chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient has a history of asthma, seasonal allergies who requests causality evaluation for relationship of new onset autoimmune thyroiditis to COVID vaccine receipt. He reports he received Pfizer mRNA 2 doses in January 2021. In July, he was found to have abnormal thyroid function on routine labs and workup demonstrated Auto immune thyroiditis He would like information on possible causality.
Tightness in chest. 5 mins. heat in chest. Extreme swelling in upper arm radiating below elbow to lower arm. Severe swelling and pain in arm. Extreme heat & redness in arm. Prednisone 10mg, cefadroxil 500mg, PRO-AIR HFA, MUCINEX DM.
After receiving Pfizer COVID19 booster, a pain in neck began in approximately 2-3 days. The pain lasted a couple days and then started to get better. A few days went by and the pain increased again.  On January 7th and 8th 2022 the pain became increasingly uncomfortable in the lower back and neck. Patient ended up passing away that evening and the coroner stated it was from a large pulmonary embolism.
day after infection-arm starting itching and swelling- 4 1/2 x 4" wheal over upper arm-right deltoid area where she had 2 injections
Several hours after receiving second injection, I had severe myalgias, headache, fever, and chills. Symptoms lasted about 36 hours.  Took tylenol which helped
hives; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (hives) and PAIN IN EXTREMITY (sore arm). At the time of the report, URTICARIA (hives) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided
Tinnitus - ringing in my left ear and a sound like crickets chirping in my right ear.
Around 4:00 am on 04/08/2021, after receiving the COVID vaccination on 04/07/2021, I developed a cough, shortness of breath, fatigue, fever, chest pains, running nose, chills, and body aches. I took Tylenol and DayQuil, but conditions continued to worsen. On 4/10/2021, I went to Urgent Care. I was given a COVID test, which came back negative, and a prescription for Azithromycin 500 mg tablets. Conditions did not improve, so on 04/12/2021, I visited Dr. with Family and Sports Medicine. I had another negative COVID test. I had a productive cough and fever of 99.2. I was prescribed Amox-Clav 875-125 mg and Predisone 50 mg. I also used my inhaler regularly. Conditions continued to worsen and I returned to Dr. on 04/16/21. X-rays were ordered for a working diagnosis of pneumonia of right middle lobe and I was prescribed Levofloxacin 750 mg and Promethazine with Codeine Syrup.
Complaint of left shoulder pain since immunization with flu vaccine at a flu clinic on 11/05/2001. Hurts at night, more pain with use right over deltoid tendon.
This was the covid Pfizer booster shoot.  I had shot on Sunday around 4:20pm, I was fine not other side effects until Wednesday when I woke up itchy all over and rashes on both inner thighs, on spots on my back and left wrist.  I called Dr for emergency appointment but the didn't have an appointment for at least a month, they told me to go to urgent care.  Went to urgent care they told me they were unsure what my reaction was but treated as an an allergic reaction.  I was given a Benadryl shot and ten days of prednisone pills. I was also told to take zertek.  My itchy did not go away, the rash/ dots on my inner thighs are gone on right leg but left leg they are still there.  I went back to pharmacy explained I now how more itching and unable to get a good night rest she suggested a cream to help sooth but not helping,  since I had the booster I am not feeling comfortable, feels like something is effecting my skin. I was told at urgent care all my vitals are normal and nothing else they can do for me.  I am not in pain just feels like my skin is being poked like bites, when  you are outside and knots are around you trying to eat at your skin.  I was home in my house from the day of the booster shot until the morning this reaction began.
very weak and dizzy; dizzy; extremely dizzy I thought I was going to faint; I thought I was going to pass out; pulse get very low it got so slow; I felt really bad; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150, expiration date: 31Jul2021), via unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included allergies to preservatives, additives, soy, corn starch, anything, even olive oil; immune system was compromised; blood clot. Concomitant medications included warfarin sodium for blood clot. The patient received first dose of Pfizer COVID-19 vaccine and was very weak and dizzy, she got dizzy for 10 minutes and decided to stay there an additional 30 minutes, just sat there and got better, like her pulse got really really low, she felt it in her neck, very slow. Second dose is scheduled for 11May2021. The decision to receive the second dose for any other reason cannot be made. The patient was referred to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Consumer stated she had vaccine first dose yesterday and she asked them for the paper work because she did have allergies 10 years ago and she now realize from reading the list here of the reaction that she did have reaction to the vaccine. The patient stated that the adverse event was not persisting, it was within the first 10 minutes and she stayed there for an hour because she was scared but it went away. Well the reaction she had was that she got extremely dizzy, she thought she was going to faint, that's the reaction she had after the vaccine. She thought she was going to pass out, and she saw her pulse get very low it got so slow. It was not just a quick feeling she felt really bad for 10 minutes. The patient underwent blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
The arm started itching and turning red and then it broken up all over, itches everything; The arm started itching and turning red and then it broken up all over, itches everything; Arm started itching and turning red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.
Right leg pain from foot to hip; He couldn't sleep because of the pain.; He states there's a bump there, but it has gone down some today.; He couldn't stand; He still has pain in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INSOMNIA, VACCINATION SITE MASS, DYSSTASIA, and INJECTION SITE JOINT PAIN in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 027L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY, INSOMNIA, DYSTASIA, and INJECTION SITE JOINT PAIN. 03-Nov-2021, the patient experienced VACCINATION SITE MASS. On 03-Nov-2021, PAIN IN EXTREMITY, INSOMNIA, and VACCINATION SITE MASS had resolved. At the time of the report, DYSTASIA was resolving and INJECTION SITE JOINT PAIN had not resolved.            No concomitant information was reported. No treatment information was reported. Patient date of birth was mentioned like this in source document 20210320 (20-MAR-2021).
7-11-21 - Pt started with cough, fever, body aches and sore throat.  7-14-21 - Pt tested positive for COVID -19 7-14-21 - Pt hospitalized. 7-18-21 - Pt transferred from local hospital to another hospital.
Patient received vaccine at 15:45. Ten minutes later at 15:55 the patient became unresponsive. He was pale sitting in chair and RN went to patient's side. He started experiencing "snorting" respirations which progressed to no breathing for approximately 4-6 secs. Vitals were O2 100% and HR 40. "Code Blue" was called. At 13:56,  patient began to respond, but was still pale/yellow, pupils dilated, clammy, and nauseous. At 13:58 patient became unresponsive, stopped breathing for approximately 4-6 seconds. Vitals were BP 88/60 and HR 40. Patient was lowered to floor with legs raised. Skin still pale/yellow, pupils dilated, and clammy. At 15:39, patient began to respond. He could tell his name and where he was located. Pt assisted to sitting up position. Vitals: HR 48. Pt stated he felt "sleepy and that he felt it was about to happen again." He remained pale/yellow, skin cold and clammy. He was placed in supine position, again, and remained aware. Patient was lifted into stretcher and transported to Emergency Department at 16:05. In ED, patient reported that he had a similar syncopal episode about 4 years ago while accompanying his wife on an OB/GYN visit. Vital signs: HR 58-65, BP 125/69. EKG revealed sinus bradycardia. CT and CXR normal. ED provider's clinical impression was determined to be vasovagal syncope. Patient received 1 L of 0.9% Sodium Chloride  and was discharged home with instructions to follow-up with PCP in 1-2 days.
clammy, faint, weak x 12-15hr;pt has had other immunizations w/o this rxn;
Routine lab work on June 9, 2022, showed that my electrolytes were low: sodium, potassium, and chloride.  Needed to take potassium chloride er 10 meq for 7 days. I will have another blood test on June 22, 2022, to recheck my values. I also noticed while taking off my sock on my left leg that I felt a lump on my lower leg.  I am usure of the exact date that I felt the lump.  I thought I must have just bumped my leg.  However,  the lump became painful, red, and swollen. Then my left lower leg became shiny, swollen, and red thus making me concerned enough to see an orthopedist on June 8, 2022.
Patient complained of some lightheadedness following vaccine administration. Had her wait 10 more minutes. Patient then stated that lightheadedness did not get worse and was somewhat better. She elected to leave. I called her about 2 hrs later - still a little lightheaded. She will contact MD. I also notified MD.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 15-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plaque forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months. There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
-Extreme fatigue day after (11/6) and 2 days after (11/8) -Mild headache 3 days after (11/8) -Severely swollen lymph nodes in left armpit (inflammed, painful to touch, painful to sleep on that side, no impact from pain medication). Symptoms started late 11/5 and are continuing on 11/8 at same severity.
Patient called the pharmacy on the evening (approx 7 pm) of 5/3/12 saying she had some swelling in her cheeks & some lip numbness & she thought it might be an allergic reaction to the shingles vaccine. Went away on its own next morning (5/4/12).
mom reports t100 to 101 until 945PM;when temp inc'd to 103.3 went to ER;Advil given, temp dec to 99.8;inc'd to 104 @ 3AM;more advil given per ER staff;t98.6 this AM 27SEP95;mom states pt did this w/DTP @ age 15mos but was told was virus
Swollen hands, feet, and joints. Initial rash over body has mostly resolved untreated. Swelling comes and goes but has not fully resolved.
Left thigh firm, no redness, no induration, no streaks, no discharge developed 24 hours post immunization administered.
This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose VARIVAX 0,5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
LPN, administered a 0.3 ml Pfizer LOT # FJ8762 dose to a child 8 years of age.
(I also had aggravation of existing neuropathy in left foot day of.) At day 10 after vaccine I had full-body hives.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EN6208), via an unspecified route of administration in left leg on 13Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included mental health, orthopedic, allergies and existing neuropathy in left foot. Concomitant medications included lamotrigine, OTC paracetamol (Tylenol) and Vitamin supplements which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had tested for COVID-19, where the nasal swab test was performed on 03May2021 and the result was obtained as negative. On 23Mar2021, the patient experienced discomfort, mostly gastro and fatigue for nearly three weeks also had aggravation of existing neuropathy in left foot day of. It was also reported on day 10 after vaccine she had full-body hives and it was very unusual for her and there was no other obvious cause. At the time of this report event outcome was recovered, on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
I felt confused and lightheaded / trouble focusing. I felt as though my speech was slightly impaired, not quite slurring, but abnormal. I had some difficulty thinking of the right words to say. My gross motor skills were not affected. This period of AMS lasted for around 2 hours, then cleared on its own. I developed an unusual headache afterwards that lasted into the next morning/ day ( I was at work at the time / 3rd shift). I came home from work and slept for 12 hours.
received an expired second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (strength, dose and route of administration were unknown). The lot numbers were K011085 and L013063 with expiration dates of 08-AUG-2016 and 04-APR-2016 respectively. There were no concomitant therapies nor adverse effects reported. This case is one of two cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician concerning a presently 7 months old patient of unknown gender. On an unknown date in 2012, the patient was vaccinated with an expired dose of ROTATEQ, Oral (lot number, expiry date, dose, route unspecified). It was reported that ROTATEQ, Oral was a month and a half past the expiration date when administered. No concomitant medications were reported. Additional information is not expected.
Ct satates that a couple of hours after taking 1st typhoid pill developed rash on wrists with swelling of one eye.  No difficulty breathing.    After taking 2nd pill rash began to spread, states rash was raised, red itchy.  Also developed joint pain and sore throat.  No hx of allergies per ct.  Currently on no medications with no underlying medical conditions per ct.  Ct. was seen by MD who recommended comfort measures only.  No difficulty breathing per ct. at any time.
Pfizer-BioNTech COVID-19 Vaccine EUA  Initally ater the vacine I experienced soreness and swelling at the site of injection.  7 hours after reciving my first dose of the vaccine I started experiencing numbness in my right arm/hand.  No weakness, just numnbess & altered sensation in the right arm.  Over the next 8 hours I felt the numbness spread to the entire right side of my body, down my leg, up my back, my abdomen, neck, and side of my face.  In the morning I went to the emergnecy department to be evaluated per the reccomendation of employee heath and my PCP.  The checked my labs and they were normal, I recived 1L NS bolus.  I then followed up with my PCP after.
Narrative: Admitted with COVID following complete vaccination with Pfizer vaccine. Patient being treated with Rocephin + Zithromax, Dexamethasone. Remdesivir is on hold at present due to reduced renal function.
Fever, (right) pain warm from injection site to elbow. Weakness in right arm.
Tenivac was shipped on the wrong day and sat out in 100 F heat; temperature strip was green and ice was melted and vaccines minimally cold; Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone.  This case involves a 16 years old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (batch number: U6265AAand expiry date: 19-Apr-2021) via intramuscular route in the left arm on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C (MENINGOCOCCAL A AND C VACCINE) on an unknown date.  It was a case of actual medication error due to product storage error temperature too high because Tenivac was shipped on the wrong day and sat out in 100 F heat.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: none.
Broke out in a profuse sweat while sleeping.; This is spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the right arm on 24Jan2021 at 10:45, (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included moebius syndrome, obesity and allergic to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications vitamins (unspecified) and reported she did not take any other medications except these after the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the right arm on 03Jan2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 Immunisation. The patient took past drug MOTRIN 400 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 26Jan2021 at 14:00, the patient broke out in a profuse sweat two nights later while sleeping. The patient did not have any other adverse events. The patient did not receive any treatment for the event. The clinical outcome of the broke out in a profuse sweat two nights while sleeping was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.