chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring.  I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest.  Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
Patient had side effects from her first dose in her right deltoid.; a lot of shortness of breath; really bad rash in the area where I got the vaccine; It's really swollen, tender; tender; painful when you press on it; itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Patient had side effects from her first dose in her right deltoid.), DYSPNOEA (a lot of shortness of breath), VACCINATION SITE RASH (really bad rash in the area where I got the vaccine), VACCINATION SITE SWELLING (It's really swollen, tender) and VACCINATION SITE PAIN (tender) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced DYSPNOEA (a lot of shortness of breath), VACCINATION SITE RASH (really bad rash in the area where I got the vaccine), VACCINATION SITE SWELLING (It's really swollen, tender), VACCINATION SITE PAIN (tender), VACCINATION SITE PAIN (painful when you press on it) and VACCINATION SITE PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had side effects from her first dose in her right deltoid.). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Patient had side effects from her first dose in her right deltoid.), DYSPNOEA (a lot of shortness of breath), VACCINATION SITE RASH (really bad rash in the area where I got the vaccine), VACCINATION SITE SWELLING (It's really swollen, tender), VACCINATION SITE PAIN (tender), VACCINATION SITE PAIN (painful when you press on it) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        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 Concomitant medications were provided by the reporter. Treatment medications includes Steroid cream , Hydrocortisone and Neosporin and antibiotics .
Breakthrough case admission after 2 vaccines Pfizer 5/21/21 LOt# Ew0177;  Pfizer 6/21/21 lot# Ew0191
Day of injection injection site was sore, but very minimal.  Exactly one week after injection, site is very red, slightly swollen, warm to touch , muscle is very hard and not pliable and very sore. On 02/04/21 at 8:00 am took 400 mg ibuprofen with minimal relief.  Took 800 mg ibuprofen at 7:00 pm  with relief from pain, but no change in urticaria symptoms.  On 02/05/21 involved area was 13 cm wide and 17 cm in length, very red, warm to the touch, muscle is still very hard and sore. Continued on ibuprofen regimen.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for tobacco use, aortic aneurysm, chronic obstructive lung disease, advanced age. Pt presented to ED on 5/21/21 with a chief complaint of generalized weakness and lost of appetite. Was found to have bacterial pneumonia without respiratory failure, suspected dehydration. On 5/23 patient was hypotensive, tachycardia, and in septic shock. Went bradycardic and asystole, when code blue called. The code was called off by family. Pt was defibrillated two times.
Child was given 0.2ml dose of undiluted Pfizer 5-12 year old vaccine. Parent was contacted 1/26/2022 and reported there had been no adverse reaction experienced up to that date/time of contact, sore arm only.
87 y/o female, BMI 29, PMHx of AFib, DM, HTN, hypothyroidism, and osteoporosis, admitted for generalized weakness on 9/2/21. Pt came from local nursing home from the covid unit, but pt was unaware that she had Covid19. Covid19 was treated with supportive care and Decadron, Lovenox, and aspirin. Pt was discharged back to nursing home on 9/3/21.
I was positive for COVID-19 on 31OCT2022, I had a fever, cough, runny nose and was very tired. I also, had a bad headache and super fatigued. I didn't seek treatment at that time, but some of the symptoms never went away so I sought treatment last week. My doctor wanted to test me for other things and all the tests were negative.
Pt was vaccinated at 2:56p,. At 3:06pm, A&Ox3, heart sounds clear, apical pulse is 88, lung sounds clear, no acute respiratory distress.  pt stated "pain in left deltoid and said that he couldn't move left arm.  BP 131/78, HR-88, R-18, O2 stat-99%. on RA.  Pt was asked to raise arm up, but left arm was raised but drooping. Pt was asked to smile, both sides equal and bilateral.  Pt was asked to repeat sentence, pt responded with slurred speech.  Pt was asked to grip both hands, left side weakness.  Radial pulse strong intact. EMS was called and activated. Pt was taken to hospital via EMS at 3:30pm for further assessment.  BP 117/74, P-86, R-18, O2 stat-96% on RA. All care transferred to EMS.
By the afternoon of receiving the vaccine - the patient - started feeling aches to Rt. arm - reddened area appeared around injection site - patient started having fever 101 degrees - 102 degrees by the night of vaccine rec'd.
Discharge Provider: MD Primary Care Provider:  MD Admission Date: 11/17/2022 Discharge Date: Nov 23, 2022 COVID Date 11/17/2022 PRESENTING PROBLEM: Generalized weakness Febrile illness, acute  Closed head injury, initial encounter  COVID  COVID-19 with multiple comorbidities Hypotension    HOSPITAL COURSE: 79 year old with a past medical history of Addison's disease, Adenocarcinoma of Lung stage I, Afib s/p ablation (2016); DM type II, HTN, Right renal artery aneurysm, Celiac disease who presented with a two day history of cough, worsening fatigue and syncope on 11/17 to ED. In ED, CT Head negative for acute abnormality.  Covid PCR (+). He was noted to be hypotensive that initially responded well to fluid resuscitation. He was started on stress dose hydrocortisone IV and home dose Florinef for his addision's due to concern for crisis. ICU was consulted due to persistent hypotension. Art line was placed and patient was started on Norepinephrine. BP improved overnight and NE was weaned the next day. Endocrinology was consulted.  His hydrocortisone was tapered.  He is continued on Florinef 0.5 mg daily.  He was started on remdesivir IV for COVID with chest x-ray showing right lower lobe opacity but he is not hypoxic and has no shortness of breath.  Patient was not aware about the need for stress dose hydrocortisone when he gets ill.  Patient was educated to redouble his hydrocortisone dose during illness.  Patient was also prescribed hydrocortisone 100 mg IM that he can use or family can administer if the patient is unable to tolerate oral intake or is confused/unconscious, respectively. Patient completed hydrocortisone taper and placed back on his home hydrocortisone and florinef dosing. PT evaluated and recommended acute rehab.  The patient demonstrated progressive improvement in his overall functioning and it was determined that he no longer would be appropriate for acute rehab.  As such the patient was discharged back to his home with arrangements for home health care
W/ 1st dose broke out in hives, w/2nd dose lips swelled as well as mouth.
Fever, chills, leg soreness, nausea, back pain, stomach pain, dishoriented.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose number unknown, single (Lot number: GH9464) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 19Sep2023, Stop date: 23Sep2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312770 same reporter/patient, different drug/event;
Day after injection I developed 99.9 elevated temp, headache, nausea, chills, and aches.  That mostly disapated after about fours hours sleep that evening.  The headache lasted most the following week, but was tolerable and minor.  I noticed near end of the week following injection that my injection site began to swell a little and turn red, very similar to a white head.  This has continued to be present now still two weeks following.
Information has been received from a medical assistant and a physician concerning a 12-month-old patient with a history of otitis media who on 19-JUL-2006 was vaccinated with a dose of Varivax. Subsequently, the following evening, the patient experienced increased temperatures. Fevers went as high as 104.3 degrees Fahrenheit and intermittent for approximately 2 and a half weeks (it was also noted that the patient's fever was 103.6 degrees Fahrenheit and "had not gone away"). The patient was also intermittently irritability. The patient's irritability was noted to have decreased. The patient appeared well between episodes. The patient had a runny nose during the course of the fever, and has been constipated. There was no evidence of rash or other symptoms. As of 01-AUG-2006 in the evening, the patient "felt hot", was shaking, and the lips were "blue". No respiratory distress or cough was noted. The patient was subsequently sleeping and appeared "totally fine". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
I have an area of residual paresthesia on my back; Since the day after the shot that area was constantly irritated; But it burns and was constantly aware of it.; Since the day after the shot that rash area was constantly irritated, just occasionally itches; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 17:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included sudden cardiac death, thyroid cancer, small rash on my chest, a burning sensation that wrapped around to a spot on my back several years ago and repaired cardiac valves. The patient had known allergies to promethazine. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID 175), liothyronine sodium (LIOTHYRONINE) and cetirizine hydrochloride (CETIRIZ); all from unknown dates, for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 12Mar2021 at 18:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, the patient experienced an area of residual paresthesia on her back, from an episode of what she thought was shingles. The patient had a small rash on her chest with a burning sensation that wrapped around to a spot on the back several years ago. Since the day after the shot that area was constantly irritated, unlike most of the time she didn't even remember it and it just occasionally itched. But it burned and the patient was constantly aware of it. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events I have an area of residual paresthesia on my back, the day after the shot that rash area was constantly irritated, but it burned and the patient was constantly aware of it and occasionally itched was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Extreme pain between wrist and elbow in inoculation arm on use of the limb; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number and expiration date not provided), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination or any medications in two weeks. On 05Mar2021, the patient experienced extreme pain between wrist and elbow in inoculation arm on use of the limb. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: patient age group was adult.
vaccine expired on 3/23/2022- no adverse effect noted, mom has no further questions
Had the Moderna vaccine on 8 February,  next day arm itchy and red circle.  Still red on Thursday 11th February  when I woke and had a terrible headache and aching neck, felt tired and had a sniffy nose, had  rough day. Friday 12th February arm not so itchy and red.  Saturday 13 February arm ok.  Then 5 days later 18 February same are of vaccine site started itching again and by Friday  morning arm itchy and very red again, and this lasted until Monday 22 February.  By Wednesday 24th it was more or less ok. Still a bit red.  So I had 2 reactions 5 days apart that each lasted 5 days.
On 3/1/2021 patient came to hospital as an outpatient for labs and CT chest after being seen in local clinic with dyspnea.  Pt had received first Moderna vaccine 1/14/2021 Lot # 141L20A and second Moderna vaccine 2/11/2021 Lot # 010M20A
Information has been received from a license practical nurse concerning a 50-year-old white adult female with an allergy to codeine who on 21-NOV-2005 at 9:30 am was vaccinated subcutaneous with a 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine (Lot#649694/0386P).  The patient was noted to be suffering from anxiety and depression at the time of vaccination.  On 21-NOV-2005, the patient developed an injection site reaction to include redness, pain, local heat and swelling, noted to be a cellulitis.  The patient was treated with antibiotics and subsequently, fully recovered.  No product quality complaint was involved.  No additional information is expected.
Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender. Slight fatigue
Miscarriage; Vaccine exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via company [reference number: SEQ19-05598] on 25-Oct-2019, concerning an adult, pregnant female patient.   The patient's medical history and concomitant medications were not reported.   The patient's last menstrual period (LMP) date, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were not reported. The patient's obstetrical history was not reported.   On an unknown date in 2009, the patient was administered unspecified flu vaccine [influenza vaccine; dose, route of administration, anatomical location, batch number and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza prophylaxis.   On an unknown date in 2009, one week after vaccination, the patient experienced miscarriage.   The case was assessed as serious.  The reporter stated that she does not feel the vaccine was related to the miscarriage.  This case is linked to case 201905503 (same reporter and same patient).  Company Comment: The patient experienced abortion spontaneous one week after vaccination with the suspect product unspecified flu vaccine. Reportedly, vaccination occurred during pregnancy at unknown gestational age. Chronology is plausible. More information is needed regarding medical history, diagnostic findings and concomitant medications to exclude potential confounders. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Reporter's Comments: The reporter stated that she does not feel the vaccine was related to the miscarriage.; Sender's Comments: The patient experienced abortion spontaneous one week after vaccination with the suspect product unspecified flu vaccine. Reportedly, vaccination occurred during pregnancy at unknown gestational age. Chronology is plausible. More information is needed regarding medical history, diagnostic findings and concomitant medications to exclude potential confounders. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported at the time of the vaccination and no adverse reaction reported since vaccine given.
The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial; Product concentrate not diluted; pain at the inoculation site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial"; PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "Product concentrate not diluted"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the inoculation site". The events "the nurse administering the vaccine on sunday mistakenly injected all of the liquid from an undiluted vial", "product concentrate not diluted" and "pain at the inoculation site" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A Distracted nurse gave the patient 6 doses of COVID vaccine in one shot. The patient was mistakenly given six doses of the Pfizer coronavirus vaccine all at once. The patient was released from a hospital on Monday without having suffered any apparent adverse reactions. On Sunday morning the patient was kept under observation for approximately 24 hours in the hospital's emergency room. She was given fluids, and anti-inflammatory and fever medications as preventative measures. The patient did not have fever and did not have any pain except for pain at the inoculation site, nor any other manifestations, was a bit frightened. She underwent blood tests regularly to monitor her immune response and determine whether she should still get the scheduled second dose after a number of weeks. The accident occurred because the nurse had an attention lapse. The nurse administering the vaccine on Sunday mistakenly injected all of the liquid from an undiluted vial. She thought that the dilution had taken place, they were both transparent liquids of the same density. Unfortunately, this contributed to the error. The incident occurred on an extremely busy day, during a period in which health workers were trying to administer as many vaccine doses as possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.