chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) (seriousness criterion medically significant). At the time of the report, COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test Positive.         No concomitant medication was mentioned.  Patient found out that she had Covid-19 when she got the 2nd shot. She had been going back and forth to the Doctor just before she got the shot. She had been having trouble taking deep breaths.  No treatment medication was mentioned.  Company Comment: This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 . The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-340415 (Patient Link).
swollen; rash; swollen lymph node under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to oats) and Drug allergy (Allergic to methanic acid).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit). At the time of the report, PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that 1 Week later after receiving vaccine that she had swollen lymph node under armpit and a rash. Arm was swollen too. Went away but came back worse last night. Treatment medication: calamine lotion.    Reporter did not allow further contact
10/30 (~30 hrs post vax, overnight): Extreme nausea, accelerated heart rate of 131 bpm, faintness, hot flashes, headache. I slept sitting up in a recliner, and took IBP, and Zyrtec, knowing history of allergies with similar reactions in the past. Drank Ginger ale. 10/31, afternoon: Still nauseous. HR normal. Throat and roof of mouth reacted to a few bites of food (banana, Everything bagel) by flaring up in extreme burning pain and swelling. I didn't eat all day.  Was able to tolerate mint tea. 10/31, early evening: Throat reacted to lettuce, beans, corn, and tomatoes with extreme burning pain and swelling again. 10/31, late evening: able to eat lettuce without a reaction. Added ranch dressing with no problem. Nov. 1: Diarrhea. Throat again reacted with burning pain and swelling to whole-grain toast with butter. Tried coffee; esophagus spasmed.
A 9 month old male received Prevnar and HEP-B vaccines on 8/21/00 and subsequently, developed redness and swelling at the site of Prevnar administration. The physician recommended treatment of acetaminophen and applications of cold compresses. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
sxs onset 9/10 including fever, SOB, cough. admitted to hospital for 9/10 thru 9/11 for COVID symptoms.
The patient presented to the emergency department with chest pain. Admitted the hospital and diagnosed with myopericarditis.
Patient has an IUD and has not had menses "for months." 7 days after the first dose of the COVID (Pfizer) vaccine, the patient had a heavy menses with nausea (described as feeling like morning sickness). 5 days after the second COIVD (Pfizer) vaccine, the patient had heavy menses with clots the size of small peas.
Patient felt tired and weak after vaccine. He also fell down 3 times due to reaction and got CT scan. Everything ok now.
Intermittent hives.  Rash lasts about an hour then resolves and appears on another part of the body.  No medications given at home. When evaluated, recommended cetirizine (non-sedating antihistamine) for symptomatic relief.  Also had transient low grade fever on the night of vaccination (8/10/2010) which did not recur.
some left arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine in her left arm and she did have some left arm soreness which resolved. The reporter did not consent to follow up. For tolerance of 2nd dose of Shingrix, refer case US2020AMR221220.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221220:same patient
Provider ordered the routine 15 month vaccines, DTaP, MMR, and varicella and patient got a DTaP, MMR, and Proquad (MMRV) in error which means he got twice the dose of MMR that is normally given.  Clinical Lead has reached out to Mom (see phone note) and certified letter mailed and receipt returned.  Parent has not called office back.  Patient may have an increased chance of the measles-like rash that can be seen in 10% of children when given their MMR. He can still get a booster after he turns 4 years of age.
My injected arm was a little bit red (about a size of a penny), I had a fever up to 101, chills, nausea, lost of appetite, fatigue and body aches all over and a severe headache. I went to our Clinic for consultation and he sent me home from work and was advised to take Tylenol. When I went home I took Tylenol (every 6 hours) and had a bed rest for the rest of the night and I felt better the next day. As of today I have a little bit of cough, sore throat and headache but all tolerable.
On approximately April 20, 2021 I began to have spotting. The bleeding increased to mucous blood clots. This has been ongoing for approximately six weeks. I have not had a period since I was 15 years old, so 17 years ago. Since this has happened, to other people I?ve encountered know someone who is having the same symptoms since their second dose of the vaccine.
Initial and follow-up information has been received from a medical assistant concerning a 12 year old female with attention deficit/hyperactivity disorder who on 23-APR-2007, 26-JUN-2007 and 25-OCT-2007 was vaccinated with a first, second and third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 07-AUG-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot number 0152X) intramuscularly in the right arm and a dose of hepatitis A virus vaccine inactivated (HAVRIX) (lot number AHAVB0233A2) intramuscularly in the left arm. No adverse event was reported. It was unspecified if the patient sought any medical attention. Additional information is not expected.
I had a strange light headed feeling shortly after and the shot was given too high which caused severe pain in my joint to where I couldn?t move my arm. My arm is still painful. I had localized edema. On Saturday, I had a bad headache and fever and joint pain. I?m still not feeling the best and I wanted you to be aware of the reaction.
Information has been received from a RN concerning a 12 month old male who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) [lot #658839/1411U] subcutaneously instead of VARIVAX (Oka/Merck). No problems were reported. The R.N. indicated that the ZOSTAVAX (Oka/Merck) vial was in a VARIVAX (Oka/Merck) box, which led to the mix-up. She could not confirm if
This spontaneous report as received from a pharmacist refers to a female patient "in their 50's" years of age. About 2 weekends ago, approximately on 09-NOV-2013 the patient was vaccinated with one dose of ZOSTAVAX. It was reported that the patient received ZOSTAVAX and then developed an injection site reaction which consisted of redness and swelling in November 2013. The outcome of the events was reported as recovering/resolving. The patient sought medical attention by speaking to the pharmacist by phone. Additional information has been requested.
itching on one side; This is a spontaneous report from a contactable consumer or other non hcp. This Consumer reported for 4 patients. This report is for 2nd of 4 patients. This consumer reported for a female patient.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date, the caller is calling about the covid Pfizer vaccine. The caller mentioned that her primary care provider had an itch on one side but the caller has it on both after receiving the Pfizer Covid vaccine. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Soapy taste, tingling in the left arm, tingling in the mouth.  Red face, throat swollen.   1 Epi dose given, NRB applied with O2.
Two months after I received the vaccine, I checked my blood I noticed it was higher that it was higher. It was subtle, I did not have a headache, flushing, heart palpitations. I made an appointment to see my doctor we discussed the change in my blood pressure increased the dosage of my current medication. It has been six months and the change in medication has not made a difference in my blood pressure. I will be going back to see my doctor next week to see if my blood pressure has come down.
Patient states that the next morning she at the injection was redness and swelling and it was tender. There wasn't a change the next day but come Saturday at the swelling worsened and was easily visible and tender. Patient states that most of the symptoms have subsided as of this morning and it is no longer tender to touch and but it feels like a small ball at the injection with no pain.
Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x  5 days, Augmentin 875mg 1 tab po bid x 10 days.
flu-like symptoms; headache; aches, pain; fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, pain and fever. In February 2021, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the headache, pain and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, pain and fever to be related to Shingrix.  Additional details were provided as follows: Reporter was spouse of patient. The patient received the Shingrix on right arm and experienced flu-like symptoms, headache, aches, pain and fever. The reporter did not consent to follow up. This case was linked with US2021034621 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034621:same reporter
First ever anaphylaxis experience started in the middle of a run. Ended up taking ambulance to hospital where I got an epi shot.
Arm suddenly became very bulbous, swollen and tender at injection site one week after shot. Lasted about 24 hrs.
5 days after taking the injection I experienced ringing in both of my ears (tinnitus) along with fullness.  The doctor removed ear wax from my ear but it did not alleviate the problem.
Extreme cold and shivering. Acute stomach pain. Slight headache.  Legs pain. Members numbness. Fever . Symptoms lasted at least 24 hrs while others are still present.  No reputable , competent clinics in the vicinity of my present location to follow up with evaluation and possible treatment.
inc fever x 8 days beginning day p/shot 29JUN95 reaching 103; in addition to fever also had headaches some diarrhea & myalgia; fever fairly well controlled w/APAP;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ oral liquid, lot# K009753 with expiration date 28-APR-2016 and lot# K001196 with expiration date 22-OCT-2015, orally (dose was not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Had very bad lymph swelling after the initial dose on day 10. Breast pain and lumps under left arm, vaccine side, running down into my ribs and up into my neck. Random migratory pain in joints along with Muscle twitching, headache over right eye, almost felt like a shingles attack. Increased heart rate, fatigue, anxiety, insomnia. Did not seek medical care as was told that those were normal reactions. Symptoms settled day before second shot on March 23. Felt okay for a week then they started back up again but even more pronounced. Have had armpit, breast, back, rib pain that feel like burning and electrical currents, heart palpitations. Random muscle twitching. Joints have been aching and cracking. Had blood work done for lymes disease in April. Negative.  In May saw an obgyn who deemed it vaccine related but could offer no treatment after testing negative to RA, Lupus, Lymes.  June 14th presented to urgent care as rib and back pain had intensified. They ran an ecg. Ecg was abnormal and was transferred to ER. June 15 Went to hospital where ekg was again abnormal, lengthened qt and st segments which indicate STEMI but clinically I didn?t present any symptoms. Was referred to cardiologist for heart issues. Still suffering back, rib, underarm pain and breast swelling with sensitivity along with random muscle twitching in various areas multiple times a day. Doctors cannot figure out what is cause and say vaccine related.
itching all over my body started about 4.5 hours (7:30 pm) after initial shot - Took 50 mg of Benadryl at 11:30 pm on March 19, 2021. Left arm feels heavy and left side of neck pain.
Experiencing redness and rash, bilaterally on facial cheeks (bucca). No SOB at time of reporting.
Pt vaccinated with DPT experienced excessively fussy, long periods of crying & irritability for over 24 hrs. Unusal high pitched cry.  Better by 48 hrs.
Muscular ache in left side of neck, sore throat, hoarseness, cough, vomiting.
Pt recvd vax & exp an unspecified reaction following vax w/Hep B vax; No further details were provided;
One of five pts who was immunized w/DTP/OPV/HIB & exp swelling & redness @ DTP inject site & extreme irritability;
No additional AE; Patient was administered the pediatric dose of VAQTA instead of the adult dose.; Dose: 25 units/0.5 mL; This spontaneous report as received from a licensed practical nurse refers to a 33-year-old patient of unknown gender.  Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-AUG-2022, the patient was vaccinated with the pediatric dose (25 units/0.5 mL) of hepatitis a vaccine, inactivated (VAQTA) (lot number: U024504, expiration date: 15-OCT-2022; route of administration not provided) instead of the adult dose (product administered to patient of inappropriate age, incorrect dosage administered). No adverse event was reported.
Hospitalization 8/5/21 on dexamethasone 6 gm IV daily for 10 days and Remdesivir for 5 days; expired 8/17/21
Pentacel vaccine on 22Oct2019 that was not reconstituted with the Hib portion; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Child patient who received who received DTAP-IPV portion HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only and Hib portion was not administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number was not reported.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested
NIGHT SWEATING; MIGRAINE; BONES HURT LIKE A HORRIBLE FLU; SKIN HURT LIKE A  HORRIBLE FLU; FEVER; This spontaneous report received from a patient concerned a female 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: Unk) 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 night sweating, migraine, bones hurt like a horrible flu, skin hurt like a horrible flu, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night sweating, fever, migraine, bones hurt like a horrible flu and skin hurt like a horrible flu was not reported. This report was non-serious.
They thought she might have had a laryngospasm and her daughter was having gastric upset; They thought she might have had a laryngospasm and her daughter was having gastric upset; near SIDS event; inflammation in her throat; GI pain; screaming; Mother sensed daughter wasn't breathing; Mother received Pfizer COVID-19 Vaccine while breastfeeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 day-old female patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 28May2021 (Lot number: EW0191, Expiration Date: 30Sep2021) as dose 1, single and transmammary, administration date 18Jun2021 (Lot number: EW0191) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (hospitalization) with onset Jul2021, outcome "unknown", described as "near SIDS event"; LARYNGOSPASM (hospitalization), ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown" and all described as "They thought she might have had a laryngospasm and her daughter was having gastric upset"; EXPOSURE VIA BREAST MILK (non-serious) with onset 28May2021, outcome "unknown", described as "Mother received Pfizer COVID-19 Vaccine while breastfeeding."; PHARYNGEAL INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in her throat"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI pain"; SCREAMING (non-serious), outcome "unknown", described as "screaming"; DYSPNOEA (non-serious), outcome "unknown", described as "Mother sensed daughter wasn't breathing". The patient was hospitalized for brief resolved unexplained event (start date: 13Jul2021, discharge date: Jul2021, hospitalization duration: 3 day(s)); for laryngospasm, abdominal discomfort (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: she had blood work and monitoring; echocardiogram: unknown results; ultrasound scan: unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200269007 maternal, infant cases
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 55-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Concomitant products included Atorvastatin and hydrochlorothiazide. On 10th June 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, feelings of weakness, tiredness and chills were not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, feelings of weakness, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. At the time of the injection (immediately), the patient commented that the injection itself was painful. The patient returned to the pharmacy on the date of reporting, and was feeling under the weather with complaints of being tired, having chills and feeling limp like a noodle (feelings of weakness). There was a large rash that was very red at the injection site. It was about 3 inches long and 2.5 inches wide and was painful to the touch. The patient stated that, it felt like a burn.
Patient received dose of Moderna when he should have received dose of Pfizer.  Patient was monitored and consulted by infectious disease physician.  No adverse symptoms or outcomes.
red rash on face that is tingly, scally, darker red rash on left side of neck that hurts when touched (but getting better at times)   puffy eyes.   all in all very uncomfortable
Body aches, headache, nausea, vomiting, fatiqued, sore throat