chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fever blisters under her nose  after booster; Fever after booster; Chills after booster; RPh told her expired  booster shot was administered to her; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Extreme fever blisters under her nose  after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PYREXIA (Fever after booster), CHILLS (Chills after booster) and EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her). On 31-Oct-2021, the patient experienced BLISTER (Extreme fever blisters under her nose  after booster). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her) had resolved. On 01-Nov-2021, PYREXIA (Fever after booster) and CHILLS (Chills after booster) had resolved. At the time of the report, BLISTER (Extreme fever blisters under her nose  after booster) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient after the booster vaccine had a fever, and chills for a couple of days and also had extreme fever blisters under their nose on Sunday 31-Oct-2021. The blisters were still going on and a week after booster vaccination the Pharmacist called the patient and informed them that they received an expired vaccine and asked to go into the pharmacy to receive another shot.  The patient was reluctant to receive another shot because of the side effects that the patient had and did not received the repeated booster shot. The patient also reported that they had not seen a doctor yet.  Lot number of the first dose was provided as not legible.
Fever and spotting (very early in pregnancy. About 4 weeks) spotting happened with fever. No damage to the pregnancy know so far. Spotting stopped
RASH ACROSS BACK OF SHOULDERS AND TOPS OF ARMS AND DOWN ARM HAS NOT GONE AWAY, NOW WORSE BY RIGHT ANKLE, ABOVE KNEES BILATER, BY ELBOWS AND BACK OF ARMS, FACE AND EARS.  HAS SEEN PCP AND BEEN TREATED WITH STEROIDS,  ALLERGY MEDICINE, H2 INHIBITOR
Both of my legs in the front only was burning and itching to the point where I could not wear any thing over them .  At night I could even let the covers touch my legs.  At night it got 5 times worse.  It lasted for about 8 days and then it went away as fast as it came.
feel completely exhausted; mild headache; joint aches; flu like symptoms; This case was reported by a consumer and described the occurrence of exhaustion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 2nd dose of Shingrix. On 27th July 2019, 1 days after receiving Shingrix, the patient experienced exhaustion, headache, joint pain and influenza-like symptoms. On an unknown date, the outcome of the exhaustion, headache, joint pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the exhaustion, headache, joint pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter reported that unfortunately was a statistic of the side effects from the shot. On Monday, The patient received Shingrix and felt completely exhausted with a mild headache, joint aches and flu like symptoms. The reporter asked should this happen for this long period of time. It would be one week on the Friday, on the reporting date.
bruising appear on my right hip; This is a spontaneous report from a non-contactable consumer (patient). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 23Mar2021 11:00 (Lot Number: EN6200) (at the age of 49-years-old) as dose 2, single for covid-19 immunisation. Medical history included cholesterol, high blood pressure and elevated uric acid. The patient had no known allergies. The patient received other concomitant medications within two weeks of vaccination. The patient did not receive other vaccine within four weeks of vaccination. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm on 18Feb2021 (Lot Number: EN6200) (at the age of 49-years-old) as dose 1, single for covid-19 immunisation and experienced grade two muscle tear in left pectoral muscle. On the day of reporting on 25Mar2021, 2 days after second vaccination, he had bruising appeared on his right hip without any related injury, pain or trauma. The patient received treatment for the event. The patient did not visit doctor for bruising till the time of reporting. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
lt jaw (cheek & ear) swollen; no fever; loss of appetite; difficulty chewing; very painful;
Pt recvd vax on 25FEB91; on 28FEB91 was seen w/diffuse papulovesicular rash confined to the legs; Pt well otherwise; Confounding factors include exposure to chickenpox & use of new detergent on child's clothes;
Patient said that she breakout in black and red dots on both arms. She also has a headache along with the rash.
No adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No additional information regarding patient's medical history, concomitant medication and concurrent condition was provided.  On 07-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S012036, expiration date 17-APR-2021 (exact dose and route of administration were not reported) for prophylaxis.   Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 48.2 (unit not provided), the time frame as 4 hours. There was no previous temperature excursion reported.  No adverse effect reported.
Redness, and swelling at the injection site, minor itching. About 20 cm of redness. No tenderness.
On Saturday 20 Mar 10 received a H1N1 on his unit. Next day developed eyelid swelling lower side, dry coughing, headache, one episode of nosebleeding. Previous Influenza Nov 09, no symptoms given at worst. Pt hx of DM II, HTN, BA, on ADVAIR, Lotrimen (Provadia) and Avandia med.
Pfizer adult vaccine stored in our freezer past the stability date of 11/23/2021 administered to patient on 12/02/2021.
The pt complained of pruritis, pain in the left deltoid at the site of injection. The area was warm, red and indurated approximately 3 cm in circumference around the injection site.
outbreak of herpes on her lips/ lip got worse/ way across the lip; outbreak of herpes on her lips/ lip got worse/ way across the lip; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200) intramuscularly, administered in Arm Left on 24Feb2021 14:45 (at the age of 72-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid condition (thyroid tests are normal and fine) and had a long history of herpes and she saw a virologist years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 25 mcg tablet once a day by mouth taken for hypothyroidism from an unspecified start date and ongoing. No vaccination was taken 4 weeks prior to COVID-19 vaccine. The patient took the first dose about a week ago and she had an outbreak of herpes on her lips. The outbreak was kind of a low grade, she had a history of herpes and stated her outbreak was not due to the vaccine. When the patient was queried about when outbreak on her lips started, she stated that she went into the vaccine with one little spot on her lip, she has a long history of herpes and she saw a virologist years ago and was suggested that she just had to watch the foods she eats, she overloads with foods that activate it and she had to cut back. Patient called her family doctor and asked if she could take valacyclovir (VALTREX) since her lip got worse, which had to do with stress and eating poorly for a while, too much coffee and not from the vaccine. She woke up yesterday morning with more working its way across the lip. She took only one dose of Valtrex yesterday and it was 500mg, and it had helped her. She was willing to live with it for whatever period of time she should wait for taking an antiviral medication. The patient stated that she would eat very clean and when she called the doctor, the nurse told her she could take Valtrex. She wanted to know if she can take it. The patient did not visit any clinic or physician office. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from timing of event occurrence , vaccination and patient current medical condition, the reported events were assessed as probably related and cannot e totally excluded  to suspected drug BNT162B2.  Case should be reassessed pending new drug information and patient follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.
Red raised rash began on both thighs in the evening of 6/10/05 and spread to both arms (worse on left arm.)  Rash and itching controlled with 1 1/2 tsp of Benadryl po.  Rash resolved on 6/12/05.  Swollen knee, swollen lower lip  and fever of 101 F occured on the evening of 6/11/05.  Immediately resolved with po Motrin.  Denied trouble breathing.  Parents chose not to contact physician.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-FEB-2015, 23-MAY-2015 and 09-JUL-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (dose, lot# and route were unknown for all the three doses) respectively. On 12-SEP-2015 the patient was inadvertently vaccinated with the 4th dose of GARDASIL (lot 2, dose and route were unknown). No adverse effects reported. Additional information has been requested.
9/16/03 Parents here for a triage, for a viral infection. Parents mention that 9/7/03 child received shots here and later same day child began to seizure, went to hospital ER via ambulance. No fever related to seizure. Denies trauma of any type, only new immunizations given earlier 9/8/03.
Pt came in for her 2 year well child check and mom informed that on 3-31-14 pt had reaction to injection. Got a Tdap and not the DTap with site reaction.
Dizziness, Weakness, Sore Arm/Tender at Site of Injection, Headache, Coughing
Initial report was received from the scientific literature on 16 November 2012. The following is verbatim from the report: "A 68-year-old woman developed elevated anti-neutrophil cytoplasmic antibodies following influenza vaccination. She was referred to a clinic with elevated anti-myeloperoxidase and anti-proteinase 3 antibodies. The antibodies were elevated on 18 October 2010. She had received an influenza vaccine on 06 October 2010 (route and dosage not stated). Four months after her vaccination, there was a sharp drop in ANCA titres. They had normalised after 7 months. Authors comment: Noteworthy in this case is the 4- to 7-month period for normalization of ANCA titers, which can be used as a guide when elevated ANCAs are suspected to be from influenza vaccination." The patient's outcome was recovered. Documents held by sender: None.
Shortness of breath. Chest tightness. Epi given. Albuterol
Mother states that a few hours after the patient received his shots she fed him and put him down for a nap.  She states she went in to check on him and he was blue in color.  She states she blew in his face and he started breathing and they took him to the Emergency Room.  The kept him over night for observation and he did not have any more episodes while there on a apnea monitor.  He was sent home with an apnea monitor and has a follow appointment with the doctor. 4/28/09-records received-presented to ED after cyanotic and apparently not breathing. Decreased po intake, fever. Impression:Acute life-threatening event, possible seizure, possible apnea spell.
She states that morning of 9/1 she woke up from sleeping with sharp, stabbing chest pain that radiated to her back with associated tingling in her left arm. The pain started abruptly, and was associated with shortness of breath, a dry cough, and nausea for which she took ZOFRAN. She states that the pain is worse with inspiration, and describes a sharp pain with inspiration in the center of her chest. She also describes pressure and tightness in the middle of her chest, and feels "tight" like she can't get a breath in. The pain is worse lying flat or leaning forward. It lasted about 2 minutes and improved. She rates the worst of it 10 out of 10 in severity, and it made her fall to the ground it was so severe. She tried to use her albuterol inhaler without relief. Nothing helped the pain get better except time. She has experiencing these symptoms in the past. For the past few months (between 1st and 2nd dose of SHINGRIX given) occasionally when she wakes up in the morning she will have some sharp chest pains with a bit of shortness of breath but it resolved spontaneously and does not persist throughout the day. She was in her usual state of health until a few months ago (after 1st dose of SHINGRIX given) which she has been feeling overall fatigue and malaise. She also has occasional hot sweats during the day and feels as though she needs to take a cold shower to cool down. She had echocardiogram done and was diagnosed with pericarditis.
With second shot, I had Lots of Saliva; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program . A patient of an unspecified age and gender received second dose of BNT162B2 (Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date at single dose for Covid-19 immunization. It was reported that, "had Sjogren's, an autoimmune disease. Body had inadequate mucus. After first COVID shot, the patient had random pain in the lymph nodes in neck. Also had a very runny nose for a week. With second shot, had lots of saliva. Understood mRNA was being used in clinical trials or to be used in clinical trials with multiple sclerosis and strongly suggested, Pfizer look into mRNA and Sjogren's". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On March 22nd, 2021 I developed a raised rash on my chest and back that is extremely itchy.  The rash covers about a 3inX3in area and lasts about 3 weeks and then it moves to a new area on my back and chest.  The rash has not stopped since it started,  It changes in location on my body but it is the same type of rash.  I went to a dermatologist and she said to put a steroid cream on it and that didn't help.
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
Pt presented with  Erythema Multiforme within 3 days of COVID vaccine
Developed tingling over body, feeling hot but no fever, fatigue, headache, motion sickness feeling, and a dimness in vision and tunnel vision in both eyes
pt recv vax;approx 36 hr later, large hives on back; fine rash on face,arms & upper torso;PC from mom; redness, soreness & low grade T;pt feeling fine now;
I got a bloody nose the day after the vaccine, which lasted for two days.  I also got a strong headache on the right side of my head, just above the ear, which I never had before.  When I get tired or stressed out, a headache in the same location still comes back, over three months later.  I had pain whenever I moved my eyes, lasting for about three days after the vaccine.  I had a fever, muscle aches, and fatigue for two days after the vaccine.
Redness and swelling at injection site within minutes after administration. Redness spread to large area of tricep but receded by 50% within minutes.
red, painful, warm area about arm p/td on 7JAN96; consistent w/cellulitis
right hand swelled up around the size(twice the size of his normal hand would be); Scrotum was swollen; Bottom lips swelled; Normal flu like symptoms; He was sore; Didn't feel well; This is a spontaneous report from a contactable nurse (patient's mother). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscularly, administered in left arm at the age of 18-year-old on 24May2021(around 1 PM) (Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscularly, administered in left arm at the age of 18-year-old on 03May2021(around 1 PM) (Lot Number: ER8737) as single dose for covid-19 immunization. The patient hadn't taken any vaccine 4 weeks prior to the COVID 19 Vaccine. There was no family history relevant to the adverse event. Nurse stated her son had the normal flu like symptoms afterwards when he was sore and didn't feel well in May2021. A day later(in May2021) his bottom lips swelled just his bottom lips there was no oropharyngeal response on the side of the lips. He took Benadryl and about 8 to 12 hours later it went down. On Thursday(27May2021), his right hand swelled up around the size, she meant twice the size of his normal hand would be, that also lasted around 12 hours or so. Today(in May2021) he called her from work and his scrotum was swollen. And she was trying to find out if this was a normal,  she was a nurse working in an emergency department and this was not a normal response in anyone else that she had heard of who had gotten the vaccine but she wanted to call to see if this was something maybe somebody else has experienced, or one of the doctor, one of the doctor that she work with prescribed a Medrol dose pack for him just in case.  The outcome of the event 'bottom lips swelled was recovering, of the event right hand swelled up around the size(twice the size of his normal hand would be) was recovered in May2021, of the other events was unknown.
received a MENACTRA vaccine at her pharmacy that had expired with no reported adverse event; Initial information received on 20-Apr-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 21 years old male patient who received a menactra vaccine at her pharmacy that had expired with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2022, the patient received once a first dose, o.5ml of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] (strength: standerd, form: unknown) via intramuscular route (lot: U6921AA, expiry date: 17-Apr-2022) in the left arm for immunization.  On 18-APR-2022 the patient reported that, received a menactra vaccine at her pharmacy that had expired with no reported adverse event (expired product administered) (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  It was reported that, Pharmacist stated that a patient received a MENACTRA vaccine on 18APR2022 at her pharmacy that had expired on 17APR2022. Pharmacist asked if there was a 1 day grace period for expired products. Pharmacist asked how to proceed. This situation was reported as a medication error due to administration of expired Menactra.  Action taken: not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.