chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling face (his face swelled up); Face swelled up due to taking Dupixent and getting the covid vaccine while on therapy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen (Batch/Lot number: unknown) at 300 mg 1x/day, second regimen from 04Apr2020 (Batch/Lot number: unknown) to 01Dec2021 at 300 mg and third regimen since 09Oct2022 (ongoing) (Batch/Lot number: unknown) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious) with onset Oct2022, outcome "unknown", described as "Face swelled up due to taking Dupixent and getting the covid vaccine while on therapy"; SWELLING FACE (non-serious) with onset Oct2022, outcome "unknown", described as "Swelling face (his face swelled up)". The events "swelling face (his face swelled up)" and "face swelled up due to taking dupixent and getting the covid vaccine while on therapy" required emergency room visit. The action taken for dupilumab was dosage not changed.  Additional information: It was reported that patient had Pfizer covid vaccine while on therapy with Dupixent and his face swelled up, he also had missed doses of Dupixent. On unknown dates, consumer had a Pfizer covid vaccine while on therapy; he had Dupixent on a Sunday than had his Pfizer vaccine on a Monday, several days later, his face swelled up. Patient only resumed therapy with Dupixent on 09Oct2022 using the doctor's sample. Treatment for the swelling included going to urgent care and was told that it was due to taking Dupixent and getting the covid vaccine while on therapy; his doctor advised him that he needed to be off Dupixent for 1 month before the covid vaccine and then one month after. Corrective treatment: An unknown corrective Urgent care for the event (his face swelled up). At time of reporting, the outcome was unknown for the event his face swelled up and unknown for the event face swelled up due to taking dupixent and getting the covid vaccine while on therapy. Reporter causality: Related. Company causality: Not reportable.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gave patient Flu vaccine when she presented to clinic for Covid vaccine.  (She had had her flu vaccine last week). The flu vaccine given was indicated for 65 years and older.
Transverse myelitis, with numbness and tingling in the feet and legs, then pain, numbness, and tingling in his back, followed by similar symptoms in his upper extremities.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter reported that just got his/her shot on friday till the time of reporting and that thing hurted so bad.
24 hours post vax pt developed 4 X 4.5 cm redness, warm to touch, slightly swollen. Pt treated with Duricef for possible cellulitis. Reaction posterior to injection site and possibly of another cause (bug bite).
No adverse reaction.  Patient was given pediarix vaccine at 23.5 weeks making the Hep B not valid since the Hep B is not valid until 24 weeks of age.
2-3 ? diameter itchy raised patch. Seems like it might be ?covid arm?
Patient felt dizzy/light headed about 5 minutes after receiving Moderna vaccine and then fainted. She was unconscious for around 1 minute before regaining consciousness. Patient reported that she had a severe fear of needles and believes that was what caused her to faint.
4/06/06 vaccine given about 3:30PM. No reaction in office. 4/7/06 mother called about 2:00PM to report child woke up at 1:00 AM. Crying complaining his arm hurt. She stated he had a red area to deltoid of left arm with it feeling warm to touch. Child not wanting to move arm. Took child to grandma to stay while she went to work. Called me, took child to PCP same day. She did no know child's temp. As she did not check it. She had been giving Tylenol and applying cool compresses. I made a f/u phone call on 4/10/06 and mother stated the arm was much better with the redness almost completely resolved.
had my 1st dose / Dec 30 2020 but have not done the 2nd dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient had reported the case for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired was it too late to get the 2nd dose.
Pt had general malaise and headache that same afternoon. The next day his symptoms progressed to dull, burning chest pain that radiated to the throat and ears along with numbness and tingling of the distal arms and hands. The chest pain was relieved by leaning forward. This continued off and on for two to three days while being monitored in the hospital. The diagnosis was myocarditis due to the vaccination.
Had the vaccine, had not problems and around 2:00 AM had explosive diarrhea and still has it 3/24/21.  Has not taken anything for the reaction.  He had no problems around the injection site, was sore for about a day but then went away.  He has called his doctor and he was informed to get an echo of his gallbladder which showed a stone, but feels it was related to the vaccine.
A nurse reported that a child received injections of Hib-Titer vaccine (haemophilus b conjugate vaccine) and Prevnar (pneumococcal 7-valent conjugate vaccine) and subsequently developed a swollen leg from the site of injection to the ankle. Both Prevnar and Hib-Titer were injected into the leg. As of the date this was reported, no further information was available.
3 hours after vaccine- felt flushed and slight aches/chills By 6 hours after vaccine had body chills/aches and fatigue  By 10 hours after vaccine I had a fever of 101c severe chills and aches and a headache. This all last for about 6-8 hours. At that point I took ibuprofen to help with the severe symptoms and it helped a lot and I was able to get relief.   24 hours after vaccine I felt fatigue and a slight headache. The fever and aches/chills were gone.
Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood cholesterol: increased (High) increased.     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.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021included no new information. On 08-Jul-2021: Follow-up received on 12-JUL-2021 contains secondary reporter contact details updated and suspect product dose months was updated.
Fever, Chills, joint pain (shoulders, elbows, wrists, hips, knees, and ankles), numbness right cheek
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 24Feb2021 as dose 2, single (Lot number: EL9269), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Probable autoimmune disorder" (unspecified if ongoing), notes: Other medical history: Probable autoimmune disorder (under review by rheumatologist); "Known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mobic, reaction(s): "Known allergies: Mobic", notes: Known allergies: Mobic; Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2
exposed to covid; nausea; loose stool; This is a spontaneous report from a contactable Other-HCP (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in arm left on 26Feb2021 at 09:30 (at the age of 41-years-old) as 1st dose, single for COVID-19 immunization. Medical history was not reported. No known allergies were reported. Patient did not have COVID-19 prior vaccination. Concomitant medications included Vitamin D Nos (VITAMIN D NOS), biotin (BIOTIN), cetirizine hydrochloride (ZIRTEC) and Collegan. On 26Feb2021, the patient experienced exposed to COVID (that evening) and tested positive for COVID on 02Mar2021, GI symptom only, nausea and loose stool. Patient did not receive treatment for the events. Patient received second dose of bnt162b2 on 19Mar2021. On 02Mar2021, the patient underwent lab tests and procedures which included Nasal swab test resulted positive. The outcome of event was recovered on an unspecified date in 2021.   No follow up attempts are possible. no further information is expected.
After 10 days of administrating MMR vaccine there was a reactions, itchy rash all over body, given Benadryl for the itch.
sweating; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
April 2nd pt received multiple vaccines: MMRV, varicella, DTaP, HIB, HEP A and PCV-13 and 2 days later on  4/4/2018 a generalized all over body rash-flat erythematous eruption occurred; mother states it started on feet and progressed upward to head. States child itching her ears; no signs of respiratory distress or poor feeding.
Myocardial Infarction descending anterior artery total blockage.  Severe middle chest pain.  Clot cleared with Catheter Stent procedure
several elderly pts exp a non-response p/3 doses of Engerix-B;
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history included shingles 22 years age before she received the vaccine and high blood pressure. The patient had CELEBREX allergy. On 2012, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included EVISTA and unspecified high blood pressure medication. On an unknown date in 2012 (reported as 4years ago) the patient developed a sensitive scalp that would result in tingling and burning sensation. The patient also mentioned that about a year ago she developed teeth and jaw discomfort. No treatment was rendered for the event. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Left thigh (where injection was given) had a six inch red blotchy rash that is still present today on 10/20/14.
Woke with rash - macular lesion scattered over trunk post neck #'s < 20.
Extreme soreness and sensitivity to touch at injection site, slight headache, slight nausea, extreme fatigue, mental fog, unusually strong appetite, chills, mild fever, hot flashes. I took ibuprofen for fever and headache. I slept as much as possible. I didn?t miss work but I wished I had taken Thursday off. I was most miserable that day.
Redness and swelling noted to be left upper arm. Some induration noted 6 x 6 area. Treatment: ice to area 15 minutes q 2-3 hours. Ibuprofen q 6 PRN.
CANNOT SLEEP; CAN'T STOP SHAKING; EYEBALLS ARE KILLING; EVERYTHING HURTING/RANDOM BODY STABS/BAD BODY ACHES; FOGGY IN THE HEAD/MISERY; JOINT PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: not reported) 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 cannot sleep, can't stop shaking, eyeballs are killing, everything hurting/random body stabs/bad body aches, foggy in the head/misery, joint pain, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot sleep, can't stop shaking, chills, headache, eyeballs are killing, joint pain, everything hurting/random body stabs/bad body aches, foggy in the head/misery and fever was not reported. This report was non-serious.
Within 45 minutes of shot,  Throat swelling, hard to breathe and swallow Severe left leg calf pain? lasted 1 month Severe chronic stomach pain( like contractions) Tasted metal  Severe dizziness for 1 month
Urticarial eruption beginning 1 day after vaccination. This is only a possible. Controlled by higher dose antihistamines or 60 mg qd of prednisone (3 days at 60 mg, then 2 days at 40 mg). On day 2, the rash recurred. I stopped the pred. at that point.  Eruption got worse x 3 days. I'm not sure of the cause, it was appearing a bit Erythema Multiforme-like. Patient transferred to Medical Ctr for biopsy.
Rash on my stomach and left arm from under my shoulder to past my elbow. It?s red, bumpy and itchy.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on 03-NOV-2011, the patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml (route and lot # not provided). On 26-JAN-2012, the patient was vaccinated with RECOMBIVAX HB dose 2, 1 ml (route and lot # not provided). On 12-FEB-2013, the patient was vaccinated with RECOMBIVAX HB dose 3, 1 ml (route and lot # not provided). No concomitant medications were reported. The nurse stated there was no adverse effects. This is one of several reports from same source. Additional information is not expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The patient developed a knot at the injection site.
Pustule formed at the site of injection , two days later swollen lymph node was palpable in the left axillary region  . Pain and discomfort under left arm and left shoulder . Treated with over the counter medication Ibuprofen , resolved on its own after a few days .
Pt recvd vax & exp low grade fever, chills, & inject site pain;
Site: Pain at Injection Site-Mild, Systemic: shingle disease-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Additional Details: pt got shingle disease after moderna shot dignosed with her md
Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 37-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 11Jun2021 09:45 as second dose, single for covid-19 immunization. (Vaccine Administered at Military Facility: No) (Vaccination facility type: clinic by public health department). Medical history included ongoing Hereditary coproporphyria, ongoing arthritis and degenerative disc disease of spine , intervertebral disc degeneration from an unknown date and unknown if ongoing. Concomitant medication included baclofen (BACLOFEN) taken arthritis and degenerative disc disease of spine from an unspecified start date and ongoing. Has been taking 6 years. Nerves messed up in spinal column from L1-S1. The patient and her son just got second doses on 11Jun2021 and she reported side effects he experienced she did not have a reaction, on 11Jun2021 around 13.00 she had sore arm. She was adds she do not want to crying, she got lab work reports got back today. And her doctor was told she may have blood cancer because blood cells are severely abnormal different sizes, shapes, colors and so many of them and he has not seen this in a very long time. She was also states he also said something about smudge cells. AE not resulted to ER visit and physician office visit. The outcome for the event was resolved on 11Jun2021.   Follow up attempts are needed. Further information has been requested.
Narrative: Patient developed diaphoresis, 4-5 seconds of loss of consciousness with pulse, was bradycardic, hypotensive, and a medical evaluation team was called. Patient was alert and oriented x 3, became normotensive, with normal  pulse, and did not require any medical treatment. Patient was stable and able leave  on their own.
Case number PHEH2015US020983, is an initial spontaneous report from a pharmacist received on 15 Oct 2015. This report refers to a 16 months old female patient. Medical history and concomitant medications were not reported. The pediatric patient was vaccinated with FLUCELVAX (batch number: 173991) 0.5 ml intramuscular in error. The case was assessed as non-serious. No adverse event was reported following this medication error.
Light headedness, dizziness, drowsiness. Tingling in fingers and toes on left/vaccinated side. All sxs lasted for about 1 hour.
Pt presented to clinic stating he lost his keys.  He proceeded to receive vaccination and was walked to observation area.  No notable events during 15 minute observation.  Approx 1.5 hours after observation pt was found in parking lot by sheriff trying to get into his car/calling his wife.  Pt was brought inside, B/P was around 130/50 HR initially around 110, Oxygen around 92%, states had light headedness after getting vaccine, states no trouble breathing and feels fine.  Was confused and unable to answer questions appropriately.  Skin was slightly pale and cold.  After approx an hour of observation oxygen dropped to high 80% and heart rate increased to 115+
Heart palpitations began roughly 24-48hrs after first vaccine. They were mild and unconcerning, but kind of annoying. Could feel heart racing, and could even feel onset of when heart was about to begin racing.  Symptoms worsened after second shot. Became more frequent and intense. On 4/27/21- that morning around 9am, symptoms began being very concerning. Heart was racing and really heavy beating. Became lightheaded at work, and finally sought medical attention. Resting walk heart rate at urgent care was 104+, and EKG was abnormal. Was sent to ER for further testing. Everything ?serious? (blood clot, etc) ruled out.
6 days after the second injection, suffered from severe vertigo, dizziness, nausea, headache and brain fog.  Was unable to focus.  Lasted 10 days.  Went to doctor twice and had MRI and MRA of brain, Carotid doppler scan, EKG.  Checked for Epley maneuver.  Fourteen days in and still off balance.  Things are coming into better focus.  Not as much brain fog.
HEART ATTACK; This spontaneous report received from a consumer via a company representative, concerned a female patient of unspecified age, race and ethnic origin. 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 administration was not reported, batch number: unknown and expiry: unknown) dose and therapy start date were not reported, 1 total, administered 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, in 2021 (11 hours post vaccination), the patient died due to heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was fatal. This report was serious (Death).; Sender's Comments: V0 20210538222-covid-19 vaccine ad26.cov2.s-Myocardial infarction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
PATIENT WAS ADMINISTERED 0.5 CC OF FLUZONE IN LA/IM DURING ROUTINE ASTHMA CHECK. PARENT NOTICED SEIZURE/FEVER AT 11PM THAT SAME DAY. PARENT PHONED PCP WHO ADVISED ER WHERE PT WAS STABILIZED. THE SEIZURE WAS A GENERALIZED TONIC-CLONIC VARIETY MOTHER STATES PT HAS ALLERGY TO CEFZIL, HAS NO PRIOR ADVERSE REACTIONS TO VACCINES, AND HAS H/O SEIZURES; THIS IS #4: PT FOLLOWED UP WITH PCP 11-7-07