
Narrative: COVID infection following COVID vaccine series 08/16, Pfizer, dose #1 09/18, Pfizer, dose #2 08/31 COVID swab, result: detected 11/05 pt cc: stufy nose body aches, tired, exposure: unknown 11/08 COVID swab, result: detected 11/08 SARS-COV-2 Variant Sequencing result: pending
pneumonia; kidney failure; This is a spontaneous report received from a contactable consumer. A 91-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208), parenteral in left arm on 17Mar2021 (at the age of 91-year-old) at single dose for COVID-19 immunsation. The patient's medical history included prostate cancer, heart disease, Alzheimer. The patient's concomitant medications included leuprorelin acetate (LUPRON) injection, via parenteral route of administration in location reported as stomach from 10Mar2021 for prostate cancer. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM6203), parenteral in left arm on 24Feb2021 (at the age of 91-year-old) at single dose for COVID-19 immunisation. It was reported that patient began feeling sick after injection. He progressively worsened and he was admitted to the hospital on 31Mar2021 with pneumonia and kidney failure. He was put on a ventilator and received dialysis along with antibiotics. Adverse events start date was reported as 18Mar2021. Adverse events were reported as serious as resulted in emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The number of days of hospitalization was reported as 6. Adverse events treatment was reported as ventilator, dialysis, and medications. The patient underwent lab tests and procedure which included COVID test post vaccination (unknown) on 31Mar2021. The outcome of the events was not resolved.
Vaccine received at 23rd day of 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product used was not provided by the reporter.     Reporter did not allow further contact.
Patient received ZOSTAVAX vaccine on 3/10/11. Called me on 3/13/11 (approx noon) to say that she had a "large red circle" around injection site & "it hurts" but has almost disappeared today.
pt recv vax 1020AM on 2AUG95; pt awoke 1130AM same day, staring, breathing funny & fast; 2PM pt had twitching of whole body, jerking of face & arm lasted few mins; seen in office 330PM t103.8, pt alert dx febrile seizure;
Patient had no known immediate ill effects or complaints directly after receiving his second COVID-19 vaccination on 03/11/2021. However, on 03/22/2021, he suffered a fatal cardiac arrhythmia while exercising on his home elliptical machine.
pt devel swelling & redness @ site of inject in deltoid muscle; rxn started day p/inject lasted 3-4 days; pt had 1 1/2" firm red induration @ site;
Pt recv vax on 12/7/98; on 12/8/98 pt exp aching, joint pain, fatigue, headaches; tx=Diflucan
Information has been received from a health professional concerning an adult female who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced spots. It was reported that the patient recovered. Unspecified medical attention was sought. No other information was provided. No other information was provided. Additional information is not expected.
I was restless in the evening of Feb. 29th, 2020, and felt very tired during day of March 1st.  I had a headache, severe left, upper-arm pain, feverish and had shivers.  I had no appetite throughout the day, and battled with  a 'racing' heart. By the morning of March 2nd, I had developed a rash on my right, lower leg and experienced itching over most of my body. The left arm pain has reduced in severity on this date (3/4/20) but is still achy.
minor soreness in arm; mild headache; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a runner and was naive to medications. Treatment product was not provided by the reporter.  Company Comment The events were downgraded to non serious due to being related to the first dose of the vaccine.   This case was linked to MOD-2021-388577 (Patient Link).; Sender's Comments: The events were downgraded to non serious due to being related to the first dose of the vaccine.
pain in my left hand; tingling / tickling sensation / felt the tingling/tickling in my left hand; My left hand went numb/left foot numb/left half of her face was numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Sep2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "pain in my left hand"; PARAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "tingling / tickling sensation / felt the tingling/tickling in my left hand"; HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "My left hand went numb/left foot numb/left half of her face was numb".  Additional information: Caller stated she received Pfizer COVID-19 vaccine first dose on 06SEP2021, received the injection in my left arm. A week after she received the vaccine started feeling pain in my left hand and numbness. The pain was not going away; afterwards I felt like my left hand went numb, not completely like anesthesia, but more like a tingling/tickling sensation. Then I felt the tingling/tickling in my left hand, and the next day the tingling/tickling started in my whole left foot, and then tingling/tickling in the left half of my face. After that, her left foot and the left half of her face was also numb.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report 2000027467-1 describes swelling of the knees and achy joints in a 12 year old female who received two injections of Lyme vaccine during a clinical trial protocol 030, center 016, pt id 3163. This report was received by the pt's attorney and has been confirmed by the study investigative site.   According to the mother, she was contacted by the investigator site to have her two children participate in the SKB pediatric study because "one of her children had Lyme disease previously and the other did not." the pt was a participant in clinical trial protocol 022 and was a placebo cross-over subject in clinical trial 030. She received doses of Lyme vaccine on 4/17/00 and 5/15/00. According to the attorney, the pt experienced "some swelling and headaches that lasted a while" after the first injection. According to the study investigator site, the pt "reported mild to moderate symptoms on her diary card." Per the attorney, the pt's mother questioned the investigative site as to whether or not the symptoms were related and whether or not her daughter should get the second shot. Per the mother "the doctor's told her that there was not problem and told her that it was perfectly okay for the children to go forward with he second shot." Since the second shot, her daughter has had "serious problems." The pt is extremely fatigued, sleeping ten hours a day and taking three to four hour naps daily. She has had swelling in her knees and aches and pains throughout her body. According to the investigative site, they received the pt's second safety postcard on 7/10/00 where it was reported that the pt had been experiencing tiredness, achy joints (knees) and headaches all continuing form 6/11/00. At the mother's request, the pt has since tested HLA-DR4 positive on 8/29/00. At the time of this report, the events are ongoing and the pt has been referred to a rheumatologist.
Three days after the injection of the second dose of Moderna, my tongue, lips, and cheeks started swelling. Broke out in ulcers above teeth, tongue, cheeks, and saliva glands swelled up as well. I began to take Benadryl and after a few days it began to work. After stopping the Benadryl the reaction began again. The symptoms are starting to rebound again and worse. Primary care physician wanted to schedule an appointment with an allergist.
Pt presents 2 days following flu vaccine with 1.5 inch diameter red firm region of deltoid left arm. No discomfort. Taking ibuprofen PRN. Instructed on use of heat.
I've had herpes simplex since I was a child. In the past, I've had maybe 1 outbreak every year or so, but since I received the Covid vaccine, I've had 4 outbreaks.; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP6955, Expiration date not reported), via an unspecified route of administration, administered in arm left on 20Mar2021 13:00 (at the age of 47-year-old) as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170, Expiration date not reported), via an unspecified route of administration, administered in arm left on 17Apr2021 13:00 as single dose for COVID-19 immunisation. Medical history included hypertension, eosinophilic oesophagitis, spondylolisthesis, herpes simplex since child; all from an unknown date an unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lysine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); all taken for an unspecified indication, from unknown start date and all received within 2 weeks of vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 04May2021, the patient reported that in the past, she had maybe 1 outbreak every year or so, but since she received the covid vaccine, she has had 4 outbreaks. The seriousness of the event was reported as non-serious. No treatment received for the event. The clinical outcome of events was resolving.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
LAIV on Thurs-am. Fri and Sat runny nose and congestion. Sat. evening 101.5 degrees fever and chills - Tylenol and Ibuprofen alternating. Sat. evening thru Sun. nite. sat evening backache and leg aches. Sun. stomach pain - no appetite, Fluids were "pushed" by mom, thru feverish days. Mon. a-m- fever broke appetite returned. Feels. better.
Pt complained of sweating, tingliness in fingertips and dizzy. Pt denied shortness of breath, rash, swelling. Wet towel given to pt. Blood pressure reading was taken. Blood pressure resumed from 99/64 - 115/76.
Pain spinal,pelvic, bone/joint in lwr body. Fever 104, chills, increasing in severity for 3 wks, then symptoms disappeared. Tx-w/2 iv fluids.
Rigors 3-4 hours after receiving flu vaccine, + fever; lasted about six hours and then stopped.
Two minutes after injection, child appeared pale and listless, bent over as if to vomit, then arched her back, eyes rolled back, arms shook seemed like to tonic clonic seizure, no fever lasting only about 5-8 seconds.
Has started to twitch in his sleep ever since receiving the flu shot.  During naps and bedtime is when you really notice it.  At times he will wake up in the middle of the night screaming and make his body stiff and arch his back. Doctors has referred me to see a neurologist.  This child never had any of this before the flu shot (combined H1N1 and standard flu).
vaccine administered to a patient with a signed consent, mother was not aware the consent was for a vaccine and wanted a test instead.
Swelling of injection site - significant redness of injection site. Had to be admitted to hospital for presumed cellulitis - elevated WBC - Cx were negative.
6-24-06, 8AM, DAD NOTICED RED,VERY SWOLLEN CIRCLES AROUND INJECTION SITES WHILE GIVING HER A BATH.  LEFT ARM WAS MUCH MORE SWOLLEN THAN RIGHT ARM.
SMALL LUMP IN LEFT THIGH AT INJECTION SITE, FUSSINESS AND CRYING THROUGH NIGHT.
Per patient, patient experienced high fever 101-102, chills, and shakes. Per pt arm is sore and turned purple. Vaccines were administered in same arm 1" a part.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: injection side hard and hot. Feel burning on the injection side. baseball size. No fever.
Pt reports red/swelling 3/27/8/ - left upper arm (lateral, given subcutaneous mid humerus) pin point noted with large area of redness/warmth, N/V intact, ROM intact. Outlined with pen. Given script for Keflex 3/26/08 - has not filled yet. Advised to fill script and apply warm packs frequently - monitor redness.
High fever; Other symptoms of a cold; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported the secondary effects of the Covid-19 Pfizer Vaccine. The consumer reported that a patient was vaccinated with Pfizer's Covid vaccine at a Medical Center on an unspecified date. The patient was having several secondary effects due to the vaccination. He has high fever and other symptoms of a cold on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Patient given 2nd dose of PCV 13 within 6 months of last vaccine of same PCV 13.