chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient took the 5-day course of Paxlovid. His symptoms cleared after a few days, and he tested negative on a rapid test. Then around 10 days after his initial positive test, he developed symptoms and had been testing positive since 18 May 2022.  Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms cleared and tested negative on rapid test. 10 days after the initial positive test, the patient developed symptoms and tested positive. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days, symptoms cleared and tested negative on rapid test. 10 days after the initial positive test, the patient developed symptoms and tested positive. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Very bad arm pain for 36 hrs. very bad  body aches for 36 hrs very bad joint pain for 36 hrs no energy for 36 hrs *Heart palpitations continuing to date
severe limp lt leg 18DEC92 PM; fever 104.6 R 330PM 19DEC92 & leg swollen;
Intense headache beginning 4/14 around 6pm. Despite rest, hydration, and acetaminophen the headache didn't subside. Headache intensity decreased around 5pm on 4/15
15 YO FEMALE HOSPITALIZED 12/26/07 FOR GUILLAIN-BARRE SYNDROME. PRIOR TO ADMISSION SHE HAD A ONE WEEK HISTORY OF NUMBNESS AND TINGLING TO HER EXTREMITIES WITH PROGRESSIVE WEAKNESS. TREATMENT INCLUDED A PROLONGED PERIOD OF INTUBATION AND VENTALTOR SUPPORT, PLASMAPHERESIS, AND IVIG. SHE WAS TRANSFERRED TO REHABILITATION UNIT 1/17/08 AND REMAINS HOSPITALIZED THERE TO DATE. THEY ANTICIPATE POSSIBLE DISCHARGE TO HOME HIS FRIDAY. PATIENT REMAINS IN A WHEELCHAIR AT THIS POINT AND IS UNABLE TO AMBULATE ON HER OWN. 3/19/08-records received for DOS 12/26/17-01/17/08-DC DX: Guillain-Barre syndrome. Presented with several day history of progressive numbness and tingling and weakness. Symptoms began six days prior to admission with right fifth digit numbness. Four days prior to admission pharyngitis and numbness and tingling in lips. Three days prior to admission increasing generalized weakness. Two days prior to admission increasingly hoarse. Day of admission demonstrated a wide based gait, holding onto wall to walk. Fell in bathtub and was unable to get up. Decreased grip strength. Ten pound weight loss one week prior to admission. Some symptoms of acid reflux and global myalgias, jaw pain, back pain. Pruritic rash on face. Required ICU care, intubation. Intravenous immunoglobulin. PT and OT. NG tube feeding. Bilateral ptosis. Developed tracheitis.  7/07/2008 Neuro consult dated 3/24/2008. pt with hx of axonal GBS, now with episodes of altered consciousness and jerking potentially related to seizure activity vs syncopal events vs pseudoseizures.  Pt d/c 3/14/08 from rehab for GBS dx. C/o fatigue and weakness by 3/22/08 and then had an episode of "being out of it" and passing out with abnormal eye movements. Concern for seizure based on jerking noted. Pt has had/has neurogenic bladder and bowel, neuropathic pain, dysphagia, depression, autonomic instability r/t GBS.  PE (+) for constricted affect, and decreased tone, bulk and strength. Unable to walk-in a w/c. Absent reflexes.
itchy left arm; little hives; swollen upper lip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and METFORMIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form once a day. At the time of the report, PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included a statin and blood pressure medication.
On April 4th (day 6) large itchy  red    rash and swollen - 9 inches long 6 inches wide starting about 1 inch below injection site.
No adverse effects reported.; One patient received improperly stored PROQUAD.; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, historical drugs and allergies were not reported.    On 07-NOV-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous route of administration, lot number S012536 with expiration date 20-OCT-2020 (anatomical location, strength, dose and frequency were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (unspecified if it was stored properly), subcutaneous route of administration, lot number  reported as S018823 with expiration date 04-SEP-2020.   It was reported that the vaccine was exposed to a range temperature of 6 degrees fahrenheit (°F) to 14 degrees (°F) (6.3 degrees °F), with a timeframe of 1 hour and 30 minutes. There was no previous temperature excursion and there was a data logger involved.  No adverse effects and no quality complaint were reported.
Constipation began early evening; Chills and fever began around 8 p.m. same day as the inoculation.
migraine; shooting chest pain; shoulder pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), CHEST PAIN (shooting chest pain), ARTHRALGIA (shoulder pain) and PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MIGRAINE (migraine), CHEST PAIN (shooting chest pain), ARTHRALGIA (shoulder pain) and PAIN IN EXTREMITY (sore arm). At the time of the report, MIGRAINE (migraine), CHEST PAIN (shooting chest pain), ARTHRALGIA (shoulder pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was reported.
about 3 hours after recieving immunizations got a a bright red rash bilateral arms,thighs and chest returned to clinic 6 hours after immunizations and seen by doctor and given RX Benadryl po.
Initial misuse report received from a healthcare professional (nurse) on 20 November 2013 and the case was received on 21 March 2014 at GPV. A 12-year-old patient (gender was not provided) had received a dose of FLUZONE intradermal on an unspecified date. It was reported that FLUZONE Intradermal vaccine had not been administered in patients less than 18 years or more than 65 years age. No adverse event was reported. List of documents held by sender: none.
COVID-19; Diarrhea; Lack of appetite; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Acid reflux (esophageal). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased). At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DECREASED APPETITE (Lack of appetite) and PYREXIA (Body temperature increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101 (High) Body temperature was 101 degree Fahrenheit. On 20-Feb-2021, COVID-19: positive (Positive) Positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. Concomitant products included High blood pressure medication, Hyperlipidemia medication and Acid reflux medication.  Patient was scheduled for second dose of mRNA-1273 on 10-Mar-2021.
Vertigo lasting 30 seconds. Very positional in nature. Left with anxiety and unbalance afterward. Discomfort in neck and upper back.
Overall body itch and rash. Benadryl not helping. Atarax 2 10mg/day not helping. Eucerin Calming Creme not helping.
Patient reported that a few days after the vaccination she noticed injection site irritation. She stated that she can feel a lump form and it has been cause pain in her arm that has not gone away. She has tried pain medication and OTC pain patches.
Information has been received from a Licensed practical Nurse concerning a 44 month old male patient, with no medical history, drug reactions or allergies reported, who on 22-MAY-2001 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck), subcutaneous route in the left upper arm (lot # unknown). There was no concomitant medication. On 23-MAY-2001, the next day following vaccination, the patient experienced pneumonia and was hospitalized. The Licensed practical Nurse reported that the patient was treated with antibiotics. On an unspecified date, a chest x ray was performed with unknown results. The Licensed practical Nurse stated that the patient was released from the hospital on 24-MAY-2001. At the time of the report the patient recovered on an unspecified date. The Licensed practical Nurse stated that the physician decided no to vaccinate the patient with a second dose of VARIVAX (Merck). Additional information has been requested.
Pt began being irritable throughout night w/unconsolable crying next day; this lasted for 3 days until pt was admitted to hosp; pt devel runny nose, congestion, low grade fever, viral illness;
Patient accidently given pfizer covid vaccine instead of fluzone influenza vaccine.  Patient was already completely vaccinated with a booster dose.  Covid doses were given on 03/09/2021, 04/05/2021, and 10/32/2021.  Patient was counseled on the event and the correct medication was given to the patient.
Per Father, she fainted in the classroom. She said she was feeling dizzy. Paramedics were called and transported her to the ER.
In 10/04/03 receive vaccination DTAP #3, HIB #3, IPV #3, Varivax, MMR, Pneumococcal #3, TB test.  the IPV and DTAP was placed left deltoid area.  In 12/03/03, mother inform was drainage pus left deltoid.  Abscess drained spontaneously-received antibiotic, seen next day , no drainage.
severe pain at shot site close to kidney stone level.; skin started pealing in 1" wide patch about 1/2" ofeach eye brow across the center of the forehead.; Patch peal every dayfor a couple of weeks leaving the skin deep dark red.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Feb2021 at 08:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included POTASSIUM CITRATE and ALLOPURINOL, all for an unknown indication from an unknown date and unknown if ongoing. On 19Feb2021 at 09:00, about 25th hour after vaccination, the patient experienced severe pain at shot site which was close to kidney stone level. On an unknown date in Feb2021, a few days after vaccination, the patient experienced skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead. Patch peal every day for a couple of weeks leaving the skin-deep dark red. Pealing subsided and redness was waning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain at shot site close to kidney stone level was resolved on 19Feb2021 at 11:00, after the duration of 2 hours whereas the events skin started pealing in 1" wide patch about 1/2" of each eye brow across the center of the forehead and patch peal every day for a couple of weeks leaving the skin deep dark red was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by 6 inches). Symptoms include runny nose, headache, fever and are ongoing since vaccine. Have not visited healthcare professional yet.
CHILD WAS A WELL BAY. aT 4 MONTHS, SHE RECEIVED HER FIRST SHOT OF DTAP,HIb,Polio and Pneumococcal. She had some crying and fever that evening. The doctor suggested to give some baby tylenol for pain. After that, she had brief episode of limp. She was not able to hold her head  or arms in the normal positions just for 10-20 seconds. She suddenly recovered and started to cry and tired. We had no clue as to why it happened. Then she had an epsiode of flu-like symptoms for which we had to take her to pediatrician's office during the weekend. The Doctor did not find any problems. The eipsode happened a week later, but just briefly again. the doctor was notified. He suggested it to be probably reflux. A barium swallow was performed and a reflux was noticed but was described as within normal pediatric range. At six months, she received a second series of the DTAP. Shortly after that, she had to taking by ambulance to emergency room for a more serious case of limping and acts of "gasping for air" in an effort to breath. A EEG was performed but was read as negative for seizures activities. The frequency has now reached 3-4 a day. We were still told that it could be reflux. I made video recordings of 4-5 episodes to show to the pediatrician. He thought that it could be atonic seizures but did not rule out reflux. She was given the third series of DTAP that same day.  So we went to see a Neurologist. He was not fully convinced that ts was seizures. He deferred any medications until he could do another EEG. A episode occured in the neurologist's office but he was not convinced that it was a seizure. A day after that, the baby had an episode of what seems to a classic seizure with shaking and drooling. We took her to peds office and was put on depakote spr 125 mg. It is three days now and she is still getting the episodes at least once a day. Vaccinations at 4, 6, and 8 months. The frequency increases after each vaccination to a full seizure after the third vaccination in December.
infection; cold; Second Dose: Date 08Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; First Dose: Date 26Feb2021 Lot EN6205), administration date: 26Feb2021, for Covid-19 immunization. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "infection"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second Dose: Date 08Mar2021". Clinical course: The patient was scheduled to get his booster tomorrow and mentioned that he had an infection and cold, and was going to get a Z Pak. He was confused if he should still continue with the shot tomorrow, in other words was it still okay to get the booster.   No follow-up attempts are possible. No further information is expected.
Not sure if related to vaccine but wonder.  After falling on right knee got very nauseous, faint, blurred vision. Felt like having a stroke. Could not respond, incoherent with eyes open.  911 called and took me to er.  Blood pressure extremely low.  Bottom number was around 40.  Don't remember top number.  Heart beat very low as well.  After laying me downand giving fluids in ambulance went back to normal.
Information has been received from a pharmacist referring to a 77 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, in her arm (dose, route and lot# were not reported). Information regarding concomitant medication was not reported. On an unknown date of September 2015 the patient developed a rash on her opposite arm where she vaccinated with ZOSTAVAX. The patient contacted the pharmacist to seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
developed sinus symptoms on 1/11/21, they progressed to coughing and wheezing.  Treated with Prednisone and antibiotics, symptoms improved and returned 3 times over the next 4 months.   Eosinophils raised to 1700 and IgE to 665.  Previously diagnosed with Eosinophilic Esophagitis.  No previous diagnosis of allergies or asthma.  Developed asthma so severe requiring albuterol nebulizers, Flonase, singulair, Symbicort, and could not continue activities of daily living.  Once off steroids symptoms progress approximately 7-10 days off with nasal congestion, coughing and wheezing.
Wheezing & shortness of breath - simultaneous flu administration, but has tolerated this well.
Pain, redness and swelling in right arm since last night. Fever with chills and nausea last night. Pt was administered pneumococcal vaccine in right arm yesterday. Pt is given Diphenhydramine 10 mg po every 6 hours, Motrin and use cold compresses. Advised not to drive.
wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (wasn't feeling good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     The patient's past medical history included Clostridium difficile infection in 2019.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (wasn't feeling good). At the time of the report, FEELING ABNORMAL (wasn't feeling good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned. She wasn't feeling good when her 2nd dose was scheduled, so she didn't go back to get it. She was now ready to get it but doesn't have the phone for the vaccination facility. She states that her daughter in law scheduled the 1st dose for her and will help her reschedule her 2nd dose.
Severe diarrhea and nausea.  Beginning at 2:00 am, and frequent visits to the bathroom approximately every 30 minutes. Bowel movements are completely liquid.
Hearing lost in right ear causing a tinny sounding echo.  Contracted Covid 19 with symptoms presenting on 10/9/22.  Sudden constant ringing in right ear began on  10/11/2022 (at least it masks the tinny echo)
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 18-NOV-2014 the patient received an expired dose of PNEUMOVAX 23 (lot # J004332, expiration date: 26-SEP-2014, route of administration, anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported. Further information was not provided. Product quality complaint (PQC) was not involved. Additional information is not expected because there was no consent for follow-up.
circular swollen area at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27th October 2023) for prophylaxis.   On an unknown date, the patient received Menveo and Boostrix. On an unknown date, less than a month after receiving Menveo and Boostrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Menveo and Boostrix.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments:  The reporter states that the patient received Menveo and Boostrix on the same day then returned a few day later with a circular swollen area at the injection site. The reporter was provided outside phone number for GlaxoSmithKline medical information for future reference and warm transfer provided. The reporter consented to follow up.