chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
PATIENT PRESENTS WITH RASH TO LEFT THIGH.  PATIENT STATES AREA SORE.  VISUALLY SWOLLEN AND VERY RED.
Severe shoulder, neck, back, and spinal pain. Day 13 pain in neck and shoulder continues, and swelling of upper arm with idd numbing sensation.
NOT TECHNICALLY CLASSIFIED AS ADVERSE EVENT , and may be considered " common side effects" but had a severe reaction to the vaccine with fever, chills, muscle and joint aches, headache, nausea, fatigue, soreness in arm at site of injection  starting approx 14 hours after injection and lasting 48 hours, with lesser effects lasting another 24 hours, and  am still not feeling fully recovered as of 1/11/21 12:11pm. Temperature highs ranged from 100.8-101.4, and I felt as badly as when I had COVID-19 in March 2020. I was unable to go to work as scheduled on Friday 1/8 and Saturday 1/9. I am concerned about getting the 2ND DOSE as it has been stated that 2nd dose may create more severe symptoms than the first. PLEASE ADVISE. Also, is there a correlation between having had COVID-19 and having strong "side effects" to the vaccine? Please advise. Thank you!
On 11/21 Developed nausea and vomiting. Vomited multiple times over course of 12 hours. Reported hip pain and right knee pain. On day of vaccination reported "his body felt weird". Described cold pain running down his arm.  Day 2 he had arm pain and felt fatigued.
Initial unsolicited report received from a consumer on 12 March 2015. A 81-year-old male patient had received first dose of FLUZONE HD (batch number was unknown and expiry date, dose and site of administration were not reported) via intramuscular route on 15-October-2014. The patient had no other vaccinations within 4 weeks of vaccination. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included Iodine and Cardiac stents. On 16-October-2014 (morning) one day after vaccination, the patient experienced arthritis and all over joint pain. The patient reported that the joint pain has persisted since then he has seem many doctors including an Orthopedic surgeon who can't find anything wrong. The patient required ER/doctor visit. Laboratory investigation included bila shoulder x-ray. Corrective treatment includes TYLENOL. At the time of report, the outcome of event was not recovered. Documents held by sender: none.
Dose 1 on 08Mar2021 and dose 2 on 20Mar2021; Feeling nauseous; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: Er8732) via an unspecified route of administration in the arm left on 20Mar2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included iodine allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and oxcarbazepine (MANUFACTURER UNKNOWN), both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: En6199) via an unspecified route of administration in the arm left on 08Mar2021(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 the patient experienced feeling nauseous ever since she took second dose and It comes every few days. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event feeling nauseous was not recovered.   No follow-up attempts are needed. No further information is expected.
Vaccine was accidentally administered incorrectly, subcutaneously rather than intramuscularly. Resulted in immediate stinging pain, burning pain, 5 inch diameter rash at injection site, bruise-like feeling, hot and tender to the touch. Itchiness increased on day two. Bruise-like pain continued for three days. Redness and swelling dissipated after three days, although still visible where injection was located. MD recommended ice and ibuprofen for swelling. This patient declined- pain and swelling tolerable to not warrant ice or ibuprofen in this writer/patient's opinion. MD stated at maximal healing on 11/05/2015.
right arm was a little sore the next day; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacist refers to a adult (age not specified) patient of unknown gender. The reporter stated that on 28-FEB-2014 the patient inadvertently received a pediatric dose of RECOMBIVAX (0.5 ml, intramuscular, site of administration not reported). No adverse effects reported. Additional information has been requested.
Facial Numbing from left ear, through cheek area and into lower left jaw. Very similar numbness to having gone to the dentist and getting a Novocain shot. The numbness lasted for 4-5 months before going away without further incident.
I received my first Moderna shot on March 22 and my second on April 19. I had very bad side effects both times, though the second was worse with chills, dizziness, some light fever, body aches, sweating. This lasted up to two weeks after my second dose. I hardly ever take sick time off, but I had to leave work several times due to vaccine symptoms showing up.  A month later, around May 15th, I started to feel a waxy feeling on the roof of my mouth and I had noticed even before this that I couldn't whistle like I normally can. By May 23, I went to the ER for facial paralysis on my right side. I was diagnosed with Bell's palsy. At this moment it's just my face, no other body parts.
she felt crappy for a full 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt bad for a full 24 hours) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (About 9 months ago). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (she felt bad for a full 24 hours). At the time of the report, MALAISE (she felt bad for a full 24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take Vyvanse during the shot.  Treatment information was not provided.   This case was linked to MOD-2021-331669 (Patient Link).
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 15-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
evening of 3OCT98 noticed area of redness morning of 4OCT98 woke up & redness inc, area warm to touch, & arm achy, indurated;presented to hlth center 5OCT98, area of redness 4 x 3/2, redness raised, area;warm to touch;itchy;dec achiness;
Pt had J&J vaccine 1 week ago and developed spontaneous afib with RVR rates to 150, difficult to rate control, admitted to hospital for conversion. Reports se felt myalgias, rhinorrhea, headache, and fatigue for several days. Today she is extremely tired.
Patient's statement: "Within 30 minutes I began having pain in my left upper arm and essentially have not been pain free since. I have had blood work, an ultrasound, X-Rays, prednisone, and am currently in physical therapy for residual pain and limited ranged of motion. I appear to have a textbook case of SIRVA - Shoulder Injury Related to Vaccine Administration."
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium
within 15 minutes of vaccine reaction patient began to have itchy face and chest, throat itching. Went to ED, treated epipen and steroids.
Received vaccine on 08/27/2020 and kept bandaid on for 4-5 days afterwards as patient would not allow parent to take off bandaid due to it being painful. Once bandaid was removed on or about 09/01/2020, parent noticed red raised bump about 10mm x 10mm in size. Following morning when parent went to check on arm, patient's shirt was stuck to area and when removed, area opened and began bleeding. Parent is going to keep area clean, apply antibiotic ointment and keep bandaged.
This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is 3th of 4 reports. A patient of unknown age and gender received PREVNAR13 Lot number J80525, Exp date: APR2016, NDC number: 0005-1971-02), single dose, intramuscular on unknown date. On unknown date the patient's injection site was red, hot and swollen, experienced fever and injection site pain. The outcome of events was unknown. Follow-up (03MAR2015): This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA001261:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA00126.
Patient received second dose on day 22. I spoke to patient at 2:40 on 6/4 and she is reporting sciatica, headache and has been sleeping all day. She said she had COVID and was in the hospital for 11 days and her symptoms started with sciatica.
-About 3 minutes after receiving the shot mouth and throat felt itchy.  The itchiness lasted until the following day. -Later that day in the afternoon around 3pm I had heavy breakthrough bleeding like I got my period which lasted for several days.  I finished my birth control pill pack the following weekend and got my normal period.   - In the afternoon of the 7th day after the shot my mouth was itchy again.  Later that night my arm was sore, hot to the touch and had a rash.  The next day the rash had spread down my arm.  My throat, tongue and eyes were itchy.  I called my PCP and spoke to a friend is an a doctor.  I took Advil and Benadryl which helped.  The rash and itchiness persisted from Mon - Thurs.   - 15 days after the shot I got a bloody nose that lasted for about 45 minutes.  I have not had a bloody nose since I was a child so thought this was worth mentioning.   - Around the same time I had headaches in the back of my head that felt like burning.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therpay with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports received from the same source. Additional information has been requested.
Severe vertigo; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 28Feb2021 at 08:00, two weeks after the first vaccination, the patient experienced severe vertigo requiring an emergency room (ER) visit. It went away after 4 days. Therapeutic measures were taken as a result of severe vertigo included anti-inflammatory steroid. Clinical outcome of the event severe vertigo was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285977 same reporter/ patient, different drug dose/ AE.
On 2/15/06 patient developed low grade fever and vomited X1.  On 2/16/06 no fever, had clonic-tonic, generalized seizure that lasted 3 minutes.  Paramedics found him post-ictal, afebrile; brought to ER where he had 2 more seizures, lasting 2 minutes.  Treated with Ativan & admitted to Ped Floor, where he was very agitated and had another seizure.  Treated with phenobarbital20 mg/kg & complete sepsis workup done.  Treated with Rocephin after spinal tap.  No more seizures and remained afebrile.  Patient returned to baseline, was playful, alert, feeding well & in no distress.  Remains on Phenobarbital and referred to Pediatric Neurologist and follow-up with pediatrician.  Discharged from hospital in stable condition.
stated she sometimes faints, and then proceeded to faint. Contacted EMTs from observation who lowered her to the ground safely where she regained consciousness. Observed in room for 15 minutes. Was able to get up and move without assistance. Went with EMT to observation area without any assistance.  Pt HR 72. Lying on floor up to 1 minute. No falls. Lying on floor up to 1 minute. Vasovagal response consistent with previous reactions post-vaccination. Currently seen sitting upright in chair A/Ox4, denies any discomfort, denied offer for fluids or food. Smiling.   Treated by paramedic and RN.
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 74 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Feb2021 at 10:00 as dose 1, single (Lot number: 004M20A), in left arm, on 06Mar2021 at 10:00 as dose 2, single (Lot number: 013A21A), in left arm, on 26Oct2021 at 17:00 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 21Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 16Jan2017; HCTZ, start date: 16Jan2017; ATENOLOL, start date: 16Jan2017; TERAZOSIN, start date: 13May2020; GABAPENTIN, start date: 12May2022, stop date: 12May2022; JARDIANCE, start date: 12May2022, stop date: 12May2022; AMITRIPTYLINE, start date: 04Jan2010; TURMERIC [CURCUMA LONGA RHIZOME], start date: 16Jan2017; CINNAMON, start date: 12May2022. Past drug history included: Norvasc, reaction(s): "drug allergy"; Clonidine patch, reaction(s): "drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown"; COVID-19 (medically significant) with onset 16Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 16Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Mar2023) Positive; (26Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse Event: Covid symptoms 14Mar2023, tested positive 16Mar2023, Paxlovid 150-100 16Mar2023 -20Mar2023. Felt good, no symptoms 19Mar2023. On 24Mar2023, had Covid symptoms again; runny nose, sneezing, congested, tested positive 26Mar2023. Covid rebound symptoms not as severe as original Covid, also no fever and fatigue with rebound.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130848 same patient different drug /event;
68 years old male with past medical history of cad s/p stents 10 years ago on aspirin and xaralto ,came today becuase of syncope,pt woke up around 2 am in morning and went to bathroom when he came back he was sweating and fell and hit the wall associated with sweating then he went to the bathroom to wash his face then he fell again but dosnt remember he hits his head then his wife called 911,PT didnt have any previouse episode,no seziure like activity or history of it,no chest pain mor palpitation ,pt denied feeling it coming,no nausea or vomiting.
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 4/09/21. Covid-19 + 1/18/22, prior admission for Covid-19 PNA 1/18-1/25/22. Presented to ED 1/31 c/o SOB. Admitted for acute respiratory failure 2/2 Covid-19 PNA/possible bacterial PNA and right sided pleural effusion. Underwent thoracentesis w/1500 mL of transudative fluid removed. She was d/c'd on 2L of O2. Hypoxia continued to worsen, intubated 2/5/22. Per pt. request terminally extubated while on sedation vacation. Transitioned to comfort care. Treated with Decadron. Expired on 2/09/2022