chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low fever; chills; headache; week muscles; joint pain; sinus pain; feeling unwell; He has flu-like symptoms; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. The patient took Advil, Flonase and pseudoephedrine, this morning he woke up feeling much better and many of his symptoms resolved, however under his armpit he has a very pronounced and tender swollen area that was not there before, he assumes it is a lymph node. On Tuesday, he had a good number of the possible side effects. He was feverish, and had chills, pounding headache, sinus pain, painful joints and generally felt pretty bad. He took Sudafed last night, Flonase and Advil and woke up this morning feeling much better. He also noticed a really swollen area near armpit, which he assumes is a lymph node, and is very tender and swollen. He doesn't want to say it is a baseball size. It is not small either. It is unusual and was not there before. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. the outcome of events was unknown.  Information about lot/batch number has been requested.
8X6 inch area of warmth, erythema and enduration 48 hours post Anthrax immunization
weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.
NOTE: the second vaccine indicated  was a booster, administered on 11/05/2021  I tested positive for COVID-19 on 12/28/2021 after going to the doctor with stomach pains, body aches, fatigue, and a persistent cough. Symptoms started approximately 5 days before diagnosis and gradually got worse. My breathing only improved to pre COVID levels within the last 2 weeks.
The vaccine immediately gave me a lot of itching in the area. Later on it spread around the body and a rash formed 1/25/10.
No adverse effects were reported; A 25 year old female patient received one dose of PROQUAD; This spontaneous report had been received from a physician concerning a 25-year-old female patient. There was no information about the patient's medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  It was reported that on 02-JUL-2019, this 25-year-old patient was vaccinated with 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age) (strength, route of administration, lot number and expiration date unknown). No adverse effects were reported.
About 7 hours after injection, began to have serious chills. Lasted all night. At 9 am the following day the chills were gone but had a fever of 102.4. Took TYLENOL. Fever came down to about 100 and stayed there the rest of the day in spite of regular does of TYLENOL. No energy and no appetite. About 11 pm fever was 101.2. Took TYLENOL and went to bed. No chills. At 8 am today, no fever or chills. Feel normal.
3/19:  Onset:  Crippling sudden headache - inability to move head (neck stiffness) went to emergency room - Cat scan - everything looked normal given migraine medicine and sent home 3/22: back pain and leg spasms set in - continuous headache and tiredness 3/25: doctor visit and shot of torodol, which relieved pain slightly 3/27: back to ER for intense leg spasms, back pain and persistent headache given torodol and prednisone shots and pills to take home That treatment worked and leg spasms went away - tightness in back persisted a bit and headaches went away 3 weeks after onset 3/31: MRI - results were normal 4/28: Allergist - believes reaction not allergy but was some type of reaction  6/29:  Neurologist (took a long time to get in to see her) - wanted to have me checked for aneurysm by vascular doctor - she suspected aneurysm or aseptic meningitis 7/12: vascular appointment - ordered an MRA 7/19: MRA - results normal 8/5: follow-up visit with Neurologist - she has concluded based on everything that it was Aseptic Meningitis probably triggered by vaccine 8/16: scheduled visit with immunologist to figure out path forward - if I should have 2nd dose or another type of vaccine
The patient had high fevers after each dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "The patient had high fevers after each dose of the vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started having difficulty breathing, feeling pressure on her chest, and flushing a couple of minutes after getting the vaccine. Symptoms resolved after 10 mins. Patient was prescribed an Epipen by her prescriber to use in case of anaphylaxis. I made a caring call an hour after, she reports being fine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 12:00 as dose 5 (booster), single (Lot number: 021H22A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicill" (unspecified if ongoing), notes: known allergies: Penicill. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Pericarditis/Myocarditis; Patient presented with epigastric/RUQ abd pain that progressed to chest pain.
Patient got pregnant after first dose of the Moderna covid19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient got pregnant after first dose of the Moderna covid19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.  Patient wants to know if she should get the second dose, and mentioned that it has been past two and a half months from her first dose of the Moderna COVID-19 vaccine, and that when she got the first dose she was not pregnant. This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious special situation of maternal exposure during pregnancy. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the first dose and it is a special situation. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Maternal exposure was reported before pregnancy, exact temporal relationship is unknown, and more information is requested.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected non-serious special situation of maternal exposure during pregnancy. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the first dose and it is a special situation. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Maternal exposure was reported before pregnancy, exact temporal relationship is unknown, and more information is requested.
Pain in the upper left arm and shoulder area, moving toward the breast; unable to move arm properly and pain later on radiated to the neck area. No redness or swelling in the upper arm area.
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age. Nurse reported that the patient was administered the first two doses in RECOMBIVAX HB (strength, formulation, lot#, dose, route and duration were unspecified) series on unspecified dates as recommended in the prescribing information. Patient, who was "a two year old", was in the provider's office more than six months after the first dose in series was administered to receive the third dose of RECOMBIVAX HB (strength, formulation, lot#, dose, route and duration were unspecified) on 26-SEP-2013. No adverse events were reported. The outcome was unknown. Additional information has been requested.
Rash all over body. Worse in groin. Swelling at injection site about the size of a quarter. No swelling of lips or eye lids. No trouble breathing. Started 6 hours after inj. (approx 10:00pm) and lasted for 2 days. Mom gave Benadryl to child. A referral was made to an allergist for this child due to having the same reaction last year after flu vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) reporting unremitting dizziness after receiving vaccination sixteen days prior. Dizziness is worsened by rising and associated with disequilibrium and vision changes. Vital signs all within normal ranges. Patient denies respiratory, gastrointestinal, and dermatologic symptoms. Physical exam is normal. Patient monitored, symptoms improved with hydration and good oral intake, and patient discharged stable to home with follow-up in place.
Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st day.
Twenty minutes after injection of the second Moderna vaccine the patient lost vision in both of his eyes. and went to the ER for eval.  They told him to see an ophthalmologist after ruling out stroke etc. Patient saw an ophthalmologist and told to get CT scan after papilledema was diagnosed with vision of HM OD and 20/100 OS.  Sent to ER for CT scan which was negative and diagnosed with MS/ optic neuropahty and given IV steroids and oral steroids with improvment of vision.   Currently on PO steroids and vision is improving.  Seen by me last Friday with papilledema remaining in both eyes.
Injection site very swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site very swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No relevant concomitant medication was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site very swollen). At the time of the report, VACCINATION SITE SWELLING (Injection site very swollen) outcome was unknown.     Treatment medication was not provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash, redness and swelling at injection site. Diagnosed as cellulitis. Treated with antibiotics x 7 days.
Information has been received from a registered nurse concerning a male patient of unknown age with no drug allergies, new born torticollis, Ventricular septal defect (VSD) and plagiocephalies who on 19-NOV-2013, was vaccinated with a first dose of ROTATEQ, 2 ml, oral (lot # not provided) and on 27-JAN-2014 was vaccinated with a second dose of ROTATEQ, 2 ml, oral (Lot # J010139, exp date 19-MAR-2015). Concomitant therapies included vitamin D (unspecified). The registered nurse stated that patient developed an unspecified rash on his face immediately after receiving his second dose of ROTATEQ on 27-JAN-2014. The nurse also stated that patient was "screaming" while his second dose of ROTATEQ was being administered. The nurse described that patient was given BENADRYL in the physician office on 27-JAN-2014 for the unspecified rash on his face after and sent home; the outcome of unspecified rash on his face was unknown. The patient was seen by an allergist "recently" on an unspecified date. Additional information has been requested.
pt recv vax 19JUN96 & 6SEP96 a varicella titer was negative;lab eval in SEP96 & in 1JUL97 revealed that did not seroconvert;
Mar90 pt vax w/ hepta B. pt exp arthralgias in shoulders and spreading to elbows and wrists over next several wks; myalgia.  Over period of months arthralgia extended to knees and ankles. Sep90 pt exp palpitations.  See worm...
Patient with PMH of HTN, HLD, CAD post CABG, Lymphoma currently undergoing chemotherapy, DVT on chronic anticoagulation with Xarelto, type 2 diabetes, BPH and GERD presented to Hospital on 09/25/2021 c/o myalgias, malaise, congestion, productive cough and SOB.  He also reported blood in urine.  In ED patient oxygen saturation at 92% on RA, but dropped to 78% when ambulating.  He was also noted to be tachycardia.  Labs showed elevated d dimer, chest x-ray showed small right pleural effusion, EKG showed sinus tachycardia with ST-T wave abnormality, Chest CTA showed no evidence of pulmonary embolism, moderate volume right pleural effusion and patchy confluent groundglass areas of opacification in both lungs.  COVID -19 test was positive.  Patient received a dose Decadron and admitted for further management.   The patient completed Remdesivir, developed progressive oxygenation failure with ARDS and was transferred to ICU on 10/08/2021.  The patient was intubated for ARDS and managed with low tidal volume ventilation.  This was complicated by septic shock due to VAP with Klebsiella nd Pseudomonoas.  Family elected to transition to comfort care.  Patient expired on 10/20/2021.
I began feeling achy and getting chills at  5:30PM, about two hours after shot was given.  Gradually I started shaking until  I was violently trembling and felt dizzy, which lasted for several hours, until 8:30 PM.  I slept on and off through the night.  When I woke up the next day, I felt very weak, like I had the flu., which lasted through the day and into the next day.
flu like shymptoms; redness at injection site; swollen at injection site; feverish at injection site; tender at injection site; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: On 6th May 2019, the patient back into physician's office due to flu like shymptoms, Red, swollen, tender and feverish at injection site.
Shingles; Information has been received from a lawyer regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 30-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a medical center for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was considered as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine Live (ZOSTAVAX).
48 hours after vaccination of 1st dose (Phizer), I felt discomfort in my feet: numbness, tingling, pulling pains. Within 2 hours after the first symptoms, the pain in the left foot began to increase and became so severe that it was not possible to step on the left leg or make any movements with the foot. This state continued for a whole day (about 24 hours). After that, the sharp pain in left foot disappeared, but unpleasant sensations in the legs still remained - heaviness, tension, numbness, periodic pulling pain (not severe)
When asked how she did with her first dose, pt stated it did not go well. "About fourteen hours after the shot, I felt like I had a stroke." Pt described not feeling numb but felt as though her body was drooping bilaterally on the entire right side. Pt does not have PCP at this time and did not go get checked at ER. Stated she had tried to call with concerns but with no answer. Pt stated she went to a pharmacist and they had told her that she looked normal. Pt stated it happened, this feeling of unilateral drooping, when she was at the store. She stated that she then went home, ate, took Rx medicine, and went to bed. She said that she slept long, then awoke feeling fine.
Patient who presents to the emergency department via squad after having an allergic reaction to the Covid 19 vaccine she received. The vaccine was given just prior to the onset of her symptoms. Her symptoms consisted of swelling in her throat, diffuse redness of her face, chest, arms. She felt short of breath. No nausea vomiting or diarrhea. She states her legs did feel numb. She was given 0.3mg of epinephrine IM and 50mg of diphenhydramine IM. By the time she was transported here she felt significantly better. She felt like the swelling in her throat it resolved. The redness is almost completely resolved. This was her first vaccine dose. -MD ER note, 2/10/21
Pt seen in our office with 6-7 pustular round pruritic lesions on (L) abdomen
Urticaria within seconds of receiving Varivax and MMR. Twin with same vaccines, same reaction.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  This nurse reported similar events in two patients. This is the first of two reports.  A 17-year-old male patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the next day after the vaccination, the patient experienced vomiting. The clinical outcome of the event, vomiting, was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016424808 same reporter, drug, event in a different patient.
Patient was given 0.5ml instead of correct dose of 0.3ml.  No adverse event experienced.
Sore arm.  Mild nausea.  Tiredness.  All for 24 hours
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored ROTATEQ (lot M041181 expiry date 31-MAY-2018) (lot N004812 expiry date 04-OCT-2018) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 35 minutes. Previous temperature excursion was reported (0°C to 1°C for 2 hours and 6 minutes). The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link. Lot number N004812 has been verified to be a valid lot number for ROTATEQ. Sender's Comments: US-009507513-1708USA008410: US-009507513-1708USA008708: US-009507513-1708USA008708: US-009507513-1708USA008710.
Client requested Pfizer primary series dose #1 of 2. Client presented vaccination card reflecting previous vaccination with Aztra Zeneca on 04.04.21. Lead RN elevated issue to the person who approved client receiving Pfizer primary series, as Aztra Zeneca is not currently approved. RN administered dose in left arm, intramuscularly. Client waited in observation 15 minutes and left after, denying any side effects.