chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given in left arm. Started to immediately get itchy and red at site of injection. Progressed to rt. arm and back of neck. Became dizzy. No acute distress. Resolved in one hour.
vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reports no adverse reactions.
No adverse event; Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Dry eyes (Just dry eyes for which I take Xiidra). Concomitant products included LIFITEGRAST (XIIDRA) for Dry eyes, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 21-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 21-JAN-2021 and Dose 2 was administered on  26-FEB-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Patient had third dose of Moderna on left arm (Lot number 011F21A)  on 29 Oct 2021. Patient had fourth dose of Pfizer on left arm (Lot FM7553) on 16 Jun 2022. On 12 Oct 2022, patient had started sneezing a lot, itchy nose, slight runny nose, body aches and had no fever and symptoms very mild and were recovering. That was first day after testing positive as a rebound after taking Paxlovid. Patient had COVID-19 treatment started on 26-SEP-2022 and last dose was administered on 1-OCT-2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The Device Date was reported as 12Oct2022.
Started with muscle aches and joint pain, headache, and fatigue. On 07/26/2015 developed sore throat, swollen glands in neck, fever of 101.2F, chills, Still had headache, muscle and joint pain.
Neurocardiogenic syncope; On 26AUG2021, a spontaneous report was received from another pharmaceutical company.  On an unknown date, a female patient (age at time of event unknown) experienced "Neurocardiogenic syncope" (PT: Syncope) after receiving BioThrax (anthrax vaccine) on an unknown date. No treatment for the event or outcome was reported.   The patients medical history included gulf war illness, asthma, allergies (unspecified), and Ehlers-Danlos syndrome. She was also being monitored for autoimmune disease. The patient also reported previous history of taking penicillin, doxycycline, clindamycin, Cymbalta, and "higher doses of sertraline."  No additional information with regards to this event was provided.  Company comment:  Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax.  ?; Sender's Comments: Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax.
Chills, fever, excruciating headache but not migraine- it was very different. Nausea and vomiting. Hips hurt, ear pain, needed help getting out of bed, needed help standing, arm pain, fever, which I never get, and no appetite. Unable to move, had to lie absolutely still, couldn't even roll over. That was day 1 after the vaccination. Day 2, it was chills, sore arm, nausea, and shortness of breathe started. Day 3, nausea, occasional stabbing headache- it felt like someone was stabbing my head with an ice pick, arm still hurt, insomnia, and hyper. Day 4, nausea, I was starting to feel better, I could get up by myself, but I had an ear ache and an itching in my ear. I was exhausted, but unable to sleep. By the 15th I could doze during the day but couldn't sleep at night. Still had ear pain. By the 16th left side of forehead hurting along with ear (on left side). 17th contacted doctor, and he prescribed steroids. I started feeling better that night after taking the steroid. On the 21st, I was still exhausted. On the 22nd, felt washed out, tried exercise but it made it worse. On the 23rd, I contacted dr. again, and had to pee every hour at night. On the 26th, Dr. did a blood test, and lab work was all over the place. It was the month from hell. Still have buzzing in my head from first dose. Steroids really helped, though.
This spontaneous report as received from a registered nurse refers to a 14 months old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with VAQTA (lot # J005010, expiry date: 23-OCT-2015)(dose and route of administration were not reported). that was exposed to temperatures out of range (multiple excursion over 24 hour period totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified date, reported as prior to the morning 23-JUN-2014) that were not supported by Merck's stability data. No adverse effects have been reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
I woke up with a horrible migraine and then experienced what felt like hot lava flowing down from my head into neck and both arms.  This unbearable feeling continued for over 9 months.  Migraines have continued as well until this date of reporting.  Only occasionally getting hot lave feeling at this time.
Rash not pruritic on hands and feet; This case was reported by a physician via call center representative and described the occurrence of rash in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 14th April 2022, 2 days after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced rash. On 15th April 2022, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The reporter was a doctor stating that a patient of his got a Kinrix vaccine (not at his clinic) and then 2 days later developed a rash on the soles of her feet and palms of her hands.  The rash was not pruritic and resolved a day later.  The doctor did not have any further information about the vaccine itself or event.  The consent to follow up was granted.
Throbbing headache sore throat,cough lasted couple days,rash started around Sunday evening groin area,butt,thighs,neck,chest.Started self care Saturday,ibuprofen,rest,Sunday started Benadryl,itch creams,cold packs,monistat,made appt.for Thursday 10/28/21 family doc.
Covid + via home test on January 15, 2023.  Had minimal cough, with body aches and fatigue.  No fever or SOB.  By February 1, 2023, began having a more significant cough on/off with relief from OTC Mucinex.  By March 1st, continued to get worse and not relieved with OTC and was affecting my ability to sleep and work effectively by March 16 had to contact urgent care for a RX for Tesselon Perles.
Large red circular hot itchy rash around injection site. Approx 5 inches in diameter
Passed away; This is a spontaneous report from a contactable consumer (patient's sister, caregiver). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunisation. Medical history included the patient was diabetic and had heart surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization in Apr2021. The reporter stated she needed help and the patient (her sister) passed away in Jul2021 and she had the cards that Pfizer got proving and had gotten the shot and they need to find out and get copies of the proof that they all received the Pfizer COVID vaccine. The reporter stated this is the card that Pfizer get signed and they need another copy. The reporter stated the family had been going through her sisters drawers and they can't find it and they were in her wallet but they were not there either. The reporter stated she didn't really need her sisters since she was dead but she needed her sisters daughter withheld and her husband withheld proof that they have been vaccinated and they received the first and second dose of the Pfizer COVID vaccine. The reporter stated her sister did not die right after her first treatment which was in Apr2021 and she just passed away in Jul2021. The reporter stated she knew for a fact that it was not related to the vaccine and did not see the need to be transferred. The patient died in Jul2021.  It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause.; Reported Cause(s) of Death: Passed away
injection site red swollen sore for over 2 days vomited fever 101.7  for 24 hours and after 24 hrs low grade temp and headache 99.4 flu like symptoms, muscle aches and unable to perform normal activities took tylenol and benadryl to alleviate fever  slept for almost 24 hrs
Approximately 30 hours after receiving the first dosage, area around the injection site became sore, a few hours later the same area began to swell. The third day after injection, you could visible see that my muscle was very swollen from the shot and the area was red and sore. By the 5th day, the swelling was not as bad but now my arm has a very large red rash, still tender to touch and it feels itchy, like an allergic reaction. I took Benadryl at night on the 6th day and I woke exactly 4 hour after and my arm felt no better.  I contact the dr.'s office that prescribes my medicines and they said to see a local dr if the red area grows any larger over night. I work at a school and the school nurse said that the  health department didn't want to give me any suggestion except to delay my second dosage.
Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTecg COVID-19 Vaccine EUA Nausea Monday4/12/2021 evening,  Fever and more nausea Tuesday 4/13/2021,  Continued fever and slight nausea, Body aches, Feels like rocks under left armpit Wednesday4/14/2021
After patient arrived back home he reportedly experienced pain at infection site, localized rash, vomiting, and diarrhea. He is not a great historian and it is unclear exactly how long after the injection the symptoms started, or how long they lasted, and he did not seek any medical attention at the time. He showed no signs of adverse reaction while still in clinic on day of injection. He has made a full recovery.
1st shot small side effects. 2nd shot loss of consciousness, seizures, causing inability to speak, form sentences, walk without support. Constant migraines, Dr's said migraine swelling could cause the rest. Never had a migraine before these shots. Oh, 1st shot abnormal periods, 2nd shot permanent period and bled for 6 mo straight. Has to take full time BC to stop that from happening. Dr visits every 2 weeks, a lot of verification. Final conclusion, tick bite complication. Also read a lot about this shot allowing suppressed tick bite complications to re-ignite. Dermatologist finally found tick bite causing alpha-gal after more than a year of incapacitating sickness that caused a 2nd from top of class girl to drop out and become home schooled, because she was either throwing up or light sensitive with the migraines.
pt recvd vax; cellulitis at site rt upper arm;given rocephin inject for tx;
Approximately 2 weeks after my second vaccine, I started experiencing significant eye problems including: chronic redness, swollen eyes, swollen eye lids, sensitivity to light, dry eyes, chronic and constant tearing that does not stop, sensitivity to changes in temperatures, sensitivity to things I don't even understand.  I can just be in a room and my eyes will start tearing uncontrollably. At times, they get mucus like film. Every single day since the second vaccine I wake up with my eyes crusted shut. There is no relief from any eye drops the opthomologists have given me.
2 hours after the flu vaccine was administered my son began getting hives. The hives were all over his body-red, raised,itchy whelps. The hives went away when Aveeno ant-itch cream was administered but new hives cont. to pop-up in different places. The peditrician's office was contacted, they did not associate the hives with the vaccine and told me to give him children's liquid Benadryl. The hives improved with Benadryl but have cont. to reoccur for over 1 week. My son is to see his Pediatrican again in 2 days.
Patient received all 3 vaccines above at an office visit. Approximately 10 minutes after administration patient fainted. Providers laid her flat and she came to roughly 30-45 seconds after start of episode. Patient was a bit disoriented for a few minutes. After this, she felt at her baseline, and left clinic with her family.
Asthmatic reaction; This is a spontaneous report received from a contactable Pharmacist. A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID vaccine approximately 3 months ago and they came down with an asthmatic reaction and based off of that they have not been able to get the second dose until this time. Basically, what the pharmacist was trying to ask was if the patient could get the second dose of the Pfizer COVID vaccine or do they need to get another COVID vaccine from another manufacturer. The outcome of the event was unknown.
First, pain around the injection site; it appeared within a few hours after the injection, but it was bearable.  Then, after about 23 hours after the injection, bad headache (especially around the eyes - which also caused light sensitivity) and general malaise. Shortly thereafter, low-grade fever (99.5 F) and significant muscle pain, all over the body.  The most worrisome side effect was the last one, which appeared during the second night after the injection (about 32-33 hours after the injection): extremely fast heartbeat / racing heart.   I did not use any treatments for these side effects.
Patient vaccinated at 1727 in COVID vaccine clinic, reported feeling like "my throat is closing" at 1739. This RN assessed for airway compromise and took VS (O2 sat: 98%, BP: 122/80 (RUA), RR: 16, HR:75 bpm). Patient observed for 30 min, patient received water and remained seated. No further reports of symptoms/adverse reactions prior to leaving clinic around 1800.
Fever, bad cough. Chills-bleeding when coughing up. Weak, still have weakness when walking.
8FEB92 @ 215PM pt became pale, began screaming, lt thigh became red & hot to touch; mom gave 2nd dose of tempra @ that time; arrived @ office 310PM MD examined pt all VS nl;
Chronic spontaneous urticaria after COVID booster.  I am on two Allegra in the morning and two Zyrtec in the evening.  I also just started Xolair injections 2 times a month.  I have had terrible hives 36 hours after the shot until the present.  I am barely able to function during the day.  AT night I wake up with terrible hives and the process starts over again.  AT times my lips will swell.  The hives can be so bad that it feels like a burn.   I can get them anywhere on my body.  As an example, my lips were swollen yesterday into today.  The swelling is now going away but this morning I woke up with the hives on my feet so that it was difficult to walk.  I am very tired from all the medicine.  With severe breakouts I am allowed an additional Benadryl.
This case was reported by a nurse and described the occurrence of a urinary tract infection in a 49 year old male subject who was vaccinated with hepatitis A vaccine inactivated plus a separate injection of hepatitis B vaccine recombinant for prophylaxis. On 6/2/05, the subject received the first dose of Havrix in the right arm and the first dose of Engerix B in the left arm. On 6/6/05, 4 days after vaccination with Engerix B and Havrix, the subject experienced blood in his urine and was hospitalized. The subject was subsequently diagnosed on 6/6/05 with urinary tract infection. The outcome of the events was not reported.
depression; crying a lot; moods and thoughts are not clear; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), CRYING (crying a lot) and MOOD ALTERED (moods and thoughts are not clear) 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. On an unknown date, the patient experienced DEPRESSION (depression), CRYING (crying a lot) and MOOD ALTERED (moods and thoughts are not clear). At the time of the report, DEPRESSION (depression), CRYING (crying a lot) and MOOD ALTERED (moods and thoughts are not clear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Developed L arm pain at injection site within 1 hour of immunization (9:30 am) Pain radiates down her arm to her fingers and up into her L neck & head. Developed a severe headache that persisted and some nausea despite Ibuprofen 600 mg at time of presentation to Employee Health 12noon.  Was released to return home from work today.
Patient called on 7/13/16 with itching and redness/tenderness at injection site.  On 7/14/16 she was at pharmacy with round, red, blistered rash at injection site area approximately 3 inches in diameter.  She stated area was sore and itchy.  She also had a low grade fever.  She had been to her doctor who had prescribed Cephalexin 500mg and Mupirocin ointment.  On 7/15/16 her doctor prescribed a Methylprednisolone 4mg dose pack.
Couldn't get up to do anything and stayed on the couch; Temp of 99.8 and 99 F; Arm was sore; Really sleepy, slept all night; Chest was tight; Dizzy/Lightheaded; Throat was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was tight) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included GABAPENTIN, SPIRONOLACTONE, DULOXETINE, MELOXICAM, ATORVASTATIN, VERAPAMIL, MULTIVITAMINS [VITAMINS NOS], FOLIC ACID and MAGNESIUM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest was tight) (seriousness criterion medically significant), DIZZINESS (Dizzy/Lightheaded), OROPHARYNGEAL PAIN (Throat was sore) and SOMNOLENCE (Really sleepy, slept all night). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and PYREXIA (Temp of 99.8 and 99 F). On 06-Mar-2021, the patient experienced FATIGUE (Couldn't get up to do anything and stayed on the couch). At the time of the report, CHEST DISCOMFORT (Chest was tight), DIZZINESS (Dizzy/Lightheaded), OROPHARYNGEAL PAIN (Throat was sore), PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Really sleepy, slept all night), PYREXIA (Temp of 99.8 and 99 F) and FATIGUE (Couldn't get up to do anything and stayed on the couch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.8 f (Inconclusive) 99.8 F and 99 f (Inconclusive) 99 F.         Treatment information were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.