chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt very sick; coughing; diarrhea; lost 10 pounds in weight; felt the pain of the injection; nauseated; Fever; COVID-19 Diagnosis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 Diagnosis), MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost 10 pounds in weight) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Multiple sclerosis, Diabetes, Obesity and Drug allergy (Allergic to Sulfa drugs). Concomitant products included VITAMIN D NOS, VITAMIN K NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Diagnosis). On 12-May-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection) and NAUSEA (nauseated). The patient was treated with VITAMIN D NOS at a dose of 20000 unit once a day; ASCORBIC ACID (VITAMIN C ACID) at a dose of 1000 unit once a day; FAMOTIDINE (PEPCID AC) at a dose of 40 mg twice a day; RIVAROXABAN (XARELTO) at a dose of UNK, qd; MELATONIN at a dose of UNK, qd; IVERMECTIN at a dose of UNK, qd and DOXYCYCLINE at a dose of UNK, qd. At the time of the report, COVID-19 (COVID-19 Diagnosis) had not resolved and MALAISE (felt very sick), COUGH (coughing), DIARRHOEA (diarrhea), WEIGHT DECREASED (lost 10 pounds in weight), VACCINATION SITE PAIN (felt the pain of the injection), NAUSEA (nauseated) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, SARS-CoV-2 test: positive positive Positive. On an unknown date, Body temperature: 103.5-104 °f High. On an unknown date, Chest X-ray: abnormal abnormal (abnormal) There was a scar tissue, and it wasn't different from any of her chest x-rays from before. The radiologist thought it could be pneumonia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.
Patient recieved dose more than 12 hours post-puncture; Patient recieved dose more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recieved dose more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Patient recieved dose more than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                             Reporter stated that the vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is 46 degree Fahrenheit to 77 degree Fahrenheit) was a little over 25 hours and 20 minutes before the first dose was administered.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-532656, MOD-2022-532500 (Patient Link).
Information has been received from a consumer concerning her 11 year old daughter with no pertinent medical history or drug reactions who in July 2009, was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported) while she had her menstrual cycle. Concomitant vaccination included meningococcal vaccine (unspecified) (manufacturer unknown) and chickenpox vaccine (manufacturer unknown). It was reported that the patient hadn't had her menstrual cycle since she received her first dose of GARDASIL. Unspecified medical attention was sought. No laboratory diagnostics studies were performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Headache; Hurt; Fever; Nausea; Joint Pain; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced headache, pain in arm, fever, nausea and joint pain. On an unknown date, the outcome of the headache, pain in arm, fever, nausea and joint pain were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, fever, nausea and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received the Shingrix vaccine and the night after receiving the vaccine he began to experience a severe headache, arm hurt, nausea, fever, and joint pain.  These symptoms resolved after 1 to 2 days. The patient gave consent to contact the physician and provided contact details for the same. The case has been linked to the case US2019170041, reported by same reporter. There was discrepancy in the outcome of the events, in the source document outcome was reported as recovered/ resolved with sequel and in the narrative outcome reported as recovered/resolved.
Case number PHEH2013US021674 is an initial spontaneous report from nurse received on 16 OCT 2013 with a follow-up received on 11 NOV 2013. This case refers to a 43-year-old male patient. He received FLUVIRIN 2013/2014 (batch number 13395P, expiry date: Mar 2014), at a dose of 0.5 ml intramuscularly in to the left deltoid on 15 OCT 2013. The nurse stated that the patient received FLUVIRIN from pre filled syringes which were kept at 54 Fahrenheit for 18 hours (temperature excursion). The reporter stated that there was no adverse drug reaction. The patient received influenza vaccine before it was found that the refrigerator had been out of range. Novartis was contacted only to receive information on the potency of the vaccine following the temperature excursion and the disposition of the remainder vaccine.  Follow-up received from the nurse on 11 NOV 2013. Updated patient demographics, site of application of FLUVIRIN and comment from the reporter.
pt recvd vax;muscle started hurting in arm & shoulder,can raise arm half way,hurts when lowered & hand becomes numb feeling,trouble going to sleep at noc due to pain;told MD who referred to hlth district cause recvd vax there;
she is having symptoms. She said she knows the headaches; not feeling good; she got a cold or something; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Dec2022, outcome "unknown", described as "not feeling good"; NASOPHARYNGITIS (non-serious) with onset Dec2022, outcome "unknown", described as "she got a cold or something"; HEADACHE (non-serious) with onset Dec2022, outcome "unknown", described as "she is having symptoms. She said she knows the headaches".  Additional information: She got the boosters, the first booster shot on Tuesday and she was having symptoms. She said she knows the headaches but she was having symptoms like not feeling good like if she got a cold or something. She wants to know if that was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Burning during the injection itself. Arm remained sore. 2 days later, arm very swollen, red, very tender and warm. I had continuous headache, fatigue, unable to work and saw the dr on 8/6/2021
could not walk 5 hours after shot was given. Limped on leg where shot was given. Gave tylenol and was able to walk again after 2 hours. Expected that reaction so I was not concerned. Began vomiting 21 hours after injection. Threw up 4 times in a 2 hour period. Would not eat or drink anything. Took him back to doctor and was told it had nothing to do with the vaccination and to treat it as a stomach flu. Gave fluids and broth in small does. Does not want to eat anything solid. No fever at time of this reporting.
The day after I received the second shot, I woke up with dizzy spells, vertigo, a fever and chills. I could barley walk and I also threw up. I am not throwing up anymore but I am still feeling dizzy and I am having trouble functioning and walking everyday. The vertigo came and went for about four weeks. I am still experiencing these side effects. Please help.
Pt complains of arm pain/loss of mobility. Daily activities are affected such as dressing.
Diarrhea; Disoriented; Chills; Being tired; Headache; Muscle ache; Vomiting; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills) and FATIGUE (Being tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DIARRHOEA (Diarrhea), DISORIENTATION (Disoriented), CHILLS (Chills), FATIGUE (Being tired), HEADACHE (Headache), MYALGIA (Muscle ache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment also included nausea medicine.
a distorted sense of taste and smell; a distorted sense of taste and smell; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 15:00 (Lot number: PE3590) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to mollusks (clams, scallops, abalone)" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 02Nov2021 14:00, outcome "not recovered" and all described as "a distorted sense of taste and smell". The event "a distorted sense of taste and smell" and "a distorted sense of taste and smell" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the within 2 weeks of vaccination. Reported that, approximately 4 days post vaccine patient noticed a distorted sense of taste and smell.  Fresh fruit (apples, plums, grapes) taste rotten. Many foods have a very muted taste or do not taste anything like patient recall. Many things have a chemical-type smell like faint gasoline or did not smell like patient recall. Her favorite candle, body lotion, some foods, some surfaces (such as car leather) smell like very strong chemical. Patient has been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
never got the 2nd shot; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 to 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that his/her patients had a Shingrix 3 to 4 years before the date of reporting but never got the 2nd shot, which led to incomplete course of vaccination. The reporter had not provided further details provided on web form. The reporter consented to follow up. The case has been linked to US2020171344, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020171344:Same reporter
Vomiting & rash p/DTP/HIB/OPV vax; poss allergic rxn to HIB titer;
hemoptysis; chronic obstructive pulmonary disease; respiratory issues; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender (currently about 75 years old). No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: respiratory issues, hemoptysis and chronic obstructive pulmonary disease. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a consumer concerning her 14 year old daughter who on 26-NOV-2007 was vaccinated with a 0.5 ml dose of GARDASIL. Secondary suspect therapy included Varicella virus vaccine live (manufacturer unknown). Concomitant therapy included influenza virus vaccine (unspecified). The patient sought unspecified medical attention. It was reported that "24 to 36 hours after receiving the vaccine" the patient experienced hives and lip swelling. The patient recovered " a couple of days later". Additional information has been requested.
My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the second day. Felt very lethargic, fatigue, laying in bed all day, sleeping. She still had nausea also experienced chills, highest temp 99.8F. Her arm pit on the right side where she got the vaccine was really sore. She basically like within a couple of days she started her period cycle again and it was very heavy and lasted one week and half almost two weeks. On 06-08-2021, at about 10pm, she was brushing her teeth when she saw black spots and she went to tell me. At about 11:30pm that night, she squatted to pat our dog and when she got up and she felt really dizzy, lightheaded so I got concerned. Her symptoms persisted and I scheduled an appointment with her pediatrician on 06-15-2021. The pediatrician ruled out anemia. Her pediatrician said she has Postural orthostatic tachycardia syndrome. Her pediatrician said that this is something manageable, she needs to strengthen her calf muscles and drink lots of water. They monitored her heart pressure and blood pressure.  Her heart rate had increased to 40bpm.  I also gave her Ibuprofen medication after the vaccine. Leading to today she has been having dizziness and light headiness every single day. My daughter is still  experiencing  symptoms, dizzy and light headed today.   For her 1st vaccine- within few days after her 1st dose, she experienced when using the treadmill, she would feel very dizzy. I did not think anything of it at first and this happened three times then it stopped. She also had a sore arm.
36-48 hours after vaccines patient with seizure. Believed secondary to pertussis.   MR received documenting an ER transfer from a local hospital for a 4 month old with possible seizure activity.  Child was feeding and suddenly had bilateral shaking of his upper/lower extremities, and his eyes became fixed for 1-2 minutes.  No cyanosis.  Episode self-resolved.  No further episodes. Child observed, treated with Zantac for probale GER. Discharge DX: Acute Shaking Episode, Possible Sandifer Syndrome.
arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. PZ9112OA) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm is sore). At the time of the report, VACCINATION SITE PAIN (arm is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided.   Treatment information not provided.
Information has been received from a nurse concerning a 14 year old female who on 26-OCT-2009 was vaccinated on the left arm with a "first dose" of GARDASIL (lot# 663451/0216Y) and a dose of VAQTA (MSD) (lot# not reported). On the same day the patient also received a dose of MENACTRA (Sanofi Pasteur), a dose of VARIVAX (MSD) and a dose of influenza virus vaccine (unspecified) (manufacturer unknown) on the right arm. Other concomitant therapy included NASONEX. The nurse reported that on 26-OCT-2009 the patient developed an injection site reaction immediately after receiving all 5 different vaccines but the injection site reaction was just on the left arm of the patient where she received GARDASIL and VAQTA. The nurse noted that the patient did not have injection site reaction on her right arm. The nurse reported that the patient was given "XYZAL" (manufacturer unknown) to treat the injection site reaction. The patient was in the clinic when the adverse event occurred. At the time of the report, the patient's outcome was unknown. Follow-up information was received from the licensed practical nurse concerning the 14 year old female patient, with hypothyroidism who on 26-OCT-2009, at 17:00 hours was vaccinated with the first dose of GARDASIL (lot # 663451/0216Y) intramuscularly into her left arm; the first dose of VAQTA (MSD) (lot #664766/0604Y) intramuscularly into her left arm; the second dose of VARIVAX (Merck) (lot # 664718/0801Y) intramuscularly into her right arm; the first dose of MENACTRA (Sanofi Pasteur) (lot # U2926AA) intramuscularly into her left arm; and the first dose of FLUZONE (Sanofi Pasteur) (lot # U3187AA) intramuscularly into her right arm. The nurse reported that on the same date, at 17:05 hours, the patient experienced a large welt at the injection site with some swelling and that it was warm to touch. On 07-NOV-2009, the patient recovered from the injection site reaction. There were no relevant diagnostic test or laboratory data performed. There was no illness at the time of vaccination. No further information is available.
On June 2, 1999 the pt developed herpes zoster that consisted of a typical rash on right distribution on back along dermatone to mid line. It was toted that no rash occured at the site of injection post vax and the rash did not occur within 42 days of vax. The pt presented to a MD at which time the papular lesions were scanned. Not recently exposed to chickenpox or shingles.
01/08/2022 began having sore throat that went away. 01/10/2022 Sore throat returned. When I picked him up from school his color was very pale, eyes blood shot, very lethargic, and no appetite. On 01/11 went to PCP and tested positive for COVID-19. Was not running fever but was very pale, bloodshot eyes, and lethargic. Was instructed to have him isolate, push fluids, and return if anything worsened. I continued to give him fluids and he continued to be lethargic for 2 days. 01/14 began regain energy, his color began to return, and his appetite was also returning. Returned to PCP on 01/18 for him to be reevaluated and everything was fine.
Symptom onset 12/6/2021, sxs included productive cough, SOB, c/p, and fevers.   received cefepime and decadron.  Was found to be hyperkalemic (most likely 2/2 missed HD), received NaHCO3 and insulin 10U in ED, resolved.  Started her on remdesivir x5 days, montelukast, and zinc.  Next day pt continued to desat and require supplemental O2 more often; started on decadron per COVID 19 txt guidelines.  SOB and coughs improved with cough medications, remdesivir, and decadron; able to tolerate RA, d/c'ed decadron (12/9-12/12), received full five days of remdesivir during admission.  Pt stable by d/c on RA (with intermittent 2L NC for comfort, no hypoxia noted),
One week after flu vaccination, she developed facial rash of both cheeks, associated with burning discomfort and peeling of the skin. Rash occurred on and off for three months. Rash was initially treated with oral steroids during ER visit which initially resolved the rash but then it recurred.