chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day after vaccine on 01/15/2021, I felt nauseous. Later on in the day around 3 PM I started having a burning in stomach, back, and chest. I took over the counter TUMS but it continued to get worse. That evening I started having a runny nose but no fever. Several days after that, I felt burning in chest and lots of pain in my back. The next four days, I had pain in right side, chest pain, back pain, twisting pain. The pain continued until the 01/25/2021, and then on the 01/26/2021 I had this very bright orange urine with red in it. I went to urgent care and they did EEG and urinalysis that came out fine with nothing abnormal. By 01/27/2021 I was fine.
p/vax pt exp rash on face, arms, legs; fever, nausea; pain in leg (muscle contractions) & armpits; itching;
Patient received vaccine and immediately felt dizzy and pain in injection arm, patient was taken via wheelchair to ED
Patient reported that she had a chill, tiredness and sore arm in 3-4 days and after 1 week. She came back and reported that she had an increased blood pressure and blood glucose. Patient had history of hypertension and diabetes type 2 but stop taking medications, to treat these conditions in the past at least 5 years due to weight loss and exercise.
This case was reported by a consumer and described the occurrence of cough with brown phlegm in a male patient who received VENTOLIN hfa-cfc free inhaler for COPD with pulmonary emphysema. A physician or other health care professional has not verified this report. The patient's past medical history included heart attack, high blood pressure, hospitalization, lung disorder, lung pain, problem breathing, recurrent pneumonia, renal pain, rheumatoid arthritis and staphylococcal infection. Concurrent medical conditions included finger osteoarthritis and osteoarthritis of hip. Co-suspect medication included ADVAIR 250/50 mcg. Concurrent medications included lisinopril, prednisone, aspirin and ibuprofen. On 2009 the patient started salbutamol sulphate (inhaled) 2 puffs four times a day as needed and then was recently switched to at 2 puff(s) twice per day. At an unknown time after starting salbutamol sulphate, the patient experienced cough with brown phlegm described as "brown cottage cheese phlegm"), choking sensation, lack of efficacy, and possible dispensing error when he said the previous prescription was 1-2 puff every four hours as need and this inhaler said 2 puffs twice a day. At the time of reporting, the events were worse. The patient was a poor historian and could not remember dates. The patient reported that his most recent VENTOLIN inhaler has instructions to take 2 inhalations in the morning and at night, and that he believes that this was a pharmacy mistake. The patient was previously taking VENTOLIN 1-2 puffs every 4 hours as needed, and has continued to use VENTOLIN as needed. He said that he uses VENTOLIN when he was coughing so that he can cough up phlegm. He said if he takes VENTOLIN while he was not coughing he feels like he was choking . Additional information received in 18 October 2013 from the consumer (patient). Co-suspect medication included influenza vaccine unspecified. In September 2013, the currently 81-year-old male patient received the influenza vaccine unspecified (details unknown). Less than months later (in September 2013 or October 2013), the subject experienced runny nose. At the time of reporting, the runny nose was unresolved. No further detail was provided. Follow-up information was received on 19 December 2013 from the patient via a program. Treatment with fluticasone propionate+salmeterol xinafoate was started on 14 December 2011 for chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient went to the hospital for a twisted foot and fell on his hip. The patient stated he had arthritis and it seemed to flare up. The patient stated he did not think it had anything to do with fluticasone propionate+salmeterol xinafoate or salbutamol sulphate. It was not reported whether the patient was hospitalized. The action taken with fluticasone propionate+salmeterol xinafoate and salbutamol sulphate was not provided. At the time of reporting, the outcome of foot twisted, fell on hip and arthritis flare was unknown.
Patient was admitted to observation level of care on 10-2 with weakness, diarrhea and AKI. Patient is noted to be positive for covid upon testing at admission.
Approximately two weeks post vax, pt experienced varicella lesions on his torso and neck. Pt had approximately 12 lesions.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient did state she's not sure if it's in her head. I called her after a few hours and she said she's totally fine.
Infection in my throat; I have pain in my shoulders, arms and legs; back pain; I have pain in my shoulders, arms and legs; back pain; I have pain in my shoulders, arms and legs; back pain; I have mucus in my chest; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID, 88 mg) taken for thyroid disorder, from an unknown date. It was reported that patient got her vaccine (clarified as Pfizer Covid vaccine) and on 29Apr2021 experiencing some infection in her throat, other than she is okay but she should say she have pain in her shoulders, arms and legs but it's not severe but she do have the side effects from shot it's my back arms and legs but its not severe. It's not severe, she is able to do her work but its very uncomfortable but not severe. Another reason is that she have mucus in her chest, this is first she notice. She got the shot the other day, the day after the shot she have back pain, arm and legs, she can work, she can cook she can do everything but she have pain. She is concerned about the mucus. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt experienced a syncopal episode after she received a FLUMIST and a Hep A (HAVRIX) vaccines. Immunizations given in supine position - syncopal event occurred when pt came to sitting position. Placed back in supine position & observed for 20-25 minutes.
This spontaneous report was received from a office manager and refers to a 12-months-old female patient. On 17-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX (lot number N029631, expiration date 23-OCT-2019) (dose and route of administration were not provided), reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Information has been received from a certified medical assistant concerning a patient who in approximately December 2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  In approximately December 2005, the patient developed a local injection site reaction which was hot to the touch.  Severe erythema was also noted.  Subsequently, the patient recovered.  The physician indicated he was concerned about this lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Initial consumer report received on 20 Jan 2010: The patient was vaccinated with H1N1 influenza A virus vaccine monovalent (manufacturer and batch number unknown) on 11 Dec 2009. The patient was diagnosed with H1N1 infection on 19 Dec 2009. The patient presented with rash on 02 Jan 2010 that developed from the arm pit to the wrist and then spread all over the body. The rash was itchy and red. The events did not recover. Outcome of the event was reported as condition unchanged.
I inadvertently gave child VFC Tdap IM rather than VFC DTaP IM. Injected (R) thigh.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Initial misuse report received on 02 December 2013 from a health care professional. A patient's whose gender, age, medical history and concomitant mediations were not reported, received a dose of FLUZXONE, FLUZONE ID, Tubersol, Pentacef, Anacel, Enactor, IPOL and Acthib (lot  number, route and site of vaccination was not reported) on an unspecified date. It was reported that the temperature was reached 32 F for  (4-8 hours over a month time period. As of 02 December 2013. Patient did not have any adverse events.  List of documents held by sender: none.
Pt came to hospital's vaccine site on 8/6/21, filled out and signed a consent form stating that it was his 1st COVID vaccine dose. Pt got the vaccine, was observed for 15 minutes, and left. No reactions observed.  Staff went to enter the vaccine into the state's database and saw that the pt had previously gotten 2 doses of the Moderna COVID vaccine, the dose given on 8/6/2021 was the patient's 3rd dose.
The redness in my arm has moved down to what seems like a vein; its hard to move my arm without severe pain; My arm hurts; from back of my shoulder all the way down it; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it). At the time of the report, ERYTHEMA (The redness in my arm has moved down to what seems like a vein), MOBILITY DECREASED (its hard to move my arm without severe pain), PAIN IN EXTREMITY (My arm hurts) and ARTHRALGIA (from back of my shoulder all the way down it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
After I got my first shot 2-days later I had a sore throat and and I started gargled with salt and warm water and I drink some hot peppermint tea and I drink a cup of Sambucol Black Elderberry with water daily I do all of this  daily. Now I got my second shot on 2/25/21 and my throat is sore and my sore throat never went away. My sore throat also changed my talking a little bit in the evening and at night. This started like I said right after I got my first vaccine shot the second day and when I got second vaccine shot on 2/25/21 then her comes the sore throat again. But like I said with the first shot on the 2/29/21 my throat got soar.
Patient called to report the area of injection to be red, swollen and painful. She reported a fever of 104 F, with chills and fever. She was advised to take TYLENOL 500mg, place a cool compress on the site and call her doctor if it became worse. She is feeling a little better after 2 days and the area is not as painful. She has not contacted her doctor so we will call her on Fri Aug 3, 2018. She is continuing to take TYLENOL at the recommended dosage on the label.
2 inch raised red area surrounding injection site. Ice and BENADRYL have been utilized. Child able to use (L) arm well no restriction.
I had respiratory issues. I had cough and congestion and the urgent care prescribed me antibiotics.
I woke up in the morning, the site was swollen. It was as big as the palm of my hand. Raised and red. Extremely itchy. Glands in my face and upper neck were swollen. Eyes were swollen. Broke out in hives below my neck into chest. About 20 hives. Raised and oozy. I was told to get in to be seen very soon by a nurse I spoke to.  I went in to the doctors office that afternoon. It was well into April until these symptoms left me. I had no problems with my second shot.
No known adverse event.   Patient went to a clinic owned by a different health system;  obtained her first covid vaccine on 3/11 - - presented to our clinic on 3/25 - and completed registration information indicating she had not had any covid vaccine and was requesting her first covid vaccine.    She then received another dose from us on 4/15/2021 - which she indicated to us was her 2nd dose.
The patient called the pharmacy at 9:50 pm on 10-1-10. She said her left arm was swollen and sore. She noticed it hurting around 4 pm. She said when her boyfriend looked at her arm he thought it was swollen to twice it's size. Called pt 10-4-10. She said she is feeling much better. Swelling went down by 10/2/10 and soreness is almost gone.
vaccine clinic  on 3/18/2021. Moderna vaccination was given.  About 10 minutes after reaction, patient started having tingling to mouth, itching all over, and burning to the back of the throat. Vitals taken at 10:28- pulse ox - 97 percent, 81 pulse, R- 20, BP 130/90. Temp- 98.1; Patient denied SOB or chest pain. Patient has hx of allergies and said Benadryl usually worked. Benadryl  25mg provided to patient  at 10:34 am.  Vitals 10:38- P- 78, Pulse ox 98 percent, BP- 130/80, R- 20;  Tingling around the throat improved, but burning to back of throat and itchy did not improve; At 10:43- Epi pen .3mg provided; Within about 3 minutes patient's symptoms started to improve; Vitals- 10:46- pulse ox 99, pulse 75, BP 132/82;  EMS called; Patient transported to Hospital.  PE- CV- RRR no murmurs Lung - CTA B No swelling noted to lips, tongue, face, extremites No rash/hives noted PATIENT INSTRUCTED NOT TO GET 2ND COVID SHOT AND CARRY EPI PEN WITH HER AT ALL TIMES (pin to top)
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Severe headaches in the right temple, lasting serval hours to 4 days. Imitrex Tylenol, firocet , ice and rest
Patient received vaccination to left arm without difficulty as preparing to leave, patient stated "I'm going to pass out" and sat down. Patient exhibited decerebrate rigidity to all four extremities. She experienced LOC, as well as a loss of bladder control. Regained consciousness  2-2 1/2 minutes later and was confused and unaware of her surroundings. Patient declined f/u treatment at area hospital. (911 called and responded as patient passed out).
Tinnitus, dizziness. Has not gone away after a full week. Have spoken to others with similar stories. They report its not going away.
itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"/itching on her arm /itching was on the caller's neck /spreading to her face and chin; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; lips were itching and swelling; Had allergic reaction to the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age (Age: 60; Unit: Unknown as reported) received first dose bnt162b2 (Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included asthma, diabetes, shellfish allergy. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for asthma. The patient previously took Advair for asthma. On an unspecified date, the patient experienced itching and tingling in her "lips, mouth, and skin" and stated the next day these symptoms transferred to her face and her chin. She reported having no trouble breathing, no weakness, no fast heartbeat, no swelling in the face or throat, and no dizziness. She stated that she spoke with a pharmacist who recommended she take Benadryl so she did for a week, which was how long her symptoms lasted before going away. 10 mins after the vaccine the caller was itching on her arm. The next day the itching was on the caller's neck. And then the next day the caller's lips were itching and swelling, and it was spreading to her face and chin the next couple of days. The caller called her primary care about this but no one was there. The caller then called the pharmacist and the pharmacist told her to get some Benadryl which she took for over a week. Second immunization coming up. Had allergic reaction to the first dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse practitioner concerning a 60 year old female who on 10-JUN-2009 was vaccinated with a dose of VARIVAX (Merck). On 10-JUN-2009 the patient experienced a nosebleed and a skin reaction after vaccination with VARIVAX (Merck). The patient had itchy, erythematous, fluid filled papules: one near left armpit, one next to her left breast, and two on her left thigh near her groin. Nose appeared normal when examined. The patient sought medical attention in the office. At the time of report,  the patient had not recovered from the itchy, erythematous, fluid filled papules. Additional information has been requested.
Within 24 hrs following vaccinations c/o swelling, pain + warmth @ injection site Rt deltoid (MENACTRA).
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician concerning an approximately 19 year old female patient who in March 2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included oral contraceptives. Subsequently, the patient fainted at the check out counter and felt to the floor in the doctor's office and cut her lip on the edge of the counter. It was reported that the patient had to go to the emergency room for treatment of the laceration stitches. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken
severe joint pain, headache, nausea, stomach pains, low grade fever. Treated with appropriate fever lowering agent
Initial Complaint:  Reported feeling hot and fell out of chair, no loss of consciousness  1600  BP 126/78  HR 68   Juice given and granola bar.  Ice pack placed on forehead 1613  BP 118/64  HR 72   Called sister to come pick her up.  Awake and alert.  Small abrasion on forehead, above left eyebrow and by left arm of her glasses.  No bleeding noted 1641  Left, ambulatory.  Discussed s/s concussion and when to seek medical attention She stated she was on a diet and hadn't eaten much that day.  5/10  Call placed/VM left.  At 11:27 AM she text messaged that she has had no further issues.  Did not need to seek medical attention.  Had experienced normal side effects (tired, chill, body aches) but they have resolved.  Stated she appreciated the follow up.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.